"Clinical Trials, Wrapped in Red Tape"

Sally Satel, a psychiatrist and resident scholar at the American Enterprise Institute, has written an op ed piece for The New York Times suggesting that the U.S. Government's rules for the protection of human subjects of research may have become excessive. She gives examples, such as:

a regulatory branch of the Department of Health and Human Services, halted a University of Michigan study of a simple five-step checklist to prevent infections at health centers. The checklist merely routinized procedures that should be performed anyway, including washing hands with soap and cleaning a patient’s skin with antiseptic. But because researchers intended to assess the checklist’s success, their work met the strict definition of “research,” and thus required patients’ informed consent. Because they had never obtained it, the human research office shut the study down.

Fortunately, the Michigan incident generated enough outcry among scientists, physicians and the public that the agency reversed itself a few weeks later. But in this, it was the exception rather than the rule.

Comment: I approve of Dr. Satel's call for a reexamination of the human subject review process. On the other hand I don't think that one can adequately demonstrate a need for a revision of those standards by use of a few examples.

One conceptual approach would be cost effectiveness analysis. Dr. Satel cites this example:

Before a 43-center study of hypertension could begin at Veterans Affairs medical centers, for example, a year and a half was spent getting all 43 boards to approve the same protocol. Each time a single board required a change to the protocol, the others had to review it and agree as well.

It seems fairly obvious that a system that delegated human subject review to a single VA review board reviewing a 43 hospital study would provide adequate protection for human subjects and cost a lot less than doing the review 43 times. Similarly, it seems clear that a review of hand washing improvement tactics need not require patient informed consent. Cost-effectiveness analysis, even quite simple analysis, might suggest improvements in the ethical review process.

Cost-benefit analysis might compare the risks to human subjects from relaxed standards for human subjects review with the risks to the general population from the delay of biomedical research and from the expenses of the human subject review which could be reprogrammed into added research if the process were simplified.

Note however that economics does not capture all of the issues. If we see informed consent as a human right, then the implication is that the right must be respected even if it costs money and or health problems. So too there are ethical limitations on the risks that the Government can impose on its citizens, even via so indirect a means as funding biomedical research.