Human Research Protection Program (HRPP) Newsletter - Spring 2017
At its December meeting, the Council of Accreditation of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) awarded the University of Wisconsin-Madion's Human Research Protection Program Full Accreditation. This successful re-accreditation lasts five years effective December 19, 2016. Again, we would like to extend a thank you to all of those who contributed to this years long process - especially those who were interviewed during our Site Visit in August.
A brief summary of the changes implemented to address the areas for improvement identified by AARHPP were presented in the Fall HRPP Newsletter.
Preventing Noncompliance and Corrective and Preventive Action Plan Guidance
As part of continued efforts to provide researchers with the tools they need to succeed, a Noncompliance and Corrective and Preventive Action Plan Working Group was created to develop resources study teams can use to prevent noncompliance, investigate the cause of noncompliance, implement corrective action plans, and develop internal Quality Assurance mechanisms. The group has published several documents to meet these ends:
- Preventing Noncompliance Guidance
- Investigating the Cause of Noncompliance and Implementing Corrective and Preventive Action (CAPA) Plans Guidance
- Developing an Internal Quality Assurance (QA) Program Guidance
Common Rule Changes
On January 19, the US Department of Health and Human Services (HHS) issued a final rule to update the federal regulations that govern human subjects research and protect individuals who participate in research - the Common Rule. HHS press release describing the final rule can be found here.
The new administration has put the final rule on hold until at least early June and its future is uncertain at this point. As the status of the common rule changes, campus researchers will be updated on how these changes will affect research at UW.
Education and Training Website
A cross campus education working group has compiled education and training resources available to human subjects researchers across campus on a new education and training website: https://research.wisc.edu/compliance-policy/human-research-protection-program/education-and-training/. This website describes some of the required and supplemental trainings that are available through various campus resources and is intended to act as a gateway to the educational opportunities available across the HRPP.
This page will be continually updated with new resources as they are made available. It will also host a centralized calendar of events for various education and training sessions that occur across campus aimed at assisting human subjects researchers.
ClinicalTrials.gov 101: New Regulations and Tips for Success
In light of a new NIH Policy that went into effect this past January, the Office of Research Policy will be hosting three informational sessions regarding how this new policy affects ClinicalTrials.gov registration and results reporting. This session will be beneficial for individuals new to ClinicalTrials.gov as well as experienced users looking to learn about the new changes. These three identical presentations will be hosted at the following times and locations:
- March 23, 2017 from 9:30 AM - 10:30 AM in 1222 HSLC
- March 23, 2017 from 11:30 AM - 12:30 PM in 114 Waisman Center
- March 30, 2017 from 2:00 PM - 3:00 PM in 134 Psychology
Registration for these sessions is required. Please complete this form to register. For questions about these sessions, please contact Peter Johnson. More information about ClinicalTrials.gov can be found at the HRPP Support Page.
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The two campus IRB offices maintain newsletters with information and announcements relevant to their researchers.