2nd Edition 2002 arena/olaw institutional Animal Care and Use Committee Guidebook


E.1. Table D. Federal Requirements: Annual Report



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E.1. Table D. Federal Requirements: Annual Report








PHS Annual Report

USDA Annual Report

Timetable

  • At least once every 12 months; may be synchronized with USDA or AAALAC reporting period

  • On or before December 1, describing activity during fiscal year (October 1 – September 30)

Submit to

  • OLAW

  • APHIS, AC Regional Director

Submitted by

  • IACUC, through the IO

  • Signed or certified by CEO or IO

Form used

  • APHIS Form 7023

Contents

Report changes in:

  • AAALAC accreditation status

  • Animal care/use program

(as described in Assurance)

  • IACUC membership

  • IO

  • Report date(s) IACUC conducted semiannual evaluations and submitted reports to IO. Include any minority views of IACUC members.

(col. B)

  • Common name and number of animals used where:

- Animals experience no pain

or distress (col. C)

- Drugs were used to alleviate

pain or distress (col. D)

- Drugs were not used to

alleviate pain or distress

because drugs would have

interfered with the results or

interpretation of the procedure

(col. E)


  • An explanation of column E procedures, as justified by the investigator and approved by the IACUC, must be summarized in an attachment. It must include species and number of animals affected.




Reference

PHS Policy IV.F.1, 2 & 4.

9 CFR Part 2, Subpart C 2.36


E.1. Table E. Federal Requirements: Suspensions

and Noncompliance








PHS Suspension/Noncompliance Report

USDA Suspension Report

Submitted by

  • IACUC through IO

Submit to

  • OLAW

  • APHIS and federal agency funding the activity

When required

  • Suspension of an activity by the IACUC

  • Serious deviation from the Guide (not previously approved by the IACUC)

  • Serious or continuing noncompli-ance with the PHS Policy



  • Suspension of an activity by the IACUC

Contents

  • Full explanation of circumstances

  • Description of corrective action taken



Reference

PHS Policy IV.C.6. & 7. and IV.F.3. & 4

9 CFR Part 2, Subpart C 2.31(d)(7)



References

AAALAC International. Connection Newsletter, Summer 2000, pages 1-4.


Potkay, S., et al. Frequently Asked Questions about the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Contemporary Topics 36(2)47-50, March, 1997.
NIH Guide to Grants and Contracts. Notice OD-00-007, 12/21/99.

E.2. Communications

It has never been easier to communicate with others, and at the beginning of the 21st century the use of nontraditional means of communication such as electronic mail (email), Web sites, and Internet chat rooms provide new opportunities for rapid communication.


Electronic communication offers advantages and disadvantages. Modes of communication available to the IACUC vary in speed and ease of use, clarity, and security. Some permit easy communication with an entire committee or an entire institution; and some include a permanent record that can be retained for later reference.
Regulations and policies
Most of the regulations governing the IACUC were written before the Inter-net became pervasive, but OLAW has presented some guidelines for the IACUC regarding the use of email and similar modes of communication (Garnett and Potkay, ILAR Journal 37:190-192, 1995).
The guidelines state that email is an appropriate medium for transmitting animal protocols, IACUC meeting agenda and minutes, institutional policies, and other matters related to the animal care and use program. However, OLAW states that the conduct of IACUC meetings should allow greater opportunity for members to interact than that permitted by email. Sequential, one-on-one communication (polling) by email, telephone, or fax should not take the place of a convened IACUC meeting or voting, although it is an appropriate mechanism for providing all IACUC members with the opportunity to call for full committee review of a protocol prior to initiating the designated reviewer method of protocol review. OLAW recommends that traditional meetings, in which a quorum of IACUC members is in the same room, should be the standard method for conducting IACUC business such as protocol review, review of annual and semiannual reports, and suspensions.
Under "exceptional circumstances" an IACUC may be permitted to conduct a meeting using electronic conferencing such as telephone or audio-visual conferences. To be considered a valid convened meeting, the

alternate approach must include a high degree of interactivity and allow for careful consideration of issues. Each member must be in direct communication with every other member in attendance, and a quorum of actively participating members must be maintained. Minutes of an electronic conference would be written and retained as for any other convened IACUC meeting.


If the IACUC wishes to use electronic methods for IACUC meetings or other activities, the proposed procedures should be described in the institutional Assurance and approved by OLAW.




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