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What is a Research Ethics Committee?

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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 .

Research organisations and research ethics committees - ESRC

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

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

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

Published: January 23, 2007

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

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

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

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

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

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

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

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

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

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

Most literature examining research ethics committees comes from wealthier countries.

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

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

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

Results of Our Case Study

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

History of research ethics committees.

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

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

Composition.

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

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Composition of RECs in Case Study

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

REC meetings.

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

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

Training of REC members.

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

Conflicts of interest.

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

Procedural and administrative issues.

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

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

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

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

REC review.

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

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

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

Challenges.

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

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

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

Suggestions.

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

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

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

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

Encouraging lessons.

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

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

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

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

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

Limitations of our case study.

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

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

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

Supporting Information

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

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

(31 KB DOC).

Acknowledgments

We are grateful for the research assistance of Rachel Harrison.

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Research Ethics Committees

First Online: 03 September 2021

Cite this chapter

Itziar de Lecuona 27

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

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

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

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Published: 18 April 2024

Research ethics and artificial intelligence for global health: perspectives from the global forum on bioethics in research

James Shaw 1 , 13 ,
Joseph Ali 2 , 3 ,
Caesar A. Atuire 4 , 5 ,
Phaik Yeong Cheah 6 ,
Armando Guio Español 7 ,
Judy Wawira Gichoya 8 ,
Adrienne Hunt 9 ,
Daudi Jjingo 10 ,
Katherine Littler 9 ,
Daniela Paolotti 11 &
Effy Vayena 12

BMC Medical Ethics volume 25 , Article number: 46 ( 2024 ) Cite this article

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The ethical governance of Artificial Intelligence (AI) in health care and public health continues to be an urgent issue for attention in policy, research, and practice. In this paper we report on central themes related to challenges and strategies for promoting ethics in research involving AI in global health, arising from the Global Forum on Bioethics in Research (GFBR), held in Cape Town, South Africa in November 2022.

The GFBR is an annual meeting organized by the World Health Organization and supported by the Wellcome Trust, the US National Institutes of Health, the UK Medical Research Council (MRC) and the South African MRC. The forum aims to bring together ethicists, researchers, policymakers, research ethics committee members and other actors to engage with challenges and opportunities specifically related to research ethics. In 2022 the focus of the GFBR was “Ethics of AI in Global Health Research”. The forum consisted of 6 case study presentations, 16 governance presentations, and a series of small group and large group discussions. A total of 87 participants attended the forum from 31 countries around the world, representing disciplines of bioethics, AI, health policy, health professional practice, research funding, and bioinformatics. In this paper, we highlight central insights arising from GFBR 2022.

We describe the significance of four thematic insights arising from the forum: (1) Appropriateness of building AI, (2) Transferability of AI systems, (3) Accountability for AI decision-making and outcomes, and (4) Individual consent. We then describe eight recommendations for governance leaders to enhance the ethical governance of AI in global health research, addressing issues such as AI impact assessments, environmental values, and fair partnerships.

Conclusions

The 2022 Global Forum on Bioethics in Research illustrated several innovations in ethical governance of AI for global health research, as well as several areas in need of urgent attention internationally. This summary is intended to inform international and domestic efforts to strengthen research ethics and support the evolution of governance leadership to meet the demands of AI in global health research.

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Introduction

The ethical governance of Artificial Intelligence (AI) in health care and public health continues to be an urgent issue for attention in policy, research, and practice [ 1 , 2 , 3 ]. Beyond the growing number of AI applications being implemented in health care, capabilities of AI models such as Large Language Models (LLMs) expand the potential reach and significance of AI technologies across health-related fields [ 4 , 5 ]. Discussion about effective, ethical governance of AI technologies has spanned a range of governance approaches, including government regulation, organizational decision-making, professional self-regulation, and research ethics review [ 6 , 7 , 8 ]. In this paper, we report on central themes related to challenges and strategies for promoting ethics in research involving AI in global health research, arising from the Global Forum on Bioethics in Research (GFBR), held in Cape Town, South Africa in November 2022. Although applications of AI for research, health care, and public health are diverse and advancing rapidly, the insights generated at the forum remain highly relevant from a global health perspective. After summarizing important context for work in this domain, we highlight categories of ethical issues emphasized at the forum for attention from a research ethics perspective internationally. We then outline strategies proposed for research, innovation, and governance to support more ethical AI for global health.

In this paper, we adopt the definition of AI systems provided by the Organization for Economic Cooperation and Development (OECD) as our starting point. Their definition states that an AI system is “a machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations, or decisions influencing real or virtual environments. AI systems are designed to operate with varying levels of autonomy” [ 9 ]. The conceptualization of an algorithm as helping to constitute an AI system, along with hardware, other elements of software, and a particular context of use, illustrates the wide variety of ways in which AI can be applied. We have found it useful to differentiate applications of AI in research as those classified as “AI systems for discovery” and “AI systems for intervention”. An AI system for discovery is one that is intended to generate new knowledge, for example in drug discovery or public health research in which researchers are seeking potential targets for intervention, innovation, or further research. An AI system for intervention is one that directly contributes to enacting an intervention in a particular context, for example informing decision-making at the point of care or assisting with accuracy in a surgical procedure.

The mandate of the GFBR is to take a broad view of what constitutes research and its regulation in global health, with special attention to bioethics in Low- and Middle- Income Countries. AI as a group of technologies demands such a broad view. AI development for health occurs in a variety of environments, including universities and academic health sciences centers where research ethics review remains an important element of the governance of science and innovation internationally [ 10 , 11 ]. In these settings, research ethics committees (RECs; also known by different names such as Institutional Review Boards or IRBs) make decisions about the ethical appropriateness of projects proposed by researchers and other institutional members, ultimately determining whether a given project is allowed to proceed on ethical grounds [ 12 ].

However, research involving AI for health also takes place in large corporations and smaller scale start-ups, which in some jurisdictions fall outside the scope of research ethics regulation. In the domain of AI, the question of what constitutes research also becomes blurred. For example, is the development of an algorithm itself considered a part of the research process? Or only when that algorithm is tested under the formal constraints of a systematic research methodology? In this paper we take an inclusive view, in which AI development is included in the definition of research activity and within scope for our inquiry, regardless of the setting in which it takes place. This broad perspective characterizes the approach to “research ethics” we take in this paper, extending beyond the work of RECs to include the ethical analysis of the wide range of activities that constitute research as the generation of new knowledge and intervention in the world.

Ethical governance of AI in global health

The ethical governance of AI for global health has been widely discussed in recent years. The World Health Organization (WHO) released its guidelines on ethics and governance of AI for health in 2021, endorsing a set of six ethical principles and exploring the relevance of those principles through a variety of use cases. The WHO guidelines also provided an overview of AI governance, defining governance as covering “a range of steering and rule-making functions of governments and other decision-makers, including international health agencies, for the achievement of national health policy objectives conducive to universal health coverage.” (p. 81) The report usefully provided a series of recommendations related to governance of seven domains pertaining to AI for health: data, benefit sharing, the private sector, the public sector, regulation, policy observatories/model legislation, and global governance. The report acknowledges that much work is yet to be done to advance international cooperation on AI governance, especially related to prioritizing voices from Low- and Middle-Income Countries (LMICs) in global dialogue.

One important point emphasized in the WHO report that reinforces the broader literature on global governance of AI is the distribution of responsibility across a wide range of actors in the AI ecosystem. This is especially important to highlight when focused on research for global health, which is specifically about work that transcends national borders. Alami et al. (2020) discussed the unique risks raised by AI research in global health, ranging from the unavailability of data in many LMICs required to train locally relevant AI models to the capacity of health systems to absorb new AI technologies that demand the use of resources from elsewhere in the system. These observations illustrate the need to identify the unique issues posed by AI research for global health specifically, and the strategies that can be employed by all those implicated in AI governance to promote ethically responsible use of AI in global health research.

RECs and the regulation of research involving AI

RECs represent an important element of the governance of AI for global health research, and thus warrant further commentary as background to our paper. Despite the importance of RECs, foundational questions have been raised about their capabilities to accurately understand and address ethical issues raised by studies involving AI. Rahimzadeh et al. (2023) outlined how RECs in the United States are under-prepared to align with recent federal policy requiring that RECs review data sharing and management plans with attention to the unique ethical issues raised in AI research for health [ 13 ]. Similar research in South Africa identified variability in understanding of existing regulations and ethical issues associated with health-related big data sharing and management among research ethics committee members [ 14 , 15 ]. The effort to address harms accruing to groups or communities as opposed to individuals whose data are included in AI research has also been identified as a unique challenge for RECs [ 16 , 17 ]. Doerr and Meeder (2022) suggested that current regulatory frameworks for research ethics might actually prevent RECs from adequately addressing such issues, as they are deemed out of scope of REC review [ 16 ]. Furthermore, research in the United Kingdom and Canada has suggested that researchers using AI methods for health tend to distinguish between ethical issues and social impact of their research, adopting an overly narrow view of what constitutes ethical issues in their work [ 18 ].

The challenges for RECs in adequately addressing ethical issues in AI research for health care and public health exceed a straightforward survey of ethical considerations. As Ferretti et al. (2021) contend, some capabilities of RECs adequately cover certain issues in AI-based health research, such as the common occurrence of conflicts of interest where researchers who accept funds from commercial technology providers are implicitly incentivized to produce results that align with commercial interests [ 12 ]. However, some features of REC review require reform to adequately meet ethical needs. Ferretti et al. outlined weaknesses of RECs that are longstanding and those that are novel to AI-related projects, proposing a series of directions for development that are regulatory, procedural, and complementary to REC functionality. The work required on a global scale to update the REC function in response to the demands of research involving AI is substantial.

These issues take greater urgency in the context of global health [ 19 ]. Teixeira da Silva (2022) described the global practice of “ethics dumping”, where researchers from high income countries bring ethically contentious practices to RECs in low-income countries as a strategy to gain approval and move projects forward [ 20 ]. Although not yet systematically documented in AI research for health, risk of ethics dumping in AI research is high. Evidence is already emerging of practices of “health data colonialism”, in which AI researchers and developers from large organizations in high-income countries acquire data to build algorithms in LMICs to avoid stricter regulations [ 21 ]. This specific practice is part of a larger collection of practices that characterize health data colonialism, involving the broader exploitation of data and the populations they represent primarily for commercial gain [ 21 , 22 ]. As an additional complication, AI algorithms trained on data from high-income contexts are unlikely to apply in straightforward ways to LMIC settings [ 21 , 23 ]. In the context of global health, there is widespread acknowledgement about the need to not only enhance the knowledge base of REC members about AI-based methods internationally, but to acknowledge the broader shifts required to encourage their capabilities to more fully address these and other ethical issues associated with AI research for health [ 8 ].

Although RECs are an important part of the story of the ethical governance of AI for global health research, they are not the only part. The responsibilities of supra-national entities such as the World Health Organization, national governments, organizational leaders, commercial AI technology providers, health care professionals, and other groups continue to be worked out internationally. In this context of ongoing work, examining issues that demand attention and strategies to address them remains an urgent and valuable task.

The GFBR is an annual meeting organized by the World Health Organization and supported by the Wellcome Trust, the US National Institutes of Health, the UK Medical Research Council (MRC) and the South African MRC. The forum aims to bring together ethicists, researchers, policymakers, REC members and other actors to engage with challenges and opportunities specifically related to research ethics. Each year the GFBR meeting includes a series of case studies and keynotes presented in plenary format to an audience of approximately 100 people who have applied and been competitively selected to attend, along with small-group breakout discussions to advance thinking on related issues. The specific topic of the forum changes each year, with past topics including ethical issues in research with people living with mental health conditions (2021), genome editing (2019), and biobanking/data sharing (2018). The forum is intended to remain grounded in the practical challenges of engaging in research ethics, with special interest in low resource settings from a global health perspective. A post-meeting fellowship scheme is open to all LMIC participants, providing a unique opportunity to apply for funding to further explore and address the ethical challenges that are identified during the meeting.

In 2022, the focus of the GFBR was “Ethics of AI in Global Health Research”. The forum consisted of 6 case study presentations (both short and long form) reporting on specific initiatives related to research ethics and AI for health, and 16 governance presentations (both short and long form) reporting on actual approaches to governing AI in different country settings. A keynote presentation from Professor Effy Vayena addressed the topic of the broader context for AI ethics in a rapidly evolving field. A total of 87 participants attended the forum from 31 countries around the world, representing disciplines of bioethics, AI, health policy, health professional practice, research funding, and bioinformatics. The 2-day forum addressed a wide range of themes. The conference report provides a detailed overview of each of the specific topics addressed while a policy paper outlines the cross-cutting themes (both documents are available at the GFBR website: https://www.gfbr.global/past-meetings/16th-forum-cape-town-south-africa-29-30-november-2022/ ). As opposed to providing a detailed summary in this paper, we aim to briefly highlight central issues raised, solutions proposed, and the challenges facing the research ethics community in the years to come.

In this way, our primary aim in this paper is to present a synthesis of the challenges and opportunities raised at the GFBR meeting and in the planning process, followed by our reflections as a group of authors on their significance for governance leaders in the coming years. We acknowledge that the views represented at the meeting and in our results are a partial representation of the universe of views on this topic; however, the GFBR leadership invested a great deal of resources in convening a deeply diverse and thoughtful group of researchers and practitioners working on themes of bioethics related to AI for global health including those based in LMICs. We contend that it remains rare to convene such a strong group for an extended time and believe that many of the challenges and opportunities raised demand attention for more ethical futures of AI for health. Nonetheless, our results are primarily descriptive and are thus not explicitly grounded in a normative argument. We make effort in the Discussion section to contextualize our results by describing their significance and connecting them to broader efforts to reform global health research and practice.

Uniquely important ethical issues for AI in global health research

Presentations and group dialogue over the course of the forum raised several issues for consideration, and here we describe four overarching themes for the ethical governance of AI in global health research. Brief descriptions of each issue can be found in Table 1 . Reports referred to throughout the paper are available at the GFBR website provided above.

The first overarching thematic issue relates to the appropriateness of building AI technologies in response to health-related challenges in the first place. Case study presentations referred to initiatives where AI technologies were highly appropriate, such as in ear shape biometric identification to more accurately link electronic health care records to individual patients in Zambia (Alinani Simukanga). Although important ethical issues were raised with respect to privacy, trust, and community engagement in this initiative, the AI-based solution was appropriately matched to the challenge of accurately linking electronic records to specific patient identities. In contrast, forum participants raised questions about the appropriateness of an initiative using AI to improve the quality of handwashing practices in an acute care hospital in India (Niyoshi Shah), which led to gaming the algorithm. Overall, participants acknowledged the dangers of techno-solutionism, in which AI researchers and developers treat AI technologies as the most obvious solutions to problems that in actuality demand much more complex strategies to address [ 24 ]. However, forum participants agreed that RECs in different contexts have differing degrees of power to raise issues of the appropriateness of an AI-based intervention.

The second overarching thematic issue related to whether and how AI-based systems transfer from one national health context to another. One central issue raised by a number of case study presentations related to the challenges of validating an algorithm with data collected in a local environment. For example, one case study presentation described a project that would involve the collection of personally identifiable data for sensitive group identities, such as tribe, clan, or religion, in the jurisdictions involved (South Africa, Nigeria, Tanzania, Uganda and the US; Gakii Masunga). Doing so would enable the team to ensure that those groups were adequately represented in the dataset to ensure the resulting algorithm was not biased against specific community groups when deployed in that context. However, some members of these communities might desire to be represented in the dataset, whereas others might not, illustrating the need to balance autonomy and inclusivity. It was also widely recognized that collecting these data is an immense challenge, particularly when historically oppressive practices have led to a low-trust environment for international organizations and the technologies they produce. It is important to note that in some countries such as South Africa and Rwanda, it is illegal to collect information such as race and tribal identities, re-emphasizing the importance for cultural awareness and avoiding “one size fits all” solutions.

The third overarching thematic issue is related to understanding accountabilities for both the impacts of AI technologies and governance decision-making regarding their use. Where global health research involving AI leads to longer-term harms that might fall outside the usual scope of issues considered by a REC, who is to be held accountable, and how? This question was raised as one that requires much further attention, with law being mixed internationally regarding the mechanisms available to hold researchers, innovators, and their institutions accountable over the longer term. However, it was recognized in breakout group discussion that many jurisdictions are developing strong data protection regimes related specifically to international collaboration for research involving health data. For example, Kenya’s Data Protection Act requires that any internationally funded projects have a local principal investigator who will hold accountability for how data are shared and used [ 25 ]. The issue of research partnerships with commercial entities was raised by many participants in the context of accountability, pointing toward the urgent need for clear principles related to strategies for engagement with commercial technology companies in global health research.

The fourth and final overarching thematic issue raised here is that of consent. The issue of consent was framed by the widely shared recognition that models of individual, explicit consent might not produce a supportive environment for AI innovation that relies on the secondary uses of health-related datasets to build AI algorithms. Given this recognition, approaches such as community oversight of health data uses were suggested as a potential solution. However, the details of implementing such community oversight mechanisms require much further attention, particularly given the unique perspectives on health data in different country settings in global health research. Furthermore, some uses of health data do continue to require consent. One case study of South Africa, Nigeria, Kenya, Ethiopia and Uganda suggested that when health data are shared across borders, individual consent remains necessary when data is transferred from certain countries (Nezerith Cengiz). Broader clarity is necessary to support the ethical governance of health data uses for AI in global health research.

Recommendations for ethical governance of AI in global health research

Dialogue at the forum led to a range of suggestions for promoting ethical conduct of AI research for global health, related to the various roles of actors involved in the governance of AI research broadly defined. The strategies are written for actors we refer to as “governance leaders”, those people distributed throughout the AI for global health research ecosystem who are responsible for ensuring the ethical and socially responsible conduct of global health research involving AI (including researchers themselves). These include RECs, government regulators, health care leaders, health professionals, corporate social accountability officers, and others. Enacting these strategies would bolster the ethical governance of AI for global health more generally, enabling multiple actors to fulfill their roles related to governing research and development activities carried out across multiple organizations, including universities, academic health sciences centers, start-ups, and technology corporations. Specific suggestions are summarized in Table 2 .

First, forum participants suggested that governance leaders including RECs, should remain up to date on recent advances in the regulation of AI for health. Regulation of AI for health advances rapidly and takes on different forms in jurisdictions around the world. RECs play an important role in governance, but only a partial role; it was deemed important for RECs to acknowledge how they fit within a broader governance ecosystem in order to more effectively address the issues within their scope. Not only RECs but organizational leaders responsible for procurement, researchers, and commercial actors should all commit to efforts to remain up to date about the relevant approaches to regulating AI for health care and public health in jurisdictions internationally. In this way, governance can more adequately remain up to date with advances in regulation.

Second, forum participants suggested that governance leaders should focus on ethical governance of health data as a basis for ethical global health AI research. Health data are considered the foundation of AI development, being used to train AI algorithms for various uses [ 26 ]. By focusing on ethical governance of health data generation, sharing, and use, multiple actors will help to build an ethical foundation for AI development among global health researchers.

Third, forum participants believed that governance processes should incorporate AI impact assessments where appropriate. An AI impact assessment is the process of evaluating the potential effects, both positive and negative, of implementing an AI algorithm on individuals, society, and various stakeholders, generally over time frames specified in advance of implementation [ 27 ]. Although not all types of AI research in global health would warrant an AI impact assessment, this is especially relevant for those studies aiming to implement an AI system for intervention into health care or public health. Organizations such as RECs can use AI impact assessments to boost understanding of potential harms at the outset of a research project, encouraging researchers to more deeply consider potential harms in the development of their study.

Fourth, forum participants suggested that governance decisions should incorporate the use of environmental impact assessments, or at least the incorporation of environment values when assessing the potential impact of an AI system. An environmental impact assessment involves evaluating and anticipating the potential environmental effects of a proposed project to inform ethical decision-making that supports sustainability [ 28 ]. Although a relatively new consideration in research ethics conversations [ 29 ], the environmental impact of building technologies is a crucial consideration for the public health commitment to environmental sustainability. Governance leaders can use environmental impact assessments to boost understanding of potential environmental harms linked to AI research projects in global health over both the shorter and longer terms.

Fifth, forum participants suggested that governance leaders should require stronger transparency in the development of AI algorithms in global health research. Transparency was considered essential in the design and development of AI algorithms for global health to ensure ethical and accountable decision-making throughout the process. Furthermore, whether and how researchers have considered the unique contexts into which such algorithms may be deployed can be surfaced through stronger transparency, for example in describing what primary considerations were made at the outset of the project and which stakeholders were consulted along the way. Sharing information about data provenance and methods used in AI development will also enhance the trustworthiness of the AI-based research process.

Sixth, forum participants suggested that governance leaders can encourage or require community engagement at various points throughout an AI project. It was considered that engaging patients and communities is crucial in AI algorithm development to ensure that the technology aligns with community needs and values. However, participants acknowledged that this is not a straightforward process. Effective community engagement requires lengthy commitments to meeting with and hearing from diverse communities in a given setting, and demands a particular set of skills in communication and dialogue that are not possessed by all researchers. Encouraging AI researchers to begin this process early and build long-term partnerships with community members is a promising strategy to deepen community engagement in AI research for global health. One notable recommendation was that research funders have an opportunity to incentivize and enable community engagement with funds dedicated to these activities in AI research in global health.

Seventh, forum participants suggested that governance leaders can encourage researchers to build strong, fair partnerships between institutions and individuals across country settings. In a context of longstanding imbalances in geopolitical and economic power, fair partnerships in global health demand a priori commitments to share benefits related to advances in medical technologies, knowledge, and financial gains. Although enforcement of this point might be beyond the remit of RECs, commentary will encourage researchers to consider stronger, fairer partnerships in global health in the longer term.

Eighth, it became evident that it is necessary to explore new forms of regulatory experimentation given the complexity of regulating a technology of this nature. In addition, the health sector has a series of particularities that make it especially complicated to generate rules that have not been previously tested. Several participants highlighted the desire to promote spaces for experimentation such as regulatory sandboxes or innovation hubs in health. These spaces can have several benefits for addressing issues surrounding the regulation of AI in the health sector, such as: (i) increasing the capacities and knowledge of health authorities about this technology; (ii) identifying the major problems surrounding AI regulation in the health sector; (iii) establishing possibilities for exchange and learning with other authorities; (iv) promoting innovation and entrepreneurship in AI in health; and (vi) identifying the need to regulate AI in this sector and update other existing regulations.

Ninth and finally, forum participants believed that the capabilities of governance leaders need to evolve to better incorporate expertise related to AI in ways that make sense within a given jurisdiction. With respect to RECs, for example, it might not make sense for every REC to recruit a member with expertise in AI methods. Rather, it will make more sense in some jurisdictions to consult with members of the scientific community with expertise in AI when research protocols are submitted that demand such expertise. Furthermore, RECs and other approaches to research governance in jurisdictions around the world will need to evolve in order to adopt the suggestions outlined above, developing processes that apply specifically to the ethical governance of research using AI methods in global health.

Research involving the development and implementation of AI technologies continues to grow in global health, posing important challenges for ethical governance of AI in global health research around the world. In this paper we have summarized insights from the 2022 GFBR, focused specifically on issues in research ethics related to AI for global health research. We summarized four thematic challenges for governance related to AI in global health research and nine suggestions arising from presentations and dialogue at the forum. In this brief discussion section, we present an overarching observation about power imbalances that frames efforts to evolve the role of governance in global health research, and then outline two important opportunity areas as the field develops to meet the challenges of AI in global health research.

Dialogue about power is not unfamiliar in global health, especially given recent contributions exploring what it would mean to de-colonize global health research, funding, and practice [ 30 , 31 ]. Discussions of research ethics applied to AI research in global health contexts are deeply infused with power imbalances. The existing context of global health is one in which high-income countries primarily located in the “Global North” charitably invest in projects taking place primarily in the “Global South” while recouping knowledge, financial, and reputational benefits [ 32 ]. With respect to AI development in particular, recent examples of digital colonialism frame dialogue about global partnerships, raising attention to the role of large commercial entities and global financial capitalism in global health research [ 21 , 22 ]. Furthermore, the power of governance organizations such as RECs to intervene in the process of AI research in global health varies widely around the world, depending on the authorities assigned to them by domestic research governance policies. These observations frame the challenges outlined in our paper, highlighting the difficulties associated with making meaningful change in this field.

Despite these overarching challenges of the global health research context, there are clear strategies for progress in this domain. Firstly, AI innovation is rapidly evolving, which means approaches to the governance of AI for health are rapidly evolving too. Such rapid evolution presents an important opportunity for governance leaders to clarify their vision and influence over AI innovation in global health research, boosting the expertise, structure, and functionality required to meet the demands of research involving AI. Secondly, the research ethics community has strong international ties, linked to a global scholarly community that is committed to sharing insights and best practices around the world. This global community can be leveraged to coordinate efforts to produce advances in the capabilities and authorities of governance leaders to meaningfully govern AI research for global health given the challenges summarized in our paper.

Limitations

Our paper includes two specific limitations that we address explicitly here. First, it is still early in the lifetime of the development of applications of AI for use in global health, and as such, the global community has had limited opportunity to learn from experience. For example, there were many fewer case studies, which detail experiences with the actual implementation of an AI technology, submitted to GFBR 2022 for consideration than was expected. In contrast, there were many more governance reports submitted, which detail the processes and outputs of governance processes that anticipate the development and dissemination of AI technologies. This observation represents both a success and a challenge. It is a success that so many groups are engaging in anticipatory governance of AI technologies, exploring evidence of their likely impacts and governing technologies in novel and well-designed ways. It is a challenge that there is little experience to build upon of the successful implementation of AI technologies in ways that have limited harms while promoting innovation. Further experience with AI technologies in global health will contribute to revising and enhancing the challenges and recommendations we have outlined in our paper.

Second, global trends in the politics and economics of AI technologies are evolving rapidly. Although some nations are advancing detailed policy approaches to regulating AI more generally, including for uses in health care and public health, the impacts of corporate investments in AI and political responses related to governance remain to be seen. The excitement around large language models (LLMs) and large multimodal models (LMMs) has drawn deeper attention to the challenges of regulating AI in any general sense, opening dialogue about health sector-specific regulations. The direction of this global dialogue, strongly linked to high-profile corporate actors and multi-national governance institutions, will strongly influence the development of boundaries around what is possible for the ethical governance of AI for global health. We have written this paper at a point when these developments are proceeding rapidly, and as such, we acknowledge that our recommendations will need updating as the broader field evolves.

Ultimately, coordination and collaboration between many stakeholders in the research ethics ecosystem will be necessary to strengthen the ethical governance of AI in global health research. The 2022 GFBR illustrated several innovations in ethical governance of AI for global health research, as well as several areas in need of urgent attention internationally. This summary is intended to inform international and domestic efforts to strengthen research ethics and support the evolution of governance leadership to meet the demands of AI in global health research.

Data availability

All data and materials analyzed to produce this paper are available on the GFBR website: https://www.gfbr.global/past-meetings/16th-forum-cape-town-south-africa-29-30-november-2022/ .

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Acknowledgements

We would like to acknowledge the outstanding contributions of the attendees of GFBR 2022 in Cape Town, South Africa. This paper is authored by members of the GFBR 2022 Planning Committee. We would like to acknowledge additional members Tamra Lysaght, National University of Singapore, and Niresh Bhagwandin, South African Medical Research Council, for their input during the planning stages and as reviewers of the applications to attend the Forum.

This work was supported by Wellcome [222525/Z/21/Z], the US National Institutes of Health, the UK Medical Research Council (part of UK Research and Innovation), and the South African Medical Research Council through funding to the Global Forum on Bioethics in Research.

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JS led the writing, contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. JA contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. CA contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. PYC contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. AE contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. JWG contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. AH contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. DJ contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. KL contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. DP contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. EV contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper.

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Shaw, J., Ali, J., Atuire, C.A. et al. Research ethics and artificial intelligence for global health: perspectives from the global forum on bioethics in research. BMC Med Ethics 25 , 46 (2024). https://doi.org/10.1186/s12910-024-01044-w

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Shampa Maji 1 ,
Debadatta Mohapatra 2 ,
Monalisa Jena 1 ,
Anand Srinivasan 1 ,
http://orcid.org/0000-0003-4063-9178 Rituparna Maiti 1
1 Pharmacology , All India Institute of Medical Sciences , Bhubaneswar , Odisha , India
2 Psychiatry , All India Institute of Medical Sciences , Bhubaneswar , Odisha , India
Correspondence to Dr Rituparna Maiti; pharm_rituparna{at}aiimsbhubaneswar.edu.in

Background Therapeutic latency, lack of efficacy and adverse drug reactions are the major concerns in current antidepressant therapies. To overcome these treatment hurdles, add-on therapy to conventional antidepressant medications may lead to better therapeutic outcomes. The present randomised controlled trial has been planned to evaluate the efficacy and safety of add-on dextromethorphan to selective serotonin reuptake inhibitors (SSRIs) in major depressive disorder (MDD).

Methods and analysis A randomised, double-blind, add-on, placebo-controlled, group sequential design clinical trial will be conducted on patients with MDD who will be randomly assigned to the control and the test group in a 1:1 ratio. Patients in the test group will get dextromethorphan 30 mg once daily, whereas patients in the control group will receive a placebo once daily as an add-on to ongoing SSRI treatment for 8 weeks. All patients will be evaluated for the primary outcome (change in the Montgomery-Åsberg Depression Rating Scale score) and secondary outcomes (treatment response rate, remission rate, Clinical Global Impression, serum brain-derived neurotrophic factor, serum dextromethorphan and treatment-emergent adverse events) over the period of 8 weeks. Intention-to-treat analysis will be done for all parameters using suitable statistical tools.

Ethics and dissemination This study was approved by the Institutional Ethics Committee of All India Institute of Medical Sciences, Bhubaneswar, India, and the study conformed to the provisions of the Declaration of Helsinki and ICMR’s ethical guidelines for biomedical research on human subjects (2017). Written informed consent will be obtained from the participants before recruitment. The results of this study will be published in peer-reviewed publications.

Trial registration number NCT05181527 .

Depression & mood disorders
CLINICAL PHARMACOLOGY
Adult psychiatry
Randomized Controlled Trial

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ .

https://doi.org/10.1136/bmjopen-2023-080500

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STRENGTHS AND LIMITATIONS OF THIS STUDY

This is the first randomised, double-blind clinical trial on dextromethorphan in major depressive disorder.

Group sequential adaptive design will allow two interim analyses and will save resources.

Being a single-centre study, generalisability may be limited.

The study is not going to compare the time to response between the study groups.

Evaluation of multiple doses of dextromethorphan and a longer follow-up period with multiple time points would have strengthened the study data.

Major depressive disorder (MDD) is a common psychiatric disorder with a substantial socioeconomic burden with a global prevalence rate of 16%. 1 The underlying pathophysiology of depression is still not understood completely. 2 Among the different proposed hypotheses, the most accepted is the monoamine hypothesis, which is the basis of conventional antidepressant medications like tricyclic antidepressants, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors. Although many medications are available, a significant proportion of patients become either partial responders (less than 25% improvement on a depression rating scale), non-responders (improvement between 25% and 50% on a rating scale) or treatment-resistant depression (TRD) patients (when at least two trials with antidepressants from different pharmacological classes in adequate dose, duration and compliance fail to produce a significant clinical improvement). 3–5 Another major concern is the therapeutic lag period with all these monoaminergic antidepressants. Additionally, most of the available antidepressant medications have many adverse effects, which increase with increments in dose. The discovery of the rapid and sustained antidepressant effect of a subanaesthetic dose of ketamine, especially in the treatment of non-responders and treatment-resistant cases, 1 6 has led to extensive clinical and preclinical research in the recent past. The US Food and Drug Administration (FDA) has also approved esketamine nasal spray for the treatment of TRD in adults. 7 As repeated doses of ketamine are related to abusive potential and many other adverse effects, 8 the search for a similar antidepressant agent is going on that acts via a similar mechanism with a better safety profile.

Dextromethorphan, a US FDA-approved over-the-counter antitussive medication, has a similar property of non-competitively blocking N-methyl-D-aspartate (NMDA) receptors of glutamate, like ketamine. 9 Additionally, dextromethorphan has serotonin reuptake transporter (SERT) inhibitory and norepinephrine transporter (NET) inhibitory properties, 10 so it can also increase the availability of serotonin in synapses, hence may achieve a synergistic effect with SSRIs. 11 12 In 2010, US-FDA approved dextromethorphan plus quinidine (Nuedexta) for use in pseudobulbar affect, 9 10 13 and currently, it is under investigation as a potential antidepressant agent in MDD ( NCT01882829 , NCT02153502 ). 10 13 A phase IIa clinical trial by Murrough et al has reported acceptable tolerability and efficacy of dextromethorphan/quinidine combination in TRD. 14 In 2022, the US FDA approved dextromethorphan hydrobromide and bupropion hydrochloride fixed-dose combination (Auvelity) for the treatment of MDD in adult patients. 15 Akbar et al , in their systematic review, evaluated the efficacy and safety of the dextromethorphan-bupropion combination for depression and highlighted the importance of evaluating the potential impact of combining dextromethorphan with other CYP2D6 inhibitors, such as antidepressants known to interact with CYP2D6, specifically in patients diagnosed with MDD. 16 Previous preclinical and clinical studies 14 17–25 on dextromethorphan in depression have been presented in online supplemental table S1 .

Supplemental material

In the present background, we hypothesise that the major concerns of antidepressant therapy, like therapeutic latency, lack of efficacy and adverse drug reactions, may be overcome by adding dextromethorphan to SSRI in MDD. As SSRIs inhibit CYP2D6, the addition of quinidine with dextromethorphan may not be reasonable and, hence, not considered in the present study. Our literature search found that, to date, there is no randomised controlled trial on dextromethorphan as an add-on therapy to first-line antidepressants like SSRIs. So, the present randomised controlled trial has been planned with an objective to evaluate the efficacy and safety of add-on dextromethorphan to SSRIs in MDD.

Objectives of the study

Primary objective.

To evaluate the change in symptoms of Depression using the Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline after 8 weeks treatment with add-on dextromethorphan in patients with MDD.

Secondary objectives

To evaluate the treatment response rate (defined as a reduction of ≥50% of the MADRS score from baseline) at 8 weeks.

To evaluate the remission rate (defined as a score of <7 MADRS post-treatment) after 8 weeks.

To evaluate clinical status assessed by Clinical Global Impression (CGI) (severity and improvement) from baseline after 8 weeks.

To evaluate the neurotrophic effect of add-on dextromethorphan in terms of change in serum level of brain-derived neurotrophic factor (BDNF) from baseline after 8 weeks.

To evaluate the serum level of dextromethorphan after 8 weeks.

To evaluate the adverse drug effect profile of oral dextromethorphan.

Study design

The proposed study is a randomised, double-blind, add-on placebo-controlled, parallel-arm, group sequential design clinical trial. The study protocol has been prepared following the guidelines of Standard Protocol Item Recommendations for Interventional Trials and registered with ClinicalTrials.gov. The present study is a single-centred study and will be conducted in the departments of Pharmacology and Psychiatry of our institute. The approval from the Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar, India, was obtained on 14 December 2021.

The present trial will follow a group sequential design with two interim analyses. The first interim analysis will be done after completion of follow-up of 34 participants (17 in each group), and the second interim analysis will be done after completion of 60 participants (30 in each group) ( figure 1 ). If the z value breaches the O'Brien-Fleming boundary of futility or efficacy during any interim analysis, the trial will be stopped ( figure 2 ).

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Study flow chart. SSRI, selective serotonin reuptake inhibitor.

O'Brien Fleming boundary targets along with sample size provided the allocation ratio is maintained as 1:1 throughout the study. (Z-score 2.868, 2.060 and 1.708 corresponds to a p value of 0. 0.0021, 0.0197 and 0.0438, respectively).

Study population and eligibility

Patients attending the outpatient psychiatry department of our institute with MDD will be screened, and enrolment will be done as per predefined inclusion and exclusion criteria. After direct communication with the principal investigator, detailed information regarding interventions, assessment methods, benefits and potential adverse reactions will be explained, and a patient information sheet will be provided to the participants. Written informed consent will be obtained from all participants before they participate in the study (participant informed consent form has been provided under online supplemental material ).

Diagnostic criteria

The diagnosis of depression will be solely clinical and Diagnostic, and the Statistical Manual of Mental Disorders-5 (DSM5) criteria 26 for diagnosing MDD will be followed:

‘A. Five (or more) of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least one of the symptoms is either depressed mood or loss of interest or pleasure.

Depressed mood most of the day, nearly every day, as indicated by either subjective report (eg, feels sad, empty, hopeless) or observation made by others (eg, appears tearful).

Markedly diminished interest or pleasure in all, or almost all, activities most of the day, nearly every day (as indicated by either subjective account or observation.

Significant weight loss when not dieting or weight gain (eg, a change of more than 5% of body weight in a month) or decrease or increase in appetite nearly every day.

Insomnia or hypersomnia nearly every day.

Psychomotor agitation or retardation nearly every day (observable by others, not merely subjective feelings of restlessness or being slowed down).

Fatigue or loss of energy nearly every day.

Feelings of worthlessness or excessive or inappropriate guilt (which may be delusional) nearly every day (not merely self-reproach or guilt about being sick).

Diminished ability to think or concentrate, or indecisiveness, nearly every day (either by subjective account or as observed by others).

Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide.

B. The symptoms cause clinically significant distress or impairment in social, occupational or other important areas of functioning.

C. The episode is not attributable to the physiological effects of a substance or another medical condition.’

Inclusion criteria

Patients diagnosed with MDD (DSM5) of either gender within the age group of 18–65 years.

Patients with MADRS scores ≥7 and ≤34 (patients having mild to moderate MDD).

Patients who are on a stable dose of sertraline 50 mg or any other SSRI therapy in an equivalent dose (fluoxetine 20 mg/day, paroxetine 20 mg/day, escitalopram 10 mg/day, fluvoxamine 75 mg/day). 27

Patients who have given written informed consent.

Exclusion criteria

Patients who have been treated with electroconvulsive therapy recently.

History of epilepsy, or other major neurological or medical disorders, head trauma.

Patients with a history of bipolar depression.

Patients with schizophrenia or other psychotic disorders.

Patients with cognitive impairment.

Initiating or stopping formal psychotherapy within 6 weeks before enrolment.

Patients with comorbidities like any malignancies, hepatic, renal, cardiovascular, neurological or endocrinal, or respiratory dysfunction.

Substance abuse history of psychoactive agents.

Pregnant and lactating mothers.

Sample size calculation

The sample size has been calculated based on the expected change in the primary outcome measure (MADRS score), and for the calculation, data have been taken from a previous randomised, controlled trial done by Kamijima et al where the mean (SD) difference in MADRS score was 7.2 (SD 7) between the groups. 28 Our calculation found that a sample size of 42/group (N=84) can achieve a power of 90% to detect an intergroup difference of 5 in the MADRS score, considering an SD of 7, alpha as 0.05 and allocation ratio 1:1.

We have planned a group sequential design with three analyses (two interim and the final analysis) during the course of the study. To control the increase in the chance of occurrence of type I error during the interim analyses, the O'Brien-Fleming boundary (with z scores and p value) has been defined as provided in figure 2 . The study will be terminated if the Z value of the effect size crosses the boundary on either side during an interim analysis. Sample size calculation was done using the software R (rpact). 29

Randomisation, allocation concealment and blinding

All the recruited patients will be randomised into two treatment groups by block randomisation using computer-generated codes. The fixed block size of 6 has been decided to be used for random code generation. The allocation ratio will be 1:1 throughout the study. For blinding purposes, the random allocation code of the participants will be generated by the investigator, who will not be involved in patient recruitment. The sequentially numbered and identical-looking medication dispensers will be used for allocation concealment. The randomisation sequence will be blinded to both participants and the investigators. For interim analysis, the randomisation code will be opened, and the analysis will be done by an investigator who will be blinded to the group allocation.

Interventions

Patients in the test group will get a dextromethorphan 30 mg capsule once daily orally as an add-on to ongoing SSRI treatment, whereas patients in the control group will get an identical-looking capsule containing a placebo (starch) once daily in addition to SSRI. Both placebo and test medication have to be consumed for 8 weeks.

Study procedure and data collection

Patients aged 18–65 years, of either gender, attending the psychiatry outpatient department of our institute, and having a diagnosis of MDD will be screened. Enrolment will be done after considering the predefined inclusion and exclusion criteria and obtaining written informed consent. A detailed history and basic clinical details will be recorded. At baseline, MADRS and CGI-S scores will be recorded. A 5 mL venous blood will be collected to estimate serum BDNF level at baseline. By using computer-generated algorithms, recruited patients will be randomised into test and control groups. Patients in the test group will get dextromethorphan 30 mg once daily orally as an add-on to ongoing SSRI treatment, whereas patients in the control group will get an identical-looking capsule containing a placebo (starch) once daily in addition to SSRI. Both placebo and test medication have to be consumed for 8 weeks. All patients are going to be followed up after 8 weeks, and post-treatment re-evaluation of all the above parameters, that is, MADRS scores, CGI scores, and serum BDNF levels, will be done. The detailed visit schedule is presented in online supplemental table S2 . There can be unscheduled visits due to deterioration of depressive symptoms or adverse drug reactions. Treatment-emergent adverse events will be reported and managed according to severity. Causality assessment will be done for adverse drug reactions by using the WHO-Uppsala Monitoring Centre (WHO-UMC) system.

Outcome measures

Primary outcome measure.

MADRS scores at baseline and 8 weeks follow-up. MADRS is a 10-item diagnostic questionnaire to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0–6; the overall score thus ranges from 0 to 60. The higher MADRS score indicates more severe depression. 30

Secondary outcome measures

The response rate of the patients, that is, percentage of patients showing 50% decrease in MADRS scores from baseline, at 8-week follow-up.

The remission rate, that is, percentage of patients achieving MADRS scores <7 at 8-week follow-up.

CGI scores: CGI-S (severity) at both baseline and follow-up and CGI-I (improvement) at 8 weeks. The CGI provides an overall clinician-determined summary measure that considers all available information, including a knowledge of the patient’s history, psychosocial circumstances, symptoms, behaviour and the impact of the symptoms on the patient’s ability to function. The CGI has two components: the CGI-Severity, which rates illness severity, and the CGI-Improvement, which rates change from the initiation (baseline) of treatment on a 7-point scale. 31

Serum BDNF level at baseline and at 8-week follow-up. Serum BDNF levels will be measured using a commercially available human ELISA kit.

Serum dextromethorphan level after completion of 8-week therapy using high-performance liquid chromatography (HPLC). For quantitative analysis of dextromethorphan, the HPLC method with fluorometric detection will be done as described by Lin et al. 32

Safety evaluation: During the follow-up visit, the occurrence of treatment-emergent adverse events will be assessed by non-directive questioning of the patient. Patients can directly access the investigators to report any adverse effects they have experienced. Whether previously known or not, all adverse events will be recorded with their description, intensity, duration, action taken, outcome and causal relationship to SSRIs and dextromethorphan. Treatment-emergent adverse events will be reported and managed according to severity. Causality assessment will be done for adverse drug reactions by using the WHO-UMC system.

Evaluation of medication adherence

The patient will be asked to return the remaining medication at the end of the 8-week period. The medication adherence (SSRI and dextromethorphan) will be calculated by pill count method. The patient will be considered compliant if there is >80% adherence to the pills used. Additionally, the serum dextromethorphan level will give an idea of compliance.

Discontinuation

In case of the following emergencies, participants will be allowed to discontinue and withdraw from the current study: (a) any allergic reactions or adverse events that should be withdrawn according to the physician’s judgement and (b) poor compliance (<80% medication adherence).

Data management

All demographic and clinical data will be captured in a case report form (CRF), and the data entry will be done with the sequence code of each recruited patient. One investigator will monitor the clinical data once a week. Signed consent forms will be attached to the individual CRF and will be accessible only to authorised investigators. A specific investigator will access and analyse the final datasheet.

Statistical analysis

Categorical variables such as gender, remission rate and response rate will be represented as percentage/proportion and continuous data like age, MADRS score, CGI score, serum BDNF as mean±SD or median and IQR if the data is non-parametric. For performing statistical analyses, R software will be used. 33 For the calculation of statistical significance, a p<0.05 will be considered. Analyses will be conducted with the intention-to-treat principle. Missing values will be analysed using multiple imputations, and the pooled data will be used for analysis. Fisher’s exact test will compare categorical variables between the groups. For comparing means/medians, the unpaired t-test/ Mann-Whitney U test (between the groups) and the two-sided paired t-test/Wilcoxon signed-rank test (within the group) will be used. The correlation between serum BDNF and disease severity treatment response will be checked using Pearson’s correlation coefficient calculation. Logistic regression will be performed to assess the factors affecting the response rates in MDD patients.

Ethics and dissemination

This study was approved by the Institutional Ethics Committee of All India Institute of Medical Sciences, Bhubaneswar, India, and the study conformed to the provisions of the Declaration of Helsinki and ICMR’s ethical guidelines for biomedical research on human subjects (2017). After explaining the benefits and harm of the study, written informed consent will be taken from all participants. The confidentiality of the study subjects will be maintained throughout the study duration by restricting access to specific investigators. They can exit from the study at their discretion. Being an academic clinical trial with limited funding, there will be no provision of post-trial access to the trial medication. In case of any treatment-emergent adverse events, the participant will be treated free of cost in the institute. The results of this research will be presented at academic conferences and published in peer-reviewed journals. The International Committee of Medical Journal Editors guidelines on authorship criteria will be followed, and the manuscript will be drafted and edited by the authors, not by any professional writers. The protocol is available on ClinicalTrials.gov, and the participant-level data set will be available from the corresponding author on reasonable request.

Study status

The recruitment started on 10 February 2022, and the follow-up of the 60th patients was completed on 30 September 2023. The second interim analysis was done for the primary outcome measure in October 2023. The result of the second interim analysis showed a statistically significant difference between the study groups in terms of reduction of MADRS score from baseline to the 8-week follow-up, and the O'Brien Fleming boundary was breached. Hence, the trial was terminated, and all secondary outcome measures were assessed.

Patient and public involvement

Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.

Therapeutic latency, lack of efficacy and adverse drug reactions are the major limitations of current antidepressant therapies. To overcome these treatment hurdles, add-on therapy to conventional antidepressant medications may lead to better therapeutic outcomes. As dextromethorphan has the property of non-competitively blocking NMDA receptors (like ketamine) with additional SERT and NET inhibitory action, we hypothesise that adding dextromethorphan to the SSRI regimen can improve clinical outcomes in MDD. So, the present randomised controlled trial has been planned to evaluate the efficacy and safety of add-on dextromethorphan to SSRIs in MDD.

In the present randomised controlled trial, the potential of add-on therapy of dextromethorphan will be evaluated in comparison to add-on placebo therapy. The efficacy parameters are the change in MADRS scoring, responder rate, remission rate and change in serum BDNF from baseline. MADRS is an established and validated scoring system to assess the severity of depression and is used widely by psychiatrists for research and clinical practice. The definition of response and remission rate has been validated by Riedel et al , and the present study will follow the same. 34 On the other hand, the neurotrophic hypothesis of depression is based on BDNF, a neurotrophin that plays a significant role in the survival and development of neurons. 35 36 The connection between the BDNF signalling pathway and MDD is well established; hence, serum BDNF has been used as a biomarker in this study. 37 38 The estimation of serum dextromethorphan will help to assess compliance and ensure the therapeutic level required for the drug effect. Though SSRIs and dextromethorphan are well-tolerated medications, all treatment-emergent adverse events will be monitored.

The proposed clinical trial is the first registered trial on dextromethorphan as an add-on therapy to first-line antidepressants like SSRIs in MDD. The major strength of the study lies in its robust methodology and statistical analysis. The proposed study has certain limitations. First, as the study is a single-centre study, the generalisability of the data may be limited. Second, the outcome parameter, like time to response, could have been included to compare therapeutic latency between the groups. Third, instead of a single dose level of 30 mg, multiple doses could have been evaluated. Investigators opted for a safe dose for the present exploratory study. However, depending on the study results, a higher dose of 45 mg and 60 mg may be evaluated in future. Fourthly, a longer follow-up period with multiple time points would have strengthened the study data. However, the previous clinical trials on dextromethorphan in MDD by Iosifescu et al and Tabuteau et al were for a duration of 6 weeks. 39 40 So, we expect to generate clinically meaningful data with a follow-up period of 8 weeks. If the study results prove favourable, prescribing add-on dextromethorphan to first-line antidepressants, the dose requirement of antidepressant medications may decrease, there may be less chance of adverse drug reactions, and it may lead to better compliance and better clinical outcomes. Hence, the present study is expected to generate evidence on the use of adjuvant dextromethorphan with first-line antidepressant medications in MDD and contribute to practising guidelines.

Ethics statements

Patient consent for publication.

Consent obtained directly from patient(s).

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Supplementary materials

Supplementary data.

This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

Data supplement 1
Data supplement 2

Contributors Research conception and design: RM and DM. Literature review: SM and MJ. Statistical plan: AS and DM. Drafting of the manuscript: SM and RM. Critical revision of the manuscript: AM and MJ. All authors approved the final manuscript as submitted and agreed to be accountable for all aspects of the work.

Funding The first author has received funding from the Indian Council of Medical Research (ICMR), New Delhi, India, vide grant number No.3/2/Decembe-2021/PGThesis-HRD(12).

Competing interests None declared.

Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Provenance and peer review Not commissioned; externally peer reviewed.

Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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Emerson Leadership Institute Hosts the Joint Provost-Faculty Senate Gender Equity Committee Meeting

The Emerson Leadership Institute (ELI) at Chaifetz School of Business hosted the Provost-Faculty Senate Gender Equity Committee (GEC) end-of-the-year meeting on Wednesday, April 24.

The ELI aims to develop and deliver education, professional development, research, and community engagement programs that shape and enable ethical leaders. Established in 2018 by the Office of the Provost, the GEC is a robust standing committee responsible for advancing the shared governance of the university via a consultative role to the Provost and Faculty Senate on issues related to faculty gender equity.

The Emerson Leadership Institute (ELI) at Chaifetz School of Business hosted the Provost-Faculty Senate Gender Equity Committee (GEC) end-of-the-year meeting on Wednesday, April 24. Submitted photo .

Since 2018, the GEC has collaborated with the Faculty Senate and engaged with various units across the campus to buttress existing work on equity, learn about equity gaps and challenges and formulate institutional recommendations.

“The ELI is proud and honored to have the opportunity to develop a strategic partnership with the GEC for future faculty gender equity initiatives” said Jintong Tang, Ph.D.,Director of the ELI and Co-Chair of the GEC.

Some exemplars of GEC recommendations that have been implemented thus far include development of:

An Office of the Ombuds for North Campus with the Faculty Senate;
A university-wide mentorship program for early-career faculty by the Division for Diversity and Innovative Community Engagement;
The Billiken Boost Program supported by the Provost’s Office; and
Changes to the End-of-Semester Student Course Feedback forms for reducing implicit bias through the inclusion of a preamble.

This committee gets the work done," said Provost Mike Lewis, Ph.D. "I can count on you all to provide much needed advice and clarity on issues of equity for faculty and your group operates with intellectual humility and collaboration that is necessary for achieving our institutional goals.”

Faculty Senate President, Christine Rollins, J.D., echoed Lewis.

“This committee is an important voice in the shared governance process for amplifying an equity lens in the work we do," Rollins said. "I am grateful for your dedication and look forward to continued progress.”

At the meeting, the GEC members raised a dry toast to Co-Chair, Terri Weaver, Ph.D., professor of psychology, for her dedication and leadership to the GEC and celebrated her retirement from the committee.

IMAGES

Asean Research Organization
Research Ethics Committee
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9. RESEARCH AND ETHICAL COMMITTEE
About the Research Ethics Committee
(PDF) Research Ethics Committees in Laboratory Medicine

VIDEO

Research Ethical Considerations
Plagiarism Softwares| Turnitin| Common causes of plagiarism| Norms of Authorship
Ethical Governance & Personnel Committee 27 September 2023
Ethics and Responsible Conduct in Scientific Research (3 Minutes)
Ethical Principles in Research
Neurohumanities Lab: Engaging Experiences for Human Flourishing [1]

COMMENTS

Ethics Committees: Structure, Roles, and Issues
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.
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.
The role of research ethics committees: Friend or foe in educational
Research ethics committees may be perceived as a friend; they have a legitimate and useful role to play by offering advice, providing a forum in which ethical principles and their application can be discussed and initiating discussion concerning problematic cases (Hammersley, 2009). In addition, ethics committees may assist in strengthening the ...
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 ...
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 ...
Relevance and Challenges of Ethics Committees
Braun, Ravn, and Frankus 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 ...
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 ...
Research Ethics Review Committee
The Research Ethics Review Committee (ERC) is a 27-member committee established and appointed by the Director-General. Its mandate is to ensure WHO only supports research of the highest ethical standards. The ERC reviews all research projects, involving human participants supported either financially or technically by WHO. ...
Ethics Committees: Procedures and Duties
Abstract. Ethics Committees (also called Institutional Review Boards, or IRBs) are common fixtures with which researchers around the world are generally quite familiar. In much of the scientific world, they are mandated by laws and regulations and research involving human subjects is generally guided and overseen by such committees.
Research Ethics Committees overview
Research Ethics Committees overview. Last updated on 4 Feb 2020. 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 ...
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 ...
Institutional review board
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed for research involving human subjects, to ensure that the projects are ethical.The main goal of IRB reviews is to ensure that study participants are ...
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 ...
Ethical Considerations in Research
Getting ethical approval for your study. Before you start any study involving data collection with people, you'll submit your research proposal to an institutional review board (IRB).. An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution's code of conduct. They check that your research materials and procedures ...
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.
Ethics committee
A Comité de Protection des Personnes (CPP) in France. In the United States, an ethics committee is usually known as an institutional review board (IRB) or research ethics board (REB) and is dedicated to overseeing the rights and well-being of research subjects participating in scientific studies in the US. Similarly in Canada, the committee is ...
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 ...
Research ethics and artificial intelligence for global health
The forum aims to bring together ethicists, researchers, policymakers, research ethics committee members and other actors to engage with challenges and opportunities specifically related to research ethics. In 2022 the focus of the GFBR was "Ethics of AI in Global Health Research". The forum consisted of 6 case study presentations, 16 ...
The importance of trust in clinical trial safety
The reviews carried out by our Research Ethics Committees ensure that the proposed research is ethical, that all the potential risks for participants are considered and that the information provided makes it clear what is involved in taking part so participants can make informed decisions about whether to take part - and give informed consent
Repurposing of dextromethorphan as an adjunct therapy in patients with
Ethics and dissemination This study was approved by the Institutional Ethics Committee of All India Institute of Medical Sciences, Bhubaneswar, India, and the study conformed to the provisions of the Declaration of Helsinki and ICMR's ethical guidelines for biomedical research on human subjects (2017). Written informed consent will be obtained from the participants before recruitment.
Animal Welfare
Animal research conducted at the basic science departments that make up Harvard Medical School falls under the purview of the Institutional Animal Care and Use Committee, or IACUC, a federally mandated body charged with ensuring that federal regulations and ethical principles and guidelines are strictly followed in the use, handling, and care ...
Emerson Leadership Institute Hosts the Joint Provost-Faculty Senate
The Emerson Leadership Institute (ELI) at Chaifetz School of Business hosted the Provost-Faculty Senate Gender Equity Committee (GEC) end-of-the-year meeting on Wednesday, April 24. The ELI aims to develop and deliver education, professional development, research, and community engagement programs that shape and enable ethical leaders.

Publications

What is a Research Ethics Committee?

Two types of RECs

REC review supports research and researchers

Research organisations and research ethics committees - ESRC

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

The rights and dignity of individuals and groups should be respected

Wherever possible, participation should be voluntary and appropriately informed

Research should be conducted with integrity and transparency

Lines of responsibility and accountability should be clearly defined

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

Further information

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

Results of Our Case Study

History of research ethics committees.

Composition.

REC meetings.

Training of REC members.

Conflicts of interest.

Procedural and administrative issues.

REC review.

Challenges.

Suggestions.

Encouraging lessons.

Limitations of our case study.

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Acknowledgments

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Research ethics and artificial intelligence for global health: perspectives from the global forum on bioethics in research

Conclusions

Introduction

Ethical governance of AI in global health

RECs and the regulation of research involving AI

Uniquely important ethical issues for AI in global health research

Recommendations for ethical governance of AI in global health research

Limitations

Data availability

Acknowledgements

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The importance of trust in clinical trial safety

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STRENGTHS AND LIMITATIONS OF THIS STUDY

Supplemental material

Objectives of the study

Secondary objectives

Study design

Study population and eligibility

Diagnostic criteria

Inclusion criteria

Exclusion criteria

Sample size calculation

Randomisation, allocation concealment and blinding

Interventions

Study procedure and data collection

Outcome measures

Secondary outcome measures

Evaluation of medication adherence