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:
- November 26th: The office will be closed in observance of the Thanksgiving holiday with no coverage, including for ARROW.
- November 27th: The office will be closed. Limited coverage for
urgent HS-IRBs and ARROW issues will be provided from 9AM to 3PM ONLY by email via email@example.com.
- WIRB offices are closed both November 26th and 27th. No WIRB coverage will be provided by the HS-IRBs those days.
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:
- Our main line staff and staff reviewers may occasionally be away from their desks, so please leave a voicemail if your call is not answered in person. Staff reviewers on call frequently check voicemail and will return your call as soon as possible.
- When leaving a voicemail, please provide your name, best number at which to reach you, and, if applicable, the IRB study number about which you are calling.
- If you prefer not to leave a voicemail, please email your question to firstname.lastname@example.org.
- If you have a question about an application already under IRB review, please contact the staff reviewer assigned to that application rather than the point of contact. The assigned staff reviewer will be familiar with your application and better able to answer you questions. The staff reviewer assigned to your application is listed in the right-hand corner of the study workspace in ARROW.
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.
- 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
- 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
- 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.