Institutional Review Boards (IRBs) Are Still Not Adequately Protecting Patients

© 2010 Peter Free

 

21 October 2010

 

The patient protection problem that became obvious with Jessie Gelsinger’s genetic therapy death in 1999 remains one in 2010

 

In 2001, I wrote about the indefensible ethical and legal circumstances of Mr. Gelsinger’s medical research death.  Since then, apparently nothing has changed.

 

Research participants are still at the mercy of a system designed, in practical application, to look out for everyone’s interests but theirs.

 

Christine Grady, writing in the Journal of the American Medical Association, noted:

 

 

To date, no published study of which I am aware has evaluated the effectiveness of IRBs [institutional review boards] in protecting research participants and few have investigated the nature, quality, or thoroughness of IRB deliberations.

 

Protection from unnecessary or excessive risk of harm is an important measure of IRB effectiveness, yet no systematic collection of data on research risks, no system for aggregating risks across studies, and no reliable denominator of annual research participants exist.

 

 

© 2010 Christine Grady, Do IRBs Protect Human Research Participants?, JAMA 304(10): 1122-1123 (08 September 2010)

 

Risks posed by research are generally not apparent to participating patients

 

Medical desperation encourages patients’ hope-based inattention to asking probing questions.

 

Research is never innocuous.  Physicians and researchers, even to the degree they think they understand them, tend to downplay risks and possible suffering.

 

Getting a knowledgeable third party fiduciary to protect the patient is still a good idea

 

I stand by the ethical and legal conclusions I reached in my earlier review of Mr. Gelsinger’s death.