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Office of Research Integrity

Documentation Requirements & Recommendations

There are specific documentation requirements and recommendations for both the IACUC and investigators.

General Recommendations | Survival Surgery Documentation | IACUC Records

General Recommendations

All investigators who use vertebrate animals in research are responsible for their humane care and use. Further, animals can only be used in experiments after all aspects of proposed care and use have been approved by the IACUC. Documentation of all procedures and treatments helps investigators andMutual collaboration facilitates proper documentation. their lab personnel ensure that all animals are used in compliance with the approved protocols.

It is recommended that all procedures involving animals be documented in hardbound lab notebooks.

For complete documentation the investigators and/or lab personnel should record the following information:

  • The date, protocol number and animal number (if identified by number);
  • For treatments: the compound or cell type, dose, route of delivery;
  • For sample collection: type (blood, urine, tissue) and amount;
  • If treatment or sample collection is performed under anesthesia: the agent, amount and route;
  • A brief note with the description and resolution of all unanticipated adverse events;
  • Following euthanasia: the method of euthanasia;
  • For procedures that are recorded electronically: the name or number of the file(s) associated with the procedure.

Survival Surgery Documentation

Pain and discomfort are a consequence of all survival surgical procedures. Humane practice requires that animals receive analgesia both pre-operatively and post-operatively (if necessary). Recognition of signs of post-surgical pain and discomfort are important for both the welfare of the animals and the scientific validity of the experimental aims. Investigators and their lab personnel should be familiar with the clinical signs of pain and distress.

It is recommended that laboratories performing survival surgery keep a record for each group of rodents, or better still for each animal that undergoes surgery. USDA regulations require that covered species have individual records for each animal, and DLAR provides these forms. This note should include:

  • The date, protocol number and animal number (if identified by number);
  • The pre-operative analgesic, its amount and route of delivery;
  • The anesthetic, its amount and route of delivery;
  • A brief note on the surgery;
  • The date, time of the post-surgical check(s) of the animal and a brief note on its clinical condition;
  • The date, time, and dose of post-surgical analgesia.

IACUC Records

The IACUC is required to meet Federal, State and Institutional standards for documentation and records retention. Required and recommended records are maintained by the IACUC and by DLAR, and retained according to established policy.

RETENTION OF IACUC RECORDS

Public Health Service Policy on Humane Care and Use of Laboratory Animals (at IV.E) and the Animal Welfare Act (9 CFR 2.35) require that IACUC records be retained for 3 years. Records relating to proposed research activities, defined by the MUSC IACUC as an Animal Research Protocol, must be retained for the duration of the activity and 3 years after completion of the activity.

Animal Research Protocols should be retained for a sufficient minimum period to allow evaluation and repetition by others of the results and to investigate an allegation of research misconduct. The MUSC IACUC, in accordance with the MUSC Record Retention Policy, defines this minimum period as six years from the termination date of the protocol. All other MUSC IACUC records will be kept for a minimum period of three years as required by the Public Health Service Policy on Humane Care and Use of Laboratory Animals (at IV.E) and the Animal Welfare Act (9 CFR 2.35). (12/10)

References:
Animal Welfare Act (9 CFR 2.35)
Public Health Service Policy on Humane Care and Use of Laboratory Animals (IV.E)
MUSC Record Retention Policy