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Office of Research Compliance
117 Research and Technology Center
Athens, OH 45701

Guidance on the IRB Process for Faculty Advisors

Purpose:  general advice for Ƶ faculty members who will serve in the “Advisor” role for graduate or medical students listed as Principal Investigators for projects submitted for review in the Human Ethics module of Cayuse 

As of Spring 2024, undergraduate students cannot serve as Principal Investigators on IRB protocols without an exception request approved by the Vice President for Research and Creative Activity. See here for information about Ƶ policies concerning who can serve as a Principal Investigator. In most cases, Faculty Advisors will need to be the Principal Investigator of record for IRB protocols undertaken by undergraduate students. 

Scope: all submissions in the Human Ethics module of Cayuse where a graduate or medical student is listed as the Principal Investigator of record, or where an undergraduate student is designing and conducting research and a faculty member serves as the Principal Investigator for an IRB protocol. 

Advisor Role & Responsibilities 

Faculty advisors for IRB submissions must be employed by Ƶ as regular faculty to serve in that role. When a graduate or medical student is the Principal Investigator and a faculty member is listed in the Advisor role, or when a faculty member is serving as the Principal Investigator for an undergraduate project, the faculty member assumes full responsibility for the oversight of the research study, including the design, development and implementation of the study plan. The faculty advisor is fully responsible for the academic quality of the research and for ensuring compliance with the terms, conditions, and policies of the sponsor and Ƶ. The faculty advisor must provide day-to-day oversight of the research project and study personnel, ensure that all study personnel are appropriately qualified and trained, be aware of and comply with all Ƶ policies and procedures and all applicable federal regulations governing the research (including requirements for data retention of research records, protocol renewals, and study close outs), protect the rights and welfare of human research subjects, and promptly report any adverse events, unanticipated problems, or other issues with the conduct of the study to the IRB.  

Faculty advisors must certify submissions in Cayuse before they can move forward in the review process. The Office of Research Compliance (ORC) stresses that faculty advisors should thoroughly read and check student submissions before certifying them, and that faculty advisors should be prepared to return submissions to students if they are not ready to be reviewed. ORC staff and IRB reviewers are responsible for evaluating protocol submissions to ensure the research plan meets the requirements for applicable regulations, policies, and ethical principles. Their primary obligation is to protect human subjects from potential harm. While staff and reviewers may provide feedback on protocol submissions and direct students to relevant resources, their roles do not extend to general guidance and support for student researchers. 

Getting Started with the IRB Submission Process 
  • The submission system for IRB protocols is . Please note that students must request a Cayuse account before they can access the system. Students can request a Cayuse account here: . Cayuse account creation for students is a manual process and may take a few business days. 
  • Please see two text-based tutorials about how to submit an IRB protocol in the Human Ethics module in Cayuse here: /research/cayuse/he. Click for a video tutorial for submitting an IRB protocol in Cayuse (you must be logged in with your Ƶ single sign on credential to view).
  • Study personnel on IRB protocols, including student investigators and advisors, must have current human subjects training through CITI on file. For IRB protocols, either "Group 2 Social Behavioral Investigators and Key Personnel training" or "Group 1 Biomedical Research Investigators and Key Personnel" is required. Please note: while you and your students may see other training courses available in CITI, only these two courses satisfy the training requirements for IRB protocols. Please see: /research/compliance/training if additional guidance is needed. 
  • The Office of Research Compliance offers guidance documents on a variety of topics for investigators working with human subjects. For student projects, we suggest the following as especially relevant: 
The IRB Review Process at Ƶ  

Once the principal investigator, any co-investigators, and a faculty advisor (if applicable) have certified an IRB submission, it is routed to ORC staff for pre-review. In most cases, submissions are returned to study teams with pre-review comments and requested clarifications before they are assigned to reviewers. Please see our guidance document on the Top 10 Common Problems to Avoid with IRB Protocol Submissions. Advisors should be prepared to assist student researchers in responding to pre-review comments so that submissions can then be routed to reviewers without major omissions or inconsistencies. 

ORC staff classify IRB protocol submissions as one of four different review types: 

Administrative Reviews, which include: 

If a project constitutes human subjects research, there are : 

Exempt; see for guidance about exempt review categories at Ƶ. In most cases, the Office of Research Compliance reviews exempt protocols, except for protocols that require a limited IRB review. 

Expedited; most expedited protocols are assigned to one IRB reviewer. Occasionally, an additional IRB reviewer is assigned. The term “expedited” does not equate to faster review, it simply means it does not need to be reviewed at a convened meeting. 

Exempt and expedited submissions are reviewed on a rolling basis and are not tied to IRB meeting dates.  

Full Board; human subjects research projects that are determined to be greater than minimal risk to participants, or that do not meet the criteria for an exempt or expedited category, must undergo Full Board review. Full board protocols are routed to all IRB members for review at a convened meeting. Please see for upcoming IRB meeting dates and their associated submission deadlines.  

The majority of researchers – even experienced researchers – can expect to receive further requested revisions after their protocols are reviewed. Review the Top 10 Common Problems to Avoid with IRB Protocol Submissions. Students should be assured that being asked to address revisions is quite usual at Ƶ and at other similar institutions. 

Managing Expectations for Student Researchers 

Timelines 

IRB review and approval take time, and the ORC strongly encourages faculty advisors to help their students budget generously for the time they will need to complete the IRB review process. Turnaround time for IRB submissions is highly variable and depends on overall ORC staff and reviewer workload and study team response times. The ORC strongly recommends that study teams plan for at least two weeks per round of review for exempt and expedited protocols when developing research timelines. Protocols submitted for full board review usually have comparatively extended turnaround times, which can also vary depending on when a protocol is submitted relative to an IRB meeting.  

Types of Research That Require Extra Review Time  

Advisors should prepare student researchers to expect longer overall review times for studies that involve: 

  • Research with participants located in countries outside the United States 
  • Collaborators external to Ƶ 
  • Vulnerable populations, such as children, prisoners, pregnant participants, and adults with impaired consent capacity 

Ancillary Reviews 

While these are uncommon at Ƶ, IRB protocols may also require ancillary reviews before approval can be issued. Advisors should prepare student researchers to expect longer overall review times for studies that involve: 

  • Issues requiring the review of the Office of Legal Affairs and/or the Privacy Office, which can include but are not limited to unusual procedures involving FERPA-protected materials, HIPAA-protected materials, and study procedures subject to GDPR 
  • Data use or material transfer agreements 

Complexity Considerations 

Faculty advisors should also consider individual students’ backgrounds and the characteristics of their degree programs when advising students about study procedures and study design for IRB protocols. If a student researcher has only limited prior experience with human subjects research and a short degree program, advisors should recommend they plan for a simpler study design with fewer procedures, as opposed to a more complex or longitudinal study design with more points of data collection. Student protocols with more complex study designs often take longer to earn final IRB approval, because increased complexity often leads to inconsistencies and inadvertent omissions that take longer to resolve. 

Ongoing Oversight Considerations for Faculty Advisors 

Modifications 

Changes to previously approved IRB protocols require modification requests to be submitted in advance in Cayuse and approved before they can be implemented. Advisors should stress to student researchers that IRB protocols are like contracts: they can be modified but not broken. Turnaround times for review of modification requests for previously approved protocols are similar to those for new studies in the same review categories. 

Renewals 

Approved protocols with expiration dates require the submission and approval of renewal applications in Cayuse prior to those expiration dates.  

Incident Reports 

Variations from approved protocols, whether within the study team’s control or not, must be reported to the IRB, as must adverse events or unexpected problems that occur during study procedures.  

Closures 

Approvals for Ƶ IRB protocols are no longer valid when their Principal Investigators are no longer affiliated with the university. This includes the graduation of student investigators. 

If study procedures need to continue after a student investigator leaves Ƶ, then the study team should plan to submit a modification request to switch the Principal Investigator role to the faculty advisor, as necessary. Alternatively, if all study procedures have concluded and the study team no longer has identifiable data in their possession or the means to relink identifiable data to individual subjects, a closure request for the protocol should be submitted. Advisors are responsible for maintaining research records from their students’ protocols in accordance with Ƶ’s data retention policies. Generally, this will mean that deidentified data and research records must be maintained for at least three years after a study’s closure or completion so that they may be retrieved in the event of future audits. In some cases – such as federally funded research, research subject to HIPAA, research regulated by the FDA, and research funded by other sponsors with other specific retention requirements – data and research records will need to be maintained for additional time. Please consult the ORC at compliance@ohio.edu for questions about requirements for research data retention.  

Contacting the Office of Research Compliance for Assistance 

Even the most experienced researchers and faculty mentors cannot be expected to know everything about the IRB review process, local university requirements, and governing regulations for human subjects research. The Office of Research Compliance is happy to help advisors help their students with any questions you may have or with any hurdles you encounter. We regret that we cannot offer individual guidance or consultations for students without their advisors’ involvement. If you (in your role as Faculty Advisor for an IRB protocol) would like to meet with ORC staff together with your advisee about their IRB protocol submission, please email compliance@ohio.edu.  

The ORC recommends that advisors become familiar with the Top 10 Common Problems to Avoid with IRB Protocol Submissions. 

 

Acknowledgment: some language is used with permission from West Virginia University’s Office of Human Research Protections.