for researchers whose work involves human subjects
clinical trials in the Medical
School to studies being conducted in such departments as psychology,
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.
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.
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
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.
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.
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.
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.
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.