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Ensuring ethical standards and procedures for research with human beings

Research ethics govern the standards of conduct for scientific researchers. It is important to adhere to ethical principles in order to protect the dignity, rights and welfare of research participants. As such, all research involving human beings should be reviewed by an ethics committee to ensure that the appropriate ethical standards are being upheld. Discussion of the ethical principles of beneficence, justice and autonomy are central to ethical review.

WHO works with Member States and partners to promote ethical standards and appropriate systems of review for any course of research involving human subjects. Within WHO, the Research Ethics Review Committee (ERC) ensures that WHO only supports research of the highest ethical standards. The ERC reviews all research projects involving human participants supported either financially or technically by WHO. The ERC is guided in its work by the World Medical Association Declaration of Helsinki (1964), last updated in 2013, as well as the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS 2016).

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About the UCL Research Ethics Committee

To support our reforms, the Research Innovation and Global Engagement Committee (RIGEC) has approved a new governance structure for research ethics at UCL. Find out more below.

Research ethics is fundamental to UCL's mission as a world-class institution dedicated to the continued pursuit of original knowledge and scientific advancement to benefit humanity and the world of the future. Research ethics committees play a central role in ensuring that research meets the highest standards of academic rigour, transparency, accountability and ethics, to safeguard and empower participants

These high standards are essential for ensuring the highest quality research and maintaining the continued trust and confidence of the wider research community and the public.

What does the UCL REC do?

The UCL Research Ethics Committee (UCL REC) has been established as a strategic committee with overarching responsibility for research ethics policy, guidance and processes at UCL. There are 3 subcommittees, including 2 to review both high and low-risk applications* (from non-LREC areas):

Life and Medical Sciences Research Ethics Committee (LMS REC) : Brain Sciences, Life Sciences, Population Health Sciences and Medical Science
Humanities, Arts and Sciences Research Ethics Committee (HAS REC) : Arts and Humanities, Bartlett, Institue of Education, Laws, Social and Historical Sciences, Mathematical and Physical Sciences and Engineering Sciences
The LREC Chairs Group: For the Chairs of the 24 Local Research Ethics Committees (LRECs) operating in faculties and departments, to facilitate the sharing of best practice and developing consistent approaches to emerging ethical issues.

Our 2 central reviewing committees will be multi-disciplinary with cross-UCL faculty representatives working in different fields and disciplines.

We are working with faculties on the membership of these committees. If you are enthusiastic about promoting ethical research practices and contributing to the advancement of knowledge at UCL, find out more about joining an ethics committee on our Become an ethics committee member page.

* High-risk applications submitted for the March 2024 deadline will undergo review by the existing UCL REC. Low-risk applications will continue to be considered on a rolling basis with applications being reviewed in order of submission.

Terms of Reference

To maintain strategic oversight of research ethics at UCL.
To develop and review institutional policy and processes on research ethics to ensure they remain fit for purpose and respond to evolving research and ethics.
To ensure that ethics policy and processes and are in line with the principles set out in the UCL Code of Conduct for Research, UCL’s commitments to equality, diversity, and inclusion, and best practice in governance.
To oversee the work of the reviewing subcommittees and to review and recommend any required changes to the research ethics governance structure.
To review and approve proposals for the establishment of new low-risk LREC Chairs Group.
To receive and discuss reports from reviewing committees on complex ethical issues, recommending approaches, approving and implementing UCL-wide guidance and commissioning expert guidance where required.
To monitor and audit practice through the receipt of annual reports and to conduct other audits as required.
To review and suggest improvements required to the research ethics IT system.
To ensure that appropriate training and advice is available for staff, supervisors and students on good practice in relation to the ethics of their research.
To develop, implement and review the system of appeals, complaints and adverse events or incidents reported regarding ethically approved research.
To report on an annual basis to UCL Research, Innovation and Global Engagement Committee an overview of the effectiveness of current ethics policy, practices and procedures in that reporting year.

The UCL REC membership will comprise Chairs from the reviewing committees, LREC Chairs Group (representing LRECs) and a range of experts to inform and support the ongoing development of research ethics review policy and process.

Page last updated: May 2024

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Research ethics committees: A forum where scientists, editors, and policymakers can cooperate during pandemics

Francesco chirico.

1 Post-graduate School of Occupational Health, Università Cattolica del Sacro Cuore, Rome, Italy

2 Centro Sanitario Polifunzionale di Milano, Health Service Department, Italian State Police, Ministry of the Interior, Milan, Italy

Katrina A. Bramstedt

3 Department of Medicine, Khalifa University College of Medicine and Health Sciences, Abu Dhabi, UAE

During public health pandemics such as COVID-19, cooperative behaviors among scientists, journal editors, policy makers and research ethics committees, are essential to promote scientific integrity and societal trust in translational research and resultant public health decisions. This cooperation is possible by expanding the current way of working to include stakeholders beyond the research team via community events and special communication channels sponsored by research ethics committees. Research ethics committees with wider communication channels, increased transparency, and enhanced knowledge exchange have the potential to improve research design, performance, dissemination, and ultimately public benefit.

During the Coronavirus Disease 2019 (COVID-19) pandemic, a fast-track peer review of COVID-19 papers submitted to journals has replaced the traditional, more time-consuming peer review process, causing concern among stakeholders in scholarly publishing. 1 However, “quick publishing” 2 is a pandemic-related phenomenon that may produce low-quality literature and, subsequently, more retractions. 3 Sometimes, even retracted articles continue to be repeatedly cited by sloppy scholars. Additionally, predatory journals and researchers can leverage the pandemic as a tool to propel their own goals. 4 Predatory journals were a troublesome presence long-before the emergence of COVID-19; however, the fast pace and competitive pandemic research setting is a ripe arena making researchers an easy target by these unscrupulous journals that provide little or no peer review, rapid publishing, and open access. 5 COVID-19 is one of the biggest public health challenges the world has confronted, and rapid, high-quality research plays a key role in the fight against the virus. Identifying categories of people that should be prioritized for COVID-19 vaccination (including boosters), as well as lockdown and physical distancing policies, are examples of how decision-making relies on scientific findings. 6 , 7 When scientists and policymakers have different attitudes and goals, this can hamper collaboration; 8 however, by working together during pandemics such as COVID-19, scientific findings can be translated into beneficial policies and procedures for the health of society.

Worldwide, the role of research ethics committees (also known as institutional review boards) has been to review and approve human research proposals to ensure novel research questions, robust study design, and the protection of research participant safety and welfare. Committee structure is generally a mix of lay volunteers and professional scientists, sometimes with subspecialty committees (e.g. social science, medical). Ideally, research ethics committees should have a multidisciplinary membership that reaches beyond the science, and also includes ethicists and patients concerned with the contextual aspects of research that impact methodology, data privacy, and the application of the research across populations. 9 The Chair at the helm of these committees is expected to guide the review process to ensure timely and constructive feedback to researchers so that their research protocols are optimized before receiving approval for study launch.

To do their job effectively, research ethics committees need to understand the research they are reviewing. Part of achieving this is by way of assigning protocol reviews to topic specialists within the committee, as well as the use of external expert reviewers as needed. Additionally, the committees can receive input from the Principal Investigator directly, answering queries and providing clarifications. We propose that the input mechanism to research ethics committees be widened for additional purposes related to understanding research proposals, as well as stakeholder opinions, and community impact. If publishers interface with research ethics committees, they can potentially develop better understandings of jurisdictional approval/exemption requirements, thereby avoiding publication delays due to incorrect assumptions or lack of awareness. If policy makers interface with research ethics committees, they can potentially develop an understanding of research risks and benefits across communities—something that is especially important if their community is facing a public health threat and they are vulnerable (e.g. socioeconomically disadvantaged, special cultural values).

While there is a time for closed [private] sessions, research ethics committees should be open to dialog with all research stakeholders (not only scientists) to gain a fuller understanding of research applications and implications, risks and benefits, and strategies for risk mitigation, as well as optimized delivery of the research review process so as to ensure a timely study launch (reducing study delays). This view is consistent with that of the World Health Organization which states, “For a [committee] decision to be ethically legitimate, it must be made in an open and inclusive process that takes into account the views of all stakeholders. Thus, research ethics committees should be encouraged to include individuals from diverse professional and social backgrounds and, where appropriate, to solicit input proactively from the community.” 9

Johns Hopkins Medicine Institutional Review Board (a research ethics committee in USA) provides an annual Community Day during which the public is invited to dialog with them about research ethics, research protections, and the research review process. 10 Events like these are important because research ethics committees and research participants (patients/community members) can have differing views regarding priorities. 11 Also, community-based participatory research will benefit from direct interaction with research ethics committees because research has shown that often these committees are not prepared for this type of research with these key stakeholders who are in fact helping shape the research question, recruit participants, collect study data, and disseminate the study results back to their community. 12 Committee events such as these could also provide a mechanism for transparent mediation of power struggles between research stakeholders. Ideally, these external research ethics committee events should be more frequent than annual, especially during public health crises when the public is participating in vaccine and treatment clinical trials, and the pharmaceutical industry has a duality of priorities (i.e. producing safe and effective product and making profit for shareholders). Community Days and other stakeholder events can be held in virtual formats using teleconferencing technology when public health crises demand physical distancing.

In Iran, three main working groups have been set up to manage COVID-19 research, including (1) research on epidemiology and public health, (2) clinical research, and (3) basic science and virology research. 13 These committees are having an additional role in research monitoring, not just protocol review. Monitoring is usually a function performed by the research sponsor, but in this instance, the committees are potentially having additional impact in research quality by checking the conduct of research themselves. In the context of COVID-19 and vaccine research, decisions to pause or abort studies or pause distribution of emergency-authorized vaccines can have profound research and clinical implications. 14

Research ethics committees and associated data safety monitoring boards are the canaries in the mines who should be audible voices not bullied by sponsors or governments. Their advocacy for science and public safety as well as research integrity means viewing them in the research co-working space, as well as the regulatory/governance space. This lens shift allows for a change in tone in the research workplace, creating a culture which is more conducive to stakeholder collaboration and shared decision-making (rather than bullying). While various governance boards will ultimately render decisions, a shared decision-making approach from the lens of collaboration and co-working potentially fosters data sharing and dialog for public health benefit.

In situations of alleged research misconduct, research ethics committees should collaborate with journal editors and publishers to ensure that the investigative process is not delayed. Timely evidence sharing in tandem with fair and expert investigations will promote prompt retraction of research which has ethical and/or scientific misconduct, limiting its use and reuse. During these situations, it is vital that research ethics committee members are free from external pressures and are able to dialog without intimidation or conflict from research stakeholders. In the end, research outputs should be trusted scientific evidence for use by government policymakers, and health officers in their pursuit of public health and safety. 8

The time burdens and administrative strain of research ethics committees are well-known, thus the idea of more tasks may not be embraced. Widening the research ethics committee's current work area might at first seem burdensome, but with efficient planning and organization of events and communication channels, the broader benefits could prove worthwhile. It would be interesting to pilot an “enhanced” research ethics committee offering service lines for editors, community, and policy-makers.

In conclusion, cooperation between scientists, editors and policymakers is essential to promote the scientific integrity of COVID-19 research and public trust. Working together does not erode stakeholder autonomy, rather it gives the autonomy of each a voice which needs to be heard, especially during the urgency of a pandemic. Research ethics committees need freedom to perform their tasks without pressure from researchers, politicians, policymakers, and funders. In the setting of a pandemic, there are many stakeholders, scientific unknowns, and time pressure. With a multiplicity of competing interests, the setting can easily be a ‘boxing ring’ of personalities and agendas; however, a collaborative forum for perspectives, debate, and ethically-driven solutions is possible. This shifts the sometimes impression of research ethics committees as a scientific bottleneck 15 to a cooperative working space. 13 Research ethics committees evolve from gatekeepers, to also a forum where all stakeholders come together to speak up for the benefit of science and society.

Declaration of conflicting interests: Prof Chirico is Co-Founder and Co- Editor in Chief of the Italy-based journal, Journal of Health and Social Sciences

Funding: The author(s) received no financial support for the research, authorship and/or publication of this article.

ORCID iD: Francesco Chirico https://orcid.org/0000-0002-8737-4368

Research organisations and research ethics committees - ESRC

Criteria for research ethics committee review.

These principles should be considered in relation to the nature of the research outlined, the context in which it is undertaken and the accepted norms and standards set by professional societies, disciplinary bodies and research organisations (ROs).

Researchers, ROs and research ethics committees (RECs) must ensure all proposals that have been recommended for funding by ESRC are appropriately reviewed before the actual research commences.

Role of a REC

A REC should review the research proposal and make a proportionate judgement concerning whether there is an appropriate balance of risks and benefits of the research.

RECs should give due regard to the consequences of the research for those directly involved in and affected by it, and to the interests of those who do not take part in the research but who might benefit or suffer from its outcomes in the future.

RECs also need to balance the safety of researchers, especially where they are working in covert situations or conducting lone fieldwork, and the benefits of the research.

RECs should review research proposals in terms of their ethics probity which will include consideration of the design, outputs and proposed conduct of the research. These should be considered in terms of the ethics issues raised (for example, whether the method of recruitment proposed puts undue pressure on individuals to participate) and the way in which they are addressed.

The scholarly or scientific standards or merits of the research are not the primary responsibility of the REC – these should be evaluated by appropriate peer review. Where the REC needs greater understanding of the scientific or scholarly merit of a proposal in order to make a judgement about ethics issues, it should seek the advice of an independent researcher with experience and expertise in the research methods and paradigm described in the proposal.

The knowledge and expectations that members of RECs bring to the ethics review of research proposals are fundamental to the way they are reviewing. This is particularly clear in some forms of qualitative research where it may be impossible or undesirable to obtain signed consent from each respondent at the outset of the research.

Where more than one perspective or ethics principle applies to a specific case, clear ethics reasoning will be required and debate should be encouraged.

Good ethics review requires sensitivity to the context in which a research study will be conducted, and good ethics reasoning requires careful thought and consideration.

Working collaboratively with researchers will best engage them in achieving the highest ethics standards in their work. Ethics review should be seen as a valuable part of research design, execution and dissemination rather than a troublesome hurdle to jump.

REC decision

RECs may give a favourable opinion on the proposal as submitted, give a provisional approval subject to the researcher meeting specified conditions (which may require further review), or reject the proposal on ethics grounds.

RECs should record and make clear how they come to their decisions, including whether ‘lead reviewers’ are designated for a proposal and whether decisions can be made on the basis of a majority view.

The decision made for a proposal, and the grounds on which it was made, should be recorded and provided to the researchers, and a copy kept on file with the proposal for a specified minimum period consistent with the RO’s policy on information retention. This period should extend beyond the lifetime of the project.

Accountability of REC decisions should be ensured within RO governance structures, and opinions given by RECs should be open to scrutiny. Certain aspects of research may need to remain confidential; for example, intellectual property needs to be protected, as do research findings pre-publication.

There should be clarity in REC operating procedures to ensure that this balance between openness and protection is consistently maintained.

Where a proposal does not meet the expected ethics standards or changes are required, it is important for the REC to give clear feedback on what needs to be amended.

Where an ethics proposal of ESRC-funded research is rejected, the ESRC lead officer should be notified by the RO representative (which may be the principal investigator or the RO’s research support office).

Ongoing review

As part of RO governance, RECs should serve to maintain ethics standards throughout the research lifecycle of a project and effectively and rapidly support researchers in resolving ethics issues as they arise. Ongoing monitoring and support should be proportionate to the nature and degree of risk and harm encountered in the research.

Where a study design is emergent, the REC should agree, with the researchers, procedures for ongoing ethics review (for example through submission of staged ethics applications relating to different aspects of the work, or through a Project Advisory Group).

Procedures for reporting to the REC (or a designated sub-committee) any unforeseen events that might challenge the ethical conduct of the research or which might provide grounds for discontinuing the study should be formally agreed with the researchers.

Where a REC or a designated sub-committee considers that a monitoring report or ad hoc audit by the RO has raised significant concerns about the ethics in the conduct of the study, it should request a full and detailed account of the research to be submitted for full ethics review conducted by the responsible REC. The REC should review the implications of the issues with assistance from non-conflicting advisory bodies, independent experts and mentors if required.

Where a principal REC or designated sub-committee considers that a study is being conducted in a way which is not in accord with the conditions of its review or in a way which does not appropriately protect the rights, dignity and welfare of research participants, it should initially arrange a meeting of all those concerned with a view to resolving the difficulties. In an extreme situation, the REC may withdraw its favourable opinion, and recommend to the appropriate body in the RO that the research be suspended or discontinued. ESRC should be informed of this decision and reserves the right to recoup its grant funding in extreme cases of ethics and research misconduct, pending further investigation.

Last updated: 16 March 2023

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The Structure and Function of Research Ethics Committees in Africa: A Case Study

* To whom correspondence should be addressed. E-mail: [email protected]

Adnan Ali Hyder,
Ademola Ajuwon,
John Appiah-Poku,
Nicola Barsdorf,
Dya Eldin Elsayed,
Mantoa Mokhachane,
Bavon Mupenda,
Paul Ndebele,
Godwin Ndossi,
Bornwell Sikateyo,
Godfrey Tangwa,
Paulina Tindana
Nancy E Kass,
Adnan Ali Hyder,
Ademola Ajuwon,
John Appiah-Poku,
Nicola Barsdorf,
Dya Eldin Elsayed,
Mantoa Mokhachane,
Bavon Mupenda,
Paul Ndebele,

Published: January 23, 2007

https://doi.org/10.1371/journal.pmed.0040003
Reader Comments

Citation: Kass NE, Hyder AA, Ajuwon A, Appiah-Poku J, Barsdorf N, Elsayed DE, et al. (2007) The Structure and Function of Research Ethics Committees in Africa: A Case Study. PLoS Med 4(1): e3. https://doi.org/10.1371/journal.pmed.0040003

Copyright: © 2007 Kass et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: This project was funded, in part, by a grant from the Fogarty International Center, National Institutes of Health R25 TW01604.

Competing interests: The authors have declared that no competing interests exist.

Abbreviations: FWA, Federal Wide Assurance; IRB, institutional review board; JHU, Johns Hopkins University; REC, research ethics committee; WHO, World Health Organization

According to international guidelines [ 1 , 2 ] and several nations' laws [ 3–5 ], research with humans requires independent ethics committee review. In the United States, committees are called institutional review boards (IRBs) [ 6 ]; elsewhere they generally are called research ethics committees (RECs). Committees are designed to: provide third party review, thereby minimizing conflicts of interest; protect the welfare of research participants through attention to risks, benefits, and informed consent; and avoid exploitation of vulnerable individuals and populations.

Most literature examining RECs comes from wealthier countries. One US study found “serious concerns” with the quality of 14% of IRB reviews [ 7 ]. Another found that IRBs focused predominantly on consent documentation, spending less time examining voluntariness, selection of participants, and risk [ 8 ]. Many US [ 9–15 ] and international [ 16–18 ] studies have found that different research ethics committees reach different conclusions when reviewing the same study.

Several scholars and advisory bodies have made recommendations to address challenges facing US IRBs [ 19–22 ]. However, there has been little research examining procedures, strengths, and challenges of RECs in developing countries. Two case reports describe disagreements between host and sponsoring country RECs [ 23 , 24 ], and an international survey reports differences in sponsoring and host country reviews [ 25 ]. Three articles describe RECs within one country (Turkey [ 26 ], Granada [ 27 ], and Sudan [ 28 ]), and five within a larger region.

Rivera described 20 RECs in Latin America, finding that only 45% had standard operating procedures and that members had limited training [ 29 ]. Coker examined RECs in Central and Eastern Europe [ 30 ]. Ten countries had national committees, most committees included non-medical members, and three provided training. The World Health Organization's (WHO) Southeast Asian Regional Office, finding that only some of the 16 respondents had national RECs, called for capacity development in the area of research ethics [ 31 ].

Most literature examining research ethics committees comes from wealthier countries.

The WHO African Regional Office found that 36% of member countries had no REC. In the countries that did have RECs, most RECs met monthly, five met quarterly, and one never met [ 32 ]. Finally, Milford examined African RECs' resource needs in the context of HIV vaccine trial preparedness, finding that 97% believed African RECs had inadequate training in ethics and HIV vaccine trials and 80% believed African RECs had inadequate training in health research ethics.

Additional information on how African RECs function, including their staffing, operating procedures, strengths, and challenges would be useful for African and international researchers working within Africa, and for growing efforts to enhance ethics capacity on this vast continent. We therefore used a case study approach to shed light on the structure and functioning of RECs in Africa.

The Johns Hopkins Bloomberg School of Public Health received a training grant from the Fogarty International Center in 2000 to train three African professionals in bioethics each year [ 33 ]. Several of these professionals explicitly seek to increase the scholarly and administrative capacity of their African RECs. In 2004, program faculty and trainees created a structured questionnaire to document the history, composition, functioning, financing, strengths, and challenges of RECs with which the trainees were affiliated. Questionnaires were completed by e-mail. Follow up e-mails clarified responses. Data were entered into Microsoft Excel and tabulated. Trainees and faculty met for two days in 2005 to refine concepts and work on the manuscript.

Results of Our Case Study

Eleven of the 12 trainees who attended the program in 2001–2004 collaborated. Nine had personal experience on one or more African REC. Another trainee secured information from her institution's REC; one contributed no data. One trainee worked with two committees in his country; another worked with two committees from two countries. Twice, two trainees from the same country were affiliated with different RECs. Thus, twelve RECs were included in this case study from nine African countries: Democratic Republic of the Congo, Ghana (2), Kenya, Nigeria, South Africa (2), Sudan (2), Tanzania, Zambia, and Zimbabwe.

History of research ethics committees.

The oldest committee was from South Africa, established in 1967. The REC of the Medical Research Council of Zimbabwe was formed in 1974 but had intermittent functioning until 1992, when it became more formally established. Two RECs began in the 1980s; eight were started within the last five years, including two (Kenya and Democratic Republic of the Congo) created by the trainee the year before data collection.

Six of the 12 RECs had Federal Wide Assurances (FWAs) from the US government, an indication that the institution had received US research funds or collaborated with US institutions [ 34 ]. Two RECs were established as a requirement of international collaboration. The remaining RECs were established because of a recognized need for independent ethics review. Trainees' efforts were responsible for existing or pending FWAs of three African institutions.

Composition.

RECs ranged from nine to 31 members. One included only physicians and scientists, while most had clinicians, social scientists, economists, nutritionists, pharmacists, statisticians, pastors, and lawyers. Ten had lay or non-scientist members; two did not (see Table 1 ). One required that a third of the members should be lay persons, including a traditional chief and representatives from local organizations. Another asked the local community to nominate a community member. None required gender balance, but all consciously included both men and women.

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Composition of RECs in Case Study

https://doi.org/10.1371/journal.pmed.0040003.t001

REC meetings.

One REC recently stopped meeting in person; reviews were conducted by the chair or individual members. All other committees met in person: two met irregularly, based on need; another met twice per year or as needed; one met every two months; and seven met monthly.

All committees (except the one that did not meet) had requirements for quorum (half, or half plus one). One required two-thirds attendance. Meeting quorum, in general, was not difficult. One trainee said members were committed to duties; two said meetings were scheduled in advance or on weekends. Two said quorum was a problem. One described significant member turnover; another said busy members had problems with punctuality and attendance.

Training of REC members.

Two committees had members with no training. Six RECs had received training only since the Johns Hopkins University (JHU)–Fogarty trainee returned and provided it. Four RECs had individual members who attended external workshops; one committee conducted Good Clinical Practice courses semi-annually.

Conflicts of interest.

All RECs required that members be excused if their protocol was under review. Other potential conflicts were raised, however, which may be harder to manage. Two discussed conflicts posed when a departmental colleague had a protocol under review. One said such reviews were sent to another department, even to a department with less expertise, to avoid conflicts. Another described unease voicing objections when fellow members' protocols were reviewed, fearing being labeled unfriendly. Another believed community members were loathe to reject protocols because studies bring employment. Another said protocols bring income to the institution and sometimes questions were not raised so projects could clear quickly.

Procedural and administrative issues.

Most RECs had basic administrative capabilities, although the REC that no longer met in person lacked any administrative infrastructure. Two RECs lacked standard operating procedures. Nine had such procedures in place, five of which had been written by the trainee upon returning to Africa. All eleven RECs that met kept minutes.

All RECs had a mechanism for reviewing research project amendments to approved studies, although most did not require a review for study changes or amendments. In four RECs, the JHU–Fogarty trainee created the amendment mechanism. Of the 12 RECs, two routinely conducted annual reviews (both instituted this practice after the trainee returned to Africa); two conducted annual reviews when required by an external funder or driven by the principal investigator; and eight did not conduct annual reviews.

All trainees said REC funding was a challenge. Three had no operating funds whatsoever. For the other nine, funding came solely or in combination from government (2), foreign agencies (1), and/or fees for reviews (6). Fees for review varied greatly. One REC used a “sliding scale,” charging US$5 for proposals submitted by students, US$10 for studies submitted by post-graduate trainees, and US$20 for all other research proposals. Another did not charge for institutional applications, but required US$365 for external applications and US$585 for industry studies. Some used a “fixed fee” structure, such as US$100 for all applications or 1% of the study's budget, once funded. All RECs benefited from “in-kind” donations of institutional resources, such as space, photocopying, mail distribution, and services of staff with other responsibilities.

Eight RECs did not pay members (though some reimbursed travel); four paid a “sitting allowance.” Five RECs had paid staff; seven did not. RECs that paid staff all had budgetary allotments or charged fees.

REC review.

The number of protocols reviewed per year varied tremendously. Three RECs reviewed eight to 12 protocols per year, three reviewed 30–50, five reviewed 100–250, and one reviewed 600 per year. Two RECs with small portfolios only reviewed internally funded protocols. Most reviewed a mixture of internal and external projects.

Seven RECs required all protocols to be reviewed, although two started this policy only after the JHU–Fogarty trainee returned to the institution. The five other RECs only reviewed research when required by the funder. Review time generally corresponded to the frequency with which the REC met. Most completed reviews in one to two months, ranging from two weeks to more than three months. Four RECs looked equally at science, ethics, and budget, while another four reviewed science and ethics, but not budget. Two spent little time on ethics, while another focused almost exclusively on ethics as another committee reviewed the science.

Trainees mentioned several strengths of their RECs. First, the creation of so many new committees is a strength in itself. Also, many committees have at least a few members who received some training in ethics, through the REC, the JHU–Fogarty trainee, or external workshops. Several trainees mentioned that their REC has a reputation with sponsors for integrity and/or that the REC provides useful feedback to researchers.

Challenges.

Inadequate training and funding consistently were mentioned as the biggest challenges. These scholars acknowledged significant time and effort for member training. Reviewers were often poorly equipped to review according to ethics criteria, which led to a disproportionate focus on the science. Trainees mentioned inadequate training of staff and administrators in REC procedures; one trainee raised the issue that RECs have weak monitoring systems due to funding constraints.

Budget constraints were mentioned by nearly everyone. Running an REC is expensive, and one trainee suggested that for this reason poor countries will simply avoid the creation of a REC unless required. Another said that governments must be made aware of the importance of research ethics to convince them to fund RECs. Several mentioned that REC members had multiple responsibilities and thus, they would be more committed if they could be paid, especially since serving on the REC might actually deny them income they would otherwise have received for that time. One REC had no stationery, space, computers, or communication facilities. In another, a foreign investigator donated $200 for stationery supplies when the REC started, but there were no other funds for staff or infrastructure. An REC started by the JHU–Fogarty trainee used the trainee's personal laptop for its official business. Trainees also used their reentry grants provided by the JHU program to help enhance REC infrastructure.

Another challenge was the tendency of a few RECs to “rubber stamp” approvals in order to secure international funding. Related to this challenge, a couple of trainees raised a concern about REC independence. One said outsiders, researchers, and politicians could interfere in the REC process, and another said the “culture of corruption” is prevalent in some parts of Africa, which could affect the integrity of the committee. In some regions, investigators could engage in “IRB shopping,” whereby they could submit their protocol to a new REC if it was rejected by a first. A few trainees were concerned about possible abuse of the expedited review option in their RECs, as expedited reviews do not incur the delay and expense of convening a full committee meeting. Two specifically mentioned a lack of national guidelines and local operating procedures as a challenge to good work. Another voiced a concern that institutions would often select “top management” individuals to be members who might not have appropriate skills or time.

Suggestions.

Given the challenges raised, it was not surprising to hear trainees suggest the need for more training, funding, independence, and political commitment to improve REC functioning. In addition, innovative suggestions also emerged: training workshops on how to interpret ethics principles in light of local norms; public outreach programs about research; creation of networks of African RECs to share materials, resources, and capacity building; creation of mechanisms to facilitate communication between host and sponsor country RECs; joint meetings between REC members and investigators to brainstorm solutions to shared challenges; human rights advocacy to help enhance participants' and researchers' awareness about rights in research; and more empirical research on ethics and African research.

This case study reports on the experience of ten African professionals with 12 African RECs. These 12 RECs represent a range of experiences, from a committee formed 30 years ago to two recent ones. All, to greater or lesser extents, are functional, although one never meets as a committee. All cite the need for additional training, more attention to ethics issues, and more funding for staffing, transportation, and supplies.

Many challenges described here are not unique to African RECs. Wealthier countries, too, have heard criticism about inadequate funding, staffing, and training of committees [ 35–40 ]. Poor countries, however, inevitably feel these needs more acutely. Further, additional challenges may arise from resources being limited. We heard of institutions or community members exerting pressure to approve research that would bring jobs, infrastructure development, money, and intellectual cache to the local setting. Kilama suggested that poverty itself is a threat to independence, since poverty can blind researchers, participants, and RECs alike to any problems in studies that bring jobs, medicines, or prestige to a community [ 41 ]. Challenges to people's integrity may be more typical where individuals can expedite or bypass usual procedures through informal transfer of funds, as occurs in some countries.

External mandates often were the impetus for a committee forming and, in some cases, contributed start-up resources. While some committees still only review externally sponsored projects, others used external requirements as a catalyst to create a conscientious committee, committed to ethics review, training, and integrity. Absent the external mandate, changes may have happened more slowly.

Encouraging lessons.

Positive lessons can be drawn from this case study. First, research ethics review is increasingly routine in Africa. More African institutions require and are equipped to provide review, all but one of the committees in this case study meet in person, and membership is relatively diverse. There are growing opportunities in Africa for training in Good Clinical Practice and research methodology. Increasingly, African investigators submit to international journals that require REC review as a condition of publication; African journals now, also, generally require REC review of published studies [ 42 , 43 ], and a special meeting of the Forum for African Medical Editors in 2005 developed further guidelines for journal submission and review, including guidelines related to ethics [ 42 ]. Nonetheless, several of these committees are new, and some were created by the trainee. In the future, other researchers may start an African collaboration, find no RECs exist locally, and will need to facilitate creation of one. More guidance exists to assist in this task, but it can appear somewhat daunting [ 44 ].

Second, these experiences suggest committees become more stable, equipped, and trained over time. Thus, some challenges described may reflect how new most African RECs are. Committees with the longest history are the most established with regard to procedures, funding, and staffing. One trainee described his REC focusing almost entirely on science when first created, with community members deferring to scientific ones. Over time, members gained training and experience, and reviews began to include more ethics.

Third, this case study suggests individuals can make a difference. RECs included here were not random: a professional associated with them had just completed intensive training in research ethics. Nonetheless, with limited funds and variable institutional support, a small number of individuals created two RECs, others created and implemented standard operating procedures, review forms, and regular review where none existed, and most now provide training for members, researchers, and/or the public.

Further progress likely will involve a confluence of funders' requirements for review, institutional commitments, and individual contributions. Indeed, successful change requires systemic commitment. One individual cannot effect long-term change without institutional support, which is more likely with national requirements for review [ 45 ]. National policies are more likely to be developed when international funders, aid agencies, and journals establish that RECs are required and review must be the norm. National and institutional commitment must be set as policy and implemented through influx of resources for RECs.

To make committees' work meaningful, however, there must be a commitment, as many have suggested, to training and better resources. We join others calling for a shared library of resources, model standard operating procedures [ 46 ], model consent forms, and copies of training presentations; fortunately, such resources increasingly are available through the Internet. African professionals must find means to access continuing ethics education [ 41 , 47 ]. Challenging ethics dilemmas will always arise in research; those tasked with resolving them will need ongoing support and training to navigate reasonable solutions.

Limitations of our case study.

This case study has several limitations. The data are self-reported, through the lens of individuals who received intensive training in research ethics. Thus, their views may reflect more sophisticated understanding of how RECs should function than other REC members might provide. Further, the capacity of RECs, as reported, was often recently enhanced due to the efforts of the JHU–Fogarty trainee. Most new African RECs presumably are not started with these resources and intellectual capacity development, so the speed with which new RECs develop procedures and skills for ethics review may happen more slowly.

This report describes 12 RECs in Africa. It does not claim to be representative of African RECs as a whole. Further, this case study examined REC functioning but does not attempt to draw a conclusion about how ethical research is in Africa. Even the most conscientious REC review does not guarantee a well-executed study. Without study monitoring, it is impossible to know the relationship between REC quality and the quality of approved research [ 48 , 49 ].

This case study examines the history, operations, strengths, and challenges of 12 African RECs. We hope this will help researchers working in Africa better understand the landscape of ethics review and help funders target resources for capacity development in a continent where health research is so critical to development, and local responsibility for research functions is critical for research.

Supporting Information

Alternative language abstract s1. french translation of the abstract by bm.

https://doi.org/10.1371/journal.pmed.0040003.sd001

(31 KB DOC).

Acknowledgments

We are grateful for the research assistance of Rachel Harrison.

1. World Medical Association (2000) Declaration of Helsinki: Ethical principles for medical research involving human subjects. Edinburgh: World Medical Association.
2. Council for International Organizations of Medical Sciences (1991) International guidelines for ethical review of epidemiological studies. Geneva: Council for International Organizations of Medical Sciences.
3. Indian Council of Medical Research (2000) Ethical guidelines on biomedical research involving human subjects. New Delhi: Indian Council of Medical Research.
4. Thailand Ministry of Public Health Ethics Committee (1995) Rule of the medical council on the observance of medical ethics. Thailand: Ministry of Public Health.
5. National Consensus Conference on Bioethics and Health Research in Uganda (1997) Guidelines for the conduct of health research involving human subjects in Uganda.
View Article
Google Scholar
7. (1996) Final report of advisory committee on human radiation experiments. New York: Oxford University Press.
20. US Department of Health and Human Resources/Office of the Inspector General (1998) Institutional review boards: A system in jeopardy. Overview and recommendations.
21. National Bioethics Advisory Commission (2001) Ethical and policy issues in research involving human participants. Available: http://www.georgetown.edu/research/nrcbl/nbac/human/oversumm.html . Accessed 19 December 2006.
22. Institute of Medicine (2002) Responsible research: A systems approach to protecting research participants. Washington (D. C.): National Academy Press.
31. WHO South East Asian Regional Office (2002) Ethics in health research. New Delhi: World Health Organization.
32. Kirigia JM, Wambebe C, Baba-Mousa A (2005) Status of national research bioethics committees in the WHO African region. BMC Medical Ethics 6.
33. Fogarty International Center (2005) International Bioethics Education and Career Development Award. Available: http://www.fic.nih.gov/programs/training_grants/bioethics/index.htm . Accessed 19 December 2006.
34. US Department of Health and Human Resources (2006) Office for Human Research Protections. Available: http://www.hhs.gov/ohrp . Accessed 19 December 2006.
35. Bell H, Whiton J, Connelly S (1998) Evaluation of NIH implementation of Section 491 of the Public Health Service Act. Mandating Program of Protection for Research Subjects.
37. US Department of Health and Human Resources/Office of the Inspector General (1998) Institutional review boards: A time for reform.
38. US Department of Health and Human Resources/Office of the Inspector General (2000) Protecting human research subjects: Status of recommendations.
39. Bliwise R (1999) Managing a medical makeover. Duke Magazine 85.
41. Kilama WL (2003) Equipping Africa's researchers for global collaboration. Science and Development Network.
42. Forum for African Medical Editors (2004) FAME editorial guidelines. Available: http://www.who.int/tdr/networking/fame/fame_guidelines.htm . Accessed 19 December 2006.
43. Central African Journal of Medicine (2006) Author guidelines. Available: http://www.ajol.info/submissions.php?jid=52 . Accessed 19 December 2006.
44. World Health Organization (2000) Operational Guidelines for ethical committees that review biomedical research. Geneva: World Health Organization.

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Role of the research ethics committee

Affiliation.

1 Academic Department of Neurosurgery, Addenbrooke's Hospital, Cambridge, UK. [email protected]
PMID: 10808899
DOI: 10.1054/nedt.1999.0349

Research ethics committees have an important role to play in ensuring the ethical standards and scientific merit of research involving human subjects. There are three important obligations placed on the ethics committee. Firstly, and most importantly, the ethics committee must ensure that the rights of research participants are protected. This is achieved by ensuring that individuals receive sufficient information, which can be easily understood, and ensuring that appropriate strategies are in place to protect participants from potential adverse consequences of the research. Secondly, the research ethics committee has an obligation to society which provides the resources for research and will ultimately be affected by the results. Thirdly, the research ethics committee has an obligation to the researcher. The research proposal should be treated with respect and consideration. The research ethics committee should strive to meet each of these obligations. All researchers should welcome the contribution made by research ethics committees to the research process because they help to ensure that research meets the high ethical and scientific standards expected by society.

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Methodology

Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on October 18, 2021 by Pritha Bhandari . Revised on May 9, 2024.

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to

protect the rights of research participants
enhance research validity
maintain scientific or academic integrity

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, other interesting articles, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research objectives with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

Prevent plagiarism. Run a free check.

Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.


Voluntary participation	Your participants are free to opt in or out of the study at any point in time.
Informed consent	Participants know the purpose, benefits, risks, and funding behind the study before they agree or decline to join.
Anonymity	You don’t know the identities of the participants. Personally identifiable data is not collected.
Confidentiality	You know who the participants are but you keep that information hidden from everyone else. You anonymize personally identifiable data so that it can’t be linked to other data by anyone else.
Potential for harm	Physical, social, psychological and all other types of harm are kept to an absolute minimum.
Results communication	You ensure your work is free of or research misconduct, and you accurately represent your results.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process , so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

You make sure to provide all potential participants with all the relevant information about

what the study is about
the risks and benefits of taking part
how long the study will take
your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymize data collection . For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymization is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
Social harm: Participation can involve social risks, public embarrassment, or stigma.
Physical harm: Pain or injury can result from the study procedures.
Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources or counseling or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine academic integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

Normal distribution
Measures of central tendency
Chi square tests
Confidence interval
Quartiles & Quantiles
Cluster sampling
Stratified sampling
Thematic analysis
Cohort study
Peer review
Ethnography

Research bias

Implicit bias
Cognitive bias
Conformity bias
Hawthorne effect
Availability heuristic
Attrition bias
Social desirability bias

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

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Research Ethics Committees

First Online: 03 September 2021

Cite this chapter

Itziar de Lecuona 27

Part of the book series: Ius Gentium: Comparative Perspectives on Law and Justice ((IUSGENT,volume 92))

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Ethics committees represent a “way of doing bioethics” that is useful in plural and democratic societies. Although there are different types of ethics committees, clinical ethics committees, national ethics committees or ad hoc committees, I will focus my analysis on research ethics committees in biomedicine. I will examine their international legal framework in order to define them, identify their functions and analyse their possible instrumentalisation. Lastly, I will provide some practical information as a member of two research ethics committees in Spain, the Bioethics Committee at the University of Barcelona and the Research Ethics Committee at Hospital Clínic de Barcelona, to draw some conclusions and make proposals.

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Research ethics committees in the regulation of clinical research: comparison of Finland to England, Canada, and the United States

Committees: Research Ethics Committees

Ethics in Clinical Research

Article 12. Universal Declaration on Bioethics and Human Rights, UNESCO ( 2005 ).

Rodotà ( 2009 ).

Beecher ( 1966 ).

De Lecuona ( 2011 ).

“The Belmont Report” Office of the Secretary Ethical Principles and Guidelines for the Protection of Human Subjects of Research The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research U.S.A, April 18, 1979.

The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Council of Europe ( 1997a ).

Casado and López Baroni ( 2018 ).

Hottois ( 1990 ).

Article 2. Convention on Biomedicine and Human Rights, Council of Europe ( 1997b ).

Annas ( 1991 ).

Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association ( 1964 ).

Brody ( 1998 ).

Research Ethics Committees: 23 Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association (WMA) Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the: 29th WMA General Assembly, Tokyo, Japan, October 1975 35th WMA General Assembly, Venice, Italy, October 1983 41st WMA General Assembly, Hong Kong, September 1989 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification added) 55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added) 59th WMA General Assembly, Seoul, Republic of Korea, October 2008 64th WMA General Assembly, Fortaleza, Brazil, October 2013.

The Council for International Organizations of Medical Sciences CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects (2016) Preamble “The term “research” refers to a class of activity designed to develop or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference. “Research” includes both medical and behavioural studies pertaining to human health. Usually “research” is modified by the adjective “biomedical” to indicate its relation to health.

Sandel ( 2013 ).

Explanatory Report to Additional Protocol on Biomedical Research of 2005 Available. http://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/195 .

Casado and López Baroni ( 2021 ).

Baron ( 2006 ).

Lysaught ( 2009 ).

European Group on Ethics in Science and New Technologies, “Statement on Clinical Trials”, 2013.

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

Evans ( 2002 ).

Casado et al. ( 2016 ).

Guide for research ethics committees members (Council of Europe 2011 ).

Mittelstadt and Floridi ( 2016 ).

The Network of ethics committees of the public universities and other research bodies http://www.ub.edu/rceue/ accessed Aug 2019

See The European Code of Conduct for Research Integrity (ALLEA, 2017).

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).

Annas GJ (1991) At law: ethics committees: from ethical comfort to ethical cover. The Hastings Center Report 21

Google Scholar

Baron J (2006) Against bioethics. MIT Press, London

Beecher HK (1966) Ethics and clinical research. N Engl J Med 274:1354–1360

Article Google Scholar

Brody BA (1998) The ethics of biomedical research: an international perspective. Oxford University Press, Oxford

Casado M, López Baroni MJ (coords) (2018) Handbook of Secular Bioethics I. Edicions Universitat de Barcelona, Barcelona

Casado M, López Baroni MJ (coords) (2021) The Oviedo Convention turns 20 years old: proposals for its modification. Edicions Universitat de Barcelona, Barcelona

Casado M, Patrao MDC, De Lecuona I, Carvalho AS, Araujo J (2016) Declaration on scientific integrity in responsible research and innovation. Edicions Universitat de Barcelona, Barcelona

Council of Europe (1997a) The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine

Council of Europe (1997b) Convention on Biomedicine and Human Rights, Article 2

Council of Europe (2011) Guide for research ethics committees members

De Lecuona I (2011) Ethics committees: the challenges facing bioethics in the 21st century. ABR 3(2):164–169

European Group on Ethics in Science and New Technologies (2013) Statement on Clinical Trials

Evans JH (2002) Playing God?. Human genetic engineering and the rationalization of public bioethical debate. The University Chicago Press, Chicago

Explanatory Report to Additional Protocol on Biomedical Research of 2005 ( http://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/195 ). Accessed 18 Aug 2019

Hottois G (1990) Le paradigme bioéthique: une éthique pour la technoscience. De Boeck Université, Paris

Lysaught MT (2009) Docile bodies: transnational research ethics as biopolitics. J Med Philos Aug 34(4):384–408

Mittelstadt BD, Floridi L (eds) (2016) The ethics of biomedical big data. Springer, London

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

Rodotà S (2009) La vita e le regole. Tra diritto e non diritto. Feltrinelli, Rome

Sandel M (2013) What money can’t buy. The moral limits of markets. Penguin, London

The Council for International Organizations of Medical Sciences CIOMS (2016) International Ethical Guidelines for Biomedical Research Involving Human Subjects

The European Code of Conduct for Research Integrity (2017)

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, USA (1979) The Belmont Report. Office of the Secretary Ethical Principles and Guidelines for the Protection of Human Subjects of Research, April 18

The Network of ethics committees of the public universities and other research bodies http://www.ub.edu/rceue/ . Accessed Aug 2019

UNESCO (2005) Universal Declaration on Bioethics and Human Rights. Article 12

World Medical Association (1964) Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects

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Department of Medicine and Bioethics and Law Observatory—UNESCO Chair in Bioethics, University of Barcelona, Barcelona, Spain

Itziar de Lecuona

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Faculty of Law, University of Trento, Trento, Italy

Lucia Busatta

Carlo Casonato

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de Lecuona, I. (2021). Research Ethics Committees. In: Busatta, L., Casonato, C. (eds) Axiological Pluralism. Ius Gentium: Comparative Perspectives on Law and Justice, vol 92. Springer, Cham. https://doi.org/10.1007/978-3-030-78475-1_4

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Research ethics and integrity

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The current NWU policy requires all research to be subjected to independent ethics review. This includes all MSc and PhD student research and any funded or unfunded research undertaken by staff and post-doctoral associates. No research can start without an ethics number as proof of the ethics review. The responsibility of the ethics review lies with the principal investigator or the student's primary supervisor. Several research ethics committees (REC) are available to review proposals. The decision on where to submit your application is influenced by the research topic and the potential risk level. The FNAS Research Ethics Committee (FNASREC) deals with all research in the Faculty of Natural and Agricultural Sciences with zero or low risk where the research topics do not fall in the scope of one of the other committees, including HREC, Animcare, and Animprod. Research with a health-related theme or that will be published in health-related journals and/or will be used to inform health-related policy needs to be reviewed by the Health Research Ethics Committee (HREC). If unsure of the nature of your study, use this decision key. All research involving animal subjects should be submitted to AnimCare or AnimProd for review. If you are unsure of which research ethics committee you need to apply to, the scope for the different committees is outlined on this site. All small project applications related to a large study previously approved by an NWU REC should be submitted to the same REC for review. When preparing a scientific proposal for an ethics review committee, highlighting key dimensions that showcase the ethical considerations of your study is crucial. These dimensions ensure that your research respects the rights, safety, dignity, and well-being of the participants. Remember that the ethics review process will not prevent you from doing research. Still, it will require that you adequately motivate your study, and if there are risks, that the potential benefits clearly outweigh them. FNASREC only review studies with no or low risk to humans or the environment. If your study has medium or high risk, it can still be done, but you will have to apply to a registered ethics committee in the NWU. FNASREC also does not review studies with health-related themes. You can still do this kind of study, but they will have to be reviewed by HREC or Animcare. Health-related research refers to any research conducted by disciplines other than health disciplines about topics or participants within the health field or investigating or striving to improve the bio-psycho-social well-being of human or animal participants. Research focusing on health infrastructure also falls under this definition.

Here are the essential elements to include in your proposal:

Study Purpose and Rationale: Clearly articulate the objectives of your research, its significance, and how it contributes to the broader field of knowledge. Explain why this research is important and justify the need for the study.
Population Description: If you use human subjects in your research, describe the target population for your study, including any specific inclusion or exclusion criteria. Highlight the characteristics that make this population relevant to your research objectives.
Sampling Strategy: If you use human subjects, detail your approach to selecting participants, including the type of sampling method (e.g., random, stratified, purposive) and the rationale behind this choice. Explain how this strategy will help achieve a representative sample of the population. The ethics committee might ask the question if the potential benefits from the study are fairly distributed, for example, do you give everyone a fair chance to participate in the study.
Negotiating Access: If you need access to a community or property, outline the steps you will take to gain access to the population or data. This includes any permissions required from institutions, communities, or individuals and how you plan to address potential access challenges.
Informed Consent: Describe the process for obtaining informed consent from participants, ensuring they understand the purpose, procedures, risks, benefits, and their rights within the study. Include how consent will be documented and the measures taken to ensure comprehension for participants with varying levels of literacy or language proficiency.
Confidentiality and Anonymity: Detail the measures you will implement to protect participants' confidentiality and anonymity. Explain how data will be stored, who will have access to it, and how long it will be retained before being securely destroyed.
Risk Assessment and Mitigation: Assess any potential risks to participants or the environment arising from the research and how these risks will be minimized. This includes physical, psychological, social, or legal risks. The risks can also be to the researchers themselves, like safety. Reputational risk to the NWU should also be considered. If the topic is sensitive, this will change the risk level of the study.
Benefits of the Research: If you have a low-risk study, it is important to discuss the potential benefits of your research, both to the participants and the wider community or field of study. Highlight how the study aims to contribute positively to the area of research.
Data Handling and Analysis: Explain how data will be collected, processed, and analysed, ensuring transparency in your methodologies and respect for participants' data.
Withdrawal Procedure: If your study has human participants, outline the process for participants to withdraw from the study, ensuring they understand their right to discontinue participation at any time without penalty.
Complaints Procedure: Include a procedure for participants to raise concerns or complaints about the study, ensuring there is a clear path for addressing ethical issues.
NWU data or participants: If the study uses data from the NWU, or uses NWU students or staff as research subjects, permission from the NWU gatekeeper will be required. If you will use existing datasets, mention it.
Ethical Considerations for Vulnerable Groups: If your study involves vulnerable populations (e.g., children, individuals with disabilities, or marginalized communities), the risk level is higher than minimal, and the study will have to be reviewed by a registered committee.

Addressing these dimensions thoroughly demonstrates to the ethics review committee your commitment to conducting ethical research that respects and protects your participants, which is fundamental to the integrity of the scientific process.

SCOPE OF NORTH-WEST UNIVERSITY SCIENTIFIC- AND RESEARCH ETHICS COMMITTEES

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We are looking for doctors and pharmacists to join our Research Ethics Committees

StepForward - are you a doctor or pharmacist.png

Research Ethics Committees, also known as RECs, review research studies taking place in the NHS and social care.

Our REC members volunteer and give their time freely to ensure that the proposed research is safe and protects the wellbeing, dignity and rights of people who will be involved as a research participant.

There are more than 80 of our Research Ethics Committees across the UK who review thousands of research applications every year.

RECs are made up from up to 15 members who offer a diverse range of perspectives to ensure a thorough and balanced ethical reviews. Everyone's view is equally important.

We have three types of REC member:

lay member - people who are not registered healthcare professionals and whose primary professional interest is not in clinical research, for example retired healthcare professionals (excluding retired doctors) and those involved in the management or administration of clinical research
lay-plus member - members of the public who have never worked in healthcare or research and have never been a member of a health service body
expert member - registered healthcare professionals, clinical trial statisticians and other experts in research

We have a number of vacancies for expert members roles at the moment and we are looking for doctors and pharmacists to volunteer to join a Research Ethics Committee.

What do REC members do?

As a REC member you will help facilitate ethical research that aims to provide evidence for improving or changing practice for some of the biggest challenges in health and social care, including cancer, dementia and COVID-19.

REC members take part in monthly online meetings via Zoom to review and approve research applications.

We ask that members attend a minimum of six meetings a year. Meeting last about half a day and require five to six hours of reading to prepare in advance.

Members also review research applications and amendments to approved studies online through our members’ portal or via email.

Outside of meetings you will take part in sub-committee work via email. This involves reviewing applications with no material ethical issues or reviewing amendments to approved research. Members usually get in involved in sub-committee work two to three times a year, with two hours of reading for in advance for each sub-committee meeting.

Can I share the role?

For expert members we also accept joint applications so you can apply to role share with a colleague who has similar experience.

'Joining a Research Ethics Committee is a chance to play a pivotal role in ensuring research is conducted with the highest ethical standards. Your contribution helps shape the future of health and social care, and we greatly value the diverse insights that new members bring.'

Find out more

If you would like to find out more about our expert REC member vacancies, or would like to apply head over to our #StepForward page .