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HS-IRBs News May 2016
Health Sciences and Minimal Risk IRBs, IRB News / Volume 8, Number 5, May 2016
HS IRBs Office Closure
The HS IRBs office will be closed Monday, May 30th, in observance of Memorial Day.
- New IRB Reliance Facilitator: Mike Bingham has transitioned from his current position as the commercial IRB specialist to a new position as the IRB reliance facilitator. Mike will be providing support for the Greater Plains Collaborative IRB consortium as well as other IRB partnerships. Mike will continue to be a member of the HS IRBs' reliance team and will provide coverage for WIRB submissions until his former position is filled. Congratulations Mike!
- Filling In: Jessie Johnson is on leave through July 2016 and Emily Jenner is filling in for her. If you have questions about reportable events or continuing reviews while Jessie is away, please contact Emily.
New Quality Improvement/Program Evaluation Decision Tool
The Quality Improvement/Program Evaluation Self-Certification Tool (also called the Research Decision Tool) has undergone several enhancements. The tool has been moved into an online platform (Qualtrics) that we hope will be easier to use. In addition, a new question (see Q3) and corresponding IRB QI/Program Evaluation Self-Certification Tool Guidance has been added regarding multsite projects. Finally, an existing question regarding project design and intent (now Q4) has been revised along with the corresponding guidance.
Please see the Guidance on Research vs. Quality Improvement and Program Evaluation for additional details and contact us with any questions.
Updates on NIH Policy and Federal Regulatory Changes
As mentioned in previous newsletters, changes to federal policies and regulations governing human subjects research (i.e., the Common Rule) are being proposed by NIH and the Office of Human Research Protections (OHRP). Although no formal announcements have been made, the following updates have been provided at recent public meetings attended by IRB administrators:
- NIH anticipates that single IRB review will be required for multisite research projects starting with its January 2017 grant cycle. NIH has not yet issued its final policy regarding single IRB review.
- OHRP has indicated it anticipates releasing the final revised Common Rule in fall 2016.
No additional details are available at this time. We will provide further updates as new information becomes available to us on these important changes.
Improving IRB Processes for Researchers
Starting with this issue of the newsletter, we will be highlighting some of the efforts underway to improve IRB processes for the research community. These projects involve HS IRBs staff as well as our colleagues across campus and are intended to help make the IRB submission and review process easier for all involved.
One of the main process improvement projects for 2016 is enhancing ARROW to allow for more efficient review of all studies for which IRB review is ceded to an external IRB, such as the NCI CIRB and IRBs at other academic institutions. With the pending federal mandate for single IRB review, an increasing number of studies will be reviewed by non-UW IRBs. Working with our colleagues in VCRGE IT, we are working on developing new workflows and forms to better accommodate these studies. Highlights of this project include:
- Allowing all studies ceded to an external IRB to be submitted through ARROW, including those reviewed by WIRB. This will enable researchers to have a record of all their studies in one system at the UW.
- Shortening the application for NCI CIRB studies and streamlining the application for studies ceded to other external IRBs. This will help reduce the administrative burden for researchers requesting review by an external IRB.
- Providing methods to update funding information and personnel for all studies ceded to an external IRB. This will permit researchers to link funding sources to an IRB protocol in ARROW, something not currently possible after studies have been ceded to an external IRB.
- Creating correspondence to formally document that review has been ceded to an external IRB. Many entities on and off campus (e.g., RSP, external funding bodies, etc.) wish to see a formal determination from the IRB to confirm that review has been ceded and new IRB letters will provide this documentation through ARROW.
If you have an questions or comments about this project, please contact Carol Pech.
Upcoming Beginners Workshop
Are you new to the HS-IRBs review process? Consider registering for our upcoming HS IRBs for Beginners workshops. This two-hour session provides an introduction to the HS-IRBs review process, resources, and the ARROW online application system. This is the last session until late this summer.
- Wednesday, May 25th, 9-11 am, HSLC 2121 - Registration available here
AAHRPP Re-Accreditation Site Visit
The UW's Human Research Protection Program (HRPP) has been an AAHRPP accredited program since 2008 (re-accredited in 2011). AAHRPP accreditation indicates that our institution follows the highest standards for ethics, quality, and human participants protections. The re-accreditation site visit is now scheduled for August 10th-12th. Many individuals throughout UW's research enterprise will be involved in this site visit, and the HRPP will assist in preparing all those involved.
Questions? We're Here to Help!
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.
- 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 firstname.lastname@example.org. 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 irbreliance.wisc.edu.
- 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.
- WIRB updates, please sign up for the WIRB listsserv by emailing email@example.com with a request to be put on the list.
- 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.