Health Sciences and Minimal Risk IRBs, IRB News / Volume 4, Number 6, June 2012
The University's human research protection program (HRPP) has been awarded full accreditation by AAHRPP, the accrediting body for IRBs and HRPPs nationwide. The accreditation process involved a rigorous review of the IRBs on campus, policies and procedures, and interviews with a number of researchers and administrators across campus. We want to thank everyone who participated in the accreditation process, which the University will undergo again in about 5 years.
The Policy and Guidance page of the HS-IRBs website has been reformatted to include version dates for all posted documents on this page. When revisions are made to any of the posted documents, the version date will be updated and a tracked changes version of the document will be posted. We hope this new format will make it easier for us to communicate important changes to HS-IRBs policies and guidance. Revisions to HS-IRBs policies and guidance will still be announced in HS-IRBs newsletters in addition to being posted on the website.
The HS-IRBs office is biding a fond farewell as well as a warm welcome to some staff members:
The HS-IRBs have entered into a reciprocal IRB agreement with the University of Minnesota that may allow studies involving both institutions to have a single IRB of record. At this time, only studies funded by ICTR and Minnesota's Clinical and Translational Science Institute are eligible for review under this agreement. If you have questions about this new agreement, please contact Carol Pech.
We are happy to share the good news that the Social Behavioral Sciences (SBS) and Education Research (ED) IRBs will be going live with ARROW in October. To provide expert assistance to study teams, the SBS and ED IRBs will have a separate ARROW helpline from the HS and MR IRBs. Specifics about the different helplines will be announced in a future newsletter. Study teams with questions about the SBS and ED IRBs transition to ARROW should contact Lee Alliet, Assistant Director for the SBS IRB, at email@example.com.
The Health Sciences IRBs do not release their rosters to study sponsors. Instead the HS IRBs have published compliance statements for both IRBs that can provided to sponsors who request rosters. The compliance statements detail which regulations the IRBs comply with, what expertise is on the boards, and identifies the IRB chairs. The HS IRBs website has a Resources section that contains information for sponsors, including these compliance statements, as well as the outcome of the FDA audit in 2011, IRB fee policy, details about UW-Madison's Federalwide Assurance (FWA), and our standard operating procedure regarding correspondence that describes why letters are not signed.
Study teams are now expected to use the Record Human Subjects Training Snapshot activity before
submitting any new applications or personnel changes. If the History tab for a submission indicates that a study team has not used the Record
Human Subjects Training Snapshot activity, the study team will be asked
to do so via a reviewer note during IRB administrative review or IRB
The snapshot activity must be used even if all study team members have completed human subjects research training so that the study team's training status is recorded in the submission's history tab. All study team members must have complete and current human subjects research training certification before a new study or personnel change can be approved.
For information on how to check training certifications in ARROW, see Using the Record Human Subjects Training Snapshot Activity in ARROW. NOTE: If a study team member's training information appears to be inaccurate or incomplete in the list generated by the Record Human Subjects Training Snapshot, please email firstname.lastname@example.org. Training information may need to be manually updated by the HS-IRBs Office for study team members who took the training without using their UW-Madison netID and password.
Whether you have a question about a specific protocol, a general question about the submission process, or need clarification about research policy, we have several ways you can reach us.