Human Research Protection Program

HITECH Act

Roles & Responsibilities

Principal Investigator (PI)

Full-time Yale University faculty member with primary responsibility for the protection of human subjects and conduct of the research. The PI is ultimately responsible for those acting on her/his behalf even if any of the PI’s responsibilities are delegated to members of the research team. When a prospective PI is not a full-time Yale faculty member, the research must be under the oversight of a full-time faculty member or approval must be sought from the Provost or, as appropriate, from the dean of the respective professional school. This approval may be granted once Yale is confident that the requesting PI has all of the requisite training, education, skills and experience to conduct human research. PI responsibilities are to:

Responsibilities of the PI

  • Ensure that there are adequate resources to carry out the research safely.  This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment and space.
  •  Oversee the research process and be responsible for the conduct of the investigators and research staff at all study sites. Ensure compliance with research protocols, and applicable federal, state, and local laws and regulations, Yale University policies, and IRB policies and procedures. When applicable, follow ICH GCP E(6) requirements as described in IRB Policy 630: Requirements for the Application of Good Clinical Practice (GCP) to the Conduct of Clinical Trials.
  • Protect the safety and welfare of research participants. Ensure compliance with the protocol's data and safety monitoring plan and report adverse events to the respective IRB, study sponsor, and appropriate federal agencies.
  • Ensure that informed consent is appropriately obtained from all participants and that participants are treated with respect and dignity.
  • Complete all required human research training, and if applicable, HIPAA training, and ensure that investigators and key study personnel complete required training.
  • Ensure professional training and expertise (including, but not limited to, appropriate training education, expertise, credentials and, when relevant, privileges) of co-investigators and research personnel is appropriate to perform the procedures assigned to them during the study. Review all pertinent IRB policies and procedures as part of the required initial training for conducting human research. Routinely review the Human Research Protection Program (HRPP) website for new or revised policies and procedures.
  • Review scientific literature to ensure that protocol interventions are consistent with current research data and do not place subjects at unnecessary risk.
  • Responsible for the adequacy of all submissions to the IRB including protocol applications, amendments, and the reporting of adverse events and/or unanticipated problems.
  • Ensure the timely continuing review of protocols and the submission of all re-approval applications before the protocol's expiration date. Report protocol expirations promptly to the appropriate IRB.
  • Submit proposed changes to the research in the form of protocol amendments to the appropriate IRB before the changes are implemented, except when such changes must be implemented immediately to ensure the health and wellbeing of research participants.
  • Protect participants' privacy and confidentiality according to applicable HIPAA policies, Yale policies, and IRB policies and procedures.
  • Maintain all study-related documentation in accordance with Yale policies, IRB policies, and federal regulations.
  • Meet the qualifications set by the University to serve as a principal investigator of a research project or acquire the appropriate approval from the Dean or Provost.
  • Comply with and sustain compliance throughout the research project with the Human Research Protection Program policy on Disclosure and Management of  Personal Interests in Human Research and the University’s policy on Conflict of Interest and Conflict of Commitment and appropriate.

Study Coordinator/Research Staff/Nurse

Individuals working on a research project under the supervision and direction of a Principal Investigator (PI). Study Coordinator, Research Staff and Nurse must:

Responsibilities of the Study Coordinator/Research Staff/Nurse

  • Perform all research-related interventions in accordance with the IRB-approved study protocol.
  • Obtain, when delegated, appropriate informed consent and/or ensure continued informed consent from all participants, and treat participants with respect and dignity.
  • Complete all required human research training, and, if applicable, HIPAA training.
  • Comply with the IRB-approved research protocols, applicable federal, state, and local laws and regulations, Yale policies, and IRB policies and procedures.
  • Comply with the protocol’s data and safety monitoring plan and report adverse events to the PI and, as appropriate, to the IRB, study sponsor, and appropriate federal agencies.
  • Protect subjects’ privacy and confidentiality according to applicable HIPAA policies, Yale policies, and IRB policies and procedures.
  • Maintain all study-related documentation in accordance with Yale policies, IRB policies, and federal regulations.
  • May act as an intermediary between the PI and the IRB, Office of Grant and Contract Administration, and study sponsor.

Chair of a Department

Department Chairs have a general responsibility for promoting the scholarly and research activities of their departments, as well as fostering sound stewardship of funds. They review applications for research projects for appropriateness, assuring that the personnel, fiscal and space demands of such projects are in the best interest of both their departments and the University as a whole.

Responsibilities of a Department Chair

  • Provide assurance to the IRB that the PI and all members of the research team are qualified by education, training, licensure and/or experience to participate in the conduct of any human research.
  • Ensure that the PI has departmental support and sufficient resources to conduct the study appropriately.
  • Attest to the existence of any real or apparent conflict of interest (COI) associated with each research project, when appropriate.
  • Identify any protocol-specific conflict of interest (COI) between said Chair and the sponsor of the research project or any particular interest in the intervention and/or method tested that might compromise the project.
  • Signify that the hypothesis and procedures of any research study in his/her department are consistent with generally accepted scientific principles in the discipline.

Faculty Advisor

A faculty advisor to a student project assumes all of the roles and responsibilities of a Principal Investigator even though the student may be a called a PI. In addition to those listed for a PI, a faculty advisor must:

Responsibilities of a Faculty Advisor

  • Ensure that the student investigators are properly trained in research compliance, protection of research participants and the proper conduct of research.
  • Review and determine that the student project has scientific merit and that the student/trainee has the necessary resources to complete the project and achieve its goals.
  • Ensure that the research is performed according to ethical principles, in compliance with all applicable federal, state and local laws, and in accordance with all Yale policies and procedures relative to the protection of human research participants.
  • Assure that the student investigator obtains IRB approval for the research study and for any subsequent revisions.