Scientists Show How to Manage COVID-19 Pandemic Without Destroying the Economy
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Scientists Show How to Manage COVID-19 Pandemic Without Destroying the Economy

On April 21, 2020, three Israeli scientists published a new study online:  Managing COVID-19 Pandemic Without Destructing the Economy  at: ArXiv (an Open Access archive for scholarly articles in physics, mathematics, and computer science owned by Cornell University.) The authors are professors at Hebrew University. Dr. David Gershon is CEO…

Evidence-Based Validation of the AHRP Mission for Disclosure & Voluntary, Informed,Consent
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Evidence-Based Validation of the AHRP Mission for Disclosure & Voluntary, Informed,Consent

 “Nothing is more fundamental to the ethical conduct of clinical trials than the informed consent of research participants. The Nuremberg Code and every subsequent major international statement about ethics and medical research enshrine this role.” In his recent article in Science and Engineering Ethics, Dr. Mark Yarborough, Dean’s Professor of…

Candida auris: A Lethal Industrial Farm Fungus  
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Candida auris: A Lethal Industrial Farm Fungus  

Candida auris is a fungus that presents multiple serious health threats that are especially concerning. It is difficult to identify, treat and contain; and it is especially persistent in that it is both resistant to treatment and to eradication methods. What makes this fungus very hard to eradicate is that…

A Bug in fMRI Software Could Invalidate 15 Years of Brain Research
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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 software used by neuroscientists in functional magnetic resonance…

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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 the Women’s Health Initiative, had examined the evidence…

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.