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University of Wisconsin–Madison

HRPP Newsletter – Winter 2019

Upcoming PREP (Professional Research Education Program) Topics

PREP, an education program for UW-Madison human subjects researchers, has completed its first year! Thirteen courses were developed from your feedback and were presented on by subject matter experts from around campus. Total attendance for these courses reached over 480, with over 85% of attendees who responded to the post-course survey agreeing or strongly agreeing that the content of the courses has been relevant and valuable. In case you missed them, the lecture-style courses have been video recorded and can be accessed on the SMPH Video Library.

As we continue to develop new educational opportunities for 2019, we’d like your input! Please take a moment to fill out this brief, anonymous survey to let us know what topics you’d like to see presented on next. Several courses are already available for registration on the Talent Management Catalog:

  • Feb. 12 – How to Manage Conflict
  • March 7 – Self-Audit Workshop: Subject Charts/Records
  • March 14 – Self-Audit Workshop: Regulatory Files/Binders
  • April 25 – Research Billing Compliance

Revised Common Rule Update

In July 2018, the implementation date of the Revised Common Rule was again delayed. This was the final delay – the Revised Common Rule regulations will go into effect January 21, 2019. UW-Madison’s HRPP policies affected by the new regulations have been updated. These updates will be posted to the HRPP policy index page following the implementation date. Information about how these changes may affect your research and other implementation details are being maintained and updated on the following pages of the IRB offices’ websites:

You can look for further communication regarding this, including further guidance, educational sessions, etc. in the coming weeks and months.

Public Posting of Consent Forms

The Revised Common Rule requires that for federally funded studies meeting the definition of a clinical trial, one IRB-approved informed consent form (ICF) that was used to enroll subjects must be posted to a publicly available website identified by OHRP. The informed consent form must be posted after the trial is closed to enrollment, but no later than 60 days after the last study visit by any subject. Below are some additional pieces of information regarding this requirement:

  • This requirement only applies to studies approved AFTER January 21, 2019 and previously approved studies that have transition to the Revised Common Rule. This requirement DOES NOT apply to studies approved prior to January 21, 2019 that have not transitioned to the requirements of the revised rule (most previously approved studies will not have transitioned).
  • Regardless of how many ICF versions existed during the course of the study, only one ICF must be posted. The study team can decide which ICF version is posted so long as the chosen version was used to enroll subjects.
  • The ICF that is uploaded should be blank and un-redacted.
    • In very rare circumstances (ICFs with confidential commercial information, controversial research, etc.), redactions or not posting the ICF at all may be permissible. Study teams with these scenarios should work with their program officer/funding agency to seek this permission.
  • OHRP has identified two public websites where ICFs can be posted to satisfy this requirement: ClinicalTrials.gov or a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021). Since all studies that are subject to this requirement also require registration at ClinicalTrials.gov, we are recommending that study teams satisfy this requirement by posting there. Additionally, campus ClinicalTrials.gov guidance pages will be updated and ClinicalTrials.gov support staff can assist study teams with this requirement.
  • Questions about this requirement can be sent to ClinicalTrials.gov_Support@research.wisc.edu.

 

If you would like to receive notifications for new HRPP Newsletters, you can subscribe to our distribution list by emailing join-hrpp_newsletter@list.wisc.edu.

The two campus IRB offices maintain newsletters with information and announcements relevant to their researchers.

  • For researchers conducting research approved by the Education and Social Behavioral IRB, an archive of the ED/SBS newsletter can be found here.
  • For researchers conducting research approved by the Health Sciences or Minimal Risk IRB, an archive of the HS/MR IRB newsletter can be found here.