University Times

Err on the side of caution, was the main message Faculty Assembly heard last week from the director of Pitt’s Institutional Review Board (IRB).

The IRB, which is the administrative body established to protect the rights and welfare of human subjects, including patients, who are recruited to participate in research activities, governs everything from questionnaires and surveys to complex drug trials and biomedical interventions.

IRBs nationally operate under federal policies of the Department of Health and Human Services and applicable regulations of the Food and Drug Administration.

Research proposals (aka protocols) are sorted by the IRB into one of three types of review: exempt, expedited and full board review.

Many IRB approval requirements would be obvious to researchers, such as listing a principal investigator (PI), providing a thorough description of the research project and detailing how subjects will be recruited, according to Christopher M. Ryan, director of Pitt’s IRB. But other regulations are less obvious and can lead to significant problems, including invalidation of the research and potential ramifications for the University for non-compliance.

“For example, in a collaborative study, if a Pitt person is the PI or co-PI on a research project at another institution, that has to be approved by Pitt’s IRB as well, because the person doing the actual research is a Pitt person,” Ryan said. There also are nebulous areas that necessitate IRB interpretation, for example who needs to be listed in a project’s protocol, or whether a proposal requires departmental scientific justification review prior to board review, he said.

Pitt’s IRB, which reviews about 1,500 new protocols annually, has jurisdiction for reviewing all research proposals involving human subjects conducted by faculty, staff or students in any school, department or academic unit, including the regional campuses. Pitt’s IRB oversight also includes human subject research at any UPMC facility.

Ryan noted that Pitt is the first university in Pennsylvania to be awarded full accreditation status for completing a new voluntary accrediting process by the Association for the Accreditation of Human Research Protection Programs, Inc., which evaluates safeguards in research programs involving human participants.

“Recently there was a re-organization in the IRB office and there have been some changes,” including modifying the board’s mission statement to include a focus on supporting the development of research studies in addition to reviewing proposals for compliance, Ryan said. “This is an important shift,” he added.

Ryan urged faculty to take advantage of the expanded services the Pitt IRB is offering. “Come early and often, go through the process with us, contact me directly, that’s what we’re here for.”

Other recent developments include additional staff to help proposals move through the pipeline more quickly, and a new training module for certification of researchers working on social and behavioral research to complement the long-standing training module for biomedical researchers.

In the near future investigators will be able to submit all types of proposals on line, and the office is developing sample consent forms that will serve as guides for investigators.

The board also conducts informal sessions to advise researchers on University and federal compliance requirements.

“We also provide direct one-on-one support to researchers,” Ryan said. Staff are available to answer specific questions, meet with investigators and their research coordinators and prepare group presentations, he added.

Pitt’s IRB has 11 board members and some 250 committee members, most of them physicians and nurses representing a number of research areas at Pitt. The board also includes non-scientific-based people and required non-institution-affiliated members who focus particularly on informed consent documents to ensure they are understandable by potential research project participants.

Ryan said that feedback for investigators from the IRB on protocols usually occurs within two to three weeks of submission.

Prior to submitting a research protocol, investigators first must obtain certification in research integrity and in human subjects research by completing the web-based training program in research and practice fundamentals (accessible at http://rpf.health.pitt.edu/rpf/index.cfm).

The IRB will not approve any protocol unless all listed investigators have completed both research training modules. Co-investigators from other institutions must submit evidence that they have completed similar programs at their home institution, according to Ryan.

Pitt affiliates who are listed as investigators (as opposed to consultants) for research conducted at other institutions likewise must submit copies of relevant IRB documents (protocols, consent forms, approval letters) to Pitt’s IRB for review.

Currently, investigators who have been certified do not need to renew certification; however, the office plans to convert to a three-year cycle of certification renewal requirements within a year, Ryan said.

Detailed instruction for submitting protocols to Pitt’s IRB are available at the IRB reference manual link on the board’s web site: www.irb.pitt.edu. The IRB’s phone number is 412/383-1480.

Ryan invited researchers to access the web site, call the main number or e-mail him directly (ryancm@upmc.edu). “Both the chairman of the IRB, Dr. Richard Guido, and I are always available to address our faculty members’ suggestions and concerns — even complaints — about any aspect of the IRB process,” Ryan said.

—Peter Hart