Guidance & Forms
General Protocol Submission Guidance
All submissions must be complete prior to review and approval. (Note: incomplete submissions cannot be processed and may result in significant delays for the researcher). If possible, please submit applications at least three – four (3-4) weeks prior to the date you need approval. The IRB Full Board meets on the first Tuesday of the month. Protocols requiring Full Board review must be received by the IRB office at least two (2) weeks prior to the next meeting to get on the agenda.
The following items are necessary for a complete submission:
- An application that is fully completed and signed (either electronically per the instructions on the form or by hand);
- Informed Consent (when applicable);
- All recruiting materials;
- All questionnaires or surveys (when applicable);
- If the Principal Investigator (PI) is a student, a Faculty Assurance Form completed by the student’s Faculty Advisor;
- Some studies may require other items such as documentation of permission to work in a school, IRB approval from a collaborating institution, etc.
All applications and forms may be submitted electronically to email@example.com. Incomplete applications will result in a delay of approval.
Several forms are available for submission of new protocols. These forms are tailored to specific types of research. Please read the descriptions of these to determine which form is appropriate for your particular protocol. The Decision Tree [PDF] provides some guidance.
- Protocols that are conducted in established educational settings and involve normal educational practices.Use Exempt Form(b)(1) [DOC].
- Protocols that only involve tests, surveys, interviews or observation of public behavior. Use Exempt Form (b)(2) [DOC].
- Protocols that only involve the collection or study of existing data, documents or records if these are publically available or recorded in such a way that research participants cannot be identified. Use Exempt Form (b)(4) [DOC].
Protocols that do not meet the criteria for exemption may qualify for Expedited Review. These are minimal risk studies that that fall into one of eight categories set forth in federal regulations (45 CFR 46.110). Use the CMU IRB Application [DOC] and the CMU Consent Form Template [DOC] or the Online Consent Template [DOC].
Protocols that are greater than minimal risk research or do meet the exemption or expedited criteria discussed above must go to the Full Board. Use the CMU IRB Application [DOC] and the CMU Consent Form Template [DOC] or the Online Consent Template [DOC].
When submitting a new protocol, please use the current CMU Consent Form Template [DOC] or the Online Consent Template [DOC] as a guide for your document. See this guidance [PDF] for instructions on customizing the template to your study. If your study involves fMRI, please use the fMRI Consent Form Template [DOC].
If you are requesting a Waiver of Informed Consent or a Waiver of Documentation of Informed Consent, indicate this in the application and fully complete those sections.
Information for Students and Faculty Advisors
When a student is the Principal Investigator for a study s/he is responsible for completing the application and indicating student status and identifying the Faculty Advisor for the study. For all student lead studies, a Faculty Assurance Form [DOC]must be completed and submitted.
Modifications to an Approved Protocol
The IRB should be notified before a change is made to a protocol. Some changes require IRB review and approval, others do not. All requests for modification should be made using the Request for Modification Form [DOC]. If you have a question about the need to submit a modification, contact the IRB office.
Things that require IRB review and approval:
- Change in study design – ex. adding a new type of study activity
- New location for conduct of the study
- A change in investigators.
Things that may require IRB notification only:
- Changes to questionnaires that are consistent with the approved questionnaire
- Change to recruiting materials that are consistent with the approved materials
Items that need to be submitted for a modification:
- Request for Modification Form [DOC]
- Updated application highlighting the changes made
- Any supporting materials that are changed such as:
- Updated consent form
- Updated and/or new questionnaires, surveys
- Updated and/or new recruiting materials
Continuing Review / Annual Renewal
Federal regulations require that IRB approved protocols be reviewed and approved no less than once every twelve months. The CMU IRB office typically sends reminder notices that a protocol is due for renewal 6 weeks prior to the first of the month in which it expires.
Items that need to be submitted for an annual renewal:
- Completed Continuing Review Form [DOC]
- Copy of the original application or an updated application if modifications have been made
- Consent Form