The Principal Investigator (PI) of a human subjects research project requiring IRB approval has certain responsibilities and makes specific assurances (agreements) with the IRB about oversight of a project.  They are outlined in the Principal Investigator Assurances and Applicable References, to summarize;

• The PI is ultimately responsible for the conduct of the research.
• The research will be conducted in compliance with laws, policies and regulations.
• The research is consistent with grant proposals or contracts submitted to sponsors.
• The PI assigns research tasks to qualified team members, and adequately trains personnel on all assigned duties.
• If the PI is unavailable, an appropriate replacement will be named to the IRB to oversee the research.
• Annual (or biennial) review will be submitted to the IRB by the identified deadline.
• Protected Health Information (PHI) will be protected and shared appropriately.
• Any significant conflicts of interest (from either the PI or any team member) will not influence the outcome of the study.
• Research subject compensation is compliant with UI policy.
• Research will not begin until IRB approval is in place. 

The Department Chair (DEO) agrees to specific assurances with the IRB about oversight of the project. 

• The PI has the appropriate qualifications to conduct the research as described in the IRB application.
• The PI has the appropriate resources, facilities, and qualified staff to conduct eh research as described in the IRB application.
• The PI has used sound study design consistent with the standards of the investigator’s area of research.
• The PI has a research subject compensation plan consistent with UI policies.
• The PI has appropriate time available to oversee the conduct of the project. 

The University of Iowa IRB has certain expectations of Faculty who oversee students conducting human subjects research requiring IRB approval.  These expectations are outlined in the Faculty Advisor Oversight Responsibilities and Assurances  document. Student PI’s must obtain the Department Chair signature and a signature from their Faculty Advisor.

• The identified subject population is the appropriate source of data to answer the research question .
• The planned method for data collection is valid and will yield data that answers the study question.
• The planned analysis of the data is appropriate and will answer the study question.

The University of Iowa allows graduate, undergraduate students and trainees in professional programs to serve as the Principal Investigator of a human subjects research project. In addition to the responsibilities outlined in the Principal Investigator Responsibilities section, Student PIs must also meet the following criteria. 

• Must include a Faculty Advisor on the research team that agrees to support the study PI in overseeing the conduct of the research.
• Complete the Student PI Training requirement and other required trainings prior to project submission. See the Role of the Student Principal Investigator.

How Does a Student PI Identify their DEO (Department Chair)?

• The general rule of thumb is the DEO will be based in the academic program, college, or department where the student PI is assigned. If the student PI is not directly associated with a program, college, or department where the research is occurring, it is acceptable for the DEO of the department where the research is occurring to sign or the department of the Faculty Advisor to sign the assurance document. 

1. Wet Ink Signatures

• Used for FDA and non-FDA regulated studies.
• Must be signed with a pen.
• Signature must be by named individual.
• Cannot use any of the following methods; signature stamp, inserting a signature, typing a name into the document.

2. DocuSign

• Used for non-FDA regulated studies.
• The assurance document can be uploaded and routed to the PI and DEO simultaneously.
• Any UI employee can obtain a DocuSign account (note: DocuSign account is not available to students through the UI license).

3.eReg

• Meets 21 CFR 11 standards.
• Utilized for FDA and non-FDA regulated studies.
• Study must be using OnCore and eReg for the study.
• A one-time training is required for the PI prior to utilizing eReg (15-30 minutes). Sign up for training and request access to eReg.

Use of eReg is encouraged for FDA regulated research if the PI wishes to use an electronic signature process.

For additional eReg resources, see the Using eReg tip sheet, and the training resources on ICTS eReg ICON Course.

Please direct eReg questions to ictms-admin@uiowa.edu. 

In addition to the assurance document signed by the Principal Investigator (PI) and Department Chair (DEO), any research study that will be conducted under full ICH-GCP standards must also submit the ICH-GCP Assurance document. The ICH-GCP Assurance document requires the following attestations.

• Awareness and compliance with ICH-GCP guidelines.
• Completion of the CITI ICH-GCP training.
• The PI will maintain a list of qualified persons to whom they delegate significant trial-related duties (delegations log).
• The PI will ensure that subjects are provided with adequate medical care for adverse events related to the trial and will inform subjects when medical care is needed for intercurrent illness.
• Familiarity with the appropriate use of the investigational product, as described in the protocol, in the current investigator’s brochure, in the product information, and in other information sources provided by the sponsor.
• If the subject agrees to participate, the PI will notify the subject’s primary care physician of the subject’s participation in the trial.
• If the subject withdraws from the trial prematurely, reasonable effort will be made to ascertain the reason, while respecting the subject’s rights and their willingness to discuss this.
• If during the trial, the PI becomes aware that a subject has an intercurrent illness which requires medical care, the PI will inform the subject. 

• UI Investigator’s Guide\IRB Standard Operating Procedures
  • Section II, Part 1.D (Assurances and Responsibilities)