Investigator Responsibilities & Informed Consent
Investigators have the primary responsibility for protecting the rights and welfare of human research subjects and are responsible for complying with all applicable provisions of their institution's Assurance. Investigators are expected to be knowledgeable about the requirements of the DHHS regulations, applicable state law, their institution's Assurance, and institutional policies and procedures for the protection of human subjects.
Investigators are responsible for:
Conducting their research according to the IRB-approved protocol and complying with all IRB determinations.
- Obtaining and documenting the informed consent of each subject or each subject's legally authorized representative, unless the IRB has waived these requirements.
- Ensuring that each potential subject understands the nature of the research and participation.
- Providing 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 this requirement. All signed consent documents are to be retained for at least 3 years after the completion of the research and according to institutional policy.
- Promptly reporting 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.
- Reporting progress of approved research to the IRB as often as, and in the manner, prescribed by the IRB.
- Promptly reporting to the IRB any unanticipated problems involving risks to subjects or others or any serious or continuing non-compliance with the DHHS regulations or determination of the IRB.
A physician may provide emergency medical care to a patient without prior IRB review and approval, to the extent permitted by applicable federal, state, or local law. However, such activities may not be considered research nor may the data be used in support of research, except to the extent required under FDA regulations. Investigators should consult with the IRB to ensure that activities that meet the regulatory definition of non-exempt human subject research undergo IRB review and approval prior to the initiation of the activities.