UWCCC HS IRBs News April 2015
The Health Sciences IRBs Cancer Center Newsletter for April 2015
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 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 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.
- 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 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 Mike Bingham or 265-9792.
WIRB Gateway News
- Mike Bingham is now the Commercial IRB specialist and will be providing support for WIRB submissions, including providing WIRB training as requested. Questions about the WIRB process can be directed to Mike or 265-9792.
- Future dates for WIRB training can be found on the WIRB Gateway page. Attendance is strongly encouraged for anybody who may work on a study that will be submitted to WIRB. You can register here for WIRB training.
NCI CIRB Updates
- New primary UW-Madison contact for questions regarding the NCI CIRB:
- Mike Bingham, Commercial IRB Specialist, is now the primary UW-Madison contact person. If you have questions about using the CIRB, please contact Mike or 265-9792. Jennifer Fenne will serve as the backup contact for CIRB questions and can be reached at 263-8914.
- Establishment of New Cancer Prevention and Control CIRB:
- The addition on the Cancer Prevention and Control CIRB (CPC) extends centralized IRB review to investigators participating in studies sponsored by the NCI’s Division of Cancer Prevention.
- The CPC CIRB began reviewing studies sponsored by the DCP-sponsored NCORP and Consortia programs in February.
- CIRB contact information: Contact the CIRB Helpdesk for all questions; Helpdesk staff will route inquiries to the appropriate person: 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.
Tips for Completing the Continuing Review Application (HS/MR IRB studies)
- Submitting IDBs
Revised IDBs may be submitted at continuing review if:
- The revised IDBs do NOT contain revisions that (1) affect the risk/benefit ratio of the study for local study subjects (i.e., will result in a change to study documents); (2) affect alternatives to study participation for local subjects; or (3) represent new information that should be provided to subjects; OR
- The information contained in the revised IDBs has already been assessed by the IRB (e.g., through a change of protocol).
In these cases, research teams will be required to upload an IDB log to the continuing review form in ARROW. As part of this form, study teams will be asked to explain why the IDB(s) that were assessed did not meet any of the 3 criteria noted above that would require submission prior to continuing review.
- Please do not solely state "this IDB does not affect the risk/benefit ratio" on the IDB log. Reasoning should be provided as to WHY the revised IDB meets ALL 3 criteria in the first bullet point, or alternatively, the log should describe how and when the information in the revised IDB was assessed by the IRB.
- If there is a summary of changes document available, please upload that as well. When completing the IDB log, please do not copy and paste the entire summary of changes into the log. The IDB log summary should cover the salient points with an emphasis on data from clinical experiences and guidance to investigators.
- If there is new risk information, please make sure to document that on the IDB log and provide justification as to why it does not affect your subject population. Please note this information, as it demonstrates that the information was reviewed and assessed by the PI.
- Withdrawals are only captured for subjects who enroll in the study (i.e., begin study treatment/procedures). Therefore, please do not enter subjects who provided consent but did not enroll in the study. Instead, these subjects should be captured in question 3.4 on the “Local Activities: Enrollment” page of the Continuing Review Form.
- Please make sure to include withdrawals for all sites under UW-Madison purview (i.e., 1 S. Park, Johnson Creek, Riverview, WIC sites, if applicable).
Package Inserts (HS IRB studies)
Revised/Updated Package Inserts that do NOT contain new risk information and will NOT result in consent form changes should be submitted via a New Information Report. The New Information report should include the following:
- Summarize the updates/changes that have been made and state why no changes to the consent form are necessary (Please note: Stating “risk/benefit ratio hasn’t changed” isn’t the same as “no new risk information pertinent to this study’s subject population has been added.” The IRB prefers the latter).
- In general, the IRB requires the most common and rare but serious risks to be included in the consent form (noting that it is up to the PI/sponsor/cooperative group/NCI to determine what falls into these categories); therefore the IRB expects the PI to determine if any of the package insert updates involve relevant risk information that needs to be added to the consent form.
The IRB expects that study teams are checking to see if there are updated package inserts and suggests study teams do this at least annually. Note: If several versions of the package insert have been released since the last check then more frequent checks may be needed. If the study team has the most recent version of the package insert and this version is several versions different than what was last submitted to the IRB, the study team can simply compare the current version to whatever was last submitted to the IRB when summarizing the changes.
Reminder: Unanticipated Problem and Adverse Event Reporting for non-VA Studies (HS/MR IRB studies)
If an adverse event occurs on a non-VA study and the study team needs to determine if the event requires reporting to the IRB please first consult our unanticipated problem/adverse event decision tree. Also keep in mind the general principle that if an adverse event is probably related to study participation and unexpected in any way, it most likely requires reporting to the IRB. If you need further assistance in determining whether an event requires reporting to the IRB, please contact Emily Jenner or Jessica Johnson. Note: Reporting requirements for VA studies are more stringent than those for non-VA studies. Please see the HS-IRBs Reporting and Submission Timeframes for more information about VA reporting requirements.