Human Subjects and 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.  To initiate review, complete an application and submit it to the IRB for review.  Call the Regulatory Compliance Administration at 412-268-1901 for answers to questions regarding the IRB or the IRB review process.

Forms and Documents

• CMU IRB Application Form - IRB_Application form
• Sample consent form for minimal risk protocols - Minimal Risk Sample Consent Template
• Application for continuing review of approved IRB protocol - IRB Continuing Review form
• Investigator Signature page - PI_Signature_Page
• IRB parental consent child assent Template 
• Miscellaneous Clauses for Human Subject Research Consent Forms Template
• HIPAA information - Hipaa information
• Anonymous or Confidential Description
• Human subject Payment forms are available on the financial forms page of the Financial Services Group website (Excel form*, PDF form*) 

*These forms are direct links to the Financial Services Group. They will be downloaded from the FSG web server.

All applications and forms may be submitted electronically to irb-review@andrew.cmu.edu. They may also be mailed or faxed to Regulatory Compliance.

The IRB meets the first Wednesday of each month.  Protocols requiring full board review must be submitted two weeks prior to the meeting to allow adequate time for review.  Protocols that qualify for expedited or exempt review can be submitted anytime and will be reviewed as they are submitted.

Training

All personnel involved in the human subject protocol must demonstrate completion of a training program on the use of human participants in research.  CMU is currently using the online training module used by NIH researchers.   Once the training program is completed, print out the certificate and send it to the Regulatory Compliance Administration office.  If a research personnel completed an approved training program elsewhere, documentation of completion must be submitted before the protocol can be fully approved.

• NIH Online Training (Human Participant Protections Education for Research Teams) 
• List of Frequently Asked Questions regarding the IRB - IRB FAQ

Human Subjects Websites

• The Belmont Report - NIH-OHSR link
• The Nuremberg Code - NIH-OHSR link
• Office for Human Research Protections (OHRP) - OHRP link
• Institutional Review Board Guidebook - IRB Guide
• Guidelines for the Conduct of Research Involving Human Subjects at NIH
• National Science Foundation (NSF) Behavioral and Cognitive Sciences - NSF Link
• National Science Foundation (NSF) The Common Rule PDF file - NSH PDF
• Carnegie Mellon's University Policy on Human Subjects - CMU Human Research link
• NIH decision charts
• Information about the Health Insurance Portability and Accountability Act of 1996 - HIPAA Information 
• OHRP Frequently Asked Questions (FAQs) for Research Involving Children - OHRP link