University of Hawai‘i
Research Compliance

Policies

IACUC Policies and Guidelines

Policy 1 – Field Studies

1.1.0 Statement

Field Studies which involve only observation, and do not harm or materially alter the behavior of the animals under study may be exempt from the formal UH IACUC protocol review and approval procedure.

1.2.0 Definition

Field study means any study conducted on free-living wild animals in their natural habitat, which does not involve animal manipulation, and which does not harm or materially alter the behavior of the animals under study {9 CFR Subchapter A — Animal Welfare, 2.31 (c)(2) and (d)(1) Animal Plant and Health Inspection Service, USDA, Animal Welfare Act}.

1.3.0 Guidelines

Investigators and/or advisors of students proposing to conduct field studies are required to submit an accurate written description of the research activity, and if applicable, any supporting references and documents (e.g. departmental, regulatory and/or funding agency) to the Chair and Compliance Office for review prior to conducting the research. The investigator and/or advisor will be notified in writing whether the proposed research is exempt from further review or will warrant formal UH IACUC review and approval prior to the research commencing.

1.4.0 Exemptions to Policy
  1. Researchers conducting field studies that request formal UH IACUC review and approval.
  2. Researchers conducting field studies that are required to undergo formal UH IACUC review and approval by regulatory and/or funding agencies.

IACUC Approved 11/96

Policy 2 – Animal Adoption

2.1.0 Statement

Euthanasia is the primary means for the disposition of animals at the end of a study; however, in some special cases animals may be put up for adoption. To determine if adoption is applicable to a protocol, refer to the guidelines and the description of animals to be considered for adoption in section 2.3.0. of this Policy.

2.2.0 Restrictions

The IACUC in consultation with the University veterinarian(s) reserves the right to make the final decision if adoption is applicable. Each request will be handled on a case by case basis. Cases which cannot be resolved and decided by the IACUC will be deferred to the Designated Institutional Official.

2.3.0 Guidelines
  • Non-restricted Species. Those species that do not have regulations place upon them which would restrict adoption. For example, the Center of Disease Control regulations on primates restricts their disposition as stated, “Imported non-human primates and their offspring may be imported and sold, resold, or otherwise distributed only for bona fide scientific, educational, or exhibition purposes.
  • No hazardous agents have been used in the species. Under Section X of the IACUC protocol form, none of the following has been used in the species: radioisotopes, biological hazards/pathogens, hazardous chemicals or drugs, recombinant DNA or other agents which would render the animals unsuitable for adoption.
  • No invasive procedures have been used on the species. Under Section VII of the IACUC protocol form, the animal has not undergone survival surgery as part of the experimental protocol.
  • Only physically normal animals will be considered for adoption. Those animals that have been examined by a veterinarian and found free of any obvious physical abnormalities or obvious infectious disease that might affect its well-being or the well-being of other animals.
  • Only socially adjusted animals will be considered for adoption. Animals will be screened by the Laboratory Animal Service (LAS) staff and the adopting agency such as the Hawaiian Humane Society (HHS) to determine their suitability for adoption. Examples of criteria for determining social adjustment will include animal’s temperament and ease of handling.
2.4.0 Logistics
  • The HHS is the primary vehicle to adopt out suitable animals for LAS.
  • If the HHS does not serve as the vehicle to adopt out animals, the IACUC and University veterinarian(s) will consult with the Designated Institutional Official to determine by what means animals can be released for adoption. In these situations, the adopting person(s) are required to agree to sign a waiver to release the University from any veterinary and legal responsibilities.

IACUC Approved 12/96

Policy 3 – Animal Euthanasia & Disposition

3.1.0 Statement

Disposition of animals at the end of experimentation or teaching/instruction activities are by euthanasia or adoption (Section IX. Of animal use protocol form). Refer to IACUC Policy 2.0 on adoption policy.

3.2.0 Restrictions
  • The University strictly prohibits human consumption of animals that have been used for experiments and treated with any known hazardous chemical agent, and/or euthanized with any known hazardous chemical agent. The chemical agents are not limited to these that are listed. Some examples are radioisotopes, biological hazard/pathogens, antibiotics or drugs, recombinant DNA or other agents.
  • University animals and their products (e.g. milk, eggs, etc.) that are used for production application (e.g. agriculture and aquaculture) may be consumed if they do not fall into section 3.2.a. and are distributed under normal commercial marketing practices. These animals are sometimes treated or fed some food/feed additives that are considered safe for human consumption provided that the administration of the additives follow the manufacturers directions, and whenever applicable, compliance with withdrawal periods are strictly practiced.
  • Otherwise, euthanized animals and tissues will be stored in formalin or refrigerated/frozen for future study or,
  • Euthanized animals and tissues will be frozen in designated freezers then incinerated.
3.3.0 Guidelines
  • The method of euthanasia chosen must be approved by the IACUC and University veterinarian’s office and preferably referenced in the 2007 AVMA Guidelines on Euthanasia.
  • If the method of euthanasia chosen by the investigator is not referenced in the 2007 Report, the investigator is required to provide scientific justification, and if available, references for the proposed method. The IACUC in consultation with the University veterinarian’s office reserves the right to make the final decision if the proposed method of euthanasia is acceptable.
  • All personnel that will euthanize animals are required to be certified as proficient in the proposed method of euthanasia by the University veterinarian’s office prior to applying the method in their research or teaching/instruction activities.

IACUC Approved 04/97

Policy 4 – Membership and Terms

4.1.0 Statement and Scope

According to Federal law, the University’s responsible administrative official must appoint an IACUC, also referred to as “the committee” to oversee and evaluate the institution’s animal programs, procedures and facilities to ensure that they are consistent with these and other applicable Federal laws, guidelines and policies.

  1. Animal Welfare Act (Public Law 89-544, 1966, as amended (P.L. 91-579, P.L. 94-279 and P.L. 99-198) 7 U.S.C. 2131 et.seq., 9 CFR Ch. 1, Subchapter A, Parts 1, 2, and 3.
  2. Public Health Service Policy on Humane Care and Use of Laboratory Animals
    (Health Research Extension Act of 1985; 42 U.S.C. 289d P.L. 99-158).
  3. US. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training (Interagency Research Animal Committee)
4.2.0 Membership
  1. Animal Welfare Act mandates that “the committee” shall be composed of a Chairman and at least two additional members of which:
    • One member shall be a Doctor of Veterinary Medicine with training or experience in laboratory animal science and medicine, who has direct or delegated program responsibility for activities involving animals at the research facility; and
    • One member shall not be affiliated in any way with the facility other than as a member of the committee and shall not be a member of the immediate family of a person who is affiliated with the facility.
  2. Public Health Service Policy mandates that “the committee” shall consist of not less than five members, and shall include at least:
    • One Doctor of Veterinary Medicine, with training or experience in laboratory animal medicine, who has direct or delegated program authority for activities at the institution;
    • One practicing scientist experienced in research involving animals;
    • One member whose primary concerns are in a nonscientific area (e.g. ethicist, lawyer, clergy); and
    • One individual who is not affiliated in any way other than as a member of the committee, and is not a member of the immediate family of a person who is affiliated with the institution.
  3. Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching recommends that “the committee” should consist of at least:
    • One Doctor of Veterinary Medicine, with training or experience in agricultural animal medicine;
    • One practicing scientist with experience in agricultural research or teaching involving agricultural animals;
    • One animal scientist who has appropriate training in the management of agricultural animals and recognized high professional credentials as verified by the scientific and professional societies in animal science;
    • One individual who is not affiliated in any way other than as a member of the committee, and is not a member of the immediate family of a person who is affiliated with the institution; and
    • Other members as required by institutional needs and applicable laws, regulations and policies.
4.3.0 Restrictions
  1. If the Committee consists of more than three members, not more than three members shall be from the same administrative unit (Animal Welfare Act: 9 CFR 2.31(b)(4)).
  2. An individual who meets the requirements of more than one of the member categories, may fulfill more than one requirement. However, no committee may consist of less than five members. (Public Health Service Policy: IV.A.3.c).
4.4.0 Membership Appointment Guidelines
  1. Members shall be appointed to the University of Hawai‘i’s Institutional Animal Care & Use Committee by the Office of the Chancellor.
  2. The Committee functions are administered through the UH Compliance Office.
  3. Membership appointments may be extended by the Office of Chancellor, through the Program’s Designated Institutional Official.
4.5.0 References

In fulfilling its mandate, the University’s IACUC uses these laws, guidelines, and policies and other published references in addition to those listed in section 4.1.0.

Marine Mammal Protection Act

Endangered Species Act

OPRR’s Institutional Animal Care and Use Committee Handbook

Guide for the Care and Use of Laboratory Animals

Institute of Laboratory Animal Resources Journal

Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching

Guidelines for the Care and Use of Fish in Research

Guidelines for the Treatment of Animals in Behavioral Research and Teaching

Guidelines for the Use of Live Amphibians and Reptiles in Field Research

Report of Committee on the Use of Wild Birds in Research

1993 & 2000 Report of the AVMA Panel of Euthanasia

IACUC Approved 06/97

Policy 5 – Ad HOC Membership and Non-member Resources

5.1.0 Statement and Scope

Federal law allows the University to recruit and appoint supplemental committee members to the committee to evaluate specific aspects of proposals submitted to the IACUC. (Source — OLAW Institutional Animal Care and Use Committee Guidebook).

5.2 0 Guidelines and Restrictions For Nonmember

Consultants/Experts/Advisors

  1. Project Proposals and Animal Use Protocols
    • The IACUC may invite consultants to assist in the review of complex issues arising out of its review of proposed activities. Consultants may not approve or withhold approval of an activity, and may not vote with the IACUC unless they are also members of the IACUC (Sources — Animal Welfare Act 9 CFR 2.31(3); Public Health Service Policy IV.C.3.)
    • Nonmember consultants, experts, and advisors may be sought to assist the committee in complex issues that require additional information and different points of reference which the regular voting membership and ad hoc members cannot provide. Example: Peer review on controversial research topics regarding the evaluation of the science, experimental procedures, and ethics.
    • The Designated Institutional Official (DIO) shall review on a case by case basis, the IACUC’s justification for nonmember resources. The DIO shall provide written approval if the need is warranted. Letters of nonmember solicitation shall originate from the office of the DIO.
  2. Facility Inspections and Program Evaluations
    • The IACUC may invite consultants to assist in conducting evaluations; however, the IACUC remains responsible for the evaluations and reports as required by the Act and regulations (Source — Animal Welfare Act 9 CFR 2.31(3)).
5.3.0 Ad Hoc Member Appointment

Ad hoc members shall be appointed through the Office of the Chancellor by the program’s DIO.

Ad hoc members have standing appointments with the committee and will be called to assist in matters when the regular voting membership requires additional information. Ad hoc members may vote only on the specific issues for which they were consulted. University offices that hold ad hoc membership on the committee are: UH Biosafety Office, UH Radiation Safety Office, UH Chemical Safety Office, Hamilton Library Science and References Technology, and some UH faculty members.

Note: UH faculty members that are ad hoc members to the committee were previously regular voting members, and thus are familiar with the responsibilities and functions of the IACUC and are retained because of their expertise or familiarity with a given issue.

IACUC Approved 06/97

Policy 6 – Avian Embryos

Policy 6.1 Avian Embryos

Policy Statement and Scope
Avian embryos are not considered live animals by U.S. regulatory agencies. OLAW interprets the PHS Policy as applicable to their offspring, only after hatching, and egg laying adults. Avian embryos that hatch, intentionally or unintentionally, are live vertebrate animals, and regulated by the IACUC.

Guidelines
Avian hatchlings and adults used for research, testing, teaching/training requires UH IACUC protocol review and approval.

Use of embryonic eggs of chickens or any other avian species requires an IACUC protocol exemption request. Humane euthanasia of embryonic eggs is required according to the following:

Carbon dioxide has successfully been applied for euthanasia of nonhatched eggs (pips). Concentrations necessary to achieve rapid euthanasia of pipped eggs or newly hatched chicks may be substantially greater (as high as 80% to 90%) than for adults of the same species. Embryonated eggs may be destroyed by prolonged exposure (20 minutes) to CO2, cooling (4 hours at 40°F), or freezing. In some cases inhaled anesthetics can be administered through the air cell at the large end of the egg. Egg addling (shaking, piercing, freezing, oiling) can also be used. Embryos in eggs that may have been opened may be decapitated.

Inadvertent hatchings may occur. The recommended method of euthanasia is CO2 euthanasia.

Other gases, cervical dislocation, decapitation, and blunt force trauma are allowed if the individual performing the procedure is properly trained and certified.

Effective Date – June 15, 2017

Policy 7 – Reporting Concerns of Animal Misuse or Abuse

7.1.0 Purpose

The University of Hawai‘i is committed to ensuring that animals used by personnel on behalf of the University are treated in a humane, ethical manner, with the highest standard of care according to applied Federal, State, and local regulations. This policy establishes a mechanism of reporting concerns regarding the misuse or abuse of animals in research, teaching, and training.

7.2.0 Statement

Reporting concerns regarding the humane care and use of animals used in research, teaching, and training is the responsibility of all institutional caretakers of animals. In accordance with Federal laws 1-3, individuals reporting violations of any regulation or standard of the Animal Welfare Act may do so without fear of being discriminated against or be subject to reprisals. The Institutional Animal Care and Use Committee is charged with the responsibility of reviewing these concerns. All complaints will be investigated.

  1. U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training
  2. Animal Welfare Act 9 CFR 2.31(c)(4), 2.32 (c)(4)
  3. Public Health Service Policy on Humane Care and Use of Laboratory Animals
7.3.0 Procedures
  1. Any complaint regarding possible inappropriate care or handling of animals should be made to one of the offices identified at the end of this notice. The verbal or written complaint should include a factual description with date, time, location, animal species, numbers and identification of animals, specific care or handling concerns, and any other relevant details. Anonymous complaints are acceptable if sufficient detail is provided to allow adequate investigation of the charges.
  2. The complainant’s identity will be kept confidential when requested.
  3. The office which initially received the complaint shall forward it to the Compliance Office as soon as possible and in no event more than 12 hours after receiving it.
  4. The Compliance Office will review the complaint, contact the IACUC Chair, and schedule a subcommittee to review the complaint within three (3) business days. If in the opinion of the Compliance Office and IACUC Chair, immediate intervention is warranted, they shall contact the Office of the Chancellor immediately.
  5. An initial review of the complaint and alleged violation shall be conducted by the IACUC (or designated subcommittee) with available information (except the name of the complainant). The subcommittee will establish the time frame necessary to investigate and determine the proper action needed to resolve the problem, and the Compliance Office will inform the complainant, if known.
  6. If the initial review of the investigation reveals that any inappropriate care of the animals may be occurring, the IACUC will provide written notification to the personnel involved of the IACUC’s concerns and provide the individual with an opportunity to respond to the complaint within 24 hours.
  7. In cases where significant problems are identified which are not satisfactorily resolved between the IACUC and the investigator, the IACUC may make recommendations to the Office of the Chancellor for immediate corrective action.
  8. The Office of the Chancellor or program designee may elect to intervene at any time to demand the Principle Investigator or Course Instructor cease and desist.
  9. Any discrimination or reprisals as a result of reporting inappropriate care of animals will be reported to the Office of the Chancellor. Fabrication of false allegations will be reported to the Office of the Chancellor.
  10. The IACUC will be responsible for maintaining a file documenting complaints, committee reviews and actions taken or recommended to rectify the problems identified. Significant violations will be reported to the appropriate Federal Agencies.
7.4.0 Contact Offices

UH-Systemwide And Island Of Oahu
Institutional Animal Care and Use Committee
Chairman, c/o Compliance Office
2538 McCarthy Mall
Snyder 410
Honolulu, HI 96822
(808) 956-4552, 956-4446

Office of the University Veterinarian
Laboratory Animal Service
2538 McCarthy Mall
Snyder 209
Honolulu, HI 96822
(808) 956-4444

Compliance Office
2538 McCarthy Mall
Snyder 410
Honolulu, HI 96822
(808) 956-4552/956-4446

Office of the Chancellor
Assistant Vice President for Research and Graduate Education
Bachman Hall 105
Honolulu, HI 96822
(808) 956-7837

Island Of Hawai‘i
Office of the Dean
College of Agriculture, Forestry, and Natural Resource Management
University of Hawai‘i at Hilo
200 West Kawili St.
Business Office 21
Hilo, HI 96720-4091
(808) 974-7393

7.5.0 Effective Date

July 2002 IACUC

Approved 07/02

Policy 8 – Criteria for Evaluating Animal Care and Use Non-compliance and Deviations

8.1.0 Public Health Service Mandate1

As an assured institution, the University of Hawai‘i and its vertebrate animal research and teaching/training programs are required to comply with the following. The PHS Policy on Humane Care and Use of Laboratory Animals (Policy) identifies three areas that require prompt reporting to the Office of Laboratory Animal Welfare — OLAW (Section IV.F., paragraph 3).

  1. Any serious deviations or continuing noncompliance with the PHS Policy
  2. Any serious deviation from the provisions of the Guide for the Care and Use of Laboratory Animal; and
  3. Any suspension of an activity by the IACUC
8.2.0 Office Of Laboratory Animal Welfare (OLAW) Guidance

According to OLAW, determination that a problem at an awardee institution falls within the meaning [letter or spirit] of (A) or (B) requires that the institution’s IACUC exercise a degree of professional judgment prior to reporting the deviation to the agency.

The language used in the Policy permits judicious application of professional judgment by animal care and use committees in determining the incidents that should be reported to OLAW.

OLAW requires any serious noncompliance or deviation of (A) or (B) with the PHS Policy or the Guide must be reported, even if identified initially by other agencies, site visitors or consultants.

8.3.0 Examples Of Occurrences That Meet Reporting Criteria
  1. Serious or continuing noncompliance with the PHS Policy
    • Failure to correct situations identified in previous semiannual evaluations and approval deficiencies
    • Conducting animal-related activities without appropriate IACUC review and approval
    • Failure of animal care and use personnel to adhere to IACUC — reviewed and approved institutional policies and procedures.
  2. Serious deviation from the provisions of the Guide
    • Conditions that jeopardize the health or well-being of animals, including accidents, natural disasters and mechanical failures resulting in actual harm or death to animals
    • Shortcomings in programs of veterinary care, occupational health or training, identified during semiannual program review and not corrected within the institutionally determined time frame.
  3. Suspension of an activity by the IACUC
    • An IACUC intervention that results in the temporary or permanent interruption of an activity involving animals.
8.4.0 Effective Date

July 2002

IACUC Approved 07/02 Reference:
1OPRR Reports: Requirements for Prompt Reporting of Problems to OPRR, 1994

Policy 9 – Guidelines and Procedures for Conducting Inquiries and Investigations into Non-compliances, Deviations, and cases of Animal Misuse or Abuse

9.1.0 Purpose

The University is required to conduct inquiries and to investigate incidents in which personnel may have conducted animal-related research and/or teaching/training activities without IACUC review and approval or have failed to comply with IACUC approved protocols, disregarded institutional policies and procedures, violated governmental laws and regulations governing animal use, and participated in activities that may have misused or abused animals.

9.2.0 Statement

Serious noncompliances or deviations are required to be reported to federal regulatory agencies (OLAW and USDA-APHIS), and in many cases, even the granting agencies (NIH and NSF) or private sponsors.

In conducting inquires and investigations, the committee should be diligent in evaluating only factual information on these incidences. For example, the committee should take into account the type of incident (unapproved procedures, housing violations, improper training or incompetent skill level, negligence or wasted animals) and the specific details of the noncompliance or deviation (e.g., species involved, procedures used, adverse effects on the animals, personnel involved).

9.3.0 Checklist For Gathering Information And Assessment
  1. The Committee may take into consideration the following questions in determining whether to report the incident to respective oversight agencies and awarding sponsors:
    • In what pain and/or distress category would the procedures have been placed?
    • What were the adverse effects on the animals being used?
    • Might the adverse effects have been prevented if the procedures had been reviewed by the IACUC and University Veterinarian?
    • Was medical intervention by the veterinary staff required?
    • Were the individuals involved aware that IACUC approval was required before performing the procedures?
    • Have the individuals repeatedly violated or disregarded IACUC policies? Were the previous violations the same or different than the current incident?
    • Was it necessary for the IACUC to intervene to temporarily or permanently interrupt the incident?
  2. After considering the questions listed above, the committee should assess the incident for the following:
    • Have the actions jeopardized the health or well-being of the animals used or resulted in the animals being harmed or dying?
    • Is there evidence that the personnel involved willfully disregarded the institution’s policy in order to perform procedures without obtaining approval from the IACUC?
9.4.0 Committee Action — Internal Procedures

The committee will consult with the Designated Institutional Official on any final action. The severity of the noncompliance will determine the level of action the committee will administer.

  • Verbal warning to the noncompliant personnel.
  • Written warning to the noncompliant personnel without copying the departmental chair or unit head (Dean or Director).
  • Written warning to the noncompliant personnel with a copy to the departmental chair or unit head (Dean or Director). Copy to Office of the Chancellor.
9.5.0 Committee Action — Reporting To Agencies And Sponsors

Professional judgment shall be exercised by the committee on a case by case basis to determine whether reporting the incidents to the oversight agencies and funding sponsors are consistent with the philosophy of institutional self regulation.

  • If there was intent to circumvent IACUC authority and animals were used or harmed. The IACUC will report.
  • If there was no intent to circumvent IACUC authority and animals were not used or harmed. The committee should consider issuing a warning to the noncompliant party. The IACUC may elect to report.
  • If there was intent to circumvent IACUC authority but animals were not used or harmed. The committee should consider issuing a warning to the noncompliant party prior to or in addition to reporting the incident to the agencies.
  • If there was no intent to circumvent IACUC authority but animals were used or harmed. The committee should consider issuing a warning to the noncompliant party prior to or in addition to reporting the incident to the agencies.
9.6.0 Additional Sanctions

In addition to the items listed in subsection Committee Action — Internal Procedures, the severity of the noncompliance may result in additional administrative sanctions that result from failure to comply with IACUC protocol review, institutional policies and procedures, government laws and regulations governing animal use, or misusing or abusing animals in University research and teaching/training activities.

  • Suspension of all of an investigator’ protocols until problem(s) is corrected.
  • Suspension of a specific protocol during retraining or education.
  • Denied access to animal facility.
  • Permanent suspension of animal use privileges.
  • Other research staff must take over work.
  • Require to attend IACUC meetings.
  • Charge noncompliant personnel for extra work by veterinary staff or animal care staff.
  • Significant salary reduction for 6 months.
  • Significant monetary fine.
  • Dismissal of noncompliant personnel.
  • Loss of research funds.
  • Require the addition of research staff.

Other* – Not limited to the current listing.

9.7.0. Effective Date

July 2002

IACUC Approved 07/02

References:

  1. OPRR Reports — Requirements for Prompt Reporting of Problems to OPRR, July 1994
  2. University of Michigan IACUC — Guidelines for Evaluating Investigator Noncompliance
  3. The IACUC Handbook, 2000, 1st Edition, Chapter 29

Policy 10 – Confidentiality and Matters of Conflict of Interest

10.1.0 Purpose

Your content goes here. Edit or remove this text inline or in the module Content settings. You can also style every aspect of this content in the module Design settings and even apply custom CSS to this text in the module Advanced settings.

10.2.0 Definitions
  • Confidential Business Information — Commercial or financial information considered to be confidential because disclosure may: (1) Impair the Government’s ability to obtain necessary information in the future; or (2) Cause substantial harm to the competitive position of the individual or business entity who provides the information.
  • Proprietary Information — Information or data belonging to an owner or proprietor, who may have exclusive rights to the manufacture and sale of a specific item.
  • Trade Secret — Any formula, pattern, device, or information that is used in business which provides a competitive advantage.
  • Sensitive Information — Information or data in which disclosure, loss, misuse, alteration, or destruction may adversely affect national security or other government (usually Federal) interest.
10.3.0 Procedures
  • Committee members are required to comply with a signed Agreement (exhibit 1) which provides the guidelines for this University’s principles on confidentiality and matters of conflict of interest. The Agreement must be signed annually.
  • Consultants to the program are required to comply by a signed Agreement (exhibit 2) which provides the guidelines for this University’s principles on confidentiality. The Agreement must be signed on a case by case review basis.
10.4.0 Conflict Of Interest Concerns
  • If an applicant submitting a protocol believes that an IACUC member has a potential conflict, the applicant may request that the member be excluded from the review of the protocol.
  • The request must be in writing and addressed to the UH IACUC Chairman at least five (5) working days prior to the distribution of the protocol to the committee for their review. The request must contain evidence that substantiates the claim that a conflict of interest exists with the IACUC member(s) in question. The committee may elect to investigate the applicant’s claim of the potential conflict.
10.5.0 Applicant’s Responsibility
  • If an applicant submitting a protocol believes that an IACUC member has a potential conflict, the applicant may request that the member be excluded from the review of the protocol.
  • The request must be in writing and addressed to the UH IACUC Chairman at least five (5) working days prior to the distribution of the protocol to the committee for their review.
  • The request must contain evidence that substantiates the claim that a conflict of interest exists with the IACUC member(s) in question.
10.6.0 IACUC Action
  • The committee may elect to investigate the applicant’s claim of the potential conflict.
  • The Chair will determine whether there is a need to assemble a subcommittee of at least four (4) members to evaluate whether the potential for conflict exists.
  • The Chair will be the deciding vote in situations where there is a tie.
  • The Chair will notify the applicant and the committee member in writing of the subcommittee’s determination.
  • If it is determined that the potential for a conflict of interest exists, the IACUC member to which the concern is focused on will be excused from the committee discussion and voting. The application will not be distributed to the member.
  • If it is determined that the potential for a conflict of interest does not exist, the IACUC member to which the concern is focused on will be allowed to participate and contribute to the committee discussion on the protocol and vote. The application will be distributed to the member.
10.7.0 Appeals

Appeals may be brought to the attention of the Program Designated Institutional Official.

10.8.0 Ethics Committee

If an applicant or any other University of Hawai‘i (UH) employee believes that a member of the IACUC has engaged in action or actions which has or have placed the committee member in conflict of interest, that complainant may bring allegations of misconduct to the attention of the UH Ethics Committee.

10.9.0. Effective Date

August 2002

IACUC Approved 07/02

UH General Counsel Reviewed and Approved 08/02

Confidentiality and Conflict of Interest Agreement (IACUC Member Version in PDF format)

Download this File

Confidentiality Agreement (Consultant Version in PDF format)

Download this File

Policy 11.1 – Availability of Committee Membership Roster

11.1.0 Purpose

Those University of Hawai‘i (UH ) faculty and staff that submit vertebrate animal use applications may obtain the current UH Institutional Animal Care and Use Committee (IACUC) roster by forwarding a written request to the program’s Designated Institutional Official at the address below:

Victoria Rivera
Director, Office of Research Compliance

University of Hawai‘i
Office of the Vice President for Research and Innovation
2425 Campus Road, Sinclair 10
Honolulu, HI 96822
(808) 956-8102 (Tel)
riveravg@hawaii.edu

Policy 12 – Public Health Service Policy Change Affecting National Institutes of Health (NIH) Grant Applications, Awards, and IACUC Review

12.1.0 Amended Public Health Service Policy

The National Institutes of Health has amended the PHS Policy on Humane Care and Use of Animals (PHS Policy) to permit institutions with PHS Animal Welfare Assurances to submit verification of Institutional Animal Care and Use Committee (IACUC) approval for competing applications subsequent to peer review but prior to award.

12.2.0 Effective Date Of Policy Amendment

September 1, 2002 (i.e., for all applications submitted for the May-June 2003 Advisory Council dates).

12.3.0 Scope And Purpose
  • IACUC verification is no longer required to be submitted prior to NIH peer review, but instead is required prior to award.
  • The purpose of the change is to enhance flexibility of institutions and reduce burden on applicants and IACUCs, allowing resources to be focused on substantive review of applications likely to be funded. The change permits funding components to require verification of IACUC approval at an earlier date if necessary.
12.4.0 NIH Principles And Expectations
  • The fundamental PHS Policy requirement that no award may be made without an approved Assurance and without verification of IACUC approval remains unchanged. The amended policy affects only the time of the submission of the verification of the IACUC review.
  • The Policy change is intended to permit flexibility and discretion on the part of the institutions. It is not a requirement that the IACUC approval be deferred. Institutional officials retain the discretion to require IACUC approval prior to peer review in certain circumstances.
  • Under no circumstances may the IACUC be pressured to approve a protocol or be overruled on its decision to withhold approval. Peer review is not a replacement for IACUC review. An institution that elects to use this policy bears the responsibility for supporting the role of the IACUC.
  • It is incumbent upon the investigators to be forthcoming and timely in conveying to the IACUC any modifications related to the project and animal usage that may result from the NIH review and award process. Should the IACUC find that an investigator has disregarded his/her responsibilities, the IACUC may determine that all animal protocols from that investigator become subject to review and approval before it will permit submission of an application to the agency from that investigator.
  • The existing PHS Policy requirement that modifications required by the IACUC be submitted to NIH with verification of IACUC approval remains in place, and it remains the responsibility of the University to communicate any IACUC-imposed changes to the NIH staff.
  • The NIH will ensure that the University is given adequate notice to allow for timely IACUC review prior to award and will take appropriate internal measures to fulfill its responsibility to establish timely feedback.

Policy 13.1 – Requirement for Personnel Training on the Website

View the policy

Policy 14 – Use of Streptozocin on Animal Subjects

14.1.0 Proprietary Name

Zanozar

14.2.0 Mechanism Of Action And General Application

Streptozocin is a synthetic antineoplastic agent that is chemically related to other nitrosoureas used in cancer chemotherapy. Streptozocin inhibits DNA synthesis in bacterial and mammalian cells. This type of antibiotic is used primarily to treat pancreatic islet cell cancer. Streptozocin is also used to treat carcinoid tumor, carcinoid syndrome, Hodgkin’s disease, pancreatic adenocarcinoma, colorectal cancer, hepatoma, pheochromocytoma, epidermoid carcinoma of the lung, lymphocytic lymphoma, Burkitt’s lymphoma, acute lymphocytic leukemia, malignant melanoma, and metastatic sarcoma.

14.3.0 Use Of Streptozocin In Animal Model Studies

Streptozocin is mutagenic. When administered parentally, it has been found to be tumorigenic or carcinogenic in some rodents.

In experiments with many animal species, streptozocin induced a diabetes that resembles human hyperglycemic nonketotic diabetes mellitus. The diabetes-like state has been studied extensively. It appears to be mediated through a lowering of beta cell nicotinamide adenine denucleo-tide (NAD) and consequent histopathologic alteration of pancreatic islet beta cells. In all species tested, the agent was found to concentrate in the liver and kidney.

14.4.0 PRECAUTIONS

Because of its known inherent renal toxicity properties, therapy with this drug is limited to patients with symptomatic or progressive metastatic disease. Streptozocin is irritating to tissues at the injection site. Extravasation may cause severe tissue lesions and necrosis.

14.5.0 Animal Pain And Distress Category Assignment

Because of the known adverse side effects experienced by human and animal subjects alike when streptozocin is administered for therapy or as a test agent, the UH IACUC has determined that animal subjects which are assigned to treatments in which streptozocin is administered should be assigned to the Animal Pain and Distress Category E.

14.6.0 Required Animal Use Protocol Information

If streptozocin is used in a study, this information is required to be provided by the applicant:

  • A clear explanation why streptozocin is proposed for use in the study,
  • Alternatives to the use of streptozocin has been investigated by at least conducting a journal article database search using an appropriate search strategy and key words (See USDA Policy 12, protocol form section V. for more details),
  • Provide the streptozocin dosage, administration schedule, and sites of administration,
  • Provide a schedule of the frequency of monitoring animal subjects following the administration of streptozocin,
  • Provide a description of the anticipated adverse side effects or symptoms expected from the animal subjects which have been treated with streptozocin,
  • Designation of key research staff personnel who will be responsible for monitoring the animal subjects,
  • Provide end points which will be used to prevent undue distress to animal subjects experiencing the agent,
  • Consultation with the UH Veterinarians office is mandatory in the design of the study, and,
  • Studies using streptozocin will be forwarded to the UH Environmental Health and Safety Office for personnel risk and assessment and hazardous agent reviews.

Effective May 11, 2006

Policy 15 – Requirement for Institutional Veterinary Consultation for Biomedical Sciences, Neurosciences, and Biotechnology-related Studies

View the policy

Revised Policy 13.1 – Requirement for Personnel Training

View the policy

Policy 16 – Personnel Additions to Animal Use Activities

16.1.0. Purpose

The purpose of this policy is to provide a mechanism by which personnel may be authorized to engage in vertebrate animal use activities under current approved protocols. Under this policy, the addition of new personnel is considered a minor protocol revision not requiring full committee review.

16.2.0. Application
  • This policy applies to only research and teaching/training support staff and scientists, visiting scientists, and students.
  • This policy does not apply to changes to the Principal Investigator (PI) designation. Federal guidelines and policy define a change made to the PI designation is a significant modification to a study and therefore requires a new full protocol application.
16.3.0. Requirements of Principal Investigators and Added Personnel
  • The PI is required to complete a standard protocol Revision identifying the individual(s) who will engage in animal use activities.
  • The PI is required to describe how and who will train the personnel within the scope of the approved protocol. (OR) Personnel who are not proficient in the procedures used in the animal use activity must be closely supervised while training in the procedures which require animal handling and/or manipulation.
  • Personnel are required to complete all necessary IACUC training requirements (e.g. WebCT certification or recertification) and any special requirements as necessary.
    • The WebCT certification testing program is located here.
    • The WebCT recertification testing module is located here.
16.4.0 Submission of Request and Review
  • The PI is required to provide one (1) signed original and four (4) copies of the protocol Revision to the Animal Welfare Regulatory Compliance Office.
  • Requests to add personnel by this mechanism can be done at any time and will normally take 2-3 business days processing time unless additional information is required.
16.5.0 Notification

The committee, on its behalf, authorizes the Chair, Vice-Chair or designee to review, and if all necessary criteria are met, to approve the request. The PI will be informed of the decision of whether personnel are qualified to engage in the animal use activities described in the protocol Revision.

View the policy

Policy 17 – Policy for Veterinary Care for the System-wide University of Hawai‘i Animal Care and Use Program

View the policy

Policy 18 – Investigator and Staff Responsibilities Prior to the Initiation of Vertebrate Animal Use Activities Independent of IACUC Review and Approval

Download this File

Policy 19.0 – Survival Rodent Surgery Procedures

View the policy

Policy 20.0 – Restriction of Movement of Animals Outside of the Vivarium

Download this File

Policy 21.0 – Vivarium Rodent Count Requirements for IACUC Protocols Policy and Standard Operating Procedure

Download this File

Policy 22.0 – University of Hawaii IACUC Guidelines on Non-Grant Funded Vermin Control at UH Campus Facilities and by Private Contractors Providing Vermin Control

Download this File

UH IACUC Policy on the Dilution of Pharmaceutical Grade Drugs and Use of Non-pharmaceutical grade drugs-agents in research animals

View the policy

Policy for Protocols Using Biological Materials/Toxins in Animals (AVS-Operated Vivaria)

View the policy

Hazardous Chemicals in Animals Policy

View the policy

IACUC Policy on Rodent and Rabbit Anesthesia and Analgesia

View the policy

IACUC Policy on Anesthesia Machine Vaporizer Calibration

View the policy

IACUC Policy on Documentation of Training in Biomedical Research Techniques

View the policy

IACUC Policy on Equipment Maintenance and Calibration (Biomedical and Neurobehavioral Vivaria)

View the policy

IACUC Policy on Genotyping Mice and Rats

View the policy

IACUC Policy on Prolonged Physical Restraint

View the policy

IACUC Policy on Rodent Toe Clipping

View the policy

Policy for Dealing with Specific Significant Changes to Animal Activities

View the policy

UH IACUC Policy on Environmental Enrichment for Rodents Used for Biomedical and Neurobehavioral Studies

View the policy

UH IACUC Policy on Euthanasia

View the policy

UH IACUC Policy on Social Housing for Biomedical and Neurobehavioral Studies in AVS-Operated Vivaria

View the policy

Overcrowded Cages Policy/SOP

View the policy

UH IACUC Policy on Retro-orbital Sinus Plexus Sample Collection or Injections in Mice

View the policy

UH IACUC Policy for Tumor Burden Studies in Mice and Rats

View the policy

UH IACUC Policy on Weight Loss in Research Animals

View the policy

IACUC Considerations for FAXITRON CP-160 Use

View the policy

IACUC Considerations for “Non-­Standard” Ultrasound Use

View the policy

UH IACUC Procedure on Volunteers, Students, and Workshop Participants Handling or Using Vertebrate Animals on UH IACUC Protocols

View the policy

IACUC Policy on Conditions for Designated Member Review

View the policy

Repeat Procedures Policy

View the policy

UH IACUC Policy 45.1 Policy for Animal Use Activities with Collaborating Institutions and Organizations Policy Statement

View the policy

UH IACUC Policy 45.1 Policy for Animal Use Activities with Collaborating Institutions and Organizations Guidance and Procedures

View the policy

SOP IACUC AVS Anesthesia Machine Usage

View the policy

SOP IACUC F/Air Canisters

View the policy

Guidance on USDA Pain Categories

View the policy

New IACUC Policy 45.1 in IACUC Policies and Guidelines

Please see new IACUC policy 45.1 in IACUC Policies and Guidelines written to provide the IACUC and University of Hawai‘i faculty guidance for procedures involving research, testing, or instruction conducted with live vertebrate animals and collaborating research institutions and organizations. For the purpose of clarification, research, testing, or instruction referenced as animal use activities.