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University of Wisconsin–Madison

HRPP Newsletter December 2023

IRB DIRECTOR HIRE

We are very pleased to announce the appointment of Lisa Wilson, JD, CHRP, as the IRB Director, effective December 3, 2023.  Lisa has served as interim IRB director since February 2023.  Most of you either know Lisa or have worked with her as she came to the IRB from the Office of Legal Affairs where she was senior legal counsel.  In that role, she advised faculty, staff and the IRB/HRPP on regulations relating to human subjects research as well as supporting many institutional stakeholders on contracts and agreements required for compliant human subjects research.

She brings a wealth of expertise and leadership to the office.  Please join us in welcoming Lisa to this leadership role.

REMINDER ON UROC REVIEW PROCESS

The UW Health/SMPH Research Operations Committee (UROC) reviews all research that utilizes UW Health services, personnel, facilities, or engages with UW Health patients, in order to assess the operational feasibility of the study.  Study teams with studies meeting these criteria are required to submit for UROC review according to their posted meeting cycle.  Submission to the IRB should occur after UROC review.  Please review UROC FAQs for additional information.

DOCUMENTING ELIGIBILITY 

A study's research record must include documentation that each participant has met all the eligibility criteria outlined in the IRB-approved protocol/application. This documentation provides evidence that participants were appropriate for participation. One way to document eligibility is by using an eligibility checklist. UW ICTR has an eligibility checklist template that can be modified to work for your particular study. When creating an eligibility checklist, ensure you are capturing all the criteria that were approved by the IRB. If you find that the criteria need to be modified, a Change of Protocol must be submitted prior to making any modifications.

ADVARRA RESEARCH PARTICIPANT PAYMENT SYSTEM GOING LIVE

The university is rolling out a new payment platform that allows for payments to research participants for stipends and travel within a single system that is integrated with OnCore, UW’s clinical trial management system.  The “Participant Payments” system launched December 1, 2023, and aims to enhance compliance while streamlining processes and workflows to increase efficiency, lower costs, and increase satisfaction.  For more information, including on how to request approval to use the system, see the Participant Payments launch announcement from the Clinical Trials Institute.

The IRB recommends informing participants in the consent form that payments will be processed via a third-party vendor.  Details about how this system works (receiving payment, setting up an account, etc.) can be provided in a supplemental document that would not require IRB review.  Study teams should review the payment language in their consent forms to determine whether revisions are needed.

GETTING HELP FROM THE IRB

If you have questions about a submission currently under review, contact the IRB Analyst assigned to your submission.

General IRB questions:  

  • Email asktheirb@hsirb.wisc.edu, To help staff answer your question, please provide a clear, concise description of your question(s). Please include the IRB study number, status of the study (e.g., not yet submitted; submitted but not approved; approved; closed; other), PI name, study aims, and a description of procedures.
  • OR call 608-263-2362 to leave a voicemail for the staff reviewer on call. The email and on call staff reviewer are not usually the same person, so please choose either email or phone and wait for a response.
  • OR join Health Sciences and Minimal Risk Research IRB staff for virtual office hours. Office hours run from 12 PM – 1 PM the first Thursday of each month. Click here for the Zoom link.

For other requests or questions:

SUBMITTING REVISED INVESTIGATOR’S DRUG BROCHURES AND PACKAGE INSERTS

Studies that use drugs and submit Investigator’s Drug Brochures (IDBs) and/or package inserts at initial review need to submit revised IDBs/package inserts to the IRB for the life of the study. Revised IDBs/package inserts should be reviewed by the PI and can be submitted at continuing review or as a change of protocol depending on the nature of the revisions.

If the revisions WILL NOT result in a change to the protocol and/or informed consent form, then the revised IDB/package insert should be submitted at continuing review. Along with the revised IDB and/or package insert, the study team must complete the IDB and Package Insert Log to explain why the revised IDB and/or package insert meets criteria to be submitted at continuing review. The explanation should be specific to the submission and take into account the nature of the revisions, information already in the protocol and/or consent form, and/or the status of the study. Some reasons you may be able to submit revised IDBs/package inserts at continuing review:

  • The revised package insert includes editorial and administrative updates and does not include any new risk information.
  • The revised IDB includes changes in frequency of risks, but the frequency changes do not impact the categories described in the consent form.
  • The revised IDB includes new risk information, but all participants are off treatment, and the risk information is only relevant to those currently on the drug.

If the revisions WILL result in a change to the protocol and/or informed consent form, then the revised IDB/package insert must be submitted as a change of protocol to the IRB within 60 days. If the revised study documents cannot be submitted to the IRB within 14 days of learning the new information, however, then a new information report should be submitted as a placeholder until the full change is submitted within the 60-day window. Some reasons you may need to submit a change of protocol, and a new information report if needed:

  • The revised IDB includes a new risk not described in the consent form and participants are still on the study drug.
  • The revised IDB includes changes in frequency of risks and the frequency changes do impact risk categories described in the consent form (e.g., risk is moving from the common to the very common category).

Please see our Investigator Manual guidance on Investigator’s Drug Brochures and Package Inserts for more information.

 

Previous editions of the HRPP Newsletter can be found here.