Guidance & Forms
NEWS: Effective July 27, 2015 SPARCS IRB will be used for all new IRB protocol submissions. Paper Forms for new protocols will not be accepted. While everyone learns the new system, it is expected that turn-around time will increase. Please submit new protocols, renewals and modifications at least 6 (six) weeks in advance. See SPARCS Roll-out for details
General Protocol Submission Guidance
All submissions must be complete prior to IRB 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. During the implementation of SPARCS IRB turn-around time is likely to be longer.
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.
All new protocols must be submitted online via SPARCS https://www.cmu.edu/research-office/sparcs/index.html.
Renewals of protocols expiring prior to November 1, 2015 should be submitted by sending a completed Continuing Review Form to email@example.com.
Renewals of protocols expiring November 1, 2015 and later should be submitted online via SPARCS. The study PI will receive an e-mail when the study is ready for conversion to SPARCS. Please submit your continuing review six weeks prior to expiration to allow for conversion and review. A quick guide for submitting the conversion is available here. [PDF]
Modifications to approved protocols should be submitted in the format of their current approval:
- If the most recent approval was on paper, submit on paper to firstname.lastname@example.org
- If the most recent approval was in SPARCS submit online via SPARCS.
The following items are necessary for a complete submission:
- A complete application;
- 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;
- Other items as required: some studies may require other items such as documentation of permission to work in a school, IRB approval from a collaborating institution, etc.
Unanticipated Events (UAPs) are called "Reportable New Information" (RNI) in SPARCS. If something needs to be reported, submit on paper if the most recent approval was on paper and via SPARCS if the most recent approval was in SPARCS.
All applications and forms may be submitted electronically to email@example.com. Incomplete applications will result in a delay of approval.
Types of Protocols
The federal regulations governing Human Subjects Research create certain categories of research and corresponding requirements. These categories are Exempt, Expedited and Full-Board. Please read the descriptions of these to determine which category is appropriate for your particular protocol. The Decision Tree [PDF] provides some guidance.
Despite that name “Exempt”, research falling in this category needs to be submitted to the IRB for review. The Exempt category includes research:
- Conducted in established educational settings and involves normal educational practices;
- That only involves tests, surveys, interviews or observation of public behavior;
- That only involves 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;
- That involves taste, food quality evaluation and food acceptance.
Research that does 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).
Research that is greater than minimal risk or does meet the exemption or expedited criteria discussed above must go to the Full Board.
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. This should be uploaded to SPARCS in the Supporting Documents section.
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 the protocol was most recently approved on paper or via SPARCS if the protocol was most recently approved in SPARCS. 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:
Paper: 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
SPARCS: Request for modification, 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:
- Continuing Review Request via SPARCS for protocols expiring November 1, 2015 and later
- Copy of the original application or an updated application if modifications have been made
- Consent Form
Surveys and Research Using CMU E-Mails
If you are interested in using CMU e-mails to conduct your research, please contact CMU's Institutional Research and Analysis. They have a well-defined process for using CMU e-mail for surveys and research projects.