Thursday, March 17, 2011

Defino Notes Big Drop in OHRP Letters and Cases

Theresa Defino, editor of Report on Research Compliance, kindly alerted me to her recent analysis of OHRP activity and allowed me to post a reprint of the article.

["Big Drop in OHRP Letters, Open Cases Raise Questions of Agency Commitment," Report on Research Compliance, March 2011, 1-3.]

Defino notes a drop in OHRP oversight activity:

In 2010, the Office for Human Research Protections issued and posted 16 determination letters, the lowest number in its 11-year history and less than half the number issued in each of the previous five years. Since 2007, the office has averaged 35 letters a year, down from a peak of 146 in 2002 and another high of 86 in 2006.

The number of determination letters is tied to the number of cases OHRP opens, and during the recent past, that number has also declined, RRC has learned, tumbling to an all-time low of six in 2009. Some tie the decline in activity to the arrival of Jerry Menikoff, whose tenure as OHRP director began in the late fall of 2008.

An accompanying table shows that in 2009, OHRP received 134 allegations of misbehavior but opened only six cases. (The figures for 2010 are incomplete.) Thus, a complainant had only an 4 percent chance of getting an investigation, compared to a 28 percent chance in 2005. If we expect cases to be opened in the year following a compaint, the numbers are closer, but still represent a decrease from 10 percent (2005-6) to 6 percent (2008-9).

Defino floats various explanations for these drops: a declining number of institutions that check the boxes extending OHRP jurisdiction to non-federally funded research, an increase in the percentage of cases referred to the FDA, efforts to resolve disputes informally, and the fact that the 2002 total represented an effort to work through a backlog of cases.

The article quotes several people, named and unnamed, lamenting the decline in determination letters, which they call "educational tools." As someone unable to figure out how the letters promote research ethics, I am less troubled by their decrease.

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