36. Principal Investigator Responsibilities
University and Affiliate investigators conducting non-exempt human subjects research (i.e., research requiring Expedited or Full Committee Review) must take direction from the IRB Chair. Investigators conducting exempt research must abide by the determinations of the Research Integrity Director or staff. (See IRB policy for review types to assess level of review for a project/package.) Investigators from non-University/non-Affiliated sites are under the same obligations.
The Principal Investigator (PI) is any individual responsible for the conduct of research involving human subjects, either for the study as a whole or for an individual site. The University IRB acknowledges only one PI for a research project.
Due to the leadership responsibilities of PIs for human subject research, University and Affiliate students, and other individuals considered to be in training may NOT serve as PIs. Note: Trainees include residents and post-doctoral students.
In circumstances of faculty-supervised trainee research, a qualified faculty member must serve as the PI. PIs are responsible for:
- regulatory compliance,
- research applications and IRB correspondence,
- supervision of trainees and other members of the research team, and
- data security.
Qualifications and Resources
PIs must be sufficiently qualified by education, training, and experience to assume responsibility for the proper and safe conduct of the research.
PIs must assure that they have sufficient time and resources to properly conduct and supervise all research for which they are responsible.
Compliance with Regulatory Requirements and Institutional Policy
PIs must comply with regulatory requirements and institutional policy, including those related to identification, management, and disclosure of conflict of interests for themselves, key personnel, and the PI's and key personnel's spouse and children when relevant to a research project.
PIs must identify and comply with requirements for approval from University, Affiliate, and external oversight bodies (e.g., radiation or biosafety committees, other federal agencies, and school districts).
PIs must ensure human subject research is designed and implemented to comply with DHHS criteria for IRB approval (as specified in §46.111 and IRB policy), and provide the IRB with sufficient information to determine these criteria are met. NOTE: All requirements for approval may not apply to exempt research.
PIs must obtain IRB approval, or determinations of exemption or "not human subject research" before initiating any research activities involving human subjects.
PIs must ensure recruitment, consent, and research procedures protect the rights and welfare of vulnerable populations or other subjects who may be vulnerable to coercion or undue influence.
PIs must ensure no participants are enrolled in human subject research following suspension or termination of study activities or IRB approval.
PIs must ensure no research activities are conducted following suspension or termination of IRB approval.
When conducting research that involves providing data/specimens to or obtaining data/specimens from an external entity, AND the data-set includes Protected Personally Identifiable Information or Protected Health Information (see the online Policy Manual Definitions), PIs must work with the Sponsored Projects or the equivalent office for Affiliate sites, to prepare and execute the required research agreement. PIs must include the fully executed agreement when submitting the project/package in IRBNet. The agreement must stipulate that the data will not be exchanged before the University PI obtains/confirms the required IRB approvals or exempt determinations."
Management and Training of Research Team Members
Research team members (Researchers) include student and co-investigators, study staff, research assistants, and coordinators.
PIs must ensure that Researchers comply with the University's human protection training requirements (see http://www.unr.edu/research-integrity/training).
PIs must ensure that Researchers are appropriately credentialed and qualified to perform their assigned duties.
PIs must ensure that Researchers execute their delegated responsibilities according to professional and ethical standards, and regulatory requirements and IRB approval.
Oversight of Human Subject Research
PIs are responsible for personally conducting or supervising all research activities.
PIs are responsible for ensuring the research is conducted according to
- sound research design and methods;
- the IRB-approved study plan (as described in researcher applications and forms);
- applicable terms of grants, contracts and/or signed funding agreements; and
- all applicable laws and regulations related to protecting the rights and welfare of human subjects.
For exempt research, investigators must ensure prospective participants are given enough information to make an informed decision about whether or not to participate, and must specify that participation is voluntary.
For non-exempt research, unless the IRB approves a waiver or alteration of informed consent or the project is excluded from the requirements for informed consent under the University's IRB-Flexibility policy, PIs must ensure that informed consent is obtained from all participants in accordance with §46.116 and as approved by the IRB.
For non-exempt research, unless waived by the IRB (or excluded under the University's IRB-Flexibility policy), PIs must ensure that consent is documented to the extent required by §46.117 and as approved by the IRB.
PIs must ensure each subject is given a copy of the informed consent document or information sheet, unless the requirement for a written consent document or information sheet is not part of IRB approval.
PIs must ensure subjects are informed about significant new findings developed during the course of the research that may relate to their willingness to continue participation, in accordance with §46.116.
PIs must ensure the accuracy and completeness of study data.
PIs must obtain prior IRB approval for modifications to the research plan or study materials including informed consent documents, unless changes are necessary to eliminate an immediate harm to participants or others. NOTE: The requirement for prior approval does not apply to minor changes for exempt research (see IRB policy Exempt Research Amendments/Modifications).
For non-exempt research, PIs must ensure continuing review requests are submitted and IRB re-approval is obtained before the expiration date.
PIs must ensure prompt reporting to the IRB of complaints, deviations from or noncompliance with the approved study plan or IRB requirements, safety reports, unanticipated problems involving risks to subjects or others, including interim findings suggesting increased risk to research participants.
PIs must permit and facilitate monitoring and review, at reasonable times, by the RI QI Officer.
PIs must permit and facilitate monitoring and auditing, at reasonable times, by sponsors, the DHHS Secretary, and other federal and state regulatory agencies as appropriate; and must promptly report such monitoring to the IRB.
PIs must obtain the required data use or materials transfer agreements to use research data/specimens from or share research data/specimens with external entities, including commercial providers and data/specimen banks.
Study records include research data (both in paper and electronic formats) and specimens; signed consent forms; IRB applications and supplemental forms; and IRB and sponsor correspondence.
PIs must ensure study records are complete, and stored securely and as approved by the IRB.
PIs must ensure study records are available for inspection by the RI QI Officer, and representatives of other regulatory bodies.
PIs must maintain records for at least three years following expirations of IRB approval or study closure or for the length of time approved by the IRB in accordance with applicable regulations, or institutional or sponsor requirements, whichever is longer.
PIs must take measures to prevent accidental or premature destruction of research records.