Research Reporter :: October 2007
Research Information from the University of Michigan

Advisory committee aids human research compliance office in creating culture of responsible research conduct

By Suzanne Tainter
DRDA

An opportunity to help the University of Michigan maintain its high reputation for protecting human subjects in research and help shape the direction of the Office for Human Research Compliance Review (OHRCR) is what motivates him to serve on the OHRCR advisory committee, says William Giannobile.

As the director of the clinical research unit for the U-M Dental School, Giannobile is well aware of the University's obligations toward human subjects and sees the need for the compliance review office in helping protect human subjects and the University.

Part of the Office of the Vice President for Research, OHRCR provides oversight to ensure adherence to regulations and excellence in human subject protection by individual investigators and the Institutional Review Boards.

"OHRCR aims to facilitate safe, ethical, efficient and high quality human subjects research," explains Ron Maio, professor of emergency medicine and director of the OHRCR.

The OHRCR reviews research studies and committees; provides education and outreach to investigators and the university community; and offers leadership and knowledge generation in the area of research compliance.

Because the OHRCR is a relatively new unit, the advisory committee has been able help shape the direction of the OHRCR in meeting the challenge of responsibly protecting human subjects and the University, says Giannobile.

The advisory committee:

Advises OHRCR on the direction and implementation of U-M human subjects research protections review
Encourages institution-wide commitment to human subjects protections
Helps determine priority risk areas, and recommends risk management strategies
Provides constructive critique and recommendations for OHRCR initiatives
Provides recommendations for the OHRCR annual compliance monitoring plans

Committee members, drawn from many disciplines across campus, represent research conducted with a variety of methods and a diversity of human subjects. OHRCR seeks people who help to mentor other researchers and who can bring feedback to the committee from their fellow investigators.

Giannobile, professor of Dentistry and Biomedical Engineering, says as a faculty member who conducts research with human subjects, he knows first hand what the study teams are facing. The regulatory burden on investigators and institutions has grown greater and more complex in recent years.

Giannobile's hope is that the advisory committee and the office are viewed by researchers as "on their side." "We want researchers to put their best foot forward in protecting human subjects in research," he says.

Four studies in the Dental School were some of the first reviewed in a new program of the OHRCR called Routine Research Educational & Regulatory Reviews (RRERR) or "not-for cause" reviews.

These are reviews by the staff of OHRCR designed to assist investigators and provide feedback for the institution in how well it is meeting its goal of ensuring the safety, rights and welfare of study participants. Unlike "for cause" reviews, the RRER reviews are not initiated by any complaint or allegation of problems.

The OHRCR staff members are "thoughtful, sensitive" people, says Giannobile, who principal investigators and study staff can rely upon for advice for regulatory concerns.

More about the RRERR program will appear in the November issue of the Research Reporter.

The OHRCR website has information on the office, the staff, the advisory committee, standard operating procedures and more. Find it at: www.research.umich.edu/orcr/

Some direct links:
OHRCR Home page
Advisory Committee
RRER Reviews

October 2007

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