Human Subjects Research

The Carnegie Mellon University Institutional Review Board (IRB)

All research involving the use of human research subjects (participants) must be reviewed and approved by the CMU Institutional Review Board (IRB) before the research can be initiated.

Research means a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge; (see 45 CFR 46.102(d)).
Human Subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. (see 45 CFR 46.102(f)).

The primary responsibility of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating in research. The IRB functions according to the guidelines of the Office of Human Research Protection (OHRP) and other federal regulatory agencies. The IRB is a committee with representation from CMU faculty and the community. The CMU IRB meets on the first Wednesday of every month. Protocols that are eligible for Exempt and Expedited Review are processed on an ongoing basis.

If you have questions about whether your activity requires review by the IRB please review the guidance below or contact the Research Regulatory Compliance Office at 412-268-1901 or irb-review@andrew.cmu.edu.

Information on how to submit a proposal to the IRB is provided below.

General Protocol Submission Guidance
New Protocols
Informed Consent
Information for Students and Faculty Advisors
Modification to an Approved Protocol
Continuing Review / Annual Renewal
Education Requirements
Documents and Forms - all new as of January 2009 and updated August 2009
Reference Information and Links
Frequently Asked Questions

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 Wednesday 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 irb-review@andrew.cmu.edu. Incomplete applications will result in a delay of approval.

New Protocols

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 provides some guidance.

Exempt Review

Protocols that are conducted in established educational settings and involve normal educational practices. Use Exempt Form (b)(1) .

Protocols that only involve tests, surveys, interviews or observation of public behavior. Use Exempt Form (b)(2).

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).

Protocols that only involve taste and food quality evaluation. Use Exempt Form (b)(6).

Expedited Review

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 and the CMU Consent Form Template or the Online Consent Template.

Full-Board Review

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 and the CMU Consent Form Template or the Online Consent Template.

Informed Consent

When submitting a new protocol, please use the current CMU Consent Form Template or the Online Consent Template as a guide for your document. See this guidance for instructions on customizing the template to your study.

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 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. 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
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 Continung Review Form
Copy of the original application or an updated application if modificaiont have been made
Consent Form

Education Requirements - updated November 2009

All personnel involved in a human subject protocol must demonstrate completion of an education program on the use of human participants in research In recent years, CMU used an NIH online course for education We recently switched to CITI which includes material geared toward social and behavioral research. As of January 1, 2010, new investigators must complete a CITI course rather than the NIH course.

To complete the required education go to CITI's website. Select Carnegie Mellon University as your "participating institution" and create an account. Once your registration is complete, you will be directed to the list of courses. Choose the human subject research module most appropriate to the type of research you conduct. The course may take a few hours to complete but can be done over a period of time. When you complete the course, CITI will e-mail your completion record to the CMU IRB. If you have done CITI education for another organization, add CMU to your profile. You will be given credit for your previous courses to the extent they overlap with CMU's requirements.

The CMU IRB will also accept the human subjects research education done via the University of Pittsburgh.