HS-IRBs News December 2014

Health Sciences and Minimal Risk IRBs, IRB News / Volume 6, Number 12, December 2014

HS-IRBs Office Closures

The HS IRBs office will be closed or have limited coverage the following days in December and early January:

  • December 24th and 25th: The office will be closed in observance of the Christmas holiday.
  • December 26th: The office will be closed. Limited coverage for urgent HS-IRBs and ARROW issues will be provided from 9AM to 3PM and ONLY by email via asktheirb@medicine.wisc.edu.
  • December 31st and January 1st: The office will be closed in observance of the New Year's holiday.
  • WIRB offices will also be closed December 24th and 25th as well as January 1st. No WIRB coverage will be provided by the HS-IRBs office on December 31st.

HS-IRBs Staff Updates

We are excited to welcome several new staff members to the HS-IRBs office:

  • Emily Jenner (ejenner@medicine.wisc.edu) has been hired as a new continuing review analyst. Emily joins us from the UW Carbone Cancer Center, where she most recently served as a compliance and monitoring coordinator. Emily will be working with Jessie Johnson on conducting reviews of continuing reviews and reportable events.
  • Mike Bingham (mbingham@medicine.wisc.edu) has been hired as the new WIRB specialist. Mike previously served the assistant director for the education research IRB on campus and has recently managed IRB operations at ProHealth. Mike will be leading our WIRB program as well as assisting with other IRB reliance agreements and partnerships.
  • Monica Esquibel has been hired as a new MR IRB staff reviewer. Monica's background is in Health Communications and she previously worked in research policy at Florida State University. Monica will be conducting review of exemptions and expedited applications. 

New: Greater Plains Collaborative (GPC) IRB Reliance Agreement

UW-Madison is a founding member of the Greater Plains Collaborative, a PCORI-funded partnership of 10 medical centers across 7 states. The HS-IRBs staff have been very involved in the creation of a GPC IRB reliance agreement and review process that will allow GPC studies to have a single IRB of record. We are proud to announce that the reliance agreement was finalized in November and the first studies are making their way through the reliance process. If you have questions about the GPC reliance agreement, please contact Carol Pech (cap@medicine.wisc.edu).

Updated: IRB Requirements for Studies Involving Collaborators and Sites Outside UW-Madison

The flowchart describing IRB oversight requirements for studies involving collaborators and sites outside UW-Madison and UW Health has been updated for clarity and to better indicate which requirements apply if a study is federally funded. Study teams are encouraged to review this chart when planning studies involving personnel or sites external to UW-Madison and UW Health.

NIH Draft Policy Regarding Single IRB Review

The NIH recently issued a draft policy regarding requiring single IRB review for multisite studies funded by NIH. Some NIH funding announcements have already included this requirement. NIH is inviting comments on the draft policy, which are due January 29, 2015.

FAQ on Changes to Exempt and Not Human Subjects Research Projects

The HS-IRBs has developed a FAQ on changes to exempt and not human subjects research projects. The change of protocol process for these types of projects differs from that for studies which have undergone full or expedited initial review.

  • For changes to projects that were determined to be not constitute research (e.g., QI/QA or program evaluation), the Research Decision Tool can be used to determine if the project still qualifies as not meeting the federal definition of research. If the tool gives a determination of “Not Research”, this certification can be kept for documentation and no separate change of protocol needs to be submitted.
  • If research teams want to make a change to a study that was determined to be exempt (Categories 1-6) from IRB review or was determined to not constitute research involving human subjects, the staff reviewer of the original application should be emailed with a brief summary of the study procedures that were approved, a description of what you wish to change, and any supporting documents (e.g. revised surveys or data collection sheets.)
  • Changes of personnel (including POC) do not need to be reported to the IRB for exempt studies, unless the PI changes. If there is a change of PI for an exempt study, please submit a new exemption application (or use the research decision tool for projects determined to be Not Research).

For more information on changes to exempt or not human subjects research projects, see Can changes of protocol be submitted for exemptions? .

Information previously provided on this page has been relocated to our new IRB website.

Please visit this page for information about connecting with the IRBs.

Keywords:newsletter, listserv, exemptions, changes, GPC, Greater Plains, reliance, oversight, multisite, collaborator, NIH   Doc ID:45063
Owner:Carol P.Group:Health Sciences IRBs
Created:2014-11-18 08:19 CSTUpdated:2015-06-09 15:14 CST
Sites:Health Sciences IRBs
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