Human Research Protection Program

HITECH Act

Sponsor Investigator

Sponsor Investigator (SI)

A Sponsor Investigator (SI) is anyone who functions as the PI of a given study and who holds an Investigational New Drug (IND) or an Investigational Device Exemption (IDE). The SI is held accountable for all the roles and responsibilities of a PI and the Food and Drug Administration (FDA) requires that the SI follow the FDA regulations for sponsors. Sponsor-specific regulations can be found on the FDA website or in Yale IRB guidance document 600 GD1 on this website.

Responsibilities of the Sponsor Investigator (SI)

  • Submit an application to the FDA if the sponsor intends to use a significant risk device in an investigation, intends to conduct an investigation that involves an exception from informed consent, or if FDA notifies the sponsor that an application is required for an investigation.
  • Start an investigation or part of an investigation only after an IRB and FDA have both approved the application or supplemental application relating to the investigation or part of an investigation.
  • Supply investigators participating in the investigation with copies of the investigational plan and the report of prior investigations of the drug or device.

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.

Responsibilities of the Principal Investigator (PI)

  • 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.
  • 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 of co-investigators and research personnel is appropriate to the role that each will be assigned in the research project. 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 IRB’s protocol-specific Conflict of Interest policy and the University‚Äôs policy on Conflict of Interest and Conflict of Commitment.