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Understanding Clinical Trials

Clinical research: what is it.

Your doctor may have said that you are eligible for a clinical trial, or you may have seen an ad for a clinical research study. What is clinical research, and is it right for you?

Clinical research is the comprehensive study of the safety and effectiveness of the most promising advances in patient care. Clinical research is different than laboratory research. It involves people who volunteer to help us better understand medicine and health. Lab research generally does not involve people — although it helps us learn which new ideas may help people.

Every drug, device, tool, diagnostic test, technique and technology used in medicine today was once tested in volunteers who took part in clinical research studies.

At Johns Hopkins Medicine, we believe that clinical research is key to improve care for people in our community and around the world. Once you understand more about clinical research, you may appreciate why it’s important to participate — for yourself and the community.

What Are the Types of Clinical Research?

There are two main kinds of clinical research:

Observational Studies

Observational studies are studies that aim to identify and analyze patterns in medical data or in biological samples, such as tissue or blood provided by study participants.

Clinical Trials

Clinical trials, which are also called interventional studies, test the safety and effectiveness of medical interventions — such as medications, procedures and tools — in living people.

Clinical research studies need people of every age, health status, race, gender, ethnicity and cultural background to participate. This will increase the chances that scientists and clinicians will develop treatments and procedures that are likely to be safe and work well in all people. Potential volunteers are carefully screened to ensure that they meet all of the requirements for any study before they begin. Most of the reasons people are not included in studies is because of concerns about safety.

Both healthy people and those with diagnosed medical conditions can take part in clinical research. Participation is always completely voluntary, and participants can leave a study at any time for any reason.

“The only way medical advancements can be made is if people volunteer to participate in clinical research. The research participant is just as necessary as the researcher in this partnership to advance health care.” Liz Martinez, Johns Hopkins Medicine Research Participant Advocate

Types of Research Studies

Within the two main kinds of clinical research, there are many types of studies. They vary based on the study goals, participants and other factors.

Biospecimen studies

Healthy volunteer studies.

Clinical trials study the safety and effectiveness of interventions and procedures on people’s health. Interventions may include medications, radiation, foods or behaviors, such as exercise. Usually, the treatments in clinical trials are studied in a laboratory and sometimes in animals before they are studied in humans. The goal of clinical trials is to find new and better ways of preventing, diagnosing and treating disease. They are used to test:

Drugs or medicines

New types of surgery

Medical devices

New ways of using current treatments

New ways of changing health behaviors

New ways to improve quality of life for sick patients

 Goals of Clinical Trials

Because every clinical trial is designed to answer one or more medical questions, different trials have different goals. Those goals include:

Treatment trials

Prevention trials, screening trials, phases of a clinical trial.

In general, a new drug needs to go through a series of four types of clinical trials. This helps researchers show that the medication is safe and effective. As a study moves through each phase, researchers learn more about a medication, including its risks and benefits.

Is the medication safe and what is the right dose?   Phase one trials involve small numbers of participants, often normal volunteers.

Does the new medication work and what are the side effects?   Phase two trials test the treatment or procedure on a larger number of participants. These participants usually have the condition or disease that the treatment is intended to remedy.

Is the new medication more effective than existing treatments?  Phase three trials have even more people enrolled. Some may get a placebo (a substance that has no medical effect) or an already approved treatment, so that the new medication can be compared to that treatment.

Is the new medication effective and safe over the long term?   Phase four happens after the treatment or procedure has been approved. Information about patients who are receiving the treatment is gathered and studied to see if any new information is seen when given to a large number of patients.

“Johns Hopkins has a comprehensive system overseeing research that is audited by the FDA and the Association for Accreditation of Human Research Protection Programs to make certain all research participants voluntarily agreed to join a study and their safety was maximized.” Gail Daumit, M.D., M.H.S., Vice Dean for Clinical Investigation, Johns Hopkins University School of Medicine

Is It Safe to Participate in Clinical Research?

There are several steps in place to protect volunteers who take part in clinical research studies. Clinical Research is regulated by the federal government. In addition, the institutional review board (IRB) and Human Subjects Research Protection Program at each study location have many safeguards built in to each study to protect the safety and privacy of participants.

Clinical researchers are required by law to follow the safety rules outlined by each study's protocol. A protocol is a detailed plan of what researchers will do in during the study.

In the U.S., every study site's IRB — which is made up of both medical experts and members of the general public — must approve all clinical research. IRB members also review plans for all clinical studies. And, they make sure that research participants are protected from as much risk as possible.

Earning Your Trust

This was not always the case. Many people of color are wary of joining clinical research because of previous poor treatment of underrepresented minorities throughout the U.S. This includes medical research performed on enslaved people without their consent, or not giving treatment to Black men who participated in the Tuskegee Study of Untreated Syphilis in the Negro Male. Since the 1970s, numerous regulations have been in place to protect the rights of study participants.

Many clinical research studies are also supervised by a data and safety monitoring committee. This is a group made up of experts in the area being studied. These biomedical professionals regularly monitor clinical studies as they progress. If they discover or suspect any problems with a study, they immediately stop the trial. In addition, Johns Hopkins Medicine’s Research Participant Advocacy Group focuses on improving the experience of people who participate in clinical research.

Clinical research participants with concerns about anything related to the study they are taking part in should contact Johns Hopkins Medicine’s IRB or our Research Participant Advocacy Group .

Learn More About Clinical Research at Johns Hopkins Medicine

For information about clinical trial opportunities at Johns Hopkins Medicine, visit our trials site.

Video Clinical Research for a Healthier Tomorrow: A Family Shares Their Story

Clinical Research for a Healthier Tomorrow: A Family Shares Their Story

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Institute of Medicine (US) Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule; Nass SJ, Levit LA, Gostin LO, editors. Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington (DC): National Academies Press (US); 2009.

Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research.

• Hardcopy Version at National Academies Press

3 The Value, Importance, and Oversight of Health Research

The previous chapter reviewed the value of privacy, while this chapter examines the value and importance of health research. As noted in the introduction to Chapter 2 , the committee views privacy and health research as complementary values. Ideally, society should strive to facilitate both for the benefit of individuals as well as the public.

In addition to defining health research and delineating its value to individuals and society, this chapter provides an overview and historical perspective of federal research regulations that were in place long before the Privacy Rule was implemented. Because a great deal of medical research falls under the purview of multiple federal regulations, it is important to understand how the various rules overlap or diverge. The chapter also explains how the definition of research has become quite complex under the various federal regulations, which make a distinction between research and some closely related health practice activities that also use health data, such as quality improvement initiatives.

The chapter also reviews the available survey data regarding public perceptions of health research and describes the importance of effective communication about health research with patients and the public.

• CONCEPTS AND VALUE OF HEALTH RESEARCH

Definitions

Under both the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Common Rule , “research” is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” This is a broad definition that may include biomedical research, epidemiological studies, 1 and health services research, 2 as well as studies of behavioral, social, and economic factors that affect health.

Perhaps the most familiar form of health research is the clinical trial, in which patients volunteer to participate in studies to test the efficacy and safety of new medical interventions. But an increasingly large portion of health research is now information based. A great deal of research entails the analysis of data and biological samples that were initially collected for diagnostic, treatment, or billing purposes, or that were collected as part of other research projects, and are now being used for new research purposes. This secondary 3 use of data is a common research approach in fields such as epidemiology, health services research, and public health research, and includes analysis of patterns of occurrences, determinants, and natural history of disease; evaluation of health care interventions and services; drug safety surveillance; and some genetic and social studies ( Lowrance, 2002 ; Lowrance and Collins, 2007 ).

The Importance of Health Research

Like privacy, health research has high value to society. It can provide important information about disease trends and risk factors, outcomes of treatment or public health interventions, functional abilities, patterns of care, and health care costs and use. The different approaches to research provide complementary insights. Clinical trials can provide important information about the efficacy and adverse effects of medical interventions by controlling the variables that could impact the results of the study, but feedback from real-world clinical experience is also crucial for comparing and improving the use of drugs, vaccines, medical devices, and diagnostics. For example, Food and Drug Administration (FDA) approval of a drug for a particular indication is based on a series of controlled clinical trials, often with a few hundred to a few thousand patients, but after approval it may be used by millions of people in many different contexts. Therefore, tracking clinical experience with the drug is important for identifying relatively rare adverse effects and for determining the effectiveness in different populations or in various circumstances. It is also vital to record and assess experience in clinical practice in order to develop guidelines for best practices and to ensure high-quality patient care.

Collectively, these forms of health research have led to significant discoveries, the development of new therapies, and a remarkable improvement in health care and public health. 4 Economists have found that medical research can have an enormous impact on human health and longevity, and that the resulting increased productivity of the population contributes greatly to the national economy ( Hatfield et al., 2001 ; Murphy and Topel, 1999 ) in addition to the individual benefits of improved health. If the research enterprise is impeded, or if it is less robust, important societal interests are affected.

The development of Herceptin as a treatment for breast cancer is a prime example of the benefits of research using biological samples and patient records ( Box 3-1 ) ( Slamon et al., 1987 ). Many other examples of findings from medical records research have changed the practice of medicine as well. Such research underlies the estimate that tens of thousands of Americans die each year from medical errors in the hospital, and research has provided valuable information for reducing these medical errors by implementing health information technology, such as e-prescribing ( Bates et al., 1998 ; IOM, 2000b ). This type of research also has documented that disparities in health care and lack of access to care in inner cities and rural areas result in poorer health outcomes ( Mick et al., 1994 ). Furthermore, medical records research has demonstrated that preventive services (e.g., mammography) substantially reduce mortality and morbidity at reasonable costs ( Mandelblatt et al., 2003 ), and has established a causal link between the nursing shortage and patient health outcomes by documenting that patients in hospitals with fewer registered nurses are hospitalized longer and are more likely to suffer complications, such as urinary tract infections and upper gastrointestinal bleeding ( Needleman et al., 2002 ). These findings have all informed and influenced policy decisions at the national level. As the use of electronic medical records increases, the pace of this form of research is accelerating, and the opportunities to generate new knowledge about what works in health care are expanding ( CHSR, 2008 ).

Examples of Important Findings from Medical Database Research. Herceptin and breast cancer: Data were collected from a cohort of more than 9,000 breast cancer patients whose tumor specimens were consecutively received at the University (more...)

Advances in health information technology are enabling a transformation in health research that could facilitate studies that were not feasible in the past, and thus lead to new insights regarding health and disease. As noted by the National Committee on Vital and Health Statistics, “Clinically rich information is now more readily available, in a more structured format, and able to be electronically exchanged throughout the health and health care continuum. As a result, the information can be better used for quality improvement, public health, and research, and can significantly contribute to improvements in health and health care for individuals and populations” ( NCVHS, 2007a ). The informatics grid recently developed with support from the National Cancer Institute (Cancer Biomedical Informatics Grid, or caBIG) is an example of a how information technologies can facilitate health research by enabling broader sharing of health data while still ensuring regulatory compliance and protecting patient privacy ( Box 3-2 ).

caBIG (Cancer Biomedical Informatics Grid). The National Cancer Institute’s caBIG Data Sharing and Intellectual Capital Workspace’s mission is to enable all constituencies in the cancer community—including researchers, physicians, (more...)

Science today is also changing rapidly and becoming more complex, so no single researcher or single site can bring all the expertise to develop and validate medical innovations or to ensure their safety. Thus, efficient sharing of information between institutions has become even more important than in previous eras, when there were fewer new therapies introduced. The expansion of treatment options, as well as the escalating expense of new therapies, mandates greater scrutiny of true effectiveness, 5 once efficacy has been demonstrated. This requires registries of patient characteristics, outcomes, and adverse events. Large populations are required to facilitate comparison of patient populations and to calculate risk/benefit estimates. For example, INTERMACS 6 (Interagency Registry for Mechanically Assisted Circulatory Support) is a national registry for patients who are receiving mechanical circulatory support device therapy to treat advanced heart failure. This registry was devised as a joint effort of the National Heart, Lung and Blood Institute, Centers for Medicare & Medicaid Services, FDA, clinicians, scientists and industry representatives. Analysis of the data collected is expected to facilitate improved patient evaluation and management while aiding in better device development. Registry results are also expected to influence future research and facilitate appropriate regulation and reimbursement of such devices. Similarly, the Extracorporeal Life Support Organization (ELSO), 7 an international consortium of health care professionals and scientists who focus on the development and evaluation of novel therapies for support of failing organ systems, maintains a registry of extracorporeal membrane oxygenation and other novel forms of organ system support. Registry data are used to support clinical practice and research, as well as regulatory agencies. Another example is the database developed by the United Network for Organ Sharing (UNOS) for the collection, storage, analysis and publication of data pertaining to the patient waiting list, organ matching, and transplants. 8 Launched in 1999, this secure Internet-based system contains data regarding every organ donation and transplant event occurring in the United States since 1986.

Information-based research, such as research using health information databases has many advantages (reviewed by Lowrance, 2002 ). It is often faster and less expensive than experimental studies; it can analyze very large sets of data and may detect unexpected phenomena or differences among subpopulations that might not be included in a controlled experimental study; it can often be undertaken when controlled trials are simply not possible for ethical, technical, or other reasons, and it can be used to study effectiveness of a specific test or intervention in clinical practice, rather than just the efficacy as determined by a controlled experimental study. It can also reexamine data accrued in other research studies, such as clinical trials, to answer new questions quickly and inexpensively. However, information-based research does have limitations. Often it has less statistical rigor than controlled clinical studies because it lacks scientific control over the original data collection, quality, and format that prospective experimental research can dictate from the start. In addition to these scientific limitations, because of its relational and often distant physical separation from the data subjects, and the sheer volume of the records involved, obtaining individual consent for the research can be difficult or impossible.

Advances in information-based medical research could also facilitate the movement toward personalized medicine, which will make health research more meaningful to individuals. The goal of personalized medicine is to tailor prevention strategies and treatments to each individual based on his/her genetic composition and health history. In spite of the strides made in improving health through new treatments, it is widely known that most drugs are effective in only a fraction of patients who have the condition for which the drug is indicated. Moreover, a small percentage of patients are likely to have adverse reactions to drugs that are found to be safe for the majority of the population at the recommended dose. Both of these phenomena are due to variability in the patient population. Revolutionary advances in the study of genetics and other markers of health and disease are now making it possible to identify and study these variations, and are leading to more personalized approaches to health care—that is, the ability to give “the appropriate drug, at the appropriate dose, to the appropriate patient, at the appropriate time.” Achieving the goals of personalized medicine will lead to improvements in both the effectiveness and the safety of medical therapies.

Public Perceptions of Health Research

A number of studies have been undertaken to gauge the public’s attitude toward research and the factors that influence individuals’ willingness to participate in research. The surveys reviewed in this chapter focus on interventional clinical trials. A review of survey questions to gauge the public willingness to allow their medical records to be used in research can be found in Chapter 2 .

The Public Values Health Research

A number of studies suggest that most Americans have a positive view of medical research and believe that research is beneficial to society. A recent Harris poll found that nearly 80 percent of respondents were interested in health research findings, consistent with previous survey results ( Westin, 2007 ). A study in 2005 compiled data from 70 state surveys and 18 national surveys and found that the majority of Americans believe maintaining world leadership in health-related research is important. Seventy-eight percent of respondents said that it is very important, and 17 percent said that it is somewhat important. Only 4 percent of Americans reported that maintaining world leadership in health-related research is not impor tant ( Woolley and Propst, 2005 ). Similar results were found in a 2007 survey—76 percent of respondents reported that science plays a very important role in our health, and 78 percent reported that science plays a very important role in our competitiveness ( Research!America, 2007 ).

The Virginia Commonwealth University 2004 Life Sciences Survey also found that most Americans have a positive view of research. In this study, 90 percent of respondents agreed that developments in science have made society better; 92 percent reported that “scientific research is essential for improving the quality of human lives”; and 84 percent agreed that “the benefits of scientific research outweigh the harmful results” ( NSF, 2006 ).

Overall Experience When Participating in Research

Little is known about the attitudes of individuals who have actually participated in medical research. However, the available evidence suggests that most research participants have positive experiences. A recent Harris Poll found that 13 percent of respondents had participated in some form of health research, and 87 percent of those felt comfortable about their experience ( Westin, 2007 ). In a study focused on cancer, 93 percent of respondents who participated in research reported it as a very positive experience; 76 percent said they would recommend participation in a clinical trial to someone with cancer. Most physicians surveyed in this study stated that they believe clinical trial participants receive the best possible care, and have outcomes at least as good as patients receiving standard cancer treatment ( Comis et al., 2000 ). Another study found that 55 percent of individuals who participated in a research study would be willing to participate again in a future research study ( Trauth et al., 2000 ).

Willingness to Participate in Research

Public opinion surveys indicate that a majority of Americans are willing to participate in clinical research studies. In 2001, a compilation of studies commissioned by Research !America found that 63 percent of Americans would be willing to participate in a clinical research study ( Woolley and Propst, 2005 ). This percentage has remained stable over time. A 2007 Research!America survey also found that 63 percent of Americans would be very likely to participate in a clinical research study if asked ( Research!America, 2007 ); 68 percent of respondents reported that their desire to improve their own health or the health of others was a major factor in deciding whether to participate in a clinical research project ( Research!America, 2007 ).

Other surveys also suggest that willingness to participate in research focused on specific diseases is quite high. In one survey, the percentage of respondents indicating a willingness to participate in a medical research study was 88 percent for cancer, 86 percent for heart disease, 83 percent for a noncurable fatal disease, 79 percent for addiction, 78 percent for depression, and 76 percent for schizophrenia ( Trauth et al., 2000 ). Respondents with greater knowledge of how research is conducted were more willing to participate ( Trauth et al., 2000 ). Another study found that 8 of 10 Americans would consider participating in a clinical trial if faced with cancer. More than two-thirds of respondents said they would be willing to participate in a clinical trial designed to prevent cancer ( Comis et al., 2000 ).

Americans also seem to be very supportive of medical research that relies on genetic data. A 2007 survey found that 93 percent of Americans supported the use of genetic testing if the information collected is used by researchers to find new ways to diagnose, prevent, or treat disease ( Genetics & Public Policy Center, 2007 ). Two separate surveys found that 66 percent of Americans would be willing to donate their genetic material for medical research ( Genetics & Public Policy Center, 2007 ; Research!America, 2007 ). However, despite this apparent positive view of genetic research, 92 percent of Americans reported they were concerned about their genetic information being used in a “harmful way” ( Genetics & Public Policy Center, 2007 ).

Many factors, in addition to concerns about privacy and confidentiality ( Genetics & Public Policy Center, 2007 ; Research!America, 2007 ), may influence an individual’s willingness to participate in a medical research study. The Trauth survey found that individuals with higher income levels, with a college or graduate degree, or with children were more likely to participate in research. Age affected willingness to participate: 57 percent of respondents ages 18–34 were willing to participate in research, but only 31 percent of respondents ages 65 or older were willing ( Trauth et al., 2000 ).

Other factors that potentially influence an individual’s willingness to participate in research are race and ethnicity. It is well documented that minorities participate in health research at a much lower percentage than white Americans. Many cultural, linguistic, and socioeconomic barriers could be responsible for this difference ( Giuliano et al., 2000 ), and study results have been variable on this issue. Several studies suggest that the low participation rates by racial and ethnic minority groups are due to their strong distrust of the medical research community compared to the general population ( Braunstein et al., 2008 ; Corbie-Smith et al., 1999 ; Farmer et al., 2007 ; Grady et al., 2006 ; Shavers et al., 2002 ).

However, other evidence suggests that the low percentage of minorities participating in research is related to minority groups’ lack of access to the research community ( Brown et al., 2000 ; Wendler et al., 2006 ; Williams and Corbie-Smith, 2006 ). Thus, it is likely that the low number of minority individuals participating in medical research is at least partly due to recruitment techniques that are ineffective for minority populations.

The survey that focused on cancer research suggests that one of the main reasons why individuals do not participate in research is lack of knowledge about the availability of clinical trials. In a survey of nearly 6,000 cancer patients, 85 percent said they were unaware of the opportunity to participate in a clinical trial. Respondents who did participate said they did so because of one of the following beliefs: (1) trials provide access to the best quality of care (76 percent), (2) their participation would benefit future cancer patients (72 percent), (3) they would receive newer and better treatment (63 percent), and (4) participation would get them more care and attention (40 percent) ( Comis et al., 2000 ).

A recommendation from a physician can also impact participation. In the United States, 48 percent of respondents to one survey reported that a physicians’ recommendation would be a major factor in deciding whether to take part in a research study. Nearly three-fourths of respondents also cited an institution’s reputation as a key factor to consider when deciding whether to participate in a study ( Research!America, 2007 ). Twenty percent of respondents in an Italian public survey indicated that the presence of a physician as a reference during a research study influenced their willingness to participate ( Mosconi et al., 2005 ).

In sum, surveys indicate that the vast majority of Americans have a positive view of medical research, believe that research is beneficial to society, and are interested in health research findings. Although little is known about the attitudes of individuals who have actually participated in medical research, the available evidence suggests that most research participants have positive experiences. Surveys also suggest that a majority of Americans are willing to participate in clinical research studies. Similar to the findings in Chapter 2 , surveys indicate that many factors, in addition to concerns about privacy and confidentiality, can potentially influence an individual’s willingness to participate in medical research, including the type of research and personal characteristics such as health status, age, education, and race. Notably, respondents with greater knowledge of how research is conducted were more willing to participate in research.

• OVERSIGHT OF HEALTH RESEARCH

Historical Development of Federal Protections of Health Information in Research

The development of international codes, federal legislation, and federal regulation of human subjects often occurred in response to past abuses in biomedical experiments (reviewed by Pritts, 2008 ) ( Box 3-3 ). The most well-known examples included (1) reported abuses of concentration camp prisoners in Nazi experiments during World War II, and (2) the Tuskegee syphilis study begun in 1932, in which researchers withheld effective treatment from affected African American men long after a cure for syphilis was found. Most of the current principles and standards for conducting human subjects research were developed primarily to protect against the physical and mental harms that can result from these types of biomedical experiments. Therefore, they focus on the principles of autonomy and consent. Although the standards apply to research that uses identifiable health information, research based solely on information is not their primary focus.

The Basis for Human Subjects Protections in Biomedical Research. Nuremberg Code The Nuremberg Code, created by the international community after the Nazi War Crimes Trials, is generally seen as the first codification (more...)

In the United States, perhaps the most influential inquiry into the protection of human subjects in research was the Belmont Report. The Belmont principles have been elaborated on in many settings, and served as the basis for formal regulation of human subjects research in the United States. In general, states do not directly regulate the activity of most researchers ( Burris et al., 2003 ). However, the Belmont Commission’s recommendations were reflected in the Department of Health and Human Services’ (HHS’s) Policy for Protection of Human Subjects Research , Subpart A of 45 C.F.R. 46 (“Subpart A”) in 1979. 9 These protections were considered a benchmark policy for federal agencies, and in December 1981, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended 10 that all federal departments and agencies adopt the HHS regulations. 11

In 1982, the President’s Office of Science and Technology Policy appointed a Committee for the Protection of Human Research Subjects to respond to the recommendations of the President’s commission. The committee agreed that uniformity of federal regulations on human subjects protection is desirable to eliminate unnecessary regulations and to promote increased understanding by institutions that conduct federally supported or regulated research. As a result, in 1991, other federal departments and agencies joined HHS in adopting a uniform set of rules for the protection of human subjects of research, identical to Subpart A of 45 C.F.R. 46, which is now informally known as the “ Common Rule .” Eighteen federal agencies have now adopted the Common Rule as their own respective regulations.

Overview of the Common Rule

The Common Rule governs most federally funded research conducted on human beings and aims to ensure that the rights of human subjects are protected during the course of a research project. The Common Rule stresses the importance of individual autonomy and consent; requires independent review of research by an Institutional Review Board (IRB); and seeks to minimize physical and mental harm. Privacy and confidentiality protections, although not defined in a detailed and prescriptive manner, are included as important components of risk in research.

The framework for achieving the goal of protecting human subjects is based on two foundational requirements: the informed consent of the research participant and the review of proposed research by an IRB. This section describes some of the basic parameters of the Common Rule (reviewed by Pritts, 2008 ). Particular provisions that interact with the HIPAA Privacy Rule are described in more detail in Chapter 4 .

Scope of the Common Rule

In general, the Common Rule applies only to research on human subjects that is supported by the federal government. 12 As noted previously, research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” 13

Under the Common Rule , a “human subject” is defined as “a living individual about whom an investigator … conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.” Private information is considered to be personally identifiable if the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

The Common Rule applies to most human subjects research conducted using federal funds, but its influence is broader because most institutions that accept federal funds sign an agreement (a Federalwide Assurance or FWA) with HHS to abide by the Common Rule requirements in all research, regardless of funding source. Nonetheless, some privately funded human subjects research is conducted outside the purview of federal regulation ( Goldman and Choy, 2001 ; Williams, 2005 ). Companies and other organizations may voluntarily choose to apply the Common Rule to their research projects, and many do. However, research projects in which compliance is voluntary are not subject to oversight or disciplinary action by HHS ( Goldman and Choy, 2001 ; Williams, 2005 ).

Informed Consent 14

The Common Rule requires that a researcher obtain informed consent (usually in writing) from a person before he/she can be admitted to a study ( Williams, 2005 ). Informed consent is sought through a process in which a person learns key facts about a research study, including the potential risks and benefits, so that he/she can then agree voluntarily to take part or decide against it.

The Common Rule informed consent regulations focus primarily on the elements and documentation of informed consent rather than on the process used to obtain it. As to the process, the regulations require that informed consent be sought only under circumstances that provide the prospective subject with adequate opportunity to consider whether to participate. The Common Rule requires that information pertaining to informed consent be given in language understandable to the subject, and that the consent does not imply that the subject is giving up his/her legal rights or that the investigator is released from liability for negligence during the conduct of the study. 15

The Common Rule also specifies a number of elements that must be provided when informed consent is sought. These elements include:

• an explanation of the purposes of the research,
• the expected duration of the subject’s participation,
• the potential risks and benefits of the research,
• how confidentiality will be maintained,
• the fact that participation is strictly voluntary, and
• who the subject can contact to answer questions about the study or about his/her rights as a research participant.

In certain limited circumstances, the Common Rule allows an informed consent to be for unspecified future research. For example, under the Common Rule an informed consent can be used to obtain a person’s permission to study personally identifiable information maintained in a repository for future, unspecified research purposes ( HHS, 2003 ).

For the most part, the required elements of an informed consent address all types of research, although some are more relevant to biomedical research (e.g., the consent must include a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject). One required element of informed consent is particularly relevant to research involving personally identifiable health information. The Common Rule requires an informed consent to include a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. 16

Institutional Review Boards

Adopting the principles of the Belmont Report, the Common Rule requires that protocols for human subjects research be reviewed by an IRB ( Box 3-4 ) before research may begin. 17 The IRB must meet certain membership requirements, including having members with different expertise and at least one member who is not affiliated with the investigator’s institution. The Common Rule specifies which level of IRB review is needed for various types of research and provides criteria for the IRB to consider during the review. Although the Common Rule does not specify the procedures an IRB must follow in its review of protocols, it does require the IRB to have written procedures for how it will review protocols and document IRB decisions.

Institutional Review Boards. According to the Department of Health and Human Services (HHS) Institutional Review Board (IRB) guidebook, “the IRB is an administrative body established to protect the rights and welfare of human research subjects (more...)

The Common Rule requires that an IRB determine the following factors are satisfied to approve proposed research:

• Risks to subjects are minimized;
• Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result;
• The selection of subjects is equitable;
• Informed consent will be sought in accordance with the rules and will be documented;
• When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects; and
• When appropriate, adequate provisions are in place to protect the privacy of subjects and to maintain the confidentiality of data. 18

An IRB may waive the requirement to obtain informed consent or approve an alteration of the consent form for some minimal risk research. The IRB may also waive the requirement for signed consent in certain circumstances. 19

Anonymized Data

As noted above, the Common Rule considers use of “private identifiable information” to be human subjects research. Data are considered personally identifiable if the identity of the subject is or may be readily ascertained by the investigator or associated with the information accessed by the researcher. 20 However, the Common Rule exempts from its requirements research that involves:

[T]he collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. 21

Otherwise identifiable data may be deidentified or “anonymized” for purposes of the Common Rule if it is coded and certain other conditions are met ( HHS, 2004 ). Under Guidance issued by the Office for Human Research Protection, information is “coded” if identifying information (such as name or Social Security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (the code), and a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimen.

Research involving only coded private information or specimens is not considered to involve human subjects under the Common Rule if the following conditions are met:

• The private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; and
• —The key to decipher the code is destroyed before the research begins;
• —The investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased;
• —IRB-approved written policies and operating procedures for a repository or data management center prohibit the release of the key to investigators under any circumstances, until the individuals are deceased; or
• —Other legal requirements prohibit the release of the key to the investigators, until the individuals are deceased.

Under this standard, when a researcher accesses or receives data that have been coded and does not have access to the identifying key, the research is not considered human subjects research and is not subject to the Common Rule ’s requirements of informed consent or IRB review and approval of protocol.

Enforcement of the Common Rule

The Common Rule requirements for informed consent do not preempt any applicable federal, state, or local laws that require additional information to be disclosed to a subject in order for informed consent to be legally effective. 22

Federal funding can be suspended or withdrawn from an institution when it is found to be in material violation of the Common Rule . 23 There is no authority to impose penalties directly on individual researchers for violations. Neither does the Common Rule expressly provide a research participant with a private right of action. It should be noted, however, that recent cases indicate that courts may be willing to hold an institution liable under common law negligence theories where the approved informed consent form is determined to be less than adequate ( Shaul et al., 2005 ). 24

FDA Protection of Human Research Subjects

Some health research is also subject to FDA regulations. The FDA is charged by statute with ensuring the protection of the rights, safety, and welfare of human subjects who participate in clinical investigations 25 involving articles subject to the Federal Food, Drug, and Cosmetic Act 26 (the Act), as well as clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including drugs, medical devices, and biological products for human use ( Box 3-5 ).

FDA Protection of Human Subjects Regulations. The Food and Drug Administration (FDA) Protection of Human Subjects Regulations aim to protect the rights of human subjects enrolled in research involving products that the FDA regulates (i.e., drugs, medical (more...)

In January 1981, the FDA adopted regulations governing informed consent of human subjects 27 and regulations establishing standards for the composition, operation, and responsibilities of IRBs that review clinical investigations involving human subjects. 28 At the same time, HHS adopted the Common Rule regulations on the protection of human research subjects. 29 The FDA’s regulations were harmonized with the Common Rule in 1991 to the extent permitted by statute. Key differences between FDA and HHS regulations include that the FDA does not allow for waiver or alteration of informed consent and requires that subjects be informed that the FDA may inspect their medical records. In addition, studies of efficacy based solely on medical records research are not permitted to support registration. Remaining differences in the rules are due to differences in the statutory scope or requirements ( Lee, 2000 ).

• DISTINGUISHING HEALTH RESEARCH FROM PRACTICE

The Common Rule and Privacy Rule make a somewhat artificial distinction between health research and some closely related health care practices, such as public health practice, quality improvement activities, program evaluations, 30 and utilization reviews, 31 all of which may involve collection and analysis of personally identifiable health information. However, determining which activities meet the definition of “research” is a major challenge for IRBs, Privacy Boards , 32 investigators, and health care practitioners because neither the regulations nor their interpretations by HHS provide clear guidance on how to distinguish research from activities that use similar techniques to analyze health information ( IOM, 2000a ).

It is important for IRBs and Privacy Boards to correctly distinguish among activities that are or are not subject to the various provisions of the Privacy Rule and the Common Rule . Only research requires formal IRB or Privacy Board review and informed consent. 33 Inappropriate classification of an activity as research can make it difficult or impossible for important health care activities, such as public health practice and quality improvement, to be undertaken. On the other hand, failure to correctly identify an activity as research could potentially allow improper disclosure of personally identifiable health information without sufficient oversight.

Thus, standard criteria are urgently needed for IRBs and Privacy Boards to use when making distinctions between health research and related activities, and the committee recommends that HHS consult with relevant stake holders to develop such standard criteria. HHS is aware of this need, and created a working document titled “What Is Research ?” However, the work on this project apparently has been delayed for unknown reasons ( NCURA, 2007 ). 34 As described below, a number of other models have already been proposed to help determine whether activities should be classified as research in the fields of public health and quality improvement, and these could be instructive for developing HHS guidance. Any criteria adopted by HHS should be regularly evaluated to ensure that they are helpful and producing the desired outcomes.

The following sections describe some ongoing efforts to develop such criteria in the fields of public health and quality improvement. The intent of the committee is not to endorse these particular models, but rather to illustrate the challenges associated with making these distinctions and establishing standard criteria.

Public Health Practice Versus Public Health Research

The Belmont Report defined health practice as “interventions designed solely to enhance the well-being of the person, patient or client, and which have reasonable expectation of success” ( CDC, 1999 ). To apply this definition to “public” health practice, the targeted beneficiary of the intervention must be expanded to include benefit to the community, rather than just a particular person. Neither the Common Rule nor the Privacy Rule provides a specific definition for public health research; rather public health research is included in the general definition of research. However, the Privacy Rule regulates public health practice differently from public health research (see Chapter 4 ).

An early model for distinguishing public health research from public health practice focused on the intent for which the activity was designed, noting that the intent of public health research is to “contribute to or generate generalizable knowledge,” while the intent of public health practice is to “conduct programs to prevent disease and injury and improve the health of communities” ( Snider and Stroup, 1997 ). The Centers for Disease Control and Prevention developed a similar method with an expanded assessment of intent. For example, the model posits that in public health research, the intended benefits of the project extend beyond the study participants, and the data collected exceed the requirements for the care of the study participants. But for public health practice, the intended benefits of the project are primarily for the participants in the activity, or for the participants’ community, and the only data collected are those needed to assess or improve a public health program or service, or the health of the participants and their community. The model also assumes that public health practice is based on well-established medical interventions and is nonexperimental ( CDC, 1999 ). However, these models both have been criticized as too subjective and too dependent on the opinion of the person conducting the activity ( Gostin, 2008 ; Hodge, 2005 ).

A new, more comprehensive model incorporating much of the previous two was recently proposed as a more objective checklist to be used by IRBs, Privacy Boards , and interested parties ( Hodge, 2005 ; Hodge and Gostin, 2004 ). The foundations for this model are specific definitions of public health research: “the collection and analysis of identifiable health data by a public health authority for the purpose of generating knowledge that will benefit those beyond the participating community who bear the risks of participation,” and public health practice: “the collection and analysis of identifiable health data by a public health authority for the purpose of protecting the health of a particular community, where the benefits and risks are primarily designed to accrue to the participating community.”

The model is based on two primary assumptions. First, the actor performing the activity in question is a governmental public health official, agent, agency, or entity at the federal, tribal, state, or local level. Second, the activity in question involves the acquisition, use, or disclosure of personally identifiable health data. The model is then divided into two stages. Stage 1 is applied to all activities, and can be used to distinguish practice from research in the easiest cases. Stage 2 is only applied to those cases that are hard to distinguish, and where Stage 1 failed to lead to a definitive IRB/ Privacy Board decision ( Box 3-6 ).

A Model for Distinguishing Public Health Practice from Research. Stage 1 Public health practice:

Quality Improvement Versus Health Research

Quality improvement has been defined as “systematic, data-guided activities designed to bring about immediate, positive change in the delivery of health care in a particular setting” ( Baily, 2008 ). Quality improvement activities do not require IRB or Privacy Board approval under the Common Rule or the Privacy Rule, which classify quality improvement as a component of health care operations. 35

However, in many cases, it is difficult for health care providers, IRBs, and Privacy Boards to determine whether a particular activity is purely for quality improvement, or whether it also entails research. One survey 36 exploring opinions in the health care community about the need for IRBs to review various quality-related activities found that physicians conducting quality improvement were less likely than IRB chairs to believe that IRB review was required for a given hypothetical activity, or that informed consent was necessary ( Lindenauer et al., 2002 ). Recently, a highly publicized case has again brought the issue to the forefront for all the stakeholders ( Box 3-7 ).

A Case Study of Quality Improvement and Research. Peter Pronovost of Johns Hopkins University (JHU) led a quality improvement effort at 103 intensive care units (ICUs) in Michigan hospitals to reduce the number of catheter-related bloodstream infections. (more...)

Some members of the health care community have proposed requiring that all prospective quality improvement activities go through external review ( Bellin and Dubler, 2001 ), while others have outlined specific criteria to differentiate quality improvement activities from research.

For example, Casarett and colleagues developed a two-part test to identify quality improvement activities. The first test is whether the majority of patients are expected to benefit directly from “the knowledge to be gained” from the initiative. This means that the patients must actually benefit from the knowledge learned during the evaluation, not just from being a recipient of the protocol itself. If the patients are generally expected to directly benefit from the knowledge gained during the activity, then the activity is quality improvement. If not, the activity is research. The second test is whether the participants would be subjected to additional risks or burdens, including the risk of privacy breach, beyond the usual clinical practice in order to make the results of the initiative generalizable. If yes, then the initiative should be reviewed as research ( Casarett et al., 2000 ).

More recently, the Hastings Center published a report exploring the similarities and differences between research and quality improvement. The report emphasized three fundamental characteristics of quality improvement and three fundamental characteristics of research. The authors argue that individuals have a responsibility to participate in the quality improvement activities because all patients have an interest in receiving high-quality medical care, and the success of a quality improvement activity depends on the cooperation of all patients. In addition, the report notes that quality improvement activities are a low risk to the patient, so there is little justification for not participating. The report also assumes that quality improvement activities are based on existing knowledge about human health and should lead to immediate local improvements in the provision of medical care.

In contrast, the report notes that participation in research should be voluntary, and decisions to participate should be based on researchers’ full disclosure of all the potential risks and benefits. In addition, the authors assert that research is designed to create new knowledge about human health, rather than relying solely on existing knowledge, and that most research does not result in any direct benefit to the institution where the research is being conducted.

The authors concluded that IRBs are not the appropriate body for the ethical oversight of quality improvement activities. They argue that IRBs unnecessarily impose high transaction costs on these activities because of the difference in the way they are conducted compared to research. For example, in research, any changes in methodology require further IRB approval. In contrast, quality improvement activities involve frequent adjustments in the intervention, measurement, and goals of the activity based on the experience of the investigators. Requiring the investigator to revisit an IRB every time a small adjustment is needed in such an activity significantly increases the amount of time and effort required to conduct the initiative and to produce meaningful data. Also, the investigators involved in quality improvement activities ordinarily are already involved in the clinical care of participants and bear responsibility for the quality and safety of an intervention. Thus, the authors argue that there is no need for the additional oversight by an IRB to protect participant safety.

Rather, the report recommended integrating the ethical oversight of quality improvement activities into the ongoing management of an institution’s health care delivery system, suggesting that oversight of quality improvement could be left with the managers of clinical care organizations, and that consent to receive treatment should include consent to participate in any quality improvement project that is minimal risk. However, the report stated that if a project has the characteristics of both quality improvement and research, the project should be reviewed as both human subjects research and quality improvement ( Baily et al., 2006 ; Lynn et al., 2007 ).

In response to the ongoing confusion over when quality improvement rises to the level of research and requires IRB review, the IOM jointly hosted a meeting with the American Board of Internal Medicine in May 2008 to discuss this issue. Key members of the quality improvement community attended, and short- and long-term solutions to this problem were proposed. However, no written report from this meeting was produced and no general consensus was reached.

• THE IMPORTANCE OF EFFECTIVE COMMUNICATION WITH THE PUBLIC

As noted previously in this chapter, surveys indicate that the vast majority of Americans believe that health research is important and are interested in the findings of research studies. The majority of patients also appear to be willing to participate in health research, either by volunteering for a study to test a medical intervention or by allowing access to their medical records or stored biospecimens, under certain conditions. Their willingness to participate depends on trust in researchers to safeguard the rights and well-being of patients, including assurance of privacy and confidentiality, and the belief that it is a worthwhile endeavor that warrants their involvement. Yet patients often lack information about how research is conducted, and are rarely informed about research results that may have a direct impact on their health. The committee’s recommendations in this section are intended to address both the public’s desire for more information about health research and to help fulfill two of the committees overarching goals of the report: (1) improving the privacy and security of health information, and (2) improving the effectiveness of health research.

Disseminating Health Research Results

Ethicists have long suggested greater community involvement in health research studies, including more communication about research results (reviewed by Shalowitz and Miller, 2008a , b ). In addition, the IOM committee identified transparency—the responsibility to disclose clearly how and why personally identifiable information is being collected—as an important component of comprehensive privacy protections. A previous IOM report also recommended improved communication with the public and research participants to ensure that the protection process is open and accessible to all interested parties ( IOM, 2002 ). Effective communication would build the public’s trust of the research community and is consistent with the principles of fair information practices.

When patients consent to the use of their medical records in a particular study, health researchers should make greater efforts at the conclusion of the study to inform study participants about the results, and the relevance and importance of those results. Learning about clinically relevant findings from a study in which a patient has participated could make patients feel more integrated into the process and could encourage more to participate in future studies. A recent United Kingdom report on the use of personal data in health research concluded that public involvement in research is necessary for the success of information-based research, and that a public informed about the value of research is likely to have greater enthusiasm and confidence in research and the research community ( AMS, 2006 ). Moreover, direct feedback with study participants could lead to improved health care for the individuals if the results indicate that an altered course of care is warranted.

Nonetheless, there are multiple impediments, beyond cost, to providing meaningful feedback to participants. A summary of the results alone, while necessary and reasonable, can be seen as a token, and also raises questions about issues such as how best to write summaries, the stage at which results should be disseminated, and how to present research with uninformative outcomes. For example, one recent study found that sharing results directly with study participants was met with overwhelmingly favorable reactions from patients, but the study also revealed some obstacles ( Partridge et al., 2008 ). In a survey of women who had participated in a randomized trial of breast cancer therapy and had received a summary of the study results by mail, 95 percent reported that they were glad they received the results. Most respondents interpreted the results correctly, although incorrect interpretation of the results was associated with increased anxiety, as was dissatisfaction with treatment.

Although some guidelines for providing and explaining study results to research participants have been proposed, they differ in details because limited data are available on this subject, and thus standards are lacking ( Partridge and Winer, 2002 ; Partridge et al., 2008 ; Shalowitz and Miller, 2008b ; Zarin and Tse, 2008 ). Because transparency is best achieved by providing graded levels of information and guidance to interested parties ( IOM, 2002 ), it will be important to develop effective and efficient ways to communicate with various sectors of the population. A commitment to the principles of “plain language” 37 will be important. Broader adoption of electronic medical records may also be helpful in accomplishing this goal.

Research Registries

One way to make information about research studies more broadly available to the public is through registration of trials and other studies in public databases. HHS should encourage such registration of trials and other studies, particularly when research is conducted with an IRB/ Privacy Board approved waiver of consent or authorization (see Chapter 4 ). Numerous clinical trial registries already exist, and registration has increased in recent years (reviewed by Zarin and Tse, 2008 ). In 2000, the National Library of Medicine established a clinical trials registry ( ClinicalTrials.gov ), which has expanded to include information from several other trial registries and to serve as the FDA-required site for submissions about clinical trials subject to the FDA databank requirement. The FDA Amendments Act of 2007 38 expanded the scope of required registrations at ClinicalTrials.gov and provided the first federally funded trials results database. It mandates registrations of controlled clinical investigations, except for Phase I trials, of drugs, biologics, and devices subject to FDA regulation.

A policy of the International Committee of Medical Journal Editors (ICMJE), adopted in fall 2005, also requires prospective trial registration as a precondition for publication ( DeAngelis et al., 2004 ). This policy led to a 73 percent increase in trial registrations of all intervention types from around the world ( Zarin et al., 2005 ). Nearly 45,000 trials had been registered by fall 2007.

However, although the development of such registries is an important first step toward providing high-quality clinical trial information to the public, no centralized system currently exists to disseminate information about clinical trials of drugs or other interventions, making it difficult for consumers and their health care providers to identify ongoing studies. The current statutory requirements for registration and data reporting in the United States are not as broad as the transnational policies of the ICMJE or the World Health Organization, which call for the registration of all interventional studies in human beings regardless of intervention type ( Laine et al., 2007 ; Sim et al., 2006 ). Moreover, noninterventional studies, such as observational studies that play an increasingly critical role in biomedical research, are not generally included in these databases. Because many noninterventional studies are conducted with an IRB/ Privacy Board approved waiver of consent or authorization, including those studies in a registry could be an important method for increasing public knowledge of such studies.

Informing the Public About the Methods and Value of Research

As noted previously, clinical trials are the most visible of the various types of health research, but a great deal of information-based health research entails analysis of thousands of patient records to better understand human diseases, to determine treatment effectiveness, and to identify adverse side effects of therapies. This form of research is likely to increase in frequency as the availability of electronic records continues to expand. As we move toward the goal of personalized medicine, research results will be even more likely to be directly relevant to patients, but more study subjects will be necessary to derive meaningful results.

However, many patients probably are not aware that their medical records are being used in information-based research. For example, the recent study that used focus groups to examine the views of veterans toward the use of medical records in research found that the majority of participants (75 percent) were not aware that “under some circumstances, [their] medical records could be used in some research studies without [their] permission,” despite the fact that a notice of privacy practices, which included a statement that such research could occur, had been mailed to all participants less than a year prior to the study ( Damschroder et al., 2007 ).

Moreover, surveys show that many patients desire not only notice, but also the opportunity to decide whether to consent to such research with medical records. Those surveys further indicate that patients who wish to be asked for consent for each study are most concerned about the potentially detrimental affects of inappropriate disclosure of their personally identifiable health information, including discrimination in obtaining health or life insurance or employment.

As noted in Chapter 2 , strengthening security protections of health data should reduce the risk of security breaches and their potential negative consequences, and thus should help to alleviate patient concerns in this regard. But educating patients about how health research is conducted, monitored, and reported on could also help to ease patient concerns about privacy and increase patients’ trust in the research community, which as noted above is important for the public’s continued participation in health research. For example, datasets are most often provided to researchers without direct identifiers such as name and Social Security number. Furthermore, identifiers are not included in publications about research results. Also, under both the Privacy Rule and the Common Rule , a waiver of consent and authorization is possible only under the supervision of an IRB or Privacy Board , and a waiver is granted only when the research entails minimal risk and when obtaining individual consent and authorization is impracticable (see the previous section and also Chapter 4 ). Finally, professional ethics dictate that researchers safeguard data and respect privacy.

Conveying the value of medical records research to patients will be important. Surveys show that people are more supportive of research that is relevant to them and their loved ones. At the same time, educational efforts should stress the negative impact of incomplete datasets on research findings. Representative samples are essential to ensure the validity and generalizability of health research ( Box 3-8 ), but datasets will not represent the entire population if some people withhold access to their health information.

Selection Bias in Health Research. When researchers are required to obtain consent or authorization to access each individual’s medical record for a research study, it is likely that individuals’ willingness to grant access will not be (more...)

In addition, an educated public could also decrease the potential for biased research samples. A universal requirement for consent or authorization in medical records research leads to incomplete datasets, and thus to biased results and inaccurate conclusions. Some large medical institutions with a strong research history and reputation (e.g., Mayo Clinic) can obtain authorization and consent rates as high as 80 percent, but the 20 percent who refuse have distinct demographic and health characteristics. In fact, even a refusal rate of less than 5 percent can create selection bias in the data ( Jacobsen et al., 1999 ; see Chapter 5 for more detail). Conveying to the public the importance of health care improvements derived from medical records research and stressing the negative impact of incomplete datasets on research findings may increase the public’s participation in research and their willingness to support information-based research that is conducted with IRB or Privacy Board oversight, under a waiver of patient consent or authorization.

Numerous examples of important research findings from medical records research would not have been possible if direct patient consent and authorization were always required ( Box 3-1 ). For example, analysis of medical records showed that infants exposed to diethylstilbesterol (DES) during the first trimester of pregnancy had an increased risk of breast, vaginal, and cervical cancer as well as reproductive anomalies as adults. Similarly, studies of medical records led to the discovery that folic acid supplementation during pregnancy can prevent neural tube defects.

Thus, HHS and the health research community should work to edu cate the public about how research is done and the value it provides. All stakeholders, including professional organizations, nonprofit funders, and patient organizations, have different interests and responsibilities to make sure that their constituencies are well informed. For example, the American Society of Clinical Oncology and the American Heart Association already have some online resources to help patients gather information about research that may be relevant to their conditions. But coordination and identification of best practices by HHS would be helpful, and research is needed to identify which segments of the population would be receptive to and benefit from various types of information about how research is done and its value in order to create and implement an effective plan.

Greater use of community-based participatory research, in which community-based organizations or groups bring community members into the research process as partners to help design studies and disseminate the knowledge gained, 39 could help achieve this goal. These groups help researchers to recruit research participants by using the knowledge of the community to understand health problems and to design activities that the community is likely to value. They also inform community members about how the research is done and what comes out of it, with the goal of providing immediate community benefits from the results when possible.

• CONCLUSIONS AND RECOMMENDATIONS

Based on its review of the information described in this chapter, the committee agreed on a second overarching principle to guide the formation of recommendations. The committee affirms the importance of maintaining and improving health research effectiveness. Research discoveries are central to achieving the goal of extending the quality of healthy lives. Research into causes of disease, methods for prevention, techniques for diagnosis, and new approaches to treatment has increased life expectancy, reduced infant mortality, limited the toll of infectious diseases, and improved outcomes for patients with heart disease, cancer, diabetes, and other chronic diseases. Patient-oriented clinical research that tests new ideas makes rapid medical progress possible. Today, the rate of discovery is accelerating, and we are at the precipice of a remarkable period of investigative promise made possible by new knowledge about the genetic underpinnings of disease. Genomic research is opening new possibilities for preventing illness and for developing safer, more effective medical care that may eventually be tailored for specific individuals. Further advances in relating genetic information to predispositions to disease and responses to treatments will require the use of large amounts of existing health-related information and stored tissue specimens. The increasing use of electronic medical records will further facilitate the generation of new knowledge through research and accelerate the pace of discovery. These efforts will require broad participation of patients in research and broad data sharing to ensure that the results are valid and applicable to different segments of the population. Collaborative partnerships among communities of patients, their physicians, and teams of researchers to gain new scientific knowledge will bring tangible benefits for people in this country and around the world.

Surveys indicate that the majority of Americans believe that health research is important, are interested in the findings of research studies, and are willing to participate in health research. But patients often lack information about how research is conducted and are rarely informed about research results that may have a direct impact on their health. Effective communication could build the public’s trust of the research community, which is important because trust is necessary for the public’s continued participation in research. Moreover, direct feedback could lead to improved health care for study participants if the results indicate that an altered course of care is warranted.

Thus, the committee recommends that when patients consent to the use of their medical records in a particular study, health researchers should make greater efforts when the study ends to inform study participants about the results, and the relevance and importance of those results. Broader adoption of electronic health records may be helpful in accomplishing this goal, but standards and guidelines for providing and explaining study results to research participants or various sectors of the public are needed.

HHS should also encourage registration of trials and other studies in public databases, particularly when research is conducted with an IRB/ Privacy Board approved waiver of consent or authorization, as a way to make information about research studies more broadly available to the public. Numerous clinical trial registries already exist, and registration has increased in recent years, but no centralized system currently exists for disseminating information about clinical trials of drugs or other interventions, making it difficult for consumers and their health care providers to identify ongoing studies. Moreover, noninterventional studies, such as observational studies that play an increasingly critical role in biomedical research, are not generally included in these databases. Because many noninterventional studies are conducted with an IRB/Privacy Board approved waiver of consent or authorization, including such studies in a registry could be an important method for increasing public knowledge of those studies.

Interventional clinical trials are the most visible of the various types of health research, but a great deal of information-based health research entails analysis of thousands of patient records to better understand human diseases, to determine treatment effectiveness, and to identify adverse side effects of therapies. This form of research is likely to increase in frequency as the availability of electronic health records continues to expand. As we move toward the goal of personalized medicine, research results will be even more likely to be directly relevant to patients, but more study participants will be necessary to derive meaningful results.

However, many patients are likely not aware that their medical records are being used in information-based research, and surveys show that many patients desire not only notice, but also the opportunity to decide about whether to consent to such research with medical records. As noted in Chapter 2 , strengthening security protections of health data should reduce the risk of security breaches and their potential negative consequences, and thus should help to alleviate patient concerns in this regard. But educating patients about how health research is conducted, monitored, and reported could also increase patients’ trust in the research community. Thus, HHS and the health research community should work to educate the public about how research is done.

It will also be important for HHS and researchers to convey the value of health care improvements derived from medical records research, and to stress the negative impact of incomplete datasets on research findings. Representative samples are essential to ensure the validity and generalizability of health research, but datasets will not be representative of the entire population if some people withhold access to their health information. A universal requirement for consent or authorization in information-based research may lead to incomplete datasets, and thus to biased results and inaccurate conclusions. Numerous examples of important research findings from medical records research would not have been possible if direct patient consent and authorization were always required.

To ensure that beneficial health research and related activities continue to be undertaken with appropriate oversight under federal regulations, it will be important for HHS to also provide more guidance on how to distinguish the various activities. The Privacy Rule makes a distinction between health research and some closely related endeavors, such as public health and quality improvement activities, which also may involve collection and analysis of personally identifiable health information. Under the Privacy Rule (as well as the Common Rule ), these activities, which aim to protect the public’s health and improve the quality of patient care, are considered health care “practice” rather than health research. Therefore, they can be undertaken without consent or authorization, or an IRB/ Privacy Board waiver of consent or authorization. However, it can be a challenge for IRBs and Privacy Boards to distinguish among activities that are or are not subject to the various provisions of the Privacy Rule and the Common Rule, and inappropriate decisions may prevent important activities from being undertaken or could potentially allow improper disclosure of personally identifiable health information.

To address these difficulties, a number of models have been proposed that outline the criteria IRBs and Privacy Boards should use to distinguish practice and research. For example, one recent model provides a detailed checklist for IRBs and Privacy Boards to use in determining whether an activity is public health research and required to comply with the research provisions of the Privacy Rule, or public health practice that does not need IRB/Privacy Board review. The committee believes that standardizing the criteria is essential to support the conduct of these important health care activities.

Thus, HHS should convene the relevant stakeholders to develop standard criteria for IRBs and Privacy Boards to use when making decisions about whether protocols entail research or practice. There should be flexibility in the regulation to allow important activities to go forward with appropriate levels of oversight. Also, it will be important to evaluate whether these criteria are effective in aiding IRB/Privacy Board reviews of proposed protocols, and whether they lead to appropriate IRB/Privacy Board decisions.

These changes suggested above could be accomplished without any changes to HIPAA by making them a condition of funding from HHS and other research sponsors and by providing some additional funds to cover the cost.

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Epidemiology is the study of the occurrence, distribution, and control of diseases in populations.

Health services research has been defined as a multidisciplinary field of inquiry, both basic and applied, that examines the use, costs, quality, accessibility, delivery, organization, financing, and outcomes of health care services to increase knowledge and understanding of the structure, processes, and effects of health services for individuals and populations ( IOM, 1995 ).

The National Committee on Vital and Health Statistics has noted that “secondary uses” of health data is an ill-defined term, and urges abandoning it in favor of precise description of each use ( NCVHS, 2007a ). Thus, the committee chose to minimize use of the term in this report.

See Standards for Privacy of Individually Identifiable Health Information , 64 Fed. Reg. 59918, 59967 (preamble to rule proposed November 3, 1999) for a discussion on the benefits of health records research.

Effectiveness can be defined as the extent to which a specific test or intervention, when used under ordinary circumstances, does what it is intended to do. Efficacy refers to the extent to which a specific test or intervention produces a beneficial result under ideal conditions (e.g., in a clinical trial).

See http://www ​.intermacs.org .

See http://www ​.elso.med.umich.edu .

See http://www ​.unos.org/Data .

The Department of Health, Education and Welfare (now HHS) had previously issued policy and guidance on the protection of human subjects. See Williams (2005) .

In its report “First Biennial Report on the Adequacy and Uniformity of Federal Rules and Policies, and their Implementation, for the Protection of Human Subjects in Biomedical and Behavioral Research , Protecting Human Subjects.”

45 C.F.R. part 46 (2005).

See 45 C.F.R. § 46.101 (2005).

See 45 C.F.R. § 46.102(d) (2005).

This section on informed consent is based largely on a Congressional Research Service report ( Williams, 2005 ), as adapted by Pritts (2008) .

See 45 C.F.R. § 46.116 (2005).

See 45 C.F.R. § 46.116(b) (2005).

See 45 C.F.R. § 46.103 (2005).

See 45 C.F.R. § 46.111 (2005). There are additional factors if the study includes subjects who are likely to be vulnerable to coercion or undue influence.

See 45 C.F.R. § 46.116(d); 46.117(c) (2005).

See 45 C.F.R. § 46.102(f) (2005).

See 45 C.F.R. § 46.101(b)(4) (2005).

See 45 C.F.R. § 46.116(e) (2005).

See 45 C.F.R. § 46.123 (2005).

See also Grimes v. Kennedy Krieger Institute , 782 A. 2d 807 (Md. Ct. App. 2001); Gelsinger v. University of Pennsylvania (Philadelphia County Court of Common Pleas filed September 18, 2000), available at http://www ​.sskrplaw.com ​/links/healthcare2.html .

The FDA has defined “clinical investigation” to be synonymous with “research.”

The Food, Drug, and Cosmetic Act Section 505(i), 507(d), or 520(g) of 21 U.S.C. 355(i), 357(d), or 360j(g) (1972).

See 21 C.F.R. part 50 (2008); 46 Fed. Reg. 8942 (1981).

See 21 C.F.R. part 56 (2008); 46 Fed. Reg. 8958 (1981).

See 45 C.F.R. part 46 (2005); 46 Fed. Reg. 8366 (1981).

The Centers for Disease Control and Prevention defines program evaluation as the “systematic investigation of the merit, worth, or significance of organized public health action,” noting that such evaluations are “systematic ways to improve and account for public health actions by involving procedures that are useful, feasible, ethical, and accurate.” They can be based on goals, processes, outcomes, or value ( http://www ​.cdc.gov/mmwr ​/preview/mmwrhtml/rr4811a1.htm ).

The Utilization Review Accreditation Commission defines utilization review as “the evaluation of the medical necessity, appropriateness, and efficiency of the use of health care services, procedures, and facilities under the provisions of the applicable health benefits plans” ( http://www ​.urac.org/about/ ).

Another type of oversight board defined by the Privacy Rule. See Chapter 4 .

Under the Privacy Rule, consent is referred to as authorization. See Chapter 4 .

Personal communication, C. Heide, Office for Civil Rights, HHS, May 29, 2008.

The Privacy Rule defines the term “health care operations” by listing a number of specific activities that qualify as health care operations. These include “conducting quality assessment and improvement activities, population-based activities relating to improving or reducing health care costs, and case management and care coordination.” See 45 C.F.R. § 164.501 (2006).

A total of 444 surveys were mailed to the medical directors of quality improvement and IRB chairs at hospitals with 400 or more beds that belong to the Council of Teaching Hospitals of the Association of American Medical Colleges, and to the editors of all U.S.-based medical journals that publish original research and appear in the Abridged Index Medicus. 236 surveys were returned, for a 53 percent response rate. The survey consisted of six brief scenarios that asked respondents to determine whether the described project needed IRB review and informed consent.

See http: ​//plainlanguage.gov/index.cfm .

FDA, Public Law 110–85 § 801 (2007).

See http://www ​.ahrq.gov/research/cbprrole ​.htm .

• Cite this Page Institute of Medicine (US) Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule; Nass SJ, Levit LA, Gostin LO, editors. Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington (DC): National Academies Press (US); 2009. 3, The Value, Importance, and Oversight of Health Research.
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Featured articles, artificial intelligence-driven radiomics study in cancer: the role of feature engineering and modeling, regulatory t cells in skin regeneration and wound healing, single-cell transcriptome profiling of sepsis identifies hla-drlows100ahigh monocytes with immunosuppressive function.

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PANX1-mediated ATP release confers FAM3A’s suppression effects on hepatic gluconeogenesis and lipogenesis

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Scientist behind Alzheimer’s drug in late-stage trials is indicted on charges of research fraud

The Summary

• A neuroscientist whose work helped pave the way for an Alzheimer’s drug candidate was indicted on charges of fraud.
• The charges are related to the alleged fabrication of research images and data that the scientist may have used to secure grants.
• The manipulation of research images is a growing concern in the scientific community.

A neuroscientist whose work helped pave the way for an Alzheimer’s drug candidate was indicted by a federal grand jury on Thursday on charges of fraud.

The indictment, announced Friday by the Justice Department , brings additional scrutiny to the work of Hoau-Yan Wang , who has had multiple studies retracted and faced an investigation by the City University of New York, his employer, that was later halted .

The charges in the indictment are related to the alleged fabrication of research images and data that Wang may have used to secure federal grants from the National Institutes of Health.

Wang, a medical professor at the City University of New York , collaborated with Cassava Sciences, a pharmaceutical company based in Austin, Texas, as it investigated an Alzheimer’s drug candidate called simufilam. He was awarded some $16 million in grants for early-stage drug development in collaboration with Cassava, according to the indictment.

The indictment charges Wang with one count of fraud against the United States, two counts of wire fraud and one count of false statements. It accuses Wang of manipulating or adding to images of Western blots, a laboratory method that researchers use to identify proteins, in order to bolster evidence and help secure grants.

The indictment also suggests that Wang may have lied to scientific journals to substantiate his research, which contributed to the early development of simufilam.

The drug is currently in a late-stage clinical trial, and some 735 patients had participated as of May 2024, according to a news release from Cassava last month.

Wang did not immediately respond to a request for comment. In 2023, he told The Wall Street Journal that a CUNY investigation made “no conclusive findings of data manipulation, consistent with what I’ve been saying for two years.”

Cassava said in a release on Friday that Wang had not participated in its most recent trial.

In a news release, the company said: “Wang’s work under these grants was related to the early development phases of the Company’s drug candidate and diagnostic test and how these were intended to work.”

Cassava added that Wang “had no involvement in the Company’s Phase 3 clinical trials of simufilam.”

A Cassava spokesperson also pointed to a news release the company issued September 2023, which said academic researchers outside of CUNY had found evidence that the drug could affect signaling pathways with suspected involvement in Alzheimer’s.

CUNY learned of the indictment on Friday, a spokesperson said in an email, adding: “The University has and will continue to cooperate to the fullest degree with the federal government’s investigation until the matter is resolved.”

The indictment doesn’t specifically name the university, drug or company, listing them instead as “University 1,” “Drug A” and “Company 1,” respectively.

Still, Cassava’s shares fell nearly 35% on Friday in a rapid plunge that triggered multiple trading halts.

Overall, the manipulation of research images and the handling of allegations of research misconduct is a growing concern in the scientific community.

The issue gained particular attention last summer, when then-Stanford President Marc Tessier-Lavigne stepped down from his post after allegations arose that images had been manipulated within his lab. Tessier-Lavigne said he never submitted papers he didn’t think were accurate and noted that a panel investigating his work did not find that he knew of misconduct within his lab.

Then in January, an amateur science sleuth made allegations of research image manipulation by top scientists at the Dana-Farber Cancer Institute , which led to subsequent retractions. Dana-Farber said it took decisive action to correct the scientific record.

Wang’s work has faced questioning for some time, as the journal Science has reported . The journal obtained a report by CUNY that found evidence suggesting research misconduct. The university halted its investigation after Science published the report .

Multiple journal articles on which Wang was an author have been retracted , according to the website Retraction Watch.

Evan Bush is a science reporter for NBC News. He can be reached at [email protected].

How Do Our Memories Last a Lifetime? New Study Offers a Biological Explanation

Whether it’s a first-time visit to a zoo or when we learned to ride a bicycle, we have memories from our childhoods kept well into adult years. But what explains how these memories last nearly an entire lifetime? 

A new study in the journal Science Advances , conducted by a team of international researchers, has uncovered a biological explanation for long-term memories. It centers on the discovery of the role of a molecule, KIBRA, that serves as a “glue” to other molecules, thereby solidifying memory formation.

“Previous efforts to understand how molecules store long-term memory focused on the individual actions of single molecules,” explains André Fenton, a professor of neural science at New York University and one of the study’s principal investigators. “Our study shows how they work together to ensure perpetual memory storage.”

“A firmer understanding of how we keep our memories will help guide efforts to illuminate and address memory-related afflictions in the future,” adds Todd Sacktor, a professor at SUNY Downstate Health Sciences University and one of the study’s principal investigators.

Discovery of a "glue" molecule's purpose affirms a concept introduced Nobel Laureate Francis Crick to explain the brain’s role in memory storage.

It’s been long-established that neurons store information in memory as the pattern of strong synapses and weak synapses, which determines the connectivity and function of neural networks. However, the molecules in synapses are unstable, continually moving around in the neurons, and wearing out and being replaced in hours to days, thereby raising the question: How, then, can memories be stable for years to decades?  

In a study using laboratory mice, the scientists focused on the role of KIBRA, or kidney and brain expressed protein, the human genetic variants of which are associated with both good and poor memory. They focused on KIBRA’s interactions with other molecules crucial to memory formation—in this case, protein kinase Mzeta (PKMzeta). This enzyme is the most crucial molecule for strengthening normal mammalian synapses that is known, but it degrades after a few days.

Their experiments reveal that KIBRA is the “missing link” in long-term memories, serving as a “persistent synaptic tag,” or glue, that sticks to strong synapses and to PKMzeta while also avoiding weak synapses.

“During memory formation the synapses involved in the formation are activated—and KIBRA is selectively positioned in these synapses,” explains Sacktor, a professor of physiology, pharmacology, anesthesiology, and neurology at SUNY Downstate. “PKMzeta then attaches to the KIBRA-synaptic-tag and keeps those synapses strong. This allows the synapses to stick to newly made KIBRA, attracting more newly made PKMzeta.”

More specifically, their experiments in the Science Advances paper show that breaking the KIBRA-PKMzeta bond erases old memory. Previous work had shown that randomly increasing PKMzeta in the brain enhances weak or faded memories, which was mysterious because it should have done the opposite by acting at random locations, but the persistent synaptic tagging by KIBRA explains why the additional PKMzeta was memory enhancing, by only acting at the KIBRA tagged sites. 

Memories are stored by the interaction of two proteins: a structural protein, KIBRA (green), that acts as a persistent synaptic tag, and a synapse-strengthening enzyme, protein kinase Mzeta (red). Drugs that disrupt the memory-perpetuating interaction (other colors) erase pre-established long-term and remote memories. Credit: Changchi Hsieh, Ph.D.

“The persistent synaptic tagging mechanism for the first time explains these results that are clinically relevant to neurological and psychiatric disorders of memory,” observes Fenton, who is also on the faculty at NYU Langone Medical Center’s Neuroscience Institute. 

The paper’s authors note that the research affirms a concept introduced in 1984 by Francis Crick. Sacktor and Fenton point out that his proposed hypothesis to explain the brain’s role in memory storage despite constant cellular and molecular changes is a Theseus’s Ship mechanism—borrowed from a philosophical argument stemming from Greek mythology in which new planks replace old ones to maintain Theseus’s Ship for years.

“The persistent synaptic tagging mechanism we found is analogous to how new planks replace old planks to maintain Theseus’s Ship for generations, and allows memories to last for years even as the proteins maintaining the memory are replaced,” says Sacktor. “Francis Crick intuited this Theseus’s Ship mechanism, even predicting the role for a protein kinase. But it took 40 years to discover that the components are KIBRA and PKMzeta and to work out the mechanism of their interaction.”

The study also included researchers from Canada’s McGill University, Germany’s University Hospital of Münster, and University of Texas Medical School at Houston.

This work was supported by grants from the National Institutes of Health (R37 MH057068, R01 MH115304, R01 NS105472, R01 MH132204, R01 NS108190), the Natural Sciences and Engineering Research Council of Canada Discovery (203523), and the Garry and Sarah S. Sklar Fund.

About New York University Founded in 1831, NYU is one of the world’s foremost research universities (with more than $1 billion per year in research expenditures, it is ranked seventh among private research universities) and is a member of the selective Association of American Universities. NYU has degree-granting university campuses in New York, Abu Dhabi, and Shanghai; has 13 other global academic sites, including London, Paris, Florence, Tel Aviv, Buenos Aires, and Accra, and US sites in Washington, DC, Los Angeles, CA, and Tulsa, OK; and both sends more students to study abroad and educates more international students than any other U.S. college or university. Through its numerous schools and colleges, NYU is a leader in conducting research and providing education in the arts and sciences, law, medicine, business, dentistry, engineering, education, nursing, the cinematic and performing arts, music and studio arts, public service, social work, public health, and professional studies, among other areas.

About SUNY Downstate Health Sciences University Downstate Health Sciences University in Brooklyn is one of four academic health centers (AMCs) in the 64-campus State University of New York (SUNY) system and the only SUNY AMC in New York City dedicated to health education, research, and patient care for the borough’s 2.7 million residents. Its flagship hospital, University Hospital at Downstate (UHD), is a teaching hospital that benefits from the expertise of Downstate’s exceptional medical school and world-class research facilities. Beyond its clinical excellence, Downstate houses a range of esteemed educational institutions, including the College of Medicine, College of Nursing, School of Health Professions, School of Graduate Studies, and School of Public Health. Downstate fosters innovation through its multifaceted biotechnology initiatives, including the Biotechnology Incubator and BioBAT, which support both early-stage and more mature biotech companies. Downstate’s research enterprise drives innovation and discovery across a wide array of disciplines. Our investigators are making discoveries that are changing the world and pushing the boundaries of what is possible in biomedicine and healthcare.

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CTIA Pilot Grant Leads to Five Years of Research Support

In the next 12 months, an estimated one in two Americans will experience financial toxicity.

While you may not be familiar with the term, you’re likely aware of the negative impact that medical care costs can have on a person’s financial well-being and/or quality of life. This particularly impacts patients with cancer.

“It’s important to give patients with cancer, tools to directly decrease their risk of experiencing the devastating emotional toll of financial toxicity and to allow patients to better prepare for financial impacts of treatment choices,” says Laila Gharzai, MD , assistant professor of Radiation Oncology and Medical Social Sciences in the Division of Outcome and Measurement Science.

Gharzai was recently awarded an ASTRO-ACS Clinician Scientist Development Grant ( CSDG ) from the American Cancer Society and American Society for Radiation Oncology. The grant provides Gharzai with protected research time (50 percent) over the next five years.

“This is incredibly important for my career as it gives me the time and space to build on my current research skills and grow into an independent investigator,” she says. “These first few years out of training are critical both for solidifying myself as a researcher in terms of my skills and for building a foundation in the areas of research I’m most interested in.”

One of the most important parts of the CTIA program is how it helps junior faculty understand the research infrastructure here at Northwestern, and connects us with amazing mentors like Jyoti Patel, MD, and Ravi Kalhan, MD, MSCI.”

Gharzai is a radiation oncologist and investigator whose academic goal is to advance cancer care while minimizing both short- and long-term side effects from treatment, spanning from physical effects to socioeconomic impacts including financial toxicity. Her scholarly work has included quantifying toxicities after treatment, such as difficulty swallowing after head and neck cancer treatment and incorporating imaging to predict for risk of toxicity.

Her CSDG project builds on Gharzai’s prior work developing a preliminary widely scalable patient-facing educational tool seeking to mitigate financial toxicity. She will use insights from implementation science to ensure that what is developed reaches patients in need and can be sustained through time.

Other ongoing CSDG grants at Northwestern have been awarded to Kelly Bachta, MD, PhD , assistant professor of Medicine in the Divisions of Infectious Diseases, and Irum Khan, MD , associate professor of Medicine in the Division of Hematology and Oncology.

Gharzai credits the NUCATS-supported Clinical and Translational Investigation Accelerator ( CTIA ) with putting her in a position to apply for the CSDG award.

“One of the most important parts of the CTIA program is how it helps junior faculty understand the research infrastructure here at Northwestern, and connects us with amazing mentors like Jyoti Patel, MD , and Ravi Kalhan, MD, MSCI ,” says Gharzai. “It’s wonderful to have the opportunity to learn from incredibly successful researchers, both to broadly understand how to be a successful researcher and more granularly to understand how to do so here at Northwestern. The opportunity to meet with these mentors regularly, for connection and support, cannot be overstated.”

Gharzai also acknowledges the role of David Cella, PhD , and Mohamed Abazeed, MD, PhD , with supporting her early academic research career at Northwestern and supporting her successful CSDG application. Gharzai will undergo additional training in implementation science as part of her CSDG under the mentorship of Sara Becker, PhD , director of the Center for Dissemination and Implementation Science.

“Dr. Becker is my secondary mentor on this CSDG grant and is absolutely a big reason that this got funded — she has such a strong research background and track record of mentorship, as evidenced by the number of people that she’s recruited to join CDIS in the short time that the center has been open,” says Gharzai. “I’m looking forward to learning from her over the next five years.

“Implementation science is so important because we spend so much time and effort working on improving cancer care, but there’s a huge gap of what we know we should do and what actually happens in the community and on our front lines. For example, we know so much about lung cancer screening in terms of who should be getting it, what the benefit is, but our rate of actually completing lung cancer screening is less than 20 percent and is worse in certain racial/ethnic groups. We can use insights from implementation science to help us bridge this gap.”

The CTIA program is supported in part by the National Institutes of Health's  National Center for Advancing Translational Sciences , Grant Number UL1TR001422. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Written by Roger Anderson

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Support for science has traditionally been bipartisan, but fights over spending have affected research funding. Mark Wilson/Getty Images

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Federal funding for major science agencies is at a 25-year low

Research funding is down in recent years despite promises made with the chips and science act..

Chris Impey , The Conversation

• Public Health

Government funding for science is usually immune from political gridlock and polarization in Congress. But, federal funding for science is slated to drop for 2025.

Science research dollars are considered to be discretionary, which means the funding has to be approved by Congress every year. But it’s in a budget category with larger entitlement programs like Medicare and Social Security that are generally considered untouchable by politicians of both parties.

Federal investment in scientific research encompasses everything from large telescopes supported by the National Science Foundation to NASA satellites studying climate change , programs studying the use and governance of artificial intelligence at the National Institute of Standards and Technology, and research on Alzheimer’s disease funded by the National Institutes of Health.

Studies show that increasing federal research spending benefits productivity and economic competitiveness .

I’m an astronomer and also a senior university administrator. As an administrator, I’ve been involved in lobbying for research funding as associate dean of the College of Science at the University of Arizona, and in encouraging government investment in astronomy as a vice president of the American Astronomical Society. I’ve seen the importance of this kind of funding as a researcher who has had federal grants for 30 years, and as a senior academic who helps my colleagues write grants to support their valuable work.

Bipartisan support

Federal funding for many programs is characterized by political polarization , meaning that partisanship and ideological divisions between the two main political parties can lead to gridlock . Science is usually a rare exception to this problem.

The public shows strong bipartisan support for federal investment in scientific research, and Congress has generally followed suit, passing bills in 2024 with bipartisan backing in April and June .

The House passed these bills, and after reconciliation with language from the Senate, they resulted in final bills to direct US$460 billion in government spending .

However, policy documents produced by Congress reveal a partisan split in how Democratic and Republican lawmakers reference scientific research.

Congressional committees for both sides are citing more scientific papers, but there is only a 5% overlap in the papers they cite. That means that the two parties are using different evidence to make their funding decisions, rather than working from a scientific consensus. Committees under Democratic control were almost twice as likely to cite technical papers as panels led by Republicans, and they were more likely to cite papers that other scientists considered important.

Ideally, all the best ideas for scientific research would receive federal funds. But limited support for scientific research in the United States means that for individual scientists, getting funding is a highly competitive process.

At the National Science Foundation , only 1 in 4 proposals are accepted. Success rates for funding through the National Institutes of Health are even lower, with 1 in 5 proposals getting accepted. This low success rate means that the agencies have to reject many proposals that are rated excellent by the merit review process .

Scientists are often reluctant to publicly advocate for their programs, in part because they feel disconnected from the policymaking and appropriations process . Their academic training doesn’t equip them to communicate effectively to legislators and policy experts.

Budgets are down

Research received steady funding for the past few decades, but this year Congress reduced appropriations for science at many top government agencies.

The National Science Foundation budget is down 8%, which led agency leaders to warn Congress that the country may lose its ability to attract and train a scientific workforce .

The cut to the NSF is particularly disappointing since Congress promised it an extra $81 billion over five years when the CHIPS and Science Act passed in 2022. A deal to limit government spending in exchange for suspending the debt ceiling made the law’s goals hard to achieve.

NASA’s science budget is down 6%, and the budget for the National Institutes of Health, whose research aims to prevent disease and improve public health, is down 1%. Only the Department of Energy’s Office of Science got a bump, a modest 2%.

As a result, the major science agencies are nearing a 25-year low for their funding levels, as a share of U.S. gross domestic product.

Feeling the squeeze

Investment in research and development by the business sector is strongly increasing . In 1990, it was slightly higher than federal investment, but by 2020 it was nearly four times higher.

The distinction is important because business investment tends to focus on later stage and applied research, while federal funding goes to pure and exploratory research that can have enormous downstream benefits, such as for quantum computing and fusion power .

There are several causes of the science funding squeeze. Congressional intentions to increase funding levels, as with the CHIPS and Science Act, and the earlier COMPETES Act in 2007, have been derailed by fights over the debt limit and threats of government shutdowns.

The CHIPS act aimed to spur investment and job creation in semiconductor manufacturing, while the COMPETES Act aimed to increase U.S competitiveness in a wide range of high-tech industries such as space exploration.

The budget caps for fiscal years 2024 and 2025 remove any possibility for growth. The budget caps were designed to rein in federal spending, but they are a very blunt tool. Also, nondefense discretionary spending is only 15% of all federal spending. Discretionary spending is up for a vote every year, while mandatory spending is dictated by prior laws.

Entitlement programs like Medicare, Medicaid and Social Security are mandatory forms of spending. Taken together, they are three times larger than the amount available for discretionary spending, so science has to fight over a small fraction of the overall budget pie.

Within that 15% slice , scientific research competes with K-12 education, veterans’ health care, public health, initiatives for small businesses, and more.

Global competition

While government science funding in the U.S. is stagnant, America’s main scientific rivals are rising fast.

Federal R&D funding as a percentage of GDP has dropped from 1.2% in 1987 to 1% in 2010 to under 0.8% currently. The United States is still the world’s biggest spender on research and development, but in terms of government R&D as a fraction of GDP , the United States ranked 12th in 2021, behind South Korea and a set of European countries. In terms of science researchers as a portion of the labor force , the United States ranks 10th.

Meanwhile, America’s main geopolitical rival is rising fast. China has eclipsed the United States in high-impact papers published , and China now spends more than the United States on university and government research .

If the U.S. wants to keep its status as the world leader in scientific research, it’ll need to redouble its commitment to science by appropriately funding research.

Chris Impey , University Distinguished Professor of Astronomy, University of Arizona

This article is republished from The Conversation under a Creative Commons license. Read the original article .

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Fears of attack and no phone signal deter women trail runners, finds study

by Simon Fraser University

Many studies have shown the health benefits of running, for both physical and psychological well-being. The researchers hope that, by identifying the features that are attractive to runners, they can help policymakers create environments that will promote an active and healthy lifestyle. Trail running has the added benefit of being immersed in nature, which is known to offer health benefits.

The study, published recently in the International Journal of Environmental Research and Public Health , asked 548 regular trail runners a series of questions to determine their preferences and concerns when engaged in the sport.

The leading concern for all trail runners (women and men alike) was slipping or falling (55.1%). The concerns of men and women differed, however, when asked about encountering other people or wild animals , and the loss of phone reception on trails.

Women respondents reported a far greater fear of other people (38.9%) and cougars (32.4%) than men, (12.6% and 21.2% respectively). In addition, 50.8% of women were concerned by loss of reception, compared with 33.8% of men.

"I think that women are just more concerned about their safety than men, and for good reasons," says Nadine Schuurman, a professor in SFU's department of geography and the lead investigator on the paper. "We all see news stories about threats to women."

Schuurman also points to social factors that disproportionally prevent women from getting out to run in the trails.

"Something I really want to look at in a future survey is how women are also constrained by household chores and childcare, because trail running is time consuming," says Schuurman. "You tend to go slower, so it takes longer to cover a distance than it does on the road, and you may have to drive to the trailhead, so it just requires a greater commitment. I think that those are disincentives for women , especially."

As well as their concerns, the researchers also asked the runners about their preferences in terms of terrain and other factors. Most respondents preferred undulating trails (57.2%), rather than steep (22.6%) or fairly flat (16.3%) routes. They also favored "buffed out" trails (56.0%) over rocky terrain (40.3%).

The research paper is the latest in a series of studies examining different factors in "runnability"—a term the researchers coined to assist in quantifying features of the built environment that facilitate or hinder running as a form of leisure or sport activity. Previous papers have examined the preferences of road runners and the neighborhood characteristics that encourage running around Metro Vancouver.

The researchers plan to continue studying "runnability," including a future survey of popular running routes using data from activity tracking app Strava, and examining the environmental factors that the most popular routes share.

"We're really honing-in or what specific environmental correlates are associated with both urban and rural running, or trail running," says Schuurman. "Runnability is different from walkability or bikeability, and we're actually looking at what makes a good running route and how you can encourage runners."

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40 Facts About Elektrostal

Written by Lanette Mayes

Modified & Updated: 01 Jun 2024

Reviewed by Jessica Corbett

Elektrostal is a vibrant city located in the Moscow Oblast region of Russia. With a rich history, stunning architecture, and a thriving community, Elektrostal is a city that has much to offer. Whether you are a history buff, nature enthusiast, or simply curious about different cultures, Elektrostal is sure to captivate you.

This article will provide you with 40 fascinating facts about Elektrostal, giving you a better understanding of why this city is worth exploring. From its origins as an industrial hub to its modern-day charm, we will delve into the various aspects that make Elektrostal a unique and must-visit destination.

So, join us as we uncover the hidden treasures of Elektrostal and discover what makes this city a true gem in the heart of Russia.

Key Takeaways:

• Elektrostal, known as the “Motor City of Russia,” is a vibrant and growing city with a rich industrial history, offering diverse cultural experiences and a strong commitment to environmental sustainability.
• With its convenient location near Moscow, Elektrostal provides a picturesque landscape, vibrant nightlife, and a range of recreational activities, making it an ideal destination for residents and visitors alike.

Known as the “Motor City of Russia.”

Elektrostal, a city located in the Moscow Oblast region of Russia, earned the nickname “Motor City” due to its significant involvement in the automotive industry.

Home to the Elektrostal Metallurgical Plant.

Elektrostal is renowned for its metallurgical plant, which has been producing high-quality steel and alloys since its establishment in 1916.

Boasts a rich industrial heritage.

Elektrostal has a long history of industrial development, contributing to the growth and progress of the region.

Founded in 1916.

The city of Elektrostal was founded in 1916 as a result of the construction of the Elektrostal Metallurgical Plant.

Located approximately 50 kilometers east of Moscow.

Elektrostal is situated in close proximity to the Russian capital, making it easily accessible for both residents and visitors.

Known for its vibrant cultural scene.

Elektrostal is home to several cultural institutions, including museums, theaters, and art galleries that showcase the city’s rich artistic heritage.

A popular destination for nature lovers.

Surrounded by picturesque landscapes and forests, Elektrostal offers ample opportunities for outdoor activities such as hiking, camping, and birdwatching.

Hosts the annual Elektrostal City Day celebrations.

Every year, Elektrostal organizes festive events and activities to celebrate its founding, bringing together residents and visitors in a spirit of unity and joy.

Has a population of approximately 160,000 people.

Elektrostal is home to a diverse and vibrant community of around 160,000 residents, contributing to its dynamic atmosphere.

Boasts excellent education facilities.

The city is known for its well-established educational institutions, providing quality education to students of all ages.

A center for scientific research and innovation.

Elektrostal serves as an important hub for scientific research, particularly in the fields of metallurgy , materials science, and engineering.

Surrounded by picturesque lakes.

The city is blessed with numerous beautiful lakes , offering scenic views and recreational opportunities for locals and visitors alike.

Well-connected transportation system.

Elektrostal benefits from an efficient transportation network, including highways, railways, and public transportation options, ensuring convenient travel within and beyond the city.

Famous for its traditional Russian cuisine.

Food enthusiasts can indulge in authentic Russian dishes at numerous restaurants and cafes scattered throughout Elektrostal.

Home to notable architectural landmarks.

Elektrostal boasts impressive architecture, including the Church of the Transfiguration of the Lord and the Elektrostal Palace of Culture.

Offers a wide range of recreational facilities.

Residents and visitors can enjoy various recreational activities, such as sports complexes, swimming pools, and fitness centers, enhancing the overall quality of life.

Provides a high standard of healthcare.

Elektrostal is equipped with modern medical facilities, ensuring residents have access to quality healthcare services.

Home to the Elektrostal History Museum.

The Elektrostal History Museum showcases the city’s fascinating past through exhibitions and displays.

A hub for sports enthusiasts.

Elektrostal is passionate about sports, with numerous stadiums, arenas, and sports clubs offering opportunities for athletes and spectators.

Celebrates diverse cultural festivals.

Throughout the year, Elektrostal hosts a variety of cultural festivals, celebrating different ethnicities, traditions, and art forms.

Electric power played a significant role in its early development.

Elektrostal owes its name and initial growth to the establishment of electric power stations and the utilization of electricity in the industrial sector.

Boasts a thriving economy.

The city’s strong industrial base, coupled with its strategic location near Moscow, has contributed to Elektrostal’s prosperous economic status.

Houses the Elektrostal Drama Theater.

The Elektrostal Drama Theater is a cultural centerpiece, attracting theater enthusiasts from far and wide.

Popular destination for winter sports.

Elektrostal’s proximity to ski resorts and winter sport facilities makes it a favorite destination for skiing, snowboarding, and other winter activities.

Promotes environmental sustainability.

Elektrostal prioritizes environmental protection and sustainability, implementing initiatives to reduce pollution and preserve natural resources.

Home to renowned educational institutions.

Elektrostal is known for its prestigious schools and universities, offering a wide range of academic programs to students.

Committed to cultural preservation.

The city values its cultural heritage and takes active steps to preserve and promote traditional customs, crafts, and arts.

Hosts an annual International Film Festival.

The Elektrostal International Film Festival attracts filmmakers and cinema enthusiasts from around the world, showcasing a diverse range of films.

Encourages entrepreneurship and innovation.

Elektrostal supports aspiring entrepreneurs and fosters a culture of innovation, providing opportunities for startups and business development .

Offers a range of housing options.

Elektrostal provides diverse housing options, including apartments, houses, and residential complexes, catering to different lifestyles and budgets.

Home to notable sports teams.

Elektrostal is proud of its sports legacy , with several successful sports teams competing at regional and national levels.

Boasts a vibrant nightlife scene.

Residents and visitors can enjoy a lively nightlife in Elektrostal, with numerous bars, clubs, and entertainment venues.

Promotes cultural exchange and international relations.

Elektrostal actively engages in international partnerships, cultural exchanges, and diplomatic collaborations to foster global connections.

Surrounded by beautiful nature reserves.

Nearby nature reserves, such as the Barybino Forest and Luchinskoye Lake, offer opportunities for nature enthusiasts to explore and appreciate the region’s biodiversity.

Commemorates historical events.

The city pays tribute to significant historical events through memorials, monuments, and exhibitions, ensuring the preservation of collective memory.

Promotes sports and youth development.

Elektrostal invests in sports infrastructure and programs to encourage youth participation, health, and physical fitness.

Hosts annual cultural and artistic festivals.

Throughout the year, Elektrostal celebrates its cultural diversity through festivals dedicated to music, dance, art, and theater.

Provides a picturesque landscape for photography enthusiasts.

The city’s scenic beauty, architectural landmarks, and natural surroundings make it a paradise for photographers.

Connects to Moscow via a direct train line.

The convenient train connection between Elektrostal and Moscow makes commuting between the two cities effortless.

A city with a bright future.

Elektrostal continues to grow and develop, aiming to become a model city in terms of infrastructure, sustainability, and quality of life for its residents.

In conclusion, Elektrostal is a fascinating city with a rich history and a vibrant present. From its origins as a center of steel production to its modern-day status as a hub for education and industry, Elektrostal has plenty to offer both residents and visitors. With its beautiful parks, cultural attractions, and proximity to Moscow, there is no shortage of things to see and do in this dynamic city. Whether you’re interested in exploring its historical landmarks, enjoying outdoor activities, or immersing yourself in the local culture, Elektrostal has something for everyone. So, next time you find yourself in the Moscow region, don’t miss the opportunity to discover the hidden gems of Elektrostal.

Q: What is the population of Elektrostal?

A: As of the latest data, the population of Elektrostal is approximately XXXX.

Q: How far is Elektrostal from Moscow?

A: Elektrostal is located approximately XX kilometers away from Moscow.

Q: Are there any famous landmarks in Elektrostal?

A: Yes, Elektrostal is home to several notable landmarks, including XXXX and XXXX.

Q: What industries are prominent in Elektrostal?

A: Elektrostal is known for its steel production industry and is also a center for engineering and manufacturing.

Q: Are there any universities or educational institutions in Elektrostal?

A: Yes, Elektrostal is home to XXXX University and several other educational institutions.

Q: What are some popular outdoor activities in Elektrostal?

A: Elektrostal offers several outdoor activities, such as hiking, cycling, and picnicking in its beautiful parks.

Q: Is Elektrostal well-connected in terms of transportation?

A: Yes, Elektrostal has good transportation links, including trains and buses, making it easily accessible from nearby cities.

Q: Are there any annual events or festivals in Elektrostal?

A: Yes, Elektrostal hosts various events and festivals throughout the year, including XXXX and XXXX.

Elektrostal's fascinating history, vibrant culture, and promising future make it a city worth exploring. For more captivating facts about cities around the world, discover the unique characteristics that define each city . Uncover the hidden gems of Moscow Oblast through our in-depth look at Kolomna. Lastly, dive into the rich industrial heritage of Teesside, a thriving industrial center with its own story to tell.

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CDC Public Health Science Agenda for Highly Pathogenic Avian Influenza A(H5N1) – June 2024

What to know.

• CDC has developed strategic priorities for improving global influenza control, prevention, preparedness, and response. These priorities guide research and surveillance activities around seasonal and pandemic influenza preparedness and response.
• CDC works to address these strategic priorities through ongoing collaboration with public and animal health partners at the local, state, and national level.
• CDC has identified the following primary HPAI A(H5N1) scientific response objectives for the current outbreak of HPAI A(H5N1) in dairy cattle, other animals, and people.

Beginning the week of March 25, 2024, the U.S. Department of Agriculture confirmed detections of highly pathogenic avian influenza HPAI A(H5N1) virus infection in dairy cows in the United States. On April 4, 2024, CDC initiated a center (National Center for Immunization and Respiratory Diseases)-led emergency response for the HPAI A(H5N1) outbreak in dairy cows with a One Health approach. Since April 2024, several human cases of H5N1 have been detected in association with the ongoing outbreak of HPAI A(H5N1) in dairy cows and other animals. Human infections have occurred in dairy workers who had direct exposure to cattle presumed to be infected with HPAI A(H5N1) virus ( H5N1 Bird Flu: Current Situation ).

The HPAI A(H5N1) viruses currently circulating in the United States have thus far not demonstrated the ability to efficiently bind to receptors that predominate in the human upper respiratory tract. This is a major reason why CDC assesses the current risk to the public from HPAI A(H5N1) viruses to be low. However, influenza viruses have potential to rapidly evolve and HPAI A(H5N1) viruses are widely prevalent globally in wild birds. Therefore, continued comprehensive and coordinated, multisectoral surveillance across public health and animal health for these viruses in wild birds, poultry, mammals, and people worldwide, are critical to determine the public health risk.

CDC has developed strategic priorities for improving global influenza control, prevention, preparedness, and response. These priorities guide research and surveillance activities around seasonal and pandemic influenza preparedness and response. CDC works to address these strategic priorities through ongoing collaboration with public and animal health partners at the local, state, and national level. Additionally, CDC has identified the following primary HPAI A(H5N1) scientific response objectives for the current outbreak of HPAI A(H5N1) in dairy cattle, other animals, and people.

Objective 1

Prevent infection and illness in people exposed to hpai a(h5n1) viruses..

Focus Area: Understanding the risk of infection among people exposed to infected dairy cattle, other animals, and their environment or contaminated animal products (e.g., raw milk).

Focus Area: Determining what measures most minimize the risk of infection among exposed persons. This includes personal protective equipment (PPE), and administrative and engineering controls.

Focus Area: Identifying host, pathogen, and exposure risk indicators for severe illness.

Focus Area: Monitoring and evaluating the effectiveness of influenza antiviral medications in preventing and attenuating illness, and public health interventions, including A(H5N1) vaccine (should it be employed).

Objective 2

Understand human infection and illness with hpai a(h5n1) virus (clinical, virologic, and epidemiologic characteristics)..

Focus Area: Monitoring for human infections using existing influenza surveillance platforms and developing strategies for enhanced surveillance and laboratory testing.

Focus Area: Determining how widespread human exposure and infection are. This includes estimating the prevalence and incidence of human infections.

Focus Area: Identifying the primary means of transmission for HPAI A(H5N1) human infections. This includes animal-to-human zoonotic transmission and transmission via fomites. It also includes assessment of how the virus gains entry and replicates in humans.

Focus Area: Describing the spectrum of human clinical illness, including prevalence of severe illness, illness resulting in hospitalization or death, and asymptomatic and pauci-symptomatic cases.

Focus Area: Describing parameters important to human infection and resolution of illness, including estimated incubation period and duration of infectiousness.

Focus Area: Employing animal models to help describe clinical presentation, virulence, and transmissibility of these HPAI A(H5N1) viruses compared to seasonal and other zoonotic influenza viruses.

Focus Area: Identifying virologic characteristics of HPAI A(H5N1) viruses. Identifying genetic markers associated with increased infectivity, transmissibility or reduced antiviral susceptibility. Tracking genetic changes that occur in the virus during animal and human infections.

Objective 3

Prepare for and mitigate the possibility of an hpai a(h5n1) virus pandemic..

Focus Area: Estimating the pandemic potential of this HPAI A(H5N1) virus with the Influenza Risk Assessment Tool (IRAT) .

Focus Area: Conducting comprehensive antigenic, phenotypic, genotypic, and evolutionary characterization of HPAI A(H5N1) viruses detected in humans and animals.

Focus Area: Identifying candidate vaccine viruses (CVVs) expected to provide protection against currently circulating HPAI A(H5N1) viruses in animals; evaluating antiviral drugs to assess emergence of drug resistant viruses; and developing diagnostic test methods and additional assays to rapidly and accurately identify HPAI A(H5N1) virus infections.

Focus Area: Estimating the impact of nonpharmaceutical interventions and medical counter measures, including pre-pandemic H5 vaccines and potential H5 vaccines made using existing candidate vaccine viruses in preventing infection and/or severe illness, should widespread person-to-person transmission occur.

Focus Area: Coordinating with the WHO's Global Influenza Programme and the Global Influenza Surveillance and Response System (GISRS) and the OFFLU animal health network (World Organisation for Animal Health, Food and Agriculture Organization, and reference laboratories) to support rapid information and resource sharing. As a WHO Influenza Collaborating Centre, the CDC Influenza Division actively supports global surveillance efforts and contributes materials, technical assistance, and data to global veterinary and public health partners to guide pandemic preparedness planning, including development/deployment of H5 diagnostic tests, monitoring for antiviral resistance, recommendations/development of vaccine candidates, and virus risk assessment.

Focus Area: Conducting immunologic and virologic pandemic risk assessment of novel influenza viruses in animal models and other model system.

Focus Area: Determining virus and host factors that impact virulence and transmission of novel influenza viruses, including conducting serology studies to determine the population immunity among the general population to HPAI A(H5N1) viruses.

Focus Area: Evaluating strategies to increase uptake of public health interventions such as vaccines.

Avian influenza or bird flu refers to the disease caused by infection with avian (bird) influenza (flu) Type A viruses.

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Romashkovo in Moscow Oblast Destination Guide Russia

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Romashkovo in Moscow Oblast, Russia

Safety Score: 4,4 of 5.0 based on data from 9 authorites. Meaning please reconsider your need to travel to Russia.

Travel warnings are updated daily. Source: Travel Warning Russia . Last Update: 2024-06-29 08:22:07

Explore Romashkovo

Romashkovo in Moscow Oblast is a city in Russia a little west of Moscow, the country's capital.

Local time in Romashkovo is now 07:37 PM (Saturday). The local timezone is named Europe / Moscow with an UTC offset of 3 hours. We know of 6 airports in the vicinity of Romashkovo, of which two are larger airports. The closest airport in Russia is Vnukovo International Airport in a distance of 10 mi (or 16 km), South. Besides the airports, there are other travel options available (check left side).

There are several Unesco world heritage sites nearby. The closest heritage site in Russia is Ensemble of the Novodevichy Convent in a distance of 9 mi (or 14 km), East. If you need a place to sleep, we compiled a list of available hotels close to the map centre further down the page.

Depending on your travel schedule, you might want to pay a visit to some of the following locations: Cheremushki, Vostochnoe Degunino, Moscow, Krasnaya Pahra and Orekhovo-Borisovo Yuzhnoye. To further explore this place, just scroll down and browse the available info.

Local weather forecast

Todays local weather conditions & forecast: 29°c / 85 °f.

Morning Temperature	20°C / 69 °F
Evening Temperature	29°C / 85 °F
Night Temperature	22°C / 71 °F
	0%
Air Humidity	41%
Air Pressure	1015 hPa
Wind Speed	Gentle Breeze with 6 km/h (4 mph) from East
Cloud Conditions	Scattered clouds, covering 45% of sky
General Conditions	Scattered clouds

Sunday, 30th of June 2024

29°C (84 °F) 23°C (73 °F) Broken clouds, gentle breeze.

Monday, 1st of July 2024

29°C (83 °F) 24°C (75 °F) Broken clouds, gentle breeze.

Tuesday, 2nd of July 2024

31°C (88 °F) 26°C (79 °F) Scattered clouds, gentle breeze.

Hotels and Places to Stay

Barvikha Hotel & Spa

Address 2,9 mi Odintsovsky District, Barvikha Village 114/3, 143083 Barvikhinskoye Russia

Checkout: 12:00 - Checkin: 14:00 Reception Weekday: 0:00 - 24:00 Weekend: 0:00 - 24:00

Postoyalets Hotel

Address 4,6 mi ul. Svobody 1 143007 Odintsovo Russia

Checkout: 23:00 - Checkin: 06:00 Reception Weekday: 0:00 - 24:00 Weekend: 0:00 - 24:00

Park Inn by Radisson Odintsovo

Address 4,4 mi Ul. Nedelina 8 143006 Odintsovo Russia

Romashkovo Farm

Address 0,5 mi Sovetskaya 14 A 143025 Odintsovo Russia

Checkout: 12:00 - Checkin: 13:00 Reception Weekday: 0:00 - 24:00 Weekend: 0:00 - 24:00

Hampton by Hilton Moscow Strogino

Address 5,5 mi Bld. 1 20 Kulakova Street 123592 Moscow Russia

Checkout: 11:59 - Checkin: 14:00 Reception Weekday: - Weekend: closed

Address 2,0 mi Novoivanovskoe rp 93 143025 Novoivanovskoe Russia

Checkout: 12:00 - Checkin: 12:00 Reception Weekday: 0:00 - 24:00 Weekend: 0:00 - 24:00

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Final Draft National Institute of Environmental Health Sciences FY2025-FY2029 Strategic Plan

A Notice by the National Institutes of Health on 06/28/2024

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National Institutes of Health, HHS.

Request for comments.

The goal of the National Institute of Environmental Health Sciences (NIEHS) strategic planning process is to set scientific areas of emphasis and priority approaches to anticipate and meet areas of opportunity for furthering environmental health sciences research, training, and translation. NIEHS makes available the final draft of the FY2025-FY2029 NIEHS Strategic Plan.

Comments must be received by 11:59:59 p.m. (ET) on July 21, 2024, to ensure consideration.

Comments should be submitted by email to [email protected] .

Dr. Nicole J. Garbarini, Office of Scientific Coordination, Planning, and Evaluation, email: [email protected] or call non-toll-free number 301-435-4642.

This Federal Register notice is in accordance with the 21st Century Cures Act, requiring NIH and its Institutes and Centers to regularly update their strategic plans. NIEHS is one of the 27 institutes and centers that makes up the National Institute of Health, and conducts and supports research on factors in the environment that affect human health.

The mission of the NIEHS is to discover how the environment affects people, in order to promote healthier lives. The vision of the NIEHS is to provide global leadership for innovative research that improves public health by preventing disease and disability. NIEHS research covers all organ systems, diseases, and conditions that could be caused or affected by environmental impacts, which are defined broadly. The NIEHS achieves its mission and vision through multidisciplinary biomedical research programs, as well as prevention and intervention efforts. NIEHS research is disseminated to inform evidence-based environmental health policies to prevent disease and protect health. The NIEHS also focuses on communication and research translation strategies that encompass training, education, technology transfer, and community engagement.

During January 31-April 20, 2023, NIEHS solicited input to its strategic planning process through public comments on its 2018-2023 Strategic Plan and its associated goals, as well as any other aspect of environmental health sciences. Approximately 169 unique responses, both individual and group, were received in response to this RFI. In April 2023, NIEHS hosted a virtual community workshop including more than 100 invited participants from across diverse sectors to provide input Start Printed Page 54014 through presentation and discussion of their ideas for priorities of the strategic plan. Reports and recommendations on key topics were generated as output of this workshop. Comment on strategic priorities in environmental health sciences was also solicited through discussion with the the National Advisory Environmental Health Sciences Council and the Board of Scientific Counselors. . Following compilation, curation, and analysis of all input, results of this curation were presented to NIEHS Senior Leadership to inform discussions and development of the plan, including Research Areas of Emphasis. and, and priority approaches for achieving the plan's translational goals.The NIEHS seeks comments from all interested parties on its final draft “FY2025-FY2028 NIEHS Strategic Plan: Health at the Intersection of People and Their Environments.”

The final draft plan may be viewed online at https://www.niehs.nih.gov/​about/​strategicplan/​finaldraft .

Dated: June 20, 2024.

Richard P. Woychik,

Director, National Institute of Environmental Health Sciences and National Toxicology Program.

[ FR Doc. 2024-14241 Filed 6-27-24; 8:45 am]

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