Att 6_IRB Approval

REVIEW OF SAFEGUARDS FOR HUMAN SUBJECTS
American Institutes for Research
1000 Thomas Jefferson Street, NW
Washington, DC 20007
Institutional Review Board
IRB00000436
Project number: 02600.008
Project Director/Proposal Author: Roger Levine
Project/Proposal title: CDC Sickle Cell Messaging
1. Type of review:
(Check one)
Expedited review
Full IRB review

(Check one)
Initial review
Scheduled re-review (e.g., annual)
Requested re-review (e.g., new data
collection component, research plan
change)

2. Review determination:
After reviewing the above project, the Institutional Review Board (or member signing
below) has determined the following:
Determination of Exemption: the project is exempt from further IRB review
because it does not constitute research or because it does not involve human subjects.
Provisional Approval: the submitted insert "project/study/proposal or other
descriptive" is approved pending development of the research plan (45CFR46.118),
which must be reviewed before enrollment of subjects or collection of data can begin.
Proposed date of review: __
Conditional Approval: data collection on all pieces of the protocol may proceed
and are approved EXCEPT the component that will obtain focus group input on
extant sickle cell materials. This component can proceed only after submission of
those extant materials to IRB for brief review/confirmation of content. All other
aspects of the focus group work are approved without exception.
Approval: approval of insert "project/study/proposal or other descriptive" is
granted and data collection can proceed. In keeping with our Federalwide Assurance
mandate, the IRB must conduct reviews at least annually for each project. This
project will be reviewed again on insert review date.
Approval Denied: approval of insert "project/study/proposal or other descriptive"
is denied and data collection may not proceed for the following reasons:

02600.008 – CDC Sickle Cell, 7.13.11

IRB Conditional Approval, Page 1

3. Consent Procedures
The Institutional Review Board has determined that consent procedures:
are not applicable to the project.
must be reviewed on

.

are approved as submitted.
are approved under the following conditions:
are not approved for the following reasons:
4. Individually Identifiable Information Safeguards
The Institutional Review Board has determined that the safeguards planned for individually
identifiable information:
are not applicable to the project.
must be reviewed on

.

are approved as submitted.
are approved under the following conditions:
are not approved for the following reasons:
5. Comments
On the basis of this review, the IRB has determined that the CDC Sickle Cell Messaging
focus group activity with adolescent and adult sickle cell patients is approved on condition
that the component of the focus group protocol dealing with review of extant materials
requires review of those materials by the IRB. All other components of the focus group
research are approved. The IRB has reviewed the accompanying materials for the submission
and concludes that the risks to the participants are minimal (pending review of the extant
messaging materials that will be reviewed during the focus groups). Consent/ assent
procedures are appropriate, and waiver of signed consent (for adults) and waiver of signed
assent (for adolescents) for telephone groups is also appropriate. Signed parental consent will
still be obtained prior to telephone focus groups involving adolescents. Adequate protections
have been assured for audio and videotapes, as well as any other data stemming from the
focus groups; protections for the comfort and safety of the sickle cell patients participating in
your focus groups is reflected in your application.
6. IRB Signature(s):
7/13/2011
Date
Susan Heil
IRB Representative
02600.008 – CDC Sickle Cell, 7.13.11

IRB Conditional Approval, Page 2

Please keep in mind that any material changes made to the study or the study procedures
require the submission of an updated IRB package.

02600.008 – CDC Sickle Cell, 7.13.11

IRB Conditional Approval, Page 3