All projects which involve the use of non-human vertebrate animals must undergo IACUC review and receive approval prior to initiation.
New Protocol Review Procedures:
- All student investigators are required to consult with a faculty advisor about the project prior to submitting the project to the IACUC.
- All investigators are encouraged to consult the Marietta College IACUC Policy and the National Research Council Guide for the Care and Use of Laboratory Animals.
- Investigators must complete the New Protocol application. New Protocol applications may be submitted at any time.
- Upon completion of the proper forms, the application is submitted to the IACUC chairperson and reviewed for completeness. If the forms are complete, the IACUC chair will begin the review process with the full IACUC. Investigators should expect this process to take approximately two weeks.
- Criteria for review include activities, pain/distress, alternatives, rationale and methods, duplication, surgery, euthanasia, housing/health, qualifications of personnel, and any deviation from requirements must be justified.
Protocol Modification Procedures:
- Requests for approval of modifications may be submitted at any time. Completion of the Protocol Modification form is required. The changes must be approved by the IACUC before any changes can be implemented in the conduct of the protocol. Student investigators must consult with a faculty mentor prior to submitting their protocol modification.
- Amendments to protocols include minor changes such as small increases in animal numbers, minor procedural changes, and personnel changes. Major changes include larger increases in numbers, addition of invasive procedures, changes in pain level, change in species, etc.
- Minor protocol changes require the review of the IACUC chairperson. Major changes will require the review of the full IACUC.
- Procedures for notification to the investigator are the same for protocol amendments as for initial protocol approvals.
Protocol Renewal Procedures:
- Protocol approval is only valid for a period of one year. Requests for renewal of an approved study must be submitted any time after approval of the protocol. However, to make sure that data collection goes uninterrupted, investigators are encouraged to submit for renewal during the final month of approval of the protocol, in order to give the IACUC ample time to review the request and approve it.
- Completion of the Protocol Renewal form is required. Approval of a renewal request must be obtained to continue a project past the original expiration date of an approved protocol.
Existing Protocol Use Procedures:
- In the Resources for Investigators area, there is existing protocol that has been approved for use at Marietta College. For investigators who desire to use an existing protocol for a study or class project, these can be a reference in place of submitting a New Protocol application.
- To qualify to use an existing protocol, student investigators must consult with a faculty mentor prior to submitting the application.
- Completion of the Existing Protocol form is required, and the code of the existing protocol must be referenced in the form.
- Only minor deviations from the existing protocol will be allowed when using the existing protocol procedure, which must be detailed in the Existing Protocol form.
What to expect after your protocol is submitted:
- The IACUC will notify investigators in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of revisions required to secure IACUC approval.
- The IACUC will communicate with the principal investigator, outlining the approval status and/or concerns, questions and/or comments of the IACUC.
- The IACUC Chairperson will convey one of the following four decisions in writing to the investigator promptly after the IACUC meeting:
- Approval: The investigator may begin the research study upon receipt of the approval notice from the IACUC.
- Approval Pending Revisions: This decision is determined when the protocol is recommended for approval by the IACUC pending the investigator's response to IACUC-directed stipulations/questions and/or revisions. The principal investigator must provide a memorandum responding to the IACUC's recommendations and questions.
- Tabled: More substantive issues regarding the protocol must be addressed. Clarifications or requested revisions may have a significant impact on the involved animals. A memorandum is sent to the investigator requesting that these issues be addressed, and investigators may be asked to attend an IACUC meeting.
- Not Approved: Questions regarding scientific merit and use of animals are of such significance that the committee finds approval of the study to be unwarranted.
Approval of a protocol is valid for one year from the approval date.