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Chapter V - Investigators and Research Staff - Roles and Responsibilities of the Principal Investigator

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THE PRINCIPAL INVESTIGATOR
The Principal Investigator (PI) is ultimately responsible for assuring compliance with applicable institutional/organizational policies and procedures, DHHS Federal Policy Regulations, and FDA regulations and for the oversight of the research study and the informed consent process. Although the PI may delegate tasks to members of his/her research team, s/he retains the ultimate responsibility for the conduct of the study.

WHO MAY SERVE AS A PRINCIPAL INVESTIGATOR
Because PI responsibilities involve direct interaction and supervision of the research team, the PI must be a current employee or affiliate of the organization/institution to oversee the conduct of the study. PIs leaving the institution/organization are responsible for notifying the IRB well in advance of their departure so that they can decide to either close the study or name another appropriately qualified individual currently at the institution/organization to serve as the PI.

GENERAL RESPONSIBILITIES OF PRINCIPAL INVESTIGATOR
As a general condition for the approval of a research study, the IRB holds the principal investigator of the study responsible for ensuring that:

  • Risks to research participants are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose the participants to risk; and, whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes;
  • Risks to human research participants are reasonable in relation to the anticipated benefits (if any) to the individual, and the importance of the knowledge that may be expected to result;
  • Selection of human participants and patients for research participation is equitable;
  • Individuals are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research, and that informed consent will be obtained from each prospective human research participant, or his/her legally authorized representative, in accordance with federal regulations;
  • Informed consent of human research participants will be obtained in advance of research participation and appropriately documented in accordance with federal regulations;
  • Where appropriate, there is routine monitoring of the data collected to ensure the safety of human research participants;
  • The privacy of human research participants is protected, and the confidentiality of data is maintained;
  • Appropriate additional safeguards are included in the study to protect the rights and welfare of human research participants who are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons).

SPECIFIC RESPONSIBILITIES OF PRINCIPAL INVESTIGATORS
The IRB holds the principal investigator of an approved research study responsible for:

  • Promptly responding to all requests for information or materials solicited by the IRB, including the timely submission of the research study for IRB renewal;
  • Ensuring that adequate resources and facilities are available to carry out the proposed research study;
  • Abstaining from enrolling any individual in a research study (i) until such study is approved in writing, by the IRB; (ii) during any period when the IRB or sponsor/principal investigator has suspended study activities; or (iii) following IRB or sponsor/principal investigator-directed termination of the study;
  • Ensuring that all associates, colleagues, and other personnel assisting in the conduct of the research study are appropriately informed of (i) the study procedures; (ii) informed consent requirements; (iii) the potential adverse events associated with study participation and the steps to be taken to reduce potential risks; (iv) adverse event reporting requirements; and (v) data collection and record-keeping criteria;
  • Conducting the study in strict accordance with the current IRB-approved research protocol except where a change may be necessary to eliminate an apparent immediate hazard to a given human research participant;
  • Reporting promptly to the IRB any deviations from the currently approved research protocol;
  • Requesting IRB approval of any proposed modification to the research protocol or informed consent documents prior to implementing such modifications;
  • Obtaining prospectively and documenting informed consent in accordance with the current IRB-approved informed consent documents (i.e., unless the IRB has granted a waiver of the consent process);
  • Maintaining adequate, current, and accurate records of research data, outcomes, and adverse events to permit an ongoing assessment of the risk/benefit ratio of study participation;
  • Reporting promptly to the IRB (and, if applicable, the sponsor and FDA) any internal or external adverse event that is 1) unexpected; 2) serious and 3) possibly or definitely related to the study;
  • Reporting promptly to the IRB any significant changes in the risk/benefit of study participation;
  • Ensuring that, in the event a research participant experiences a significant adverse event, every reasonable effort is made to provide the participant with adequate care to correct or alleviate the consequences of the adverse event to the extent possible;
  • Ensuring that human research participants are kept fully informed of any new information that may affect their willingness to continue to participate in the research study;
  • Ensuring that all listed investigators have the appropriate credentials to conduct the portion of the study in which they are involved and have completed the required Human Participant Research Training modules (see Appendix C);
  • Ensuring that conduct of the research study adheres to Good Clinical Practice guidelines, if applicable. If the study is regulated by the FDA, ensuring that all research investigators and coordinators have completed the Good Clinical Practices training required by the IRB (see Appendix C);
  • Maintaining adequate and accurate research participant records to reflect adherence to protocol specific requirements.

Responsibilities of investigators are further detailed in the references outlined below.

  • 1572 Statement of the Investigator;
  • 21 CFR 312.50: General Responsibilities of Investigators;
  • 21 CFR 812.100: Responsibilities of Investigators: Biologics;
  • 21 CFR 812.110: Responsibilities of Investigators: Devices;
  • DHHS: Office of Human Research Protections (OHRP): Frequently Asked Questions.

SUB-INVESTIGATORS AND RESEARCH STAFF
Appropriately qualified sub-investigators and research staff may perform tasks as delegated by the Principal Investigator but they do not accept primary responsibility for the research study.

GENERAL RESPONSIBILITIES OF THE SUB-INVESTIGATOR AND RESEARCH STAFF

  • Completing required organizational/institutional and protocol specific training;
  • Adhering to the federal regulations, state and local laws, institutional policies and procedures surrounding the safety and protection of human participants;
  • Assuring participant privacy and confidentiality according to HIPAA guidelines, and other relevant policies and procedures.
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