Chapter 4 - Roles and Responsibilities of Investigators and Research Staff
The Principal Investigator (PI) is ultimately responsible for assuring compliance with applicable University IRB 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 student of the University and/or UPMC who is operating within their University or UPMC role to oversee the conduct of the study. PIs leaving the institution are responsible for notifying the IRB well in advance of their departure so that they can make arrangements to either close the study or name another appropriately qualified individual currently at the institution to serve as the PI.
The following individuals may serve as PI(s):
- Faculty members: All categories of compensated faculty members may serve as PI if their School allows them to serve as Principal Investigator on applications for sponsored funding administered through the University. Adjunct faculty of the University, including lecturers and instructors, are not permitted to serve as a PI or Faculty Mentor but may serve as co-investigator. Faculty with a “visiting” title cannot serve as PI unless it is temporarily assigned during transition from another institution.
- Staff: Other University, UPMC, or UPP staff may serve in this role if they have appropriate qualifications to conduct the research and if they have obtained approval to conduct the research from their immediate supervisor.
- Students: Students may serve as principal investigators for their own research projects and are responsible for submitting the IRB application. However, when a student is listed as the PI, a faculty mentor must be listed on the protocol submission. If a student from another institution is also a staff member at the University or UPMC, a faculty mentor is not required. In these circumstances, all requirements listed above under “Staff” must be met.
Note: The IRB reviews and holds student research projects to the same standards as human subject research conducted by faculty or staff. IRB approval or exemption must be obtained prior to initiating any research activity under IRB oversight. “Retroactive” IRB approval or exemption is not permitted under federal regulations and University policy. Failure to obtain IRB approval for research with human subjects may preclude the use of the previously collected data and could result in other institutional sanctions.
General Responsibilities of Principal Investigators
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 subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose the subjects to risk; and, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes;
- Risks to human research subjects 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 subjects 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 subject, or his/her legally authorized representative, in accordance with, and to the extent required, by University policies and federal regulations;
- Informed consent of human research subjects will be obtained in advance of research participation and appropriately documented in accordance with, and to the extent required, by University policies and federal regulations;
- Where appropriate, there is routine monitoring of the data collected to ensure the safety of human research subjects;
- The privacy of human research subjects 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 subjects who are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, individuals with impaired decision-making capacity, 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) reportable new information 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 subject;
- Reporting of deviations that meet the definitions outlined in Chapter 17 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 reportable new information 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 considered to be unexpected, 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 subject experiences a significant adverse event, every reasonable effort is made to provide the subject with adequate care to correct or alleviate the consequences of the adverse event to the extent possible;
- Ensuring that human research subjects 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 applicable University required training modules;
- Ensuring that conduct of the research study adheres to Good Clinical Practice guidelines, if applicable. If the study meets the NIH definition of a clinical trial, ensuring that all research investigators and coordinators have completed the Good Clinical Practices training required by the University IRB;
- Maintaining adequate and accurate research subject records to reflect adherence to protocol specific requirements.
- Complying with additional requirements for federal agencies as outlined in Chapter 26.
Responsibilities of investigators are further detailed in the references outlined below.
- DHHS: Office of Human Research Protections (OHRP): Investigator Responsiblities FAQs
- FDA: Statement of the Investigator Form FDA 1572 FAQ [pdf]
- FDA: Guidance: Investigator Responsibilities - Protecting the Rights, Safety and Welfare of Study Subjects [pdf]
- FDA: 21 CFR 312, Subpart D: General Responsibilities of Sponsors and Investigators: Drugs
- FDA: 21 CFR 812, Subpart E: Responsibilities of Investigators: Devices
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 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, institutional regulations, and HRPO policies and procedures.
Version 10.9.2015; revised 11.2.2018