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Compliance and Research Protection NewsSummer, 2005 If you read the winter Compliance Newsletter you may be wondering what happened to our promised on-line protocol management system for human subjects and animal use protocols. API’s projects at Tufts and BU have been taking longer to come to fruition than API anticipated and they put our protocol management system installation on the back burner until Fall 2005. The delay is disappointing especially as we had been hoping to use the relative quiet of the summer to get the system up and at least to a testable stage. We’ll keep you posted on progress. A recent change in the Office of Research Affairs was the departure of our Attending Veterinarian, Andy Darrigrand, who retired suddenly at the end of June for health reasons. We wish him well in his retirement and move to Kansas City to be nearer his family. We also welcome Joanne Huyler who is our new Attending Veterinarian. Dr. Huyler is a consultant with an office in Hatfield and is Director of Laboratory Animal Care at Smith College . Last December EH&S hired Vincent Chase to Head the Radiation Safety Services Program and the Radiation Safety Officer. He comes to us with twelve years experience as Radiation Safety Officer with pharmaceutical research and development firms where his work included the safe use of fork lifts, radiofrequency radiation, open beam lasers and large NMR spectrometers as well as overseeing the safe use of radionuclides. Please tell your colleagues and associates about this newsletter. email: hilaryw@ora.umass.edu ____________________________________________ The Vice Provost for Research has provided support for an IACUC-sponsored speaker, Dr. Mark Blumberg from the University of Iowa Psychology Department, who will be on campus on December 6. His seminar will be sponsored jointly by the IACUC and the MCB and NSB Graduate Programs. Dr. Blumberg is a neurobiologist whose interests include the development of thermoregulation in mammals and the ontogeny and function of sleep in neonates. In July U.S. Department of Agriculture (USDA) inspectors conducted their annual inspection of our animal facilities and program. Our record-keeping, paperwork, protocols and procedures received particularly close scrutiny this year. They didn’t identify any problems in those areas and gave us an excellent report. Following a lawsuit brought by The Humane Society of the United States , USDA is once again making its inspection reports of animal research facilities available through its web site. In a study published in Contemporary Topics in Laboratory Animal Science last winter, Balcombe et al. (2004) argued that stress induced by routine handling may affect research animals’ immune response and cloud the interpretation of scientific findings. Their conclusions were based on a review of 80 published studies. The AALAS Executive Committee took the unusual step of including an editorial in the same issue characterizing the article as an opinion piece that is “selective in scope and does not include a rigorous review of current methods and studies concerned with detecting or observing effects of stress in laboratory animals.” In an article published in the same journal in March, Pekow examined ways in which research animal stress may be defined, measured and interpreted. AALAS discusses the differing viewpoints expressed in these articles on its website at http://www.aalas.org/considerations.htm. Balcombe, J., N. Barnard, C. Sadusky (2004) Laboratory Routines Cause Animal Stress. Con. Top. Lab. An. Sci, 43 (Nov.): 42-51. Interpreting Stress in Laboratory Animals. Con. Top. Lab. An. Sci, 43 (Nov.): 7. Pekow, C. (2005) Defining, measuring, and interpreting stress in laboratory animals. Con. Top. Lab. An. Sci, 44 (Mar.): 41-45 John Hopkins Pays Settlement for Animal Welfare Violations Johns Hopkins University (JHU) of Baltimore, Maryland, recently paid a $25,000 settlement after being cited by USDA for allegedly failing to give adequate care to animals used in research as noted in the following items. The USDA found incidents occurring from 1998 to 2003 in which animals were not given anesthesia or proper veterinary care during painful experiments. Researchers modified projects without first obtaining approval from JHU's Institutional Animal Care and Use Committee. In conjunction with this action, JHU has announced that it has improved its oversight system. In a separate complaint involving JHU, The Humane Society of the United States (HSUS) contacted the NIH’s Office of Laboratory Animal Welfare (OLAW) in February 2005, following a tip that JHU personnel had improperly euthanized animals and consequently stored the still-live animals in a refrigerator. JHU was also allegedly disposing animal carcasses improperly. The complaint involved mainly mice and rats, species not covered by the Animal Welfare Act, so The HSUS contacted OLAW, which extends its animal welfare oversight to rats, mice and all other vertebrate animals used in federally funded research programs. OLAW responded that on two separate occasions at JHU, a live rat had been discovered in a cooler following a euthanasia attempt. According to OLAW, JHU has since developed guidelines and standard operating procedures regarding rodent euthanasia. Source: The Chronicle of Higher Education, August 10, 2005 ____________________________________________ A summary report on best practices and lessons learned about protecting human subjects in international research studies has been released. The report describes highlights from an August 2004 conference entitled, "Roadmap for Success in International Research: Strategies for Protecting Human Research Subjects Globally" and contains synopses of the conference sessions which discussed current ethical issues surrounding the design and conduct of biomedical and social science/behavioral research in international settings. The report is available at http://www.rti.org/pubs/protecting_research_subjects.pdf. On June 15 OHRP launched a new public education campaign. “Taking Part in Research: It’s Your Decision” provides information about issues to consider when thinking about participating in clinical trials and other research studies. The centerpiece of the campaign is a one-page pamphlet that guides readers through a series of questions to consider as they discuss the option of participating in research with their health-care provider, family members and others. OHRP distributed copies of the pamphlet to some 6,000 research institutions throughout the country in order to gain broader access to local communities. Bulk copies (up to 300 per requestor) are available free by calling 800-444-6472 or you can download the pamphlet, along with related information, at http://www.hhs.gov/ohrp/outreach/ and reproduce it locally. The IRB wants to remind researchers that IRB approval to conduct research with human subjects comes with a requirement to inform the IRB of changes to the project. IRB approval is needed before making changes like modifying the project design, procedures, consent forms, or advertising materials, adding new key personnel, or changing the subject population. The IRB approval letter has been reformatted effective September 2005 to include these and other researcher responsibilities. Faculty and staff sponsoring student research projects must also sign off on proposed changes before the IRB approval is requested. The procedure to request approval for modifications can be found at http://www.umass.edu/research/comply/protocolchanges.html. ____________________________________________ In June Dr. Claudia Mickelson, Deputy Director of the Biosafety Program at MIT and past Chair of the NIH Recombinant DNA Advisory Committee visited the campus sponsored by the Vice Provost for Research. Her topic was the critical role IBCs play in fostering public trust in the effectiveness of research oversight. This role is increasingly important in an era of media reports of lab-acquired infections, emerging disease threats like SARS and avian flu, and bioterrorism. Although federal policy only mandates IBC oversight of research using rDNA, many IBCs review all research with biosafety, biosecurity, public health and ethical implications. Hot topics for IBCs include vector safety, transgenics, stem cell research, select agents, DNA vaccines, pharmacogenomics and genetic privacy, infection control, and “dual use” research (biological research that could generate knowledge and technologies that could be misused to threaten public health or national security). Dr. Mickelson recommends institutions conduct a biosafety compliance self-assessment, clearly define the IBC’s responsibilities, and provide guidance to the IBC on balancing transparency with security of information. This is especially pertinent when the research involves select agents or is “dual use”. On the topic of dual use research, the National Science Advisory Board on Biosecurity (NSABB) held its Inaugural Meeting at the end of June. The agenda included discussion of criteria for identifying dual use research and the role of codes of conduct in life sciences research, scientific communication, chemical synthesis of genomic sequences, and international perspectives. The meeting agenda can be found at http://www.biosecurityboard.gov/meetings_archive_062005.asp and the web cast is also archived there. The 5th edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL) should be out this fall. It will include an updated Agent Summary Statement for Influenza and revised recommendations for the safe handling of influenza viruses in the laboratory. In May the CDC posted interim CDC-NIH influenza biosafety recommendations on its website at www.cdc.gov/flu/han050305.htm. ____________________________________________ The 1994 “Policy and Procedures of Laboratory Clean Out of Hazardous Materials” was recently revised as part of the larger task of reviewing and revising EH&S’ Laboratory Health and Safety Manual. According to this policy the faculty member assigned to a laboratory is responsible for the proper disposal of hazardous materials in the space. In the absence of a supervising faculty member, the department head/chair either assigns a faculty member or requests that EH&S inspect the facilities to determine if the laboratory has been properly cleaned and decontaminated. For space being renovated or demolished the University contracts with a vendor, with the approval of EH&S, to clean and decontaminate the room(s). A contractor will pay special attention to abandoned unlabelled containers. Problems resulting from improper management of hazardous materials when a lab is closed out must be addressed by the department head/chairperson, appropriate dean, director of EH&S and the chairperson of the appropriate safety committee (Institutional Chemical Safety Committee, Radiation Use Committee, or Institutional Biosafety Committee). EH&S will not be responsible for any additional cleanup costs, regulatory action or fines resulting from non-compliance with the policy.
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