Principal Investigator (PI) Eligibility
Who is eligible to serve as a Principal Investigator (PI)?
The PI must be an institutionally affiliated individual who is qualified to assume overall responsibility for the ethical and regulatory conduct of a research project.
Eligibility to serve as PI is determined by institutional policy and the level of risk involved in the research. Specific eligibility for particular roles (e.g., students, adjunct faculty, affiliate clinical faculty in the ³ÉÈËÖ±²¥ College of Osteopathic Medicine, emeritus faculty) is addressed in separate FAQ within this section.
Under what circumstances may student serve as PI?
Students may serve as PI only for minimal risk research projects and only under the direct supervision of an institutionally affiliated faculty member who agrees to provide appropriate oversight and mentorship for the duration of the project.
The IRB reserves the right to limit or restrict student PI eligibility for certain minimal risk projects when the nature, complexity, population involved, or regulatory considerations of the research warrant additional oversight. In such cases, the IRB may require an eligible faculty member to serve as PI, with the student listed as a co-investigator.
The IRB may determine that a student is not eligible to serve as PI for a minimal risk project based on factors including, but not limited to:
- Involvement of vulnerable populations
- Sensitive research topics
- Complex study design or data collection procedures
- Investigator experience or training considerations
- Institutional or regulatory requirements
Are adjunct faculty eligible to serve as PI?
No. Adjunct faculty are not eligible to use IRB review services and, therefore, may not serve as PI. However, adjunct faculty may serve as a faculty advisor on eligible student research projects, provided that:
- The student is eligible to serve as PI under institutional policy
- All IRB submission and oversight requirements are met
Are affiliate clinical faculty in ³ÉÈËÖ±²¥'s College of Osteopathic Medicine eligible to serve as PI?
No. ³ÉÈËÖ±²¥ COM affiliate clinical faculty are not eligible to use IRB review services and therefore may not serve as PI.
However, affiliate clinical faculty in ³ÉÈËÖ±²¥ COM may serve as a faculty advisor on eligible student research projects, provided that:
- The student is eligible to serve as PI under institutional policy
- All IRB submission and oversight requirements are met
Are emeritus faculty eligible to serve as PI?
Emeritus faculty may serve as PI only if their official emeritus appointment letter explicitly authorizes research activity and use of IRB review services. The IRB may require additional oversight or restrict PI eligibility as appropriate.
Can there be more than one PI on a research project?
No. Only one PI may be listed per research project. The PI is responsible for the project's ethical conduct, regulatory compliance, and oversight.
Can a research project have co-investigators?
Yes. A research project may include multiple co-investigators. Co-investigators contribute to the conduct of the project, but do not assume the overall responsibility of the PI. All co-investigators should be listed as key personnel (or research staff) in the applicable IRB application.
How can I determine whether I am eligible to serve as PI?
If you are unsure about your eligibility, contact the IRB at irb@une.edu before submitting a protocol. The IRB can help determine whether your appointment status and project risk level meet PI eligibility requirements.
Faculty Responsibilities
What is my role as a faculty advisor?
The Faculty Advisor (FA) and the student share the responsibility for the ethical conduct of student research. The FA is responsible for ensuring that research activities involving human subjects are reviewed and approved by the ³ÉÈËÖ±²¥ IRB before they are initiated. The FA is expected to take an active role in student research activities and provide supervision for the duration of the project. The FA is professionally responsible for all research activities and must review, approve, and sign the student’s research protocol before submission to the IRB. When a Faculty Advisor signs a student’s protocol application, the FA commits to meeting their responsibilities as outlined in this guidance.
What are my responsibilities as a faculty advisor?
- Take an active role. From the time a student researcher begins to prepare their research proposal for submission, to the time the student has completed their research, the FA is expected to serve an active role throughout the entire process. This includes assisting students when they are presented with questions and comments from the IRB during the review process.
- Be informed of IRB requirements. Contact the IRB to discuss policies and procedures for obtaining IRB review before the student initiates any research activities. FAs are expected to be familiar with the institutional requirements for the conduct of human subjects research.
- Complete the required CITI Training. FAs are expected to be familiar with the ethical and regulatory requirements for research with human subjects.
- Know what must be reviewed. Any research with human subjects at ³ÉÈËÖ±²¥, and/or conducted by any ³ÉÈËÖ±²¥ personnel, requires some level of review/determination from the IRB. If you are unsure about what level of review the student’s planned activities will need, it is your responsibility to contact the IRB for guidance.
- Assist students with protocol submission. When proposed activities involve research with human subjects, it is the responsibility of the FA to assist students in preparing and reviewing materials for IRB review and ensuring that the submission meets the requirements for review as indicated in the protocol form. FAs are responsible for reviewing the project's scientific integrity and ensuring that all requested materials are included in the submission and of reviewable quality.
- Educate students. FAs are responsible for communicating to the student the IRB’s role and the ethical importance of research review. Students must also complete the required CITI training for human subjects research before submitting an application to the IRB.
- Maintain high ethical standards. FAs ensure that projects are conducted to the highest ethical standards and that students understand and implement these ethical standards in the conduct of the research.
- Help students navigate the IRB process. FAs contact the IRB to determine the requirements for submission to the IRB and help students understand the ³ÉÈËÖ±²¥ IRB process. FAs should serve as the primary contact between the IRB and the student researcher.
- Oversee changes. FAs should ensure that, before a change is initiated to an approved protocol, an amendment outlining the proposed changes has been approved by the IRB. All changes/amendments must be reviewed and signed by the FA before submission to the IRB.
- Report any adverse events or other research-related problems to the IRB as soon as possible.
- Ensure that continuing review requirements are satisfied when applicable.
- Ensure the study is closed at the conclusion.
Do I need to apply for a student classroom project exclusion?
Faculty teaching a course that involves research methods or systematic investigations (e.g., activities involving both data collection and quantitative/qualitative data analysis) via interaction with individuals outside the course are required to submit a Student Classroom Project Exclusion for review 2 weeks prior to the course starting.
Please refer to the Student Classroom Project Guidelines (PDF) for frequently asked questions about this topic.
Understanding Human Subjects Research and IRB Review
What is research?
The federal human subjects protection regulations defines research as:
"A systematic investigation*, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge**."
*Is there a question to be answered? Will data be collected and analyzed to answer that question?
**An activity intended to obtain knowledge that may be applied to populations outside of the specific study population.
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Does my project constitute human subjects research?
If you are in doubt about whether your proposed project constitutes human subjects research that requires IRB review and oversight, please submit a Research Determination Request Form (PDF) for evaluation before the project is initiated. The Office of Research Integrity (ORI) will issue you a determination letter indicating whether the proposed work is or is not human subjects research.
When there is an intent to publish your work, the ORI recommends that you submit a Research Determination Request prior to starting your project because some journal editors may require you to provide an IRB determination letter as a prerequisite for publication.
If the project has already started or has been completed, ORI cannot retrospectively issue a research determination letter.
What are the different levels of review for human subjects research?
There are four levels of review for human subjects research:
- Administrative
- Reviewed by the Office of Research Integrity (ORI)
- Exempt
- Exempt projects are reviewed by ORI using the Belmont Report ethical principles
- Expedited
- Expedited review applied to specific categories of research with no more than minimal risk. One IRB member typically reviews studies using the federal IRB approval criteria.
- Full Board
- All studies that do not qualify as exempt or expedited must be reviewed by the full board via the federal IRB approval criteria. Additionally, the full board is tasked with the review of all greater than minimal risk studies.
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What is minimal risk research?
The probability and magnitude of harm or discomfort in the research are not greater than those ordinarily encountered in daily life or during the performance of routine psychological examinations or tests.
Exempt Research
- Reviewed by the Office of Research Integrity
- Research must fit within one or more of the six allowable exemption categories at ³ÉÈËÖ±²¥
- Research is low risk
- Most social, behavioral, and educational research qualifies as exempt
- Common examples include research involving interviews, focus groups, surveys, and retrospective chart review projects
- Issued an exemption determination letter
Non-Exempt Research
- Reviewed by the IRB
- All research that does not qualify as exempt
- Minimal risk research projects are typically reviewed by one IRB member. This process is called an expedited review.
- Greater than minimal risk research projects are reviewed by the entire committee at a convened IRB meeting. This process is called full board review.
- Biomedical research involving an intervention is often non-exempt
- Issued an approval letter
What are the six exemption categories recognized at ³ÉÈËÖ±²¥?
A description of each of the six categories is available in Appendix A of the Application for Exempt Research Projects.
What are the federal IRB approval criteria used to evaluate non-exempt research projects?
- Risks to participants are minimized: (i) by using procedures that are consistent with sound research design and which do not unnecessarily expose participants to risk, and (ii) whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.
- Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies participants would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
- Selection of participants is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving participants vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
- Informed consent will be sought from each prospective participant or the participant's legally authorized representative, in accordance with, and to the extent required by the Federal Regulations [45 CFR 46.116/21 CFR 50].
- Informed consent will be appropriately documented in accordance with, and to the extent required by the Federal Regulations [45 CFR 46.117/21 CFR 50].
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants.
- When appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
- When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants.
Submissions, Review, and Outcomes
I do not have approval or exemption for a project that I have already completed. Can I still submit my project for IRB review?
No. Retrospective exemption or approval letters cannot be issued for projects that were not submitted for review prior to the project being initiated.
How far in advance should I submit my application for review?
If Administrative Review is Required
- Submissions that require administrative review (e.g., Research Determination Request, Student Classroom Project Exclusion, Case Study, and Notification Form) are typically processed within 1 week, assuming that the application is complete and all required supplemental material has been submitted.
New Exempt Research Projects
- New Exempt Research projects should be submitted 2–3 weeks prior to the anticipated research start date (assuming the submission is of good quality and the Principal Investigator responds to requested modifications in a timely manner).
Non-Exempt Research Projects
- Expedited Review is reserved for minimal-risk research that does not qualify for exempt review (see six exempt categories above). Applications should be submitted 1 month prior to the anticipated start date of the project.
- Full Board Review is reserved for greater than minimal risk research and is reviewed by the full IRB committee. Applications should be submitted at least 2 months prior to the anticipated start date of the project to account for multiple review cycles as deemed necessary by the convened board (see ‘deferral’ FAQ below).
Amendments
- Amendments involving only key personal changes are typically processed within 3 business days assuming the application is complete and all required supplemental material has been submitted. All other amendments should be submitted 2-4 weeks prior to the anticipated start date (depending on the complexity of the requested changes).
My non-exempt research project was reviewed by the full board and the IRB issued a deferral. What does that mean?
Deferral means that the convened board was not able to determine that the federal IRB approval criteria for research were met. The full board can issue a deferral when:
- The IRB doesn’t have enough information about the study, and subsequently cannot tell the investigator what details need to be confirmed in order to secure approval; and/or
- The IRB requires substantive changes/actions that cannot be relayed to the investigator in a directive or prescriptive manner.
A deferral means that the investigator’s response must come back to the full board for review at a convened IRB meeting.
The approval letter issued for my non-exempt research project specifies an expiration date. What does that mean?
If your project was assigned an expiration date, this means you will need to submit an Application for Renewal 60 days prior to the project’s expiration date listed on the current approval letter.
Research that continues after the approval period has expired is research conducted without IRB approval. All research activities must stop, including recruitment, enrollment, consent, interventions, interactions, data collection, and data analysis.
If approval lapses for more than 60 days, the IRB will not accept an Application for Renewal. Instead, you will need to submit a Study Closure Report Form and a new Application for Non-Exempt Research Projects for review.
What do I need to do at the conclusion of my research project?
For exempt research projects and non-exempt research projects that are not assigned an expiration date, the Office of Research Integrity will send the Principal Investigator a link to an online Project Status Survey for completion. The survey link will be provided before the project end date has occurred (as specified in the exempt or non-exempt application).
A Study Closure Report Form is required to be submitted for non-exempt research projects that have been assigned an expiration date. When the research project concludes — whether by withdrawal, termination, completion, or otherwise — you must submit a Study Closure Report Form within 30 days. Please submit this form when you are no longer:
- Obtaining data through interaction or intervention with participants; and/or
- Collecting, using, or analyzing identifiable private data about participants.
Full Board Schedule
When are full board meetings held?
Full board review is typically reserved for non-exempt research involving greater than minimal risk. The IRB meets on the second Wednesday of every month from 2–4 p.m.
What are the submission deadlines?
Complete submissions for full board review must be received at least 21 days before the scheduled IRB meeting. This timeframe allows IRB staff to conduct a pre-review and work with investigators to resolve required modifications or clarifications before materials are distributed to the convened IRB.
Submission by the deadline does not guarantee placement on the meeting schedule. Projects requiring substantive revisions that cannot be resolved before agenda finalization may be deferred to a subsequent meeting.
Submissions received after the 21-day deadline will not be scheduled for the upcoming meeting and will instead be reviewed at the next scheduled IRB meeting.