Human Subjects

 

 

Institutional Review Board

The role of the Institutional Review Board (IRB) is to review all the proposed research involving human subjects and to ensure that subjects are treated ethically and that their rights and welfare are adequately protected.

The IRB process is administered through the Research Compliance Unit. Investigators and student researchers are not allowed to solicit human subject participation or begin data collection prior to receiving IRB approval in writing.

 

Collaborative Institutional Training Initiative (CITI)

Prior to receiving IRB approval, researchers must participate in the online education program sponsored by the Collaborative Institutional Training Initiative and the University of Miami. Developed by national  IRB experts, the CITI program covers human subject research through a series of modules. At the end of the program modules, researchers will receive certification, which is good for three years.  For more information on this online training program and to participate in the program go to to www.citiprogram.org.

 

IRB Protocol Submission

An IRB protocol application submitted for review consists of the following submitted in the order given here:

  1. Protocol Application with signatures
  2. Letter requesting permission to designated agent of cooperating institution of agency (if required)
  3. Letter from designated agent of cooperating institution or agency (if required)
  4. Consent forms, assent forms, recruitment ads, HIPPA forms (as necessary)
  5. Research instrument
  6. Certificate of research training from all persons associated with the research project

All submissions must be typed, legible and suitable for photocopying on the official IRB application form. The IRB Research Associate will request additional information or a resubmission if materials are not sufficiently legible, if sections are incomplete, or if required documentation is missing.

 

Resources

For IRB related questions, please contact us at: