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NIH enacts new regulations to increase accountability

by Shannon Condon
Office of the VP for Academic Affairs and Provost

New regulations published in the Federal Register last summer concerning financial conflict of interest (FCOI) will go into effect Aug. 24. The regulations are quite extensive and represent a significant change to the preceding regulations set in 1995.

The purpose of the National Institutes of Health (NIH) regulations is to protect the objectivity of research. This overreaching goal of protection will be accomplished via a variety of enhanced oversight mechanisms.
Specifically, NIH will require conflict of interest training for all investigators prior to engaging in Public Health Service (PHS) funded research. Institutions will be required to make publicly accessible, via their website, all identified PHS FCOI which will include the name of the investigator, company, nature of the FCOI, value of the FCOI, grant and role on the grant. In addition the NIH is asking institutions to gather more data to report to the NIH, and the frequency of reporting has increased.

The NIH also is implementing the requirement for retrospective reviews in cases of non-compliance.
It is important to understand that conflicts naturally arise in many different business environments. The environment of academic medicine and health care have transformed significantly during the past decade. Health care providers and scientists are making advancements in the field of medicine and human health at a record pace. Many of the successes achieved in health care outcomes are the result of public institutions collaborating with private industry.

The relationships that exist between government, academia and industry are seen as essential, not only today but in the future, to developing entrepreneurial and innovative approaches to delivering the highest quality health care.
As MUSC moves forward with fully executing the 2010-2015 strategic plan in line with its campaign branding of "Changing What's Possible," it is recognized that the relationships between public institutions and private companies can sometimes be complex. The COI Office is partnering with researchers, educators, administrators and patient care providers to promote an environment of quality and integrity in which to advance biomedical discoveries and clinical care. Increased transparency and accountably strengthens the commitment to the students being educated, the patients being served and the public who instills its trust in the institution.

Conflicts of interest, if properly identified, can be managed so as not to compromise the integrity of the institution or impede its mission. To this end, MUSC will conduct its annual COI disclosure, which is scheduled to take place in April. The disclosure process is the initial step in understanding relationships that exist between employees of MUSC and outside companies, and the nature of these relationships.

For information about conflict of interest or changes to the NIH regulations visit http://www.musc.edu/coi or email condonsf@musc.edu.

Conflict of Interest information sessions
Two information sessions will be held at noon, March 28 in the Institute of Psychiatry Auditorium and at noon, April 18 "lunch and learn" sponsored by the Success Center in the Ashley River Tower auditorium.

For information on the sessions, email condonsf@musc.edu.

 

 

Friday, March 16, 2012

The Catalyst Online is published weekly by the MUSC Office of Public Relations for the faculty, employees and students of the Medical University of South Carolina. The Catalyst Online editor, Kim Draughn, can be reached at 792-4107 or by email, catalyst@musc.edu. Editorial copy can be submitted to The Catalyst Online and to The Catalyst in print by fax, 792-6723, or by email to catalyst@musc.edu. To place an ad in The Catalyst hardcopy, call Island Publications at 849-1778, ext. 201.