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Policy and Procedures - March 20213.4 IACUC MembersRole To participate as a member of the IACUC, the committee that oversees theinstitution’s animal program, facilities and procedures and that reviews and approvesevery research protocol that involves the use of animalsResponsibilities Review, at least once every six months, the institution’s program for humane care anduse of animals, using the “Guide for Care and Use of Laboratory Animals” (theGuide) as a basis for this evaluation Inspect, at least once every six months, all the institution’s animal facilities using theGuide as a basis for evaluation Review and investigate concerns involving the care and use of animals at theinstitution Make recommendations to the IO on any aspect of the institution’s animal program,facilities or personnel training Review and approve, require modifications in (to secure approval), or withholdapproval of proposed activities related to the care and use of animals Review and approve, require modification in (to secure approval), or withholdapproval of proposed significant changes to approved IACUC protocols regarding thecare and use of animals Prepare for, by reading the full agenda, and attend IACUC meetingsAccountabilities To the IO and IACUC Chair for IACUC operationsAuthorities Stop or interrupt an animal research study upon evidence of a hazard to the safety ofstudy personnel Authorize the IACUC Chair to grant full approval for conditionally approvedsubmissions7

Policy and Procedures - March 20213.5 IACUC AdministratorRole To establish and direct the operations of effective, efficient systems for protocol,facilities and program reviews by the IACUC in compliance with regulatory policyResponsibilities Ex-officio, non-voting member of the IACUC Coordinate and schedule IACUC meetings, facility inspections and laboratory sitevisits by IACUC Promptly convey IACUC decisions to investigators in writing Coordinate and schedule reviews of institution’s animal care and use program byoutside agencies Act as a resource for investigators and IACUC members for regulatory issues and thestatus of protocols Prepare, maintain and update as required all institutional policy and proceduredocuments, forms and website Prepare semi-annual BLAF and laboratory inspection report for IACUC review andapproval and submission to IO Screen IACUC submissions for accuracy and completeness and correspond withinvestigator if documentation is inaccurate and/or incomplete Prepare and distribute agenda to IACUC Ensure a quorum is present at every IACUC meeting Declare the loss of a quorum resulting in the suspension of official business if asufficient number of members depart during a convened meeting Prepare IACUC meeting minutes Prepare memos for IACUC Chair’s signature advising PIs of actions taken by IACUCat convened meeting Ensure that each approved IACUC protocol receives continuing review on theschedule established by the IACUC, but no less than annually Maintain all IACUC records and manage access to records Review field work studies approved by outside institutions for compliance withregulatory guidance Function as point of contact between the IACUC and regulatory agencies Establish and maintain all correspondence with accrediting and regulatory agenciesinvolved in laboratory animal research and care, including annual reporting Develop and administer training for IACUC members and training for PrincipalInvestigators on IACUC policies and procedures Review publications and other sources of information, including applicable local andnational meetings, for information pertinent to the IACUC and Principal Investigatorsand distribute and/or discuss such information Participate in recruitment of IACUC members Process and maintain IACUC membership files including CVs Meet regularly with the IACUC Chair and IOAccountabilities To the IACUC Chair for IACUC administration8

Policy and Procedures - March 2021 To the Institutional Official for IACUC operationsTo the Laboratory Director for ORA AdministrationAuthorities Terminate IACUC meeting upon loss of quorum9

Policy and Procedures - March 20213.6 IACUC Principal InvestigatorRole Design and conduct properly approved research studies involving animalsResponsibilities Know and adhere to federal and BNL rules and regulations governing researchinvolving animals. Submit research protocols and amendments to approved protocols to the IACUC forapproval prior to start of work Retain copies of all correspondence with the IACUC Submit substantive annual reports of the results of research conducted under IACUCprotocols. Identify in the IACUC protocol all personnel working on the protocol, including otherinvestigators, technicians, etc. Direct the work of staff members conducting research under IACUC protocols. Ensure that all protocol personnel are appropriately qualified and that training is keptup 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, and ensure that research procedures thatare followed 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, by proper methods. Ensure that all approved protocols, amendments, and terminations are distributed to allprotocol personnel, and that such personnel have read and understand the documents. Promptly report animal distress or unexpected death to Attending Veterinarian and/orBLAF staff. Report any unusual or adverse event or unanticipated problem to the IACUC. Maintain records according to Sponsor’s requirements or for at least three yearsfollowing completion of research. Make records available for inspection by the IACUC or other federal or stategovernment agencies as required.Accountabilities To the IACUC To the Department Chair To the Department Training CoordinatorAuthorities Stop or interrupt an animal research study upon evidence of a hazard to the safety ofstudy personnel Stop or interrupt an animal research study if an issue of animal welfare and/orprotocol compliance arises10

Policy and Procedures - March 20214.0 AUTHORITY AND RESPONSIBILITY OF THE IACUC4.1 Authority4.1.1 The IACUC has the authority to review the animal program and facilities,and to approve, to require modification as a condition of approval, torequire additional information prior to committee review or prior toapproval, and to withhold approval of proposed research that is within itsscope of authority.4.1.2 The IACUC has the authority to suspend, limit, or terminate any ongoingapproved protocol.4.1.3 The IACUC has the authority to determine whether or not a researchactivity is covered by these policies and procedures, and whether theactivity requires review by the IACUC.4.2 Responsibilities4.2.1 To review, at least once every six months, the institution’s program forhumane care and use of animals, using the Guide as a basis for thisevaluation;4.2.2 To inspect, at least once every six months, all the institution’s animalfacilities using the Guide as a basis for evaluation;4.2.3 To prepare reports of the IACUC evaluations defined above, and submitthem to the Institutional Official;4.2.4 To review concerns involving the care and use of animals at theinstitution;4.2.5 To make written recommendations to the Institutional Official regardingany aspect of the institution’s animal program, facilities or personneltraining;4.2.6 To review and approve, require modifications in (to secure approval), orwithhold approval of those activities related to the care and use of animalsand consider the following in such review:4.2.6.1 Justification for the use of animals, the choice of species and thenumber of animals;4.2.6.2 Assurance that the activity will be conducted in accord with theAnimal Welfare Act insofar as it applies to the activity, and that theactivity is consistent with the Guide unless acceptable justification fora departure is presents;4.2.6.3 Procedures with animals will avoid or minimize discomfort, distress,and pain to the animals, consistent with sound research design;4.2.6.4 Procedures do not unnecessarily duplicate previous experiments;4.2.6.5 Procedures that may cause more than momentary pain or distress toanimals shall be performed with appropriate sedation, analgesia oranesthesia, unless the use of such pain relief measures iscontraindicated for scientific reasons and is justified in writing by thePI;11

Policy and Procedures - March 20214.2.6.6 Animals that would otherwise experience severe or chronic pain ordistress that cannot be relieved for scientific reasons shall beeuthanized at the end, or if appropriate, during the procedure;4.2.6.7 Living conditions for the animals will be appropriate for their speciesand contribute to their health and comfort. The housing, feeding anddaily care of the animals will be directed by a veterinarian or otherscientist trained and experienced in the proper care, handling and useof the species being maintained or studied. All exceptions to theGuide for housing, feeding and care must be justified by the PI andapproved by the IACUC;4.2.6.8 Medical care for animals will be available and provided as necessaryby a qualified licensed veterinarian;4.2.6.9 Personnel conducting procedures on the species being maintained orstudied will be appropriately qualified and trained in those proceduresand such training and qualifications will be documented;4.2.6.10 Methods of euthanasia used will be consistent with therecommendations of the American Veterinary Medical Association(AVMA) Panel on Euthanasia, unless a deviation is justified forscientific reasons in writing by the investigator.4.2.7 Report any unanticipated problem involving risk to an animal or anyinstance of serious, or continuing noncompliance with OLAW or anyinvoluntary suspension/termination of a protocol to OLAW and theresearch sponsor.12

Policy and Procedures - March 20215.0 RECRUITMENT, TRAINING, ORGANIZATIONAL STRUCTURE ANDMEMBERSHIP5.1 IACUC Recruitment and Training5.1.1 IACUC members are recruited from BNL employees, as well asneighboring institutions and the local community. Prospective IACUCmembers are interviewed by the IACUC Chair and/or the IACUCAdministrator, and their credentials are reviewed by both. The IACUCChair and Administrator then, if appropriate, recommend to the IO that theindividual be appointed to the IACUC. The IO sends a letter ofappointment.5.1.2 When an individual accepts an appointment to the IACUC, the IACUCAdministrator sends a letter explaining the operations of the IACUC andincludes links to the following documents: the BNL/NIH Assurance, theOLAW “Public Health Service Policy on Humane Care and Use ofLaboratory Animals” and the National Research Council “Guide for theCare and Use of Laboratory Animals”.5.1.3 The IACUC Administrator provides new members with anorientation/training session prior to their first IACUC meeting. Arefresher of this training is given every two years. New IACUC membersalso take the CITI Essentials for IACUC Members, which is good forthree years.5.1.4 The BNL Continuing Education policy provides new materials regardingupdates on animal research policies, as well as educational seminars andlectures given at BNL throughout the year. The IACUC Administrator,Chair and IACUC members attend various national meetings throughoutthe year, and disseminate any new information to the IACUC membersand investigators as appropriate.5.2 Appointment of Committee Members5.2.1 The Chair of the IACUC shall be appointed to a two to three-year,renewable term by and shall report directly to the IO.5.2.2 A Deputy Chair shall be appointed by the IACUC Chair and serve as theChair in his/her absence.5.2.3 The IO shall appoint all members of the IACUC to a two to three-year,renewable term.5.3 Composition of the IACUC5.3.1 Membership shall be in accordance with applicable federal policies:5.3.1.1 shall be comprised of one Chair and at least four additional votingmembers;5.3.1.2 shall include at least one doctor of veterinary medicine;5.3.1.3 shall include at least one non-scientist;5.3.1.4 shall include at least one practicing scientist experienced in researchinvolving animals;13

Policy and Procedures - March 20215.3.1.5shall include at least one member who is not now, nor was, withinthe past five years, affiliated with BNL and who is not part of theimmediate family of a person who is affiliated with BNL;5.3.2 Committee membership shall include the BLAF Manager as an ex-officio,non-voting member to serve as a liaison between the BLAF and theIACUC and the NASA Liaison as a non-voting, ex-officio member toserve as a liaison between NASA and the IACUC.5.3.3 The Committee shall be sufficiently qualified through the experience,expertise and diversity of its members, including consideration of race,gender, and cultural background and sensitivity to such issues ascommunity attitudes, to permit complete and adequate review of researchactivities conducted by BNL.5.3.4 The Committee shall be able to ascertain the acceptability of proposedresearch in terms of institutional commitments and regulations, applicablelaw, and standards of professional conduct and practice.5.3.5 The IACUC shall have the option to invite individuals with competence inspecial areas to assist in reviewing of issues which may require expertisebeyond, or in addition to, the expertise available on the IACUC. Such“specialists” shall not have voting rights.5.4 IACUC Membership Change Criteria5.4.1 The IACUC Chair and/or members may be removed from the IACUC forcause, as determined by the IO, or for administrative reorganization of thecommittee.5.4.1.1 Causes for removal from the committee may include, but are notlimited to: inappropriate personal conduct, poor attendance orinadequate participation in IACUC activities, or repeatedinadequate performance of assigned IACUC duties.5.4.1.2 Administrative reorganization of the committee may be requiredfrom time to time to maintain an effective compositional balanceas the membership of the IACUC changes due to expirations ofmembership terms and withdrawal or retirement of members fromthe committee.5.5 Non-Affiliated Members5.5.1 All non-BNL members are indemnified by a clause in the Prime Contractwith DOE.5.5.2 All non-BNL members are reimbursed 50 per meeting attended.5.6 Occupational Health and Safety Program5.6.1 A brief synopsis explaining the occupational health concern of exposuresto animal allergens and controls that can be taken will be posted at theentrance of the animal facility for all visitors to read before entering. Anyconcerns by the visitor can be addressed by the Occupational MedicalClinic or the Safety and Health Services Division.14

Policy and Procedures - March 20216.0 QUORUM AND VOTING6.1 A quorum shall consist of a majority of the voting members of the Committee. Aquorum is required for protocol review and suspension votes. The votingCommittee members comprising any quorum shall not have a conflict of interestwith respect to the matter being decided. Conflicted members may participate inthe discussion of the matter, but may not vote on the matter nor contribute to thequorum (see 6.4). Members may participate via conference call.6.2 Voting privileges shall be limited to those members present at the meeting.Alternates may not vote if the primary member is present. Proxy votes are notaccepted. A majority vote is required for any IACUC determination.6.3 Abstentions: A member may abstain from voting on a protocol. The abstentionwill be included in the minutes of the meeting.6.4 Conflict of Interest: If a member has, or is perceived to have, a conflict ofinterest with the matter under review, they must recuse themselves from votingand may be required to leave the room while the IACUC is voting.6.5 Minority Views: All minority views of the semi-annual report shall be recordedand transmitted in the semi-annual report to the Institutional Official.15

Policy and Procedures - March 20217.0 MEETING SCHEDULE AND AGENDA PREPARATION7.1 Meeting Schedule7.1.1 IACUC meetings are scheduled to be held once a month. Meetings maybe held by teleconference. Any use of telecommunications will be inaccordance with NIH Notice NOT-OD-06-052 of March 24th, 2006,entitled Guidance on Use of Telecommunications for IACUC Meetingsunder the PHS Policy on Humane Care and Use of Laboratory Animals.7.1.2 Members are polled prior to each meeting to ensure a quorum. There mustbe a quorum on each vote excluding members who will be required torecuse themselves due to conflict of interest.7.1.3 The IACUC Chair, Administrator, a Principal Investigator or IACUCmember may request an interim meeting, which may be called at theIACUC Chair’s discretion.7.2 Conduct of the Meetings7.2.1 Items are reviewed in the order in which they appear in the Agenda.7.2.2 Principal Investigators may request to be present to explain aspects ofinitial applications during a meeting should the committee desire; howeverthey must absent themselves during discussion and voting on theirprotocol.7.2.3 Voting is done in a closed session.7.3 Preparation of the Agenda7.3.1 The Agenda is prepared by the IACUC Administrator7.3.1.1 The IACUC Administrator ensures that all PIs are notified of anAnnual/Triennial Review at least two months in advance of theprotocol expiration date.7.3.1.2 The IACUC Administrator collects all items from PIs for Initial,Amendment, Annual and Triennial Reviews and compiles theAgenda.7.3.1.2.1 The Agenda includes the minutes from the previousmeeting and may also contain educational informationbeneficial to the IACUC.7.3.1.2.2 The Agenda includes all relevant documentation foreach protocol under review whether Initial, Annual,Triennial or Amendment.16

Policy and Procedures - March 20218.0 COMMITTEE RECORDS AND MINUTES8.1 Records Storage8.1.1 All administrative records of the IACUC are maintained in the ORAOffice.8.1.2 All active protocol files are maintained in the ORA Office.8.1.3 Access to these offices is restricted to designated personnel and the roomsare secured when the staff is absent.8.1.4 Records considered to be inactive are filed in the BNL Record HoldingArea and are held for a minimum of 75 years.8.2 Protocol-Specific Records.8.2.1 Each Protocol is assigned a unique number by the IACUC Administrator.Numbers are assigned sequentially.8.2.2 Records for each protocol, including all documentation reviewed by theIACUC, and correspondence relating to the protocol, as well as therelevant portions of minutes of the IACUC meeting, are maintained in anindividual protocol file.8.2.3 Protocols are filed numerically.8.3 Minutes and Agendas8.3.1 Minutes are taken at the meeting and are as inclusive as possible to recordthe true breadth of discussion by the IACUC.8.3.1.1 Minutes shall include the time of meeting, voting and alternatemembers present, the arrival and departure of members during thecourse of the meeting.8.3.1.2 All votes are recorded in the minutes listing number for, againstand abstaining, along with major discussions and any conditions

The Guide for the Care and Use of Laboratory Animals: The American Veterinary Medical Association (AVMA) Panel on Euthanasia: Public Law 99-158, Section 495 "Animals in Research": New York State Department of Health Regulations, Subpart 55-1 "Approval of Laboratories and Institutions for Use of Living Animals and for .