December 21, 2014

Humane Care and Use of Laboratory Animals

Marine Biological Laboratory
Policy No. K.1.4

ORAE

Initiated by:Chair, Institutional Animal Care and Use Committee
Approved by:Director/CEO
Date:November 5, 1999
Revision:
Distribution:MBL Community

1.0Policy Statement:
Marine Biological Laboratory (MBL) hereby states its policy to comply with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions.

2.0Applicability
This policy is applicable to all research, research and educational training, and biological testing activities, hereinafter referred to as activities, involving live, vertebrate animals supported by the Public Health Service (PHS) and other agencies that are conducted at this institution, or at another institution as a consequence of the subgranting or subcontracting of a PHS-supported activity by the institution. “Institution” includes the following branches and major components of the Marine Biological Laboratory: the Laboratory Animal Facility, the Marine Resources Center and the Office of Education.

3.0Institutional Policy

3.1This institution will comply with all applicable provisions of the Animal Welfare Act and other statutes and regulations relating to animals.
3.2This institution is guided by the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Research and Training.
3.3This institution acknowledges and accepts responsibility for the care and use of animals involved in activities covered by this assurance. As partial fulfillment of this responsibility, this institution will make a reasonable effort to ensure that all individuals involved in the care and use of laboratory animals understand their individual and collective responsibilities for compliance with this assurance as well as all other applicable laws and regulations pertaining to animal care and use.
3.4This institution has established and will maintain a program for activities involving animals in accordance with the Guide for the Care and Use of Laboratory Animals (Guide).

4.0Institutional Program for Animal Care and Use

4.1The lines of authority and responsibility for administering the program and ensuring compliance with this policy are:

4.2The institution has established an Institutional Animal Care and Use Committee (IACUC), which is qualified through the experience and expertise of its members to oversee the institution’s animal program, facilities, and procedures. The IACUC consists of at least five members, and its membership meets the compositional requirements set forth in the PHS Policy at IV.A.3.b. Attachment 1 contains a list of names, position titles, and earned degrees or other credentials of the IACUC chairperson and members.
4.3The specific procedures, which the IACUC will follow to fulfill the requirements, set forth in the PHS Policy at IV.B. are:

4.3.1.Review semi-annually the institution’s program for humane care and use of animals, using the Guide as a basis for evaluation. During this review, modifications, recommendations and updated requirements suggested by the Guide, IACUC committee members, or MBL Veterinarian to improve the humane use of laboratory animals will be discussed, evaluated and, where appropriate, integrated into the MBL’s IACUC program.
4.3.2.Inspect semi-annually all of the institution’s animal facilities (including satellite facilities) using the Guide as a basis for evaluation. A quorum of the IACUC will tour the animal facilities. The inspection will follow a specific checklist of categories and items to be evaluated. Concerns or deficiencies brought forth by the IACUC will be noted on the checklist. Recommendations for improvements will also be listed.
4.3.3Prepare reports of the IACUC evaluations as set forth in the PHS Policy at IV.B.3. and submit the reports to the Institutional Officer (IO) of the MBL. The IACUC reviews the MBL’s Animal Use Policy on a twice-annual basis. This annual review of Animal Facilities and the results of these reviews are reported to the IO by way of semi-annual reports. A specific checklist of categories and recommendations for improvements are listed as well as a timeline for action items.
4.3.4.Review in special meetings any concerns involving the care and use of animals at the institution, which are submitted to the chairperson of the IACUC in writing. It is the policy of the Marine Biological Laboratory to provide a means for individuals to express concerns involving the care and use of animals. All inquires will be directed to the Institution’s Veterinarian or IACUC Chair who will insure their complete anonymity. Further, there will be no threat of, or reprisals against, any person expressing those concerns. Notices of this policy will be posted on employee bulletin boards and in the Animal Care Facility.

Concerns raised by individuals other than IACUC members may be of two types: immediate or ongoing. Immediate concerns are referred to the Veterinarian or IACUC Chair, who then reports on the concerns and their intermediate disposition to the IACUC at the next meeting. If deemed necessary, a meeting of the IACUC may be initiated by the Veterinarian or Chair. Concerns that are not of an immediate nature are placed on the next meeting agenda and discussed as new business. After consideration of the concern and possible measures to be taken to alleviate it, the IACUC will recommend an appropriate response. The Veterinarian or Chair then transmits to the individual, the IACUC’s response addressing the concerns or questions that have been expressed. If an inquiry raises serious or important questions that need to be corrected, the IACUC as a body ensures that appropriate actions as necessary are taken including immediate suspension of the questioned activity(ies) by the investigator or institution. All serious actions or activity suspensions taken by the IACUC are submitted to the Institutional Officer and reported immediately to OPRR. These, along with any other minor or routine concerns and responses, plus minority opinions are included as an appendix to the Annual Report to OPRR.
4.3.5.Make written recommendations to the Institutional Officer regarding any aspect of the institution’s animal program, facilities or personnel training. The IO administers the MBL’s OPRR Assurance Program. Thus, matters dealing with IACUC issues are brought to and carried forward by the IO to the Director as a written and signed affidavit. This reporting structure covers the MBL veterinarian, IACUC Chairperson and the MBL’s IACUC Proceedings.

4.3.6.The committee will review sections of the PHS applications or proposals related to the care and use of animals as specified in IV.C. After review and discussion by the committee, the chairperson will submit in writing acceptance of, required modifications to, or reasons for disapproval of such applications to the applicant and to the IO.

The IACUC will meet on a routine basis as needed throughout the year. A majority of members (quorum) must be present. The IACUC Secretary will record proceedings of the meetings and votes taken for protocol approvals as official minutes of the meetings. The IACUC will review protocols from in-house and summer researchers involving the care and use of animals in research. Protocols will be submitted on a standard form for initial review. The IACUC protocols will be received by the Chair who will assign a current protocol number and then the protocols will be logged in by the IACUC Secretary. The Chair, Veterinarian, or any IACUC Scientist may present and review protocols at the IACUC meeting. All protocols must be approved by majority vote prior to animals being ordered for research.

To avoid unnecessary delays in research or teaching schedules, the Chair, after consultation with the Veterinarian, may allow under the Institution’s blanket protocol, the ordering of animals to be covered under a protocol that has been submitted, falls within the criteria normally acceptable to the IACUC, and is awaiting IACUC approval review. However, full IACUC approval must be secured prior to their use by the investigator(s). This may be expeditiously done by Polling: circulating said protocol to all Committee members, soliciting their comments within a designated time period, and allowing any member to call for a complete meeting of the IACUC if he/she feels there are aspects of the protocol needing clarification or full Committee discussion is warranted. If there are no comments or objections by Committee members, the Veterinarian or Chair may then approve the protocol and use of the animals under the Designated Member Review procedure.
4.3.7.Review and approve, require modifications in (to secure approval) or withhold approval of proposed significant changes regarding the use of animals in ongoing activities as set forth in the PHS Policy at IV.C. The committee will review all proposed significant changes regarding the use of animals when ongoing activities are brought to their attention by the veterinarian in charge, or by written request of applicant. After discussion by the committee, the chairperson will submit in writing, acceptance, required modification to, or reasons for denial of such changes to the applicant and the institutional official.
4.3.8. Notify investigators and the institution in writing of its decision to approve or withhold approval of those sections of applications or proposals related to the care and use of animals, or of modifications required to secure IACUC approval as set forth in the PHS Policy at IV.C.4. Written acknowledgement and acceptance by the principal investigator of the terms or conditions for IACUC approval must be received before research activities can begin.

4.3.9.Conduct continuing review of each previously approved, ongoing activity covered by PHS Policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with the PHS Policy at IV.C.1-4. at least once every three years. After review and approval of the initial animal care and use protocol, two annual renewal submissions are allowed for expedited review. A full protocol review is required every three years. The annual reviews will specify in detail any modification to the original approved protocol and the current yearly animal usage.
4.3.10.As an agent of the institution, the IACUC shall, with respect to PHS-supported and other supported activities, be authorized to suspend an activity involving animals as set forth in the PHS Policy at IV.C.6. The committee’s chairperson will be authorized to suspend immediately an activity involving animals in accord with specifications set forth in IV.C.6. The infraction or incident will be presented to the IACUC along with written testimony, explanation, or justification of the activity by the principal investigator involved. The IACUC will consider all the evidence and render a decision on the future of the activity and privilege of the principal investigator to conduct future animal research at the Marine Biological Laboratory.

4.4The individuals authorized by the institution to verify IACUC approval of those sections of applications and proposals related to the care and use of animals are the IACUC Chairperson, the MBL Veterinarian, the Institutional Officer, the Director and CEO.
4.5The health program for personnel who work in laboratory animal facilities or have frequent contact with animals is:

4.5.1Each caretaker will have a physical examination and medical and work history taken prior to beginning work as a caretaker.
4.5.2Pre- and post-employment serum samples will be taken and stored for each caretaker.
4.5.3Tetanus vaccinations will be kept up-to-date.
4.5.4Yearly physical examinations will be required for each caretaker.
4.5.5Protective clothing, gloves, masks, etc., will be provided.
4.5.6Each caretaker will be personally educated by the committee chairperson or veterinarian concerning potential health hazards in the facility. Methods of prevention will be developed when needed.

The MBL Animal Care Facility will have first aid kits available for use by a research or caretaker who may be bitten or scratched by an animal. On-the-job injuries of a serious nature will be sent to the Falmouth Hospital. For allergies and other medical issues of concern to specific individuals or projects, appropriate preventive measures will be taken after discussion with the Veterinarian, the MBL Safety Officer, and with the Hospital staff, as necessary.

4.6As part of this institution’s program for animal care and use, this institution will provide the following training or instruction to scientists, animal technicians and other personnel involved in animal care, treatment or use. Formal instruction will be scheduled annually for course assistants and scientists prior to the beginning of each course, upon arrival of all new personnel, and upon major changes in protocol procedures.

The veterinarian will be responsible for providing training to the Animal Caretaker and various animal users at the MBL. Training will include both general programs and specific programs. General programs will provide, at least annually, instruction in the following subjects:

4.6.1Review of the necessity of humane treatment of laboratory animals.
4.6.2Review and discussion of methods to decrease the number of animals used in research.
4.6.3Review and demonstration of methods of care for each species to be used. Specifically, the following subjects will be covered: methods of handling the animals, the maximum number of animals per cage, food and water requirements of the animals, etc.
4.6.4Review methods of observation to use for detection of medical problems.
4.6.5Review of methods of euthanasia available and provide training in such methods.

Specific training will be tailored to the needs of the individual. This training will include such subjects as the application of anesthesia, demonstration of aseptic surgical methods, pre and post surgical care, in-depth methods of proper maintenance of the animal facility, methods of handling animals in which hazardous agents have been used. A “completion of training report” will be filed by the veterinarian at the next scheduled IACUC meeting.

5.0Institutional Status
As specified in the PHS Policy at IV.A.2 as Category 2, all of this institution’s programs and facilities for activities involving animals will be re-evaluated by the IACUC at least twice each year. The IACUC will continue to use the Guide as a basis for evaluating the institution’s programs and facilities. This report will contain a description of the nature and extent of this institution’s adherence to the Guide. Any departures from the Guide will be identified specifically and reasons for each departure stated. Where program and facility deficiencies are noted, the report will contain a reasonable and specific plan and schedule for correcting each deficiency. The report will distinguish significant deficiencies from minor deficiencies. Semi-annual reports of the IACUC evaluation will be maintained by this institution and made available to OPRR upon request.

6.0Record Keeping

6.1This institution will maintain for at least three (3) years.

6.1.1A copy of this assurance as approved by PHS.
6.1.2Minutes of IACUC meetings, including records of attendance, activities of the committee and committee deliberations.
6.1.3Records of application, proposals and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld.
6.1.4Records of semi-annual reports and other recommendations as forwarded to the IO.
6.1.5Records of accrediting body determinations, including the USDA registration number (14-119).

6.2This institution will maintain records that relate directly to applications, proposals, and proposed changes in ongoing activities reviewed and approved by the IACUC for the duration of the activity and for an additional three (3) years after completion of the activity.
6.3All records shall be accessible for inspection and copy by authorized OPRR or other PHS representatives at reasonable times and in a reasonable manner.

7.0Reporting Requirements

7.1On or before each anniversary of approval of this assurance, this institution will report in writing to the Office for Protection of Research Risks (OPRR):

7.1.1Any change in the status of the institution (e.g. if the institution becomes accredited by AAALAC), any change in the description of the institution’s program for animal care and use as described in this assurance, or any changes
in IACUC membership. If there are no changes to report, this institution will submit a letter to OPRR stating that there are no changes.
7.1.2Verification that the IACUC has conducted an annual evaluation of the institution’s program and facilities and submitted the evaluation to the Institutional Officer.

7.2This institution will provide the OPRR promptly with a full explanation of the circumstances and actions taken with respect to:

7.2.1Any serious or continuing noncompliance with the PHS Policy.
7.2.2Any serious deviations for the provisions of the Guide.
7.2.3Any suspension of an activity by the IACUC.

8.0Policy Clarification and Updates:
Policy clarification and updates are available from the Chairperson of the IACUC committee or from the Office of the Chief Academic and Scientific Officer.