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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
- 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 (firstname.lastname@example.org) 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 (email@example.com) 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 (firstname.lastname@example.org).
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? .
- Urgent issues (e.g., subject safety concerns), please call our main line (608-263-2362) and ask to speak with the staff reviewer on call for the day. Please do NOT use email for these kinds of questions.
- General IRB questions, please call our main line (608-263-2362) to speak with the staff reviewer on call or email email@example.com. These are the quickest ways to get help with general questions.
- Specific questions regarding the status of your review and/or reviewer notes, please contact the staff reviewer assigned to your application.
- Help with single IRB review and reliance questions, email firstname.lastname@example.org.
- Assistance with ARROW or technical questions, email email@example.com.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing firstname.lastname@example.org.
- Consultations: For investigators seeking assistance on a specific program or application, HS-IRBs staff are available for individual consultations. To request a consultation, complete the HS-IRBs Presentation and Consultation Request Form.
- Presentations: The HS-IRBs office is available to provide the research community with presentations and trainings on a variety of topics. To request a presentation, complete the HS-IRBs Presentation and Consultation Request Form.