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

'Why us?' becomes 'Glad we did' say researchers in new routine review program by human research compliance office

By Suzanne Tainter
DRDA

No one really likes having someone look over your shoulder, say the research teams that stepped up to be among the first to have their human subject protection efforts reviewed by the Office of Human Research Compliance Review. But now that the review is over, the investigators and study staff say they are glad they did it.

"Even though I thought the reasons for conducting the reviews were good, I still thought "why me?" says Kirsten Ambrose, a study coordinator in the Chronic Pain and Fatigue Research Center. "I was pleased at the end of it. It was rewarding to learn we actually had done a pretty good job."

The OHRCR has initiated a new "not-for-cause" review program 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, these reviews are routine, not prompted by a complaint or an allegation of problems.

Ambrose points out that no one wants to add another administrative process, but the U-M definitely wants to pay attention to protecting human subjects. These reviews can help catch problems before they become nightmares, she says, recalling high profile stories of problems at other institutions.

Participants in the reviewed study, led by David A. Williams, associate professor of rheumatology, are people with fibromyalgia as well as healthy control subjects. The study includes exercise and relaxation interventions, brain imaging, and blood, saliva, and DNA samples.

Ambrose says the review team helped them keep perspective on what's really important. When conducting research, the team "can get caught up in the minutiae." The review was a reminder that "keeping subjects safety and confidentiality is paramount," she says.

The review also confirmed that the time her team spends in training for best practices in research and research administration is worth it. If the reviews help to uncover niches that are not well addressed that could be incorporated in future training, she points out.

Though his study doesn't involve any medical procedures, it still gets careful scrutiny by the U-M Institutional Review Board(IRB), says Marc Zimmerman, principal investigator on the "Youth Empowerment Solutions for Peaceful Communities (YES)," a community based intervention with middle school students aimed at reducing violence.

It is quite an administrative feat to keep track of all the consent forms from parents and assents from the students, making sure data is kept only from participants with the proper forms, as well as ensuring the confidentiality of the data.

"Review is a scary idea, but if we're doing everything we're supposed to be doing, we really shouldn't be afraid of it," says Zimmerman.

"I was never really worried the study would be shut down, but when you start looking you never know what you might find," says Zimmerman, who is the chair of the Dept. of Health Behavior and Health Education, School of Public Health. "The review helped us get even better," he says.

The OHRCR staff tried to make the process as transparent as possible, say the researchers. Before the review, they outlined what they were looking for. "I knew what to expect. I wasn't blindsided," says Ambrose. After the review, the team received a draft of the report before it was distributed to the IRB.

Ambrose was also reassured to learn the reviewers were themselves experienced researchers, and thus would understand that data collection does not always go according to plan.

Zimmerman says it is important that the OHRCR staff communicate to researchers that they are not coming in as the compliance police, looking to shut down a project. "Rather, we need to educate U-M researchers that the reviews are a way to help the University become a model for the rest of the nation in how to protect human subjects in research," he says.

Office of Human Research Compliance Review

The Office of Human Research Compliance Review (OHRCR) aims to facilitate safe, ethical, efficient and high quality human subjects research. It provides oversight to ensure adherence to regulations and excellence in human subject protection by individual investigators and the Institutional Review Boards (IRB).

Part of the Office of the Vice President for Research, the OHRCR senior staff includes director Ron Maio and research compliance associates Terry Vandebosch and Elizabeth Beattie. All the staff have extensive human subjects research experience.

The staff reviews research studies and committees; provides education and outreach to investigators and the university community; and offers leadership in research compliance.

The goal of a new program, Routine Research Educational & Regulatory Reviews (RRERR), is to be sure that U-M is meeting the highest possible ethical standards in the conduct of research with human subjects. For the coming year, these reviews will focus on adherence to the IRB-approved protocol and human subject regulations for the informed consent process, inclusion and exclusion criteria, and data confidentiality.

The OHRCR Web site provides information on the reviews, the staff, standard operating procedures and more. Find it at: www.research.umich.edu/ocrc/

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

November 2007

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