AttI - IRB Approval

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control

and Prevention (CDC)

M emorandum

O

Date

d

ctober 12, 2011

From

Barbara R. DeCausey, MPH, MBA

Chief, Human Research Protection Office

Subject

HRPO Approval of Amendment to CDC Protocol #6128.0, “Test of Effectiveness of Screening Recruitment Messages among African American Women in North Carolina" (Exemption)

To

Ingrid Hall, PhD, MPH

NCCDPHP/DCPC

The CDC Human Research Protection Office has received your submission for review of changes to exempt protocol #6128.0, "Test of Effectiveness of Screening Recruitment Messages among African American Women in North Carolina." I find that this research activity remains exempt under 45 CFR 46.101(b)(2). This amendment was to: include two audiences of African American and Latina women; add four focus groups of Latina women; add additional materials for recruitment, consent, and discussion guides for Latina women; and enumerate the addition of the four focus groups.

As a reminder, additional changes to this protocol may not be implemented until they are reviewed and determined to be consistent with the exemption categories. Also, you will be asked to confirm that no changes have occurred in the protocol or the related science that would affect the ethical appropriateness of the research or this exemption no later than three years from the current expiration date of 06/05/2014.

Please be reminded that the investigators remain responsible for appropriate human research protections even for research that is exempt from regulations for protecting human subjects.

If you have any questions, please contact your National Center Human Subjects Contact or the CDC Human Research Protection Office at (404) 639-4721 (or by e-mail at Human Subjects Review - OD on the global CDC global address list or at huma@cdc.gov).

cc:

Joan Redmond Leonard