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Clinical Trials:
Protecting Human Subjects in Research

by Jeff Worley

"There are a lot of players who share responsibility for the protection of human subjects in research," says Ada Sue Selwitz, who has shaped UK's research oversight activities since 1979.

It all begins with the researcher who is required by federal law to bring his or her project before the appropriate institutional review board (UK has three IRBs for medical research and one for non-medical projects). The IRB, a committee of health-care professionals and community members, reviews the protocol to look at the ethics of the research before deciding whether or not a trial can begin. After the research protocol is approved, there are several points at which the IRB continues to review the project: periodic review for continuing projects, review when there is any modification to the protocol, and reviews when any unanticipated problems or adverse effects are reported.

Selwitz points to the peer review system for federally funded research as another protection for clinical trial volunteers."Even before a project is funded, other scientists may be raising ethical concerns about a proposal," says Selwitz.

During the life of a clinical-trial project, the researcher is required to provide periodic reports to the sponsor. The sponsor, in turn, is required to report any problems to the FDA.

In a large clinical trial, another safeguard is the Data Safety Monitoring Board, comprised of scientists who monitor a trial's progress and who have the authority to stop a trial if they have concerns about data as it comes in. If a trial does not have a monitoring board, a researcher is required to set up a data safety monitoring plan.

The Office of Human Research Protections, a federal IRB regulatory agency in the Department of Health and Human Services, has the responsibility to ensure that an institution conducting clinical trials is in compliance with federal regulations and policies for the protection of human subjects in research.

The University of Kentucky will expand its mandatory human subjects protection training program this fall to include all key personnel on projects involving human subjects. Over 900 UK researchers have already completed the required education program.

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