The Principal Investigator (PI) is ultimately responsible for assuring compliance with applicable University IRB policies and procedures, federal (includes Food and Drug Administration and Department of Health and Human Services), state, and local regulations, and for the oversight of the research study conduct 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 at the University and/or affiliated hospital for whom the IRB acts as the IRB of Record. 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 if their School or department allows them to serve as Principal Investigator.
- Staff: Other University 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 advisor must be listed on the protocol submission.
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.
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 continuation/administrative review;
- 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 minor and major deviations from the currently approved research protocol in accordance with the Reportable Problem or Event Policy;
- 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 (i.e. within 10 calendar days) to the IRB (and, if applicable, the sponsor and FDA) any internal or external reportable event that is considered to be unexpected, serious, and related or possibly related to the study;
- Reporting promptly to the IRB any significant changes in the risk/benefit of study participation;
- 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.
- Maintaining adequate and accurate research subject records to reflect adherence to protocol specific requirements.
Other Key Personnel
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. These personnel include: Co-Investigators, Research Assistants, Research Coordinators, Research Physicians, and Research Nurses.
General Responsibilities of Key personnel
- 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 Wright State IRB policies and procedures.