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Essential Principles to Remember:

  1. If you have submitted an IRB application for renewal and indicated on it that you have had no new enrollment to date, but then you enroll a new participant while you are awaiting IRB approval of your renewal, please notify your Board Specialist immediately.
  2. DUHS IRB Approval expires at 12 AM on the expiration date listed on the Notification of Approval.
  3. At the time of expiration of IRB Approval, all study activities, including ascertainment, recruitment, consent, data collection and data analysis, must cease. If you wish to continue certain activities directly related to subject safety, please e-mail Dr. John Falletta and Jody Power to request permission to continue those activities until IRB approval is reinstated.
  4. An Adverse Event must be reported to the IRB if it: (i) is more likely than not related to study activities; and (ii) represents a new risk; and (iii) is unanticipated.  In addition, an expected event that is occurring at a frequency or intensity greater than originally anticipated must be reported to the IRB.
  5. A Protocol Deviation/Violation must be reported to the IRB if it: (i) affects subject rights and welfare, or (ii) affects subject safety; or (iii) affects the integrity of study data; or (iv) affects the subject's willingness to continue in the study; or (v) is specifically requested by a government agency, internal/external auditor, medical monitor, or the IRB.
  6. CLICK HERE to see the timeline requirements for your Continuing Review (Renewal) submissions to the IRB.  Note that the investigator will be required to submit a deviation report for a late submission.
  7. A sponsor's waiver of inclusion criteria also requires IRB approval prior to implementation.
  8. Enrollment occurs when the consent form is signed, not when the subject is randomized.  Therefore, an estimate of screen failures should be incorporated into the target enrollment submitted to the IRB.
  9. If a research participant who is a minor turns 18 years old while on a study, the IRB requires that the participant be re-consented as an adult.
  10. If you receive word that you will be audited by a federal agency (FDA, OHRP, NIH, etc.), please notify the IRB immediately and we will assist you.
  11. To see the Listing of Specimens that May Be Excluded from Routine Submission to Surgical Pathology (also called the Tissue/Medical Devices Exceptions List), CLICK HERE.
  12. Investigators and their study staff must not share their USER IDs and passwords with each other.  You must not use anyone else's USER ID and password to access any Duke system.  This includes the e-IRB system.
  13. To see the Process for Just-In-Time (JIT) Funding and IRB Review (posted 10/11/2011), CLICK HERE.
  14. Please remember to use the most current version of the consent form template and DUHS IRB-approved Standard Language whenever you submit a new or amended consent form.  You can find the most current versions on both the IRB web site and the eIRB web site.  Please do not use old templates that you may have saved on your computer.
     
 

It is the responsibility of the research team to make timely submissions to avoid expiration of IRB approval. Reminders from the DUHS IRB office are provided solely as a courtesy to the research community.

 

FAQs About IRB Policies & Procedures

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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