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HRPP Newsletter - Spring 2018
Change to 5-Year Replacement/Renewal Policy
Since 2000, the University of Wisconsin-Madison’s Human Research Protection Program maintained a 5-year replacement/renewal policy. With some exceptions, this policy required study teams to submit replacement/renewal initial review applications every five years for non-exempt human participants research. The IRBs, working with the Associate Vice Chancellor for Research Policy and Compliance, have determined that this requirement can be eliminated for most studies.
Effective immediately, the 5-year replacement/renewal policy will no longer be in place. To facilitate the transition, the UW-Madison IRBs will proceed as follows for applications already submitted to the IRB as 5-year replacement/renewal studies:
- If the submission includes changes of protocol, the UW-Madison IRBs will continue processing those as replacement initial reviews
- If the submission does not include changes of protocol, UW-Madison IRB Offices will reach out to the study team to find out whether they prefer to continue with the initial review or submit a continuing review to extend the study.
Please note that the campus IRBs still have the authority to require the submission of a replacement application instead of a continuing review application if the IRB determines that a de novo assessment of the research study is warranted. Examples of when a new application may be requested include when the IRB determines the need for a re-evaluation of the study is appropriate because an amendment or an accumulation of revisions across the life of the study appear to require a substantive re-assessment of prior determinations in regard to the research or substantive revisions to applicable regulations and laws suggest the need for a re-evaluation of the research in light of such changes. We expect requests for replacement studies to occur rarely in future.
Introducing PREP: the Professional Research Education Program
A cross-campus education working group has been working to expand the educational offering to UW-Madison researchers. You may have completed a Needs Assessment Survey in late 2017 that was created to gauge the training needs of our research community. Your input helped us to prioritize the creation of these new opportunities when creating PREP.
PREP is a new education program open to all UW-Madison faculty, staff, and students who conduct human subjects research. PREP’s goal is to prepare the UW-Madison research community to conduct safe and compliant human subjects research by offering ongoing continuing education and professional development opportunities. Presentations will cover a variety of topics and be presented by subject matter experts from around campus. For a full list of upcoming events, go to the Upcoming Education Opportunities section of the Human Research Protection Program (HRPP) Education and Training webpage or to the "Professional Research Education Program (PREP)" category of the Office of Talent Management (OTM) Course Catalog.
The first session, titled Ensuring Patient Safety and Ethics in the Trenches, will take place on June 5, 2018. This session will address the importance of ethics and patient safety. Shari Zeldin (Department of Medicine) will lead an active discussion of ethical and patient safety considerations related to informed consent, inclusion and exclusion criteria rationale, the difference between clinical care and clinical research, and much more.
As a reminder, the HRPP maintains a comprehensive calendar of educational sessions related to human subjects research and can be found here.
Revised Common Rule Update
In January 2018, the implementation date of the Revised Common Rule was delayed until July 19, 2018. At the moment, the federal government is seeking comment on whether or not to delay the rule for an additional 6 months. In addition to the delay, the federal government is considering allowing institutions to implement certain burden reducing provisions during this additional delay. In anticipation of these changes, we have been extending some of these burden reducing provisions to non-VA, non-FDA regulated studies that are not federally supported. Information about Common Rule changes is being kept up to date on the following pages:
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The two campus IRB offices maintain newsletters with information and announcements relevant to their researchers.