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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:
- The HS-IRBs website has moved to a new platform and is now searchable by both keyword and full text. Users can leave feedback on any document on the website as well as indicate whether they find a document to be helpful or not. Feedback from study teams is important to helping us improve our services, so we hope to hear from you.
- The Health Sciences IRBs ARROW Help page includes a large number of FAQs on how to use ARROW, including screenshots demonstrating how to navigate through different processes. Additional materials posted on this page include ARROW reference videos and information on how to request an ARROW consultation.
- Revised Guidance on the Five Year Renewal Policy and Replacement Studies in ARROW was posted in July and includes important information on when to submit replacement studies as well as when to close studies that are being replaced.
- Information on how to preview what uploaded consent and assent documents will look like after they have been approved and stamped in ARROW was posted in June. Please see the [Link for document 18856 is unavailable at this time.] for details.
- A VA Research - Overview is now available on the HS-IRBs website. This page includes links to VA policies and guidance as well as VA template documents.
AAHRPP Site Visit UpdateAAHRPP (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 WebsiteThe 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:
- Submissions approved by the IRB with an administrative hold , for which the correspondence will describe additional requirements that need to be met before the submission can be approved.
- Approvals of continuing reviews for studies with a protocol number of 2007 or earlier, for which the correspondence will indicate whether a replacement study must be submitted within the next year due the campus five year renewal policy .
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 email@example.com. 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 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.