AppendixJ_2_IRBApprovalIntervention

IRB ID Number: 13251
Office of Research Protection

Institutional Review Board Notice of Approval
Federalwide Assurance No. 3331
Title of Study: Develop and Implement UCARE4LIFE Message Library
RTI Project Number: 0213543.001.001
RTI Proposal Number (if no Project Number)
Project Leader: Jennifer Uhrig
Project Team Member Contact (if different from Project Leader): Jennie Harris
Source of Funding for this Study:
Health Resources and Services Administration
Date Submitted to IRB: April 25, 2013 (revised)
Level of Review (check one):
Full , IRB Meeting Date: April 16, 2013
Expedited , category: Choose an item.

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 for adults and minors for whom 45CFR46.404 (Subpart
D—Additional DHHS Protections for Children Involved as Subjects in Research
does not apply
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:
02-19-2014
(No human subjects research can occur after this date without continuing review and approval.)

May 3, 2013
Signature - IRB Member or Chair

Date of IRB Approval

Juesta M. Caddell, PhD
Name - IRB Member or Chair (print or type)
Copy sent to project leader on May 3, 2013
Entered into MIS
OHRP acknowledgement received for participation of prisoners in DHHS-funded studies on:

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