35. Requirements and Responsibilities of Principal Investigators for Human Research Projects

Updated August 26, 2022

Requirements for individuals to serve as the Principal Investigator (PI) for human research differ from those required for an individual to be the PI on a sponsored project under the auspices of the University of Nevada, Reno (the University).

The Principal Investigator is any individual responsible for the conduct of research involving participants, either for the study as a whole or for an individual site. The University IRB acknowledges only one PI for a research project.

This policy is concerned with requirements and responsibilities to be the PI for human research projects.
Contact Sponsored Projects for information about the University's requirements to be the PI on sponsored projects.

Requirements for University Employees to Serve as the PI for Human Research

University employees must meet one of the following criteria to serve as the PI for human research projects that are exempt under DHHS regulations or the University's IRB Flexibility Policy, or non-exempt (thus requiring IRB review, approval, and oversight).

Faculty at the University with renewable appointments as defined in the University Administrative Manual (see UAM section 2,511).
Valid and current contract as Community Faculty at the University of Nevada School of Medicine who have agreed to contract Terms of Appointment for PI responsibilities.
Visiting faculty or scientists during the time they are on the University payroll and endorsed in writing from his/her sponsor.
Full-time classified staff at the University, with signature approval from the appropriate dean/director.
University of Nevada, Reno Emeritus/Emerita faculty in residence who wish to continue their research programs, with signature approval from the appropriate dean/director and the Vice President for Research and Innovation (VPRI).

NOTE: Individuals with Letters of Appointment (LOA) at the University require special consideration because of the time limits associated with their employment. Research Integrity will evaluate individuals with Letters of Appointment at the University on a case-by-case basis to determine if they may be the PI for human research. If Research Integrity determines they may be the PI, individuals with LOA must provide documentation of approval, support, and specification of responsibilities from the Chair of the program that established the LOA. The documentation must also:

indicate if the LOA is expected to be continued in subsequent semesters or is short-term, and
specify who will be responsible for the protection of human research participants and the research records and data when the LOA contract is not in effect (e.g., between semesters, over the summer).

Requirements for Individuals from Affiliate Sites to be PI for Human Research

"Affiliate Sites" refers to institutions that have an inclusive, signed agreement (generally a Memorandum of Understanding) that allows the University IRB to be the IRB of Record for human research conducted at or on behalf of the Affiliate Site. To serve as a principal investigator for human research submitted for exempt determination by the University Research Integrity or for review, approval, and oversight by the University IRB, individuals at Affiliate Sites must meet one of the following criteria:

She/he/they is faculty at the Site;
She/he/they is clinical staff at the Site; or
She/he/they is otherwise considered a qualified representative or agent of the Site, as determined/confirmed by the Affiliate Site.

Requirements for Individuals from Other External Sites to be PI for Human Research

Individuals from other external sites who wish to be the PI for exempt or non-exempt human research to be conducted under the auspices of the University Research Integrity or IRB must contact the Research Integrity Director to establish a written agreement for the University IRB to be the IRB of Record for the research. The individual must also provide Research Integrity with a copy of her/his/their CV or other documentation of her/his/their educational, professional, and research experience.

Individuals Who May Not Serve as PI for Human Research Projects

The following categories of individuals are not eligible to serve as PI for human research that is overseen by the University’s Research Integrity office (for exempt research) or IRB (for non-exempt research):

Adjunct faculty who are not emeritus faculty;
Emeritus faculty who are not determined to be "in residence;"
Temporary faculty; and
Students and individuals in training (e.g., post-docs, residents).

NOTE: Due to the leadership responsibilities of PIs for human 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.

NOTE: The Vice President for Research and Innovation retains the right to reject, suspend or remove any PI or co-investigator.

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 participants are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose the participants to risk; and, whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes;
risks to human research participants 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 participants 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 participant, 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 participants 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 participants;
the privacy of human research participants 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 participants 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 participant;
reporting of deviations;
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 participant experiences a significant adverse event, every reasonable effort is made to provide the him/her with adequate care to correct or alleviate the consequences of the adverse event to the extent possible;
ensuring that participants 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;
maintaining adequate and accurate research records to reflect adherence to protocol specific requirements;
complying with additional requirements for federal agencies.

Additional Responsibilities of Principal Investigators for the Conduct and Oversight of Human Research

PIs are also responsible for ensuring the following:

Sound research design and methods;
Clear and detailed description of the protocol/IRBNet submission;
The available nonclinical and clinical information is adequate to support the proposed research;
Maintenance of the IRB-approved study plan (as described in researcher applications and forms);
The research is conducted according to applicable terms of grants, contracts and/or signed funding agreements;
The research is conducted according to all applicable laws and regulations related to protecting the rights and welfare of participants;
All persons assisting with the research are qualified and adequately informed about the protocol and their research-related duties and functions;
The PI is available to research staff when needed;
The PI provides evidence of his or her qualifications through up-to-date curriculum vitae or other relevant documentation requested by the IRB or the regulatory authority;
If applicable, the PI is familiar with the appropriate use of the investigational product, as described in the protocol, in the current investigator brochure, in the product information, and in other information sources provided by the sponsor.
All study team members, including PI, are qualified by training and experience for their roles and responsibilities in conducting research and are knowledgeable about the organization’s policies and procedures. PI only delegates responsibility to staff commensurate with their training and qualifications.
The PI ensures the informed consent document and process adheres to regulations and University policy, even if the responsibility for obtaining consent has been delegated to another study team member.
The PI provides information on medical or psychosocial resources that participants may need as a consequence of the research.

The PI provides information and processes for participants to submit concerns, complaints or requests for information; timely respond to complaints and requests for information from participants; engage Research Integrity staff/IRB as appropriate.

For exempt research, PIs must ensure that 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 participant 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 that researchers and research staff respond to complaints and requests for information from participants.

PIs must ensure participants 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, as noted in the IRB policy regarding Exempt Research Amendments/Modifications.

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. She/he/they should know which laws, regulations, codes, and guidance govern their research studies and are knowledgeable about requirements pertaining to specific research studies, including the University’s policies and procedures. The IRB may request evidence of his or her qualifications through up-to-date curriculum vitae or other relevant documentation.

PIs must ensure that they have sufficient time and resources to properly conduct and supervise all research for which they are responsible. This includes, but is not limited to sufficient investigator time, adequate number of appropriately qualified research team members, adequate facilities, equipment, and space. PIs should also ensure access to a population that will allow recruitment of the necessary number of participants. PIs must not commence a research study without adequate resources to protect participants and should stop a research study if resources become unavailable.

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 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 participants.

PIs must ensure recruitment, consent, and research procedures protect the rights and welfare of vulnerable populations or other participants who may be vulnerable to coercion or undue influence.

PIs must ensure no participants are enrolled in 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 dataset includes Protected Personally Identifiable Information or Protected Health Information (see the online Policy Manual Definitions), PIs must work with 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.

The Principal Investigator 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 her/his research team, s/he retains the ultimate responsibility for the conduct of the study.

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.

PIs must ensure that Researchers are appropriately credentialed and qualified to perform their assigned duties including but not limited to appropriate training, education, expertise, credentials and, when relevant, privileges or licensures to perform procedures assigned to them during the study. PIs need a method to verify that all persons assisting with the research are adequately informed about the protocol and their research-related duties and functions.

PIs must ensure that Researchers execute their delegated responsibilities according to professional and ethical standards, and regulatory requirements and IRB approval.

Reporting Requirements

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 participants or others, including interim findings suggesting increased risk to research participants.

PIs must permit and facilitate monitoring and review, at reasonable times, by the Research Integrity Research Compliance 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 ensure that provisions for data and safety monitoring are adequate and that results from data and safety monitoring are provided to the IRB. In clinical trials, the sponsor addresses monitoring the data and safety monitoring pursuant to the written agreement annually at continuing review.

Study Records

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 are approved by the IRB.

PIs must ensure study records are available for inspection by the Research Integrity Research Compliance 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.