HSO and the UI Human Research Protection Program (HRPP) require, at a minimum, submission of these documents for all new project applications.  Note HSO Staff may request additional documents depending on the specific details of your study:

• Consent documents:  the consent, assent and other consent document types (which may include treatment beyond disease progression, sub-studies, extra genetic testing / future use consents, pregnant partner*, etc.).  These documents should have institutional language edited into them accordingly.
  • * - Unless directed by the study sponsor, you do not have to submit a pregnant partner consent form during the new project application. You can let HSO staff know in your submission comments that you will submit a modification to add a pregnant partner consent form if the situation arises.  This helps reduce review burden for a consent form that may never be needed.
• Protocols, including clarifications, letters and summary documents related to the current version.
• Investigational Brochures.
• Investigational New Drug (IND) or Investigational Device Exemption (IDE) documents.
  • If Iowa’s PI is the IND sponsor, we will require forms 1571, 1572 and 3672, along with either A) FDA documentation showing the study may proceed, or B) documentation showing the FDA received the IND application.
• Mass email or noon news requests.
• Any recruitment letter / individual email template already approved by the External/Commercial IRB OR created especially for use ONLY at Iowa that requires UIHC Electronic Medical Record Information / HIPAA information for recruitment purposes. 
  • The following verbiage MUST be provided to the subject at the time the recruitment letter / email is sent:
    • We obtained [mail/email addresses] from University of Iowa Health Care medical record database with permission from the Institutional Review Board (IRB) of Record (an ethical review board that approved this research study) and/or from the UI Health Care designated Privacy Officer or Board (that approved access to protected health information for the limited purpose of recruiting for this study).
  • You will need to do one of the following:
    • Modify the existing letter/email template with the above statement and submit to the External/Commercial IRB for approval.
    • For physical letters, you may create a cover sheet containing the above statement so it can be included with the recruitment letter.  Be sure the External/Commercial IRB approves this. 
    • Verify in HawkIRB workflow that you will NOT be using any letters or email to recruit subjects.
• IRB of Record documents:
  • For Academic IRBs, attach a copy of the External IRB’s approval memo and a copy of the lead site’s IRB submission to the IRB of Record.
  • For Commercial IRB, attach a DRAFT copy of the site level submission that you intend to submit.
  • For NCI CIRB, attach a copy of the study-specific worksheet, the Initial Review Application submission and the standalone HIPAA Information Sheet.
• A copy of the Assurance document.

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.
  • 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.

There are instances where the IRB of Record approved the modification, and HSO also approved the modification in HawkIRB pending approval from an HRPP committee.  Should the HRPP committee(s) require changes, HawkIRB will now allow you to submit another modification simultaneously to address any HRPP concerns. Once satisfied, the HRPP Committee(s) approvals will apply to both modifications and both forms will be released at the same time.  

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.
  • This includes any serious adverse device effects (anticipated or unanticipated) occurring in any subject regardless if they are enrolled at Iowa or a separate non-UI research site.
• 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.

Studies are to be closed at the External IRB before they are closed in HawkIRB. Once the study has been closed at the External IRB, the study team should follow the guidelines below to closeout the study in HawkIRB:

1. If any modifications, continuing reviews, or reportable event forms have been approved at the External IRB since the last HawkIRB submission, submit these items BEFORE submitting a closure form.
2. Initiate a closure form in HawkIRB for the study and attach the Closure Notice from the External IRB as an attachment. (NOTE: For WCG studies, please enter “Closure” in the Work Order # field in EXT.1)
3. Once the closure form is submitted in HawkIRB, the study will be automatically closed.

NOTE: Studies cannot be reopened in HawkIRB once closed. If a study is closed inadvertently in HawkIRB, a new HawkIRB Project form will need to be created.

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

Coming Soon! HSO has automated approval of research team member changes meeting certain requirements for all projects relying on an External IRB.  This means an HRPP approval (with approval memo) will immediately be issued, bypassing the normal HSO review process.  The HRPP approval will be captured on the HawkIRB project summary page.  The modification must meet these requirements:

• Limited ONLY to changes in UI team members in questions II.2 and V.28 (if applicable).     
• Does NOT apply if there are modifications to ANY attachments or any other HawkIRB questions.
• Does NOT apply if the UI team member is:
  • The PI.
  • Key personnel.
  • Has a conflict of interest (COI).
  • Appointment type of Adjunct, Complimentary appointments, Visiting Professors, or Affiliate.

Please note the PI is solely responsible for verifying all research team member updates are in accordance with the External/Lead IRB's policies and procedures. 

Consents/Assents, protocols and External IRB application (if applicable) should be uploaded as a revised version, not as new documents. For more information on how to attach a new version of (or stack) a document in HawkIRB, See Step by Step Instructions for Modifying an Attachment.

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.