IRB...

Since I didn't explain the IRB (rhymes with "herb") in that last post...

The IRB (Institutional Review Board) is the watchdog group that meets to discuss research studies, comprised mostly of health professionals and a few members from the community at large (surprisingly, these range from realtors to ministers).

Although their meetings are open to the public, I have to confess that I have no desire to go...not because I am afraid it would be boring...but because I'd rather imagine them as some arcane and mysterious group whose members wear robes and chant words of power over the endless offerings of paper.

One of my friends, who does psychiatry research (more on that some other time), today had to submit 12 (TWELVE) copies of each of these: a 297 page protocol, a 14 page consent form, the 4 page submission form, the 2 pages which comprise hospital requisition forms A and B, and the 1 page grant routing form. That is 3,816 pieces of paper, for a 4 hour meeting which will cover probably 10 other protocols.

Now, I know at least one person who sits on the board (but who cleverly throws everyone off by being not only normal but nice -- and he really expects us to believe he is a surgeon? HA) and I KNOW he has no time to look over the protocols in advance, because he is scheduled so tightly he literally runs from one hospital to the other, never has time to eat, and has a BMI of 11 (ok, so that's an exaggeration, but probably not by much).

Among other functions, the theory is that the group examines the protocol and makes sure it presents no ethical dilemma; also that any potential risk is outweighed by any potential benefit.

The IRB also examines the consent form to make sure that the risks are clearly defined and not downplayed and that benefits are not presented in such glowing terms that people expect miracles. They have to make sure that no coercive or even persuasive language is included...just the facts, ma'am.

Now add into those 10 new protocols the fact that they have to review ongoing protocols every year...you can probably add at least 10-20 of those into the meeting (some of these studies go on for years, after all)...and the fact that any study that deals with cancer or radiation (if you're really unlucky it has both) has to have been reviewed by those departments which generates another report or two...and if the study is also being done at the VA, you can add another 20 pieces of paper...and we never, ever get any of it back.

See? Magic is the only way they can possibly get it done. I can see them raising their hands to the sky while burning the stacks of paper...summoning the Research Gods to guide their oracular decisions to give to us, their faithful supplicants.