OFFICE OF EXTRAMURAL RESEARCH REVISED GUIDANCE REGARDING IACUC APPROVAL OF
CHANGES IN PERSONNEL INVOLVED IN ANIMAL ACTIVITIES
RELEASE DATE: June 6, 2003
NOTICE: NOT-OD-03-046
Update: The following update relating to this announcement has been issued:
March 11, 2014 - See Notice NOT-OD-14-063. Request for Information: Invitation to Comment on Proposed Guidance
Regarding Significant Changes to Ongoing Animal Activities.
National Institutes of Health (NIH)
This notice amends guidance provided in 1995 to Public Health Service (PHS)
awardee institutions and Institutional Animal Care and Use Committees
(IACUCs) concerning IACUC approval of changes in personnel involved in animal
activities. This is in accord with efforts to reduce the regulatory burden
of provisions of the PHS Policy on Humane Care and Use of Laboratory Animals
(PHS Policy) and, as applicable, the USDA animal welfare regulations (AWRs).
The Office of Laboratory Animal Welfare (OLAW), NIH, and the USDA Animal
Plant Health Inspection Service (APHIS) concur with the guidance provided in
this notice.
BACKGROUND
PHS Policy (IV.B.7) (http://grants.nih.gov/grants/olaw/references/phspol.htm)
and USDA regulations (9CFR 1, chapter 1, Part 2, 2.31(c)(7))
(http://www.nal.usda.gov/awic/legislat/awafin.htm) require the IACUC to
"review and approve, require modifications in (to secure approval) or
withhold approval of proposed significant changes regarding the use of
animals in ongoing activities." In 1995, the NIH Office for Protection from
Research Risks, now OLAW, published guidance regarding examples of
"significant change" to approved research protocols (Lab Animal 24 (9):24-26,
1995)(http://grants.nih.gov/grants/olaw/references/laba95.htm). This
guidance was intended to assist IACUCs in determining when a full or
designated member review process is required under the provisions of the PHS
Policy and the USDA AWRs. One of the examples of "significant change"
provided was " changes in personnel involved in animal procedures; "
The rationale for that guidance was based on the need for the IACUC to ensure
the performance-based outcome that all personnel conducting procedures on
animals are appropriately identified, adequately trained and qualified, and
that they are enrolled in applicable occupational health and safety programs.
IACUC APPROVAL OF CHANGES IN PERSONNEL INVOLVED IN ANIMAL ACTIVITIES
Members of the research community have pointed out circumstances under which
strict adherence to this earlier guidance may be unnecessarily burdensome on
IACUCs and research teams, without adding to the intended protections. For
example, IACUC approval of the replacement for a key research technician or
post doctoral fellow on a protocol may entail prolonged delays in a research
project, even when the individual named as a replacement has already been
fully certified by the IACUC as qualified to perform the same procedures on a
different protocol. In addition, some institutions have applied full or
designated review requirements for adding individuals with minimal direct
involvement in animal procedures to the protocol.
OLAW, in consultation with USDA, APHIS, Animal Care, is hereby revising the
1995 guidance on review mechanisms for personnel changes on a protocol.
IACUCs may, by institutional policy, classify certain proposed additions and
changes in personnel, other than the Principal Investigator, as "minor"
provided that an appropriate administrative review mechanism is in place to
ensure that all such personnel are appropriately identified, adequately
trained and qualified, enrolled in applicable occupational health and safety
programs, and meet other criteria as required by the IACUC. The IACUC
remains responsible for confirming that all IACUC review criteria regarding
personnel training and qualifications are maintained and documented (PHS
Policy IV,C,1 and 9CFR 1, chapter 1, Part 2, 2.31). Institutions will be
held accountable for ensuring the performance-based outcome that all
individuals involved in animal-related activities are competent to do so.
This guidance is intended to provide substantial reduction of burden on
IACUCs and research teams without diminishing the crucial oversight of
personnel training and qualifications.
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 360, MSC 7982
Bethesda, Maryland 20892-7982
Telephone: (303) 402-5913
FAX: (301) 402-2803
[email protected]
