Compliance and Research Protection News

Winter, 2006

We would like to welcome Terri Bechta who was recently hired by EH&S as the Hazardous Materials Inventory Control Manager in charge of the CHEMs database and Laboratory Health and Safety Services. Terri graduated from the University with a B.S. in Chemical Engineering and a minor in Chemistry.  Her professional background includes research and development chemist at Stanhome Inc., Director of Research & Development and Quality Assurance for W.F. Young Inc., a manufacturer of cosmetic and topical pharmaceutical items for the human and veterinary markets and insecticides for horses and dogs, environmental engineer in the paper industry, and Corporate Manager of Environmental Health and Safety for Merrimac Paper Company.  For the past four years Terri has been Environmental Health and Safety Manager at Hampshire College .  Please join EH&S in welcoming Terri to UMass.

Check EH&S news at the end of this newsletter for more about CHEMS.

Please tell your colleagues and associates about this newsletter.

If you have a topic for future newsletters please contact Hilary Woodcock at:  

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

______________________________________________________ IACUC

A roundtable with Dr. Mark Blumberg from the University of Iowa last December brought vividly home to participants the impact of vandalism by animal rights activists on research. In November 2004 the Animal Liberation Front (ALF) vandalized University of Iowa Psychology Department animal research labs, including Dr. Blumberg’s. ALF claimed to have removed more than 400 animals, poured acid on research documents, and destroyed computers. Dr. Blumberg pointed out that institutions like UMass Amherst are attractive soft targets but that there are relatively inexpensive measures available to us that would make us a bit less soft.

The University of North Carolina (UNC) at Chapel Hill has been a target of People for the Ethical Treatment of Animals (PETA) activism for several years.  PETA recently filed its second formal complaint calling on NIH to act against UNC for alleged deficiencies. In October 2005 NIH released a report of its second investigation which confirmed that conditions at UNC were not in compliance with the government policy and guidance and citing ineffective leadership, communication, and record keeping in UNC-Chapel Hill’s animal research facilities which reportedly led to missed veterinary treatments for animals and delays in euthanasia, failures to provide adequate food, water, and sanitary conditions, … (failures) to provide post-operative analgesic treatments, and deaths caused by premature weaning, and cage overcrowding.  This news item was excerpted from the January Animal Research News & Analysis Newsletter put out by the Human Society of the United States and their source was: NIH-Report of Investigation of Allegations of Noncompliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals at the University of North Carolina at Chapel Hill, October 25, 2005.  A summary of the report can be found at PETA- Excerpts of Report.

In defense of ethical biomedical research using animals, Americans for Medical Progress have launched a new website for research advocacy at www.amprogress.org with postings on the challenges posed to biomedical research through animal rights advocates’ activities, information about the humane nature of animal-based research, and stories about the importance of animal-based research to medical progress 

It is clearly important for diverse stakeholders with differing viewpoints on using animals in research to talk to each other. To this end the “Dialogue Forum on the Use of Animals in Medical Research” facilitates discussion about animal research issues. The Dialogue Forum’s goal is to increase understanding of issues, invite debate, and create constructive relationships to find common ground between groups with different positions on the use of animals in biomedical research.

NIH (nih.gov) is considering whether to update the Guide for the Care and Use of Laboratory Animals , and is collecting new information, methods and practices, published data, and advances in humane care and use of lab animals. The deadline for submission of material to NIH is February 28, 2006 .

A recent audit conducted by the U.S. Department of Agriculture Inspector General criticized some APHIS officials for lax performance, and cited a failure of the Eastern Division of the USDA’s Animal and Plant Health Inspection Service’s (APHIS) Animal Care unit (AC) to aggressively pursue enforcement for violations of the Animal Welfare Act. [“Audit Report, APHIS Animal Care Program Inspection and Enforcement Activities, Report No: 33002-3-SF”, at http://www.usda.gov/oig/new.htm.] This failure was attributed to “a lack of clear National guidance.” PETA vice president Mary Beth Sweetland told the AP “… fines (for Animal Welfare Act violations) are laughable. … Violations of the Animal Welfare Act are not taken seriously at all.”

AP, October 21, “Audit Says Animal Welfare Officials Lax”
http://www.sfgate.com/cgibin/article.cgi?f=/n/a/2005/10/20/national/a161422D38.DTL

______________________________________________ Human Subjects

Continuing and Final Review  

If you are a researcher with expedited or full board IRB approval for a project involving human subjects the IRB reminds you that you are responsible for providing continuing review information before the approval expiration date. Studies that the IRB has decided are exempt from IRB oversight do not typically require further oversight or continuing review.  Nevertheless the rights and welfare of subjects in those studies still require protection so you must report changes to your study design to the IRB to be sure that your proposed modifications have not changed the level of risk.

Final Reports

Once your study is completed please remember to submit your final report to the IRB.  This requirement applies to all studies, whether they were exempt, had expedited review, or full board approval.  As a general guideline, you should forward a final report to the IRB when:

·    enrollment of subjects is closed, and

·    data collection is complete, and

·    data are de-identified, e.g. data are being maintained in such a way that identifiers are separated from the coding system, or data are in a secure location, and

·    there is no additional research beyond the original intent planned for these data.

Note that it is the continued responsibility of the research team to maintain the confidentiality of the data. 

Please contact the Human Research Protection Office at 545-3428; humansubjects@ora.umass.edu or check the web page at http://www.umass.edu/research/comply/Guidelines/continuing_final_review.htm for more information. 

____________________________________________________ Biosafety

The NIH Office of Biotechnology Activities (OBA) has produced a handy compilation of its guidelines for “Reporting Recombinant DNA Research-Related Accidents or Violations of the NIH Guidelines” . This compilation reminds administrators, IBCs, Biological Safety Officers, and investigators of OBA’s requirements and clarifies their implementation. Accidents involving rDNA research leading to personal injury, illness or a breach of containment need reporting to OBA.  Minor spills generally don’t.

Boston is proposing stringent new regulations for biological laboratories along the lines of proposed State legislation. Mayor Menino said that Boston ’s proposed regulations will:

• “Strengthen and broaden responsibilities of IBCs;
• “Mandate public disclosure of high risk research;
• “Insure greater public involvement in regulatory oversight process;
• “Mandate regular onsite inspections;
• “Address the need for laboratory involvement in emergency planning;
• “Establish standards for staff training, for safe operations, and for effective security;
• “Establish ‘whistle blower’ protection for lab employees”

The Boston Public Health Commission expects to vote on a final regulation at its February meeting.

The BPHC press release can be read at http://www.bphc.org/news/press_release_content.asp?id=298

We reported earlier that the 5th edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL) would be available in fall 2005. CDC/NIH now expects publication in summer 2006. BMBL 5 th edition will have new sections on “Biosecurity”, “Decontamination”, “USDA standards”, “rDNA issues”, “new agent summaries”, and “Occupational medicine”. The editors say they have managed to include all this new material and still preserve the handy paperback format.

__________________________________________________ EH&S News

With the hiring of Terri Bechta as the Hazardous Materials Inventory Control Manager in charge of the CHEMs database the next phase of the ChEMS program is being planned. Terri’s department, located at present in a trailer by the Lederle Graduate Research Tower , will eventually be a central receiving and distribution location for chemicals delivered to campus. The big advantage of central receiving for chemicals is that EH&S personnel will be able to barcode chemicals before they are delivered to the lab and keep the CEMS inventory up to date. EH&S is well aware that it is essential they can provide a fast turnaround between receipt of a chemical and getting it to its final destination, and the plan is to provide same-day service. Before this service goes online there are many procedural issues to be worked out, and working out a smooth system will be one of Terri’s first tasks. Issues that must be addressed range from the general (ProCard ordering procedures, training before the system goes online) to the very specific (what to do with leaky packages). Terri plans to introduce herself and present an outline of her plans to Departmental Safety Coordinators at their next meeting.

Mandated On-Line Compliance Training - How's Your Department Doing? The Provost mandated that only individuals who have successfully completed the required annual EH&S Hazardous Waste and Right-to-Know trainings may work in laboratory operations. It is the responsibility of each department to monitor compliance with these training requirements and to assure that the names listed on all departmental Laboratory Safety Information cards are current and checked against the documented training record.

Departmental designated training managers need to review the status of your departmental employee training. Go to: http://ehstrain.ehs.umass.edu/owlj/servlet/TrainingManager?datasrc=OwlEHS
to assign required trainings to employees in your department and to check training certification status. A username and password is needed to access this site. If you need help, contact EH&S at 545-2682.
Note: New employees are listed separately, and you'll need to specify their training requirements.

To find out how well your department is complying with mandated training EH&S issued a report as of January 20, 2006 which can be found at: http://www.ehs.umass.edu/Multi_Department_Stats.pdf.

EH&S’ Lab and Fire Safety Training Schedule for Spring 2006.

*Special departmental training, please call Nancy for available space

To register for training, call Nancy at 5-2682 or email: ncraig@ehs.umass.edu

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