Question

Federal regulations suggest that the one non-scientist on an IRB should be a lawyer, ethicist, or member of the clergy.

Do you agree or disagree, and why or why not?

Answer 1

Federal regulations suggest that the one non-scientist on an IRB should be a lawyer, ethicist, or member of the clergy. I agree to this point. The intent of the requirement for diversity of disciplines is to include members who had little or no scientific or medical training or experience. In the past, lawyers, clergy and ethicists have been cited as examples of persons whose primary concerns would be in non-scientific areas. The involvement of non-scientist and unaffiliated members in the IRB review process has strong ethical and regulatory grounding. A lawyer, ethicist, or member of the clergy can best be considered when it comes to evaluation on ethical or regulatory grounds. They are the ones best qualified as public and community representatives.

The requirement for inclusion on IRBs of at least one member whose primary concerns are in nonscientific areas flows from the conviction that prospective review of research by a diverse group of individuals is most likely to protect human subjects and promote ethically sound research. Non-scientist IRB members is to make the conduct of research accountable to the public. The regulations specify that the IRB should be sufficiently qualified through the experience, expertise and diversity of its members to promote respect for its advice and counsel.

From a practical standpoint, a study has been conducted to determine the extent non-scientists fulfill the requirements specified by the regulations and how IRBs draw on and implement non-scientists’ diverse viewpoints and experiences. Participants in the study believed their role was to represent the community of human subjects, and 94% reported that their main contribution was simplifying the consent forms. 94% of participants had positive experiences working with scientist IRB members. Forty-seven percent of participants identified lack of education and training as a problem, and 78% wanted more intensive education and training for future non-scientist/nonaffiliated members. IRB reform should include better training for non-scientist and nonaffiliated members so that they can take on more active roles. In addition, measures are needed to strengthen the relationships between scientist and non-scientist and nonaffiliated members.

Non-scientist members are active participants in NIH's IRBs and that their points of view are taken seriously and valued by other members.

Hence the one non-scientist on an IRB being a lawyer, ethicist, or member of the clergy is the best public and community representation. The only point to note here is that IRB should provide better training for non-scientist so that they can take on more active roles.