36. Responsibilities: Principal Investigators
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 IRBs acknowledge 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
- PIs must comply with regulatory requirements and institutional policy, including those related to financial interests when relevant to a research project.
- PIs must identify and comply with requirements for approval from University or 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.
- 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.
- PIs must provide the IRB with all data safety monitoring reports they receive, either at continuing review (for benign reports) or within five days of receipt if safety concerns are noted.
Management and Training of Research Team Members
Research team members (Researchers) include student and co-investigators, study staff, research assistants, and coordinators.
- PIs must comply with the University's human protection training requirements (see http://www.unr.edu/research-integrity/training).
- 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
o sound research design and methods;
o the IRB-approved study plan (as described in researcher applications and forms);
o applicable terms of grants, contracts and/or signed funding agreements; and
o all applicable laws and regulations related to protecting the rights and welfare of human subjects.
- Unless waived by the IRB, PIs must ensure that informed consent is obtained from all participants in accordance with §46.116 and as approved by the IRB.
- Unless waived by the IRB, 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 exempt research, PIs must ensure Annual Status Reports are submitted within 12 and 24 months following approval of the research plan (unless the study is closed).
- 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 noncompliance with the approved study plan or IRB requirements, and of unanticipated problems involving risks to subjects or others.
- PIs must permit and facilitate monitoring and review, at reasonable times, by the RIO 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.
- PI must provide the IRB with all data safety monitoring reports they receive, either at continuing review (for benign reports) or within five days of receipt if safety concerns are noted.
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 RIO QI Officer, and representatives of other regulatory bodies.
- PIs must maintain records for at least three years after the research ends, 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.