Human Research Protection Program (HRPP) Newsletter - Fall 2016
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:
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
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.
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.
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:
The two campus IRB offices maintain newsletters with information and announcements relevant to their researchers.
AAHRPP Re-Accreditation Site Visit Update
Voluntary Post Approval Monitoring
Changes to Study Document Expiration
Joint Outreach Presentations
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.
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.