Notice Number: NOT-OD-05-034
Update: The following update relating to this announcement has been issued:
Key Dates
Release Date: February, 24, 2005
This Notice provides guidance to Public Health Service (PHS) awardee institutions and Institutional Animal Care and Use Committees (IACUCs) on the prompt reporting requirements of the PHS Policy on Humane Care and Use of Laboratory Animals (Policy) (http://grants.nih.gov/grants/olaw/references/phspol.htm). This guidance is intended to assist IACUCs and Institutional Officials in determining what, when, and how situations should be reported under IV.F.3 of the Policy, and to promote greater uniformity in reporting. This Notice supersedes the January 12, 1994 Dear Colleague letter from the former Division of Animal Welfare, Office for Protection from Research Risks (now the Office of Laboratory Animal Welfare, or OLAW).
Background
PHS Policy, IV.F.3, requires that:
"The IACUC, through the Institutional Official, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to:
a) any serious or continuing noncompliance with this Policy;
b) any serious deviation from the provisions of the Guide [for the Care and Use of Laboratory Animals] ; or
c) any suspension of an activity by the IACUC."
IACUC suspensions of activities are cited at IV.C.6 and 7 of the Policy, and require a convened meeting of a quorum of the IACUC and the vote of a majority of the quorum present. The Institutional Official must review the reasons for suspension in consultation with the IACUC, take appropriate corrective action and report that action with full explanation to OLAW.
All institutions with Animal Welfare Assurances are required to comply with the provisions of IV.F.3. The Institutional Official signing the Assurance, in concert with the IACUC, is responsible for this reporting.
Reporting promptly to OLAW under IV.F.3 serves dual purposes. Foremost, it ensures that institutions deliberately address and correct situations that affect animal welfare, PHS-supported research, and compliance with the Policy. In addition, it enables OLAW to monitor the institution's animal care and use program oversight under the Policy, evaluate allegations of noncompliance, and assess the effectiveness of PHS policies and procedures.
The underlying foundation of the PHS Policy is one of institutional self-evaluation, self-monitoring and self-reporting. Public Law 99-158 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm) requires that institutions be provided a reasonable opportunity to take corrective action before a grant or contract is suspended or terminated, and it is OLAW's role to assess whether the corrective actions reported by institutions under IV.F.3 are adequate. OLAW will assist the reporting institution in developing definitive corrective plans and schedules if necessary. Compliance actions affecting an award are rare because institutions are usually able to address incidents successfully and take appropriate actions to prevent recurrence.
Guidance on Prompt Reporting
A comprehensive list of definitive examples of reportable situations is impractical. Therefore, the examples below do not cover all instances but demonstrate the threshold at which OLAW expects to receive a report. Institutions should use rational judgment in determining what situations meet the provisions of IV.F.3 and fall within the scope of the examples below, and consult with OLAW if in doubt. OLAW welcomes inquiries and discussion and will provide guidance with regard to specific situations. Situations that meet the provisions of IV.F.3 and are identified by external entities such as the United States Department of Agriculture or the Association for Assessment and Accreditation of Laboratory Animal Care International, or by individuals outside the IACUC or outside the institution, are not exempt from reporting under IV.F.3.
Examples of reportable situations:
conditions that jeopardize the health or well-being of animals, including natural disasters, accidents, and mechanical failures, resulting in actual harm or death to animals;
conduct of animal-related activities without appropriate IACUC review and approval;
failure to adhere to IACUC-approved protocols;
implementation of any significant change to IACUC-approved protocols without prior IACUC approval as required by IV.B.7.;
conduct of animal-related activities beyond the expiration date established by the IACUC (note that a complete review under IV.C is required at least once every three years);
conduct of official IACUC business requiring a quorum (full Committee review of an activity in accord with IV.C.2 or suspension in accord with IV.C.6) in the absence of a quorum;
conduct of official IACUC business during a period of time that the Committee is improperly constituted;
failure to correct deficiencies identified during the semiannual evaluation in a timely manner;
chronic failure to provide space for animals in accordance with recommendations of the Guide unless the IACUC has approved a protocol-specific deviation from the Guide based on written scientific justification;
participation in animal-related activities by individuals who have not been determined by the IACUC to be appropriately qualified and trained as required by IV.C.1.f;
failure to monitor animals post-procedurally as necessary to ensure well-being (e.g., during recovery from anesthesia or during recuperation from invasive or debilitating procedures);
failure to maintain appropriate animal-related records (e.g., identification, medical, husbandry);
failure to ensure death of animals after euthanasia procedures (e.g., failed euthanasia with CO 2);
failure of animal care and use personnel to carry out veterinary orders (e.g., treatments); or
OLAW recognizes that there may be levels of morbidity and mortality in virtually any animal-related activity, including those associated with the care and use of animals in research, testing, and teaching that are not the result of violations of either the Policy or the Guide . OLAW offers the following examples of situations which may not meet the threshold for reporting, based on consideration of the circumstances by the IACUC.
Examples of situations not normally required to be reported:
death of animals that have reached the end of their natural life spans;
death or failures of neonates to thrive when husbandry and veterinary medical oversight of dams and litters was appropriate;
animal death or illness from spontaneous disease when appropriate quarantine, preventive medical, surveillance, diagnostic, and therapeutic procedures were in place and followed;
animal death or injuries related to manipulations that fall within parameters described in the IACUC-approved protocol; or
Time Frame for Reporting
Institutions should notify OLAW of matters falling under IV.F.3 promptly, i.e., without delay. Since IV.F.3 requires a full explanation of circumstances and actions taken and the time required to fully investigate and devise corrective actions may be lengthy, OLAW recommends that an authorized institutional representative provide a preliminary report to OLAW as soon as possible and follow-up with a thorough report once action has been taken. Preliminary reports may be in the form of a fax, email, or phone call. Reports should be submitted as situations occur, and not collected and submitted in groups or with the annual report to OLAW.
Information to Be Reported
Include as many of the following items of information as possible in the initial contact with OLAW. A follow-up report may address anything not known at the time of the initial report and should summarize the institution's corrective action. If a long term plan is necessary, describe the plan and include a reasonable schedule. This information will allow OLAW to assess the circumstances and actions taken to correct and prevent recurrence of the situation.
Information to be included:
Animal Welfare Assurance number (http://grants.nih.gov/grants/olaw/assurance/300index.htm);
relevant grant or contract number(s) if the situation is related to an activity directly supported by PHS;
a full description of any potential or actual affect on PHS-supported activities if the situation is not directly supported by the PHS but is in a functional, programmatic, or physical area that could affect PHS-supported activities (e.g., inadequate program of veterinary care, training of technical/husbandry staff, or occupational health; inadequate sanitation due to malfunctioning cage washer; room temperature extremes due to HVAC failures);
full explanation of the situation, including what happened, when and where, the species of animal(s) involved, and the category of individuals involved (e.g., principal or co-principal investigator, technician, animal caretaker, student, veterinarian, etc.);
description of actions taken by the institution to address the situation; and
Preliminary and final reports should be made to:
Director, Division of Compliance Oversight
Office of Laboratory Animal Welfare
National Institutes of Health
Rockledge 1, Suite 360, MSC 7982
6705 Rockledge Drive
Bethesda, MD 20892-7982
Phone: 301-594-2061
FAX: 301-402-2803
E-mail: [email protected]
Inquiries
For questions or further information, contact:
Director, Office of Laboratory Animal Welfare
Office of Extramural Research,
Office of the Director, National Institutes of Health
RKL 1, Suite 360
6705 Rockledge Dr .
Bethesda , MD 20892-7982
(For express or hand-delivered mail use zip code 20817)
Telephone (301) 496-7163
[email protected]