# BROOKHAVEN NATIONAL LABORATORY

# INVESTIGATOR GUIDE

## FOR THE CARE AND USE OF LABORATORY ANIMALS

Brookhaven National Laboratory

Bldg. 490

PO Box 5000

Upton, NY 11973-5000

http://www.bnl.gov/ora/IACUC.asp

Institutional Official: Peter Bond (631) 344-4063

IACUC Chair: Diane Cabelli (631) 344-4361

IACUC Administrator: Darcy Mallon (631) 344-3362

**[ABBREVIATIONS]{.underline}**

Addendum(a) -- Amendment to modify procedures in an approved activity

AWA -- Animal Welfare Act

AV -- Attending Veterinarian

BLAF -- Brookhaven Laboratory Animal Facility

BNL - Brookhaven National Laboratory

BSA - Brookhaven Science Associates, LLC

Continuing Review -- Review (at least annually) of approved protocols

DEA -- Drug Enforcement Agency

DHHS - Department of Health and Human Services

DOE - Department of Energy

IACUC -- Institutional Animal Care and Use Committee

NIH - National Institute of Health

OBER - (DOE) Office of Biological and Environmental Research

OLAW - Office for Laboratory Animal Welfare

ORA - BNL Office of Research Administration

PHS -- Public Health Service

PI -- Principal Investigator

Recap - Form Summarizing Activity for a Protocol

USDA -- United States Department of Agriculture

**[TABLE OF CONTENTS]{.underline}**

**1.0 Establishment of the BNL IACUC 1**

2.0 The Office of Research Administration 2

**3.0 Role & Responsibilities/Accountabilities & Authority (R2A2) 3**

**4.0 Protocol and Review Categories 4**

**5.0 IACUC Review 5**

**6.0 Initial Protocol Review 7**

**7.0 Addendum to A Protocol 11**

**8.0 Continuing Review 12**

**9.0 Procedures to Begin an Approved Protocol 13**

**10.0 Procedures to Suspend or Terminate A Protocol 14**

**11.0 Determination of Corrective Actions/Sanctions 15**

**12.0 IACUC Policies Pertaining To Animal Research 17**

**1.0** **[ESTABLISHMENT OF THE BNL IACUC]{.underline}**

> 1.1The Institutional Animal Care and Use Committee (IACUC) is
> established and authorized by a memo from the Laboratory Director in
> accordance with Federal policy. Its jurisdiction includes all research
> involving live vertebrate animals performed at or in conjunction with
> Brookhaven National Laboratory (BNL) and its employees, regardless of
> the PI's appointment or relationship to BNL. The Laboratory Director
> will act as Institutional Official (IO), or may delegate this
> authority in writing.
>
> 1.2 The IACUC is appointed by and reports to the IO.
>
> 1.3 The lines of authority governing the operations of the BNL IACUC
> are shown in the following Organizational Chart.

![](media/image1.wmf)

**2.0 [THE OFFICE OF RESEARCH ADMINISTRATION]{.underline}**

> 2.1 The Office of Research Administration (ORA) is authorized and
> established by the Laboratory Director.
>
> 2.2 The ORA is responsible to the Laboratory Director and the
> Institutional Official for the IACUC.
>
> 2.3 A mission of the ORA is to provide administrative support to the
> IACUC and to provide administrative/regulatory advice and direction to
> investigators whose research involves the use of live vertebrate
> animals.
>
> 2.4 With respect to the support to the IACUC, the goal is to help
> assure that all research involving animals conducted at BNL complies
> with the following federal policies and guidance:

-   The PHS Policy on Humane Care and Use of Laboratory Animals:

> http://grants1.nih.gov/grants/olaw/references/phspol.htm

-   The Guide for the Care and Use of Laboratory Animals:

> http://www.nap.edu/readingroom/books/labrats/

-   The American Veterinary Medical Association (AVMA) Panel on
    Euthanasia:

> <http://www.avma.org/resources/euthanasia.pdf>

-   Public Law 99-158, Section 495 "Animals in Research":

> <http://grants.nih.gov/grants/olaw/references/hrea1985.htm>

-   Animal Welfare Act

-   New York State Department of Health Regulations, Subpart 55-1
    "Approval of Laboratories and Institutions for Use of Living Animals
    and for Requisition and Allocation of Animals from Pounds"

> 2.5 With respect to providing administrative/regulatory advice and
> direction to investigators, the goals are to:

-   Serve as the party responsible for the dissemination of information
    regarding the rules and regulations governing research involving
    live vertebrate animals.

-   Provide guidance to the investigators with respect to their
    responsibilities in performing research involving live vertebrate
    animals.

-   Serve as a focal point for communication between investigators using
    live vertebrate animals and the Attending Veterinarian, the IACUC
    Chair, the IACUC as a whole and the BLAF Manager and staff.

**3.0 [ROLE & RESPONSIBILITIES/ACCOUNTABILITIES & AUTHORITY
(R2A2)]{.underline}**

# IACUC PRINCIPAL INVESTIGATOR 

### Role

Design and conduct properly approved research studies involving animals

### Responsibilities

-   Know and adhere to federal and BNL rules and regulations governing
    research involving live animals.

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-   Submit research protocols and addenda to IACUC for approval prior to
    start of work.

-   Retain copies of all correspondence with the IACUC.

-   Submit substantive annual reports of the results of research
    conducted under IACUC protocols.

-   Identify in the IACUC protocol all personnel working on the
    protocol, including other investigators, technicians, etc.

-   Oversee the conduct of staff members conducting research under IACUC
    protocols.

-   Ensure that all protocol personnel are appropriately qualified and
    that training is up to date, including facility-specific training.

-   Follow all Brookhaven Laboratory Animal Facility (BLAF) policies and
    procedures.

-   Ensure that animals are properly handled and monitored during a
    procedure or surgery, as defined in the IACUC approved protocol.

-   Ensure that research procedures used are those defined in the IACUC
    approved protocol.

-   Ensure that animals receive appropriate post-procedure care and
    monitoring.

-   Ensure that animals are transported, on and/or off site, under
    proper conditions.

-   Ensure that all approved protocols, addenda, and terminations are
    distributed to all protocol personnel, and that such personnel have
    read and understood the documents.

-   Promptly report animal distress or unexpected death to AV and/or
    BLAF staff.

-   Report any unusual or adverse event or unanticipated problem to the
    IACUC within 72 hours.

-   Maintain records according to Sponsor's requirements or for at least
    three years following completion of research.

-   Make records available for inspection by the IACUC, the United
    States Department of Agriculture (USDA) or other federal or state
    government agencies as required.

### Accountabilities

-   To the IACUC

-   To the Department Chair

-   To the Department Training Coordinator

### Authority

-   Stop or interrupt an animal research study upon evidence of a hazard
    to the safety of study personnel

**4.0** **[PROTOCOL AND REVIEW CATEGORIES]{.underline}**

4.1 **Protocol Categories**

> 4.1.1 **IACUC Protocol:** All studies involving live, vertebrate
> animals must be reviewed by the IACUC.
>
> *Investigators are encouraged to submit separate protocols for work
> involving a different PI and/or different funding source. For research
> involving live, vertebrate animals that is to be carried out under a
> Cooperative Research and Development Agreement (CRADA), a stand alone
> IACUC protocol shall be submitted that will serve to appropriately
> separate the results and other proprietary information about that
> project from research carried out under other programs.*
>
> 4.1.2 **Exempt Research:** A study is considered to be Exempt if it
> does not involve live, vertebrate animals.
>
> 4.2 **Protocol Review Categories**: Protocols are reviewed under the
> following categories:
>
> 4.2.1 **Preliminary ORA Review**: This review determines if the
> protocol is under the jurisdiction of IACUC regulations and ensures
> the protocol package is complete and accurate.
>
> 4.2.2 **Preliminary Review by the AV:** The protocol is reviewed by
> the AV. The AV may require additional information and/or revision
> prior to approving the protocol for submission to the IACUC.
>
> 4.2.3 **Initial Reviews**: Following the above Preliminary Reviews and
> approval, an initial protocol is forwarded to the IACUC for review.
>
> 4.2.4 **Addendum Review**: This review is required whenever a
> Principal Investigator wishes to amend, change, modify or otherwise
> alter any procedures under an approved protocol.
>
> 4.2.5 **Continuing Review**:
>
> 4.2.5.1 Each protocol must be reviewed by the IACUC no less than once
> per year.
>
> 4.2.5.2 At the time of an Initial, Triennial or Addendum Review, the
> IACUC shall determine an appropriate approval period that shall not
> exceed one year, but which may be of shorter duration either at the
> request of the PI or as a result of other concerns arising during
> protocol review which mandate a shortened approval period.

6.  **Triennial Review:** Every three years, each continuing protocol
    must be re-submitted as a new protocol and undergo an Initial
    Review.

> *The new protocol will replace the old version, so all continuing work
> must be clearly included in the triennial submission, including new
> procedures, newly added drugs and all addended items which the
> investigator wishes to carry forward in the continuation of his/her
> studies.*

**5.0** **[IACUC REVIEW]{.underline}**

> 5.1 All protocols and addenda will be reviewed by the IACUC in one of
> the following ways:
>
> 5.1.1 **Full Committee Review**
>
> 5.1.1.1 All Initial, Continuing, Triennial and major amendments of
> active protocols are given full committee review.
>
> 5.1.1.2 Minor addenda may be granted expedited review.

5.1.2 The decision of the full committee shall be one of the following:

> 5.1.2.1 **Approval:** The protocol can be initiated or continued.
>
> 5.1.2.2 **Conditional Approval:** The protocol is approved pending the
> Principal Investigator's providing clarification of issues raised in
> the protocol package that are not considered serious. Evidence of
> compliance with IACUC conditions must be provided in writing by the
> Principal Investigator to the IACUC Secretary. For conditional
> approvals, the IACUC Chair will be authorized by the IACUC to review
> the response and grant final approval.
>
> 5.1.2.3 **Tabled:** Additional information considered to be of
> substantial importance must be submitted, reviewed and approved by the
> full committee review before a final determination can be made.
>
> 5.1.2.4 **Rejected:** The IACUC has determined the protocol cannot be
> approved, even with modifications.
>
> 5.1.2.5 **Inactive:** A protocol is considered inactive when studies
> are discontinued by order of the PI or the IACUC.

5.2 **Expedited Review**

> 5.2.1 Expedited Review is used for minor addenda.
>
> 5.2.1.1 Expedited Review may not be used for initial, annual or
> triennial reviews or for significant changes to an approved protocol.
>
> 5.2.1.2 Minor changes may include, but are not limited to: addition of
> another strain of the same animal species, change in sex of animal to
> be used, up to 10% increase in number of animals requested, addition
> of non-invasive, non-stressful procedure(s), additional sample
> collection times, change of the room where the experiment takes place.

5.2.2 The procedure for Expedited Review is as follows:

> 5.2.2.1 A Preliminary Review is done as described in Preliminary
> Review.
>
> 5.2.2.2 The IACUC Chair and AV review the Addendum.
>
> 5.2.2.3 If they concur that Expedited Review and approval is
> appropriate, all IACUC members are provided with information regarding
> the proposed addendum, including the IACUC Protocol number, protocol
> title, name of the PI, the nature of the proposed Addendum and a
> deadline date for requesting a full review.
>
> 5.2.2.4 Any IACUC member may request full committee review for the
> proposed Addendum. If any such request is made, the Addendum must be
> reviewed at the next regularly scheduled IACUC meeting.
>
> 5.2.2.5 If full committee review is not requested, the IACUC Chair, in
> consultation with the AV, reviews the addendum.
>
> 5.2.3 If approved, the IACUC Chair signs and dates the Expedited
> Approval Form.
>
> 5.2.3.1 The PI and BLAF Manager are notified by Approval Memos.

4.  In conducting an Expedited Review, the IACUC Chair may exercise all
    of the authority of the IACUC except that the Chair may not
    disapprove the proposed addenda. A research activity may be
    disapproved only after Full Committee Review.

5.3 **Administrative Review**

> 5.3.1 For very minor changes to a protocol, administrative review and
> approval can be used to correct non-substantive discrepancies and/or
> changes to personnel (excluding PI).
>
> 5.3.2 These changes will be reviewed and approved by the IACUC
> Administrator.
>
> 5.3.3 If approved, the IACUC Administrator notifies the PI and BLAF
> Manager.

5.4 **Grant Submission Review**

> 5.4.1 When a grant proposing the use of live, vertebrate animals is
> approved for funding, the PI must submit the grant application and
> proposed IACUC protocol or addendum to a currently approved protocol
> to the ORA.
>
> 5.4.2 The submission will be processed as an Initial Application or
> Addendum.
>
> 5.4.3 For NIH Grant proposals, an IACUC protocol must be approved by
> the committee prior to the award of funds. It is the responsibility of
> the prospective grantee to ensure that a protocol or addendum and
> associated copy of the grant proposal are submitted for review in a
> timely fashion so as not to cause a delay in the award of funds and so
> as not to necessitate the calling of an emergency meeting of the
> IACUC.

**6.0** **[INITIAL PROTOCOL REVIEW]{.underline}**

6.1 **Preparation**

> 6.1.1 For a new protocol, PI obtains an IACUC Protocol form
> [http://www.bnl.gov/ora/files/doc/Form001Protocol.doc](http://www.bnl.gov/ora/files/doc/Form001Protocol.doc)).
>
> 6.1.2 The PI must be familiar with federal and BNL regulations:
> http://www.bnl.gov/ora/IACUCSITE.html
>
> 6.1.3 The PI should confer with the AV during preparation of a
> protocol.

6.2 **Preliminary Review**:

> 6.2.1 All submissions receive a Preliminary Review by the ORA.
>
> 6.2.2 **Preliminary Review Procedures**
>
> 6.2.2.1 The ORA assigns a number to the protocol.
>
> 6.2.2.2 The ORA forwards the protocol to the AV for review and
> approval for submission to the IACUC
>
> 6.3 **Full Committee Review Procedures**
>
> 6.3.1 The following elements are considered in the IACUC review:
>
> 6.3.1.1 Hypothesis and general aims;
>
> *This should be a short summary in lay terms.*
>
> 6.3.1.2 Species and number of animals required and justification of
> same;
>
> List total number of animals for project (maximum 3 years). *Include
> extra animals for training purposes and to cover unexpected losses.
> For animals that will be shipped to BNL from another institution, a
> health report from that institution's animal facility will be
> required. Investigators are encouraged to contact the BLAF at 631
> 344-3620 as early as possible in the submission process.*
>
> 6.3.1.3 Unusual housing and husbandry requirements including
> restriction of food or water;
>
> *For animals equipment/supplies/food that will be shipped to BNL from
> another institution, a health report from that institution's animal
> facility will be required. Investigators are encouraged to contact the
> BLAF at 631 344-3620 as early as possible in the submission process.*
>
> 6.3.1.4 Adequacy of training and experience of personnel in the
> procedures used;
>
> *All personnel listed here must be on the appropriate Occupational
> Health Protocol and should only include those who will be performing
> hands-on work with the animals.*
>
> 6.3.1.5 Rationale and purpose of the proposed use of animals.
>
> *Section D.3 of the application must list everything that will be done
> to the animal. It must be written in language that is readily
> understandable to the lay person. Flow diagrams or charts are often
> helpful. Clearly indicate the end point of the experiment and
> disposition of the animals. Indicate dose of agent and/or irradiation
> to be administered. Use ranges whenever possible instead of single
> specified doses.*
>
> 6.3.1.6 Certification that the use of less-invasive procedures or
> other alternatives are not available or not appropriate.
>
> *Must include a written narrative describing the methods and sources
> used to determine that alternatives to painful/distressful procedures
> were not available. PIs must consider the "Three Rs" **Replacement**
> of animals with non-animal models, **Reduction** to minimize the
> numbers of animals to the greatest extent possible, and **Refinement**
> of procedures so as to maximally reduce the amount of potential pain,
> discomfort, distress or morbidity. A literature search must be
> performed to investigate such alternatives. The Research Library Staff
> is available to assist with the search. For rats and mice, if an
> anesthetic is used solely for immobilization purposes, such as imaging
> and tissue harvest, a literature search for alternatives to
> pain/distress is not required.*
>
> 6.3.1.7 Appropriate sedation, analgesia and anesthesia.
>
> *This should be discussed with the AV during preparation of the
> protocol. All substances to be administered should be listed. Security
> procedures of controlled substances must include room and building
> number of lock box location.*
>
> 6.3.1.8 Conduct of multiple major survival surgeries.
>
> *If more than one survival surgery will be performed, this must be
> justified.*
>
> 6.3.1.9 Postoperative care.
>
> *Include who, what, where and how often*
>
> 6.3.1.10 Criteria and process for timely interventions, removal of
> animals from a study, or euthanasia if painful or stressful outcomes
> are encountered;
>
> *This must be clearly but succinctly described. The AV can provide
> guidance for this section.*
>
> 6.3.1.11 Method of euthanasia or disposition of animal;
>
> *Should include a rationale for the selected method of euthanasia,
> verification that the selected method is the most humane possible
> given scientific constraints, and how death will be confirmed.*
>
> 6.3.1.12 Safety of working environment for personnel;
>
> 6.3.1.13 PI's assurance that the work does not involve unnecessary
> duplication of established principles;
>
> 6.3.1.14 Shipping procedures, if applicable
>
> *This is particularly important for investigators that will make use
> of BNL User Facilities and will then transport their animals to their
> home or other institution.*
>
> 6.3.1.15 IACUC approval from other institutions, if so required;
>
> 6.3.1.16 The approval period desired.
>
> *An initial protocol can be approved for up to three years provided
> that it is reviewed and approved for continuation at least once a year
> over the three year period. PIs may request a shortened approval
> period if they so desire.*
>
> 6.3.1.17 Agents to be administered to animals:

-   Protocols may be approved that include specific categories/classes
    of drugs to be administered, with the exception that Schedule 1 and
    Schedule 2 DEA regulated compounds are to be specifically and
    individually identified in the protocol and approved by the IACUC.

-   Each continuing review of the protocol [must]{.underline} include a
    complete list of the agents and doses administered over the course
    of the approval period.

-   For any substance that is to be administered at concentrations
    exceeding the ED50, or with an unknown ED50, IACUC approval must be
    obtained in advance of using the compound.

-   Protocols involving Schedule I or Schedule II compounds must list
    each compound to be used and use of Schedule I compounds must be
    approved by the CRC Pharmacist prior to IACUC review and approval.

-   Co-administration of two or more research compounds or drugs at
    pharmacological doses must be specifically reviewed and approved by
    the IACUC. Doses and potential interactions must be detailed in the
    protocol.

> *This does not include radiotracers and/or anesthetics although it is
> a responsibility of the PI, with the AV's concurrence, to ensure that
> the drugs to be administered at pharmacological doses to anesthetized
> animals will not interfere with the efficacy or lack of toxicity of
> the anesthetic.*

6.4 **Notification of Determination**

> 6.4.1 The ORA forwards the determination of the IACUC to the PI in a
> memo that contains one of following determinations:
>
> 6.4.1.1 **Approved**
>
> 6.4.1.1.1 The Approval Memo informs the PI of the date of IACUC
> approval and the approval period.
>
> 6.4.1.1.2 An Approval Memo is also sent to the BLAF Manager, along
> with a copy of the protocol.
>
> 6.4.1.2 **Conditionally Approved**
>
> 6.4.1.2.1 The Conditional Approval Memo includes a list of the
> conditions to be met or questions to be answered.
>
> 6.4.1.2.2 Compliance with IACUC conditions must be provided in
> writing. If acceptable, the IACUC Chair is authorized by the IACUC to
> review the response and grant final approval.
>
> 6.4.1.3 **Tabled**
>
> 6.4.1.3.1 The Tabling Memo is sent to the PI listing the conditions to
> be satisfied.

2.  The PI is informed that no work may begin until the conditions are
    satisfied and the full IACUC has approved a revised protocol.

3.  The PI is also notified of the due date for response to ensure that
    the protocol will be reviewed by the full committee at the next
    IACUC meeting.

> 6.4.1.4 **Rejected:**
>
> 6.4.1.4.1 The Rejection Memo is sent to the PI listing the reasons for
> rejection.
>
> 6.4.1.4.2 The PI has the right to respond in writing or in person to
> the IACUC regarding the rejection of a protocol for performance at
> BNL.
>
> 6.5 Additional BNL reviews and approvals may be required to carry out
> a given protocol. BNL officials may not approve the initiation of
> animal research that has not received approval from the IACUC.
> However, BNL officials may disapprove performance of a study under an
> IACUC protocol if their reviews so justify.

**7.0 [ADDENDUM TO AN APPROVED PROTOCOL]{.underline}**

> 7.1 A PI must receive approval from the IACUC any time s/he wishes to
> deviate from the protocol originally approved by the IACUC. No change
> in procedures can be initiated until the IACUC has approved the change
> either through full committee or expedited review.
>
> 7.2 Personnel additions or deletions, excluding Principal Investigator
> changes, should be e-mailed to the ORA for Administrative Review and
> approval.
>
> 7.3 **Procedures for an Addendum Review:**
>
> 7.3.1 A Preliminary Review determines whether a Full Committee Review
> is necessary or whether Expedited or Administrative Review is
> warranted.
>
> *Please contact the ORA to receive guidance with respect to this
> determination prior to submitting signed addendum.*
>
> 7.3.2 Addenda determined to require a Full Committee Review are
> processed as for Initial Review as follows:
>
> 7.3.2.1 The Addendum is submitted by the PI to the ORA.
>
> 7.3.2.2 The ORA reviews the package for completeness and forwards the
> addendum to the AV for review and approval for submission to the
> IACUC.
>
> 7.3.2.3 The IACUC may choose to be more restrictive in the protocol
> approval period as a result of the addendum and/or they may restrict
> the approval period of the addendum.
>
> 7.3.3 The ORA forwards the determination of the IACUC to the PI and
> BLAF Manager, as in the Initial Review.

**8.0** [**CONTINUING REVIEW**]{.underline}

> 8.1 The approval period is determined by the IACUC during a Full
> Committee Review and shall not exceed one year, but may be of shorter
> duration either at the request of the PI or as a result of other
> concerns arising during protocol review which mandate a shortened
> approval period.
>
> 8.2 It is IACUC policy that a protocol that has reported no animals
> used for three consecutive years shall be inactivated and the PI shall
> be informed they must submit a new application to re-initiate the
> studies.
>
> 8.3 **Procedures for Continuing Review**:
>
> 8.3.1 Two months in advance of the approval period expiration date,
> the Continuing Review package, consisting of the current Recap Sheet,
> Summary Form and the IACUC Continuing Review Form, is sent to the PI.
>
> 8.3.1.1 The Continuing Review Form requests the following information:
>
> a\) PI name;
>
> b\) protocol title;
>
> c\) reporting period;
>
> d\) funding source;
>
> e\) species and number of animals placed on study and pain/distress
> category;
>
> f\) a progress report of work done and data collected during the
> reporting period, conclusions reached and a copy of any such progress
> reports provided to funding agencies;
>
> I*nclude drugs used if a class of drugs was approved.*
>
> g\) unanticipated findings, morbidity or mortality involving the
> animals, the cause(s) if known and how these problems were resolved;
>
> h\) personnel/staff changes since the last IACUC approval;
>
> i\) a description of what is to be studied during the coming approval
> period;
>
> *This should be a short list of goals*
>
> j\) a literature search for alternatives to procedures causing
> momentary or slight pain or distress to the animal
>
> k\) The form must be signed by the PI and their Department Chair, and
> include a current, approved ESR number.
>
> 8.3.1.2 The Recap and Summary forms should be reviewed for accuracy.
> Any discrepancies should be marked and returned along with the
> Continuing Review Form. *These forms should not be returned unless
> they contain corrections.*
>
> 8.4 The completed Continuing Review Package is returned to the ORA.
>
> 8.4.1 The IACUC review and approval process for Continuing Review is
> the same as for an Initial Review.
>
> 8.4.2 The continuing approval period is determined by the IACUC. (see
> 8.1)
>
> 8.4.3 The ORA forwards the determination of the IACUC to the PI and
> BLAF Manager, as in the Initial Review.

**9.0** **[PROCEDURES TO BEGIN AN APPROVED PROTOCOL]{.underline}**

> 9.1 Following approval of a protocol or addendum, the ORA sends an
> Approval Memo to the BLAF Manager. The Memo includes the approval
> period and any restrictions on the protocol. The BLAF Manager receives
> a copy of the Initial Protocol or Addendum.
>
> 9.2 When a PI wishes to begin a study, they contact the BLAF Manager.
>
> 9.3 Before the study starts, the BLAF Manager confirms:
>
> 9.3.1 that the protocol has been approved and that any restrictions
> associated with the study are being addressed;
>
> 9.3.2 that the correct species of animal is being used;
>
> 9.3.3 that staff are available and have the necessary training to
> participate in the study;
>
> 9.3.4 that the BLAF is properly equipped and staffed to handle the
> study.

**10.0 [PROCEDURES TO SUSPEND OR TERMINATE A PROTOCOL]{.underline}**

> 10.1 The IACUC has the authority and responsibility to suspend and/or
> terminate any protocol when such action is warranted under the federal
> guidelines and/or BNL policies. A PI may voluntarily suspend or
> terminate a protocol.
>
> 10.2 **Voluntary Process**:
>
> 10.1.1 The PI notifies the ORA of his/her decision to suspend or
> terminate a protocol by completing a Protocol Termination Form.
>
> 10.1.2 The PI has the responsibility to report to the IACUC any
> unanticipated events and to voluntarily interrupt the protocol until
> appropriate changes in the protocol can be approved by the IACUC.
>
> 10.1.3 The ORA then notifies the BLAF Manager in writing of these
> actions.
>
> 10.3 **Involuntary Process**: An involuntary suspension or termination
> of a protocol may be made only at a convened meeting with a quorum of
> the IACUC

**11.0 [Determination of Corrective Actions/Sanctions]{.underline}**

1.  All allegations reported to the IACUC shall reviewed by the IACUC.

11.1.1 If the IACUC, by a majority vote, finds the allegations do not
have merit, the report is considered closed and the PI is notified in
writing.

11.1.2 If the IACUC, by majority vote, finds the allegations have merit
and represent noncompliance, the following guidelines are to be used to
determine corrective actions/sanctions:

> 11.2 **For Serious or Continuous Noncompliance Issues**
>
> 11.2.1 Acts of noncompliance are deemed serious if they can or do
> affect the health, safety or well being of animals or personnel or
> represent continuing or willful noncompliance with Federal or BNL
> policies. Examples of serious issues would be the failure of animal
> care and use personnel to adhere to IACUC - reviewed and approved
> protocol procedures, institutional policies and procedures or a
> serious deviation from the provisions of the Guide.
>
> 11.2.2 If the IACUC determines the reported problem is serious, it
> may, in consideration of the nature of the research study and the
> reported problem, institute one or more of the following sanctions:
>
> 11.2.2.1 Terminate IACUC approval of the research study
>
> 11.2.2.2 Suspend IACUC approval of the research study pending
> completion and acceptance by the IACUC of a written plan for the
> correction and /or prevention of the problem
>
> 11.2.2.3 Suspend further animal orders for the research study pending
> completion and acceptance by the IACUC of a written plan for the
> correction and/or prevention of the problem
>
> 11.2.2.4 Institute and complete an IACUC-mandated corrective action
> plan
>
> 11.2.2.5 Take such other action as the IACUC deems appropriate

11.3 **Minor Noncompliance Issues**

11.3.1 Acts of noncompliance are deemed minor if they do not affect the
health, safety or well being of animals or do not represent continuing
or willful noncompliance with Federal or BNL policies. If the IACUC
determines that the reported problem is minor, it may, in consideration
of the nature of the research study and the reported problem take one or
more of the following actions:

> 11.3.1.1 Elect to make corrective action only
>
> 11.3.1.2 Provide a verbal and/or written listing of the issue of
> noncompliance to the investigator and require a corrective action plan
> including a required completion date at a regular meeting of the IACUC
> and recording this incident in the IACUC minutes
>
> 11.3.1.3 Provide a written listing of the issue of noncompliance to
> the investigator and require a corrective action plan within a
> specified time period specified by the IACUC. The letter may or may
> not be copied to the investigator's department chair depending on the
> IACUC's decision on the sanction.

11.4 **Reporting**

> 11.4.1 All suspensions will be reported to OLAW, USDA (if applicable),
> AAALAC and the PI's funding agency by the IO.
>
> 11.4.2 All serious or continuing noncompliance issues and their
> resolution will be reported to OLAW and the agency funding the study
> by the IO.

**12.0 [IACUC POLICIES PERTAINING TO ANIMAL RESEARCH]{.underline}**

> 12.1 The use of ether is not permitted in the BLAF
>
> 12.2 With the exception of the fish housed in the Fish Facility in the
> Biology Department, no animals can be removed from the BLAF and
> maintained outside of the BLAF or an approved satellite facility for
> more than 24 hours (12 hours for USDA regulated species). Requests for
> exceptions to this rule due to extenuating circumstances may be
> reviewed and approved by the BLAF Manager.
>
> 12.3 A search for alternatives to pain and/or distress must be
> performed for each initial and continuing submission and addendum (if
> applicable). The details of the search must include the dates
> searched, the source used, the keywords searched, and the results of
> the search. A list of websites are available at
> http://www.nal.usda.gov/awic/alternatives/alternat.htm.
>
> 12.4 The IACUC will decide for each protocol, based on risk assessment
> and risk reduction, the necessity of continuously monitoring animals
> undergoing experimental procedures. The IACUC shall require a detailed
> description of how the risk will be minimized (through monitoring,
> design of apparatus, etc.). Animals under anesthesia must always be
> monitored by the research investigators until they have fully
> recovered.
>
> 12.5 Approval must be obtained from institution(s) collaborating with
> BNL on an animal research protocol. These approvals must be updated on
> an annual basis as part of the annual review of the IACUC protocol.
>
> 12.6 Only under extremely rare circumstances will IACUC protocols that
> use a paralytic agent without an anesthetic be approved.
>
> 12.7 Multiple survival surgeries and/or food/water restriction must
> have a strong scientific justification by the PI.
>
> 12.8 Montgomery's endpoint criteria for the euthanasia of moribund
> animals will be followed. PIs, or their designees, must monitor all
> animals on their protocols after treatment at least three times during
> the week to ensure that they are not moribund. A record must be kept
> stating that the animal's condition was satisfactory. This record
> should include time, date and initials of person performing
> monitoring, as well as comments on the condition of the animal. The
> final authority of whether animals should be euthanized will remain
> with BLAF staff and/or the AV. BLAF staff will make every effort to
> contact the PI prior to euthanizing an animal. PIs must ensure that
> BLAF staff has contact telephone numbers for them and/or their
> designees, including home telephone numbers and/or beeper numbers.
>
> 12.9 All personnel working directly with animals must be in compliance
> with the Occupational Health Program. For more details, see the BLAF
> Policies and Procedures Manual.
>
> 12.10 All personnel working with animals must be appropriately trained
> and qualified. The BLAF offers a Laboratory Animal Training Program
> (LAT 1). LAT 1 is an introduction to federal, state and local laws
> that govern the use of animals in research and the consequences of
> non-compliance. All personnel working with animals are required to
> receive this training. Please contact the BLAF Manager for details, or
> refer to the BLAF Policies and Procedures Manual.
>
> Instruction for LAT 2, which is a hands-on procedural training, will
> be given on a case by case basis by the AV or qualified instructor.

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