Guidance & Forms
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 six (6) weeks prior to the date you need approval.
The IRB Full Board usually meets on the first Tuesday of the month, however, this date may be adjusted for holidays. 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, modifications to protocols and protocol renewals must be submitted online via SPARCS https://www.cmu.edu/research-office/sparcs/index.html.
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.
Reportable New Information
Reportable New Information (RNI) is information the IRB must be made aware, such as work done outside of the approved protocol, participant problems and adverse events. Advising the IRB of this is done through the RNI functionality in SPARCS.
Information to include in the RNI: Describe in detail what happened, why it happened, what was done to address the issue, and what will be done in the future to ensure it does not happen again.
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.
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 research and demonstration projects that are conducted or supported by Federal department or agency
- That involves taste, food quality evaluation and food acceptance
- That involves storage or maintenance of identifiable private information or identifiable biospecimens for secondary research use
- That involves secondary research for which broad consent was obtained for research involving the use of identifiable private information or identifiable biospecimens for secondary research use
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 nine 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 above must go to the Full Board.
When submitting a new protocol, please use the current CMU Consent Form Template [DOCX] or the Online Consent Template [DOCX] 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 [DOCX].
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-led studies, a Faculty Assurance Form [DOCX] must be completed and submitted. This document must be signed and uploaded to SPARCS in the Supporting Documents section.
Course-Related Student Projects (CRSP) - When students conduct research as a course assignment, for educational purposes, there are some conditions under which IRB approval may not be required. Course-related student projects are usually limited in scope and designed to teach students how to conduct research or other vocation-related activities. The course-related projects typically are not intended to further scientific knowledge in a particular field of study, suggest generalizable results, or to lead to scholarly publication. The CMU IRB has released a Guidance [PDF] which outlines the basis for when these course-related projects do not meet the regulatory definition of Human Subjects Research and therefore do not require IRB approval. The CMU IRB also has released a Course-Related Student Project Checklist [DOCX] to assist course instructors and student researchers in determining whether a project can be conducted without IRB approval. PLEASE NOTE: Honor’s, Master’s, and Doctoral thesis and dissertation projects that involve research with human subjects always require IRB review and approval.
Modifications to an Approved Protocol
The IRB should be notified before a change is made to a protocol. All requests for modification should be made via SPARCS. If you have a question about the need to submit a modification, contact the IRB office.
Things that require IRB review and modification approval:
- Change in study design – ex. adding a new type of study activity
- Change in funding
- New location for conduct of the study
- A change in investigators.
- Changes to questionnaires that are consistent with the approved questionnaire
- Change to recruiting materials that are consistent with the approved materials
- 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 for some protocols. The SPARCS system sends reminder notices that a protocol is due for renewal 90, 60, 30 and 15 days prior to expiration. Requests for Continuing Review are processed via SPARCS.
Studies that are not given an expiration date are given a Check-In date. Through the Check-In process, researchers are asked to update the IRB as to the status of the study. The SPARCS system sends reminder notices a protocol is due for Check-In 60, 30 and 15 days prior to the official Check-In date.
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.
Research Involving Minors
If you are conducting research that includes interactions with minors, you must comply with CMU's policy on the Protection of Minors. Contact CMU's Child Protection Operations office for details.