IRB Approval

IRB ID Number: 13011
Office of Research Protection

Institutional Review Board Notice of Approval
Federalwide Assurance No. 3331
Title of Study: Medical Device Decision Analysis: A Risk Tolerance Pilot Study
RTI Project Number: 0302907 RTI Proposal Number (if no Project Number)
Project Leader: Juan Gonzalez
Project Team Member Contact (if different from Project Leader): Valerie Tower
Source of Funding for this Study: FDA
Date Submitted to IRB: April 5, 2012
Level of Review (check one):
Full , IRB Meeting Date:
Expedited , category: 7: Behavioral - surveys, focus groups, etc.

Type of Review (check one):
Preliminary review (The grant application/contract proposal and protocol submitted to the IRB are in
concordance with regard to the scientific conduct of the study, informed consent content, and all other issues
pertaining to the protection of human subjects. (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: January 27, 2013
(No human subjects research can occur after this date without continuing review and approval.)
April 9, 2012
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: 4-10-12
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]