IRB Approval for OMNI Gp. 1

OMB #: 0925–0216
Expiration Date: xx/xxxx

Title of Study: EVALU ATION OF THE OMNI GENERATION I COHORT OF THE FR AMINGH AM HEART
STUDY
Protocol Number: H-24583
RE: Continuing Review
Review Type : Full Board
Action: Approved
Date of Action: January 09, 2013
Date Revisions Were Accepted: January 13, 2013
Date of Expiration: January 08, 2014
Funding Source: NIH/National Heart Lung, and Blood Institute (NHLBI)
Award #: NO1-HC-25195 (contract) & 1 R01 HL107385 grant
Protocol Version # : 1.769039
Consent Form(s):

Study Consent From
Title
1-Omni 1 Spanish Cell Line Consent Form
1-Omni 1 Cell Line Consent Form English
1-Omni 1 Examination 4 Spanish Consent
Form
1-Omni I Examination 4 Consent Form
Blood Draw Consent for Cell Line Creation
CTA DD Omni 1 - Offsite

Version Number
Version 2.2
Version 2.2
Version 2.4

Version Date
01/19/2012
01/19/2012
07/24/2012

Outcome
Approved
Approved
Approved

Version 2.4
Version 1.769035.2
Version 1.769035.2

07/24/2012
02/15/2011
02/15/2011

Approved
Approved
Approved

Dear Dr. Philip A. Wolf,
At the January 09, 2013th Panel Purple Institutional Review B oard (IRB ) meeting, chaired by
Sanford Auerbac h, M.D., the above referenced protocol was reviewed. It has been determined
that this study meets the requirements set forth by the IRB and is hereby approved. This protocol
is valid through the expiration date indicated above.
The study may not continue after the approval period without additional IRB review and approval
for continuation. You will receive an email renewal reminder notice prior to study expiration;
however, it is your responsibility to assure that this study is not conducted beyond the expiration
date.
Please note: this approval does NOT represent approval of any aspects of this study that have
not been previously approved by the IRB unless they are specifically noted in the amendment
description.
Please be aware that only IRB-approved informed consent forms, validated with current approval
dates generated by the INSPIR system, may be used when informed consent is required. Any

H-24583

PI Name: Philip A. Wolf, MD

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OMB #: 0925–0216
Expiration Date: xx/xxxx

changes to the approved protocol or informed consent documents must be reviewed and
approved prior to implement ation unless the change is necessary for the safety of subjects.
You must report to the IRB unanticipat ed problems involving risk to subjects or others according
to the process posted on the IRB website (www.bumc.bu.edu/irb ). The IRB must also be
informed of any new or significant information that might impact a research participant's safety or
willingness to continue in your study.
Investigat ors are required to ensure that all HIPAA requirements have been met prior to initiating
this study. Once approved, validated HIPAA forms may be found wit hin INSPIR under Study
Documents.
It is the responsibility of the PI to ensure that all required institutional approvals have been
obtained prior to initiating any research activities.
Sincerely yours,

Signature applied by Debora Perez on 01/ 13/2013 07:13: 52 PM EST
IRB Analyst

H-24583

PI Name: Philip A. Wolf, MD

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