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UWCCC HS-IRBs News October 2014
The Health Sciences IRBs Cancer Center Newsletter for August 2014
KBThis newsletter is designed to provide UWCCC study teams with consistent and important information related to human subjects protection policies, regulations and guidance. Note that policies and procedures may differ depending on whether a UW HS IRB, an NCI Central IRB (CIRB), or the Western IRB (WIRB) is providing IRB oversight for a study. The UWCCC HS IRBs newsletters will be archived on the HS IRBs website so that they will be searchable for future reference. If there is a topic that you would like addressed in a future newsletter, please send a detailed description of the topic to firstname.lastname@example.org .
Note that in addition to the UWCCC HS-IRBs listserv, the HS IRBs host two other listservs: one for general updates and announcements (including a general HS IRBs newsletter) , and one for people who use Western IRB (WIRB).
To be added or removed from the listserv for this newsletter, individuals should submit a request to the HS IRBs office by emailing email@example.com with the subject ‘UWCCCIRBNews Add/Remove’.
Have a question? The HS-IRBs Office Can Help
- General questions: The fastest way to get answers to general questions is to email askTheIRB@medicine.wisc.edu or call 263-2362 to speak with the IRB staff point of contact. If asking about a specific study, please provide the study ID number in the message.
- Urgent issues: If you need assistance from the IRB office with an urgent issue (e.g., reportable event, subject safety concerns), please call 263-2362 and ask to speak with the point of contact. Please do NOT email these questions to asktheirb or other IRB office staff.
- Questions about responding to reviewer notes: If you have questions about how to respond to a Reviewer Note in ARROW, contact the staff reviewer assigned to reviewing your application. Individual contact information can be found here .
- IRB Consultations: If you would like to request a meeting with an IRB staff reviewer to discuss specific questions about an upcoming study, complete the HS IRBs Consultation Request Form .
- ARROW assistance: If you need technical assistance with ARROW, email your question to firstname.lastname@example.org
- WIRB Connexus assistance: If you need technical assistance with Connexus, email your question to email@example.com
- NCI Central Institutional Review Board (NCI CIRB) assistance: If you have questions about using the CIRB, please contact Jennifer Fenne at firstname.lastname@example.org or 263-8914.
- Farewell: Colette Wagner, the HS-IRBs' Commercial IRB Specialist, left the office at the beginning of September.
- Filling In: Staff Reviewers Brandy Stoffel and Jackie Lee will be providing support for WIRB submissions, including providing WIRB training as requested. Questions about the WIRB process can be directed to Brandy Stoffel (email@example.com or 265-4390).
Updates to WIRB procedures were recently sent out to the WIRB Listserv . If you missed the email the updates can also be found on the WIRB Gateway under News and Announcements. The updates related to WIRB submissions include changes to consent templates, COAs, CPU contact and application, and Reportable Information. The WIRB ListServ is for those who would like updates about the WIRB submissions process. If you are not already receiving updates about WIRB, please email firstname.lastname@example.org requesting to be put on the list.
NCI CIRB Updates
- The CIRB IT Integration has resulted in several changes:
- Access to IRBManager and to CIRB documentation now requires logging in to the CTSU website: https://www.ctsu.org/Public/Default.aspx?ReturnUrl=%2f
- There is no longer a public list of CIRB-approved protocols on the CIRB website; it’s now necessary to log in to the CTSU site to find out if a new study has been approved by a CIRB.
- All current protocol-specific CIRB documentation is now on the CTSU website, rather than on the CIRB website. (The Participant’s Area now houses only historical information on studies.)
- There is a new URL for IRBManager: https://nci.my.irbmanager.com
- The CIRB website (www.ncicirb.org) still includes important information about how the CIRB works. The CIRB Standard Operating Procedures were updated on 10/1/14; the SOP document is an important resource if you have questions about how the CIRB conducts its reviews and how responsibilities are divided between the CIRB and local sites.
- CIRB contact information: To contact the CIRB with general questions, use the CIRB Helpdesk: email@example.com or (888) 657-3711. Questions related to reviews done by the CIRB’s Local Context Subcommittee (e.g. Annual PI Worksheets, Study Specific Worksheets, locally-developed materials) can be directed to: firstname.lastname@example.org. LaTisa Hernandez, Sr. CIRB Local Context Coordinator, is the UW’s point of contact in the CIRB Office.
Wisconsin law regarding exposure to x-ray radiation requires a variance for certain uses of x-ray that do not meet the state’s definition of healing arts purposes. HS IRB guidance is currently being developed regarding when this statute applies to research procedures and the process for requesting a variance. Note that HS IRB staff are providing information about the variance process to study teams when they identify a protocol that comes under this state law.
A Note on Using Canned Language in your ARROW Application (HS IRB studies)
Canned language can be helpful when preparing your ARROW application. The template language can provide consistency among applications that can speed up the review process. If you do choose to copy language from one application to another it is important to carefully read the statement in the context of the new application to ensure that it is still accurate. Some tips on using canned language are:
- RECRUITMENT METHODS: Consider language that needs to be added if this is a multisite study and UW is the IRB of record for other sites. How might the recruitment methods differ among sites?
- PRIVACY AND CONFIDENTIALITY: Review the language per study to ensure that it continues to be correct for your Disease Orientated Research Group (DOWG). Also, consider what language may need to be added if this is a multisite study with UW as the IRB of record for other sites.
- DATA AND SAFETY MONITORING PLAN: Ensure that the description of study monitoring includes protocol-specific interim analyses or other monitoring measures.
- WAIVER OF INFORMED CONSENT: Ensure that the language accurately reflects how/if pre-screening data will be recorded, stored and/or destroyed. Will pre-screening data be entered into a database for future potential studies? Will screen-fail data be available to study monitors?
- INFORMED CONSENT: Some canned language states that the subjects can take home the consent to review with family and friends prior to signing. Ensure that this is appropriate language for the research procedures being proposed and the timeline for treatment. Are there times when the consent needs to be signed on the date the study was presented to the subject? If this is the case, ensure that there are appropriate measures described in the application to ensure that the subject fully understands the study and has had their questions answered.
Jessica Johnson will be presenting a one-hour Reportable Events Refresher session to the Cancer Center on Tuesday November 11th from 2 – 3 pm in K4/618. Topics at this session will include:
- Discussion of AE drug attributions
- Differences in what is required to be reported to different reviewing groups
- Determinations the IRB makes regarding Unanticipated Problems and Noncompliance
- Corrective Action Plans
- Tips for what to include in your reports
Future IRB for Beginners Workshops
The upcoming IRB for Beginners Workshop dates have been posted. Check out the Health Sciences IRBs website for future dates and information about how to register.