A little reminder of why we have IRBs. Did I mention it is still Black History Month?

Reputable citizen-journalist Comradde PhysioProffe has been investigating the doings of a citizen science project, ubiome. Melissa of The Boundary Layer blog has nicely explicated the concerns about citizen science that uses human subjects.

And this brings me to what I believe to be the potentially dubious ethics of this citizen science project. One of the first questions I ask when I see any scientific project involving collecting data from humans is, “What institutional review board (IRB) is monitoring this project?” An IRB is a group that is specifically charged with protecting the rights of human research participants. The legal framework that dictates the necessary use of an IRB for any project receiving federal funding or affiliated with an investigational new drug application stems from the major abuses perpetrated by Nazi physicians during Word War II and scientists and physicians affiliated with the Tuskegee experiments. The work that I have conducted while affiliated with universities and with pharmaceutical companies has all been overseen by an IRB. I will certainly concede to all of you that the IRB process is not perfect, but I do believe that it is a necessary and largely beneficial process.

My immediate thought was about those citizen scientist, crowd-funded projects that might happen to want to work with vertebrate animals.

I wonder how this would be received:

“We’ve given extensive thought to our use of stray cats for invasive electrophysiology experiments in our crowd funded garage startup neuroscience lab. We even thought really hard about IACUC approvals and look forward to an open dialog as we move forward with our recordings. Luckily, the cats supply consent when they enter the garage in search of the can of tuna we open every morning at 6am.”

Anyway, in citizen-journalist PhysioProffe’s investigations he has linked up with an amazing citizen-IRB-enthusiast. A sample from this latter’s recent guest post on the former’s blog blogge.

Then in 1972, a scandal erupted over the Tuskegee syphilis experiment. This study, started in 1932 by the US Public Health Service, recruited 600 poor African-American tenant farmers in Macon County, Alabama: 201 of them were healthy and 399 had syphilis, which at the time was incurable. The purpose of the study was to try out treatments on what even the US government admitted to be a powerless, desperate demographic. Neither the men nor their partners were told that they had a terminal STD; instead, the sick men were told they had “bad blood” — a folk term with no basis in science — and that they would get free medical care for themselves and their families, plus burial insurance (i.e., a grave plot, casket and funeral), for helping to find a cure.

When penicillin was discovered, and found in 1947 to be a total cure for syphilis, the focus of the study changed from trying to find a cure to documenting the progress of the disease from its early stages through termination. The men and their partners were not given penicillin, as that would interfere with the new purpose: instead, the government watched them die a slow, horrific death as they developed tumors and the spirochete destroyed their brains and central nervous system. Those who wanted out of the study, or who had heard of this new miracle drug and wanted it, were told that dropping out meant paying back the cost of decades of medical care, a sum that was far beyond anything a sharecropper could come up with.

CDC: U.S. Public Health Service Syphilis Study at Tuskegee
NPR: Remembering Tuskegee
PubMed: Syphilitic Gumma

Your Grant In Review: Overstuffing the Vertebrate Animals Section

There is little doubt that shortening the length of the NIH R01 application from 25 pages to 12 put a huge premium on the available word space. The ever declining success rates have undoubtedly accelerated the desire of applicants to cram every last bit of information that they possibly can into the application.

Particularly since StockCritique^TM having to do with methodological detail has hardly disappeared.

It is possible that a somewhat frustrated, tongue-in-cheek comment of YHN may have led some folks astray.

Since I am finally getting serious about trying to write one of these new format grants, I am thinking about how to maximize the information content. One thought that immediately strikes me is….cheat!

By which I mean taking sections that normally I would have put in the page-limited part of the grant and sneaking them in elsewhere. I have come up with the following and am looking for more tips and ideas from you, Dear Reader.
1) Moving the animal methods to the Vertebrate Animals section. I’m usually doing quite a bit of duplication of the Vertebrate Animals stuff in my General Methods subheading at the very end of the old Research Design section. I can move much of that, including possibly some research stuff that fits under point 4 (ensuring discomfort and distress is managed), to the Vertebrate Animals section.

Now mind you, one of my always perspicacious commenters was all over me right from the start:

DM – Please don’t encourage people to cheat their way out of 12 pages. Please tell them to write a 12-page grant.
I would warn grant-writers to be careful of cheating too much. I was at a study section recently where someone lost about a point of score because one of the reviewers (it wasn’t me, although I agree with the reviewer) complained about “cheating” by moving methods into the vertebrate animals section.

That was all back in March 2010. Here we are down the road and I have to say, DearReader, I am hearing a constant drum beat of irritation at people who cheat in just this way. My suggestion (a serious one) is to be very wary of putting what should be your research plan methods into the Vertebrate Animals section.

I am hearing and seeing situations in which reviewers pretty obviously are ticked and almost certainly are punishing the applications accordingly. Nobody likes a cheat. I have even heard of rare cases of people having their grants kicked back, unreviewed, because of this.

So be careful. Keep the Vertebrate Animals section on task and put your Methods where they belong.