Protocols, Amendments & Renewals

An approved protocol is valid for one year and may be renewed twice for a total of three (3) years of study. At the end of three years, a new protocol must be submitted to the IACUC and a new protocol number assigned to the project. The new protocol should include all of the criteria mandated for the initial review. Investigators are notified by the Office of Research Protections and Integrity to submit annual renewal paperwork and to submit the new protocol to the IACUC prior to the third anniversary of the original approval date of their current protocol. Review of new and continuing protocols is conducted according to the following process:

Step 1: ORPI will conduct an initial review of the application for form completion. The application is forwarded to the Attending Veterinarian (AV) for input and review of animal pain/distress level, proposed procedures and use of analgesics/anesthetics, humane endpoints, method of euthanasia, etc. Both the ORPI and the AV construct a summary of questions or concerns for the Principal Investigator (PI) to address, or request clarifications, if needed, to ensure adequate IACUC review.

NOTE: In addition to the AV and the ORPI, other Committee members may be asked to “pre-review” the application (e.g., the Director of Laboratory Animal Resources; the Environmental Health and Safety representative, the Occupational Health and Safety representative, etc.) and provide feedback to the ORPI.

Step 2: The ORPI provides feedback to the PI via email regarding any edits/requests for clarification or additional information. The PI can opt to revise and re-submit the application before dissemination to the full Committee, or can choose to receive all requests for revision/clarification after the full Committee has reviewed the submission. If there are no questions for the PI to address, or no requests for revisions, the ORPI will notify the PI of the application status via email and will proceed to the next step in the review process.

Step 3: The application is distributed to the IACUC via email for their determination of the level of review needed for the protocol (i.e. Designated Member Review or Full Committee Review).

Step 3.1: If full committee review is not requested, the ‘Designated Member Review’ (DMR) process is implemented. In this process, at least one (1) IACUC member, designated by the Chairperson and qualified to conduct the review, reviews the application and has the authority to approve, require modifications to secure approval, or request full committee review of the application.

Step 3.2: If the application must go to full committee for review, the application is distributed to the entire IACUC at least one (1) week prior to the Committee’s monthly meeting. The Chairperson assigns a voting member of the Committee to be the lead reviewer of the application and begin discussion of the application at the next meeting.

Step 3.3: When a protocol is reviewed at a duly convened meeting and it is determined that substantive information is lacking such that a response from the PI is required, the IACUC may take either of the following actions:

a. Require modifications to secure approval and require that the revised protocol be returned for FCR at a subsequent duly-convened meeting; OR
b. Because all members of the UNC Charlotte IACUC have agreed in advance in writing, the committee may use “DMR Subsequent to FCR” based on the following:

1. All IACUC members have agreed in advance in writing that the quorum of members present at a convened meeting may decide by unanimous vote to use DMR subsequent to FCR when modification is needed to secure approval;
2. In this scenario, it is understood that any member of the IACUC may, at any time, request to see the revised protocol and/or request FCR of the protocol.
3. The approval date is the date that the designated member approves the study. Animal work conducted before this date will be reported to OLAW as a serious noncompliance with PHS Policy.

NOTE: A quorum, consisting of 50 percent of the voting members plus one member, must be present at the IACUC meeting in order to take action on the application. Approval of research projects may only be granted with the approval vote of a majority of the quorum present. The Committee may take the following actions: approve the application, require modifications to secure approval, or withhold approval.

IACUC members must recuse themselves from voting and are restricted from being selected as a reviewer in the DMR review process in the following situations: a) protocols where they are named principal investigator, b) where they are identified in specific roles on the protocol to perform animal research, or c) are involved in other support activities on behalf of the investigator (i.e. peer reviewer for any associated grants, financial backer for the investigator’s start-up company which supports the experimentation under review by the IACUC, etc.).

Following the convened meeting or DMR review, the IACUC Coordinator conveys any concerns or requests for revision to the investigator in writing via email in a timely manner and manages the revision process thereafter.

All experimentation involving the use of hazardous biological, chemical or radioactive agents in animals will be reviewed by the IACUC in conjunction with concurrent review by other compliance committees/review bodies (i.e. Institutional Biosafety Committee for biohazards, Radiation Safety Committee for radiation hazards, and the Environmental Health and Safety Office for chemical hazards). No experimentation proposing use of hazardous agents/materials can be performed until the respective compliance committee(s)/review body(ies) has/have reviewed and approved the proposed project.

When conditions for approval have been met and any additional regulatory committee review and approval is in place, the ORPI notifies the investigator and Institutional Official in writing that approval has been granted and the study may begin. In addition, the Director of Laboratory Animal Resources is similarly notified that the study work may begin.

If approval is denied, the ORPI similarly notifies the investigator and provides the Committee’s rationale for denying approval. The investigator can submit a new protocol or file an appeal in writing to the IACUC.

Any planned revision to an approved protocol must be submitted via an Amendment Form to the Office of Research Protections and Integrity via email (uncc-iacuc@charlotte.edu) for review and approval prior to implementation. The IACUC distinguishes proposed changes to protocols as either minor or major/significant. See the “Amendment Classifications and IACUC Review Processes Policy” for a listing of examples of minor and major amendments:

Prior to submitting an amendment to the IACUC, the principal investigator must consult with the Attending Veterinarian regarding the category of the proposed change (i.e., minor or major). If the proposed change is not in either of the categories above, the Attending Veterinarian will make the determination regarding the category on a case-by-case basis. The Principal Investigator must consult with the Attending Veterinarian regarding potential painful procedures as well as changes in anesthesia, analgesia and euthanasia.

IACUC approval for all proposed changes to an approved application (i.e. minor and major amendments) is required prior to the 1) procurement of animals; 2) commencement of activities and 3) the implementation of proposed changes to the approved protocol.

Minor Amendments:

Minor amendments may be reviewed by the Committee Chair and/or the Attending Veterinarian and do not require full committee review unless either party requests it.

Major Amendments:

All major amendments require full Committee review.

Step 1: All amendments are first checked by the ORPI for form completion. The amendment is forwarded to the Attending Veterinarian (AV) for input and review of the proposed procedures Both the ORPI and the AV construct a summary of questions or concerns for the Principal Investigator (PI) to address, or request clarifications, if needed, to ensure adequate IACUC review.

Step 2: The ORPI provides feedback to the PI via email regarding any edits/requests for clarification or additional information. The PI can opt to revise and re-submit the application before dissemination to the full Committee, or can choose to receive all requests for revision/clarification after the full Committee has reviewed the submission. If there are no questions for the PI to address, or no requests for revisions, the ORPI will notify the PI of the application status via email and will proceed to the next step in the review process.

Step 3: The amendment is distributed to the IACUC via email for their determination of the level of review needed for the protocol. The Committee may ask for any one of the following review options: 1) use of the Designated Member Review process, 2) review by a quorum of the full Committee at a convened meeting, 3) submission of a new protocol.

Step 3.1: If full committee review is not requested, the ‘Designated Member Review’ (DMR) process is implemented. In this process, at least one (1) IACUC member, designated by the Chairperson and qualified to conduct the review, reviews the amendment and has the authority to approve, require modifications to secure approval, or request full committee review of the application.

Step 3.2: If the amendment must go to full committee for review, it is distributed to the entire IACUC at least one (1) week prior to the Committee’s monthly meeting. The Chairperson assigns a voting member of the Committee to be the lead reviewer and begin discussion of the amendment at the next meeting.

NOTE: A quorum, consisting of 50 percent of the voting members plus one member, must be present at the IACUC meeting in order to take action on the amendment. Approval of major amendments may only be granted with the approval vote of a majority of the quorum present. The Committee may take the following actions: approve the amendment, require modifications to secure approval, or withhold approval.

Following the convened meeting or DMR review, the IACUC Coordinator conveys any concerns or requests for revision to the investigator in writing via email in a timely manner and manages the revision process thereafter.

When conditions for approval have been met and any additional regulatory committee review and approval is in place, the ORPI notifies the investigator and Institutional Official in writing that approval has been granted and the proposed changes may be implemented. In addition, the Director of Laboratory Animal Resources is similarly notified.

If approval is denied, the ORPI similarly notifies the investigator and provides the Committee’s rationale for denying approval. The investigator can submit a new amendment or file an appeal in writing to the IACUC.

NOTE: A maximum of three (3) major amendments per protocol can be submitted for IACUC approval without requiring submission of a new protocol. More than three major amendments require submission of new protocol.

Per Federal guidance, the IACUC has approved the option of the administrative handling of the following types of significant (major) amendments:

• Anesthesia, analgesia, sedation, or experimental substances;
• Euthanasia to any method approved by the AVMA Guidelines for the Euthanasia of Animals; and
• Duration, frequency, type, or number of procedures performed on an animal.

However, all of the following conditions MUST be met in order for administrative handling (without IACUC review and approval) to be used:

1. Attending Veterinarian consultation is documented in writing. The AV, per this guidance will be reviewing proposed changes for the impact they may have on animal pain/distress; AND
2. The proposed change does not raise any concerns with the AV (i.e. possibility for potential for increased animal pain/distress; personnel training/proficiency issues; etc.); AND
3. The AV can confirm that the change is covered by an IACUC approved policy, guideline, and/or SOP (without deviating from parameters laid out in such documents).

NOTE:  The AV has the authority to request that the significant change/major amendment be reviewed and approved by the IACUC (i.e., Designated Member Review or Full Committee Review).

In cases where the types of significant (major) amendments allowable for administrative handling conform to all of the above conditions, the Office of Research Protections and Integrity (ORPI) can process them once the AV consultation is received. Please also refer to the Amendment Classifications and Review Processes Policy for more guidance.

Unless otherwise specified by the IACUC, protocol approvals are valid for one year and may be renewed twice for a total of three (3) years of research. The project is terminated if the investigator fails to have the renewal approved by the anniversary of the original approval. The Office of Research Protections and Integrity (ORPI) sends reminders to investigators of the upcoming anniversary date and the requirement for submission of renewal paperwork. Annual renewal forms are submitted by email to uncc-iacuc@charlotte.edu.

Each annual renewal form is reviewed by a member of the IACUC, and the full Committee is regularly notified of annual renewals approved subsequent to the last convened meeting. Any member may at any time request review of an annual report at a convened meeting of the Committee.