35. w88 and Responsibilities of Principal Investigators for Human Research Projects

Updated July 22, 2024

The Principal Investigator (PI) is the individual responsible for the design and conduct of research involving w88 participants, either for the study as a whole or for an individual site. In general, the University IRB acknowledges only one PI for a research project.

w88 for a person to serve as the PI for human research may differ from those required for a person to serve as the PI on a sponsored project under the auspices of the University of Nevada, Reno (the University). PIs of sponsored projects involving human participants must meet the w88 of both the University and the IRB.

This policy addresses the w88 and responsibilities to serve as the PI for human research projects. w88 apply to human research projects that areexemptunder DHHS regulations or the University's w88 Flexibility Policy, ornon-exempt(thus requiring w88 review, approval, and oversight).
Contact Sponsored Projects for information about the University's w88 to serve as the PI on sponsored projects.

w88 for University Employees to Serve as the PI for Human Research

Faculty at the w88 with renewable appointments as defined in the w88 Administrative Manual (see UAM section 2,511);
Visiting faculty or scientists who are w88 employees, with signature approval from the department chair and the appropriate dean/director;
Full-time classified staff at the w88, with signature approval from the appropriate dean/director; or
University of Nevada, Reno Emeritus/Emerita faculty in residence who wish to continue their w88 programs, with signature approval from the appropriate dean/director and the Vice President for w88 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. w88 Integrity & Security 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 w88 research. If Research Integrity & Security 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 w88 research participants and the research records and data when the LOA contract is not in effect (e.g., between semesters, over the summer).

w88 for Clinical/Community Adjunct Faculty to Serve as the PI/Co-PI for Human Research

Clinical/Community Adjunct Faculty may serve as a Co-PI for w88 research when a University of Nevada, Reno faculty member with a renewable appointment (see UAM section 2,511) serves as Co-PI.

w88 for Individuals from Affiliate Sites to serve as PI for Human Research

"Affiliate Sites" refers to institutions that have a signed agreement (generally a Memorandum of Understanding) that allows the University w88 to be the w88 of Record for w88 research conducted at or on behalf of the Affiliate Site. To serve as a principal investigator for a w88 research project submitted for exempt determination or for review, approval, and oversight by the University IRB, individuals at Affiliate Sites must meet one of the following criteria:

Faculty member at the Affiliate Site;
Clinical staff at the Affiliate Site; or
Otherwise considered a qualified representative or agent w88 Affiliate Site, as determined/confirmed by the Affiliate Site.

Individuals Who May Not Serve as PI for w88 Research

The following categories of individuals are not eligible to serve as PI for w88 research that is overseen by the University’s Research Integrity & Security 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., undergraduate and graduate students, post-docs, residents).

In circumstances of faculty-supervised trainee w88, a qualified faculty member must serve as the PI. w88 are responsible for:

regulatory compliance,
w88 applications and IRB correspondence,
supervision of trainees and other members of the w88 team.

NOTE: The Vice President for w88 and Innovation retains the right to reject, suspend or remove any PI, Co-PI or other w88 team member.

General Responsibilities of Principal Investigators

As a general condition for the approval of a w88 study, the IRB holds the principal investigator of the study responsible for ensuring that:

risks to w88 participants are minimized by using procedures which are consistent with sound w88 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 w88 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 w88 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 w88 research participant, or their legally authorized representative, in accordance with, and to the extent required, by University policies and federal regulations;
informed consent of w88 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 w88 research participants;
the privacy of w88 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 w88 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 w88 study responsible for:

promptly responding to all requests for information or materials solicited by the IRB, including the timely submission of the w88 study for IRB renewal;
ensuring that adequate resources and facilities are available to carry out the proposed w88 study;
abstaining from enrolling any individual in a w88 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 w88; (iii) the potential adverse events associated with study participation and the steps to be taken to reduce potential risks; (iv) reportable new information w88; and (v) data collection and record-keeping criteria;
conducting the study in strict accordance with the current IRB-approved w88 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 w88 protocol or informed consent documents prior to implementing such modifications;
obtaining prospectively and documenting informed consent in accordance with the current w88-approved informed consent documents (i.e., unless the w88 has granted a waiver of the consent process)
maintaining adequate, current, and accurate records of w88 data, outcomes, and reportable new information to permit an ongoing assessment of the risk/benefit ratio of study participation;
reporting promptly to the w88 (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 w88 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 participant with adequate care to correct or alleviate the consequences w88 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 w88 study;
ensuring that all listed investigators have the appropriate credentials to conduct the portion of the w88 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 w88;
complying with additional w88 for federal agencies.

Additional Responsibilities of Principal Investigators for the Conduct and Oversight of w88 Research

w88 are also responsible for ensuring the following:

Sound w88 design and methods;
Clear and detailed description w88 protocol/IRBNet submission;
The available nonclinical and clinical information is adequate to support the proposed w88;
Maintenance of the w88-approved study plan (as described in researcher applications and forms);
The w88 is conducted according to applicable terms of grants, contracts and/or signed funding agreements;
The w88 is conducted according to all applicable laws and regulations related to protecting the rights and welfare of participants;
All persons assisting with the w88 are qualified and adequately informed about the protocol and their w88-related duties and functions;
The PI is available to w88 staff when needed;
The PI provides evidence of their qualifications through up-to-date curriculum vitae or other relevant documentation requested by the w88 or the regulatory authority;
If applicable, the PI is familiar with the appropriate use w88 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 w88 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 w88 team member.
The PI provides information on medical or psychosocial resources that participants may need as a consequence of the w88.
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 w88 Integrity & Security staff/IRB as appropriate.

For exempt w88, w88 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 w88, unless the IRB approves a waiver or alteration of informed consent or the project is excluded from the w88 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 w88.

For non-exempt w88, unless waived by the w88 (or excluded under the University’s w88-Flexibility policy), PIs must ensure that consent is documented to the extent required by §46.117 and as approved by the w88.

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 w88 approval.

PIs must ensure that researchers and w88 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 w88 that may relate to their willingness to continue participation, in accordance with §46.116.

w88 the accuracy and completeness of study data.

PIs w88 obtain prior IRB approval for modifications to the w88 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 w88, as noted in the IRB policy regarding Exempt w88 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. They should know which laws, regulations, codes, and guidance govern their research studies and are knowledgeable about w88 pertaining to specific research studies, including the University’s policies and procedures. The IRB may request evidence of their 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 w88 for which they are responsible. This includes, but is not limited to sufficient investigator time, adequate number of appropriately qualified w88 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 w88 study without adequate resources to protect participants and should stop a w88 study if resources become unavailable.

Compliance with Regulatory w88 and Institutional Policy

PIs must comply with regulatory w88 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 w88 for approval from University, Affiliate, and external oversight bodies (e.g., radiation or biosafety committees, other federal agencies, and school districts).

PIs must ensure w88 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 w88 for approval may not apply to exempt research.

PIs must obtain IRB approval, or determinations of exemption or “not w88 subject research” before initiating any research activities involving participants.

PIs must ensure recruitment, consent, and w88 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 w88 following suspension or termination of study activities or IRB approval.

PIs must ensure no w88 activities are conducted following suspension or termination of IRB approval.

When conducting w88 that involves providing data/specimens to or obtaining data/specimens from an external entity, AND the dataset includes Protected Personally Identifiable w88 or Protected Health w88 (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 w88 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 w88 study and the informed consent process. Although the PI may delegate tasks to members of their w88 team, they retain the ultimate responsibility for the conduct of the study.

Management and Training of w88 Team Members

w88 team members (Researchers) include student and co-investigators, study staff, w88 assistants, and coordinators.

w88 that Researchers comply with the University’s human protection training w88.

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 w88 are adequately informed about the protocol and their w88-related duties and functions.

PIs must ensure that Researchers execute their delegated responsibilities according to professional and ethical standards, and regulatory w88 and IRB approval.

Reporting w88

For non-exempt w88, 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 w88, 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 w88 Integrity & Security w88 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 w88.

PIs must ensure that provisions for data and safety monitoring are adequate and that results from data and safety monitoring are provided to the w88. In clinical trials, the sponsor addresses monitoring the data and safety monitoring pursuant to the written agreement annually at continuing review.

w88 Records

PIs must obtain the required data use or materials transfer agreements to use w88 data/specimens from or share w88 data/specimens with external entities, including commercial providers and data/specimen banks.

Study records include w88 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 w88.

PIs must ensure study records are available for inspection by the w88 Integrity & Security w88 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 w88, whichever is longer.

PIs must take measures to prevent accidental or premature destruction of w88 records.