How much is “just right”? Informed consent and the Goldilocks dilemma

by Sylvia Baedorf Kassis, MPH, PRIM&R Blog Squad member

PRIM&R is pleased to bring you more blog posts from the PRIM&R Blog Squad. The Blog Squad is composed of four PRIM&R members who are devoted to blogging prior to, during, and after the 2010 Advancing Ethical Research Conference.

One of the issues that I have been grappling with more and more these days is the notion of informed consent for tissue banking. The informed consent process itself can be somewhat nebulous—what does it mean to explain a study, and all its consequences, to someone who is considering participating? How can researchers ensure processes are in place to foster comprehension of the procedures that participants will be asked to undergo? Most importantly, what might be the potential risks and consequences, and what alternatives exist outside the research realm?

This process can be difficult enough for a “simple” survey study or a “basic” clinical trial, where the procedures are already defined and there is an isolated question to be answered. What if a researcher wants to bank samples in a repository for use in future research studies? What does this really mean to research participants? And how can we, as regulatory and ethical professionals, better advise researchers on the language that should be used in consent forms and infused into the consent process?

To me, it seems like Goldilocks’ dilemma. If the consent language is too specific, future research on the banked samples might be limited. If the language is too broad, the participants may not really be able to appreciate the implications of storing their samples for future research uses. Even though those future uses may secure IRB approval, does that mean the participants would have consented? Consider the obvious example of the plight of the Havasupai, and how the tribe’s stored biological samples were used in ways that, despite IRB approval, betrayed their understanding of the research. So, just like Goldilocks, we’re unsure how we can get informed consent for future use of samples “juuuust right!”

I’m excited to attend the 2010 AER conference to find answers to questions like these. While in past years I have covered a veritable smorgasbord of topics, this time my focus is specifically on tissue banking. Starting with the Advanced Tissue Banking pre-conference program, and following up with various related sessions at the conference, I hope to gain the knowledge to address the recurring key issues when advising researchers at my institution on storing research samples for future uses.

The Havasupai case has been so interesting because it has, once again, brought to the foreground the principle of respect in research. Respect is at the heart of ethical research. Even if research on stored samples is IRB-approved, it does not necessarily follow that the research participants who originally provided the samples would agree to that use if they were to be asked. In our day-to-day efforts to review and approve human research studies, I believe this is an important lesson to remember.