IRB Approval

IRB ID Number: 13732
Office of Research Protection

Institutional Review Board Notice of Approval
Federalwide Assurance No. 3331
Title of Study: Insurance Coverage, Employment Status, and Copayments/Deductibles Faced by Young Women
Diagnosed with Breast Cancer
RTI Project Number: 0211965.048
RTI Proposal Number (if no Project Number)
Project Leader: Sujha Subramanian
Project Team Member Contact (if different from Project Leader):
Source of Funding for this Study: CDC
Date Submitted to IRB: August 27, 2015
Level of Review (check one):
Full , IRB Meeting Date:
Expedited , category: 7: Behavioral - surveys, focus groups, etc.

Type of Review (check one):
Preliminary review (For DHHS grants where RTI is prime, the grant application/contract proposal and protocol
submitted to the IRB are in concordance (45 CFR 46.103(f)). Do not involve human subjects or data until
pretest or full study is approved.)
Amendment, describe:
Add study site(s):
Pretest/Pilot Test:
Renewal
Full Implementation
Study Closure
IRB Approval of Special Conditions (check all that apply to this review):
Waiver of Signed Informed Consent/Parental Permission
Waiver of elements of Informed Consent or requirement for Informed Consent/Parental Permission
Participation of Pregnant Women (Worksheet B submitted by project team)
Participation of Prisoners (Worksheet C submitted by project team)
Participation of Prisoners in DHHS-funded studies (OHRP acknowledgement required)
Participation of Minors (Worksheet D submitted by project team)
IRB Agreement of Nonsignificant Risk Device Study Determination
HIPAA Waiver of Authorization
Please note the following requirements:
• If unexpected problems or adverse events occur, the project team must notify the IRB.
• If there are changes in study procedures or protocol or any data collection materials (brochures, letters,
questionnaires, etc.) the project team must notify the IRB before they are implemented.
•
The project team is required to apply for continuing review as long as the study is active, which includes
participation of human subjects or possession of human data or specimens.
•

Expiration Date of IRB Approval:
February 19, 2016
(No human subjects research can occur after this date without continuing review and approval.)
August 27, 2015
Signature - IRB Member or Chair

Date of IRB Approval

Ina Wallace, PhD
Name - IRB Member or Chair (print or type)
Copy sent to project leader on: August 27, 2015
Entered into MIS
OHRP acknowledgement received for participation of prisoners in DHHS-funded studies on:

Office of Research Protection, Institutional Review Board
3040 Cornwallis Road, Research Triangle Park, NC 27709-2194, USA
Telephone: 919-316-3358 Fax: 919-316-3897 [email protected]