Attachment 2 Letter of Protocol Approval from NHLBI Institutional Review Board

Office of Clinical Affairs,
Bldg 10, CRC. Room 6-5140
Bethesda,Maryland 20892-1608
DATE:
TO:
FROM:

SUBJECT:

July 25, 2013
Tiffany M. Powell- Wiley, M.D.,
Principal Investigator, NHLBI
Richard Cannon , M.D.
Chair,NHLBI IRB
IRB Initial Review of Protocol T-H-0284, Cardiovascular Health and Needs Assessment in Washington D.
C. - Development of a Community-Based Behavioral Weight Loss Intervention

Your Initial review application was reviewed and approved at the July 16, 2013 NHLBI Institutional Review Board(IRB).You
will receive final approval of this initial review once the Office of Protocol Services has completed processing this action.
The protocol expiration date is July 15, 2014.You must complete the continuing review, to include the IRB review and the
processing of this action by the Office of Protocol Services, prior to this expiration date.
IMPORTANT INFORMATION ABOUT YOUR PROTOCOL:
Please use this final approved version of the protocol and consent as a guide for documents submitted for the next
continuing review.
ANY change in research activity MUST receive IRB review and approval prior to implementation. Request for review of
changes should be submitted as an amendment.
Adverse or unexpected/unanticipated events or new information that may alter the risk or benefit determination or
subjects' willingness to continue in the study must be reported to the Clinical Director and IRB in accord with NIH policy.
Additional reporting (for example, to the sponsor or FDA) may also be required.
Please contact the Office of Clinical Affairs if you have any questions and/or concerns.
You can e-mail us at nhlbi_diroca@nhlbi.nih.gov