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 WCG 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 WCG or immediately after approval. Questions regarding the HawkIRB Modification form should be directed to uiwirb@uiowa.edu. Any questions regarding the submission process to WCG can be directed to clientservices@wirb.com

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
• 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), the Joint Office for Compliance (JOC), Holden Comprehensive Cancer Center Protocol Review (PRMC), and 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 should be submitted to the commercial IRB of Record but do not need to be submitted in a HawkIRB modification form.

Specific Conditions for Modifications to Approved Protocols

• Consent Documents

A standard Modification to the application should be submitted in HawkIRB concurrently with the modification submission to WCG.  The required UI language cannot be altered in any way

• Record of Consent

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

• Research Team Changes

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.

 

A standard Modification to the application should be submitted in HawkIRB concurrently with the Modification submitted to WCG. When adding new study team members, human subjects training certification and an eCOI disclosure must be completed prior to the addition of the new members to the HawkIRB application.

• Attachments

Consents/Assents, protocols and the draft WCG application should be uploaded as a revised version, not as new documents. Any additional documents submitted to WCG should be attached in zip folder labeled "Submitted_To_WCG_Month.Date.Year." The date included in the label should be the date the modification was submitted to WCG. The zip folder should be uploaded to the Copy of External IRB Application Section on the Attachments page.

• Other Committee Reviews and Institutional policies

The Principal Investigator must notify any 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: 

CIRC

If a new financial interest arises for any study team member, you must submit 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

P&T

You must have approval by P&T prior to submission of the modification to WCG if new drugs are being added to the protocol. In the Modification Form, answer the appropriate questions under Section V. Other Committee Review - Pharmacy and Therapeutic.

You will need to create and submit a new G-12 if new drugs are being added that are NOT FDA-approved.

MRPC

You must have approval by MRPC of any of the following modifications prior to submission of the modification to WCG:

• Change in the Principal Investigator: Submit revised MRPC cover page with new PI signature
• Change in radiation prescriber: submit revised MRPC Internal Radiation Form with new prescriber information
• Change in the number of subjects receiving radiation: submit justification (statistical power analysis) for increasing the number of subjects
• Change in the radiation protocol: submit revised MRPC application and WCG consent document(s

Other Post-Approval Submissions to WCG

• Serious and/or unexpected adverse experiences or major protocol violations that result in additional risk to subjects require the submission of a Reportable Event Form in HawkIRB. WCG should also be notified concurrently. Additional reporting by the Human Subjects Office may be required, depending on the protocol and the funding source.
• The UI PI is responsible for reporting all REFS occurring at the University of Iowa to the Lead IRB consistent with the Lead IRB’s reportable events guidance and the timeframes established by the Lead IRB.  In addition, REFS will need to be submitted through HawkIRB  if they fall into one of the following categories:
  • Any REF 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 are events that did not occur at the University of Iowa but still impact Iowa subjects.  These will be New Information REFs.
  • Other sites’ REFs do not need to be reflected in HawkIRB unless instructed to do so by the Lead IRB. 
• WCG will notify the HSO of Continuing Reviews of the approved protocol. The WCG Coordinator will work with the research team to initiate a Continuing Review Form in the Hawk IRB application.  All WCG approved documents will be uploaded to the Continuing Review to allow review, as applicable, by the HRPP Committees.  This review will occur post WCG approval of the Continuing Review.  A hold will not be placed on continuing reviews.  
   
• WCG will notify the HSO of any Project Closures.  The WCG Coordinator will initiate a Project Closure Form for the HawkIRB application.