Office of Research Affairs

Compliance and Research Protection News


Spring 2004

In this Issue:

The IACUC

Human Subjects

Biosafety

Research Ethics

Shipping Hazardous Materials

Most of the action on the regulatory front that impacts research continues to be in the area of biosafety and biosecurity. New federal initiatives to promote biosecurity in life science research will very probably result in requirements from federal agencies for another oversight committee for institutions that receive federal funding. Details are in the "Biosafety" section.

Searches are under way to make the new hires in Environmental Health & Safety to replace the people who retired at the end of last year. Hopefully in the Fall newsletter we will be able to introduce you to some new people.

In this issue Craig Ruberti reports on new guidelines for handling and shipping hazardous materials soon to be on the EH&S website.

If you have any comments on this newsletter or want more information on these topics please contact Hilary Woodcock at:

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

We would like to be able to update the 1999 USDA animal use data we quote in the animal user’s training.  These data are five years old and do not include data for mice, rats, birds or cold-blooded vertebrate animals.  We haven’t found a more comprehensive and up-to-date source for statistics on research animal use in the United States.  However, the Canadian Council on Animal Care recently published a survey report for 2001 and their numbers are interesting.  It was no surprise to see mice leading the field at 34% of the total animals used in Canadian research, teaching and testing.  But the next highest is fish (29%), followed by rats (14%), chickens (10%), cattle (3%), and wild birds (2%).  These six categories accounted for over 90% of Canada’s use of animals for research, teaching and testing.  Of course, Canada’s research priorities may be somewhat different from the USA’s.  The full report can be found in Resource, Vol. 27, No.1, Winter 2003-2004 at (http://www.ccac.ca/english/facts/pdfs/aus2001-all.pdf).

On the regulatory front the United States Department of Agricultural (USDA) says it has increased enforcement of Policy #12 (http://www.aphis.usda.gov/ac/policy/policy12.pdf) that requires a search for alternatives for procedures that may cause animals pain or distress.  If a project involves procedures that may cause pain or distress, an investigator must maintain search results in the event that a USDA inspector requests them, including a summary of the key words used in a literature search for alternatives, the databases and other sources utilized, the years covered, and the date of the search.  Exactly whether this means we need to do things differently from the way we have been keeping those records is not clear at the moment.  At UMass a USDA inspector can already review this basic information by checking the animal use protocol.  It is something to check with the USDA inspector when he/she is next on campus.

There were some good discussions at the April “Advanced IACUC” conference hosted by SCAW (Scientists Center for Animal Welfare).  Among the questions discussed was “Must protocols synchronize with grants (i.e. one grant = one protocol)?”  The short answer is “No”.   A protocol stands alone and IACUC approval is for the work described in the protocol.  On the other hand, by signing off on a grant proposal the PI and institution assures the funding agency that the work with animals described in the proposal will receive appropriate review and oversight by the IACUC.  Somewhere in the oversight process the work described in a proposal should be compared with the protocol that covers it.  We were advised that when the title of a protocol covering the work described in a proposal does not match the proposal title there is potential for confusion and perhaps delays at the funding agency’s end.  A suggestion for PIs from the federal agency representatives at the SCAW meeting is to note the grant(s) covered by the protocol below the signature block on the protocol.  A suggestion for IACUCs is to note on the approval letter the grant number and title if different from the protocol title.  The further from a protocol’s initial approval date the harder it is to keep track of such things, but it is recommended that the approval letter be updated if the project described in a new grant is covered by an old protocol.  It all sounds like good advice though not so easy to stay on top of in the real world.

In case you are wondering what happened with the pending new legislation reported in a previous Compliance News that would, among other things, bring unsponsored research using human subjects under IRB oversight, it has so far not gone anywhere.  H.R. 3594 was introduced by Representative DeGette on November 21, 2003, and on December 4 it was referred to the House Energy and Commerce Subcommittee on Health. But no further action has occurred on this legislation.

We mentioned in the winter Compliance News that at least annual update reviews for sponsored projects using human subjects are required by law.  That the Office of Human Research Protections (OHRP) takes the re-review process seriously was brought home to us by the way that Federal Regulators are pushing the U. of Alabama-Birmingham to improve their Human-Subjects Protections.  In a letter dated March 10 the OHRP noted that during the past year Alabama-Birmingham's institutional review board suspended three unreported research projects because of "serious or continuing noncompliance" with federal regulations for the protection of human subjects. Two of the suspensions resulted from the repeated failure of the scientist to renew IRB approval of the projects.

On May 12 Health and Human Services Secretary Tommy G. Thompson released new guidance for protecting research subjects from possible harm caused by financial conflicts of interest in research studies.  The guidance document entitled “Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection” is for Institutional Review Boards (IRBs), investigators, research institutions, and other interested parties.  It applies to all human subjects research conducted or supported by HHS agencies or regulated by the Food and Drug Administration.  The HHS press release is at:  http://www.hhs.gov/news/press/2004pres/20040512.html

The Sunshine Project (http://www.sunshine-project.org), an “international non-profit organization … working against the hostile use of biotechnology in the post-Cold War era”, caused a stir last winter by requesting the most recent sets of Institutional Biosafety Committee (IBC) minutes from 389 research institutions, including UMass Amherst.  As well as requesting IBC minutes, which they are entitled to according to NIH policy, they requested information about use of Select Agents.  Many institutions felt uncomfortable about sharing this information with the Sunshine Project and there were some creative responses to the request.  Sunshine Project is threatening action against recalcitrant institutions and, without reference to this particular furore, NIH recently put out a set of questions and answers about handling requests for information from the public. These are posted on the IBC page of NIH’s Office of Biotechnology Activities web site: http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm

If you are looking for online courses with research ethics relevance, the Johns Hopkins Center for Alternatives to Animal Testing (CAAT) has announced a free online course on “Enhancing Human Science/Improving Animal Research” consisting of 12 lectures with slides, resource lists, and study questions.  It addresses issues such as experimental design, humane endpoints, environmental enrichment, pain management, and the impact of stress on the quality of data.  We have not been covering this last item in our animal users’ training but would be a worthwhile and relevant addition.  You can take a look at the Johns Hopkins course, and take it if you wish, by registering at the CAAT web site at http://caat.jhsph.edu

Shipping hazardous material is sometimes a necessary component of campus research.  Dozens of hazardous materials arrive on campus and must be distributed to labs around the campus.  The traffic goes the other way too.  Researchers need to ship hazardous materials like flammable liquids, compressed gases, toxic substances, biological agents, radioactive materials and even dry ice to other researchers, institutions or other destinations.

There are risks associated with the transportation of such materials and government agencies like the Department of Transportation (DOT), the Environmental Protection Agency (EPA) and the International Air Transport Association (IATA) all regulate the shipment of hazardous materials.  The regulations are intended to minimize the risk to the public and the environment.  They mandate proper packaging and labeling and DOT requires appropriate training for personnel involved in shipping hazardous materials.  Non-compliance with these regulations can bring stiff penalties including individual fines of up to $250,000 and imprisonment of up to a year.  A university that fails to ensure appropriate shipment and handling of hazardous materials is additionally subject to fines of up to $500,000 per violation. 

A determination of which materials are hazardous is a first step towards complying with the safety regulations.  DOT defines a hazardous material as any substance that could adversely affect public safety, handlers or carriers during transportation.  There are nine categories of hazardous materials:

If you work with potentially hazardous materials it is essential you know whether your material is covered by the regulations and abide by them both for safety’s sake and to avoid the risk of fines. The UMass Environmental Health & Safety Department (EH&S) is compiling guidance and resources to help you determine whether you are dealing with a hazardous material and to support the shipment of hazardous materials off-campus.  These materials be available through EH&S’ website (www.ehs.umass.edu) by the end of June 2004. In the meantime, should you find yourself in a situation that requires the shipping of hazardous materials, please contact Craig Ruberti or Joe Meagher at EH&S at 5-2682.

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

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