| New office helping researchers meet federal rules by Daniel J. Fitzgibbons, Chronicle staff
And as most people on campus know, the long arm of the government bureaucracy insinuates itself into nearly every aspect of university life. From privacy of student records to the use of animals in research to financial aid and foreign students, there are corresponding federal rules and reporting mandates. One of the areas most keenly affected by federal regulation is research. Principal investigators often find themselves ensnared in a complex web of regulations governing how research is conducted, how money is spent and accounted for, and how the results are shared. Concerned by the rising demands of federal regulatory agencies on campus researchers, interim Vice Chancellor for Research Fred Byron last summer created a new office to help faculty understand and negotiate governmental rules. Hilary Woodcock, who previously served as program administrator in Molecular and Cellular Biology, was appointed the campus's first research compliance coordinator. The need for the new post "reflects the endless proliferation of federal regulations," said Byron. "We need to be more systematic about dealing with these matters. The time has come to be more professional by creating an office that is dedicated to helping researchers and students." Citing Woodcock's familiarity with the science community, Byron said she will be an important resource to faculty and others involved in research activities. "We need people to give the proper training to students, postdocs and faculty," he said, "and to explain the regulations clearly." "At the end of the day, there are certain serious requirements that have to be met," he added. To that end, Woodcock has been working with campus committees and offices concerned with a range of issues regulated by federal agencies, such as radioisotopes, animal care, recombinant DNA research, and the use of syringes and controlled substances. Since coming on board last August, Woodcock has focused a lot of attention on the pending implementation of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, whose regulations become effective April 14. "It's a very benign sounding act," said Woodcock, "intended to protect health record privacy." However, as the U.S. Department of Health and Human Services crafted regulations to implement the legislation, it became apparent that HIPAA's reach goes far beyond safeguarding records used by health care providers. The act also applies to all health information created or received by public health authorities, employers, schools and universities. Woodcock said HIPAA has implications for campus researchers who use human subjects in their studies. For the approximately 12 departments and programs that employ human subjects, the legislation means extra work to ensure that informed consent is obtained from study participants and that additional safeguards are in place to protect the privacy of the volunteers. Since many of the HIPAA regulations still have not been published, Woodcock has also been busy monitoring the latest information coming out of HHS. Last week, she attended a HIPAA workshop in Washington, D.C. As the effective date for HIPAA draws closer, Woodcock said researchers who may be overwhelmed by the new requirements should remember that help is available. "My role is to deal with the wording on informed consent," she said. "I'm also the go-to person for information." "This is a service to faculty and students," said Byron. "We need to be ahead of the curve and be aware of what's ahead and unfortunately, it's all going in one direction. ... We want to comply in as undemanding a fashion as we possibly can and give training in a concise way so our researchers can focus on their work." |
