OFFICE OF EXTRAMURAL RESEARCH GUIDANCE REGARDING ADMINISTRATIVE IACUC ISSUES AND 
EFFORTS TO REDUCE REGULATORY BURDEN

Release Date:  February 12, 2001

NOTICE:  NOT-OD-01-017

National Institutes of Health

This notice provides guidance to Public Health Service (PHS) awardee 
institutions and Institutional Animal Care and Use Committees (IACUCs) 
concerning the following two administrative IACUC issues: use of alternate 
IACUC members and IACUC protocol and programmatic review at collaborating 
institutions.  It further provides an example of an existing drug shelf life 
extension program that may be utilized to extend the expiration date of 
certain pharmaceuticals in an animal care and use program.  A renewed 
Memorandum of Understanding (MOU) among USDA, FDA and NIH is also announced. 

BACKGROUND

The Office of Laboratory Animal Welfare (OLAW), NIH, and the USDA Animal and 
Plant Health Inspection Service have continued to work with the NIH Advisory 
Working Group on Regulatory Burden established in January, 2000, to assist 
and advise the NIH on issues and recommendations presented in the report "NIH 
Initiative to Reduce Regulatory Burden."  As a result of ongoing discussions 
about administrative issues dealing with the ways that IACUCs function and 
efforts by IACUCs to conduct business more efficiently, OLAW is issuing the 
following guidance.  The purpose of the guidance is to ensure that IACUCs 
policies and procedures are in accordance with the PHS Policy on Humane Care 
and Use of Laboratory Animals and, as applicable, the USDA animal welfare 
regulations (AWRs).  The USDA Animal and Plant Health Inspection Service 
(APHIS) has reviewed and concurs with the guidance provided in this notice.

USE OF ALTERNATE IACUC MEMBERS

Although PHS Policy and the USDA AWRs are silent on the use of alternate 
IACUC members, OLAW and APHIS agree that alternates may be utilized if the 
following provisions are met:

o  Alternates must be appointed by the chief executive officer (CEO) of the 
entity for which the committee is established, or by the official to whom the 
CEO has specifically delegated, in writing, authority to appoint IACUC 
members.  Alternates should be listed on the IACUC rosters submitted to OLAW 
with Assurances and annual reports.

o  There must be a specific one-to-one designation of IACUC members and 
alternates.  This is necessary to ensure that a committee is properly 
constituted, even when alternates are serving.  For example, an alternate for 
a non-affiliated IACUC member would need to also meet the non-affiliated 
member requirements.   Use of a pool of alternates would not be consistent 
with this requirement. 

o  An IACUC member and his/her alternate may not contribute to a quorum at 
the same time or act in an official IACUC member capacity at the same time.   
An alternate may only contribute to a quorum and function as an IACUC member 
if the regular member for whom they serve as alternate is unavailable.  

o  Alternates should receive IACUC training or orientation similar or 
identical to what is provided regular IACUC members.

o  Alternate members would be expected to "vote their conscience" as opposed 
to representing the position of the regular member for whom they serve.

o  Alternate members may be permitted to attend IACUC meetings and 
participate in other IACUC activities even when the regular member is 
present, at the discretion of the institution, although as stated above they 
may not contribute to the formation of a quorum or vote unless the member for 
whom they substitute is not available.

NO REQUIREMENT FOR DUPLICATE REVIEW 

There are many circumstances that involve partnerships between collaborating 
institutions or relationships between institutional animal care programs. 
OLAW and APHIS agree that review of a research project or evaluation of a 
program or facility by more than one recognized IACUC is not a federal 
requirement.  

It is imperative that institutions define their respective responsibilities.  
PHS Policy requires that all awardees and performance sites hold an approved 
Animal Welfare Assurance.  OLAW negotiates Interinstitutional Agreement 
Assurances of Compliance when an awardee institution without an animal care 
and use program or IACUC will rely on the program of an Assured institution.  
Assured institutions also have the option to amend their Assurance to cover 
nonassured performance sites, which effectively subjugates the performance 
site to the Assured institution and makes the Assured institution responsible 
for the performance site.

If both institutions have full PHS Assurances, they may exercise discretion 
in determining which IACUC reviews research protocols and under which 
institutional program the research will be performed. It is recommended that 
if an IACUC defers protocol review to another IACUC, then documentation of 
the review should be maintained by both committees.  Similarly, an IACUC 
would want to know about any significant questions or issues raised during a 
semiannual program inspection by another IACUC of a facility housing a 
research activity for which that IACUC bears some responsibility or exposure.

DOD SHELF LIFE EXTENSION PROGRAM (SLEP)

The Department of Defense Shelf Life Extension Program (SLEP), on the 
internet at http://www.jrcab.army.mil/fda/page1.html, was developed 
to defer drug replacement costs of date sensitive military reserve stock by 
extending the useful life of pharmaceutical products.  The program involves 
the identification of candidate items by DOD Service representatives to a 
Joint Readiness Clinical Advisory Board, which submits products to the FDA.  
The FDA requires submission of samples and evaluates candidate materials 
using original manufacturer's test data to establish a protocol for testing.  
The testing conducted by the FDA is comprehensive and scientifically sound, 
and FDA bases expiration date extensions on conservative estimates of the 
useful life of the product as substantiated by the test results.   The FDA 
grants the extensions as specified by lot number, expiration date, and 
manufacturer that have been stored under appropriate conditions.

Institutional animal care and use programs, although ineligible to submit 
candidates for testing, may access the database of items tested and 
expiration date extensions.  Identified pharmaceutical products (specified by 
lot number) used in animal care and use programs that have new expiration 
dates need not be replaced until after the new expiration date.  Both OLAW 
and USDA will recognize the validity of the new expiration dates assigned 
through the SLEP program.

MEMORANDUM OF UNDERSTANDING 

In January, 2001, USDA, FDA and NIH renewed a Memorandum of Understanding 
(MOU) Concerning Laboratory Animal Welfare.  Since 1995 the three agencies 
have operated under an MOU that provides for enhanced communication and 
allows common concerns of the agencies to be managed in a consistent and 
coherent manner in spite of differing statutory or regulatory mandates.  The 
MOU is perhaps most effective in serving to ensure that the differing 
approaches of the agencies are harmonized without unnecessarily increasing 
regulatory burden.  Renewal of the MOU signals a willingness to continue the 
long-standing cooperation that has been of mutual benefit to the agencies 
while fostering proper animal care and welfare.  The new MOU is posted at:  
http://grants.nih.gov/grants/olaw/references/finalmou.htm.

INQUIRIES

For questions or further information, contact:

Carol Wigglesworth
Senior Policy Analyst
Office of Laboratory Animal Welfare
Office of Extramural Research
6705 Rockledge Drive
RKL 1, Suite 1050, MSC 7982
Bethesda, Maryland 20892-7982
Telephone: (301) 402-5913
FAX: (301) 402-2803
carol_wigglesworth@nih.gov

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