Protocol Management

Does your research require getting a protocol approved by one or other of the compliance committees on campus?  If so you might have noticed some different faces, or at least email identities, in the administrative loop.  Barbara Miller has taken over much of the protocol management for the IACUC for research using animals.  Nancy Swett is the point person for the IRB in managing human subjects protocols.  Lisa Lipshires is working closely with Val Steinberg and the IBC to manage recombinant DNA protocols. 

One size really doesn’t fit all when it comes to protocol management.  On this campus we must review protocols for three areas of research – research using human subjects, research using animals, and research using recombinant DNA.  Each research area has its own history of oversight, legislative history, source of regulations and guidelines, style of regulations and guidelines, kinds of review levels, and requirements for its oversight committee. 

Barbara, Lisa and Nancy have each had different problems to work out, different information to store and access, and different procedures to adjust to.  Perhaps one day we will have a comprehensive electronic protocol management system that is sophisticated enough to deal with the 500 or so protocols of various kinds that are currently reviewed and processed on this campus.  In the meantime the folk in the Office of Research Affairs are putting a smooth and efficient system in place to manage and track your protocols.

                                                                                            Biosafety and a National Survey

At present most institutions responding to the survey reported that they do not provide formal training for their IBC members even though this is strongly recommended.  Val Steinberg will address this by making a short presentation to the IBC members on selected topics at future meetings.

                                                                                   The Patriot Act and the Response Act

After September 11, 2001 Congress has been enacting legislation to combat terrorism.  So far this has produced two laws, the USA Patriot Act and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.  Both laws restrict access to certain biological agents and toxins and have set a series of deadlines for institutions to comply with the various provisions of these acts.  Don Robinson and Val Steinberg at Environmental Health and Safety are making sure UMass complies with these deadlines.

The Patriot Act provides that “Restricted Persons” may not possess or access agents on the list of “Select Agents”.  The list of categories defining “restricted persons” includes alien-nationals from Cuba, Iran, Iraq, Libya, North Korea, Sudan and Syria.  People from these countries who were lawfully-admitted to the United States for permanent residence are, however, excluded from this restriction. 

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires that agencies and institutions limit access of Select Agents to “only those individuals the registered [facility] determines have a legitimate need to handle or use” them.  This act also requires that each facility identify its personnel with access to Select Agents and the names must be forwarded to the Attorney General to conduct a background review.

                                                                                                                    IACUC Inspections

It is semi-annual inspection time again for the Animal Care and Use Committee.  Every six months the Office of Laboratory Animal Welfare requires that the IACUC members inspect all the animal care and use areas on this campus as well as satellite facilities. 

In the next few weeks IACUC members will be checking for good housekeeping standards and record-keeping, out of date drugs, and the general state of the facilities.  In these inspections the IACUC follows the same procedures as the USDA inspector who from time to time drops by to inspect our facilities.  If the IACUC finds areas in a lab that need improvement they will let the researcher know so the problem can be addressed. 

Like just about all the activities for which the IACUC is responsible, these inspections have two main goals.  The first is to ensure that animals used for research on this campus are housed, cared for, handled and treated so as to maximize their general comfort and welfare and minimize their discomfort and distress.  The second is to ensure that, as a campus, we are in compliance with the many regulations that govern animal care and use in research.

                                                                                                                            HIPAA Update

There is a general feeling that providing training in RCR and research ethics, which is currently only required for graduate students supported by NIH training grants, is the wave of the future. It is likely that we will eventually be required by law to provide such training. 

In the meantime, the Graduate Council’s Ethics of Research and Professional Ethics committee is surveying graduate students to determine their perceptions of their needs for research ethics training, and is organizing a conference in October to discuss ethics issues. The committee is currently soliciting proposals for awards of up to $10,000 to develop instructional tools and courses in research ethics.  The deadline for receipt of proposals is April 11.