January 21, 2000
BIRMINGHAM, AL — The University of Alabama at Birmingham has received notification from the federal Office for Protection from Research Risks (OPRR) that it must conduct an additional review of some federally funded research projects involving human subjects.
About 25 percent of UAB’s research projects could be affected. Research with currently enrolled participants will continue as long as their physicians and the University’s Institutional Review Board (IRB) determine that it is in the participant’s best interest. The IRB has a process to expedite such projects so that they will continue uninterrupted.
New participants will be enrolled in the projects as soon as the additional review is completed. These reviews are under way now. “UAB has always been committed to the highest level of integrity in all of its research, especially that which involves human subjects and patients. We appreciate the confidence OPRR is showing in UAB as we continue approving new projects and following their guidelines,” said Dr. Joan Lorden, associate provost for research.
“The issues raised by OPRR can and will be addressed expeditiously. Many of these items had already been addressed at UAB and were in the process of being implemented. OPRR has commented favorably about steps already taken by UAB.”
The OPRR is reviewing IRB practices at universities nationwide.
It is important to note that:
- UAB’s research program has not been suspended; some projects involving human subjects must be reviewed again following OPRR’s interpretation of the federal regulations. These reviews are under way by the IRB.
- Unlike other universities which have received more stringent notifications, UAB has full authority to continue reviewing and approving research projects.
Persons enrolled in studies or trials who have any questions about the project or program in which they are participating should contact the clinic or office involved.
OPRR oversees all institutions for compliance with Department of Health and Human Services regulations for protection of human research subjects. The IRB is a committee that reviews all UAB research involving human subjects.