Attachment 6a CDC project determination

“Preventing HIV Risk Behaviors among Hispanic Adolescents”

Attachment 6a: IRB Project Determination

(Centers for Disease Control and Prevention)

FULL BOARD – APPROVED AS MODIFIED

June 18, 2008

Guillermo Prado, PhD
University of Miami
Center for Family Studies
Medical Campus, Locator Code: D22

 

HSRO STUDY NUMBER:	20080117
STUDY TITLE:	Preventing HIV Risk Behaviors among Hispanic Adolescents
IRB MEETING DATE:	6/12/2008
STUDY APPROVAL EXPIRES:	6/11/2009

On June 12, 2008, the Social and Behavioral Sciences IRB  determined that the above referenced study is approved as modified.  This study has been approved for the inclusion of minors pursuant to 45 CFR 46.405.  This review confirms that the grant application is consistent with the goals of the research proposed.

APPROVAL INCLUDES:

New Research Protocol
Grant Award # PS07-003, Minority HIV/AIDS Research Initiative (MARI)
Research Materials (English Versions Only)

• Adolescent Assessment Battery

• Parent Assessment Battery

• Recruitment Flyer

 

NOTE: Translations of IRB approved study documents, including informed consent documents, into languages other than English must be submitted to HSRO for approval prior to use.

NOTE: Please note that no subjects are to be enrolled until a Certificate of Confidentiality is obtained from the NIH.  Once one is obtained, an amendment must be sent to the HSRO to release the informed consent forms so that recruitment may begin.

This study must be conducted in accordance with IRB approval and you must use the documents as modified by the IRB. If you do not accept the changes made by the IRB, the study must not be initiated. If the changes are not acceptable, you may withdraw the study or appeal to the IRB. Should you have any questions, please contact Simonnette Thompson, IRB Regulatory Analyst, at (305) 243-9916 or via e-mail at SThompson2@med.miami.edu.

A request to continue this study must be submitted to the HSRO at least 45 days before IRB approval expires. If this study does not receive continuing IRB approval prior to expiration, all research activities must cease, and may officially be suspended or terminated

All principal investigators must abide by and comply with all policies and procedures for the conduct of human subject research as posted on the HSRO website (http://www.hsro.miami.edu)

Sincerely,

  

Amanda Coltes-Rojas, MPH, CIP
Associate Director
Regulatory Affairs & Educational Initiatives

/cg

cc:

IRB File

Guillermo Prado

Stephanie Donahue

EXPEDITED – APPROVAL

April 27, 2009

Guillermo Prado , Ph.D.

University of Miami

Department of Center for Family Studies

Medical Campus, Locator Code: D22

HSRO STUDY NUMBER: 20080117

STUDY TITLE: Preventing HIV Risk Behaviors among Hispanic Adolescents

IRB ACTION DATE: 4/24/2009

STUDY APPROVAL EXPIRES: 4/23/2010

On April 24, 2009, an IRB Chair approved the following items under the expedited review process.

APPROVAL INCLUDES:

Continuing Report (CRR006911)

NOTE: Please note that no subjects are to be enrolled until a Certificate of Confidentiality is obtained from the NIH. Once one is obtained, an amendment must be sent to the HSRO to release the informed consent forms so that recruitment may

begin.

A request to continue this study must be submitted to the HSRO at least 45 days before IRB approval expires. If this study does not receive continuing IRB approval prior to expiration, all research activities must cease, and may officially be suspended or terminated.

All principal investigators must abide by and comply with all policies and procedures for the conduct of human subject research as posted on the HSRO website (http://www.hsro.miami.edu)

Sincerely,

[This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature]

Amanda Coltes-Rojas, MPH, CIP

Director

Regulatory Affairs & Educational Initiatives

/vc

cc: IRB File

Guillermo Prado

Stephanie Donahue

Human Subjects Research Office (M809)

PO Box 016960, Miami, Florida 33101

1500 NW 12 Avenue, Suite 1002, Miami, Florida 33136

Tel: 305-243-3195

Fax: 305-243-3328