Focus Group about Cigarette Smoking during Pregnancy - IRB approval

IRB ID Number: 12465
Office of Research Protection

Institutional Review Board Notice of Approval
Federalwide Assurance No. 3331
Title of Study: Formative Focus Groups on Cigarette Smoking During Pregnancy and Adverse
Outcomes, Including Birth Defects
RTI Project Number: 0210637.009.001.005 RTI Proposal Number (if no Project Number)
Project Leader: Brenda Stone-Wiggins
Project Team Member Contact (if different from Project Leader): Mary Council
Source of Funding for this Study: CDC
Date Submitted to IRB: September 15, 2009
Level of Review (check one):
Full , IRB Meeting Date:
Expedited , category: 7: Behavioral - surveys, focus groups, etc.
Type of Review (check one):
Preliminary review (Do not involve human subjects or data until pretest or full study is approved.)
Pretest/Pilot Test
Full Implementation:
Amendment, describe:
Add study site(s):
Renewal
Study Closure
IRB Approval of Special Conditions (check all that apply):
Waiver of Signed 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 received)
Participation of Minors (Worksheet D submitted by project team)
IRB Agreement of Nonsignificant Risk Device Study Determination
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: September 16, 2010
(No human subjects research can occur after this date without continuing review and approval.)

Signature - IRB Member or Chair
Timothy C. Wilcosky, Ph.D.
Name - IRB Member or Chair (print or type)
Copy sent to project leader on: September 17, 2009
Entered into MIS

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]

September 16, 2009
Date of IRB Approval