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Compliance and Research Protection NewsWinter, 2005 If you have visited the Vice Provost for Research web pages recently you will have noticed our new "University of Massachusetts Amherst" look. We are now working to improve the organization of the animal use/IACUC pages to make them easier to navigate. Still on the subject of the web, the contract with API was signed in December for the purchase of a web-based protocol management system for projects using human or animal subjects. Once in place, the new system will allow researchers to complete and file protocols on-line. API tells us that tailoring a system for UMass will take several months. Much of the development of the protocol forms and “work flow” systems will be done remotely, using the Boston University system as a template, but API anticipates being on campus some time around the end of April to put the finishing touches to the system and train us in its use. If you will be affected by the switch to the new protocol management system, Margaret Burggren (if you work with human subjects) or Hilary Woodcock (if you work with animals) will keep you up-to-date with progress as the project goes forward. We hope to be able to provide some demos in the coming months before finally going live with the new system next summer. API is currently working with BU on a project management system for their Biosafety Committee. Perhaps this will be in UMass’ future too. Please tell your colleagues and associates about this newsletter. email: hilaryw@ora.umass.edu ____________________________________________ In December the Massachusetts Society for Medical Research, Inc. hosted a meeting on “Harmonization of IACUCs and IBCs – Finding Common Ground”. Maureen O’Leary (EH&S) and Hilary Woodcock (Office of Research Affairs) attended the meeting. There is evidently a lot of interest at the moment in promoting close cooperation between IACUCs and IBCs. Alan Shipp at the Office of Biotechnology Affairs at NIH zeroed in on the parts of NIH’s rDNA Guidelines that directly impact animal research. Projects that use animals and need biosafety review include:
The different histories of IACUCs and IBCs make the two committees complementary in their roles in overseeing animal research with biosafety issues. The Animal Welfare Act stemmed from public pressure to right past wrongs and protect animal welfare. Regulations drawn up in the 1970s to ensure safe use of rDNA technology were proactive, driven by a desire to address the safety of the public and the environment, and nurture responsible science in the use of a new technology. Thus the IACUC reviews projects from the animal welfare perspective, ensuring pain and distress is minimized (including pain and distress from adverse phenotypes). The IBC reviews the same project from the perspective of risks to human health. Is there the potential for transfer of genetically altered material or vectors to humans? Are there risks to the environment through spills, escape, interbreeding with wild stock, consumption by humans or other animals? Do the containment procedures provide adequate protection from these risks? Are there adequate decontamination methods? The UMass IACUC has been working closely with the Biosafety Officer (BSO) in EH&S to ensure that projects using animals that need biosafety review receive it prior to the IACUC approving the project. IACUC protocols are pre-screened in the compliance office to determine whether they need biosafety review, and those that do are forwarded to the BSO. The BSO participates in IACUC discussions of the protocol and may require review by the IBC. You are unlikely to notice any difference in the time it takes for a protocol that needs biosafety review to receive final approval since the two reviews proceed concurrently. ____________________________________________ In October the Office for Human Research Protections (OHRP) made available an updated set of Human Subject Regulations Decision Charts. The revised charts are graphic aids to assist institutional review boards (IRBs), investigators, and others determine if an activity is research involving human subjects that needs IRB review under the requirements of the U.S. Department of Health and Human Services regulations 45 CFR part 46. The charts are organized to clearly address questions like:
You can find the charts at http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm. If you are an investigator, note that although you may believe that your project fits into one of those exempt categories you will still need to submit a protocol to the IRB office for determination of its review level. If your research already involves working with human subjects here is an item for your spring calendar. Judy Brooks from the Education Division of the Office of Human Research Protections (OHRP) will be speaking on "the basics of human subjects research" and "emerging (and troublesome) issues" on the morning of April 15th. The event is still in the planning stage so if there are issues that you would like her to address they might be worked into the program. Internet research is a possible topic. Give Margaret Burggren in ORA a call at 545-3428 if you have a topic you would like discussed. Also of interest, on the afternoon of April 15 the Graduate School Ethics Grant Program will be discussing the Lessons Learned in Teaching Ethics at the Graduate Level. Times and locations will be announced. ____________________________________________ In December the Office of Biotechnology Affairs (OBA) at NIH sent out a memo reminding all institutions receiving NIH funding for research involving recombinant DNA molecules of the need for biosafety review and oversight of all research involving rDNA at that institution. The reminder, says OBA, is related to the upsurge in interest in research related to biodefense and emerging infectious disease threats. The memo goes on to say that: “In the coming year, the National Institutes of Health (NIH) will be conducting site visits at selected institutions to obtain further information on IBC compliance with the NIH Guidelines and to educate institutions more directly about requirements that apply to the conduct of recombinant DNA research”. At the moment we don’t know how NIH plans to select institutions to visit. ____________________________________________ Shipping hazardous materials (defined by the DOT as any substance that could adversely affect the safety of the public, handlers or carriers during transportation) is heavily regulated by governmental and non-governmental agencies. The most comprehensive government regulations are administered by the International Air Transportation Association (IATA) and the Federal Department of Transportation (DOT). The US Postal Service, FedEx and UPS rules for the shipment of hazardous materials are even stricter than DOT and IATA. The bottom line is that regulations governing shipping hazardous materials are very complex and carry stiff fines and jail terms for individuals and even heavier fines for organizations (up to $500,000) for non-compliance. Because of the complexity of the regulations and the stringent requirements for shipping hazardous materials, the Department of Environmental Health and Safety (EH&S) recently implemented a new program for shipping hazardous materials to ensure we, as a campus, are in compliance with the regulations. A draft of EH&S’ new procedures can be found at http://www.ehs.umass.edu/prog_hazmat2-new.html together with links to lists of hazardous materials. At the present time only EH&S personnel have appropriate training, are up-to-date with the regulations, and are certified to ship hazardous materials. EH&S will prepare the declaration of dangerous goods and ensure that packaging, labeling, and paperwork are all correct. Once the package has been prepared it’s the sender’s responsibility to arrange the pick-up with the commercial carrier. The following brief instructions for shipping hazardous materials come from EH&S’ draft guidelines web site:
EH&S asks that you plan well in advance when they need to ship. The regulations are very complex. Compounds that are shipped may require additional time and steps to properly prepare. If you have any questions check out the FAQs at http://www.ehs.umass.edu/prog_hazmat2-new.html or call 545-2682.
Still on the topic of hazardous materials, a second major project just getting underway in EH&S is the campus-wide mercury abatement program . Mercury persists in the environment and accumulates in the food chain, posing a risk to human health and ecosystems. Mercury and other persistent bioaccumulative toxin (PBT) reduction is one of the program areas in the State Sustainability Program formed in July of 2002 to help state agencies minimize the environmental impact of their activities. Brian Fitzpatrick of EH&S has been attending “state sustainability” meetings and is applying for a 10K state grant to launch the UMass’ fledgling mercury reduction program. The approach will be in three parts:
A plan must be submitted to the state for review by April 22 of this year. This project will be an expensive one and Brian is looking into other sources of funding to support the effort.
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