In collaboration with First Clinical Research, each month we share a new question and accompanying anonymous survey, designed to encourage critical thinking about questions in clinical research and highlight discussion generated by the prior month’s question.
This month's question:
Researchers have identified a previously unknown but fairly common viral disease in certain developing countries: infant maternalitis, in which an infant is born with a serious allergy to the mere presence of his or her mother. For reasons that are not understood, even awareness of the mother’s presence can provoke the condition. You are a member of an IRB reviewing a study protocol for a painless, inexpensive test that would, with 100% accuracy, identify infants with this disease so they can be separated from their mothers before the disease appears. After that, the condition becomes permanent and untreatable. The protocol requires consent by both parents.
Will you vote to approve the study? When making your vote, will you consider only the welfare of the child or also the welfare of the mother? For these and further questions, take the survey here.
Last month's question posed readers with a situation in which they had to decide whether or not to approve a study that would seek to recruit participants via an auction. Just 3.8% of participants would approve the study unconditionally; most of the rest of the respondents were split between rejecting it outright, approving it with conditions, and deferring approval until certain conditions were met. A sizeable majority of such conditional approval required the removal of the auction recruiting method. You can find the full report here.
The Question of the Month also appears on the IRB Forum. The IRB Forum is a robust community of IRB professionals engaged in an ongoing discussion of the latest issues and questions that arise for human subjects protections professionals. An account is free, and gives you access to an invaluable resource—the insight of your peers.
PRIM&R thanks Norm Goldfarb of First Clinical Research for allowing us to share this feature with our community!