A Bug in fMRI Software Could Invalidate 15 Years of Brain Research

Cluster failure: Why fMRI inferences for spatial extent have inflated false-positive rates, by Swedish neuroscientists Anders Eklund, Tom Nichols, and Hans Knutsson, published in the Proceedings of the National Academy of Sciences (2016) reveals the discovery of a major flaw in the . . . Continue reading →

Two medical treatment disputes: hormones for healthy women; statins for healthy men & women

I. Hormone replacement therapy (HRT) For decades the norm in clinical practice was to prescribe hormone replacement therapy, a combination of estrogen plus progestin to menopausal women – despite the lack of scientific evidence of its safety and benefits. Science journalist, Barbara Seaman, founder of . . . Continue reading →

Scientific reports validate the “controversial” findings reported in The Lancet, 1998

Contrary to the claim made by BMJ’s editor in chief, Dr. Fiona Godlee that she was “unaware of any peer reviewed paper replicating Andrew Wakefield’s research or confirming his claims to have identified a new syndrome of regressive autism and inflammatory bowel . . . Continue reading →

Nobody Should Volunteer for Clinical Trials As Long As Research Data Is Secret

An urgent call for a debate about the ethics of data secrecy. Absent the humanitarian raison d’etre for enrolling in a clinical trial, no human being should be put at any–even minimal risk–without adequate compensation as a laborer and the protection of Workmen’s Compensation insurance.   

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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.

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