4
Dec2011

PRIM&R is pleased to bring you a live post from the second day of the 2011 Advancing Ethical Research Conference and the PRIM&R Blog Squad. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging prior to, live from, and after our conferences.

Yesterday's quote of the day? “Sending a consent form to multiple institutional review boards (IRBs) for multiple separate tweaks is a bureaucracy that needs to be muzzled.”

Clearly, Robert Califf, MD, a speaker on Panel I—Increasing the Public’s Understanding of Clinical Research: Opportunities for the Research Community, is in favor of the way the Advanced Notice of Proposed Rulemaking (ANPRM) addresses multi-center studies.

My afternoon has been filled with ANPRM, and I have to say that I’m getting what I came for from this conference!  I felt like a dunce, but I finally mustered the courage to raise my hand and ask, ”So where did the ANPRM come from?"  No one laughed, so I guess it was ok to ask. The speaker said it exploded after an article written by Ezekiel Emanuel and Jerry Menikoff was published in the New England Journal of Medicine. According to my sources, the article did a good job of explaining how the Common Rule has not been revised since 1991 and pointing out the limitations in the existing regulations. Thus, following a Presidential Executive Order to review all regulations, the ANPRM was born.

Ivor Pritchard, my all time favorite Fed, made some clarifications about ANPRM in Panel
I. The ANPRM poses the question whether all biospecimens should be treated as though they are identifiable so that they always fall under human subjects regulations. The ANPRM also proposes the application of HIPAA-like privacy protection rules for protecting data rather than the HIPAA rules themselves.

Ivor also reviewed some of the comments that were received in response to the ANPRM:

  1. Investigator registration of excused research:  No one likes it!!
  2. Single IRB review for multi-site research:  Respondents were split.
  3. Templates for informed consent: Respondents were split.

PRIM&R’s point of view was also discussed:

  1. High efficiency is not a moral imperative in IRB work.
  2. The responsibility for better protocols and less legalistic consent forms should be "on" principal investigators (PIs) and sponsors.
  3. Sanctions should be applicable to PIs and sponsors, not only to the institution as a whole.
  4. Consent should be a process. It should not be confined to a single document. Central IRB review of multi-site studies should not be mandated, but should be an option available in addition to local review.

When asked when the new rules would be final, Ivor got up from his chair and felt around in his pockets for a few minutes.  After an awkward silence, he said he forgot his crystal ball.

I also really enjoyed the keynote this morning and Seth Mnookin`s presentation. At lunch, I found myself discussing our electronic submission system the whole time, so  I failed to poll my table on the ANPRM today. I guess I`ll have to save that for Speed Mentoring later tonight!

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