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21 February 2006

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Elisea Proctor

Hopefully it is okay to blow off a little steam on this blog. I will not mention my school affiliation. I voluntarily serve on my institution's IRB and I am a doctoral student; it has been a wonderful learning experience serving on the IRB. I have served in this capacity for three (3) years. I take leave from my regular job to serve in this capacity. At times, we have to review two-three files during a high volume period. The University is a Research I; my research is in the social sciences As a minority student part-time student, it has been quite helpful to serve in this capacity as I feel I am making a vital contribution to the university as the Board members have responsibility to review expedited files, as well as review full board files. At times, I will admit I have felt very disconnected from the university before serving on the Board.

I submitted my amendment for my research project 16 days ago; my project is an exempt file. It still has to be reviewed by a compliance specialist, however. The general policy is you, as investigator will hear from the board regarding your file in 5 days. As a member of the Board, we are sent a reminder if we are assigned a file and we go over the five days, even by one day. It has been drilled into us how important the projects are and that we must act quickly. If we see we can not review the file, it must be reassigned immediately. I have even been told on one occasion that the investigator is collecting data in three days. I totally understood. I was having technical issues with reviewing the on-line survey which was part of this file.

Well, as I mentioned, I submitted my amendment 16 days ago. I sent an e-mail to the compliance officer on the fifth day to determine if they received the amendment. I was informed yes, they had received the file. I was a bit concerned as I had not heard from the IRB. I called seven days after I had not heard from the IRB concerning the status. The status would generally be: a) approval or, b) you need to make changes and resubmit documents with the changes. On approximately the tenth day I call the IRB office. They indicated they "have not gotten to my file and to be patient" and they will get to it by what would essentially be the 13th day of having my file. That would be fine, as I was scheduled to collect data on the 17th day, which is tomorrow.

I sent an e-mail last night to check just one more time. That would mean I would have one day to get everything copied and to properly prepare myself. At 5:00pm today, I have still not heard from the IRB concerning my file. I am not asking for any special treatment. Please just respond in a timely manner as you indicate and require all Board members to comply with the requirements. I now have to identify a new set of subjects because I am supposed to meet with them tomorrow in a city 2.5 hours away.

Thank you for creating this blog. As a Board member I felt it would be quite difficult to talk to anyone on campus concerning my dilemma. This has helped.

Any comments are welcome.

Melissa Lauritch

I was just alerted to a conference taking place at Northwestern University Law School in Chicago April 6-7 entitled "Censorship and Institutional Review Boards". Here's the link for more info: http://irbinfo.blogspot.com/

Melissa Lauritch

Excellent IRB FAQs by the way. I'd like to alert you to a great website called IRB Forum (http://www.irbforum.org), which basically covers everything IRB. You can access the discussion topics by registering on the site (it's free). You can sign up for the discussion e-mails (I must warn you though, you will be bombarded with e-mails) or you can simply browse or search the discussion topics online. I don't recall any discussion threads regarding law professors and IRBs, but I'm sure if you post a question you'll receive a number of helpful responses. Many of the frequent responders are extremely knowledgeable about IRB matters.

Arnie

Very good site, greate content !!

Mark Hall and Ron Wright

The 2004 AALS Conference had a session on IRBs and law professors. Based on that, and some discussions at the Wake Forest law school, we (Mark Hall and Ron Wright) developed a set of FAQs about legal research and IRBs, which we're happy to share with anyone who wants to see them, or post on this blog if someone tells us how to do that.

Ed. note: These IRB FAQs have now been posted on the ELS Blog at: http://www.elsblog.org/the_empirical_legal_studi/irb.html
-jjc

Melissa Lauritch

As the director of my IRB office at a non-medical research institution, I offer the following advice:
When in doubt contact your IRB office! My staff and I are always available to assist researchers who have questions about review categories, completing forms, whether their project requires IRB review, required training, etc. Many institutions have this information on their website, but often times it's cumbersome to wade through and I always tell researchers to call the IRB office directly if they can't readily find what they're looking for. Researchers shouldn't be required to know the governing regs backwards and forwards like the IRB office personnel - that is their job. Most institutions use one form for all research conducted at their institution and one size doesn't always fit all. In my experience, IRB personnel understand that some questions on the forms are difficult to answer because they may not apply. You may also want to contact your IRB office to see if they offer any training. My IRB office gives general presentations to researchers on a regular basis and we have an open door policy, so if researchers stop by we're happy to sit down and discuss their project.

Joe Doherty

This is emblematic of the many problems facing law professors who want to do empirical research. Faculty rarely discover that most legal research can be conducted under IRB exemptions, because the toe of the IRB learning curve is so long. The costs are similar to those faced by law professors in applying for research grants or in learning empirical methods; these are skills that a graduate student would acquire in the course of his PhD program, but are not part of the law school student experience.
At UCLA we have tried to solve the problem by designating one staff person with IRB experience to walk everyone through the process. It's part of our effort to institutionalize support for empirical research, in the same way that the library supports textual research.

Ross Cheit

I am intrigued and a bit puzzled that law professors apparently are rarely before IRBs. I am constantly before mine, and the kind of research I do could well be done at a law school. The federal definition of research is broad enough to cover any kind of research (other than oral history) that involves interviewing. My IRB even told me that working with trial transcripts required IRB approval because the transcripts -- all public documents --contained "personal information." I think that that is madness; but of course, saying that does not speed up the process of approval.

Something tells me that if every law professor were subject to this burdensome process that pressure would mount to change the system to protect those it was designed to protect in the first place: subjects of medical and other human *experiments.*

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