Attachment 4 a

IRB ID Number: 13237
Office of Research Protection

Institutional Review Board Notice of Approval
Federalwide Assurance No. 3331
Title of Study: Perceptions of Health Risk from Smokeless Tobacco Products and Nicotine Replacement
Therapy among Pregnant Women and Women Planning a Pregnancy
RTI Project Number: 0211965.032.000
RTI Proposal Number (if no Project Number)
Project Leader: Julia Kish Doto
Project Team Member Contact (if different from Project Leader): Katherine Kosa
Source of Funding for this Study: CDC
Date Submitted to IRB: May 21, 2013
Level of Review (check one):
Full , IRB Meeting Date:
Expedited , category: M: Minor changes in approved research

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: revised moderator’s guide
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: November 19, 2013
(No human subjects research can occur after this date without continuing review and approval.)

Signature - IRB Member or Chair

May 23, 2013
Date of IRB Approval

Jamia Bachrach
Name - IRB Member or Chair (print or type)
Copy sent to project leader on: May 23, 2013
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 orpe@rti.org