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Report on Research Compliance

News and Analysis for Colleges, Universities and Teaching Hospitals

Big Drop in OHRP Letters, Open Cases Raise Questions of Agency Commitment

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.

Adult Stem Cells Repair Brain Damaged Cess Without Transplant

Before 2007,  the research community had dogmatically insisted that only embryonic stem cell research would be medically useful, and that adult stem cell research was a waste of resources and effort.  The contentious debate was framed as between “enlightened” scientists and religious fundamentalists. Like many dogmatic theoretical constructs–this one proved…

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How FDA Facilitated the Cost of a Drug to Skyrocket

The FDA granted market exclusivity to KV for an old drug that had been available from special pharmacies that custom-compound treatments not approved by the FDA, for $20 a shot. By granting KV market exclusivity, women could no longer obtain the drug, Makena, at a reasonable price– KV set the price at $1,500 a shot.

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Inside Psychiatry’s Battle to Define Mental Illness

The authoritative expert who chaired the DSM-IV revision has become a formidable critic whose publicly expressed views about psychiatry’s diagnostic assessments and prescribed treatments–mostly chemical interventions–validate the criticism expressed by the Alliance for Human Research Protection for more than a dozen years.