University's human-subjects research committee implements new rules

By Roger Segelken

Hoping to engender a campuswide "culture of compliance" with federal rules governing human-subjects research, a Cornell oversight committee has instituted a few rules of its own.

Beginning Dec. 1, when the University Committee on Human Subjects (UCHS) requires much more detailed proposals from investigators hoping to conduct studies that involve humans, investigators also must complete a self-education program -- and that's just the start of their learning process.

"All Cornell students, faculty and staff members who conduct any sort of research involving humans also will need to understand federal requirements for informed consent," said UCHS chair Elaine Wethington. "Everyone must be aware of guidelines for determining which studies are exempt from regulation -- rather than assuming they are exempt -- as well as the requirements for faculty oversight of student-run research.

Elaine Wethington, associate professor of human development and chair of the University Human Subjects Committee, reviews research proposals at the committee's Nov. 1 meeting in Day Hall. Behind her is Betty Kassman, left, an Ithaca community representative on the committee, and Dennis Regan, associate professor of psychology and former chair of the committee. Nicola Kountoupes/University Photography

"Furthermore," said Wethington, the associate professor of human development who heads the 15-member committee, "new rules and regulations are still being debated on the federal level. More rules will be phased in over the next several years, so stay tuned."

The all-volunteer UCHS meets monthly to review (and approve or return for further refinement) all proposals for research that involve human subjects, regardless of the source of funding. Proposal forms, which have been expanded from two to nine pages, are found at the Office of Sponsored Programs web site http://www.osp.cornell.edu/Compliance/UCHS.html. They cover not only biomedical research with human subjects, but also all social and behavioral research conducted from Cornell's Ithaca campus and affiliated units. (A separate committee and set of rules govern human-subjects research at the Weill Cornell Medical College in New York City and its affiliates.)

Discipline-specific subcommittees of the UCHS review proposals before they are submitted to the full committee, and proposals or proposal renewals are required for each year of research projects.

Completion of an education program, such as the Training Program for Researchers in the Use of Human Subjects (a self-tutorial with quizzes at the compliance web site), has been recommended for the last year but now is absolutely required, Wethington said, consistent with policies at other major research universities. And the online tutorial, which takes about 45 minutes to complete, should be regarded as a minimum, she added. "Researchers also should be fully familiar with any requirements of their disciplines, such as codes of ethics of professional societies, as well as with all local, state and federal regulations that pertain to their particular research." Other, more detailed and specific training programs are offered by the National Institutes of Health and the National Cancer Institute, Wethington said, noting: "Our committee and the Office of Sponsored Programs can point researchers to training opportunities, but the researchers are responsible for training themselves."

Consent documents, which advise prospective subjects of their rights and risks while participating in research, are another focus of UCHS concern. A template for consent documents is available at the compliance web site. Research proposals must include either the text of written consent documents that subjects will sign or scripts for verbal consents to which subjects are asked to listen and agree.

Some kinds of research -- such as interviews of public officials -- are exempt from human-subjects rules, but researchers may no longer "self-exempt" themselves, Wethington emphasized. "Only the UCHS can issue a certificate of exemption, after reviewing a proposal," she said. "The certificate of exemption must be renewed once a year, and the committee must be informed of any changes in research that might affect the exemption.

Calling for more conscientious supervision by faculty members of student-run research, Wethington said: "Even after taking the training programs, many students cannot produce an acceptable application. Students need discipline-based training as well, and their departments have to get involved and stay involved."

If all the tougher requirements for conducting human-subjects research at Cornell make UCHS seem like a cranky bunch of busybodies, there's a good reason, Wethington said. The university must file a multiple project assurance with the federal government, certifying that a locally based institutional review board (the UCHS at Cornell) oversees researchers' compliance with all rules and regulations. "If something goes wrong, the university's reputation is on the line," the UCHS chair said, "so there's plenty of incentive to make sure our researchers know the rules."

And why do UCHS volunteers do all their work for no compensation (except a free lunch once a month)?

"I can't answer for the other members, but here's my reason," Wethington said. "This committee is one of the things that helps preserve Cornell's reputation as a first-rate research institution. There are so many worthwhile, innovative studies under way here at Cornell. I'd like to help the investigators make sure their studies are conducted 'by the book.'"