UWCCC HS-IRBs News August 2014
The Health Sciences IRBs Cancer Center Newsletter for August 2014
This 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 IRB 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 firstname.lastname@example.org 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.
- WIRB questions: Call 262-7544 to get answers to WIRB related questions.
- 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.
- Urgent WIRB issues: If you need urgent assistance with a WIRB study, contact WIRB Client Services at 1-800-562-4789.
- 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 or WIRB Gateway 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 email@example.com
- WIRB Connexus assistance: If you need technical assistance with Connexus, email your question to firstname.lastname@example.org
- NCI Central Institutional Review Board (NCI CIRB) assistance: If you have questions about using the CIRB, please contact Jennifer Fenne at email@example.com or 263-8914.
It is allowable to submit a continuing review and a change of protocol at the same time in ARROW.
WIRB will not allow a change in research to be submitted with site progress reports in Connexus.
For studies being submitted in ARROW, you should be submitting your continuing reviews 60 days prior to expiration. If a change of protocol needs to be submitted before the continuing review is approved, DO NOT HOLD THE CHANGE OF PROTOCOL. Submit your change of protocol as soon as the revised study documents are ready to be submitted in ARROW. The IRB Staff Reviewers assigned to the continuing review and the change will work with the Point of Contact to coordinate these reviews, based on the expiration date of the study and the urgency of the change.
PLEASE NOTE: if the change of protocol is related to the study risks, and will result in changes to the consent form the study team should follow the following guidelines when requesting re-stamping/re-approval of the current consent forms:
If the proposed changes include the addition of new and/or increased study risks, then the previously-approved consent documents can still be re-approved as part of the continuing review if:
- no reportable event related to the change of protocol is pending resolution;
- the study team has not suspended the study to enrollment pending approval of the change of protocol; and
- the new risk information can be adequately conveyed to subjects via an oral process pending approval of the revised consent documents (i.e. the change in risk information is not so substantial that it would be difficult to orally summarize for the subject).
If these criteria are met, the study team must provide the following information in the continuing review application before the consent documents will be reapproved:
- A brief justification of why enrollment on the study should be allowed to continue; and
- Confirmation that subjects will be orally informed of the new risk information and clarification of how this will be done and documented.
- If the change of protocol has YET to be submitted to the IRB: Confirmation that when the study team receives the revised documents, a change of protocol will be submitted to the IRB within 60 days of receipt of those documents.
When to Submit IDBs versus Package Inserts (HS IRB and WIRB studies)
The timeframes for submitting to the UW IRBs and WIRB differ. See below for guidance on submitting the appropriate IDBs or Package Inserts in a timely manner.
IDBs: If a research study involves testing or evaluating a drug or drugs, an Investigational Drug Brochure (IDB) should be provided to the IRB for any drugs for which an IND was issued at the time of initial review. In some cases IDBs are created for drugs under study even if the drugs are FDA-approved. IDBs are required to be provided to the IRB in these cases only if the study sponsor requires the study team to do so or there is substantive information in the IDB (e.g., efficacy and safety of the drug in the subject population for the study) that is not within other documents provided to the IRB.
- IDBs in ARROW: Updates to IDBs should be should be submitted as a change of protocol, new information report, or at continuing review as outlined in this guidance document .
- IDBs in Connexus: If your sponsor/CRO hasn’t submitted this document on your behalf, WIRB IDB updates should be uploaded through WIRB Connexus as an administrative change within 10 business days of receipt for sponsor/CRO. A separate Change in Research submission can be made shortly after if necessary. Or, the IDB update can be submitted with a Change in Research within 10 business days of receipt form the sponsor/CRO.
Package Inserts: For any drugs being tested or evaluated as part of the research that are FDA-approved, the study team should provide the IRB with package inserts rather than IDBs.
- Package Inserts in ARROW: Revised package inserts that contain information relevant to the research study should be provided when they are issued as New Information Reports when no changes to the IRB application or other materials are required or as Changes of Protocol when updates to the IRB application or other materials are needed.
- Package Inserts in Connexus: If your sponsor/CRO hasn’t submitted this document on your behalf, package inserts for the WIRB be uploaded through WIRB Connexus as an Administrative Change within 10 business days of receipt for sponsor/CRO. A separate Change in Research submission can be made shortly after if necessary. Or, the package insert can be submitted with a Change in Research within 10 business days of receipt form the sponsor/CRO.
Additional information about submitting in ARROW: Please see the IDB and Package Insert Decision Tree for assistance in determining which documents should be provided to the IRB in ARROW.
Please Note: Whatever document was provided at Initial Review of the study (IDB or Package Insert) is the document that will be required to have all updated versions submitted to the IRB throughout the life of the study.
- For Package Insert/IDB updates that involve new risk information → submit these via a Change of Protocol.
- For Package Insert updates that do NOT contain new risk information → submit these via a New Information report.
- For IDB updates that do NOT contain new risk information → submit these at the next Continuing Review.
Handling Changes Related to NCTN Restructuring (HS IRB and CIRB studies)
Protocols affected by the consolidation of NCI cooperative groups as part of the National Clinical Trials Network initiative will require updating to use new NCI group names. It's expected that the coordinating site for each affected study will update the group names as part of study-wide protocol amendments. Here are things to keep in mind when submitting local changes of protocol related to consolidation of NCI cooperative groups, for studies under UW HS IRB or MR IRB purview, and for studies under NCI CIRB purview:
HS IRB/MR IRB Studies
- Be sure to update all local study materials that include the group name. In the ARROW application, check for changes in the data and safety monitoring plan and privacy and confidentiality sections (the areas of the application most likely to refer to the group name).
- Update consent forms and HIPAA forms for studies that are open to enrollment.
- If there are UW subjects currently enrolled on a study and there are no other changes to consent or HIPAA forms that would require re-consent or re-authorization, it is not necessary to have subjects sign an updated consent form or HIPAA form. However, all currently-enrolled UW subjects, including those in follow-up, should be informed in writing of the change in the name of the group coordinating the trial. In this case, the change of protocol submission should include a template letter for subjects that explains the change.
- If a change of protocol including updates to the group name has already been approved by the HS or MR IRB without revisions to HIPAA forms or without a letter to subjects, submit an updated HIPAA form and/or template letter along with the next HS IRB change of protocol you submit for the study.
NCI CIRB Studies
- Follow guidance on the HS IRB website and the UWCCC SOP for CIRB studies for submitting revised consent forms and HIPAA authorizations.
- Revised HIPAA forms and letters (if applicable) can be submitted in ARROW once the CIRB has approved an amendment that includes the change in cooperative group name.
- Note that, after UW review, letters to subjects will also require CIRB approval as locally-developed materials. Submit them for CIRB review as part of a revised Study-Specific Worksheet.
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.
All new WIRB users are required to attend required training held monthly in the HS-IRBs Office. Check out the WIRB Gateway website under the topic of Contact Information for our 2014 schedule.