All Cornell faculty members, staff scientists, university staff members, extension directors and staff and students who use human subjects in research and evaluation should prepare for more rigorous requirements governing their studies, according to the University Committee on Human Subjects (UCHS).
The new protocols for human-subjects research at Cornell's Ithaca campus and affiliated units will take effect Nov. 15. New, more detailed forms for submitting proposals will be posted by Nov. 9 on the human subjects compliance web site: http://www.osp.cornell.edu/.
"The committee reviewed and revised our protocols to ensure that Cornell University is in full compliance with all applicable federal laws and, of equal importance, that we meet our ethical obligation to protect the health and well-being of those who participate in research," said Kraig Adler, vice provost for life sciences. "We are doing our best to create an environment where researchers are free to conduct productive studies and where subjects can be confident that their health and safety is of utmost importance."
UCHS chair Elaine Wethington, an associate professor of human development in the College of Human Ecology, said the review was prompted, in part, by increased federal scrutiny to human-subjects research at other institutions -- and in particular, at Johns Hopkins University. After a 24-year-old woman in an asthma study died on June 1, the federal Office for Human Research Protections halted most of the 2,400 federally financed studies at Johns Hopkins for five days. Johns Hopkins' institutional review board, the equivalent of the UCHS at Cornell, was cited for failing to provide adequate oversight of the asthma experiment.
"Federal regulations require that any study of humans as research subjects, regardless of the source of funding, be reviewed and approved by an institutional review board before the study begins," Wethington said. "And Cornell's UCHS requires that proposals for the use of humans must be submitted in time to complete the review process before the start date of research."
In addition to experiments and clinical research on health, the more rigorous requirements apply to all surveys, focus group studies, qualitative interviews, evaluations and observational studies conducted by Cornell faculty, research investigators, staff, extension staff and students, regardless of their source of funding. Federal regulations require the review of all projects involving human subjects, including those ultimately classified as "exempt" by UCHS.
In the past, the UCHS proposal-review process has taken up to one month, and the all-volunteer, 18-member committee will try to maintain that standard, Wethington said. "But we hope that investigators will understand if the review process takes a little longer, at least at first, just as they should understand why there is more paperwork involved." Expanding the proposal paperwork from two pages to 10 will give the committee the information it needs to make sure studies are conducted in a safe and proper manner, she said.
Among other changes in procedures for human-subjects research will be the requirement that investigators immediately report to UCHS any "adverse events" and "amendments" that occur during the studies. An adverse event might be as extreme as the death of a subject or an unexpected pharmaceutical reaction, Wethington said. Adverse events also include incidents that may have led to compromising the confidentiality of participant names and other study records. Amendments include other changes in studies, such as revision of survey questions from those that originally were proposed.
Also to be clarified will be the definition of what constitutes human-subject studies. "If you are interviewing people for an oral history project, for example, that is a human-subjects study," Wethington said, " and you will be required to abide by the same protocols as a researcher who is doing psychological or medical studies."
Studies conducted by students in classes as a means of instruction and senior honors theses that involve human subjects also must be reviewed and approved by UCHS. "Participants in those studies are entitled to full human-subjects protection," Wethington said. Routine class evaluations conducted by faculty are excluded.
At the present time, there are about 600 human-subjects studies approved by and registered with the UHSC, according to Denise Clark, director of Cornell's Office of Sponsored Programs. That number is likely to rise, Clark said, as more investigators realize that their work falls under the definition of human-subjects research.
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