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36. Responsibilities: Investigators

An investigator is any individual responsible for the conduct of research involving human subjects, either for the study as a whole or for an individual site. If the research is conducted by a team at a study site, the investigator is the responsible leader of the team. See below for University requirements to serve as a PI.

  • Prior to commencing any human subjects research, investigators must obtain IRB approval, affirmation of exempt status, or "not human subjects" determination as applicable to the research.
  • Investigators must be sufficiently qualified by education, training, and experience to assume responsibility for the proper and safe conduct of the research.
  • Investigators must assure that they have sufficient time and resources to properly conduct and supervise the research for which they are responsible.
  • Investigators are responsible for complying with regulatory and institutional requirements, including those relating to financial interests when these are relevant to the research.
  • Investigators are responsible for personally conducting or supervising the research.
  • Investigators are responsible for ensuring that research is conducted according to
    • sound research design and methods;
    • the IRB-approved study plan (protocol);
    • the applicable terms of the grant, contract and/or signed funding agreements; and
    • applicable laws and regulations, including those for protecting the rights, safety, and welfare of human subjects.
  • Investigators are responsible for ensuring that members of the research team, including study staff and trainees, are appropriately qualified, trained and supervised.
  • When responsibilities are delegated to members of the research team, investigators must ensure that those members execute their delegated responsibilities appropriately.
  • Investigators are responsible for providing the IRB with sufficient information and materials to make the required determinations in §46.111.
  • Unless waived by the IRB, investigators are responsible for ensuring that informed consent is obtained in accordance with §46.116 and as approved by the IRB.
  • Unless waived by the IRB, investigators are responsible for ensuring consent is documented to the extent required by §46.117 and as approved by the IRB.
  • Investigators are responsible for providing a copy of the informed consent document to each subject, unless the requirement of a written consent document is not part of the IRB approval.
  • Investigators are responsible for providing subjects with significant new findings developed during the course of the research that may relate to their willingness to continue participation, in accordance with §46.116.
  • For research involving subjects who may be vulnerable to coercion or undue influence (i.e., vulnerable populations), investigators are responsible for including additional safeguards to protect the rights and welfare of these subjects.
  • Investigators will abstain from enrolling any individuals in IRB-approved research during any period when the IRB, sponsor or PI has suspended study activities; or following IRB, sponsor or PI-directed termination of the study.
  • Investigators are responsible for identifying the need for and obtaining approval from all relevant oversight bodies (e.g., radiation or biosafety committees, school districts).
  • For non-exempt research, investigators must obtain prior IRB approval for any modifications to the research protocol or informed consent documents.
  • For non-exempt research, investigators must obtain IRB re-approval for protocol renewals (i.e., submit for continuing review of the research) before the expiration date.
  • Investigators must permit and facilitate monitoring and auditing, at reasonable times, by the IRB of record, funding entities, sponsors, the Secretary, and other federal and state regulatory agencies, as appropriate; and to promptly report such monitoring to the IRB.
  • Investigators shall ensure prompt reporting to the IRB of any noncompliance with the approved protocol or requirements of the IRB, and of unanticipated problems involving risks to subjects or others.
  • Investigators are responsible for the safe and secure storage of research data (whether in paper or electronic formats) and for protecting the confidentiality of the data in accordance with the approved protocol.
  • Investigators are responsible for the accuracy and completeness of study data.
  • Investigators must submit written reports to the IRB as required by the IRB, including continuing review documents to the IRB as necessary to maintain IRB approval.
  • Investigators must maintain records appropriate to the research (e.g., the study plan, consent forms, and correspondence from the IRB) and permit inspection of the research records in accordance with §46.104(j).
  • Investigators must maintain records for at least three years after the research ends or for the length of time specified in applicable regulations, or institutional or sponsor requirements, whichever is longer.
  • Investigators must take measures to prevent accidental or premature destruction of research records.

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