Aaauggghhhh! I'm in IRB hell!

[rivka]

We've been awarded a grant to study the effects of spiritual attitudes on immune functioning in HIV+ people. Two years of funding - they sent us the first check on July 1. So we send the Institutional Review Board (a.k.a. "Human Subjects Committee) our proposed research design on July 13. On August 2 they met to discuss our protocol, decided that it was "high risk" because we were asking questions about sex and drugs (thus putting our study in the same category as studies of experimental drugs), and came up with a list of changes we would need to make before they would approve our protocol. They didn't actually get around to mailing the letter until August 15. It didn't actually reach us until August 28, because they sent it to the wrong address. But that was okay, because the only person we could discuss it with went on vacation until September 4.

Among other requirements, they want us to get a "certificate of confidentiality" from the U.S. Department of Health and Human Services. Essentially this protects us (and our subjects) from being subpoenaed and required to release information about our subjects' illegal activities. It's frustrating, because we've been collecting this kind of data for years without needing a certificate, and all of this information is probably already in their medical records, but sure. Whatever. It's a fine idea. Except that the contact person at NIMH tells me that it will take 6 to 8 weeks to obtain the certificate.

But that's not all: the IRB won't approve our protocol unless we have a certificate. And NIMH claims that they won't issue a certificate unless the project is (you guessed it) IRB-approved.

At this point, counting all the delays and waiting periods we've been quoted, we're looking at being able to enroll our first subject around Christmas time. That's not going to work. We've only got two years to do the whole study, and we'll have used up a quarter of our time getting all the necessary permissions. I don't think the funding agency is going to be particularly pleased with that.

(As I was writing this, I just got a callback from my contact person at NIMH. She's just figured out that our research involves HIV. That's an entirely different agency, could I please call NIAID instead, and start over?)

In combination with the mess over my hiring, and the mess over getting our clinical services contract approved, this is just the last goddamned straw. How in hell does any research get done anyway? Why the hell are we even bothering to try to accomplish anything?

I give up.

Then, after I give up, I'll take a deep breath and start revising the protocol.

Comments

this is freaking ridiculous!!!

[bunyip.livejournal.com]

Talk about being tied up, and not in the fun way. This is a total red tape nightmare... I hope that this can be sorted out.

[sashajwolf.livejournal.com]

I think it's cool that the certificates exist at all, though. I don't think we have that here in England.

[rivka.livejournal.com]

Oh, having these certificates available is definitely a good thing. If we already had one, I'm sure I'd be singing its praises. :)

Perhaps research data is protected differently in England? Otherwise, I don't know what would prevent the police from reading scientific journals to find out who's doing research on (for example) drug abuse, and then requiring the researchers to release their records and arresting anyone who admitted to illegal acts. But obviously if that sort of thing were being done, there wouldn't be any research on such matters - and that isn't the case.

[sashajwolf.livejournal.com]

I think what prevents this is that (a) the police don't give a particularly high priority to small drug crime here, particularly not to arresting end-users who aren't actually causing a breach of the peace or otherwise making a nuisance of themselves - I remember one case where a busybody tried to get the police to arrest people who had appeared on a chat show and admitted to drug use, and the police refused; (b) researchers in this sort of area typically seem to set up their studies so that people can register anonymously with no record of their real identity, so the records wouldn't be much use to the police anyway. But that's just my impression based on adverts I've seen in newspapers from researchers trying to recruit volunteers.

Liz