Various Lies

Monday, February 15, 2010

IRB: Irritating Risible Banal



I understand the need for Institutional Review Boards (IRBs). There have been too many travesties of justice committed on the defenseless and innocent in the name of progress.

Or, to put it another way, back before we were Enlightened about the Rights of Man we could be real assholes to each other. Although I would encourage anyone who is interested to look beyond your politically correct textbook, or CITI training manual and read about the work done and understand the time period in question. Paul Offit's "Vaccinated" is a good example, dealing with the use of mentally handicapped children as "guinea pigs" for vaccine research. Maurice Hilleman's defence of this tactic does have some credibility given the state of Human Subjects Protection at the time (or lack thereof). Not all of "Them" were soulless monsters. Perceptions were different back then and we must be careful of using too broad a brush stroke when applying the tar and feathers. Hilleman is a fucking hero and there should be a statue to him in every schoolyard in america.

Anyway, I digress from my rant. Ahem, excuse me while I work up the necessary ire, and if you are easily offended turn away now for this might be bluer than most.

As I said, I understand the need for Institutional Review Boards and the necessity of getting neutral, experienced, third-party observation of any protocol involving human subjects. However, you are taking the fucking piss when i am trying to submit an exempt IRB and it still takes, literally, hours of fucking paperwork. I am working on an IRB for an anonymous survey of the users of the database I administer (maybe a few dozen people). All we want to know is whether, in their opinion, the DB is performing its function: making their data collection & analysis easier. There's no possible repercussion for a negative answer, nor is there any possible repercussion for failing to provide Consent and thus declining to take part in our survey. It is 8 motherfucking questions about whether the DB works as we promise and, if not, what can we do to make it better.

I spent all day Thursday and Friday working on it. I got maybe a third of the way through... I think. The system we have to use (automated, of course) provides no guidance as to your % completion. I spent an hour or two just struggling with the second page of the questionnaire because it kept asking me for information that wasn't actually included in any of the possible combinations of questions being asked. I ended up calling for help on that one.

By the end of the day on Friday I thought I'd made pretty good progress.

Well, i just logged on to have another crack at it, and it came up with a nice official looking dialogue box telling me a new version of the form had been come out and I needed to convert my current form to the new one. Apparently someone has a pretty fucked up sense of humour, because "convert" apparently means DELETE pretty much everything I did last week. The only thing remaining is the motherfucking "title" page and of course, the second page that I got stuck on last week.

Thank you very fucking much. Whoever the fuck designed this system wants their fucking arse kicking. I know Faculty bleat endlessly about the amount of administrative bullshit they have to wade through, and I really feel for them. This is not what they signed up for (or rather, it is, but isn't clearly marked on the tin). It is wankery like this make the practice of Science such a fucking chore.

If I'm having this much trouble with a fucking exempt survey, then imagine my dread of the next one: requesting permission to harvest Electronic Medical Records for a text-mining/data-mining study for an Alzheimer's grant.

The fucking President and all his little congressmen (and congresswomen) run around like fucking chickens with their balls cut off wailing about how we need to do Big Science and Spend the Public money wisely, and they event futile, irritating piss-poorly-planned hurdles like the motherfucking HITECH Act without the vaguest consideration of the fucking consequences of their actions.

Fucking genius! Make us encrypt EMR and Personal Health Information to Federal standards (FIPS 140-2). And make it a scary Act by empowering the very division of government (Health & Human Services) that enforces it with the need to fine failure to enact in order to fund it's own witch hunt. But of course, don't take into account the fact that the manufacturer of the world's most popular web-browser doesn't auto-support this.

Assholes. (uSoft and the Gubmint).

And of course They demand that the only ay to try and get some fucking money to do your research is to try and do Big Science and gather medical records for the good of mankind, but make the system that protects those records either (probably) corrupt it's pointless, or so impossible to manage completion is needlessly Sisyphean.

12 comments:

Genomic Repairman said...

Dude you want to read about ethical violations just look no closer than the new book out about HeLa. Oh and I've got a digitized copy of a BBC Channel 2 Documentary on the thing if you want it. Its kind of artsy fartsy but it was pretty good and delved into the issues of the history of the cells, ethical concerns, interviews with the Lacks family, and the contamination issue. They also have some pretty good scientists featured in the documentary.

tideliar said...

Hell yeah, I;d love to see that. I saw a book review, I think it was, on Dr. Isis blog but I haven't had time t read it yet. Chuck it along to my Gmail address if you like.

Genomic Repairman said...

Its so damn big (1.3 Gb) I'm just going to upload it to my Google Documents tomorrow and just share it with you and anyone else who wants it and that way you can pull it down and keep a copy since its DRM free (since we digitized it from a fucking VHS tape).

tideliar said...

Nice. I have access to a couple of document servers, but getting you access *in* is hard. I can get shit *out* just fine though, if I ever return the favour we can play superinternationalsecretspy...

...which sounds really fucking gay. Sorry...I went for Bourne Identity and came out with Pink Panther...

Genomic Repairman said...

We started out super suave James Bond and degenerated into a queer version of Get Smart. Did you ever get the calendar shit ironed out?

tideliar said...

PiT left some comments to try and help but I think I wasn't clear about synching my calendar not my email. So, no. Not yet :(

Anonymous said...

Fuck is that easier on the eyes.

IRB. I swear our one is more worried about corporate branding than actual ethics.

-antipodean

tideliar said...

Hey Antipodean, thanks for the feedback! Changing the background was something I'd been thinking about for a while. The black was a bit...emo. And I'd read on a couple of blogs how some people have trouble reading white text on a dark background, especially if the page renders with a small font.

You're in biotech/pharma aren't you (if you're who I think you are). Branding is a major part of your product output. The only branding I have to worry about (at my lowly level) is making sure I use the right fonts & colours in the style sheets when I build webpages :/

Anonymous said...

And I had thought that you were a 16 year old girl with daddy issues until you started yarning on about clinical research. Thank god you didn't go with a hot pink background...

I'm not in biotech/pharma. I'm talking about a University IRB.

-antipodean

tideliar said...

I once shagged a 16 year old girl with daddy issues...does that count?

Anonymous said...

It could be a count depending on local legal custom.

-antipodean

Genomic Repairman said...

I posted the HeLa documentary to my youtube page.

http://www.youtube.com/user/genrepair