All submissions must be complete prior to IRB review and approval. Please note that incomplete submissions cannot be processed and may result in significant delays. Applications should be submitted at least six (6) weeks prior to the date approval is needed.

The IRB Full Board typically meets on the first Tuesday of each month. However, this date may be adjusted to accommodate holidays or quorum requirements.

Meeting agendas close one week prior to the scheduled meeting. To be included on the agenda, any protocol requiring Full Board review must meet the following requirements:

• Be fully complete,
• Have undergone IRB staff pre-review, and
• Have all staff comments or requests addressed before the agenda closes.

All IRB submissions (new protocols, modifications to protocols, protocol renewals and reportable new information) must be submitted 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);    
• All additional subject-facing materials (e.g., videos, images, audio, text, etc.) (when applicable);
• All device descriptions and product manuals (when applicable);
• If the Principal Investigator (PI) is a student, a Faculty Assurance Form completed by the student’s Faculty Advisor; and
• Other items as required—some studies may require other items such as documentation of permission to work in a school or company, IRB approval from a collaborating institution, documentation of permission to conduct research in a foreign country, certified translations of documents, etc.

Reportable New Information (RNI) is information the IRB must be made aware of, such as work done outside of the approved protocol, participant problems, and adverse events. Notification to the IRB is done through the RNI functionality in SPARCS.

Information to include in the RNI, as appropriate for the type of information/event: Details regarding what happened and why it happened, the number of subjects affected, and a Corrective and Preventative Action plan (CAPA) describing what was done to address the issue, and what will be done in the future to ensure it does not happen again for this or other research. If data was collected without IRB approval or outside of the approved protocol procedures or enrollment numbers, you may include a request to retain and use the data. The IRB will evaluate this request and the CAPA during its review of the RNI.

The federal regulations governing Human Subjects Research create certain categories of research and corresponding requirements.  These categories are Exempt, Expedited and Full-Board.  Each type of review has very specific criteria under which a study may be approved. Details of the types of review, the process for submission and what the possible IRB determinations include are described in detail in the Investigator Manual, available in the SPARCS Document Library.

When submitting a new protocol, please use the current CMU Consent template or the Exempt Consent Guidance and Example Language document (available in the SPARCS Document Library) as a guide for your consenting process. 

If you are requesting a Waiver of Informed Consent or a Waiver of Documentation of Informed Consent, indicate this in the protocol template and fully complete those sections.

When a student is the Principal Investigator for a study they are responsible for completing the application, indicating their 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.

Note: Honor’s, Master’s, and Doctoral thesis and dissertation projects that involve research with human subjects always require IRB review and approval.

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.

Changes that require IRB review and modification approval:

• Change in study design (e.g., adding a new type of study activity or procedures);
• Change in funding;
• New location for conduct of the study;
• A change in investigators;
• Changes to questionnaires that are inconsistent with the currently-approved questionnaires (e.g., new topics being asked, increase in sensitivity, risk, or amount of questions/time commitment required, additional questionnaires);
• Change to recruiting materials that are inconsistent with the currently-approved materials (e.g., adding procedures, risks, inclusion/exclusion criteria, compensation); and
• Any supporting materials that are changed such as: updated consent form, updated and/or new questionnaires, surveys, updated and/or new recruiting materials.

Federal regulations require that some IRB approved protocols be reviewed and approved no less than once every twelve months. Your approval letter will list an expiration date for your study, when applicable. The SPARCS system will send 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 requiring continuing review must follow the same timeline for submission as initial studies and Principal Investigators are responsible for submitting their research for Continuing Review allowing for sufficient time for the IRB to review and approve the study prior to expiration.

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.

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.