McClelland honored for efforts to ensure research compliance

L.A. Cicero Kathy McClelland

McClelland and her staff handle more than 100 calls a day about laws governing human and animal research.

Kathy McClelland's job as the university's director of research compliance lies at the heart of Stanford's research mission. For that reason, she has been selected as one of the two winners of this year's Marshall O'Neill Award, which faculty bestow upon a staff member every year for enduring and exceptional contributions to Stanford's research enterprise.

From her office on Welch Road, she and her staff of 25 receive more than 100 calls a day from researchers and others throughout campus with questions about laws pertaining to human subjects and lab animals. This research can include anything from a clinical investigator browsing patient charts that contain private information to a psychology student who is designing a questionnaire for surveying classmates.

And yes, McClelland also ensures that all research complies with regulations for industry-sponsored clinical trials, many of which involve the testing of pharmaceutical products and cardiovascular devices on people. Research, as McClelland defines it, usually involves a formal hypothesis, systematic data collection and the reporting of findings for generalizable knowledge.

"These laws are very complex," McClelland said. "There's a lot of interpreting we need to do here in the office."

McClelland, along with Susan Sebbard, assistant director of the Stanford Humanities Center, will be honored today at 4 p.m. in the Faculty Club as co-recipients of this year's Marshall O'Neill Award. Each will receive a $3,000 cash prize.

McClelland is responsible for Stanford's Human Research Protection Program (HRPP) across five affiliated entities, including the university itself, Lucile Packard Children's Hospital, Stanford Hospital and Clinics, the Veterans Affairs Palo Alto Health Care Systems and the Palo Alto Institute for Research and Education. In her role, she designs, develops and implements a university-wide research compliance program.

However, such is her expertise that she has repeatedly had an impact on research compliance policies at the national level—so that they are constructive rather than merely bureaucratic, according to Ann Arvin, associate dean of research and the Lucile Salter Packard Professor of Pediatrics.

"Her views are sought by the federal government offices involved in research oversight," Arvin wrote in a letter nominating McClelland for the award, "and her standing with the leadership of these agencies is extraordinarily important to Stanford."

Coming to Stanford in 1979, McClelland worked for several years as an administrative associate in the departments of Cell Biology and Chemistry. From 1981 to 1986, she served as the institutional review board medical manager in the School of Medicine Dean's Office. After that, she spent almost 10 years in the Sponsored Projects Office, eventually joining the Office of the Dean of Research in 1995 as research compliance director.

McClelland said inspectors from the U.S. Department of Agriculture routinely show up on campus unannounced several times annually, and every couple of years, officials from the Food and Drug Administration perform their own inspections. She added that the advanced research often conducted at Stanford means that, if anything, inspectors are more thorough here than at some other institutions.

Currently, McClelland's office is finalizing preparations for a crucial site visit by the new Association for the Accreditation of Human Research Protection Programs. In less than a month, the association will send four inspectors, who will conduct 100 interviews over four days. McClelland said, "It's probably going to be the most intense inspection that the HRPP has ever seen."