University Times

Question: Which of the following projects would qualify as research requiring approval from Pitt’s Institutional Review Board (IRB)?

• Conducting an opinion survey among students or the general public.

• Having people write about their personal experiences.

The answer is: Both projects require IRB approval if the researcher intends to publish the resulting data and writings, or an analysis of them.

The IRB is a federally mandated, peer-review group responsible for safeguarding the rights and welfare of people who volunteer for research studies. Most of the projects reviewed by the IRB involve biomedical research, but much of the psychosocial research going on at Pitt likewise requires IRB approval as well as informed consent from human subjects.

“There is a lot of confusion among faculty in the social sciences and the humanities about when they need to seek IRB approval of a research project,” said psychology professor Irene Frieze, chairperson of Pitt’s IRB Advisory Committee for Psychosocial Research. “In general, the answer is that anyone doing research based on interacting with people needs IRB approval,”

As an example of a project that would not require IRB approval, Frieze cited a classroom survey that some of her students administer to fellow students, whose anonymous answers are then analyzed and used by the class in writing papers. “This is done for teaching purposes only,” Frieze said. “There is no intent to publish these data. Such activities do not qualify as research and do not need IRB approval.”

Provost James V. Maher established the five-member psychosocial research committee last term to advise the administration on protecting human subjects in psychosocial research projects and to facilitate communication between the psychosocial research community and the IRB.

In a Feb. 24 memo to faculty, research associates and postdoctoral fellows announcing the advisory committee’s appointment, Provost Maher wrote: “Although the social justification for, and the regulations governing, research involving human subjects are the same for both biomedical and psychosocial research, the implementation can have a different look and feel as a result of the very different research activities involved in psychosocial research.

“Treating a terminally ill patient with an experimental drug is different, from a risk/benefit perspective, from conducting a survey of middle school children and their parents, even though the principles of informed consent are fundamental to both activities,” Maher noted.

Last fall, professors from the social sciences and humanities complained at meetings of Faculty Assembly and Senate Council that Pitt’s IRB, which is dominated by Health Sciences researchers accustomed to reviewing biomedical projects, did not understand psychosocial research and tended to interpret federal regulations as strictly as possible, demanding the maximum amount of information from researchers and informed consent from volunteer subjects.

“Sometimes, psychosocial researchers are put through enormous hoops in terms of what they’re required to do to satisfy the IRB,” said Frieze. “I’ve personally heard lots of complaints.”

One professor in Pitt’s School of Arts and Sciences told the University Times: “The guiding principle of the IRB seems to be to protect the University from any conceivable lawsuit or suspension of funding. Protecting the safety of human subjects is only incidental.”

The professor, who asked not to be identified out of fear of retaliation by Pitt administrators (“They’ve punished me for speaking out about these things in the past,” he said) complained that the IRB requires researchers to go to absurd lengths to comply with federal regulations such as the Health Insurance Portability and Accountability Act (HIPAA), which took effect in April 2003.

“The IRB insists that I include, in an informed consent form for a study of perceptual responses, a whole rash of statements like ‘All records pertaining to your responses will be kept locked and coded.’ It is inconceivable that anyone from outside the University would be interested in anyone’s perceptual responses,” the professor said. “This isn’t HIV status we’re talking about. Nevertheless, I must include all of these paragraphs absolving UPMC – which isn’t even involved in my research – and Pitt.

“It wouldn’t have been so aggravating if the IRB had told me upfront to include this language, but it wasn’t until they were reviewing the third version of my proposal that they brought this stuff up. I’m spending days complying with a four-page, point-by-point response that the IRB sent me to the latest version of my proposal.

“I’m literally losing sleep over this. I’m so angry, I can’t sleep.” Frieze said she plans to write about her committee’s findings, and offer IRB-related advice to psychosocial researchers, this fall in the University Times.

– Bruce Steele