13
Feb2013

by Andrea Johnson, JD, CIP, Regulatory Specialist in the Research Integrity Office at Oregon Health and Science University 

It seems like just yesterday that I was walking around in beautiful 65-degree weather outside the San Diego Convention Center, overhearing discussions on the U.S. Public Health Service Syphilis Study at Tuskegee. The start of the New Year really has a way of making time fly, but I’m getting back in the swing of things.

In my office, we recently had a discussion about prioritizing some potential improvements to our institutional review board (IRB) process. One of the ideas we discussed was adding structure to the process through which researchers request a waiver or alteration of informed consent. Right now, researchers are simply asked in our questionnaire whether they plan to use a consent form, and if not, why not. If the questionnaire indicates that the researcher intends to waive or alter the informed consent form or process, the IRB makes a determination, based on the information provided in the questionnaire, the protocol, and other supporting documents, whether such a waiver or alteration meets the regulatory criteria. The improvement we considered involves creating a form for researchers to use when requesting a waiver or alteration that asks them to address each criterion specifically. As my coworkers piped up with pros and cons of each scenario, I thought, “Hey, this sounds like a session at the Advancing Ethical Research (AER) Conference!”

An interesting concern voiced by one of my colleagues regarding developing a more detailed form was that it may encourage researchers to seek a waiver when they don’t truly need one. Of course, the IRB must still find that all criteria are met, but if we start with the presumption that the researchers can obtain consent and leave it to them to tell us that they cannot, we may end up with a slightly higher bar for the “impracticable” element (45 CFR 46.116(d)(3)). But does that lead to better human subjects protections? Does it unduly hinder research? Our group didn’t really reach a consensus.

The benefit to maintaining our status quo is that, as I’m sure many of you know, researchers tend to provide much more information if you ask an open-ended question than they would if you hint at the answers that you are seeking.

On the other hand, the creation of a form that requests specific information relevant to each criterion for granting of a waiver or alteration of consent may offer an educational benefit. We hope that, such a form would also help guide the IRB by pointing reviewers directly to the information that addresses the waiver criteria. Finally, it would simplify and enhance documentation of the IRB’s determination. And yet, who really wants another form to fill out?

These puzzles are what keep me coming back to research ethics. Even a seemingly small issue has so many facets to consider.

I haven’t had a chance yet, but I am really looking forward to digging through the 2012 AER Conference Passport. Perhaps I will find some guidance on this issue and many others, and I’m sure I will come up with new questions and things to think about, too. Since you couldn’t clone yourself (yet…discuss!) and attend  five sessions at once, the Conference Passport is a great way to get a taste of the sessions you missed, as well as refresh your memories of the ones you attended.

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