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Research safety: Revamped program aims to protect human subjects

By Cliff Foster

Ann Morrison, assistant professor of special education, heads the new Human Research Protection Program. “This is the time to really expand and bring these issues of research integrity to the forefront,” she says.
An ambitious new campaign called the Human Research Protection Program is under way at Metropolitan State University of Denver to raise awareness about ethics and regulations governing the treatment and protection of human research participants.

The University set up a review committee in 1994 to ensure research proposals comply with the ethical principles and rules established by the federal government to safeguard the rights and welfare of people who volunteer for research projects. But the program is getting a significant makeover, including a revamped website that will launch this week.

The website will include an overview of the ethics of conducting research with humans. It will also provide materials and information for investigators—a term synonymous with researchers—who are developing research protocols.

One of the primary goals of the program is to work with investigators in incorporating the protection of human participants into their methodology while preserving their research objectives, says Ann Morrison, assistant professor of special education. She had served for about a year on the old Human Subjects Review Committee and recently became chair of its nominal successor, the Institutional Review Board (IRB). Besides the work of the board, the campaign she heads includes educational support and training elements.

“Human subjects protection is about how we treat the human beings who volunteer to participate in our research,” says Morrison, who plans to give presentations on the issue and the IRB process to faculty and student researchers.

"Every institution that receives federal funding has to comply with the more than 600 pages of ethics, regulations and guidance” published by the Office for Human Research Protections (OHRP), a division of the U.S. Department of Health and Human Services.

The campaign is unfolding amid several initiatives by the University, including the launch of the Undergraduate Research Program, the addition of master’s degrees in teaching, accounting and social work, and a push to obtain more grant funding.

“This is the time to really expand and bring these issues of research integrity to the forefront,” Morrison says.

Put simply, any research proposed by faculty, students or outsiders teaming up with the University and using human subjects must be reviewed by the IRB. The board doesn’t pass judgment on the merits of the research or the methodology. Rather it requires the investigator to submit an application describing the research and outlining how he or she intends to recruit subjects and protect their privacy, safety and anonymity, among other things.

Some proposals can be reviewed by Morrison alone or one of the board members; others are examined by the entire panel if “there is a possibility for high risk for the research participants,” she says.

In the past, roughly 200 reviews have been conducted annually, with a small percentage disapproved and turned back to the researcher. Some rejected proposals are revised and resubmitted; others are abandoned.

A key aim of Morrison’s effort is to clear up misconceptions that some research using human subjects is exempt from review. Another important goal is to make the IRB process more efficient with quicker turnaround times to ensure timely responses.

“All of this is to ensure there are protections in place to prevent research abuses and that there are protections in place for the human beings who volunteer their time to help us develop scholarship in our disciplines,” Morrison says.

The other members of the IRB are:

Lisa Badanes, assistant professor of psychology
Judson Faurer, professor of management
Bethany Fleck, assistant professor of psychology
Chris Jennings, assistant professor of technical communications
Mark Mazurek, assistant professor of biology
Aaron Richmond, associate professor of psychology
Anna Ropp, assistant professor of psychology
Jessica Rossi-Katz, assistant professor of speech communication
Joan Hackett Taylor, a member from the community
Ben Thompson, assistant professor of human performance and sport.


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