Friday, February 10, 2012

VA IRB is "Kafkaesque and Dickensian"

Writing in Bioethics Forum, a team of interview researchers describe the Veterans Administration IRB process as "Kafkaesque and Dickensian."

[Jenny E. Ostergren, Marguerite E. Robinson, Molly J. Dingel, Bradley Partridge, Barbara A. Koenig, "Kafkaesque and Dickensian: The Human Subjects Protection Maze," Bioethics Forum, 9 February 2012.]

They explain:

In a multisite study we conducted interviews at addiction treatment programs to explore patients’ views about an emerging genetic understanding of addiction. We thought the IRB review process at the Veteran's Administration Medical Center included among our sites would be relatively straightforward; ours was a low-risk interview study with stringent procedures in place to protect participant confidentiality, and our protocol had been approved by IRBs at other sites without difficulty. We never anticipated that it would take a full year to gain IRB approval and that due to further delays resulting from institutional rules and policies we would be able to conduct only six of the 20 planned interviews . . .

While special efforts to protect veterans and those with stigmatized disorders such as substance use are clearly important, the emphasis placed on the minute details of the process has created an endless labyrinth in which the main objective of providing protection for research participants is lost.

With Dickens scholars arguing--on the bicentennial of his birth--that Dickens's novels did not lead to policy reforms, let's hope that the IRB world finds its Upton Sinclair.


Anonymous said...

The VA has lots of IRBs. Our organization had a project involving the VA a few years ago and I don't remember anyone going through the sort of agony described here. The whole process was unremarkable.

As someone who has done multi-site research, I would agree that the process of obtaining approval from lots of sites is onerous (and necessarily so). But in my experience there's a lot of variation between sites. Some IRBs are well run and easy to work with; others are a nightmare.

Zachary M. Schrag said...

Thanks for this comment. If competence is the norm and nightmares the exception, an appeals process (as envisioned by the ANPRM) might provide an effective remedy.