Institutional Animal Care & Use Committee (IACUC)

Definition: The chairperson needs to be knowledgeable and effective as a leader. This individual needs to have the full support of the Institutional Officer and sufficient stature to perform the functions of the positions without jeopardy to career or position. The Chairperson is appointed by the Institutional Official. The chairperson plays an active role in the oversight of all IACUC activities. The Chair serves five constituent groups: Senior Administration (CEO and IO); the scientific community; other members of the IACUC; the federal government; the public. It is not recommended that the Attending Veterinarian be the IACUC chairperson due to real or perceived conflicts of interest.

Responsibilities: The IACUC Chair has the responsibility for overseeing the coordination and implementation of effective, efficient systems for protocol review and program review by the IACUC in compliance with the PHS (Public Health Service) policy and the AWA (Animal Welfare Act). Specifically, the Chair should:

1. Ensure that the IACUC has a quorum present at all meetings.
2. Declare the loss of a quorum resulting at the end of official business if a sufficient number of members depart.
3. Prepare and/or oversee the preparation of meeting minutes, agendas, and reports and submit appropriate documents to the IO in accordance with PHS policy and the AWA.
4. Report to the IO any activities which have been suspended by the IACUC for non-compliance as required by PHS policy.
5. Ensure the establishment of a written system of communication for the IACUC with the investigators concerning the approval status of protocols and the steps necessary to secure approval.
6. Stay abreast of the most recent regulatory trends and interpretations.
7. Evaluate and champion policy and practice initiatives to improve the animal care and use program.
8. Have regular interaction with other institutional committees, occupational health and safety, physical plant, human resources.
9. Assign designated reviewers for protocols.
10. Advise PIs.
11. Educate and support IACUC members, PIs, and others regarding the IACUC process.
12. Participate in facility inspections.
13. Communicate regularly with the IO, Attending Veterinarian, IACUC Administrator and staff.
14. Serve as spokesperson for the IACUC.

Definition: The Attending Veterinarian (appointed by the I.O. as the University Veterinarian with direct or delegated program authority and responsibility for activities involving animals at the institution as defined under the Animal Welfare Act and PHS policy) serves on the Institutional Animal Care and Use Committee and shall have appropriate training or experience in laboratory animal medicine and science and have direct or delegated program responsibilities for activities involving animals at the institution. This individual should have graduated from an accredited veterinary school, have a certificate issued by the American Veterinary Medical Association’s Education Commission for Foreign Veterinary Graduates, or have received the equivalent formal education as deemed appropriate by the APHIS administrator. (PHS Policy (IV,A,3,b,1) and AWAR (2.31,b,3,i).

Responsibilities: The role of the IACUC Attending Veterinarian is to:

1. Provide veterinary consultation on the recognition and palliation of pain.
2. Direct the animal care and use program.
3. Provide medical care.
4. Conduct aseptic surgery and post-operative care.
5. Provide oversight on multiple major survival surgeries resulting from a veterinary condition in an animal that also had experimental surgery.
6. Advise the IACUC on new procedures or procedures with the potential to cause pain and distress that cannot be reliably controlled.
7. Ensure that veterinary care is available to mitigate the illnesses, lesions or behavioral abnormalities associated with animal restraint.
8. Serve as Designated Reviewer for Observational Studies.
9. Serve as a resource for IACUC members, PIs, and graduate students on issues related to animal welfare.
10. Assist with training and education of IACUC members, PIs, students, etc. as needed.
11. Provide expertise on matters of animal health and welfare, including, but not limited to the use of proper anesthesia and analgesia in laboratory animals in the relief of pain and distress; discussion of the possible complications related to procedures used or a disease model proposed; provide a review of the plans for appropriate and timely medical intervention.
12. Conduct an initial review of protocols for completeness prior to submission to the IACUC committee.
13. Serve as a member of the IACUC.

Definition: Someone who is not affiliated with the University in any manner, intended to represent the general community interests in the proper care and treatment of animals. This person may not be the immediate family of a person affiliated with the institution. Public members should not be laboratory animal users. (AWAR 2.31,b,3,ii;PHS Policy IV, A, 3,b,4)

Responsibilities: The role of the Non-Affiliated member is to:

1. Play an active role in all IACUC activities.
2. Make persistent, straightforward inquiries about matters that are undetected by the institutional members of the IACUC.
3. Critically review protocols.
4. Serve as a designated reviewer when appropriate.
5. Attend monthly IACUC meetings.  Must be present at the meetings for business to be conducted.
6. Participate in six-month facility inspection and program reviews.

Definition: A person whose primary concern is in a non-scientific area having no obvious connections to any area of science. Individuals may have some scientific training but clearly do not qualify as a practicing scientist with experience in research involving animals.

Responsibilities: The role of the Non-Scientist member is to:

1. Play an active role in all IACUC activities.
2. Make persistent, straightforward inquiries about matters that are undetected by the institutional members of the IACUC.
3. Critically review protocols.
4. Serve as a designated reviewer when appropriate.
5. Attend monthly IACUC meetings.  Must be present at the meetings for business to be conducted.
6. Participate in six-month facility inspection and program reviews.

Definition: A practicing scientist knowledgeable about the types of research and teaching being reviewed and conducted; at least one with laboratory animal experience. USU policy is to represent all areas having involvement with animal research. No more than three scientists from one department/administrative unit should be on the USU IACUC.

Responsibilities: The role of the Scientist member is to:

1. Play an active role in all IACUC activities.
2. Make persistent, straightforward inquiries about matters that are undetected by the institutional members of the IACUC.
3. Critically review protocols.
4. Serve as a designated reviewer when appropriate.
5. Attend monthly IACUC meetings.  Must be present at the meetings for business to be conducted.
6. Participate in six-month facility inspection and program reviews.

Definition: The individual who is authorized to legally commit on behalf of the research facility that it will meet the requirements of the AWA. PHS policy defines the IO as the individual who signs and has the authority to sign the institution’s Assurance, which commits the institution to meet the requirements of PHS policy.

Responsibilities: The role of the Institutional Official:

1. Has the authority to sign the University’s Assurance and commit the institution to meet the requirements of AWA.
2. Commits the institution to meet the requirements of PHS policy.
3. Receives inspection reports and recommendations from the IACUC.
4. In consultation with the IACUC, determines whether deficiencies are minor or significant, determines corrective actions or suspensions, and reports such actions to regulatory and funding agencies.
5. Receives notification of the IACUC’s decision to approve or withhold its approval of animal activities.
6. Receives and transmits annual reports to NIH/OPRR and to APHIS.
7. May subject protocols that have been approved by the IACUC to further review and approval but may not approve an activity that has not been approved by the IACUC.
8. Ensures that all personnel involved in animal care, treatment, and use are qualified to perform their duties and that specific training is provided to those personnel.
9. Ensures that training and instruction and the qualifications of personnel are reviewed with sufficient frequency to fulfill the research facility’s responsibilities.
10. Ensures the University has an attending veterinarian who provides adequate veterinary care to its animals in compliance with the AWA.
11. Ensures that the University maintains the required records for the specified time periods.

Link: IACUC Application Decision Chart

New Protocol Application
https://harrisburgu.qualtrics.com/jfe/form/SV_cT3Djf7Ni0u4CAS

Animal welfare regulations require that an Institutional Animal Care and Use Committee (IACUC) review and approve all activities utilizing vertebrate animals in research and teaching prior to their starting. This includes review of any significant changes during ongoing activities. Each approved protocol must be reviewed by the IACUC at least annually. The information requested below is necessary for the IACUC to fulfill its responsibility of oversight and evaluation of animal care and usage at Harrisburg University as described in the “Guide for the Care and Use of Laboratory Animals” (National Research Council, 1996). Questions may be directed to IACUC@HarrisburgU.edu.

The process

1. Applicants must complete the Application Form for Teaching, Studies, or Amendments.
2. Depending on the request a full or partial IACUC committee review shall be conducted.
3. After an initial review is conducted, written or verbal clarifications may be requested by the IACUC committee. The initial review might take up to 15 business days to complete.
4. After an initial review is conducted, written edits or additional information may be requested by the IACUC committee. The timeframe in this step depends on the ability of the applicant to implement edits and answer questions.
5. Final decision will be communicated in the form of an official letter regarding approval or denial of the proposed protocol. The final decision might take up to 10 business days after the IACUC receives all reviews requested.

Instructions

Please type or insert your responses in the space provided on the online application form. You must submit a separate protocol for each species proposed for use. Within a given species, you may include information for multiple research or teaching activities.

Suggestions

• This form must be completed and submitted online (https://harrisburgu.qualtrics.com/jfe/form/SV_cT3Djf7Ni0u4CAS). You can develop your answers in a word editing software (e.g., MS Word). Then you can type, or copy/paste, responses in the designated boxes and/or check the designated check boxes.
• Please respond to all questions on the form. If a particular question does not apply to your project/study, please indicate this as N/A.
• Summary and description of methods must be developed to avoid jargon. Please define any acronyms.
• Provide sufficient detail to allow evaluation by the IACUC.
  • Clearly and separately describe each procedure or use of an animal. Describe what exactly will be done to the animal, who will be doing it (student or faculty/staff. If both students and instructors will be involved in a procedure or animal use. Include the frequency and time points over the project/study/course that procedures will take place.
  • Include how long the animals will be maintained. Include dose, route of administration and frequency of any drugs to be administered.
  • Describe methods used in behavior studies (including use of noxious stimuli or other methods of positive or negative reinforcement).
• We estimate that it takes at least 10-16 work hours to complete this form and the companion SOPs.
• You will be notified regarding acceptance of the protocol or if modifications are required by the IACUC.
• For questions, contact the IACUC administrator at IACUC@HarrisburgU.edu.

Amendments

Federal regulations require to submit any change to an approved protocol to the IACUC for review and approval before those are implemented; this process is known as amendment. More than one amendment may be made to an approved protocol. The IACUC determines whether the changes are sufficiently different from the aims of the initial protocol, requiring more information, justification, or requesting an entirely new protocol submission for approval.

Suggestions
Same suggestions as for new applications apply to amendments.
We estimate that it takes at least 2-8 work hours to complete this form and the companion SOPs.

Amendment Processing Timelines
Administrative and minor amendments are usually approved within 10 business days.

Significant amendments are reviewed by the full IACUC and are usually reviewed within 15 business days.

Written e-mail confirmation that an amendment has been approved must be received before any changes are implemented to a protocol. Please plan accordingly.

Standard operating procedures (SOPs) are a set of written steps or a set of practical, specific instructions about how to conduct standardized processes without loss of effectiveness. SOPs are important to maintain the utmost standard of animal care, use, and husbandry.  The IACUC must review and approve all written procedures involving the potential to cause pain and distress and should review all written operating procedures pertaining to animal care and husbandry (Guide for the Care and Use of Laboratory Animals, 8^th Ed. National Academy Press).

Here an example of an SOP (BBRC SOP Cub Measurements-2015.pdf)

• Apply for Research or Teaching Protocol Application (https://harrisburgu.qualtrics.com/jfe/form/SV_cT3Djf7Ni0u4CAS)
• Federal regulations require to submit any change to an approved protocol to the IACUC for review and approval before those are implemented. More than one amendment may be made to an approved protocol. The IACUC determines whether the changes are sufficiently different from the aims of the initial protocol, requiring more information, justification, or requesting an entirely new protocol submission for approval.

• Amendment Processing Timelines
  • Administrative and minor amendments are usually approved within 10 business.
  • Significant amendments are reviewed by the full IACUC committee for review and are usually reviewed within 15 business days.
• Written or email confirmation that an amendment has been approved must be received before any changes to a protocol are implemented. Please plan accordingly.
• Apply for an Amendment Form (https://harrisburgu.qualtrics.com/jfe/form/SV_4ZSXUXNixkPbRfU)