SADShooter:
How's about if the following were true?
Also (Actual, not rhetorical questions. I do not know the answer.):
1. Do hospital boards have the stones to say, "No thanks" to a study that might bring in $$$ and has been given the stamp of approval by gov't?
2. How rubber-stampy are the hospital boards in general?
Re: the possible NIH malfeasance. If it happened, the actors should be placed at the disposition of any impacted, desirous parents for
carte blanche justice. I would willingly assist any too infirm or otherwise act in proxy. It suggests a level of conspiracy I find challenging, as technical data would be hard to conceal/manipulate at the local professional level. Not impossible, but a considerable feat.
Re: your IRB questions.
1) Research also equals potential liability and public scrutiny. (Witness the case under discussion) and the attendant compliance structures. So, it is a risk management issue. (I'd page MillCreek, but he's already responded to the APSRM bat-signal). Another point is that many, not all, but many, studies are expected to operate on a lean budget, so in-kind support and cost-sharing come into play, and it isn't a huge net gain to the recipient bellying up to Uncle Sugar's trough. Private industry trials are generally a richer field. Keeping our program afloat financially is one of my primary tasks, and one source of the gray in my beard.
2) There are specific mandates for board composition, including multi-disciplinary medical members and non-medical advocates for vulnerable populations. In my experience they take the ethical obligations damn seriously. It's an unpaid drudgery that most people don't take on for fun or profit.
Case in point: I have a contract for incoming money on hold pending IRB approval. The institution will not sign off on the agreement until the IRB approval is verified. The IRB will not sign off until all stipulations have been fully addressed. This is for a DoD sponsored trial.
We did previously have a big, complex trial halted by the DSMB for futility. Interim results were inconclusive, and they determined enrolling more patients (which would have meant more money for participating sites) wouldn't change the outcome.
My boss is a Bronze Star recipient (Vietnam medic), well-regarded researcher, and an IRB Chair. My institution has four separate committees. He's out, but if I get a chance I'll ask him if he knows anything about this situation