HS-IRBs News June 2012
Health Sciences and Minimal Risk IRBs, IRB News / Volume 4, Number 6, June 2012
HS-IRBs Office Closed on Independence DayThe HS-IRBs Office will be closed Wednesday, July 4th in observance of Independence Day. The ARROW helpline also will not be staffed on July 4th.
UW-Madison Human Research Protection Program Awarded Full Accreditation
The University's human research protection program (HRPP) has been awarded full accreditation by AAHRPP, the accrediting body for IRBs and HRPPs nationwide. The accreditation process involved a rigorous review of the IRBs on campus, policies and procedures, and interviews with a number of researchers and administrators across campus. We want to thank everyone who participated in the accreditation process, which the University will undergo again in about 5 years.
New and Improved Policies and Guidance Page
The Policy and Guidance page of the HS-IRBs website has been reformatted to include version dates for all posted documents on this page. When revisions are made to any of the posted documents, the version date will be updated and a tracked changes version of the document will be posted. We hope this new format will make it easier for us to communicate important changes to HS-IRBs policies and guidance. Revisions to HS-IRBs policies and guidance will still be announced in HS-IRBs newsletters in addition to being posted on the website.
HS-IRBs Office Staffing Transitions
The HS-IRBs office is biding a fond farewell as well as a warm welcome to some staff members:
- Farewell: Anna Martin, our continuing review analyst, is leaving the office at the end of June. She will continue to work part-time for the HS-IRBs for several months. We want to thank Anna for all of her hard work this past year, particularly with completing reviews of all the remaining the legacy applications. We wish Anna all the best and will miss having her in the office.
- Filling In: With Anna's departure, several people are assisting with reviews of continuing review applications. Bekka Williams, a graduate student assistant, is overseeing the review process for all full continuing reviews. She can be reached at firstname.lastname@example.org or 263-0385. Gretchen Anding and Carol Pech are reviewing expedited continuing reviews for the MR and HS boards, respectively. Questions about any continuing review can be directed to Carol Pech until the new continuing review analyst starts (see below).
- Welcome: Brooke Mechelke joined the HS-IRBs Office in June as a new staff reviewer. Brooke comes to us from the UW Carbone Cancer Center. Brooke will be primarily supporting the HS-IRB and will be assisting the office with developing its education and outreach program. Welcome Brooke!
- Welcome Back: Jessica Johnson will be returning to the HS-IRBs office as our continuing review analyst, a position she held previously. Jessie also will serve as the point person for the review of reportable events and assist with other reviews as needed. Jessie's first day back will be July 16th. Welcome back Jessie!
New: Reciprocal IRB Agreement with the University of Minnesota
The HS-IRBs have entered into a reciprocal IRB agreement with the University of Minnesota that may allow studies involving both institutions to have a single IRB of record. At this time, only studies funded by ICTR and Minnesota's Clinical and Translational Science Institute are eligible for review under this agreement. If you have questions about this new agreement, please contact Carol Pech.
Social Behavioral Sciences and Education Research IRBs Going Live with ARROW!
We are happy to share the good news that the Social Behavioral Sciences (SBS) and Education Research (ED) IRBs will be going live with ARROW in October. To provide expert assistance to study teams, the SBS and ED IRBs will have a separate ARROW helpline from the HS and MR IRBs. Specifics about the different helplines will be announced in a future newsletter. Study teams with questions about the SBS and ED IRBs transition to ARROW should contact Lee Alliet, Assistant Director for the SBS IRB, at email@example.com.
Study Sponsor Requests for IRB Rosters and Other IRB Information
The Health Sciences IRBs do not release their rosters to study sponsors. Instead the HS IRBs have published compliance statements for both IRBs that can provided to sponsors who request rosters. The compliance statements detail which regulations the IRBs comply with, what expertise is on the boards, and identifies the IRB chairs. The HS IRBs website has a Resources section that contains information for sponsors, including these compliance statements, as well as the outcome of the FDA audit in 2011, IRB fee policy, details about UW-Madison's Federalwide Assurance (FWA), and our standard operating procedure regarding correspondence that describes why letters are not signed.
Reminder: Using the Record Human Subjects Training Snapshot Activity
Study teams are now expected to use the Record Human Subjects Training Snapshot activity before
submitting any new applications or personnel changes. If the History tab for a submission indicates that a study team has not used the Record
Human Subjects Training Snapshot activity, the study team will be asked
to do so via a reviewer note during IRB administrative review or IRB
The snapshot activity must be used even if all study team members have completed human subjects research training so that the study team's training status is recorded in the submission's history tab. All study team members must have complete and current human subjects research training certification before a new study or personnel change can be approved.
For information on how to check training certifications in ARROW, see Using the Record Human Subjects Training Snapshot Activity in ARROW. NOTE: If a study team member's training information appears to be inaccurate or incomplete in the list generated by the Record Human Subjects Training Snapshot, please email firstname.lastname@example.org. Training information may need to be manually updated by the HS-IRBs Office for study team members who took the training without using their UW-Madison netID and password.
- 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.