HS-IRBs News - September 2011

Health Sciences and Minimal Risk IRBs, IRB News / Volume 3, Number 9, September 2011

New: HS-IRBs Listserv Guidance

The HS-IRBs office has issued new guidance regarding its listserv. The HSIRBs maintain a listserv to provide study teams and other people on campus with information and updates about the HS-IRBs. Listserv announcements may include, but are not limited to, monthly HS-IRBs newsletters, information about the ARROW system, and updates regarding changes to human subjects research regulations, guidance, or policies. The listserv serves as the primary means by which the HS-IRBs provide study teams with important information and study teams are expected to review all HS-IRBs listserv announcements, including monthly newsletters.

Effective immediately, subscription to the HS-IRBs listserv will be mandatory for individuals listed as a principal investigator or a point of contact on a HS or MR IRB protocol. The HS-IRBs office has subscribed principal investigators and points of contact to the listserv, hence no action on the part of study teams is required to comply with this requirement. Subscription to the listserv is being mandated to help ensure that study teams receive important updates from the HS-IRBs office.

Please see Health Sciences IRBs News page for additional details.

Welcome to New Subscribers to the HS-IRBs Newsletter

The HS-IRBs office would like to welcome new subscribers to the newsletter! Here are a few updates from recent newsletters that you may have missed:

AAHRPP Site Visit Update

AAHRPP (Association for the Accreditation of Human Research Protection Programs) completed its site visit at UW-Madison at the end of September. We thank everyone who participated in the site visit, including study teams and IRB members. The campus HRPP (human research protections program) will respond to AAHRPP's comments later this fall and updates on the accreditation process will be provided in future newsletters.

Revised FAQ on Working with ARROW Email Notifications

The FAQ on working with ARROW email notifications has been revised to include additional information on the purpose of notifications and what study teams should do in the event they believe they are not receiving notifications from ARROW.  The revised FAQ also clarifies that study teams are responsible for monitoring their IRB submissions and should regularly review their ARROW inboxes to keep track of their submissions. Please see the revised FAQ on Working with Email Notifications for additional information.

New FAQs Section of the HS-IRBs Website

The homepage of the HS-IRBs website now includes a section with frequently asked questions. These FAQs contain a brief answer to the question as well as links to additional information, when applicable. If you have suggestions for FAQs that you would like to see added, please send them to us as feedback to this newsletter.

Reminder: Reviewing IRB Correspondence

Study teams should review all correspondence issued by the IRB to check for any instructions or requests not conveyed through reviewer notes or other avenues. This is particularly important in the following cases:

Comment Period Extended for Proposed Revisions to Federal Human Subjects Research Regulations

The Office of the Secretary of the Department of Health and Human Services (HHS) is proposing revisions to the federal regulations governing human subjects research (i.e. the Common Rule).  The proposed revisions are broad and HHS is inviting the public to comment on the potential changes. The comment period has been extended to is open until October 26, 2011.

A summary of the proposed revisions can be found here: http://www.hhs.gov/ohrp/humansubjects/anprmchangetable.html. 

The full description can be found here: http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18792.htm

  • 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 asktheirb@hsirb.wisc.edu. 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 askarrowirb@hsirb.wisc.edu.
  • Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
  • 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.