The full-text of this policy is available at http://grants.nih.gov/grants/olaw/references/phspol.htm
B. Functions of the Institutional
Animal Care and Use Committee
As an agent of the institution, the IACUC shall with respect to PHS - conducted or supported activities:
1.review at least once every six months the institution's program for humane care and use of animals, using the Guide as a basis for evaluation;
2.inspect at least once every six months all of the institution's animal facilities (including satellite facilities) using the Guide as a basis for evaluation;
3.prepare reports of the IACUC evaluations conducted as required by IV.B.1. and 2. of this Policy, and submit the reports to the Institutional Official. (NOTE: the reports shall be updated at least once every six months upon completion of the required semiannual evaluations and shall be maintained by the institution and made available to OPRR upon request. The reports must contain a description of the nature and extent of the institution's adherence to the Guide and this Policy and must identify specifically any departures from the provisions of the Guide and this Policy, and must state the reasons for each departure. The reports must distinguish significant deficiencies from minor deficiencies. A significant deficiency is one which, consistent with this Policy, and, in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health or safety of the animals. If program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule for correcting each deficiency. If some or all of the institution's facilities are accredited by AAALAC or another accrediting body recognized by PHS, the report should identify those facilities as such.);
4.review concerns involving the care and use of animals at the institution;
5.make recommendations to the Institutional Official regarding any aspect of the institution's animal program, facilities, or personnel training;
6.review and approve, require modifications in (to secure approval) or withhold approval of those components of PHS-conducted or supported activities related to the care and use of animals as specified in IV.C. of this Policy;
7.review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities; and
8.be authorized to suspend an activity involving animals in accordance with the specifications set forth in IV.C.6 of this Policy.
C. Review of PHS-Conducted or Supported Research Projects
1.In order to approve proposed research projects or proposed significant changes in ongoing research projects, the IACUC shall conduct a review of those components related to the care and use of animals and determine that the proposed research projects are in accordance with this Policy. In making this determination, the IACUC shall confirm that the research project will be conducted in accordance with the Animal Welfare Act insofar as it applies to the research project, and that the research project is consistent with the Guide unless acceptable justification for a departure is presented. Further, the IACUC shall determine that the research project conforms with the institution's Assurance and meets the following requirements:
2.Prior to the review, each IACUC member shall be provided with a list of proposed research projects to be reviewed. Written descriptions of research projects that involve the care and use of animals shall be available to all IACUC members, and any member of the IACUC may obtain, upon request, full committee review of those research projects. If full committee review is not requested, at least one member of the IACUC, designated by the chairperson and qualified to conduct the review, shall review those research projects and have the authority to approve, require modifications in (to secure approval) or request full committee review of those research projects. If full committee review is requested, approval of those research projects may be granted only after review at a convened meeting of a quorum of the IACUC and with the approval vote of a majority of the quorum present. No member may participate in the IACUC review or approval of a research project in which the member has a conflicting interest (e.g., is personally involved in the project) except to provide information requested by the IACUC; nor may a member who has a conflicting interest contribute to the constitution of a quorum.
3.The IACUC may invite consultants to assist in the review of complex issues. Consultants may not approve or withhold approval of an activity or vote with the IACUC unless they are also members of the IACUC.
4.The IACUC shall notify investigators and the institution in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval. If the IACUC decides to withhold approval of an activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
5.The IACUC shall conduct continuing review of each previously approved, ongoing activity covered by this Policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with IV.C.1.-4. at least once every three years.
6.The IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with applicable provisions of the Animal Welfare Act, the Guide, the institution's Assurance, or IV.C.1.a.-g. of this Policy. The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present.
7.If the IACUC suspends an activity involving animals, the Institutional Official in consultation with the IACUC shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to OPRR.
8.Applications and proposals that have been approved by the IACUC may be subject to further appropriate review and approval by officials of the institution. However, those officials may not approve an activity involving the care and use of animals if it has not been approved by the IACUC.
D. Information Required in Applications-Proposals for Awards Submitted to PHS
1. All Institutions
Applications and proposals (competing and non-competing) for awards submitted to PHS that involve the care and use of animals shall contain the following information:
Non-competing applications and contract proposals for other than full and open competitions need not repeat the informationrequired by IV.D.1.a.-e. if the information was complete in the last competing application or proposal and there are no significant changes to that information. However, the application or proposal must contain a statement to that effect. If there are significant changes in the information, then the application or proposal must specifically identify them and state the reasons for the changes.
2.Institutions That Have an Approved Assurance
Applications or proposals (competing and non-competing) covered by this Policy from institutions which have an approved Assurance on file with OPRR shall include verification of approval (including the date of the most recent approval) by the IACUC of those components related to the care and use of animals. For competing applications or proposals only, such verification may be filed at a time not to exceed 60 days after the receipt deadline date. If verification of IACUC approval is submitted subsequent to the submission of the application or proposal, the verification shall state the modifications, if any, required by the IACUC. The verification shall be signed by an individual authorized by the institution, but need not be signed by the Institutional Official.
3.Institutions That Do Not Have an Approved Assurance
For applications and proposals covered by this Policy from institutions that do not have an approved Assurance on file with OPRR, the signature of the official signing for the applicant organization shall constitute a declaration that the institution will submit an Assurance when requested by OPRR. Upon such request, the institution shall prepare the Assurance as instructed by OPRR and in accordance with IV.A. of this Policy. The authorized IACUC shall review those components of the application or proposal as required by IV.C. of this Policy. Upon IACUC approval of those components of the application or proposal the institution shall submit the Assurance to OPRR.
E. Recordkeeping Requirements
1.The awardee institution shall maintain:
2.All records shall be maintained
for at least three years; records that relate directly to applications,
proposals, and proposed significant changes in ongoing activities
reviewed and approved by the IACUC shall be maintained for the
duration of the activity and for an additional three years after
completion of the activity. All records shall be accessible for
inspection andcopying by authorized OPRR or other PHS representatives
at reasonable times and in a reasonable manner.
F. Reporting Requirements
1.At least once every 12 months, the IACUC, through the Institutional Official, shall report in writing to OPRR:
2.At least once every 12 months, the
IACUC, at an institution which has no changes to report as specified
in IV.F.1.a.-c. of this Policy, shall submit a letter, through
the Institutional Official, to OPRR stating that there are no
changes and informing OPRR of the dates of the required IACUC
evaluations and submissions to the Institutional Official.
3.The IACUC, through the Institutional Official, shall promptly provide OPRR with a full explanation of the circumstances and actions taken with respect to:
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Last updated February 16, 2001