IRB Approval for OMNI Gp. 2

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

Title of Study: EVALU ATION OF THE OMNI GENERATION II COHORT OF THE FRAMINGHAM HEART
STUDY
Protocol Number: H-22681
RE: Continuing Review
Review Type : Full Board
Action: Approved
Date of Action: 09/12/2012
Date of Expiration: 09/11/2013
Funding Source: NIH/National Heart Lung, and Blood Institute (NHLBI)
Award #: NO1-HC-25195 (contract) & 1 R01 HL107385 grant
Protocol Version # : 1.766476
Consent Form(s):

Study Consent From
Title
5-Omni Gen 2- Cell Line Spanish
Omni2(2) Spanish Consent Form
3-Blood Draw Consent for Cell Line
Creation
2-CTA DD Omni 2 Exam 2 - Offsite
Omni2(2) English Consent Form

Version Number
Version 1.1
Version 1.2
Version
1.766473.2
Version
1.766473.2
Version
1.766473.3

Version Date
10/03/2011
07/25/2012
10/29/2010

Outcome
Approved
Approved
Approved

10/29/2010

Approved

07/16/2012

Approved

Dear Dr. Philip A. Wolf,
At the 09/12/2012th Panel Purple Institutional Review Board (IRB) meeting, chaired by Dr.
Sanford Auerbac h, the above referenced protocol was reviewed. It has been determined that this
study meets the requirements set fort h by the IRB and is hereby approved. This protoc ol 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.

H-22681

PI Name: Philip A. Wolf, MD

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

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
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 i nitiating
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 09/ 13/2012 02:38: 37 PM EDT
IRB Analyst

H-22681

PI Name: Philip A. Wolf, MD

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