Human Research Protection Program (HRPP) Newsletter - Fall 2016

AAHRPP Re-Accreditation Site Visit Update

On August 10-12, 2016, UW-Madison's Human Research Protection Program (HRPP) underwent its AAHRPP re-accreditation Site Visit. The site visit was an opportunity for all of us to demonstrate how we use our policies and procedures to ensure the protection of human research subjects. The site visitors had wonderful things to say about our program and provided only a couple of areas for improvement. Those areas for improvement led to HRPP changes described here:

• For industry sponsored studies, a new question is being added to the ARROW application that asks whether the Clinical Trial Agreement requires adherence to the International Council for Harmonization of Good Clinical Practice (ICH-GCP) Guidelines. The IRB will use the answer to this question to ensure ICH-GCP Guidelines relevant to IRB oversight are applied during its review.


• To assist study teams in applying ICH-GCP Guidelines when required, GCP Training is available via the CITI Program and has been required for personnel on applicable studies since August of this year. In addition, a checklist has been created to help study teams ensure their consent forms contain the appropriate required elements of consent when ICH-GCP Guidelines apply.


• Research teams are responsible for ensuring language in IRB-approved consent documents for their studies regarding provisions for medical care or other services for research-related injuries is consistent with the wording in the contracts and funding agreements supporting those studies. This requirement applies regardless of the IRB that reviews the study (e.g., a UW IRB or IRB external to the UW) and has been in place for studies reviewed on behalf of the UW by the Western IRB since 2008. We are now clarifying that ensuring the consistency of consent forms and contracts/funding agreements applies to all studies. The Summary of Investigator Responsibilities document has been updated to reflect this requirement.

Finally, thank you to all of those who helped with preparation for the visit, especially those who were interviewed. A final decision about our re-accreditation will be made in December by AAHRPP's Council on Accreditation

Voluntary Post Approval Monitoring

For researchers looking to ensure their study is being conducted in accordance with applicable campus policies and federal regulations, a request for a voluntary Post Approval Monitoring Visit can be made by emailing Ryan Moze. Investigators who successfully complete voluntary monitoring will be exempt from routine monitoring for a period of 12 months.

In addition to voluntary monitoring, staff from the PAM Program can be consulted prior to initiation of a study (shortly after IRB approval). At this type of consulting visit, PAM staff will meet with a study team to discuss plans for how the study will be conducted and review any planned documentation methods. PAM staff will make recommendations where appropriate and provide documentation tools as necessary.

Changes to Study Document Expiration

This coming January, IRB approval stamps will no longer contain expiration dates. Stamped study documents (conset forms, assent forms, information sheets) will no longer expire, and will only be re-stamped when a document changes. As is the case now, study teams should continue to use the most recently approved version of a study document. For more information on this change or if you have questions, you can visit this FAQ.

Joint Outreach Presentations

Going forward, the Office of Research Policy will be giving joint outreach/education events with the two IRB Offices. These types of events will be hosted several times per year. For more information or to request a location or topic, contact the HRPP. Details for one such upcoming event is below:

• HS/MR IRB Joint Presentation - Dec 6, 2016 at 11:00 AM in CSC Room G5/113


• Post-IRB Approval Submissions and Post-Approval Monitoring
  This session will start with HS/MR IRB staff discussing the what, when, and how of IRB submissions that occur after IRB approval (continuing review, change of protocol, closure, and reportable events). In addition, PAM Program representatives will give an overview of the program and discuss the most common findings from PAM Reviews. Register here.

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.