A student PI must be qualified to oversee a study and have the resources and guidance to conduct it responsibly. Student PIs should select a Faculty Advisor with experience conducting human subjects research and knowledge of the IRB review process to aid them with designing and conducting their research. Student PIs must complete CITI human subjects training appropriate for their discipline, the student PI training in ICON, and an eCOI financial disclosure form before HawkIRB will allow them to complete a new project form. 

Best Practices for Student PIs

• Work closely with your Faculty Advisor for the duration of the study, from conceptualization and study design to data analysis and reporting. Meet regularly to ask questions and update your faculty advisor on progress.
• Access Human Subjects Office resources to educate yourself about federal regulations and institutional policies that apply to your research. These resources include HawkIRB training sessions, an ICON Course for Researchers, the IRB Connection Newsletter, and IRB Office Hours.
• Maintain IRB approval during data collection and while working with identified data.
• Respond promptly to questions from the IRB and Human Subjects Office. 
• Before you leave the UI, submit a Project Closure form if the study is complete OR submit a Modification form to transfer the study to a different PI.

Make a data storage plan for when you close a study and leave the University of Iowa. IRB record storage requirements in the UI IRB SOP and investigator Guide (Section II, Part 23) apply to documentation of IRB approval—primarily in the HawkIRB system—and documentation of informed consent. Required storage time varies: Three (3) years for a study without HIPAA privacy statements in the informed consent document, and six (6) years for studies with HIPAA privacy statements. 

Note: According to VA policy, students may not serve as the PI for a project conducted at the VA Health Care System or using VA resources. Faculty or staff will need to serve as the PI of these projects. 

Student PI Training Requirement

Students conducting research as principal investigators are required to complete two modules in the ICON course for researchers. These modules introduce users to the HawkIRB eResearch application system and must be completed before the HawkIRB system allows a student PI to complete a New Project Form.

All PIs and research team members must complete human subjects protection training in the CITI Program. Follow the directions carefully to make sure you complete the correct training(s).

Tips for Getting Started

• Course-Related Student Projects. Human subjects research conducted for course assignments under the supervision of a faculty member or instructor may not require IRB review and approval. However, students and instructors in these courses should refer to the Course-Related Student Projects Policy to determine if the project may require review and approval. Honors, Master’s and Doctoral thesis projects involving human subjects research will always require IRB approval.

• Review types. Depending on the level of risk to subjects and the subject population, a study may qualify for Exempt Status, Expedited Review or Full Board Review. For more information, see Types of Review.

• Human Subjects Research Determinations (HSRD). Federal guidelines specify types of projects that do not meet the regulatory definition of human subjects research. UI faculty, staff, trainees and students and VA Health Care System (VAHCS) personnel can submit a Human Subjects Research Determination (HSRD) form to ask if a project requires IRB review.

• Allow Enough Time! Student PIs should plan for IRB review to take approximately 4-6 weeks for a new study, regardless of whether it receives expedited review or qualifies for exempt status. Allow ample time to discuss research design with your faculty advisor or course instructor. Attend IRB Office Hours or call the HSO with questions about draft HawkIRB forms. Start the review process as early as possible to ensure sufficient time to address and/or correct issues that may delay IRB approval.

• International Research. It is particularly important that investigators conducting international research allow sufficient time for review given that additional approvals and documentation may be required. Obtain in country ethics board approval (if required) or Local Context Review prior to submission to the UI IRB.  

Student PI Assurances

Assurances are the agreements the PI makes with the IRB about oversight and conduct of the project. Student PIs make the same Assurances as any other PI: 

1. You are ultimately responsible for the conduct of the study
2. You agree to comply with all applicable UI policies and procedures, and applicable federal, state and local laws.
3. The application is consistent with proposals submitted to external funding agencies.
4. The research will only be performed by qualified personnel
5. All team members are adequately trained and supervised
6. You will obtain IRB approval prior to implementing any changes in the research (except in an emergency, if necessary to safeguard the wellbeing of a human participant).
7. You will find someone else to oversee the project if you are unable to do so yourself.
8. You will obtain Continuing Review from the IRB, according to the regulatory requirements and institutional policies
9. You agree to comply with all federal regulations and policies related to accessing, use or creation of protected health information
10. You attest that neither you nor any member of your research team have a significant financial interest in the outcome of the study
11. You agree to follow the UI Cash Handling policy if you provide any compensation to research subjects.

You agree not to begin the research until you receive IRB approval.

The Faculty Advisor of a student research project must be a UI faculty or staff member able to provide sufficient time, attention, and guidance to a student PI. Faculty advisors make sure the project design is scientifically sound, the HawkIRB application is thorough and detailed, and the study is conducted in an ethical manner. 

According to UI policy (University of Iowa Operations Manual, Section II, Ch. 27.4), “Teachers who assign or supervise research conducted by students also have an obligation to consider carefully whether those students are qualified to adequately safeguard the rights and welfare of subjects.” 

Provide Instruction and Guidance about Study Design and Data Analysis 

The IRB focuses primarily on protecting the rights, safety, and welfare of human subjects in accordance with federal regulations and UI IRB policies. Ensuring that risks to subjects are minimized and that anticipated benefits are reasonable requires that the IRB consider a study’s scientific merit. To aid the IRB, a faculty advisor should evaluate whether a student PI has designed sound research by asking: 

• Is the research question appropriate for the field of study?
• Is the subject population appropriate to answer the research question? 
• Are data collection methods appropriate and likely to yield useful data? 
• Are data analysis plans sound and likely to produce interpretable results?

Provide Assistance with HawkIRB Applications 

Faculty Advisors should review HawkIRB applications and all attached documents prior to submission to ensure its completeness and accuracy. Faculty advisors must be named as a member of the research team in HawkIRB and may serve as delegates to student PIs to monitor New Project Form completion. 

Refer Student PI to Available Resources 

Encourage student PIs to access educational resources on the HSO website designed to assist researchers in complying with federal regulations and university policies for human subjects research. Point advisees to any departmental requirements and professional ethical standards. Additional Resources:

• IRB Policies and Procedures
• Institutional Policies
• State and Local Laws 

Provide Oversight and Guidance in the Conduct of the Research 

The Faculty Advisor oversees the conduct of the research and provides guidance for the following activities as required: 

• Submitting required Modification, Continuing Review, and Reportable Event Forms (REFs) 
• Educating students about how and when to close the project in HawkIRB 
• Monitoring the progress of the study
• Monitoring, addressing, and reporting problems related to a study to the IRB
• Communicating with student PIs conducting off-campus research.

Faculty Advisor Assurances 

All PIs sign an Assurance Document when they submit a New Project Form in HawkIRB. In addition to the required signature of the Department Executive Officer (DEO) or Department Chair that all PIs must obtain, student PIs must obtain the signature of their Faculty Advisor indicating the soundness of the study and agreement to supervise the conduct of the research to protect human subjects. Assurance made by the faculty advisor include: 

1. to meet regularly with the student PI to monitor the study 
2. to educate the student PI on research methods as well as the ethical conduct of human subjects research 
3. to make sure the study is conducted as approved by the IRB 
4. to arrange for other qualified faculty/staff to oversee student research if the faculty advisor is absent 
5. to implement and oversee cash handling procedures if subjects are receiving compensation. 

Faculty Advisors should only agree to serve in this capacity if they are available to make these assurances with the IRB.