Personnel Changes

Have you visited the Vice Chancellor for Research web pages or heard from the office of the Director of Animal Care or the Office of Research Affairs on compliance issues lately? If so you might  have noticed changes in personnel and office organization since the summer.

In June 2001 Maggie Delano resigned as Campus Veterinarian and Director of Animal Care to become Associate Director of Animal Care at Worcester Medical School though she continued as Campus Veterinarian until André Darrigrand took over in October of this year. Steve Plouff, previously Assistant Director of Animal Care, is the new Director of Animal Care.

Hilary Woodcock became Research Compliance Coordinator in August. She is charged with developing and implementing a comprehensive University Compliance Program which includes all federally-regulated research areas. Jeane Harris took advantage of the early retirement opportunity and Barbara Miller is the new Assistant to the Compliance Coordinator and Animal Care Director.

                                                                                Homeland Security and the Patriot Act

Many investigators at UMass Amherst are engaged in research that could potentially  be affected by the laws governing homeland security. If you are among them (or even if you are not) you will have heard from our Biosafety Officer in EHS, Val Steinberg, as she gets word from agencies charged with implementing the new regulations coming out of the Patriot Act. Up until now the principal concern of these agencies has been data-gathering. The next set of regulations from DHHS and USDA on implementation of the Patriot Act were issued this week (12/9/02) and you will be hearing shortly from Val Steinberg in EHS about their implications for this campus.

                                                                                  Human Subjects Research and HIPAA

The arena of research using human subjects is another in which the regulatory scene is in flux. Legislation sponsored by DeGette and Greenwood is at present working its way through Congress. If passed this will require that all human subjects research (not just federally-sponsored research) be brought under the oversight of the Institutional Review Board (IRB). So UMass' present policy of allowing unsponsored human subjects research to be reviewed at the departmental level may have to be revised. Most academic research institutions of a comparable size to UMass have already adopted IRB oversight of all human subjects research. On this campus we are preparing for these changes by developing a plan that will use our existing expertise in oversight of human subjects research at the departmental level yet put the IRB in the oversight loop.

                                                                                                           Research Using Animals

Over the last few years the Institutional Animal Care and Use Committee (IACUC) and Maggie Delano developed a system for managing animal care and use on this campus. Their efforts have ensured that this campus satisfies the federal requirements and have developed into a support system for animal users that helps avoid the regulatory pitfalls that are so easy to fall into.

Animal care and use is the only area of federally-regulated research that receives regular on-site inspections by a federal agency. Periodically a USDA inspector drops by for an unannounced visit and reviews our animal use facilities, procedures, protocols, and paperwork. We were cited for a few issues of non-compliance after the inspector's most recent visit in August. The good news is that none of the items for which we were cited are difficult to fix or to prevent in the future if we take care of basic housekeeping and management of our research areas.

Nancy Swett in the Office of Research Affairs has got our new basic web-based training modules for animal users up on the web. These modules are based on the NIH web-based training. Nancy can track who has visited the site and completed the training. Web-based training is not a substitute for the classroom training required for new animal users but is available for annual update training.

More good news in the area of animal care and use is that there are no new regulations on the horizon.

                                                                                         Responsible Conduct of Research

Over the past couple of years there have been rumors of up-coming new legislation concerning the provision of training for researchers in research ethics and the responsible conduct of research. At the present time, however, a federally-mandated requirement for providing this training only applies to graduate students supported by Training Grants and certain Fellowships. Many institutions have not waited for Congress to pass a law and make this training available to all researchers on their campuses. Here at UMass several departments and programs include some research ethics training in their curriculum and a group of faculty have been discussing the development of a broader-based course that will be available to a wider audience.