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Protocol Decision Guides

Under the umbrella of The U.S. Department of Health and Human Services (HHS) sits The Office for Human Research Protections (OHRP), which provides leadership in the protection of the rights, welfare, and well-being of human subjects involved in research. The resources linked below are published by the OHRP to help guide you when answering the following questions:

  • Is IRB approval required?
  • Are you engaged in "research" under TSU Policy and Federal Regulations?
  • Does what you are doing involve "human subjects"?
  • What kind of IRB review should you request?

Note:  These guides are not intended to be a substitute for the need to understand the ethical and legal issues involved in responsible conduct of research.

  Human Subject Regulations Decision Charts  - Graphic  aids for investigators and others who decide if an activity is research involving human subjects that must be reviewed by an IRB.  
  OHRP Video  - Video  explaining research use of human biological specimens and other private information.


If you need to report a study-related injury, or if you have questions, please contact the IRB Administrator at irb@tnstate.edu.

If you have any concerns regarding integrity and ethics in research and scholarship at Tennessee State University, contact IRB Administration at irb@tnstate.edu . The confidentiality of anyone who contacts the office will be protected under the  Whistleblower Protection Act . Working together we will promote the highest standard of integrity and ethics in research and scholarship.