Human subject research policy changes proposed

The U.S. Public Health Service would like all university public health researchers to be trained in the responsible conduct of their work.

Last year the service, part of the U.S. Department of Health and Human Services, designed a policy for training all contributing research staff on topics such as protecting human and animal subjects, managing their data, and avoiding conflicts of interest and authorship disputes. Researchers could attend lectures at their own campuses, take on-line courses or view CD-ROM programs set up by the health service.

The proposed federal policy is one that researchers at many universities, including UC Davis, think is unnecessary, said Ahmad Hakim-Elahi, director of sponsored programs in the Office of Research. The office oversees faculty research proposals for conformity with university policy.

"The university believes its researchers are doing a good job on their own," Hakim-Elahi said.

In February, Congress set implementation of the policy back from a proposed starting date of Oct. 1, citing concerns about insufficient notice offered to the public and government and the possibility that the service may have overstepped its bounds in developing the proposals.

However, the federal health department's Office of Research Integrity is again moving forward on the requirements, said Lawrence Rhoades, director of the Division of Education and Integrity at the office. He considers the education essential for increasingly complex university research and noted that many universities only offer training on how to deal with human and animanl subjects.

Instead, Rhoades' office proposes that universities provide training in nine subject areas - from how to resolve authorship disputes in research publication and manage data, to developing appropriate mentor-trainee relationships and collaborative efforts. Additionally, Rhoades said, the health service intends to have all faculty principal investigators, as well as student and post-graduate researchers, take the courses. "Now, it's assumed faculty have the training," he said.

UC Davis does provide federally mandated training for researchers dealing with human subjects, Hakim-Elahi said. And a faculty committee looks at possible conflicts of interest in research projects, Hakim-Elahi said.

"The general perception is that federal policies are too constraining," he said. "Yet UCOP is reviewing our current practices to ensure full compliance with the spirit of the policies, even if they aren't enacted."

The Office of Research Integrity met this month with organizations such as the American Association of Medical Colleges and the Council on Government Relations, which monitors university and federal research efforts, to get their input on the policies.

After the office wraps up discussions, the health department could hold a public meeting to discuss the research proposals, or re-post the plan in the Federal Register, Rhoades said. The eventual research proposals could also ultimately be re-issued as a guidance, which would not be binding for universities, he said. Final efforts are on hold until President Bush appoints an assistant secretary for health and human services.

Meanwhile, an informal group meeting with the UC Office of the President is offering its own voluntary research ethics courses.

Topics could include data management, mentoring and peer review, said Rebecca Landes, principal analyst for the UCOP Office of Research.

"There are things people can learn (ahead of time) rather than learning it on the job, which can be a negative experience," she said.

The ad-hoc group, composed of research officers and faculty from across the UC campuses, will soon present their proposals to faculty.

"The university's mission is teaching, research, and public service. Instruction on research ethics includes all of these elements," Landes said. "Although the government policy has been suspended, we feel sure that expectations concerning training and assurance have not changed. It is essential that UC fulfill these expectations."

Primary Category

Tags