Investigator attendance at review board reviews: hindrance or help?

Probably neither, Johns Hopkins study says

Inviting researchers to attend institutional review board sessions designed to approve these same investigators’ requests to conduct research involving human subjects doesn’t seem to affect the efficiency of the process one way or the other, a new study led by Johns Hopkins bioethicists suggests.

The findings are the result of one of the few studies to date that have sought to verify or challenge a fairly wide perception that inviting participation by so-called principal investigators, or PIs, could introduce more inefficiencies in what already is a lengthy and detailed process beset by scheduling problems, poor investigator-IRB relationships and administrative delays. Some researchers have suggested an opposing view: that inviting PIs can improve efficiency.

“The limited data on IRBs indicate they do not routinely invite PIs to attend convened meetings,” says Holly Taylor, assistant professor in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health and assistant director of empirical research at the Johns Hopkins Berman Institute of Bioethics. She and her coauthors on the review of IRB practices at The Johns Hopkins University say one national estimate found that fewer than 9 percent of IRBs require PIs to attend the meetings.

Under federal law and regulations, and to assure the safety and welfare of research volunteers, all institutions that receive federal funds to conduct human subject research require review and approval by an IRB, a group generally composed of senior scientists not involved in the research under review along with individuals who represent the lay community. Bioethicists and others familiar with human research protocols also may be involved.

Among other things, IRBs carefully consider questions such as whether the study’s science is valid and generalizable, whether its benefits outweigh risks that volunteers might encounter, and whether volunteers will be adequately informed about the study to consent to participate.

While serving as members of four IRBs at the Johns Hopkins University School of Medicine, Holly A. Taylor, Nancy E. Kass and other bioethicists at theBerman Institute of Bioethics noticed that some IRBs regularly invite PIs when their research plans are discussed while other IRBs do not.