Faculty Policies and Procedures Handbook

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G. Responsibilities of Investigators

Investigators have the primary responsibility to:

  1. Protect the rights and welfare of human research subjects and comply with all applicable provisions of the UT IRB policy.
  2. Be knowledgeable about the requirements of the HHS regulations, applicable state law, and institutional policies and procedures for the protection of human subjects.
  3. Conduct their research according to IRB-approved protocol
  4. Obtain and document the informed consent of each subject or each subject's legally authorized representative and provide a copy of the IRB‐‐‐approved informed consent document to each subject or the subject's legally authorized representative at the time of consent, unless the IRB has specifically waived either of these requirements.
  5. Ensure that each potential subject understands the nature of the research and participation.
  6. Promptly report proposed changes in previously approved human subject research activities to the IRB. The proposed changes may not be initiated without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subjects.
  7. Promptly report to the IRB any unanticipated problems involving risks to subjects or others or any serious or continuing non‐compliance with the HHS regulations or determination of the IRB.