11 Dec

IRB SOP Update for December 11, 2012

Jonathan | December 11th, 2012

Our office would like to keep you informed of any changes made to the IRB Standard Operating Procedures as policies and guidelines progress. Today, we published a new, December 2012 version of our SOPs at http://oric.research.wvu.edu/r/download/148564. The following is a list of sections that were changed in this version and a synopsis of what was changed for each:

3.3.2, category 4
Added reference to see 3.3.6 for clarification of exemption category 4 determination.

3.3.6 (added as a section)
Added additional criteria for collection of data from medical records to be exempt: (1) Data must exist at the time of application and (2) the data must be recorded without codes or links to patient identifiers (e.g., medical record number).

3.14, paragraph 1
For a disapproval, termination, or suspension, the notification must also now be copied to the respective department chair.

5.4, number 10
Specifies language that must be added to informed consent documents for clinical trials.

The heading for this section has changed from Waiver of Informed Consent to Waiver of Informed Consent for Planned Emergency Research.

5.12 (added as a section)
Specifies procedure for protocol amendments without consent form changes.

5.13 (added as a section)
Specifies procedure for protocol amendments with consent form changes.
Corrected reference to informed consent from section 5.8 to section 5.9.
Deleted the sentence that read “At the time of review, the IRB will determine if written consent from participants for use of the HUD is necessary.”

8.2.1, number 10
Added the statement that “Protocol violations must be reported within thirty (30) days of the PI being made aware of the violation.”

9.4, paragraph 1
Added the statement for exceptions or deviations that “These reports must be filed with the ORIC within thirty (30) days of the PI being made aware of the violation”

10.2, paragraph 2
Added the statement that “The identity of any entity bringing a complaint, concern, and/or allegation of non-compliance to the attention of the ORIC shall be kept confidential to the greatest extent possible.”