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Compliance In Focus
Posted by Natalie Jarmusik on Mon, Jun 9, 2014

Ethical Crossroads at the NIH: When Conflict of Interest Meets Informed Consent

If you’re at all familiar with the scientific community then you’ll probably recognize the NationalEthical Crossroads at the NIH   When Conflict of Interest Meets Informed Consent Institutes of Health, also known as the NIH, as scientific research’s biggest advocate. Part of the U.S. Department of Health and Human Services (HHS), the NIH serves as our nation’s premiere medical research agency, granting greater than 80% of its budget to research and academic institutions through the distribution of almost 50,000 competitive grants. With such a generous hand for developing research, there is no question as to why so many academic and medical professionals both welcome the support and praise the involvement of the NIH in their research ventures.

Recently, however, one group of individuals is singing a different tune.

Public Citizen is a non-profit, consumer rights advocacy group based out of Washington D.C. Often referred to as a government ‘watchdog,’  Public Citizen prides itself on fighting for the public interest and promoting public health and safety – even if this means going up against a big dog like the NIH. Their intent to preserve the well-being of human subjects was very clear when they revealed earlier this month the NIH’s possible conflict of interest in a clinical study involving pre-term infants. Originally meant to examine the effects of high and low oxygen levels on premature babies, in 2013 this study was accused of neglecting the most basic standard for protecting patients from harm in medical research: providing an informed consent document that honestly and clearly detailed the risks and benefits available to these very fragile infants. A $20 million clinical trial held at 23 separate academic institutions, the SUPPORT study, as it came to be known, underwent investigation by the government’s Office of Human Research Protections (OHRP) and was indeed determined to be neglectful in its responsibility to provide an accurate informed consent document. A letter issued in March of 2013 in which the OHRP delivered such judgment was eventually redacted and no sanctions were administered to SUPPORT study officials at the University of Alabama (UAB) – the site at which the study was centered. The question is: What changed the OHRP’s mind?

On May 20, 2014, Public Citizen released e-mail correspondence between NIH officials and the OHRP indicating possible interference with the OHRP’s final verdict on the clinical study. The emails indicated several rounds of reviewing and editing drafts of a second letter that would ultimately remediate any course of action for sanctions on UAB scientists. By June 2013 the letter was released just as NIH officials published commentary in The New England Journal of Medicine (NEJM) in defense of the SUPPORT trial. In light of this new information Public Citizen is claiming that the NIH, including Director Frank Collins, unethically influenced the OHRP’s final opinion of the SUPPORT trial and worked heavily to coordinate the second letter’s release with the timing of the NIH’s commentary in the NEJM. Furthermore Public Citizen, as well as members of Congress, is calling for a serious investigation at the HHS to uncover how deeply rooted this interference from the NIH might be.

What do you think? This issue has generated some passionate conversations within IMARC and might do the same within your organization. Try discussing this topic with your colleagues and leave any thoughts you have below!

Photo Credit: StockMonkeys.com

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Topics: Informed Consent, NIH, SUPPORT Study

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