The FDA can't simply "coast" to better oversight

Determine that risks to subjects are minimized

Determine that risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result

Determine the applicability of 21 CFR Part 812 [which governs studies of devices] and failed to make a risk determination for the investigational device study

Ensure that basic elements of informed consent are included in the IRB-approved consent form

Demonstrate its ability to ascertain the acceptability of the proposed research in terms of regulations, applicable law, and standards of professional conduct and practice

That's quite a thorough list of failures. In response, Coast enacted a moratorium on starting any new reviews of FDA-regulated studies. Any other reviews can still begin, and previously approved projects will continue. Meanwhile, Coast will undertake an internal audit.

While this is a positive development, I certainly hope that there are more changes to come. The system of protecting research subjects in the US, with its reliance upon IRBs which are either affiliated with the research institution or contracted through private companies, is an embarrassment: IRB members too often have significant, undisclosed conflicts of interest (1, 2, 3). Increasingly, a "research underclass" makes ends meet by getting paid to enroll in trials. Human subjects research is moving to vulnerable populations, including prisoners and developing countries (1, 2). In order to facilitate the latter practice "off-shoring," the FDA has abandoned the long-standing Declaration of Helsinki in favor of its own rules.

It's not as if no one has noticed: A 2007 report from the inspector general of the Department of Health and Human Services strongly criticized the FDA for its failure to protect research subjects. And a 2005 investigative report in Bloomberg Markets [PDF] exposed the shortcomings of IRBs-for-hire.

The one bad apple of Coast IRB shouldn't distract us - and Congress - from the very rotten barrel in which it lies.

HT to the Wall Street Journal Health Blog.

Previously on Biopolitical Times:

• Draft federal stem cell policy gets it right
• Do Convicts Have A Right to DNA Testing?
• Parents might know what's best for their children, but do scientists?
• Cloning the Dead