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.

Staff Updates

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:

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:

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.

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.