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Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Geneva: World Health Organization; 2011.

Cover of Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants

Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants.

Iii standards and guidance for members of the research ethics committees.

The primary task of an REC is the ethical review of research protocols and their supporting documents. Approval or disapproval is based on the ethical acceptability of the research, including its social value and scientific validity, an acceptable ratio of potential benefits to risks of harm, the minimization of risks, adequate informed consent procedures (including cultural appropriateness and mechanisms to ensure voluntariness), measures to ensure protection of vulnerable populations, fair procedures for selection of participants, and attention to the impact of research on the communities from which participants will be drawn, both during the research and after it is complete. The review take into account any prior scientific reviews and applicable laws.

Standard 7. Ethical basis for decision-making in research ethics committees

The REC bases its decisions about research that it reviews on a coherent and consistent application of the ethical principles articulated in international guidance documents and human rights instruments, as well as any national laws or policies consistent with those principles. The REC makes clear the specific ethical guidelines on which it relies in making decisions and makes them readily available to researchers and the public. When an REC develops reliance agreements for review of research under its jurisdiction by another REC, it is the responsibility of the delegating REC to assure that the same ethical principles serve as the basis of the other REC's decision-making.

To aid in determining the ethical acceptability of research protocols, an REC may utilize a checklist to ensure that all relevant criteria are considered during review and that, as a general rule, similar protocols are treated similarly. When an REC determines that an approach it has taken on a particular ethical issue in the past is no longer appropriate, it provides an explicit rationale for its change in position. In communicating decisions about particular protocols to researchers, the REC explains its analysis of any significant ethical issues that arose in the review.

As articulated in more detail in international ethics guidelines and the research regulations of a number of jurisdictions, key criteria include, but are not limited to, the following.

1. Scientific design and conduct of the study

Research is ethically acceptable only if it relies on valid scientific methods. Research that is not scientifically valid exposes research participants or their communities to risks of harm without any possibility of benefit . RECs should have documentation from a prior scientific review, or should themselves determine that the research methods are scientifically sound, and should examine the ethical implications of the chosen research design or strategy. Unless already determined by a prior scientific review, RECs should also assess how the study will be conducted, the qualifications of the researcher (s), the adequacy of provisions made for monitoring and auditing, as well as the adequacy of the study site (e.g. availability of qualified staff and appropriate infrastructures).

2. Risks and potential benefits

In ethically acceptable research, risks have been minimized (both by preventing potential harms and minimizing their negative impacts should they occur) and are reasonable in relation to the potential benefits of the study. The nature of the risks may differ according to the type of research to be conducted. REC members should be aware that risks may occur in different dimensions (e.g. physical, social, financial, or psychological), all of which require serious consideration. Further, harm may occur either at an individual level or at the family or population level.

3. Selection of study population and recruitment of research participants

Ethically acceptable research ensures that no group or class of persons bears more than its fair share of the burdens of participation in research. Similarly, no group should be deprived of its fair share of the benefits of research; these benefits include the direct benefits of participation (if any) as well as the new knowledge that the research is designed to yield. Thus, one question for research ethics review to consider is whether the population that will bear the risks of participating in the research is likely to benefit from the knowledge derived from the research. In addition, ethically acceptable research includes recruitment strategies that are balanced and objectively describe the purpose of the research, the risks and potential benefits of participating in the research, and other relevant details.

4. Inducements, financial benefits, and financial costs

It is considered ethically acceptable and appropriate to reimburse individuals for any costs associated with participation in research, including transportation, child care, or lost wages. Many RECs also believe that it is ethically acceptable to compensate participants for their time. However, payments should not be so large, or free medical care or other forms of compensation so extensive, as to induce prospective participants to consent to participate in the research against their better judgement or to compromise their understanding of the research.

5. Protection of research participants' privacy and confidentiality

Invasions of privacy and breaches of confidentiality are disrespectful to participants and can lead to feelings of loss of control or embarrassment, as well as tangible harms such as social stigma, rejection by families or communities, or lost opportunities such as employment or housing. RECs should therefore examine the precautions taken to safeguard participants' privacy and confidentiality.

6. Informed consent process

The ethical foundation of informed consent is the principle of respect for persons. Competent individuals are entitled to choose freely whether to participate in research, and to make decisions based on an adequate understanding of what the research entails. Decisions for children or adults who lack the mental capacity to provide informed consent should be made by an authorized surrogate decision-maker.

RECs should examine the process through which informed consent will occur, as well as the information that will be provided. RECs may waive the requirement of informed consent only when doing so is consistent with international guidelines and national standards.

While informed consent to research is important, the fact that a participant or surrogate may be willing to consent to research does not, in itself, mean that the research is ethically acceptable.

7. Community considerations

Research has impacts not only on the individuals who participate, but also on the communities where the research occurs and/or to whom findings can be linked. Duties to respect and protect communities require examining by the REC and, as far as possible, are aimed at minimizing any negative effects on communities such as stigma or draining of local capacity, and promoting, as relevant, positive effects on communities, including those related to health effects or capacity development. Researchers should actively engage with communities in decision-making about the design and conduct of research (including the informed consent process), while being sensitive to and respecting the communities' cultural, traditional and religious practices.

Standard 8. Decision-making procedures for research ethics committees

Decisions on research protocols designated for review by the convened REC are based on a thorough and inclusive process of discussion and deliberation. Protocols involving no more than minimal risk and burden to research participants may be reviewed on an expedited basis by one or more members (rather than the full committee), if the REC has established written procedures permitting such a procedure.

  • During meetings of the REC , members engage in discussions to elicit all concerns and opinions related to the protocols and the associated documents under consideration. The REC's rules ensure that the discussions are respectful of all opinions and allow for varied beliefs to be aired. The Chair fosters a respectful and inclusive tone and allows adequate time for deliberation, during which only REC members participate and decisions are made only by those who were present during the entire discussion. The Chair is responsible for the decision-making process, in particular for determining when consensus is needed to achieve the decision. Researchers, funders, or others directly associated with the protocol in question are not present during committee deliberations.
  • REC members recognize the limitations of their knowledge and seek external input when necessary, particularly in relation to research that involves people whose life experiences may differ significantly from those of the committee members.
  • Decisions are arrived at through either a vote or consensus. Consensus does not require that all REC members support the decision, but that all members consider the decision at least acceptable and no member considers the decision unacceptable. A pre-defined method determines when votes will be taken and how many favourable votes will be needed for a proposed research to be approved.

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Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press through the WHO web site ( http://www.who.int/about/licensing/copyright_form/en/index.html ).

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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, 

PLOS

Published: January 23, 2007

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

Table 1

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.

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Relevance and Challenges of Ethics Committees

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This article explores the role of ethics committees in ensuring ethical research and innovation, which is essential for maintaining trust in science and innovation. The paper argues that the ethics infrastructure must function at the levels of research and innovation institutions, as well as regional and national levels, and should follow agreed-upon rules and requirements. The changing role of ethics committees is discussed, emphasizing their involvement in investigating potential research misconduct and coordinating the activities of all ethics committees within an institution. The article concludes that for a research and innovation institution, it is of crucial importance to consider the entire ethics infrastructure, including the functions of different ethics committees and ways of implementation through transparency, involvement, policies, procedures, and communication to safeguard that both researchers and the public have trust in ethics infrastructure and ethics committees.

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  • trust in science

1 Introduction

Science is a social arrangement in which different stakeholders (e.g. research-performing organizations, research funding organizations, publishers, and ethics committees) should fulfill their distinctive roles.

Since science is a collective enterprise, it is necessary to build mutual trust. Trust should be built between researchers and innovators, and with society. Researchers and innovators must be able to trust the results of previously conducted research. Society must be able to trust researchers and innovators by giving them the means to carry out research and contribute to it, e.g. participating as research subjects or participating in co-creation. Researchers and innovators can be trusted if they are trustworthy, meaning that they behave honestly, are objective, respect the autonomy and privacy of research subjects, treat animals and the environment with care, and are responsible. To ensure trust in science, it is necessary not only that researchers and innovators fulfill their responsibilities, but also that they have the willingness to do so. Researchers and innovators and research and innovation organizations (both research performing and funding organizations) bear the responsibility for fostering trust in science and ethical research.

Research and innovation organizations should create and sustain environments that encourage ethical research and innovation through education and clear policies e.g. the Singapore Statement [ 1 ]. In The Bonn PRINTEGER Statement [ 2 ] the role of the leaders of institutions is specified and institutional responsibilities are described, e.g. increasing transparency in misconduct cases, having effective and safe whistle-blowing channels, establishing a research integrity committee, and appointing an ombudsperson. Moreover, in its report the European Science Foundation has stressed the need to set structures at the national level as well. They have outlined that successful approaches to promoting good research practices include establishing an adequate institutional framework, which includes research ethics committees and research integrity offices, both at the institutional and national levels [ 3 ]. Additionally, it should be pointed out that the governance system of ethical research and innovation should fit each country, taking into account its size, research infrastructure, and available resources [ 3 ]. Furthermore, if unintended consequences emerge, the system should be revised or policies should be changed accordingly [ 4 ]. Also, it should be analyzed whether the members of the research and innovation institutions are motivated to act according to operating principles.

According to Sarah R. Davies, issues related to research integrity can also be regarded more broadly, as a form of soft governance implemented through codes, norms and ELSI (ethical, legal, and social implications) activities [ 5 ]. Therefore, ethics committees should be seen and should function as a part of the governance system of ethical research and innovation. Such a system includes stakeholders (e.g. researchers, administration, case investigators), and procedures and requires an ethics-promoting climate [ 6 ]; it also consists of oversight, instruction, and policies [ 7 ].

One example of an ethical system of governance for research and innovation in organizations has been developed within the Horizon 2020 project ETHNA. Having a clear implementation and governance system that fits the research-performing or funding organizations including responsible research and innovation (RRI) office(r), ethics codes, policies, and tools shows commitment to ethical research and to carrying out research and innovation activities in a responsible way.

2 Ethical Research: From Fragments to the Whole Research Process

It is expected that research and innovation are done ethically and with high quality. Ethical norms should be followed through all stages of research, from planning and applying for research grants to the publication of research results.

While research ethics has been focusing on the protection of research subjects, research integrity has emerged as a response to misconduct cases, mainly about fabrication, falsification, and plagiarism (FFP). Research misconduct is understood more broadly than FFP, especially in Europe. For example, Foeger and Zimmermann state that “[research misconduct] also covers, for example, destruction of primary data, unjustified authorship, and the sabotage of research activities or dishonest attempts to lower the scientific reputation of another researcher” [ 8 ]. A more specific list of possible acts of misconduct is presented by Faintuch and Faintuch [ 9 ] comprising the following issues: lack of protection of data, violation of confidentiality, clandestine data access; animal abuse; inadequate human consent regarding aims and benefits, risks and harms, coercion or exploitation of subjects; ghost authorship Footnote 1 , questionable personal credits, failure of registration and ethical approval, breach of good (clinical) practices, lack of transparency regarding the relationship with funders, undisclosed commercial or personal interests, noncompliance with publisher ethics, nonprofessional language, salami slicing Footnote 2 , lack of sharing data with co-investigators, study participants, other authorized parties, harassment, bullying, disrespectful behaviour, dishonest mentoring of students, fellows, junior staff, misuse of research funds, false or exaggerated academic titles, qualifications, professional experience, retaliation against whistle-blowers, deceit, scamps, pseudoscience, malicious misconduct allegations. Often, these practices emerge due to the reward criteria in research that value quantity over quality. This issue needs to be dealt with at the level of science as a system. The aforementioned list includes not only acts from the realm of research integrity but also covers the domain of research ethics. It has increasingly been argued (e.g. Ron Iphofen [ 13 ]) that the two of them be viewed together, as both are required for ethical research and innovation. Another definition of research ethics and research integrity is provided by Ana Marušić in this book in her chapter “Evidence-based Research Integrity.” Braun, Ravn, and Frankus [ 14 ] showed that while research ethics committees do their task before researchers begin the actual research, research integrity offices handle possible misconduct cases after the research has been done and a concrete action or behavior has taken place. Whereas the first of them focuses on planning and design, and the other on conduct and implementation, both are needed to safeguard ethical research. At the practical level, the platform “The Embassy of Good Science” is the outcome of the European Commission’s initiated and funded research projects EnTIRE and VIRT2UE within the H2020 program, focusing both on issues of research integrity and research ethics.

3 What Do We Mean When We Talk About Ethics Committees?

When encountering the term ‘ethics committee’, one must pay attention to its meaning, as any committee or commission that deals with ethical issues can be called an ethics committee. Thus, there are committees that deal with ethical issues in different contexts, with different tasks, and at different levels.

Historically, research ethics committees have the longest tradition in ethical research. Their main task has been to ensure the rights and well-being of human research subjects and/or animals participating in research. As such, they constitute an additional safeguard mechanism, both for subjects and researchers. Based on the written documents submitted to the committee, the task of such committees is to weigh the risks and benefits of the study. Only studies with a proportional relationship between scientific validity, social value, fair participant protection, favorable risk-benefit ratio, independent review, informed consent, respect for participants, and collaborative partnership [ 15 ] should be conducted. The role of ethics committees originated in medical research. For example, in the Helsinki Declaration of the World Medical Association [ 16 ], it has been a requirement since 1975 to obtain the ethics committee’s approval before starting a study. Later, this requirement of prior approval was extended from biomedicine to other fields of research. Social scientists have seen this development as problematic, as the requirement coming from biomedicine may not be suitable for social sciences and humanities [ 17 , 18 ]. The need to obtain the approval of the ethics committee before starting the research may derive from national legislation, but it may also be required, for example, by research funding agencies or journals where the results of the research are to be published.

At the practical level, the Council of Europe’s Steering Committee on Bioethics has worked out a “Guide for Research Ethics Committee Members” [ 19 ]. The guide addresses issues related to the appointment of research ethics committee members, emphasizing that the process should be transparent and fair. The requirements for the composition of the committees can be determined either at the level of national law or through guidance documents (e.g. the ETHNA framework) giving recommendations on the number of members of the committee, their qualifications, involvement of lay persons (those whose expertise is not in a specific type of research and who are there to represent the perspective of participants). Having clear policies and making them known is very important for addressing possible conflicts of interest.

However, several critical notes have been addressed to ethics committees. It has been claimed that the requirement of an ethics review is often only formal [ 20 ]. From the initial idea to help researchers to balance risks and harms and consider possible benefits of the research and innovation project or proposal [ 20 ], the process has boiled down to checking relevant boxes from the checklist or ethics issues table. As such, the “tick the right box” approach does not serve the original purpose of analysing the ethical aspects of one’s research and innovation project.

Based on the situation in the United States, it has been claimed that institutional review boards are understaffed, overburdened; that they do not devote enough time, lack sufficient experience, and do not have institutional support [ 21 , 22 ]. Additionally, there have been discussions on how to define and measure the quality of an institutional review board [ 23 , 24 ]; how to deal with inconsistencies in research ethics committee review [ 25 ]; how to address the disciplinary distinctions in the ethics review process, [ 26 ] and the reasons why retrospective review should be added to a prospective one [ 27 ].

Although this is quite a tough slate of criticism to be dealt with, these issues can be addressed at the institutional or national level by providing resources, education, and training opportunities. The ETHNA project has given its input by creating a set of guidance tools and a toolbox to help institutions [ 28 ]. Additionally, the recommendation has been made that institutional review boards be accredited [ 29 ]. Increasing institutional support can mean various things, from hiring more support staff for the ethics committee to providing more training opportunities for members of the institutional review board [ 21 ], or requiring ethics committee members to obtain obligatory ethics training.

At the same time, ethics committees can not only review research but also deal with the investigation of possible cases of misconduct. In addition to the ‘ethics committee’, the body may also bear the name of the ‘ethics commission’, ‘integrity committee’, ‘research integrity board’, or ‘misconduct commission’, etc. Also, investigations are mentioned in the Bonn PRINTEGER Statement [ 2 ], where it is stated that the integrity committee can function either at the institutional or national level. However, the document does not specify whether appeals can be carried out at the national or institutional levels. Whereas the PRINTEGER Statement focuses on the level of research-performing organisations, the ENRIO handbook “Recommendations for the Investigations of Research Misconduct” [ 30 ] provides guidance both at the local and national level, e.g. regarding which decisions should be handled at what level and discusses the advantages of local or national bodies. The mutual learning exercise (MLE) in the research integrity final report gives a recommendation “to create a national research integrity body that could help coordinate, monitor, educate, communicate and promote research integrity in a country” [ 3 ]. In addition to establishing a national body, having national-level research integrity officers is important [ 3 ]. With regard to oversight, the MLE report suggests having an appeal system for research integrity investigations. This would be especially important in countries where there are no research ethics and integrity bodies at a national level [ 3 ].

Since the field of responsible research and innovation covers more than research integrity, the ethics infrastructure at all levels should be adapted accordingly. This should go hand in hand with processes determining that necessary regulations and guidance documents on all types of ethics committees are in place. Firstly, the lack of regulations on ethics committees might be a cause for various misconduct cases. Secondly, the ethics infrastructure should cover all aspects of ethics committees, from ethics review to integrity investigations. Thirdly, both should be in place, a regulatory framework as well as good practice guidance documents. We now turn to ethics (governance) bodies at the institutional level of a research and innovation institution.

4 What Should the Ethics Committee(s) Do?

One of the biggest challenges for a research and innovation institution is to work out an ethical governance system that suits the institution and serves it well. For ethics committees within the ETHNA System [ 28 ] the following activities are recommended for consideration.

First, the question should be considered what is the purpose of the ethics committee on research and innovation and how does the committee relate to the RRI Office(r) whose task it is to disseminate the concepts of the ETHNA system, establish performance indicators and monitor the progress of the system in the organization? Different options are available, as the committee can function as a governance committee by keeping an eye on the practical implementation of responsible research and innovation, but it can also create the space for discussions over procedures, commitments, and values.

Second, the question arises of the scope of the ethics committee. Who are the internal and external stakeholders to be involved in deliberations on ethical governance? Does the committee cover one or all of the key aspects of responsible research and innovation: research integrity, gender perspective, open access, and public engagement, or only one of them?

Third, the main principles of action of the ethics committee should be agreed upon. Having such principles, making them known, and acting on them are of crucial importance for building and maintaining trust, both within the institution and with external stakeholders. Within the ETHNA system, the focus is on the following principles: confidentiality, impartiality, fairness, anonymity, the accuracy of information, and fair, respectful, and mediated agreements [ 28 ]. One question that arises is whether it is possible to act based on the principle of anonymity when personal contact and additional queries for information might be needed for mediating and agreement.

Fourth, choosing a suitable model of the ethics committee for the research performing or research funding organization is crucial. In a way, this is the cornerstone aspect of the whole system. The ethics committee, its size, needs and resources should fit the institution and should help implementing the ethical governance of RRI in the organization. Does the institution need a standing or an ad hoc committee? Both have their advantages and disadvantages. Having a permanent committee enables continuous operation, so for large research and innovation institutions this would be recommended. However, if the number of situations to be dealt with is low and resources are limited, it would be advisable to have an ad hoc committee instead.

Fifth, what are the functions of the ethics committee members, and what kind of profiles are needed? The way members of ethics committees are selected or nominated and the period of appointment should be known within the institution and by external stakeholders. Other aspects to consider are: how does renewal take place? For how many terms can a person be a member of the ethics committee? How does replacement or dismissal take place? What are the tasks of the secretary? Is the secretary a member of the committee or a member of the committee’s support staff? What IT solutions are there or needed to support the work of the committee?

The solution provided by the ETHNA System is to nominate a committee for 4 years, but there are also other possible solutions, e.g. for a period of three years or five years. The next step is to map what profiles of people are needed in the ethics committee. What are the research and innovation and teaching activities the institution is carrying out? For example, doing research with human subjects, animal research, or research on biobanks or genetically modified organisms requires special expertise and potentially also a separate committee for reviewing these research projects. As such, it can be that in an institution there are separate ethics review boards for health research and biobank research, social sciences and humanities, animal research, and genetically modified organisms. One joint characteristic is that all of these committees should have a representative from the Ethics Committee of the institution and an ethics expert, and a law expert. Depending on how you are building up or changing the system, it can also be that the ethics and/or governance committee consists of representatives of the other ethics committees of the institution (mostly chairpersons). For example, the University of Liverpool in the United Kingdom has a research integrity and governance committee [ 31 ] that among other tasks has to oversee the work of other committees.

The sixth activity should be about describing the objectives assigned to the ethics committee. Those can include raising awareness, providing advice, helping with conflict resolution, and updating good practice guidelines, among others.

Seventh, what are the principles of the action of the ethics committee? This means that the frequency and interval between committee meetings should be thought through. For standing committees, it can be once a month, and for ad hoc committees whenever necessary. Compared to review and investigation committees, governance committees with the task of oversight and monitoring, and updating policies, should meet a couple of times a year. The schedule should be agreed upon and the information should be made publicly available (on the website of the institution or the webpage of the committee). How is the quorum for decisions decided? In most cases, this means that half of the members should be present. At the practical level, there can be differences, depending on whether or not the secretary is a member of the committee. Do external experts participate in decision-making? Is voting allowed or should deliberations take place until a consensus is reached? How often will the committee issue various reports? How will the body in the institution approve the establishment of the ethics committee on research and innovation?

Eighth, what are the monitoring indicators for the ethics committee? There should be progress indicators and performance indicators and these should be included and made known in the action plan of the ETHNA system.

5 Implementation of the Ethics Infrastructure

For a research and innovation institution, it is important to take into account whether the creation of committees and ethics infrastructure starts from scratch or if the already existing elements are changed and/or developed. If the existing system is changed and developed further, it is necessary to consider, negotiate and communicate tasks and responsibilities. How do ethics committees relate to ombudspersons and/or good science counselors? Would something be taken away from one committee and given to another? Will any new additional committees be created? Will some of the committees have their duties stripped? It is also necessary to consider how all parties affected by these changes are interconnected and how to involve them in the process, providing them with information about possible changes and asking for feedback.

Implementation of the ethics infrastructure also depends on the size of the research and innovation organization or research funding institution as well as on the size and institutional structures of the country where the institution operates. One way to create or change the system is to think about all the different stages of research and innovation and what is needed there. For example, a committee or committees are needed to review the research proposals in the planning stage, then to handle possible misconduct cases. Alternatively, there may also be a need for a committee governing the whole system and providing counseling at all stages of research and innovation. Additionally, does the governance committee also act as an appeal committee, or are there other committees at the regional and/or national level to manage the appeals?

It also needs to be considered whether it is necessary to do everything by yourself in your institution or whether there is a possibility to cooperate, especially in a small country and in a small research and innovation institution. Additionally, there might be regulatory aspects to be taken into account, such as the ones specifying that some types of research and innovation activities should be reviewed by a specific body not at the same institution, and should rather be done by a regional or national committee(for example this might be the case for clinical trials in some countries). For a small institution in a small country, it can very well be that all the tasks related to governance, review, and investigations take place in one single ethics committee.

To sum up, it is of crucial importance to think through the following questions. Why does the research and innovation institution need an ethics committee? What should the committee do? Do you change the current system or start anew? How do you involve all stakeholders in the process? Do you have the necessary resources (people, infrastructure, etc.) to implement the ethics infrastructure?

When creating a system of ethical governance, it is especially important to avoid making all researchers and innovators feel like their primary task is to constantly prove that all is done by regulations and guidelines of good practice.

Rather than only expecting compliance with codes and regulations, policies should be supportive and aim toward good outcomes. For example, Zwart and Meulen [ 32 ] are of the opinion that only using bottom-up processes can foster ethics and integrity in research, and that integrity work must take place in everyday research settings. This should be done by research institutions by facilitating open dialogue and fostering a culture of deliberation, e.g. by creating a safe space for discussing issues from everyday practice. Nevertheless, Zwart and Meulen are of the opinion that the focus should be at the institutional level, not on the level of an individual researcher; not on exposure and punishment, but rather on having a supportive ecosystem. Therefore, a supportive culture is needed, and creating it is the responsibility of the leaders. Furthermore, there should be a variety of training available, for various stakeholders. In this process, not only ethics committees for review and investigation of possible misconduct are needed, but in addition, there should also be persons in the research and innovation institution to whom people can turn to get advice (before handing in an application to get research ethics approval or an application that a misconduct investigation should be started). This can be a good science counselor, ombudsperson, ethics officer, research integrity office or officer. Such persons should also act as mediators giving advice, as well as listening to feedback and the reactions of the users of the ethics infrastructure to further enhance the system.

To implement ethical infrastructure and to help leaders of institutions, another project funded by the European Commission, SOPs4RI, has also worked out templates and guidelines for writing research integrity promotion plans, both for research-performing organizations and research funding organizations [ 33 , 34 , 35 ]. The name “promotion plan” might be misleading, since the actual focus is broader, covering preparation (diagnosis, assessing readiness, finding the right people, creating the plan), execution, and monitoring. This is similar to the ETNHA action plan as the plan has to be concrete and contain concrete actions, listing specific responsibilities and deadlines.

At the practical level, it should be thought through how the dissemination of the role and functions of the ethics committees in a research and innovation institution should take place. Furthermore, will there be educational activities provided about the ethical infrastructure in general for members of different ethics committees (new and current) and for researchers and innovators? Whose task will it be to provide them? The plan should have a concrete bearer of responsibility, be it the ethics officer, the research integrity officer, the ethics committee chair, or someone else.

If the earlier questions remain unspecific, let us consider two concrete examples. First, since the framework program Horizon Europe, the European Commission changed the table on ethical issues by adding the category artificial intelligence [ 36 ]. Who in the research and innovation institution should be aware of this requirement and who has to organize educational activities and the communication plan for those to whom it is relevant? Furthermore, does this require that the duties of the ethics review committee members have to be updated and the members educated, so researchers and innovators can submit research protocols encompassing AI to the ethics review committee of the research and innovation institution? Does the institution need to update its policies? For more specific debate about issues related to AI, see the chapter “Ethics and Development of Advanced Technology Systems in Public Administration” by António da Costa Alexandre and Luís Moniz Pereira in this book.

The other case is about chatbot ChatGPT, the AI tool that can create sentences and, in some cases, has been listed as an author of a research paper [ 37 ]. Who has to provide information about the possible threats of this development? Should the guidelines and policies about investigating possible misconduct be changed? What can the governance committee do regarding this challenge? Do the institution and ethics committee members have the knowledge to assess whether a text (e.g. research project submitted for ethics review) has been written by a researcher or a chatbot? Would it be possible to provide training about this matter for members of the institution (including members of the ethics committee)?

In these cases, it is not possible to provide a solution that would be suitable to all research and innovation institutions, but each institution should have a bearer of responsibility that fits its ethics infrastructure. Additionally, for successful implementation, a transition period is recommended to carry out communication activities and to enable the institution members to take part in the educational activities.

To sum up and return to the action and implementation plans, a question that needs further elaboration -- and not just being marked in proposed plans -- is whether the writers of the plan are in a position to write down the specific bearers of responsibility for each task and area or whether the bearers of responsibilities have to be specified by leaders of the institution at a later point. Additionally, it should be realized that there might be some issues that can only be dealt with to some extent at the institutional level as they may also require being addressed at the national level (e. g. national policy). Limitation of consideration to only one level may hinder the impact of creating and maintaining a culture of ethics and integrity.

6 Conclusion

Ethics infrastructure and governance are needed to safeguard trust in science. Ethics committees have an important role in the ethics infrastructure ensuring ethical research and innovation. The infrastructure must function at the institutional level and there should be cooperation with the national level. The tasks of the ethics committee(s) within the research and innovation institution can vary, from issuing approvals to investigating (possible) misconduct to governance of the system. An example of an ethical system of governance for research and innovation in organizations developed was introduced based on the results of the H2020 ETNHA project, with a special focus on activities related to ethics committees. Additionally, for successful implementation of the system of ethical governance in a research and innovation institution, an action plan should be followed. Through involvement, and communication of policies and procedures, the plan should safeguard that both researchers and the public have trust in ethics infrastructure and ethics committees.

Ghost authorship means that someone who has contributed substantially to the manuscript is not named as an author or given acknowledgment. It is problematic as it compromises academic integrity and may mask conflicts of interest [ 10 ]. Ghost authorship has also been addressed concerning ethics committees. David Shaw has claimed that when ethics committees improve the quality of a research proposal by suggesting major revisions, they should be acknowledged for their contribution. Ethics committees are ghost authors if they are not credited as authors or their contribution is not mentioned in the acknowledgment section [ 11 ].

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I would like to thank the reviewers of this chapter for their helpful suggestions and Tiina Kirss for her help with English expression.

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Lõuk, K. (2023). Relevance and Challenges of Ethics Committees. In: González-Esteban, E., Feenstra, R.A., Camarinha-Matos, L.M. (eds) Ethics and Responsible Research and Innovation in Practice. Lecture Notes in Computer Science, vol 13875. Springer, Cham. https://doi.org/10.1007/978-3-031-33177-0_8

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Research Ethics Committees overview

There are more than 80 NHS Research Ethics Committees across the UK. They exist to safeguard the rights, safety, dignity and well-being of research participants. 

RECs consist of up to 15 members, a third of whom are 'lay' - their main professional interest is not in a research area, nor are they a registered healthcare professional. 

RECs review research proposals and give an opinion about whether the research is ethical. They also look at issues such as the participant involvement in the research. The committees are entirely independent of research sponsors (the organisations responsible for the management and conduct of the research), funders and the researchers themselves. This enables them to put participants at the centre of their review. 

Search Research Ethics Committees

Listings, contact information and meeting dates  for Research Ethics Committees (RECs) within the UK Health Departments’ Research Ethics Service.

RECs review around 6,000 research applications across the UK covering a wide range of research. On average, they give an opinion in less than 40 days: well within the statutory timeline of 60 days. 

If you are applying to one of the following types of Research Ethics Committee, you will need to click on the relevant link:

  • Ministry of Defence REC (MoDREC)     
  • Higher Education Institution (HEI) REC

REC annual reports 

The Department of Health  Governance Arrangements for Research Ethics Committees  requires that the Appointing Authority receive and adopt the  Annual Reports for the Research Ethics Committees (RECs) . 

Annual reports for the following periods are available: 

  • April 2016 to March 2017
  • April 2015 to March 2016  
  • April 2014 to March 2015  
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  • April 2012 to March 2013  
  • April 2011 to March 2012

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Research ethics committees (RECs) are an important part of a healthy research culture. Their role is to consider the ethical implications of research. Traditionally this has focussed on the need to protect research participants (both human and animal), but in recent years their role in supporting researchers, and promoting research integrity more generally, has been increasingly recognised.

Two types of RECs

It is important to distinguish two types of research ethics committees. The first type is often set up to consider ethical issues that may be relevant to researchers working in specific areas. These might include the ethics of research into genetic modification, climate engineering, dual-use research (e.g., research with military applications), or research using potentially contentious methodologies such as “ human challenge ” trials (where participants are intentionally infected with diseases such as COVID). As these are difficult and complex areas, the main output is often in the form of guidance or position statements that can be applied by researchers, their institutions, funders, and ultimately policymakers. Consequently, these committees are convened at a fairly high level by organisations with an interest in the area of research being considered. They normally include scientific and legal experts alongside those with a specific interest in the topic under consideration (such as patient groups).

But the second, and far more common, type of research ethics committee is those set up by universities, research organisations, or health care providers (such as the NHS) to consider the ethical issues relating to individual, and often very specific, research projects. These Research Ethics Committees — abbreviated as RECs and referred to as Institutional Review Boards (IRBs) in the United States — provide a point-in-time review of a very detailed research protocol before the research is allowed to start. They aim to provide an opinion as to whether the research, if carried out in accordance with the detailed protocol, will meet accepted ethical norms. Exactly what these norms are, and how they can be addressed, is a complex question that may need to take into account guidance created by the first type of ethics committee described above. As such, although RECs still need to have suitably experienced individuals, it is more important that they are also suitably independent from the researcher (and their funder) to ensure they give an ethical opinion that is free from as many conflicts of interest as possible. Scientific or research expertise is important, but so is the voice of non-expert members. Quite often researchers will not be allowed to publish their work if they cannot prove it was reviewed by a REC before it started.

REC review supports research and researchers

REC review is criticised by researchers as being too lengthy, burdensome, or bureaucratic. This is often because it is confused with wider governance processes relating to issues such as data protection, health and safety, financial management, etc. While such issues are important, the fact that they are related to specific, often legally prescribed, arrangements means that they are governance issues that are the responsibility of the research institution (e.g., the university) to review and approve. The distinction between governance approvals , and ethics opinion , is extremely important if the aim is to create systems that provide robust, but proportionate, support to research and researchers. While in some contexts committees are expected to review both governance and ethics issues, there is an increasing recognition that governance is best handled separately by expert research officers, freeing RECs to consider the more complex ethical issues that may arise in any given research project.

Written by Dr Simon Kolstoe, UKRIO Trustee .

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Our principles: research ethics committees.

All parties involved in research have an active role to play in creating and sustaining a culture of rigorous ethical reflection.

We acknowledge that RECs have many competing obligations, with duties to protect participants, researchers and research organisations which mean they are constantly working to achieve many goals; we encourage RECs to engage with researchers in all stages of a project’s research lifecycle.

The principles below should also be considered during any ongoing monitoring of ESRC-funded projects.

Research should aim to maximise benefit for individuals and society and minimise risk and harm

A REC review of a project should consider the ethical conduct of the research whilst also facilitating high quality ethical research; this includes high-impact activities and new forms of research, for example, co-production. The review should be proportionate to the potential benefits and level of risk of the proposed research. RECs should determine the degree of risk and potential harm that may be tolerable in relation to the potential benefits.

The rights and dignity of individuals and groups should be respected

The primary role of the REC review is to ensure that the research will respect the dignity, rights, welfare and, where possible, the autonomy of participants and all parties involved in and potentially affected by the research.

Wherever possible, participation should be voluntary and appropriately informed

The REC should consider the information provided by the researchers regarding consent and voluntary participation, and evaluate how researchers justify and mitigate risks associated with withholding information and the adequacy of any proposed debriefing.

Participants should, wherever possible, take part in research voluntarily and there should not be any coercion or inappropriate influence.

The REC should be confident that participants will be given sufficient information about the research to enable them to make an informed decision about their participation. REC members should also be aware that there may be instances where this is not practical or desirable (for example, for methodological reasons, or covert or crowd research).

Research should be conducted with integrity and transparency

RECs should ensure that they fulfil their role and responsibilities with integrity and record their decisions and feedback in a transparent way.

Lines of responsibility and accountability should be clearly defined

The remit and responsibilities of the RECs should be clear; RECs should be committed to training and development to enable them to fulfil their role. Where the REC feels that it does not have the expertise to review a proposal, it should seek the help of independent bodies or external members. The REC’s performance is subject to review by the research organisation.

The independence of research should be maintained, and where conflicts of interest cannot be avoided they should be made explicit

RECs should be able to conduct ethics review in a wholly independent and impartial manner without any conflicts of interest and with a focus clearly on the ethics of research proposals.

Independence can be achieved by a committee composed of members from a wide range of disciplines and includes external members, within a policy and governance structure that establishes the right of the REC to pass opinions free of influence.

Secondary RECs that comprise members from only one discipline or a small number of closely related disciplines may be regarded as too closely aligned with the interests of researchers.

Further information

Criteria for research ethics committee review

Conflicts of interest, complaints and appeals

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  • PPLE - Politics, Psychology, Law and Economics (bachelor)
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Please note: UvA locations are closed on Tuesdays and Wednesdays. Follow this link for more information .

Committee for ethics in research

There are several reasons to ask for advice from an ethics committee:

  • Societal considerations: it's important to assess whether your research is in line with the ethical standards prevailing in society.
  • Legal certainty: you need to consider whether your research could potentially lead to legal consequences and how to mitigate these risks.
  • Risks of dual use and unintended use of results.

Main Navigation

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NeurIPS 2024, the Thirty-eighth Annual Conference on Neural Information Processing Systems, will be held at the Vancouver Convention Center

Monday Dec 9 through Sunday Dec 15. Monday is an industry expo.

research ethics committee contact

Registration

Pricing » Registration 2024 Registration Cancellation Policy » . Certificate of Attendance

Our Hotel Reservation page is currently under construction and will be released shortly. NeurIPS has contracted Hotel guest rooms for the Conference at group pricing, requiring reservations only through this page. Please do not make room reservations through any other channel, as it only impedes us from putting on the best Conference for you. We thank you for your assistance in helping us protect the NeurIPS conference.

Announcements

  • The call for High School Projects has been released
  • The Call For Papers has been released
  • See the Visa Information page for changes to the visa process for 2024.

Latest NeurIPS Blog Entries [ All Entries ]

Important dates.

If you have questions about supporting the conference, please contact us .

View NeurIPS 2024 exhibitors » Become an 2024 Exhibitor Exhibitor Info »

Organizing Committee

General chair, program chair, workshop chair, workshop chair assistant, tutorial chair, competition chair, data and benchmark chair, diversity, inclusion and accessibility chair, affinity chair, ethics review chair, communication chair, social chair, journal chair, creative ai chair, workflow manager, logistics and it, mission statement.

The Neural Information Processing Systems Foundation is a non-profit corporation whose purpose is to foster the exchange of research advances in Artificial Intelligence and Machine Learning, principally by hosting an annual interdisciplinary academic conference with the highest ethical standards for a diverse and inclusive community.

About the Conference

The conference was founded in 1987 and is now a multi-track interdisciplinary annual meeting that includes invited talks, demonstrations, symposia, and oral and poster presentations of refereed papers. Along with the conference is a professional exposition focusing on machine learning in practice, a series of tutorials, and topical workshops that provide a less formal setting for the exchange of ideas.

More about the Neural Information Processing Systems foundation »

Job Postings

Find employment opportunities with legislatures, states and public policy organizations.

Posted May 9, 2024

Pew Charitable Trusts

Principal Associate, Fiscal and Economic Policy, State Fiscal Health

Washington, D.C.

Competitive

Senior Associate, Fiscal and Economic Policy

Anchorage Legislature

Alaska Legislative Ethics Committee Administrator

Anchorage, Ala.

Range: $3,169.50 to $3,753.75 bi-weekly

Posted May 6, 2024

Legislative Council Service

New Mexico Legislative Council Service Director

Santa Fe, N.M.

$114,000 to $221,000 p/year

Washington State Senate

Budget Fellows

Hybrid/Olympia, Wash.

The current salary is $6,615 per month.

Posted May 3, 2024

Maryland General Assembly, Department of Legislative Services

Legislative Assistant, Office of Policy Analysis

Annapolis, Md.

Range: $40,000 - $50,000 commensurate with experience.

Full Time (On-site)

May 31, 2024 by 5:00 pm MT

Responsibilities

The New Mexico Legislative Council Service (LCS) seeks a director to oversee the day-to-day operations and strategic vision for the agency. The LCS is a permanent nonpartisan legislative agency serving all members of the Legislature. The LCS provides bill drafting and legal research for all legislators, the Governor, and state agencies and institutions. It provides impartial and accurate information, reports, and provides oversight for the Capitol building and grounds.

The director oversees the management team that supervises drafters, legal researchers, legislative library, information technology services for legislative staff and legislators, capital outlay, print shop, historians, accounting, and human resources for the Legislature, except for the Legislative Finance Committee and the Legislative Education Study Committee. The director coordinates with all legislative agencies to prepare the legislative branch's budget. The director also administers legal cases brought by and against the Legislature, the census redistricting process, ethics complaints, and requests for public records under the Inspection of Public Records Act.

The director oversees the Legislative Building Services management team that is responsible for the maintenance, safety, care, and preservation of the Capitol complex buildings and grounds. Oversight includes making and enforcing all rules and regulations for all persons in and around the Capitol.

The director serves in a non-partisan capacity and must maintain confidentiality. The director is responsible for the coordination and organization of the meetings of the Legislative Council, which is comprised of sixteen bipartisan, bicameral members, and is co-chaired by the Senate President Pro Tempore and the Speaker of the House.

Qualifications

  • Juris doctorate degree
  • Knowledge of the legislative process
  • Ability to work under pressure and availability to work long hours, especially during legislative sessions
  • Excellent oral and written communication skills
  • Ability to establish and maintain positive working relationships with legislators, elected officials, staff, and the general public
  • Maintain political impartiality
  • Computer proficiency

Preferred Qualifications:

  • 10 years of relevant experience
  • 5 years of supervisory/leadership experience
  • Bill drafting experience
  • Proficient with information technology hardware and software, as well as a working knowledge of cybersecurity

Compensation:

The director works at the pleasure of the Legislative Council. Annual compensation ranges from  $114,000 to $221,000 and will be negotiated based on experience and education. The position includes a comprehensive benefits package available to all state legislative employees.

How to Apply

Persons interested in applying for the Legislative Council Service Director position should submit the following information:

  • Letter of interest specifically addressing the qualifications described in this announcement;
  • A current resume;
  • A list of at least 3 professional references.

Send all application materials to lcsdirectorsearch@nmlegis . gov .

Application Deadline: 5:00 pm MT on May 31, 2024

Contact NCSL

For more information on this topic, use this form to reach NCSL staff.

  • What is your role? Legislator Legislative Staff Other
  • Is this a press or media inquiry? No Yes
  • Admin Email

Submit a Job Announcement

List your legislative, governmental or policy-related job. Fees may apply.

IMAGES

  1. Asean Research Organization

    research ethics committee contact

  2. Research Ethics Committee

    research ethics committee contact

  3. Research Ethics Committee

    research ethics committee contact

  4. Research Ethics Committees (RECs)

    research ethics committee contact

  5. Committee Members

    research ethics committee contact

  6. HS Research Ethics Committees

    research ethics committee contact

VIDEO

  1. Ethics Exchange: Paediatrics and Research with Children

  2. Wits in 60 Seconds

  3. #voicesofWEEC24

  4. 82 Ethical Governance and IREC

  5. Research Integrity and Ethics Series (session 4): Biological and Environmental Safety

  6. PSF webinar: Research Ethics Committees

COMMENTS

  1. Ethics Committees: Structure, Roles, and Issues

    Abstract. An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality, and honesty.

  2. Research Ethics Service and Research Ethics Committees

    The Health Research Authority and the Devolved Administrations provide a Research Ethics Service so that research proposals relating to their areas of responsibility can be reviewed by a Research Ethics Committee (REC). Research Ethics Committees protect the rights, safety, dignity and wellbeing of research participants.

  3. Standards and guidance for members of the research ethics committees

    Standard 7. Ethical basis for decision-making in research ethics committees. The REC bases its decisions about research that it reviews on a coherent and consistent application of the ethical principles articulated in international guidance documents and human rights instruments, as well as any national laws or policies consistent with those principles.

  4. Ensuring ethical standards and procedures for research with human beings

    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 ...

  5. The role of research ethics committees: Friend or foe in educational

    These research ethics committees have several obligations: ensuring the rights of participants are protected, fostering academic integrity within and beyond their institutions, and a responsibility to the wider society which may be affected by the research results as well as to the researcher themselves. ... How much contact have you had with ...

  6. Committees: Research Ethics Committees

    Research ethics committee is one of the three types of ethics committees that can be found. A research ethics committee is an independent, multidisciplinary body that performs the review of the research protocol. Throughout its development it was called differently, and these differences still remain in different countries in the world.

  7. The Structure and Function of Research Ethics Committees in ...

    According to international guidelines [1,2] and several nations' laws [], research with humans requires independent ethics committee review.In the United States, committees are called institutional review boards (IRBs) []; elsewhere they generally are called research ethics committees (RECs).Committees are designed to: provide third party review, thereby minimizing conflicts of interest ...

  8. Research Ethics Committees

    Research ethics committees represent a practical bioethics that is useful in plural, democratic societies provided that there is adequate training and strengthening of skills in bioethics, and also that procedures are fostered that allow proper decision-making. In this way, the committees will be able to adequately perform the duties assigned ...

  9. Relevance and Challenges of Ethics Committees

    Historically, research ethics committees have the longest tradition in ethical research. Their main task has been to ensure the rights and well-being of human research subjects and/or animals participating in research. ... One question that arises is whether it is possible to act based on the principle of anonymity when personal contact and ...

  10. Research made simple: ethics committee approval

    Research ethics committees. RECs came to prominence in the second half of the 20th century. The internationally recognised Declaration of Helsinki— first adopted in 1964, but amended several times since then—states all researchers need to secure REC approval before commencing research involving human participants, in order to safeguard the health and well-being of those involved.2 RECs can ...

  11. PDF Guidance for research ethics committees for rapid review of research

    mandatory, can follow. Principal investigators should contact the research ethics committee as soon as possible to communicate their intention to submit a high-level overview of research (for example, is it a trial of a new medicine or vaccine, an observational study, or a survey), so that the committee is aware of protocols that may be ...

  12. Research Ethics Committees overview

    Listings, contact information and meeting dates for Research Ethics Committees (RECs) within the UK Health Departments' Research Ethics Service. RECs review around 6,000 research applications across the UK covering a wide range of research. On average, they give an opinion in less than 40 days: well within the statutory timeline of 60 days.

  13. The roles of research ethics committees: implications for membership

    The purpose of a Research Ethics Committee in reviewing the proposed study is to protect the dignity, rights, safety and well-being of all actual or potential research participants. And the Economic and Social Research Council's research ethics framework for social science research [3] states: A Research Ethics Committee (REC) is defined as a ...

  14. What is a Research Ethics Committee?

    News. Research ethics committees (RECs) are an important part of a healthy research culture. Their role is to consider the ethical implications of research. Traditionally this has focussed on the need to protect research participants (both human and animal), but in recent years their role in supporting researchers, and promoting research ...

  15. Governance arrangements for research ethics committees

    Research organisations (ROs) have a duty to make sure their RECs are functioning appropriately, and are resourced to do so. Ethics review timeframe should not exceed 60 days unless there are circumstances beyond the control of the RO. RECs should provide supportive, reflexive governance to researchers and operate a system of ongoing monitoring ...

  16. Ethical Considerations in Research

    Revised on June 22, 2023. 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 ...

  17. CONTACT

    CONTACT US . Address. UiTM Research Ethics Committee, Office of Deputy Vice Chancellor (Research and Innovation), Level 3 Bangunan Wawasan, 40450 Shah Alam, Selangor, Malaysia. Telephone.

  18. Our principles: research ethics committees

    RECs should be able to conduct ethics review in a wholly independent and impartial manner without any conflicts of interest and with a focus clearly on the ethics of research proposals. Independence can be achieved by a committee composed of members from a wide range of disciplines and includes external members, within a policy and governance ...

  19. IRB Rosters

    IRB Information The IRBs are registered with the Office of Human Research Protections. The University of North Carolina at Chapel Hill has the following IRBs, shown with their OHRP numerical designation: IRB Rosters The UNC-CH rosters listed here are the … Read more

  20. Contact Us

    Contact Our Office Mona Campus Research Ethics Committee. 2nd Floor, Faculty of Medical Science Teaching & Research Complex (FMSTRC) The University of the West Indies Mona, Kingston 7. Tel: (876) 873-7431/ 970-4892. Email: [email protected]. Office Hours. Mondays - Fridays 8:30 AM to 4:30 PM

  21. Contact

    The Danish National Center for Ethics. EAN number: 5798000362109. CVR number: 11 80 66 19. Email: [email protected]. You can send secure mail to us via the Digital Post solution. If you need to contact a specific employee or case handler, you can find contact information on us at: The Danish National Center for Ethics website.

  22. Committee for ethics in research

    There are several reasons to ask for advice from an ethics committee: Societal considerations: it's important to assess whether your research is in line with the ethical standards prevailing in society. Legal certainty: you need to consider whether your research could potentially lead to legal consequences and how to mitigate these risks.

  23. 2024 Conference

    Reflections on the NeurIPS 2023 Ethics Review Process: Nov 23, 2023 NeurIPS Newsletter - November 2023: Nov 20, 2023 ... Neural Information Processing Systems Foundation is a non-profit corporation whose purpose is to foster the exchange of research advances in Artificial Intelligence and Machine Learning, ... Contact. 1269 Law St, San Diego ...

  24. New Mexico Legislative Council Service Director

    Alaska Legislative Ethics Committee Administrator. Anchorage, Ala. Range: $3,169.50 to $3,753.75 bi-weekly ... The LCS provides bill drafting and legal research for all legislators, the Governor, and state agencies and institutions. ... Contact Us x. Denver 7700 E. First Place Denver, CO 80230. 303-364-7700. Washington, D.C.