Compliance News Fall 2003

Office of Research Affairs

Compliance and Research Protection News

Fall 2003

In this Issue:

Well Labor Day and Hallowe'en have come and gone and another summer is history. Some familiar faces have moved on, moved into other positions, or are weighing their early retirement options. These changes have included a key one for research compliance - the appointment of Paul Kostecki this September to the new position of Vice Provost for Research.

We lost Lisa Lipshires, who had been managing rDNA and biosafety protocols in the Office of Research Affairs, to the School of Nursing. Bev Strakose in ORA has taken over that area of protocol management.

Margaret Burggren in the Office of Research Affairs, with Nancy Swett's assistance, now manages compliance relating to research using human subjects and is Administrator for the Institutional Review Board (more about these changes below).

In the Spring newsletter we reported our hope of acquiring an online protocol management system for the campus. Funding was not forthcoming for this project so it is on the back burner for the near future. We are, however, moving one step closer to making our protocol management system more secure and efficient by moving our protocol databases onto the OGCA server. Until now these databases have resided on three stand-alone PCs, one for biosafety/rDNA, one for human subjects protocols, and one for animal use protocols. The move to the OGCA server will remove one level of inconvenience associated with the old system. Anyone in OGCA and the Office of Research Affairs who needs information from these databases will be able to do so from their own desks. And we will all sleep better at night with the knowledge that the databases are backed up daily.

Please forward this newsletter to your colleagues and associates.

If you wish to be removed from this mailing list please contact Hilary Woodcock at:

email: hilaryw@ora.umass.edu
voice: 413-577-0387

The IACUC

One of this summer’s projects was to develop Occupational Health and Safety guidelines and procedures for animal users. This joint effort involved Compliance Coordinator Hilary Woodcock, the Attending Veterinarian Andy Darrigrand, the Animal Care Director Steve Plouff, the Biosafety Officer in EHS Val Steinberg, and Wende Graves at UHS. Available services relating to OHS for animal users include free pre-employment health screenings, keeping shots up to date, training in the use of personal protective equipment, lowering the risk of developing allergies, OHS training for animal users, and information about diseases that can be transmitted from animals to humans (zoonoses). “Occupational Health and Safety for Animal Users” will be available on the compliance web site by the end of November.

The risk of contracting a zoonotic disease is generally very low, but if you work with animals and become sick you can now check out a Safety Sheet for the species you work with at http://www.umass.edu/research/aco/faq.html. The Safety Sheets include links to information about zoonoses.

October is IACUC semi-annual inspection month. Recent citations by USDA make it clear that, although we get a perfect scorecard in most areas following a USDA inspection, there are some problem areas. This is not an animal care issue. Problems are related to deferred maintenance issues, and to a lack of awareness among some researchers that all areas in labs and animal care facilities where work is done with animals need to be kept squeaky clean. Following a recommendation by the IACUC, Steve Plouff is putting in place a new housekeeping policy for procedures rooms and suites in the animal care facilities. Animal care personnel can clean up after researchers as needed to maintain animal care facilities to a high standard of cleanness and sanitation. Animal Care will bill the responsible lab’s PI for the clean up. Details are being worked out and we’ll be letting researchers know how the new plan will work in the next couple of weeks.

There have been no major changes in the regulations but a minor change makes researchers’ lives a little easier. It is now officially OK to report changes in personnel working on a project to the IACUC via a memo rather than an addendum to the protocol.

The Patriot Act and Select Agents

Over the past year Don Robinson and Val Steinberg in Environmental Health and Safety ensured the campus complied with the phase-in of the requirements of the Patriot Act and regulations concerning the use of select agents on this campus. An inspection by the CDC in connection with the new regulations went well and the campus has met a series of deadlines for compliance. But, like other institutions, we are now bumping up against a November 12 deadline for full compliance with all provisions in the Interim Final Rule implementing Title II of the Public Health Security and Bioterrorism Preparedness and Response Act.

The bad news is that the government was unable to complete its personnel screening obligations within its
own time frame.The good news is that effective today (November 3) CDC and HHS have amended the
applicability requirements to allow for the issuance of provisional registration certificates for all entities,
and provisional grants of access for all individuals, from whom the Attorney General has received all of
the information required to conduct a security risk assessment if those entities and individuals that
otherwise meet all of the requirements.  Contact Val Steinberg at 545-2682 if you are uncertain
where you stand.

Human Subjects

There has been a personnel change in the administrative support for human subjects research. Effective a couple of weeks ago, Margaret Burggren took over this role from Hilary Woodcock. One of her priorities in the next few months is to revamp the human subjects web-based training materials. We hear from many researchers in the social and behavioral sciences (and we are listening!) that our online training materials, like most institutions’, have a distinct bias towards biomedical research. We have plans for fixing this but just how soon the change will come about depends on the staff resources available for the project.

Another major project in the Office of Research Affairs is phase two of our planning to ultimately bring all human subjects research (sponsored and unsponsored) under IRB oversight. Phase one involved meetings with representatives of local human subjects review boards and the IRB to thrash out a plan for integrating the activities of local human subjects review boards and the IRB for this campus. Phase two is information-gathering. Starting October 1 local boards forward a short registration form to the IRB when they approve a project. This information will tell us the numbers and kinds of research projects using human subjects that are being reviewed across campus. We will use this information to plan for phase three which will bring all human subjects research conducted by UMass researchers under the IRB oversight. Currently, the favorite model for achieving this maintains local oversight of some unsponsored research with local boards represented on the IRB. But this plan could change as we develop a better understanding of the scope of the project.

Following the April 14 deadline for compliance with HIPAA and the Privacy Rule, a routine for compliance with HIPAA regulations has been shaking out. What seems to work best for most UMass researchers who are impacted by HIPAA regulations is to use the same forms and processes as the covered entity with which they are collaborating. Thus if you are working with a Baystate Medical Center collaborator and need access to your subjects’ protected health information (PHI) stored at BMC you should use BMC’s Authorization form and it will be reviewed at BMC for HIPAA compliance. You can contact the BMC IRB for further information about obtaining BMC’s Authorization template and their review process. There is a click on the BMC IRB website at http://www.baystatehealth.com/3489/3522/4740/ through which to email them.

Research Ethics

Over the past year the Graduate School has been taking the lead in raising awareness on campus of research ethics. Last spring the Graduate School’s Ethics Committee, a subcommittee of the Graduate Council, invited proposals for grants to support projects that would foster dialogue on professional and/or research ethics on this campus. Three projects were funded. Ann Herrington (English), Heidi McKee (English) and Irving Seidman (School of Education) are offering a series of forums titled “The Ethics of Person-Based Educational Research” for graduate students doing person-based qualitative research. Robert Zussman (Sociology) is putting together a two-day conference focusing on issues relevant to field-based anthropological and sociological research. Phil Nasca (Biostatistics and Epidemiology) is offering a one-semester course for SPHHS graduate students in spring 2004 that will cover professional ethics, ethical research principles and ethical standards in clinical practice.

The Graduate School also sponsored a survey by Phil Nasca to compile information about perceptions and practices on this campus among faculty and graduate students about research ethics. He presented his findings at a recent Ethics Workshop sponsored by the Graduate School titled ‘Unraveling the “Messiest” Questions in Research Ethics’.

A total of 115 faculty and 403 graduate students responded to the survey. The majority of faculty respondents indicated a growing interest in ethics training among government and non-government sponsors of university research and among national professional organizations. Less than 10% of faculty respondents indicated that their departments taught a semester long course in research or professional ethics. However 55% reported that their departments provided some form of ethics training including full graduate courses, seminars and individual training sessions. The six most frequently covered topics are codes of professional conduct (75%), plagiarism, proper citation, and other academic honesty issues (68%), research standards of practice established for specific disciplines (62%), authorship, patents, and other intellectual property issues (52%), maintaining security and confidentiality of records (58%), use of human subjects in research (50%), and conflicts of interest and scientific misconduct (47%).

Both faculty and students emphasized the need for trainings to create an understanding of the underlying cultural and societal basis for ethical behavioral in research and professional conduct. The faculty supported the need for students to establish a basic framework for thinking about ethical issues, a framework that would provide guidance when making future decisions. Faculty and students said that trainings should include an introduction to the practical aspects of conducting ethical research including the treatment of both human and animal research subjects, the role of Institutional Review Boards, design of effective informed consent forms and procedures, and the impact of federal and state laws and regulations on data access and confidentiality. Another common theme concerned the ways in which corporate, military and government sponsors can influence research and professional ethics. These concerns included potential conflicts of interest and the respective roles both the sponsor and the grantee play in ensuring that ethical research practices and professional standards of conduct are followed.

On that topic, another highlight of the ‘Unraveling the “Messiest” Questions in Research Ethics’ workshop was the thought-provoking Keynote address by Sheldon Krimsky from Tufts University on “The Corporate Influence on Academic Research and Its Social Costs”. He highlighted the dilemmas facing academic institutions when they accept corporate dollars to support their research enterprise, and made convincing arguments that the climate and culture of the research enterprise are inevitably altered by these collaborations. If you are curious to know more about his views on this topic, the New York Times covered an interview with Dr. Krimsky in its September 23 issue. There is a link to the article at http://www.gene-watch.org/press/NYT-krimsky.html.