Human Experimentation and Speedy For-Profit Ethical Review Boards

Not long ago, most human experiments testing the safety and efficacy of new drugs were done in academic medical centers and, although paid for by the drug industry, they were under some degree of control by the medical school/teaching hospital complex. In order for such experiments to be allowed, an institutional ethical review board (IRB) associated with the medical center had to approve the protocol, informed consent and other aspects of the study.

Over the last 15 years we have witnessed the exponential growth of for-profit human experimentation companies (HECs), most of which are entirely outside academic medical centers. Promising faster results for the drug companies who pay for these studies than the more “cumbersome” academic centers, they are still required to obtain approval from an ethical review board to conduct the studies. However, since they are not affiliated with a medical center, they use non-academically connected ethical review boards. Most, if not all, of these boards also operate on a for-profit basis.

But in order to deliver the faster clinical trial results drug companies desire, approval by the ethical review process also must occur as quickly as possible so as not to hold up the pace of the HEC. A recent ad by such a for-profit ethics company, Colorado-based Coast Institutional Review Board, on its Web site, exemplifies this ethical race:

Coast IRB is a new breed of IRB. We are committed to the basics: Speed - Next day turn around time (Check out our Next Day Guarantee).

A graphic on their Web site points out that “The time you save using Coast IRB can be easily translated into savings for your company. Even a 2-day delay can cost you as shown in the diagram below [diagram estimates $6.02 million savings for a one-day turnaround time for IRB approval instead of 2 days].” Hence, the importance of the “Next Day Guarantee.”

Unfortunately for Coast IRB, the Food and Drug Administration (FDA) recently investigated this speedy process and found that it was a bit too slick. A warning letter to the company in March of this year stated that:

FDA, in order to protect the rights or welfare of subjects, is suspending Coast IRB’s use of expedited review procedures until further notice
because of Coast IRB’s failure to follow FDA regulations regarding the use of expedited review procedures.

This violation of FDA procedures by a for-profit ethical review board is not meant to imply that the not-for-profit academic IRBs never do anything wrong. However, gaining more business by ads that guarantee a one-day turnaround may make more money for for-profit IRBs but may endanger, as FDA pointed out, the protection of the rights or welfare of subjects of human experimentation.