HS IRBs News October 2018

Health Sciences and Minimal Risk IRBs, IRB News/Volume 10, Number 7, October 2018

IRB for Beginners Workshop Update

The Health Sciences IRBs Office has scheduled a new IRB Beginners Workshop for Tuesday, November 13th from 2-3 PM. The workshop will be held in Room 1335 of the Health Sciences Learning Center (HSLC). The one-hour workshop provides training on the HS IRBs' processes, regulatory approval process, resources, and ARROW online application system. Workshop attendance is encouraged for those new to the HS IRBs process or looking for help on how to effectively submit an IRB application. To register for the workshop, please click here

ARROW FAQ: Finding People in the Study Team Member List

One of the most common questions received by the ARROW help desk (askarrowIRB@medicine.wisc.edu) is how to find people in the IRB application. Individuals may not appear in the personnel list if they are new to the UW or if they have not been previously listed in an IRB application. Our FAQ —What if I can't find someone in ARROW? — includes self-service steps for study teams to assist them in finding people in the ARROW application. The ARROW help desk is also available to help study teams if they need additional assistance finding individuals in ARROW.

Single IRB Review Reminders

As the research community adjusts to the new federal mandates for single IRB (sIRB) review, please keep the following in mind: 
  • The NIH single IRB review policy applies only to proposals submitted on or after January 25, 2018 and some types of awards are excepted from this policy (e.g., training grants). While most NIH-funded studies will eventually require sIRB review, we are still in a transitional period and researchers are encouraged to consult with their program officer or grants management specialist if they have questions about whether the sIRB requirement applies to their study. 
  • While many provisions of the revised Common Rule will become effective January 2019, the sIRB requirement is not effective until January 2020 and will not apply to exempt research. 
  • Researchers needing a letter of support from the HS IRBs office regarding sIRB review to include in a grant submission should contact the HS IRBs Reliance Team at least one week prior to their submission deadline. 
If you have any questions about sIRB review, please contact the HS IRBs Reliance Team (irbreliance@wisc.edu). 

Guidance for Studies Involving Investigator-Held INDs or IDEs

Study teams may find the following guidance helpful when planning a study involving an IND or IDE that will be held by a UW-Madison investigator:
  • The investigator should reach out to the UW institute for Clinical & Translational Research (ICTR) IND/IDE Consultation program to obtain guidance regarding FDA requirements for INDs or IDEs and the FDA submission process. 
  • If the study will be reviewed by a UW-Madison IRB, the IRB application cannot be reviewed by the convened board until the IND or IDE has been confirmed. While IRB staff will conduct pre-review while an IND or IDE is pending, formal IRB review will not occur unless 30 days have elapsed after an IND or IDE application has been submitted to the FDA. Study teams can assist the IRB office by letting us know when an IND or IDE application has been submitted to the FDA, such as including a note when the application is submitted via ARROW. IRB approval is not required in order for an IND or IDE application to be submitted to the FDA. 
  • Investigators holding an IND or IDE may need to meet additional requirements, such as registering with the UW-Madison FDA Regulated Research Oversight Program and completing training specific to the investigator-sponsor role. 

Keywords:beginners, workshop, training, ARROW, personnel, single IRB, sIRB, FDA, IND, IDE   Doc ID:87129
Owner:Monica E.Group:Health Sciences IRBs
Created:2018-10-24 12:37 CSTUpdated:2018-11-27 08:33 CST
Sites:Health Sciences IRBs
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