HSO/IRB Fees When Relying on Another IRB

For information regarding IRB Fees, please click here for the most current fee schedule.

Post Approval Submissions

It is the responsibility of the Principal Investigator to be aware of all University of Iowa policies and procedures that may affect the conduct of their research.  Regardless of the IRB of record, it is the Principal Investigator's responsibility to adhere to these policies.  This also includes any Human Research Protection Program Committee policies, reviews and approvals.  The Human Subjects Office provides HawkIRB as a venue for the HRPP committees to complete these reviews when an External IRB serves as the IRB of record.  All items listed in the following sections below should be submitted to the HSO, via a HawkIRB modification, either in conjunction with submission to the External IRB or immediately after approval. Questions regarding the HawkIRB Modification form should be directed to uirb-external@uiowa.edu or uiwirb@uiowa.edu (if using WCG).

The UI Human Research Protection Program (HRPP) requires review and submission in HawkIRB for the following categories of modifications:

  • Changes or additions to:
    • Consent documents: the consent, assent, other consent documents
    • Protocols, including clarifications, letters, and summary documents
    • Investigational Brochures
    • Device-related Investigational New Drug (IND) or Investigational Device Exemption (IDE) documents
    • Research team member changes
    • Mass email or noon news requests
    • Site-specific recruitment materials (specific to Iowa site)
  • Correction notices issued by the IRB of Record. For example, if the external IRB issues a revised/corrected approval notice, it will include the type of correction. Corrections can include administrative changes and additional documents reviewed. 
  • Changes to the current external IRB application content or a “yes” response to a question in a HRPP Committee checklist in Section XIV. Section XIV contains checklists for the Human Research Protection Program (HRPP) committee(s). Depending on the study, applicable checklists will be required:
    • Pharmacy & Therapeutics (P&T) Committee
    • Medical Radiation Protection Committee (MRPC)
    • Research Billing Compliance (RBC)
    • Division of Sponsored Programs (DSP)
    • Holden Comprehensive Cancer Center Protocol Review (PRMC)
    • Nursing Research Committee (NRC)
  • Changes related to policies and procedures outlined in the UI Operations Manual. The HawkIRB application will need to be updated and, if applicable, HRPP Committee review(s) may be required.

All other types of modifications, including study-wide evaluation tools, recruitment materials, and other items that are not specifically intended for use only at the Iowa site, should be submitted to the commercial IRB of Record but do not need to be submitted in a HawkIRB Modification form.

The UI PI must report all reportable events that occur in UI subjects to the Lead IRB consistent with the Lead IRB’s reportable events guidance and the timeframes established by the Lead IRB.  In addition, reportable events will need to be submitted through HawkIRB if they fall into one of the following categories:

  • Any reportable event occurring at the University of Iowa
    • Non-Compliance (Serious and/or Continuing)
    • Unanticipated Problems
    • HIPAA/Confidentiality breaches 
  • Events that required a change in the consent or protocol due to either a new risk, procedural change, or a change in an existing risk profile.  These events may not have occurred at the UI but they impact UI subjects.  These will be New Information REFs.
  • Study suspensions or terminations by the IRB, sponsor or regulatory agency
  • Other sites’ reportable events do not need to be reflected in HawkIRB unless instructed to do so by the Lead IRB. 

  • The External IRB will notify the HSO and the study team of Continuing Reviews for the approved protocol. The research team is responsible for initiating a Continuing Review Form in the HawkIRB application.  
  • All External IRB approved documents will be uploaded to the Continuing Review to allow HSO review.  This review will occur after External IRB approval of the Continuing Review.
  • IRB compliance data, on a research study level, is shared with many other UI\UIHC electronic systems.  Failure to submit Continuing Review forms via HawkIRB with the revised IRB approved annual review date, could result in problems obtaining federal funding award dollars, the use of the EPIC Research Module, or the removal of the study being advertised on the UIHC Clinical Research and Trials website.

The External IRB will notify the study team of any Project Closures.  The research team is responsible for initiating a Project Closure Form in the HawkIRB application.

Specific Conditions for Modifications to Approved Protocols

Submit a Modification form in HawkIRB concurrently with the modification submission to the External IRB.  UI required template language cannot be altered in any way.

It is the PI’s responsibility to update the Record of Consent section in HawkIRB, as appropriate, if study procedures, contact personnel, or other information changes during the course of a study.  Modified versions are completed via the ROC section of the HawkIRB submission.

UI policy requires any team members being added to the research team have training in human subjects protections. Research team members include the Principal Investigator and all other individuals (faculty, staff, or student) who have contact or interactions with research subjects or with their private, identifiable information must be certified. Technicians performing standard clinical procedures that are part of the research protocol, such as a blood draw, do not need to be named as a member of the research team and do not need to be certified.

Submit a Modification form in HawkIRB for all research team changes when relying on an External IRB. Research team members must be added and approved in the HawkIRB application prior to taking part in any study activities. External IRBs may handle research team changes differently. Please reach out to the External IRB  regarding their policies for when to report research team changes .

WCG and Advarra notified the HSO that they only need to review the following research team member changes:

  • Change in PI
  • Updates to key personnel
  • Research Team Members listed on the consent form or recruitment materials

Consents/Assents, protocols and External IRB application (if applicable) should be uploaded as a revised version, not as new documents. For more information on stacking documents in HawkIRB, click here.

Other Human Research Protection Program (HRPP) Committee Reviews and Institutional policies

The Principal Investigator must notify all applicable committees of changes to the research protocol that may affect the HRPP committee approval.  This notification occurs via a modification to the HawkIRB application. Some specific instances where this may apply are listed below:

If a new financial interest arises for any study team member, the study team is responsible for submitting a disclosure in the eCOI system. Please see the Conflict of Interest in Research website for more information, including a definition of what may constitute a conflict and how to disclose if one may exist.

You must have approval by P&T prior to submission of the modification to the External IRB if new drugs are being added to the protocol, if new risks have been added for current drugs, or if current drug brochures have changed. In the Modification Form, answer the appropriate questions under Section V. Other Committee Review - Pharmacy and Therapeutic. You will need to add any severe and key complications to the ROC.5 section in HawkIRB if new drugs are being added that are NOT FDA-approved.

You must have approval by MRPC of any of the following modifications prior to submission of the modification to the External IRB. MRPC review is initiated through HawkIRB. Please submit a modification in HawkIRB for the following changes prior to submitting a modification to the External IRB:

  • Change in the Principal Investigator
  • Change in radiation prescriber
  • Change in the number of subjects receiving radiation
  • Change in the radiation protocol

Please see the MRPC Application Form Assistance for more information regarding MRPC’s review process.