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Transmittal Notice

  1. Explanation of Material Transmitted: This revised chapter outlines the policy for protection of National Institutes of Health (NIH) personnel who work with or around nonhuman primates (NHPs). It establishes requirements for training, supervision, use of personal protective equipment, medical surveillance, accident reporting, and wound care. This revision deletes an appendix and includes revised definitions and new references.
  2. Filing Instructions:

Remove: NIH Manual 3044-2, dated 01/26/12.
Insert:NIH Manual 3044-2, dated 12/24/15.

PLEASE NOTE: For information on:

This policy establishes requirements for training, supervision, compliance, personal protective equipment, medical surveillance, accident reporting, and wound care with the intent to minimize the overall number of accidents, injuries and exposures sustained by NIH employees, contractors, and other personnel who work with nonhuman primates (NHPs) or enter rooms and areas containing NHPs.

This policy is applicable to all NIH-conducted or supported intramural activities involving animals (NCI Frederick is not included). All NIH components, contractors, or institutions with which NIH has collaborative or cooperative agreements must comply as applicable with the Animal Welfare Regulations (AWR), Public Health Service Policy on Humane Care and Use of laboratory Animals (PHS Policy) and other Federal statutes and regulations relating to animals. 

NIH intramural policy requires that each investigator or person involved with the care and use of nonhuman primates be appropriately qualified and trained in the NHP procedures they conduct. Training must also address the use of appropriate Personal Protective Equipment (PPE), wound care, and reporting procedures for injuries and exposures. Each investigator or person with direct contact to nonhuman primates or their tissues or body fluids must participate in the NIH Animal Exposure Program (AEP), or an equivalent program. All injuries or exposures involving nonhuman primates, tissues, or waste must be reported to the NIH Occupational Medical Service (OMS) upon completion of wound care. 

  1. Guide for Care and Use of Laboratory Animals, NRC 2010,  ISBN: 978-0-309-15400-0 (Book), 
    ISBN: 978-0-309-15401-7 (PDF). 
    http://grants.nih.gov/grants/olaw/guide-for-the-care-and-use-of-laboratory-animals.pdf

  2. Occupational Health and Safety in the Care and Use of Research Animals, NRC, 1997, ISBN: 0-309-05299-8 
    (book), ISBN: 0-309-05377-3 (PDF). http://www.nap.edu/openbook.php?isbn=0309052998

  3. Occupational Health and Safety in the Care and Use of Research Animals, NRC, 2003, 
    ISBN: 0-303- 08914-X (Book), ISBN: 0-309-50779-0 (PDF). http://www.nap.edu/catalog/10713/occupational-health-and-safety-in-the-care-and-use-of-nonhuman-primates

  4. NIH Manual Policy 1340, “NIH Occupational Safety and Health Management”.  

  5. NIH Manual Policy 3015, “Admittance of Minors to Hazardous Areas”.

  6. NIH Manual Policy 1743, “Keeping and Destroying Records,” Appendix 1, NIH Records Control Schedule. 

  7. NIH Occupational Medical Service. https://www.ors.od.nih.gov/sr/dohs/HealthAndWellness/OccupationalMedical/Pages/oms_main.aspx

  8. NIH Occupational Medical Service Animal Exposure Program. http://www.ors.od.nih.gov/sr/dohs/documents/IV.2%20Animal%20Exposure%20Program.pdf

  9. Cohen, J.I., et al, “Prevention of and Therapy for B Virus Exposure,” Clinical Infectious Diseases,
    2002, 35:1191-203. http://www2.gsu.edu/~wwwvir/PDFs/2002%20B%20Virus%20Guidelines.pdf

  10. Centers for Disease Control and Prevention and National Institutes of Health. 
    Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition. Washington, DC: US Government Printing Office. 2007.

  11. Centers for Disease Control and Prevention and National Institutes of Health. Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition. Section VIII—Agent Summary Statements and Section 
    VIII-E: Viral Agents.
     Washington, DC: US Government Printing Office. 2007.

  12. CDC National Institute for Occupational Safety and Health (NIOSH). Hazard ID 5: Cer
    copithecine herpesvirus
     1 (B virus) Infection Resulting from Ocular Exposure
    .

  13. NIH Exposure Control Program for Non-Hospital Personnel, 2015.  http://www.ors.od.nih.gov/sr/dohs/Documents/NIH%20Exposure%20Control%20Plan.pdf

  14. NIH Delegations of Authority, Program: General No. 31, NIH Intramural Animal Care and Use Program. https://www.delegations.nih.gov/DOADetails.aspx?id=1673

  15. Medical Clearance of Transient Visitors into NIH Animal Facilities, NIH Deputy Director for Intramural 
    Research memorandum dated 7May2015.http://www.ors.od.nih.gov/sr/dohs/Documents/Medical%20Surveillance%
    20of%20Transient%20Visitors%20into%20NIH%20Animal%20Facilities.pdf

E. Definitions

  1. Animal Exposure Program (AEP) - That portion of the NIH occupational health program, specifically designed for NIH personnel who work in animal facilities and/or areas where research animals are housed or used, and/or NIH personnel who have significant contact with research animals or their fresh tissues or body fluids (significant contact determined by the Principal Investigator or Immediate Supervisor).  The AEP is directed and managed by the Occupational Medical Service (OMS), Division of Occupational Health and Safety (DOHS).  NIH Institute and Center programs without OMS-DOHS directed AEP programs shall implement equivalent AEPs, as appropriate.

  2. Animal Facility Management — An individual or individuals at each nonhuman primate (NHP) facility assigned direct responsibility for NHPs and/or facilities that may contain NHPs. 

  3. Animal Research Advisory Committee (ARAC) – A component of the NIH Intramural Animal Research Program whose members include the Chairs of each IC Animal Care and Use Committee (ACUC).  The ARAC serves as an advisory body to the Institutional Official.

  4. ARAC Guidelines - Guidelines developed and approved by the ARAC to assist the NIH Intramural Animal Research Program in providing consistent laboratory animal care and use across the NIH Intramural Research Program (IRP). http://oacu.od.nih.gov/ARAC/index.htm

  5. ACUC-approved Animal Research Facility – An animal holding facility or special procedure area/facility and its personnel, which are overseen by an animal research program and its IC ACUC.

  6. Animal Study Proposal (ASP) – Written plan for research involving animal models that must be reviewed and approved by the IC ACUC before animal activities can be conducted.

  7. Awake Procedures – Activities and/or manipulations that place an individual at reasonable risk of contact with an awake NHP or its feces or body fluids. Examples of awake procedures include placing food in a NHP cage or feedbox, using a squeeze-back mechanism, jumping a NHP to another cage or transport device, pole and collar work, placing a NHP in a chair or other restraint device, or behavior recording within a 2 foot radius.

  8. Awake Procedure Trainer – Individual responsible for documenting trainee competency in awake procedures and providing additional awake procedures training, if needed. This trainer would be the Principal Investigator/Immediate Supervisor or their designee. The trainer must have successfully completed the Working Safely with Nonhuman Primates Course and mandatory annual NIH safety courses sponsored by the NIH Division of Occupational Health and Safety (DOHS).

  9. Contract Personnel - Individuals employed by a contract company to provide services at NIH.

  10. Division of Occupational Health and Safety (DOHS) – A component of the Office of Research Services, Office of Management, Office of the Director. Serves as the NIH operational component in developing and implementing NIH-wide safety and health programs through surveillance, consultation, training and education. http://www.ors.od.nih.gov/sr/dohs/Resources/Pages/Animal-Related-Personnel.aspx  

  11. Exposures - The contact of a person’s naked skin or mucous membranes to NHP saliva, cells, or body fluids.  Exposures include NHP bite, scratch or splash incidents.

  12. Gloves:

    1. Exam gloves – Vinyl, latex or nitrile gloves which prevent contamination of skin by wet or dirty surfaces.

    2. Arm length bite protection gloves - Heavy, reinforced gloves, usually of leather or similar material. The sleeves of these gloves should extend up to or over the elbows offering protection of the hands and forearms. These gloves usually prevent an animal bite from breaking the skin; however, they may not prevent an animal from biting or causing injury.

  13. Hand sanitization – The use of foam or liquid hand rubs to reduce skin pathogens. Hand sanitization is not a substitute for hand washing.

  14. Hand washing – The use of soaps coupled with copious rinsing with free flowing water.

  15. Institute/Center (IC) – Programs within the NIH IRP that participate in animal-based research.

  16. IC-Animal Care and Use Committee (IC-ACUC) - A committee appointed via delegated authority from the Institutional Official by the Director or Scientific Director of the IC. The committee oversees the IC's animal research program, facilities and procedures, including the key functions of reviewing and approving requests to use animals in Animal Study Proposals.

  17. Immediate Supervisor (IS) – Individual with direct responsibility for personnel listed as trainees under this chapter. The IS can include facility managers, facility veterinarians, PI staff, contract managers, etc.

  18. Institution – The NIH Intramural Research Program including its facilities and contracted or subcontracted activities performed in accordance with NIH Policy Manual 3040-3 or other applicable acquisition regulations.

  19. Institutional Official (IO) – The NIH Deputy Director for Intramural Research (DDIR). The Director, NIH, as the Chief Executive Officer of the institution, has delegated to the DDIR the authority and responsibility for compliance of the NIH Intramural Research Program with US Public Health Service Policy, the Guide for the Care and Use of Laboratory Animals, and the US Department of Agriculture Animal Welfare Act Regulations.

  20. Macaque Monkeys – A category of NHPs commonly used in biomedical research at NIH, such as rhesus, cynomolgus, and pigtail monkeys. Macaque monkeys are carriers of Herpes B Virus/Macacine herpesvirus.  Any tissues or body fluids derived from macaques are considered to be potentially contaminated with Herpes B Virus. 

  21. Minor – A person under the age of 18 years old.

  22. Mucous Membrane Protection - A device or combination of devices which protect the mouth, nose and eyes from splash or droplet contamination; such as a full face shield, surgical face mask combined with form fitting goggles or approved protective glasses, etc.

  23. Nonhuman Primate (NHP) –Any member of a NHP species held or used for research at NIH.

  24. NHP Course Trainer – Individuals at the IC and/or facility level who conduct one or both portions of the “Working Safely with Nonhuman Primates” training course. These individuals may be animal care or research staff members. Typically trainers are also involved with the oversight or daily care of the IC’s NHPs.

  25. NHP Facility – Any buildings, rooms, or areas, including satellite facilities and lab spaces, where NHPs may be housed or held for research manipulations to include surgical manipulations and imaging.

  26. NHP Tissues and Body Fluids – Any primary cells, tissues, blood or body fluids derived from NHPs. 

  27. Occupational Medical Service (OMS) – A component of DOHS that develops and implements the Animal Exposure Program. http://www.ors.od.nih.gov/sr/dohs/OccupationalMedical/Pages/oms_main.aspx

  28. Personal Protective Equipment (PPE) – Items of clothing (i.e. lab coats, shoe covers, face masks, gloves, etc.) or equipment (i.e. face shields, eye goggles, etc.) designed to prevent or limit exposure to potentially harmful agents to personnel. The hazards addressed by protective equipment include biohazards, physical, electrical, heat, chemicals, and airborne particulate matter.   https://www.osha.gov/SLTC/personalprotectiveequipment/

  29. Principal Investigator (PI) – A scientist designated by the Laboratory/Branch Chief or the IC Director or Scientific Director who is responsible for conducting or managing an animal study in compliance with this policy, the Public Health Service Policy on Humane Care and Use of Laboratory Animals, the Guide for the Care and Use of Laboratory Animals, and the US Department of Agriculture Animal Welfare Act Regulations.  The PI certifies acceptance of this responsibility by signing the Animal Study Proposal.

  30. Standard Operating Procedure (SOP) – Detailed, written procedures that describe how to perform a particular task or overall duty/responsibility.

  31. Street Clothes Covering – A garment such as a lab coat or coveralls, worn to cover and protect street clothes from contamination when the individual is inside an animal facility. This garment should not be worn outside the animal facility. A uniform may be substituted for a covering garment; but a uniform should not be worn outside the animal facility without an appropriate covering.

  32. Trainee – Those individuals who do not have documented training and experience in handling and working with nonhuman primates.

  33. Transient Visitors—A category of animal facility visitors who are authorized to enter an animal room when accompanied by an escort trained in proper animal room entry procedures and practices.  Transient visitors are not authorized to have direct contact with animals. Transient visitors may include, but are not restricted to: federal employees and contractors, maintenance and construction workers, general public members, nonaffiliated ACUC members, special volunteers, guest workers, and visiting postdoctoral fellows.

  34. Uniform – Clothing dedicated for use only in the animal facility. In most circumstances, it would not be worn outside the animal facility without appropriate covering.

F. Responsibilities

  1. The DOHS is responsible for:

    1. Providing general guidance on the selection and use of personal protective equipment for animal facilities and other areas that support animal research. Specific PPE guidance shall also be provided to PIs and facility managers when NHP activities involve working with infectious diseases, hazardous chemicals, etc.

    2. Selecting and approving occupationally required respirators.

    3. Periodically reviewing training documentation as part of their safety inspections.

    4. Reviewing training documentation as part of an incident investigation involving a NHP-related injury or illness.

    5. Regularly reviewing injury and illness occupational reports and making accident information available to the Associate Director for Training of the Office of Animal Care and Use (OACU).

    6. Providing appropriate medical support services for animal research (e.g. pre-placement medical evaluations; risk assessment; AEP enrollment; care for work related injuries, exposures and illnesses; and Worker’s Compensation.)

  2. The IC ACUC is responsible for:

    1. Ensuring all individuals working with NHPs receive initial safety awareness training by completing the “Working Safely with Nonhuman Primates” course as outlined in section G.2.

    2. Ensuring those individuals working with awake NHPs receive competency assessment and additional training (if needed).

      1. Research staff members:

        1. Performance of NHP awake procedures are delineated in the PI’s Animal Study Proposal(s).

        2. Competency for conducting NHP awake procedures are listed as part of their ASP Training and Experience documentation records; and if additional training is needed, it are documented in the PI’s training records.

      2. Animal program staff members:

        1. Performance of NHP awake procedures are described and delineated in facility SOPs.   

        2. Training and experience related to performing NHP awake procedures are documented in the facility’s training records.

  3. The Associate Director for Training, OACU is responsible for:

    1. Developing and managing the NIH-wide training program.

    2. Providing NHP Course Trainers with the information and outline to administer the “Working Safely with Nonhuman Primates” course.

    3. Ensuring training addresses safe and humane NHP work practices, adheres to DOHS safety standards, and addresses DOHS-identified accident report trends of potential problem areas.

  4. The Principal Investigator (PI) or Immediate Supervisor (IS) is responsible for:

    1. Completing both components of the “Working Safely with Nonhuman Primates” course if NHPs are a listed in their animal study proposals.

    2. Ensuring their research staff members working with NHPs comply with the provisions of this PM and any other special requirements or procedures specific to the facility within which they are conducting NHP procedures. In addition, the PI/IS will take corrective action for failure to comply with the provisions of this policy.

    3. Being prepared to provide copies of all NHP training documentation to DOHS during routine safety surveys and/or having copies available for DOHS during incident investigations involving NHP-related exposures, injuries or illnesses.

    4. Being prepared to provide copies of all NHP training documentation to their IC ACUC if requested.

    5. Ensuring a trainee’s competency in conducting awake NHP procedures is appropriate and fully documented before allowing a trainee to perform these procedures independently.

    6. Ensuring that trainees who have not performed NHP procedures and/or NHP awake procedures within the past 6 months, e.g. summer students, document their re-taking the initial NHP Safety Awareness and if applicable, the NHP Awake Procedures training before working with NHPs.

  5. Animal Facility Management is responsible for:

    1. Providing and maintaining Macaque Bite/Scratch/Splash Kits.

    2. Obtaining clinical samples from NHPs that are involved in personnel-related accidents, illnesses, or exposures.

    3. Completing the Macaque Health Report form located in the Macaque Bite/Scratch/Splash Kit for submission to OMS following a macaque-related accident, illness or exposure.

  6. The trainee is responsible for:

    1. Adhering to all provisions of this Policy Manual.

    2. Completing the initial safety awareness training.

    3. Completing any additional training that their PI/IS has established for them prior to attempting unsupervised, procedures on a NHP.

  7. NHP Course Trainers are responsible for:

    1. Conducting one or both components of the safety awareness training course: “Working Safely with NHPs.”

    2. Entering into the OACU training database, documentation of trainees’ completion of the second component of the “Working Safely with NHPs” course. Training rosters for the first component, if conducted separately, should be kept at the IC level.

  1. Personnel Restrictions:

    1. All personnel including Transient Visitors, who have not been appropriately trained, and will be entering facilities containing NHPs must be accompanied by a responsible facility staff member who is knowledgeable in the behavior and handling of NHPs.

    2. Minors may not work with or be present for procedures or research activities involving awake NHPs.

    3. Transient Visitors must meet the medical testing requirements established by the facility Animal Program Director prior to entering a NHP animal facility or room as noted in DOHS memorandum: Medical Clearance of Transient Visitors into NIH Animal Facilities.

  2. Training:

    1. All personnel working directly with NHPs or regularly entering a facility containing NHPs shall complete the “Working Safely with NHPs” safety awareness training course prior to unsupervised entry.

    2. Those individuals having interaction with awake NHPs may also need additional training in approaching and handling NHPs. Certification is ensured by the Principal Investigator or Immediate Supervisor that a basic level of competency in performing awake procedures has been achieved. See PI/IS responsibilities paragraph E.4.

    3. The safety awareness training course: “Working Safely with NHPs” (NHP Course) consists of two components:

      1. “Working Safely with NHPs” video/CD, quiz and review of pertinent NIH Policy Manuals; and

      2. Review of facility PPE requirements and location of bite/scratch/splash kits and eyewash stations.

    4. The first component of the training is the responsibility of each IC that owns NHPs and may be offered separately at the Institute level or may be delegated to other responsible individuals.

    5. The second component of the training must be conducted at the NHP facility level.

    6. Personnel entering multiple facilities where they work directly with NHPs or enter NHP facilities without supervision, must complete the second component of the training for each facility.

    7. Upon completion of both components of the “Working Safely with NHPs” course, the NHP Course Trainer will document the trainee course completion in the OACU Training database.

    8. Transient Visitors who do not directly handle NHPs and/or infrequently enter a facility containing NHPs, must complete the second component of the “Working Safely with NHPs” safety awareness training course. The second component of the course addresses the facility’s PPE requirements, location of bite/scratch/splash kits, and eyewash stations. 

  3. Personal Protective Equipment:

    1. All individuals entering a NHP room must wear appropriate personal protective clothing and equipment which meets or exceeds the guidance established by the NIH Animal Research Advisory Committee (ARAC):Guidelines for Personnel Protection in Animal Facilities http://oacu.od.nih.gov/ARAC/documents/PPE.pdf

    2. Individuals participating in animal study proposals (ASP) which involve additional safety hazards such as infectious diseases or hazardous chemicals must consult with the DOHS safety recommendations written into the approved ASP(s) or a DOHS Safety Specialist.

  4. Occupational Medical Services:

    1. All persons having direct contact with NHPs and their tissues or body fluids must participate in the NIH AEP provided by the OMS.

    2. All contract personnel having direct contact with NHPs and their tissues or body fluids must participate in an AEP that is equivalent to that offered by OMS of the NIH and which is provided by their employer.

    3. Transient Visitors are not required to participate in the AEP; however,  prior to entering NHP holding and procedure areas, Transient Visitors will be required to comply with the facility health screening requirements (i.e., provide proof of TB testing, Measles vaccination, Measles titer or Measles infection history.) as determined by the facility’s Animal Program Director.

  5. Employee Wound Care and Reporting Procedures for All NHP-related Injuries/Illnesses/Exposures:

    1. ALL personnel involved in injuries and exposures involving NHPs, NHP wastes, fresh NHP tissues or body fluids, or potentially contaminated equipment must immediately initiate wound or mucous membrane first aid.  OMS must be contacted as soon as possible after the occupational exposure regarding any additional treatment and/or follow-up care instructions.

    2. After initial wound or mucous membrane care is completed and appropriate medical treatment is sought, the individual must report the incident/exposure to their PI/IS and the animal facility management where the NHP is housed.

    3. Another individual can contact OMS, the animal facility management, and the individual’s PI/IS to report the incident while the injured person is receiving first aid or seeking medical attention. 

  6. Employee Wound Care and Reporting Procedures for Macaque-related Injuries/Illnesses/Exposures:

    1. General wound care guidance for macaque bite, scratch or splash exposures is found in the document: “Macaque Bite, Scratch & Splash Care Instructions for Employees”.

    2. The management staff for each NHP facility is responsible for maintaining an adequately stocked Macaque Bite/Scratch/Splash Kit.

    3. The Macaque Bite/Scratch/Splash Kit must be located in an easily accessible area. Changes in locations and/or instructions related to these kits must be communicated to the NHP Course Trainer and subsequently forwarded to all prior trained individuals.

    4. The facility NHP Course Trainers are responsible for showing the location and contents of the Macaque Bite/Scratch/Splash Kits and the locations of the eyewash stations to the research and animal care staffs during the second component of the “Working Safely with NHPs” training.

  7. Fresh Tissue/Body Fluid Users:

    1. Macaque monkeys and their tissues and body fluids are potentially infected with Herpes B Virus/Macacine herpesvirus.  

    2. Principal investigators (PIs) and their research staff handling fresh tissues, blood or body fluids from macaques (Rhesus, Pigtail, and Cynomolgus monkeys) outside an ACUC-approved ASP or NHP animal research facility, are required to register their work and the experimental use of these materials with the NIH Institutional Biosafety Committee (IBC) via PI-DASHBOARD
      http://www.ors.od.nih.gov/sr/dohs/BioSafety/Pages/Registrations.aspx

    3. The NIH-IBC registration will incorporate/identify all associate investigators, technicians, and affiliated lab personnel who will in any manner handle the macaque tissues, blood or body fluids regardless of their status on a given Animal Study Proposal.

    4. Individuals at the NIH who will in any manner handle fresh macaque NHP tissues, blood or body fluids must have documentation indicating they are current with the mandatory DOHS safety training courses  especially:

      1. Working Safely with HIV and Other Bloodborne Pathogens for Non-Hospital Personnel  for first time attendees, or

      2. The annual Bloodborne Pathogen Refresher Course (Online)

    5. Macaque  monkey tissues, blood or body fluids fixed and/or preserved in formalin, glutaraldehyde, or paraformaldehyde (and using well-documented, evidence-based methods shown to be effective in rendering samples non-infectious) are not considered ‘fresh’ and do not require registration with the NIH IBC PI-DASHBOARD.

    6. Work with fresh tissue, blood, or body fluids derived from ‘New-World’ NHP species (squirrel monkeys, owl monkeys, cebus monkeys, tamarins, marmosets, etc.) does not require an IBC registration.

    7. Veterinary care procedures performed by the veterinary or animal care staff within an animal research facility are exempt from NIH-IBC registration.

    8. Changes to experimental work with fresh macaque tissues, blood or body fluids already registered (and related to an already-approved registration) must be submitted as an amendment to the existing NIH-IBC registration. Amendments are also required to update personnel and location-of-work changes.

    9. If fresh macaque NHP tissues, blood or body fluids are provided by a PI to another NIH laboratory or individual working outside of an ACUC-approved NHP animal research facility:

      1. The receiving PI must hold an NIH IBC-approved registration to receive the material.      

      2. The NIH-IBC registration must be established prior to the transfer and receipt of the samples.

      3. The transferring PI is responsible for ensuring the receiving PI holds an NIH IBC-approved registration for work with this material in NIH laboratories outside of ACUC-approved NHP animal research facilities.

    10. If fresh macaque NHP tissues, blood or body fluids are provided by a PI to another laboratory or individual outside of the NIH, the transferring PI is responsible for ensuring that the receiving laboratory or individual:

      1. Knows the human health related risks associated with the handling of fresh macaque NHP tissues blood or body fluids, and

      2. Understands their responsibility for being in compliance with their institution’s policies and procedures relating to the handling of potentially infectious material.

    11. Once a sample is appropriately transferred to another laboratory (i.e. research, clinical, pathology, etc.), the receiving PI and laboratory is thereby responsible for the subsequent disposition of the transferred material in accordance with this policy.

  8. Compliance:

    1. All NIH employees, contract personnel and other personnel working directly with NHPs shall comply with procedures set forth in this Policy Manual.

    2. Continued failure to comply with requirements set forth in this policy shall be reported to the Scientific Director and/or Institute Director and may result in suspension of the privilege to use NHPs in research protocols or other disciplinary action.

    3. The Institutional Official shall be informed of such infractions and may impose additional disciplinary actions.

H. Records Retention and Disposal

All records pertaining to this chapter must be retained and disposed of under the authority of NIH Manual 1743,"Keeping and Destroying Records," Appendix 1, "NIH Records Control Schedules" (as amended). These records must be maintained in accordance with current NIH Records Management and Federal guidelines. Contact your IC Records Liaison or the NIH Records Officer for additional information. 

I. Internal Controls

The purpose of this manual is to establish requirements for training, supervision, compliance, personal protective equipment, medical surveillance, accident reporting, and wound care with the intent to minimize the overall number of accidents and injuries sustained by NIH employees, special volunteers, and visitors who work with nonhuman primates or enter nonhuman primate rooms. 

  1.   Office Responsible for Reviewing Internal Controls Relative to this Chapter: Office of Animal Care and Use and the Office of Intramural Research.

  2.   Frequency of Review (in years): Ongoing with formal reports presented to the Animal Research Advisory Committee (ARAC) semiannually, annually and triennially as described below.

  3.   Method of Review:

    1. The procedures implemented by this chapter receive an ongoing review by the Office of Animal Care and Use (OACU) via their interface with all IC-ACUC’s on a continuous basis. Any significant changes in training policies or animal procedures are noted and acted upon as needed rather than at a specified time.

    2. Semi-annually the IC-ACUC’s perform a complete review of their animal care programs, a component of which is a review of the adequacy of IC training and experience. These semi-annual reports are filed with OACU. The OACU staff members review these reports, prior to their submission for review by the DDIR, and the OACU Director then provides a consolidated report to the ARAC regarding trends, concerns, etc. that affect the Intramural Animal Care and Use Program (ACUP).

    3. Annually the Division of Occupational Health and Safety compiles a report of bite and scratch injuries related to work with nonhuman primates and presents this to the NIH Occupational Safety and Health Committee and the ARAC. This report provides a basis for discussion of trends seen within this work arena and provides an avenue for both the NIH as well as the Intramural ACUC’s to develop new guidance if concerns exist.

    4. Triennially, the Intramural ACUP is visited by their accrediting organization, the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC). Training and experience with NHPs is a part of AAALAC’s extensive review of the NIH. AAALAC provides a report of their findings to NIH which in turn is presented to the ARAC for deliberation and resolution.

    5. The Intramural Research Program (IRP) must make annual reports to both the United States Department of Agriculture and the NIH Office of Laboratory Animal Welfare (OLAW.) These agencies have regulatory authorities over the NIH IRP Animal Care and Use program. Per the PHS Policy, instances of significant noncompliance are required to be reported to OLAW.

    6. In addition, the IC Directors or Scientific Directors participate in the Annual Intramural Self-Assessment of Management Controls, through completion of a set of comprehensive checklists of questions, several of which address concerns covered by this chapter. This process is managed by the Office of Intramural Research.

  4. Review Reports are sent to: the Deputy Director for Intramural Research and the Deputy Director for Management.


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