Att 7_ORAU IRB Determination

Oak Ridge Site-wide IRB (FWA #00005031)
August 21, 2015
Title of Study:
Investigator:
Type of Review:
Expedited Category

SLE Focus Groups
Ben Wilburn
Non-Committee Review
(7)(a) Behavioral research, (6) Voice, video, digital, or
image recordings
IRB Submission ID: ORAU000139
Funding: Other
Documents Reviewed: • ATTACHMENT_A_Protocol_Summary.docx,
Category: IRB Protocol;
• Appendix I Potential Participating Clinics.docx,
Category: Other;
• ATTACHMENT_B_Full_Protocol.docx, Category:
IRB Protocol;
• ATTACHMENT_C_Discussion_Guides.docx,
Category: Recruitment Materials;
• Appendix M Office Recruiting Script.docx,
Category: Other;
• ATTACHMENT_D_Participant_Screeners.docx,
Category: Recruitment Materials;
• Appendix J K L Participant Information Sheets.docx,
Category: Other;
• ORSIRB__Initial_Study_application_ lupus 6-215.pdf, Category: Other;
• Appendix F Mock Up of Schedule.docx, Category:
Other;
• Appendix H Recruiting Poster.docx, Category:
Other;
• Appendix G IRB Planning.docx, Category: Other;
Action:
Approval Date:
Expiration Date:
Consent Waiver:

Approved
8/21/2015
8/20/2016
Waiver of consent documentation

Before the expiration date or within 30 days of study closure, whichever is earlier, you
must submit a continuing review application/ progress report. To submit a continuing
review navigate to the active study and click “Create Modification / CR.”

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This approval is based on an appropriate risk/benefit ratio and a study design wherein the
risks have been minimized. All research must be conducted in accordance with this
approved submission.
Any changes in the approved research activity or to previously approved materials must
be approved by this office prior to initiation. Please use the appropriate revision forms for
this procedure.
All unanticipated problems or adverse events must be reported to this office (see DOE
Order 443.1B). Please use the appropriate form for this procedure. All FDA and sponsor
reporting requirements should also be followed.
Report all NON-COMPLIANCE issues or COMPLAINTS regarding this study to this
office (see DOE Order 443.1B).
Please note that all research records must be retained for a minimum of three years.
If continuing review approval is not granted before the expiration date of 8/20/2016,
approval of this study expires on that date and all study activity that involves human
subjects must cease.
Sincerely,
The Oak Ridge Site-wide IRB
ORSIRB@orau.org
865-574-4359

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