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PRIM&R director comments about new Common Rule’s informed consent requirements

It seems as though everyone involved in human subject protections struggles with the informed consent process. The desire to provide complete information to subjects can collide with a need to keep informed consent forms and processes simple and understandable. Eliza Hurley, director of the research professional organization Public Responsibility in Medicine and Research (PRIM&R), recently shared her thoughts on some of the revised rule’s informed consent-related provisions. Click on the link to read them in full.

One interesting point is that the new rule requires information must be presented to potential subjects in a way that facilitates their understanding of what the research involves and the reasons why one might choose or decline to participate. However, as noted in a separate PRIM&R webinar, the rule as currently written provides no specifics regarding what form that presentation of information may, or should, take. It will be interesting to see what guidance, if any, will become available on that point and also how institutions will choose to implement it.