Principal Investigator Assurances and Applicable References
To educate investigators on the responsibilities associated with human subjects research at the University of Iowa and the specific assurances (agreements) with the IRB about the oversight of the project. This page also provides some important references with further information.
Principal Investigator Assurances
When the Principal Investigator (PI) submits a new project to HawkIRB, an assurance document is signed. These are agreements the PI makes with the IRB on how they will conduct the research with the aim to protect human participants in research.
All University of Iowa Principal Investigators agree to the following at the time of submission of a HawkIRB application:
I am ultimately responsible for the conduct of the study.
The PI will ensure the study is conducted according to what is approved by the IRB, and according to federal, state and local laws. The PI will educate appropriate research team members on the conduct of the study, and this education process is ongoing throughout the course of the study. The PI may evaluate the progress or issues with the study and redesign as needed, and if any changes in procedures are required, a modification form should be submitted and approved by the IRB. If a sponsor is involved in changing procedures, the PI will stay informed and will modify the procedures and/or risks in HawkIRB.
Office of Human Research Protections (OHRP) FAQ – Investigator Responsibilities
I agree to comply with all applicable UI policies and procedures, and applicable federal, state and local laws.
The PI will educate themselves on the appropriate policies, laws, and procedures on the federal, state, and local level to ensure that they have the awareness to comply with these during their project. The PI will also ensure that those on their research team are properly trained in the procedures and applicable policies.
Food & Drug Administration (FDA) Policy 21 CFR 50 *
University of Iowa (UI) Operations Manual:
- 27.4 General Policy and Procedures for Review of Research Projects Involving Use of Human Subjects
- 27.6 Ethics in Research
University of Iowa IRB Policies and University of Iowa Investigator’s Guide (UI Guide)
ClinicalTrials.gov Regulations and Requirements
The application is consistent with proposal(s) submitted to external funding agencies.
The information in your HawkIRB application should match what was submitted to external funding agencies, if applicable. Some information can be copied and pasted from the proposal into the corresponding sections of HawkIRB, but please edit to use lay language. The HSO recommends double checking how information pasted in HawkIRB to ensure special characters pasted correctly. Differences can be described in Section I.4 or a separate explanation can be included in the funding source attachment category.
- Section I, Part 2.A: Division of Sponsored Programs
- Section I, Part 15: Overall Approval
- Section II, Part 1.A: Beginning the IRB New Project Application
- Section II, Part 4: HawkIRB Section III Funding/Support
- Section II, Part 19.A: Modifications
The research will only be performed by qualified personnel. All persons assisting with the research are adequately informed about the protocol and their research-related duties and functions.
The PI will ensure that those on the research team are properly trained in the procedures of the study, as well as applicable policies and laws that they will need to follow. The education of the research team is ongoing throughout the project. The HSO suggests the PI has regular and clear communication with the research team performing procedures.
21 CFR 56.102(h) FDA Definition of an Investigator *
21 CFR 312.53(a) Selecting Investigators and 21 CFR 312.53(d) Selecting monitors *
21 CFR 812.43(a) Selecting Investigators and 21 CFR 812.43(d) Selecting monitors *
45 CFR 46.116 General Requirements for Informed Consent
FDA Information Sheet – Recruiting Study Subjects *
FDA Information Sheet – Screening Tests Prior to Study Enrollment *
FDA Information Sheet – A Guide to Informed Consent *
University of Iowa Record of Consent
I will not implement any changes in the approved IRB application, study protocol, or informed consent process without prior IRB approval (except in an emergency, if necessary to safeguard the well-being of a human participant).
The PI and research team must conduct the study as described in HawkIRB, so the IRB can approve all aspects of the study before the project begins. If any changes are needed, these changes must be made to the HawkIRB application in a modification form and the form must be approved by the IRB before the changes can occur. Examples of changes include a room number change, updated contact information, a new protocol change from the sponsor, updates to attachments, or a new research team member. If there is an emergency and a change is needed for a participant, the well-being of the participant is the primary concern, and then the research team must report the change to the IRB as soon as possible.
OHRP FAQ – What should investigators do if they want to revise an IRB-approved research study?
Human Subjects Office (HSO) FAQs – Modifying an Approved IRB Application or Materials
UI Guide Section II, Part 19.A Modifications
If unavailable to conduct this research personally, as when on sabbatical leave, I will arrange for another investigator to assume direct responsibility for the study. Either this person is named as another investigator in this application, or I will notify the IRB of such arrangements.
If a PI will not be available to perform research oversight or activities, they need to find another qualified person to perform these activities. This could include sabbatical or personal leave, or a period of time where the PI is out of contact with the research team. The type of study determines the course of action to take if the PI will be absent for an extended period. For a higher risk study, especially if there is a risk of adverse events, there must be a PI on-site for prolonged absences and the IRB office will need to be notified with a HawkIRB modification. For minimal risk studies that the PI can be contacted in a reasonable amount of time, a modification may not be necessary. Please check with the HSO if you will need to be absent and have questions about what course of action you will need to take.
UI Guide Section II, Part 19.A Modifications
I will obtain Continuing Review approval prior to 12:01 am on the date the approval for the study expires. I understand if I fail to apply for continuing review, approval for the study will automatically expire, and all study activity must cease until IRB approval is granted.
The PI will need to update the HSO/IRB office with how the project is progressing on a regular basis. This continuing review (CR) will ask the research team to answer some questions about the project’s progress, enrollment, and reportable events or complaints. CRs should also include data safety monitoring reports, if applicable. After a CR, the informed consent document will be populated with a new date and the research team should use this newest consent form version for consenting all upcoming participants. The HSO also recommends that old versions of consent forms should be destroyed.
OHRP Guidance on IRB Continuing Review of Research - for on-going studies approved under pre-2018 regulation
FDA Guidance – IRB Continuing Review after Clinical Investigation Approval *
HSO FAQs – Continuing Review of IRB-Approved Research
UI Guide Section II, Part 20: Continuing Review
If protected health information is used or created as part of this research project, the research team agrees NOT to reuse or disclose the information to any other person or entity (beyond the named research team) except as required by law, for authorized oversight of the research project, or unless subsequent IRB approval is obtained for such reuse or disclosure.
If the research team uses or makes protected health information (PHI) for the project, the research team cannot disclose or reuse that information to any person who is not on the research team in HawkIRB, or any organization in a way that is different from how it is described in HawkIRB. Data will be kept in secure locations. Information given to the project’s sponsor needs to be approved by the IRB.
If members of the research team access protected health information from a covered component in order to seek consent and authorization for research, such access is necessary for the research, is solely for that purpose, and the information will not be removed from the covered component.
Research teams wanting to recruit participants for their research project must affirm that accessing PHI information is necessary for the research, will only be used for that HawkIRB project form, and will not be removed from the covered component.
UI Guide Section II, Part 5.D – HIPAA
Neither I nor any member of the research team has a significant financial interest, as defined by the University of Iowa Operations Manual, whereby the value of the interest to me or any member of the research team could be influenced by the outcome of the study.
The PI will educate themselves on the definition of conflict of interest and procedures involving reporting them. The evaluation of conflicts of interest is an ongoing process throughout the study. All members of the research team will need to submit their Conflict of Interest information on an annual basis in order to submit applications and modification forms in HawkIRB.
University of Iowa Conflict of Interest in Research
PCORI Applicant Resources -- Policy on Conflict of Interest
NIH Grants & Funding - Financial Conflict of Interest
NSF Grants & Funding – Chapter V Grantee Standards
UI Guide Section I, Part 2.G: Conflict of Interest in Research Committee
UI Human Subjects Office - Human Research Protection Program (HRPP)
UI Operations Manual: 18.6 – Conflict of Interest in Research
UI Operations Manual: 18.7 - Institutional Conflict of Interest in Human Subjects Research
If the above stated research study has a plan to compensate the research subjects participating in this project, I acknowledge that our unit has a Cash Handling Procedure that has been approved by Accounting Services.
Any time participants will receive compensation such as money or gift cards, research teams will need to have an approved plan for this distribution, including having a cash handling procedure. If the participant will receive a check from the eVoucher system and it is issued from Accounts Payable directly to the participant, the cash handling memo is not applicable. Since 2017, research participants that will be paid more than $100 at a time, or that will receive more than $600 in a year will need to fill out a substitute W-9 tax form. The HSO recommends participants be paid in a timely manner.
UI Guide Section II 12.G: Subject Compensation
Research Subject Compensation Policy & Procedures
UI Accounting and Financial Reporting - Research Subject Compensation
UI Accounting and Financial Reporting - Cash Handling Deposits Policies and Procedures
I assure that the proposed research is not currently being conducted and will not begin until IRB approval has been obtained.
Research teams should obtain permission from the IRB to conduct research before any procedures or recruitment begin. The PI cannot identify or recruit subjects until the project has been approved in HawkIRB. Physician PIs can make a list of their own eligible patients but must have IRB approval before they can recruit. A feasibility assessment can provide an unidentified list of individuals that have a certain diagnosis or those that meet eligibility criteria, by requesting that med records run a report. In order to look at medical records to identify and recruit participants, the PI needs to request and get approval for a partial waiver of HIPAA authorization.
HSO- What to Expect During the IRB Review Process
UI Guide Section I, Part 19: Notification of Approval
* FDA references are applicable to studies involving drugs, devices and biologics. Studies that do not involve drugs, devices and biologics are not subject to FDA regulations.
For printable version: Principal Investigator Assurances and Applicable References
Version 4, 10/20/25