Training commences for researchers whose work involves human subjects

By Rebecca Arrington

From clinical trials in the Medical School to studies being conducted in such departments as psychology, sociology, anthropology, economics and the Curry School of Education -- research involving human subjects is extremely broad-based at U.Va. To ensure that researchers across disciplines and across Grounds understand the University's requirements, as well as the federal guidelines, for proper conduct of human subject research, the Office of the Vice President for Research and Public Service has developed a new, online training program.

Beginning Oct. 1, all affected U.Va. researchers, either submitting a new protocol or requesting a continuation of a previously approved plan -- regardless of the funding source -- must complete this tutorial, said Dave Hudson, associate vice president for research. He estimates the number of researchers affected to be roughly 1,000, made up mostly of faculty members, along with some graduate and undergraduate students.

U.Va.'s training mandate coincides with one from the National Institutes of Health, also effective Oct. 1. It requires all investigators submitting NIH applications for grants or proposals for contracts or receiving new or non-competing awards for research involving human subjects to be educated on the protection of human research participants.

Hudson said that the NIH implemented its policy, just as the University did, to ensure that the highest standards are in place in regard to research involving human subjects. Legalities aside, "We have an ethical and moral obligation to see that researchers are educated about their responsibilities" in regard to this research, he said.

U.Va.'s new training program will provide up-to-date information about the regulatory requirements for conducting research. It reviews core concepts for the responsible conduct of research, and guides researchers through the major principles for conducting research in a way that is consistent with federal and U.Va. requirements and with accepted scientific standards, Hudson said.

The University is committed to protecting the rights and ensuring the safety of human subjects participating in research. This is done through two separate institutional review boards at U.Va. -- the Human Investigation Committee, which oversees all biomedical research, and the Institutional Review Board for Behavioral Sciences, which reviews non-biomedical research.

Because U.Va. reviews all researchers' protocols annually, all researchers conducting studies involving human subjects will complete the new mandatory training within a year, Hudson said.

This time last year, U.Va. phased in a similar training program, also ahead of NIH regulation, for researchers using animal subjects in their studies. "Increased training is an important part of our program," Hudson said. As a result, the University isn't having to scramble to meet NIH mandates, he said.