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Aug2012

Laura Stark, PhD, serves as an assistant professor of medicine, health and society at Vanderbilt University. Her research focuses on medicine, morality, and the modern state. Her recent publication, Behind Closed Doors: IRBs and the Making of Ethical Research, explores the development of human subjects protections regulations and the manner in which these rules are played out within institutional review boards (IRBs) today. Stark will be onsite at the 2012 Advancing Ethical Research (AER) Conference to lead a research ethics book group lunch and sign books on Wednesday, December 5. Leading up to her talk, Stark will be sharing a series of blog posts based on her book. For more information and to register for the book group lunch, please visit our website.

As Americans count down to the November presidential election, one thing is certain: neither candidate will win a unanimous vote. President Barack Obama and Governor Mitt Romney can only dream of getting the same level of consensus from American voters that IRB members reach in their decisions on protocols. Think back to your last full-board meeting. At the end of deliberations, were there any split decisions or were all of the votes unanimous?

Voting is typically thought of as a way to settle disagreements. Yet at the end of IRB meetings, boards rarely report split decisions. A board with ten members will be more likely to report a 10-0 decision rather than a 6-4 decision about whether to to approve, request modification, or decline approval of a protocol.

What explains this distinctive approach to voting, and why does it matter?

Critics often claim that IRBs create bureaucratic road blocks and do little actually to protect research participants or encourage greater respect for human rights. From this view, it would be easy to read IRBs’ unanimous votes as thoughtless votes—as bureaucratic formalities rather than as end products of hefty moral, legal, and scientific debates.

As a social scientist, I studied three IRBs intensely over the course of one year, and some critics might be surprised by what I found.  Board members typically started meetings with serious disagreements over protocols. There were no gnashing teeth and slashing claws, to be sure. IRB members, instead, had respectful and honest differences of opinion. Yet by the end of the meetings, everyone agreed with the best course of action. They voted. And the outcomes were almost always unanimous. The puzzle was how members moved from disagreement to unanimity—with civility and swiftness.

I found that IRB members used what I call “warrants for expertise.” Warrants are people’s reasons for holding their opinion or taking action. We often use warrants in everyday conversation to justify our views and deeds.

IRB members justified their opinions in patterned ways—using one of three types of “warrants.” They justified their views using either “matters of fact” (a recent article reported similar failure rates); “personal experience” (my father would not understand this form); or “professional experience” (the participants I studied responded differently). Once they decided whose “warrant” was the best, then they were persuaded to agree with the person's opinion, too.

The next question is which of the three warrants is most often convincing. What is your guess?  I report these findings and more analysis in the first chapter of my new book, Behind Closed Doors: IRBs and the Making of Ethical Research. Spoiler alert: professional experience tends to be most persuasive. In the book I explain why this is the case and what effect it has on boards and researchers.

I will be speaking at the 2012 AER Conference in December about more findings from  my new book—and how IRB members can harness these findings for more effective meetings and relationships with researchers and each other. The book also reports details of  my research methods:  I sat in on the full-board meetings of these IRBs, audio recorded most meetings (with consent), analyzed how the deliberations unfolded, and interviewed most of the board members. I interviewed a national-sample of IRB chairs, as well, to see whether the boards I studied were unusual or typical. (It turned out they were unusually open—to being studied and to fostering improvements in the regulatory system.) 

I am eager to learn about your experiences and hear your responses to the book. I hope to see you at the conference, but in the meantime, feel free to leave a comment below or send me an email.

And let's all wish the presidential candidates sweet dreams of consensus!

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