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The Oxford Textbook of Clinical Research Ethics

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The Oxford Textbook of Clinical Research Ethics is the first systematic and comprehensive reference on clinical research ethics. Under the editorship of experts from the National Institutes of Health of the United States, the book offers a wide-ranging and systematic examination of all aspects of research with human beings. Considering historical triumphs of research as well as tragedies, the textbook provides a framework for analysing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the textbook examines issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent as well as focused consideration of international research ethics, conflicts of interests and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research with human beings.

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The Ethics of Research with Human Subjects

Protecting People, Advancing Science, Promoting Trust

• © 2018
• David B. Resnik 0

National Institutes of Health, National Institute of Environmental Health Sciences, Research Triangle Park, USA

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• The first book to develop a philosophical framework for thinking about the ethics of research with human subjects from the perspective of trust
• Provides guidance for investigators and oversight committees based on insights from moral theory, and the psychology and philosophy of trust
• Contains research and guidance of value to both the novice and expert alike

Part of the book series: International Library of Ethics, Law, and the New Medicine (LIME, volume 74)

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Table of contents (12 chapters)

Front matter, introduction.

David B. Resnik

Historical Background

Moral theory, trust as a foundation for research with human subjects, informed consent, privacy and confidentiality, vulnerable subjects, research integrity, regulatory reform, back matter.

• ethics of research
• research with human subjects
• moral theory
• research integrity
• ethics and informed consent
• research ethics
• human research ethics
• the perspective of trust
• ethical research dilemmas
• research design and benefits
• special duties of beneficence

About this book

This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles,contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust.

Authors and Affiliations

About the author.

Dr. Resnik has an M.A. and Ph.D. in philosophy from the University of North Carolina at Chapel Hill and J.D. from Concord University School of Law. He received his B.A. in philosophy from Davidson College.  Dr. Resnik was an Associate and Full Professor of Medical Humanities at the Brody School of Medicine at East Carolina University (ECU) from 1998-2004, and an Associate Director of the Bioethics Center at ECU and University Health Systems from 1998-2004.  Dr. Resnik was Assistant and Associate Professor of Philosophy at the University of Wyoming (UW) from 1990-1998, and Director of the Center for the Advancement of Ethics at UW from 1995-1998. Dr. Resnik has published over 200 articles on various topics in philosophy and bioethics and is the author of 8 books. He serves on several editorial boards and is an Associate Editor of the journal Accountability in Research. Dr. Resnik is also Chair of the NIEHS Institutional Review Board.  Dr. Resnik’s research interests focus on ethical,philosophical, and legal issues in scientific research.  

Bibliographic Information

Book Title : The Ethics of Research with Human Subjects

Book Subtitle : Protecting People, Advancing Science, Promoting Trust

Authors : David B. Resnik

Series Title : International Library of Ethics, Law, and the New Medicine

DOI : https://doi.org/10.1007/978-3-319-68756-8

Publisher : Springer Cham

eBook Packages : Religion and Philosophy , Philosophy and Religion (R0)

Copyright Information : Springer International Publishing AG 2018

Hardcover ISBN : 978-3-319-68755-1 Published: 23 January 2018

Softcover ISBN : 978-3-319-88654-1 Published: 04 June 2019

eBook ISBN : 978-3-319-68756-8 Published: 09 January 2018

Series ISSN : 1567-8008

Series E-ISSN : 2351-955X

Edition Number : 1

Number of Pages : XIII, 316

Number of Illustrations : 12 b/w illustrations

Topics : Research Ethics , Research Methodology , Science, Humanities and Social Sciences, multidisciplinary

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• Research Ethics

Research Ethics

A philosophical guide to the responsible conduct of research.

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• Cited by 14

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• Gary Comstock , North Carolina State University, Raleigh
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Book description

Education in the responsible conduct of research typically takes the form of online instructions about rules, regulations, and policies. Research Ethics takes a novel approach and emphasizes the art of philosophical decision-making. Part A introduces egoism and explains that it is in the individual's own interest to avoid misconduct, fabrication of data, plagiarism and bias. Part B explains contractualism and covers issues of authorship, peer review and responsible use of statistics. Part C introduces moral rights as the basis of informed consent, the use of humans in research, mentoring, intellectual property and conflicts of interests. Part D uses two-level utilitarianism to explore the possibilities and limits of the experimental use of animals, duties to the environment and future generations, and the social responsibilities of researchers. This book brings a fresh perspective to research ethics and will engage the moral imaginations of graduate students in all disciplines.

“…Unique in several respects…it conveys an imperative for ethical thinking, decision-making, and moral action in research…it stimulates the moral imaginations of readers, and motivates a question-asking approach to research ethics..." - Doody's Review Service

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Frontmatter pp i-vi

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Contents pp vii-x

List of contributing authors pp xi-xii, acknowledgments pp xiii-xvi, introduction pp 1-20, part a - protect my interests pp 21-38, 1 - report misconduct pp 39-57, 2 - avoid plagiarism pp 58-67, 3 - beware intuition pp 68-78, 4 - justify decisions pp 79-90, part b - promote our interests pp 91-104, 5 - articulate reasons pp 105-117, 6 - write cooperatively pp 118-132, 7 - protect manuscripts pp 133-143, 8 - clarify statistics pp 144-154, part c - respect strangers’ rights pp 155-168, 9 - inform subjects pp 169-183, 10 - mentor inclusively pp 184-201, 11 - recognize property pp 202-217, 12 - reveal conflicts pp 218-228, part d - honor all interests pp 229-242, 13 - treat humanely pp 243-266, 14 - preserve environments pp 267-273, 15 - cultivate responsibility pp 274-284, conclusion pp 285-287, index pp 288-292, full text views.

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The SAGE Handbook of Qualitative Research Ethics

• Ron Iphofen
• Martin Tolich - University of Otago, New Zealand
• Description

Part One: Thick Descriptions Of Qualitative Research Ethics Part Two: Qualitative Research Ethics By Technique Part Three: Ethics As Politics Part Four : Qualitative Research Ethics With Vulnerable Groups Part Five: Relational Research Ethics Part Six: Researching Digitally

See what’s new to this edition by selecting the Features tab on this page. Should you need additional information or have questions regarding the HEOA information provided for this title, including what is new to this edition, please email [email protected] . Please include your name, contact information, and the name of the title for which you would like more information. For information on the HEOA, please go to http://ed.gov/policy/highered/leg/hea08/index.html .

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This is a landmark collection in the field of qualitative research ethics, and a Handbook with a key message.  The contributions are full of insights about ethical issues in diverse research contexts, populations and methods. Taken together they build the case for an institutional approach to ethical review for qualitative research that can deal with specificity and complexity.  Iphofen and Tolich’s Handbook will be richly informative for academic researchers but it should be required reading for ethics committee members. 

I doubt there are many, if any, qualitative researchers who are not mindful of the ethical responsibilities they bear when investigating social situations. These responsibilities go far beyond the procedural requirements of ethics reviews and require careful thought and on-going review. By considering various ethical perspectives whilst reflecting the diversity of qualitative approaches and techniques, the contributions to this handbook demonstrate the need to treat each research endeavour as a unique instance, requiring a unique ethical response. In doing so it offers a valuable resource to both experienced researchers and those who are just starting out alike.

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The Ethics of Research with Human Subjects: Protecting People, Advancing Science, Promoting Trust (International Library of Ethics, Law, and the New Medicine, 74) 1st ed. 2018 Edition

This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles,contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust.

• ISBN-10 3319687557
• ISBN-13 978-3319687551
• Edition 1st ed. 2018
• Publisher Springer
• Publication date January 23, 2018
• Part of series International Library of Ethics, Law, and the New Medicine
• Language English
• Dimensions 6.14 x 0.94 x 9.21 inches
• Print length 332 pages
• See all details

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Dr. Resnik has an M.A. and Ph.D. in philosophy from the University of North Carolina at Chapel Hill and J.D. from Concord University School of Law. He received his B.A. in philosophy from Davidson College.  Dr. Resnik was an Associate and Full Professor of Medical Humanities at the Brody School of Medicine at East Carolina University (ECU) from 1998-2004, and an Associate Director of the Bioethics Center at ECU and University Health Systems from 1998-2004.  Dr. Resnik was Assistant and Associate Professor of Philosophy at the University of Wyoming (UW) from 1990-1998, and Director of the Center for the Advancement of Ethics at UW from 1995-1998. Dr. Resnik has published over 200 articles on various topics in philosophy and bioethics and is the author of 8 books. He serves on several editorial boards and is an Associate Editor of the journal Accountability in Research. Dr. Resnik is also Chair of the NIEHS Institutional Review Board.  Dr. Resnik’s research interests focus on ethical,philosophical, and legal issues in scientific research.  

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• Publisher ‏ : ‎ Springer; 1st ed. 2018 edition (January 23, 2018)
• Language ‏ : ‎ English
• Hardcover ‏ : ‎ 332 pages
• ISBN-10 ‏ : ‎ 3319687557
• ISBN-13 ‏ : ‎ 978-3319687551
• Item Weight ‏ : ‎ 1.46 pounds
• Dimensions ‏ : ‎ 6.14 x 0.94 x 9.21 inches
• #411 in Business Ethics (Books)
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APA Handbook of Ethics in Psychology

Editor-in-Chief: Samuel J. Knapp, EdD

Available formats

• Table of contents
• Contributor bios
• Book details
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Discussions of ethics in psychology often focus primarily on misconduct, punishment, and legal sanctions, and too often ignore aspirations, values, principles, and virtues. The net effect of this unbalanced approach creates an atmosphere in which psychologists have viewed ethics as unpleasant and frightening, instead of inspiring and uplifting. Psychologists naturally must be concerned about laws, codes, and regulations, but these documents do not constitute the beginning and end of the conversation on ethics.

The editors of this 2-volume reference propose that ethics is best viewed as a striving toward the highest ethical ideals, not just as an injunction against rule violation—a perspective they refer to as "positive ethics" or "active ethics"—and they encourage psychologists to elevate their ethical observance above the minimal standards found in law and enforceable ethics codes.

Against this backdrop, handbook contributors investigate the complexities of ethical behavior in clinical, educational, forensic, health, and "tele-" psychology. Several chapters zero in on the teaching of ethics and on ethically minded research relevant to professionals working in experimental psychology.

By comparison with many ethics textbooks, this two-volume handbook covers a wider range of subjects and pursues them in greater detail. For instance, it reflects important recent advances in research and technology that present new opportunities and challenges for practice and scholarship. Also, it takes a serious look into some burgeoning new areas such as life coaching and providing services over the Internet. These are just two examples of developments that present fascinating, novel ethical questions that deserve attention.

Significant perspectives presented in the handbook include:

Ethics is more than the knowledge of the laws, rules, and regulations that govern the profession and discipline of psychology.

• Competent psychologists rely on overarching ethical theories, as well as laws and regulations, when they live up to their highest ethical ideals.
• Attention to ethical issues is especially important as psychologists move into new and increasingly complex areas of practice.

Volume 1: Moral Foundations and Common Themes

Editorial Board

About the Editor-in-Chief

Contributors

Series Preface

Introduction

I. Moral Foundations

• Ethical Foundations of Psychology Richard F. Kitchener and Karen S. Kitchener
• Ethics and Ethics Codes for Psychologists Stephen H. Behnke and Stanley E. Jones
• Social Justice and Civic Virtue Melba Vasquez
• Ethical Decision Making in Mental Health Contexts: Representative Models and an Organizational Framework R. Rocco Cottone
• Institutional Ethical Conflicts With Illustrations From Police and Military Psychology Carrie H. Kennedy

II. Ethics in Professional Practice

• Competence Thomas F. Nagy
• Emotional Competence and Well-Being Leonard J. Tamura
• Competence With Diverse Populations Dianne S. Salter and Beatrice R. Salter
• Boundaries, Multiple Roles, and the Professional Relationship Rita Sommers-Flanagan
• Religion, Spirituality, and Mental Health Alan C. Tjeltveit
• Sexualized Relationships Janet L. Sonne
• Informed Consent to Psychotherapy (Empowered Collaboration) Andrew M. Pomerantz
• Confidentiality and Record Keeping Mary Alice Fisher
• Treating Clients Who Threaten Others or Themselves Elizabeth Reynolds Welfel, James L. Werth Jr., and G. Andrew H. Benjamin
• Ethical Issues With Patients at a High Risk for Treatment Failure Samuel J. Knapp and John Gavazzi
• Ethical Issues and the Beginning and End of Therapy Jeffrey N. Younggren and Denise D. Davis
• Ethics and Business Issues in Psychology Practice Jeffrey E. Barnett and Lindsay Klimik
• The Regulation of Professional Psychology Stephen T. DeMers and Jack B. Schaffer
• Risk Management for Psychologists Samuel J. Knapp, Bruce E. Bennett, and Leon D. VandeCreek

Volume 2: Practice, Teaching, and Research

I. ethical issues with subpopulations, specialized settings, and emerging areas.

• Treating Children and Adolescents Gerald P. Koocher and Jessica Henderson Daniel
• Ethical Considerations in the Psychological Evaluation and Treatment of Older Adults Shane S. Bush
• Ethical Issues in Multiperson Therapy Linda K. Knauss and Jeffrey W. Knauss
• Assessment and Testing Donald N. Bersoff, David DeMatteo, and Elizabeth E. Foster
• The Health Care Setting: Implications for Ethical Psychology Practice Stephanie L. Hanson and Thomas R. Kerkhoff
• Ethical Challenges in Forensic Psychology Practice Michael C. Gottlieb and Alicia Coleman
• School Psychology Susan Jacob and Megan M. Kleinheksel
• Ethics in Industrial–Organizational Psychology Joel Lefkowitz
• Life and Executive Coaching: Some Ethical Issues for Consideration Sharon K. Anderson, Patrick Williams, and Allison L. Kramer
• The More Things Change, the More They Stay the Same: Ethical Issues in the Provision of Telehealth Anthony S. Ragusea
• Positive Ethics Applied to Public Education Through Traditional Media and the Internet David J. Palmiter Jr.

II. Ethical Issues of Academic and Training Psychologists

• Creating Ethical Academic Cultures Within Psychology Programs Peter A. Keller, J. Dennis Murray, and David S. Hargrove
• Negotiating the Complex Ethical Terrain of Clinical Supervision Rodney K. Goodyear and Emil Rodolfa
• Teaching Ethics: Models, Methods, and Challenges Elizabeth Reynolds Welfel

III. Ethical Issues in Scholarship and Research

• Ethics Issues in Scholarship Jeffrey E. Barnett and Linda F. Campbell
• The Responsible Conduct of Psychological Research: An Overview of Ethical Principles, APA Ethics Code Standards, and Federal Regulations Celia B. Fisher and Karyn Vacanti-Shova
• Research With Vulnerable Populations Joan E. Sieber
• Ethical Issues in Internet Research Michael Hoerger and Catherine Currell
• Deception in Research Allan J. Kimmel
• Laboratory Animal Research Ethics: A Practical, Educational Approach Jennifer L. Perry and Nancy K. Dess

Samuel J. Knapp, EdD, ABPP, has been the director of professional affairs for the Pennsylvania Psychological Association since 1987. His primary area of interest is in professional ethics. His other areas of interest include mental health and well-being, public policy advocacy, and religion and psychology.

In addition to writing several books, numerous book chapters, and more than 80 peer reviewed articles, Dr. Knapp has given more than 250 professional presentations, mostly on ethical issues. Through his work with the Pennsylvania Psychological Association, Dr. Knapp has provided thousands of consultations on ethics to psychologists. In return, these consultees have enriched him by instructing him on the issues they face daily, and their issues provide much of the content for his publications and presentations. He feels much appreciation for the board of directors of the Pennsylvania Psychological Association for allowing him to serve the psychological community in Pennsylvania in this manner.

Among his other ethics related activities, Dr. Knapp coordinates an annual "Ethics Educators" workshop in Pennsylvania; has served as a member of the Task Force responsible for rewriting the 2002 APA Ethical Principles of Psychologists and Code of Conduct ; coauthored an ethics text book ( Practical Ethics: A Positive Approach with Leon D. VandeCreek); served as a consultant for the APA Insurance Trust, where he worked on the well-received book Assessing and Managing Risk in Professional Practice ; and received the 2009 award for ethics education from the APA Ethics Committee. He also teaches ethics in the doctoral program in clinical psychology at the Philadelphia College of Osteopathic Medicine.

Dr. Knapp is part of a cadre of psychologists, most of whom participated in this volume, who work from the framework of positive (or active, or integrated) ethics, which attempts to shift the focus on ethics education away from an emphasis on laws and disciplinary actions to a broader approach that appreciates the importance of overarching ethical principles and striving for ethical ideals. A positive perspective permeates many of the chapters in this handbook.

Dr. Knapp is married to Dr. Jane Heesen Knapp, an accomplished psychologist in her own right. They have two children, Michelle Nakasone (married to Jon Nakasone) and Valerie Dietrich (engaged to Greg McClellan); one grandson, Cale Nakasone; and currently share their loving home with Lucy, a mixed breed terrier, and Violet, a Manx cat.

Include handbook chapters in customized course books with APA Custom Course Books .

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StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

StatPearls [Internet].

Research ethics.

Jennifer M. Barrow ; Grace D. Brannan ; Paras B. Khandhar .

Affiliations

Last Update: September 18, 2022 .

• Introduction

Multiple examples of unethical research studies conducted in the past throughout the world have cast a significant historical shadow on research involving human subjects. Examples include the Tuskegee Syphilis Study from 1932 to 1972, Nazi medical experimentation in the 1930s and 1940s, and research conducted at the Willowbrook State School in the 1950s and 1960s. [1]  As the aftermath of these practices, wherein uninformed and unaware patients were exposed to disease or subject to other unproven treatments, became known, the need for rules governing the design and implementation of human-subject research protocols became very evident.

The first such ethical code for research was the Nuremberg Code, arising in the aftermath of Nazi research atrocities brought to light in the post-World War II Nuremberg Trials. [1]  This set of international research standards sought to prevent gross research misconduct and abuse of vulnerable and unwitting research subjects by establishing specific human subject protective factors. A direct descendant of this code was drafted in 1978 in the United States, known as the Belmont Report, and this legislation forms the backbone of regulation of clinical research in the USA since its adoption. [2]  The Belmont Report contains 3 basic ethical principles:

• Respect for persons
• Beneficence

Additionally, the Belmont Report details research-based protective applications for informed consent, risk/benefit assessment, and participant selection. [3]

• Issues of Concern

The first protective principle stemming from the 1978 Belmont Report is the principle of Respect for Persons, also known as human dignity. [2]  This dictates researchers must work to protect research participants' autonomy while also ensuring full disclosure of factors surrounding the study, including potential harms and benefits. According to the Belmont Report, "an autonomous person is an individual capable of deliberation about personal goals and acting under the direction of such deliberation."  [1]

To ensure participants have the autonomous right to self-determination, researchers must ensure that potential participants understand that they have the right to decide whether or not to participate in research studies voluntarily and that declining to participate in any research does not affect in any way their access to current or subsequent care. Also, self-determined participants must be able to ask the researcher questions and comprehend the questions asked by the researcher. Researchers must also inform participants that they may stop participating in the study without fear of penalty. [4]  As noted in the Belmont Report definition above, not all individuals can be autonomous concerning research participation. Whether because of the individual's developmental level or because of various illnesses or disabilities, some individuals require special research protections that may involve exclusion from research activities that can cause potential harm or appointing a third-party guardian to oversee the participation of such vulnerable persons. [5]

Researchers must also ensure they do not coerce potential participants into agreeing to participate in studies. Coercion refers to threats of penalty, whether implied or explicit, if participants decline to participate or opt out of a study. Additionally, giving potential participants extreme rewards for agreeing to participate can be a form of coercion. The rewards may provide an enticing enough incentive that the participant feels they need to participate. In contrast, they would otherwise have declined if such a reward were not offered. While researchers often use various rewards and incentives in studies, they must carefully review this possibility of coercion. Some incentives may pressure potential participants into joining a study, thereby stripping participants of complete self-determination. [3]

An additional aspect of respecting potential participants' self-determination is to ensure that researchers have fully disclosed information about the study and explained the voluntary nature of participation (including the right to refuse without repercussion) and possible benefits and risks related to study participation. A potential participant cannot make a truly informed decision without complete information. This aspect of the Belmont Report can be troublesome for some researchers based on their study designs and research questions. Noted biases related to reactivity may occur when study participants know the exact guiding research questions and purposes. Some researchers may avoid reactivity biases using covert data collection methods or masking critical study information. Masking frequently occurs in pharmaceutical trials with placebos because knowledge of placebo receipt can affect study outcomes. However, masking and concealed data collection methods may not fully respect participants' rights to autonomy and the associated informed consent process. Any researcher considering hidden data collection or masking of some research information from participants must present their plans to an Institutional Review Board (IRB) for oversight, as well as explain the potential masking to prospective patients in the consent process (ie, explaining to potential participants in a medication trial that they are randomly assigned either the medication or a placebo). The IRB determines if studies warrant concealed data collection or masking methods in light of the research design, methods, and study-specific protections. [6]

The second Belmont Report principle is the principle of beneficence. Beneficence refers to acting in such a way to benefit others while promoting their welfare and safety. [7]  Although not explicitly mentioned by name, the biomedical ethical principle of nonmaleficence (not harm) also appears within the Belmont Report's section on beneficence. The beneficence principle includes 2 specific research aspects:

• Participants' right to freedom from harm and discomfort
• Participants' rights to protection from exploitation  [8]

Before seeking IRB approval and conducting a study, researchers must analyze potential risks and benefits to research participants. Examples of possible participant risks include physical harm, loss of privacy, unforeseen side effects, emotional distress or embarrassment, monetary costs, physical discomfort, and loss of time. Possible benefits include access to a potentially valuable intervention, increased understanding of a medical condition, and satisfaction with helping others with similar issues. [8]  These potential risks and benefits should explicitly appear in the written informed consent document used in the study. Researchers must implement specific protections to minimize discomfort and harm to align with the principle of beneficence. Under the principle of beneficence, researchers must also protect participants from exploitation. Any information provided by participants through their study involvement must be protected.

The final principle contained in the Belmont Report is the principle of justice, which pertains to participants' right to fair treatment and right to privacy. The selection of the types of participants desired for a research study should be guided by research questions and requirements not to exclude any group and to be as representative of the overall target population as possible. Researchers and IRBs must scrutinize the selection of research participants to determine whether researchers are systematically selecting some groups (eg, participants receiving public financial assistance, specific ethnic and racial minorities, or institutionalized) because of their vulnerability or ease of access. The right to fair treatment also relates to researchers treating those who refuse to participate in a study fairly without prejudice. [3]

The right to privacy also falls under the Belmont Report's principle of justice. Researchers must keep any shared information in their strictest confidence. Upholding the right to privacy often involves procedures for anonymity or confidentiality. For participants' data to be completely anonymous, the researcher cannot have the ability to connect the participants to their data. The study is no longer anonymous if researchers can make participant-data connections, even if they use codes or pseudonyms instead of personal identifiers. Instead, researchers are providing participant confidentiality. Various methods can help researchers assure confidentiality, including locking any participant identifying data and substituting code numbers instead of names, with a correlation key available only to a safety or oversight functionary in an emergency but not readily available to researchers. [3]

• Clinical Significance

One of the most common safeguards for the ethical conduct of research involves using external reviewers, such as an Institutional Review Board (IRB). Researchers seeking to begin a study must submit a full research proposal to the IRB, which includes specific data collection instruments, research advertisements, and informed consent documentation. The IRB may perform a complete or expedited review depending on the nature of the study and the risks involved. Researchers cannot contact potential participants or start collecting data until they obtain full IRB approval. Sometimes, multi-site studies require approvals from several IRBs, which may have different forms and review processes. [3]

A significant study aspect of interest to IRB members is using participants from vulnerable groups. Vulnerable groups may include individuals who cannot give fully informed consent or those individuals who may be at elevated risk of unplanned side effects. Examples of vulnerable participants include pregnant women, children younger than the age of consent, terminally ill individuals, institutionalized individuals, and those with mental or emotional disabilities. In the case of minors, assent is also an element that must be addressed per Subpart D of the Code of Federal Regulations, 45 CFR 46.402, which defines consent as "a child's affirmative agreement to participate in research; mere failure to object should not, absent affirmative agreement, be construed as assent."  [9] There is a lack in the literature on when minors can understand research, although current research suggests that the age by which a minor could assent is around 14. [10]  Anytime researchers include vulnerable groups in their studies, they must have extra safeguards to uphold the Belmont Report's ethical principles, especially beneficence. [3]

• Enhancing Healthcare Team Outcomes

Research ethics is a foundational principle of modern medical research across all disciplines. The overarching body, the IRB, is intentionally comprised of experts across various disciplines, including ethicists, social workers, physicians, nurses, other scientific researchers, counselors, mental health professionals, and advocates for vulnerable subjects. There is also often a legal expert on the panel or available to discuss any questions regarding the legality or ramifications of studies.

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Disclosure: Jennifer Barrow declares no relevant financial relationships with ineligible companies.

Disclosure: Grace Brannan declares no relevant financial relationships with ineligible companies.

Disclosure: Paras Khandhar declares no relevant financial relationships with ineligible companies.

This book is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) ( http://creativecommons.org/licenses/by-nc-nd/4.0/ ), which permits others to distribute the work, provided that the article is not altered or used commercially. You are not required to obtain permission to distribute this article, provided that you credit the author and journal.

• Cite this Page Barrow JM, Brannan GD, Khandhar PB. Research Ethics. [Updated 2022 Sep 18]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

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• The historical, ethical, and legal background of human-subjects research. [Respir Care. 2008] The historical, ethical, and legal background of human-subjects research. Rice TW. Respir Care. 2008 Oct; 53(10):1325-9.
• The Belmont Report at 40: Reckoning With Time. [Am J Public Health. 2018] The Belmont Report at 40: Reckoning With Time. Adashi EY, Walters LB, Menikoff JA. Am J Public Health. 2018 Oct; 108(10):1345-1348. Epub 2018 Aug 23.
• Informed consent in human experimentation before the Nuremberg code. [BMJ. 1996] Informed consent in human experimentation before the Nuremberg code. Vollmann J, Winau R. BMJ. 1996 Dec 7; 313(7070):1445-9.
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Big and little histories: sizing up ethics in historiography.

This book introduces students to ethics in historiography through an exploration of how historians in different times and places have explained how history ought to be written and how those views relate to different understandings of ethics. No two histories are the same. The book argues that this is a good thing because the differences between histories are largely a matter of ethics. Looking to histories made across the world and from ancient times until today, readers are introduced to a wide variety of approaches to the ethics of history, including well-known ethical approaches, such as the virtue ethics of universal historians, and utilitarian approaches to collective biography writing while also discovering new and emerging ideas in the ethics of history. Through these approaches, readers are encouraged to challenge their ideas about whether humans are separate from other living and non-living things and whether machines and animals can write histories. The book looks to the fundamental questions posed about the nature of history making by Indigenous history makers and asks whether the ethics at play in the global variety of histories might be better appreciated in professional codes of conduct and approaches to research ethics management. Opening up the topic of ethics to show how historians might have viewed ethics differently in the past, the book requires no background in ethics or history theory and is open to all of those with an interest in how we think about good histories.

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Emma Campbell is Associate Professor/Reader in the School of Modern Languages and Cultures at The University of Warwick (U.K.). Focusing on medieval textual traditions written in French, Campbell’s research considers how the study of medieval culture can speak to modern and contemporary ideas, notably in relation to feminist, queer, and transgender studies, postcolonial theory, and translation studies. Her scholarship is interested in how the medieval past and critical theory unsettle received ideas and, in so doing, offer ways to explore alternative perspectives on familiar concepts and historical narratives. Campbell has published on a broad range of medieval French texts prior to the fourteenth century, including major traditions such as saints’ lives and bestiaries. Her work has been supported by numerous awards, including grants from U.K. funding bodies such as the Arts and Humanities Research Council. Her most recent book, Reinventing Babel in Medieval French: Translation and Untranslatability (c. 1120–c. 1250) , contributes both to discussions of premodern authorship and textuality, and to debates about the importance of historical translation beyond medieval studies. Earlier publications on saints, including Campbell’s first book Medieval Saints’ Lives: The Gift, Kinship and Community in Old French Hagiography , explore how medieval hagiography provides an important site for challenging established social, sexual, and gender norms. Campbell is co-editor of Rethinking Medieval Translation: Ethics, Politics, Theory and of Troubled Vision: Gender, Sexuality and Sight in Medieval Text and Image . Her new book project, A Moral Ecology of Creation , explores the importance of another major medieval textual tradition for questions of enduring relevance to the present, by examining how medieval bestiaries have an unexpected significance for sex-gender histories.

Research Focus

A Moral Ecology of Creation: Gender and Sexuality in Medieval French Bestiaries

While at the Society for the Humanities, Campbell will work on a third monograph, provisionally titled A Moral Ecology of Creation: Gender and Sexuality in Medieval French Bestiaries . Medieval bestiaries are moralized accounts of the natural world that describe animals, birds, and stones and interpret them in Christian terms. These texts circulated widely in medieval Europe, often in illuminated copies. A Moral Ecology of Creation argues that bestiaries—particularly those in French—are part of the long history of sex-gender diversity and, within that setting, speak back to cultural discourses that presume nature’s timelessness and universality, including concepts of ‘natural’ sex and gender. This book project relates to the theme of ‘Crossings’ both by adopting an intersectional approach to the shifting forms that gender and sexuality take in bestiaries and by attending to the linguistic and formal crossings that condition how such texts participate in the history of sex-gender plurality. A Moral Ecology of Creation , the first in-depth study of sex and gender in Latin and vernacular bestiaries, explores how current research on sex-gender formations—including scholarship in transgender studies and animal studies—can elucidate bestiaries’ multifaceted treatment of gender and sexuality in text and image. It shows how the ‘moral ecology’ of bestiaries’ engagements with nature—the way these texts use non-human beings to reflect on the ethics of gendered embodiment, sexuality, and social behaviour among humans—varies over time and across different bestiary redactions. This imaginative shaping of gender and sexuality by reference to the natural, creaturely world opens new ways of understanding not only the historical complexity of sex and gender definition but also the capacious vision of gender and sexuality that defines pre-modern conceptions of nature.

SHUM Courses - Spring 2024

• SHUM 4689 : Sex, Gender, and the Natural World in Medieval Culture
• SHUM 6689 : Sex, Gender, and the Natural World in Medieval Culture