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 faculty or staff of the University and/or a person who is operating within their University. 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:
- Faculty members: All categories of compensated faculty members may serve as PI. Adjunct faculty of the University, including lecturers and instructors, are not permitted to serve as a PI but may serve as co-investigators.
- Staff: Staff may serve in this role if they have appropriate qualifications to conduct the research.
Note: Given the responsibilities of PIs, at SFA, students may NOT serve as principal investigators for their own research projects and CANNOT submit an IRB application.
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, 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 subject;
- 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 considered to be 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 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;
- maintaining adequate and accurate research subject records to reflect adherence to protocol specific requirements.
Responsibilities of investigators are further detailed in the references outlined below.
- 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
Co-Investigators and Research Staff
Appropriately qualified co-investigators and research staff may perform tasks as delegated by the Principal Investigator (PI) but they do not accept primary responsibility for the research study.
General Responsibilities of the Co-Investigator and Research Staff
- 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, policies, and procedures.