Role of lay person in ethics committee: Bridging expertise and public trust

INTRODUCTION

The need for rigorous ethical oversight is critical in clinical research to ensure that participants’ rights and welfare are protected. Ethics committees (ECs) provide independent review and oversight for research studies, assessing the potential risks and benefits to protect human subjects. However, scientific expertise alone may not suffice in capturing the diverse ethical considerations essential to evaluating research proposals. The inclusion of lay persons on ECs introduces a valuable perspective by providing a nonscientific viewpoint that reflects societal concerns and cultural sensitivities and therefore membership of a layperson is mandatory in the research EC. This article discusses the role of lay persons in EC, emphasizing their importance and responsibilities, based on authoritative guidelines and regulations.

Defining the Lay Person’s Role in ECs.

WHO IS A LAY PERSON?

A literate person who has not pursued a medical science/health-related career in the last 5 years and is aware of the local language, cultural, and moral values of the community. Lay persons bring a nonexpert perspective to ECs.

WHO CAN SERVE AS LAY PERSON

According to ICMR Guidelines 2017,[1] a lay person is nonaffiliated, literate person from the public or community who has not pursued a medical science/health-related career in the last 5 years, may be a representative of the community from which the participants are to be drawn and is aware of the local language, cultural and moral values of the community. It is desirable that he is involved in social and community welfare activities. This implies that a lay person should possess a level of literacy that allows them to understand the potential risks and benefits of research proposals, how the research might impact participants or society, and help them to participate actively in discussions, and contribute effectively to the ethical review process.

The Code of Federal Regulations 45 Part 46 and FDA regulations at 21 CFR 56.107 (c) states that each IRB should include at least one scientific member, one nonaffiliated member with the institution, and one nonscientific member. If only one nonscientific member in the IRB, it should be the layperson.[2] ICMR guidelines 2017 states that, minimum one nonaffiliated member should be the part of the quorum and preferably the lay person should be the part of the quorum while new drugs and clinical trial rule[3] mandates the presence of lay person in the quorum.

ROLES AND RESPONSIBILITIES OF THE LAY PERSON IN ETHICS COMMITTEES

Lay members often serve as the bridge between the researchers and the community, ensuring transparency in research activities and public accountability. This role is crucial for maintaining public trust in clinical research and can facilitate more effective communication and feedback channels between participants, their communities, and the research team.

Lay person is mainly responsible for ethical review of the proposal. Informed consent document (ICD) along with translation(s), evaluation of benefits, and risks from the participant’s perspective and to see whether benefits justify the risks. A core component of ethical oversight involves assessing ICDs. Lay members are crucial in ensuring that these documents are clear, comprehensible, and culturally sensitive. This is particularly vital when dealing with vulnerable populations, such as children, the elderly, or those with cognitive impairments, where the risk of exploitation or misunderstanding is higher. He/she serve as a patient/participant/community representative and bring in ethical and societal concerns. By voicing community expectations and potential concerns, lay persons contribute to research that is respectful of local practices.

The lay person must also be free of any conflict of interest – they should not have any personal, financial, or professional connections that might influence their impartial judgment regarding the research under review. Their role is to ensure that ethical considerations reflect the concerns of the general public, focusing on the welfare and rights of research participants, informed consent, fairness, and societal impact.

When recruiting lay members for ECs, diverse backgrounds such as retired professionals, educators, and community members such as homemakers are common. Each institution, while adhering to the flexible administrative guidelines, may select an appropriate layperson to serve as a committee member at its discretion.

According to the recommendation on IRB Membership and definition of Nonscientist under 45 CFR 46 and 21 CFR 56 attorney, clergy member, ethicist, etc., can serve as nonscientific members if justified by their qualifications or perspective.[2] However, they often face challenges in understanding their role, which involves viewing research proposals from the perspective of a participant. They are encouraged to voice concerns when explanations or consent forms are unclear. However, lay members may struggle to articulate specific changes needed, reflecting a broader issue where even experts outside the field sometimes engage based on their own interests or knowledge, rather than the ethical focus required.

BALANCING EXPERTISE AND PUBLIC INTERESTS: THE CHALLENGES

Lay members may find it challenging to comprehend medical and scientific aspects of research protocols, especially when they involve complex methodologies or scientific jargon. Training on ethical principles guiding human research, how to critically assess ICDs and familiarity with key regulations, such as the Declaration of Helsinki, Good Clinical Practice, and local regulatory frameworks, can mitigate some of these challenges. Continuous support and accessible resources are needed to empower lay members to fulfil their role effectively. Lay members can often identify the issues based on their perspectives, but may find it difficult to articulate precise changes needed to make research materials clearer or more accessible. A study conducted by NIH[4] to learn about nonscientist members’ perceptions of their roles and experiences reported that nonscientific members face a range of issues that impact their participation and effectiveness in research oversight like many nonscientific members perceive their primary role as reviewing ICDs, as this task requires less scientific expertise. However, this narrow focus may limit their contributions to other critical areas of protocol review, such as assessing the equitable selection of subjects or the adequacy of privacy protections. In addition, nonscientific members may feel uncomfortable raising questions about scientific design or broader human subjects’ protections, particularly in discussions dominated by scientific experts and may feel that their perspectives are not as valued or respected as those of scientific members. Some report discomfort in participating in discussions, due to a lack of confidence in speaking up or asking questions about complex issues. Although they are vital for incorporating community values and ensuring public accountability, only a fraction of members identify themselves as public or community representatives.

The chairperson and member secretary plays a key role in fostering inclusive discussions, encouraging lay members to share their views, and ensuring their contributions are valued equally. Similarly, they may support lay members by providing premeeting resources, seeking their feedback, and facilitating training to enhance their confidence and participation. However, as lay members engage regularly with clinical protocols, ICDs, and ethical discussions, they naturally gain familiarity with research terminology, methodologies, and ethical considerations. While this increasing familiarity aids in more meaningful contributions, it may compromise the Lay person’s essential role.

CONCLUSION

To safeguard the research participants is of course equally the duty of the medical members, but it is the presence of lay members on the committee that is intended to reassure public opinion that the participant’s interests are fully protected.