HS-IRBs News November 2015

Health Sciences and Minimal Risk IRBs, IRB News / Volume 7, Number 11, November 2015

Deadline Approaching for Comments on Changes to Human Subjects Research Regulations 

As mentioned in previous Health Sciences IRBs newsletters, significant changes to the federal regulations governing human subjects research are being proposed by the Department of Health and Human Services (HHS). The proposed changes affect a wide range of research and, if implemented, will directly impact many researchers. The deadline for comments to HHS on the proposed changes is December 7, 2015.

UW-Madison’s Human Research Protection Program has developed a webpage with resources about the proposed changes, including summaries of the changes and links to relevant webinars. The [Link for document 57445 is unavailable at this time.] page also includes an online form through which researchers can send questions or comments about the proposed regulatory changes to the campus HRPP.

HS IRBs Office Closures

The HS IRBs office will be closed or have limited coverage the following days in November:

HS IRBs Office Staffing Update

Marc Korobkin, JD, has joined the office as our new education and outreach specialist. Marc comes to us from the Center for Patient Partnerships and has extensive experience in developing and delivering educational programming in a variety of formats. Marc will be coordinating the HS IRBs current outreach efforts as well as implementing new educational initiatives that will be announced in future newsletters. Welcome Marc!

Tips for Using the HS IRBs Point of Contact Service

Researchers can call our main line at 263-2362 to be connected with an experienced IRB staff reviewer on call every business day to answer questions. This is called our point of contact service. To make the most use of this service, please keep the following tips in mind:

Changes to Training Snapshot Activity in ARROW

The Record Training Snapshot activity in ARROW now runs automatically whenever an application is submitted to the IRB, including during the IRB administrative and pre-review proccesses. Study teams are still encouraged to use the snapshot before submitting an application when they wish to confirm that all study team members have complete and current training certifications.

Other changes are coming to the training snapshot to facilitate the implementation of Good Clinical Practice training requirements in 2016 and will be announced in future newsletters.

New Human Research Protection Program Newsletter

The campus Human Research Protection Program (HRPP) is now providing a twice-yearly newsletter to inform members of the research community about issues relating to human research protections. All PIs and points of contact on IRB applications will receive the newsletter as well as those who join the HRPP listserv. To see the HRPP newsletter and instructions for joining the HRPP listserv, please see the Human Research Protection Program Newsletter page.