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 asktheirb@medicine.wisc.edu.

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 asktheirb@medicine.wisc.edu with the subject ‘UWCCCIRBNews Add/Remove’.

Have a question?  The HS-IRBs Office Can Help

A Reminder about Submitting a Change of Protocol and Continuing Review Simultaneously (HS IRB and MR IRB studies)
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:
  1. no reportable event related to the change of protocol is pending resolution;
  2. the study team has not suspended the study to enrollment pending approval of the change of protocol; and
  3. 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:

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.

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.

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.

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

NCI CIRB Studies 

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.