Office of Research Affairs

Compliance and Research Protection News


Fall 2004

In this Issue:

The IACUC

Human Subjects

Export Controls

EH&S News

Hopefully the campus community is by now aware that this summer the Research Administration offices moved to the former Career Center at 70 Butterfield Terrace behind Hills South.  Our move was reported in several places including an August 20 “In the Loop” article and the recent Research Access Newsletter.  

Research Affairs (ORA) and administrative offices relating to compliance are located behind the big solarium windows.  Office of Grant and Contract Administration (OGCA) offices have the ground and third floors.  Industrial Liaison and Economic Development (ILED) and Commercial Ventures and Intellectual Property (CVIP) are on the top floor.  All these administrative offices relocated from Goodell.

Telephone numbers for the offices remain the same. The new ZIP code is 01003-9340. Parking in Lot 52 can be accessed from Career Center Way and there is ample visitor parking.  If you need to park in Lot 52 for longer than fifteen minutes you will need to ask for a temporary permit from the office you are visiting.

Career Services has moved to 524 Goodell.

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

On June 4, 2004, the US Department of Agriculture (USDA) published a final rule amending the Animal Welfare Act (AWA) regulations' definition of "animal."   Previously all birds, and rats and mice bred for use in research, were excluded from the AWA regulations.  The amendment brings birds not bred for research under the AWA.  The revised definition became effective on June 5, 2004 but USDA will not implement its coverage of birds until USDA/APHIS determines how to regulate their care and use.  APHIS is collecting information on the minimum standards appropriate in facilities, health and husbandry, and transportation in general and for specific types of birds.  It will review comments on how to regulate birds before drawing up final guidelines.  It also plans to determine whether it needs to establish specific standards for rats and mice covered by the AWA i.e. not bred for research. 

In the last newsletter we reported some Canadian statistics for use of animals in research.  Switzerland has now released its 2003 Animal Research Statistics.  In Switzerland, like the US and Canada, mice and rats are the most popular research species but there has been an 88% increase in the use of reptiles and amphibians since 2002 and a reduction by about half in the use of sheep, bovines and hamsters.  The source of these statistics is the Swiss Federal Veterinary Office.

If your research involves human subjects you will be aware that faculty, staff and students, directly involved in research sponsored by a funding agency are required to complete an education program in human subjects protection.  Many UMass researchers have already taken either the NIH training or UMass training modules located on the Veteran’s Administration web site and we have received many comments from researchers in the social and behavioral sciences that both the NIH and UMass training modules have too much of a biomedical focus for their needs.  The UMass Human Subjects Institutional Review Board (IRB) has remedied this by offering training options through the Collaborative IRB Training Initiative (CITI).  The new training modules feature basic courses in the Protection of Human Research Subjects from either the Biomedical or the Social / Behavioral Research modules so investigators can select the training focus most appropriate for their research.   Information on the new training can be found at:  http://www.umass.edu/research/training.html.  If you have already done the training on the NIH or VA sites you do not need to take the CITI training but should submit your Certificate of Completion with your protocol application materials.

The Office for Human Research Protections (OHRP) recently issued guidance on research involving coded private information or human biological specimens. The document also references pertinent requirements of the HIPAA Privacy Rule that may be applicable to research involving coded private information or specimens. You can find the document, Guidance on Research Involving Coded Private Information or Biological Specimens at http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf.

The Penn State Office of Research Protections most recent newsletter issue has a piece titled “The Oral History Debate: Is it Research?” which is interesting reading.  It provides guidelines as to how they determine whether an oral history project is or is not “research”.  You can find the article at http://www.research.psu.edu/orp/publications/Newsletter/Issue_3/oral_history.htm

                                            US Export Control Laws: Could They Impact Your Research?

A good starting place for discussion of this topic is back-to-back editorials by Donald Kennedy in Science, August 20 and 27 2004, on “Academic Health”.   Regarding export controls, Dr. Kennedy wrote: “The Association of American Universities and the Council on Governmental Relations [COGR] created a task force to collect information about troublesome provisions in research awards…….  including restrictions on publication and on distribution to foreign nationals.  Especially disturbing was a common requirement that “if the Contractor will have access to or generate unclassified information that may be sensitive or inappropriate”, the contract language must prohibit the contractor from releasing any of that unclassified information to anyone outside the organization.”  He states that, out of 138 instances, 47 institutions reported the clause.  Restraints on publication were found in 71 other cases.  OGCA has a link to the COGR paper on their web site at http://www.umass.edu/research/ogca/export_controls.htm.

Export Control regulations are implemented by the Department of Commerce through its Export Administration Regulations (EAR), and the Department of State through its International Traffic in Arms Regulations (ITAR).  “Export" here refers not only controlled technology and information leaving the United States, but also to transmitting technology or information to someone who is not a US citizen or permanent resident within the United States (a "deemed export").  Discussions with foreign researchers or symposium attendees can be "deemed exports"!

Answers to three questions help determine if export control regulations apply to your research.

1. Does the information, technology, or material with which you work fall into a controlled category?  The laws place restrictions where the information or material could have military applications or economic protection issues, where the US Government has concerns about the destination country, organization, or individual, or about the potential use of the information or material.  You can find the ITAR list and EAR information at http://www.access.gpo.gov/nara/cfr/waisidx_03/22cfr121_03.html and http://www.access.gpo.gov/bis/ear/ear_data.html (section 734).  If your research is not covered by ITER or EAR export control regulations do not apply to you.

2. If your research is on either the ITAR or EAR list next ask: Is my research “fundamental research”?  Fundamental research is not restricted by export controls.  But accepting contract restrictions may change your research from fundamental research to technical data.  Your research is not “fundamental research” if the institution accepts restrictions on the publication of the information resulting from the research, or if the research is federally funded and specific access or dissemination controls regarding the resulting information have been accepted by the university or the researcher.   

3. Finally, if you determine that export controls could apply to your research, ask:  Will I be “exporting” the results of my research, data, a material, software, etc.?  Even if you are not planning to send anything to another country, the answer to this question could still be “yes” because of the issue of “deemed exports”.   If a foreign national (faculty, staff, post-doctoral scholars, visiting faculty, graduate students, research or teaching assistants, among others) is to participate in your research and/or have access to items or
information, export control regulations will apply and you will need to obtain a license from the appropriate government agency. 

For assistance in determining whether your research is regulated by export control regulations contact OGCA.  For general information the Bureau of Industry and Security has an excellent overview of EAR regulations in its “Introduction to Commerce Department Export Controls” at http://www.bxa.doc.gov/licensing/exportingbasics.htm. 

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

© 2004 University of Massachusetts Amherst,  Site Policies. This site is maintained by the Office of Research Affairs.