PRIM&R is pleased to introduce this recurring feature to Ampersand, in collaboration with First Clinical Research. Each month, we’ll feature 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 places you in the FDA commissioner’s seat:
You are the Commissioner of the FDA. A friend has informed you of the following situation: Over 1,000 people with severe, refractive emphysema have banded together to test a drug that is approved for asthma but not emphysema. Participants “drew straws” to determine which of them would ask their physicians for a prescription. While the FDA has no authority over the practice of medicine, it does have authority over clinical studies that create generalizable knowledge.
What would you do? Take the survey.
March’s Question of the Month grappled with the problem of informed consent for residents of a nursing home, where capacity for consent varies substantially from person to person and over time. From the discussion of the results of the survey:
“A significant number of respondents see legally authorized representatives (LARs) as the solution to this dilemma. FDA draft guidance recommends the use of an LAR when the cognitive capacity of a (potential) participant fluctuates, i.e. can vary over time. However, the guidance does not explicitly address the situation when a participant is fully competent to give consent part of the time. It is not clear what role an LAR would play when a nursing home resident is fully competent to give consent. Note that most or all people are not fully competent to give consent 100% of the time, e.g., when they are very tired and facing a 30-page consent form written at a grade-14 reading level.”
For the full report, download the results here (PDF).
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!