FHS IRB Approval

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

Title of Study: THE FR AMINGH AM HEART STUD Y (All Cohorts)N01-HC-25195 1910G
Protocol Number: H-32132
RE: New Protocol
Review Type : Full Board
Action: Approved
Date of Action: January 16, 2013
Date Revisions Were Accepted: February 07, 2013
Date of Expiration: January 16, 2014
Funding Source: NIH/National Heart Lung, and Blood Institute (NHLBI)
Award #: NO1-HC-25195 and R01HL107385
Protocol Version # : 1.1
Consent Form(s):

Study Consent From
Title
English Cell line
consent form
English Cell line
consent form
Spanish Cell line
consent form
Spanish Cell line
consent form
Omni 1(4) Spanish
Cons ent
Omni 1(4) Spanish
Cons ent
Omni 1(4) English
Cons ent Form
Omni 1(4) English
Cons ent Form
Offspring Exam 9
Cons ent Form
Offspring Exam 9
Cons ent Form

Version Number
Version 1.2

Version Date
01/25/2013

Outcome
Approved

Version 1.0

01/11/2013

Void

Version 1.1

01/25/2013

Approved

Version 1.0

01/11/2013

Void

Version 1.1

01/25/2013

Approved

Version 1.0

01/11/2013

Void

Version 1.1

01/25/2013

Approved

Version 1.0

01/11/2013

Void

Version 1.1

01/25/2013

Approved

Version 1.0

01/11/2013

Void

Dear Philip A. Wolf, MD:
At the 01/16/2013th Panel Orange Institutional Review Board (IRB) meeting, chaired by David
Kaufman, the above referenced protocol was reviewed. It has been determined that this study

H-32132

PI Name: Philip A. Wolf, MD

Page 1

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

meets the requirements set forth by the IRB and is hereby approved. This protocol is valid
through the expiration date indicated above.
This approval corresponds with the versions of the protoc ol and consent form(s) indicat ed above.
Protocol Specific Determinations and Findings
- This protoc ol is minimal risk.
- This protoc ol will be ex pedited in the futu re.
- The waiver of cons ent for Gen. 1, Gen. 2, and Omni 1 cohorts is approved for this study.
Requirements
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 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 subject s.
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 Jesse Anders on on 02/07/2013 09:18:22 AM ES T
Jesse Anderson
IRB Analyst

H-32132

PI Name: Philip A. Wolf, MD

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

Title of Study: THE FR AMINGH AM HEART STUD Y N01-HC-25195 1910G
Protocol Number: H-22762
RE: Continuing Review
Review Type : Full Board
Action: Approved
Date of Action: May 09, 2012
Date of Expiration: Ma y 08, 2013
Funding Source: NIH/National Heart Lung, and Blood Institute (NHLBI)
Award #: NO1-HC-25195 plus ancillary grant R01HL107385
Protocol Version # : 1.769336
Consent Form(s):

Study Consent From
Title
1 - Offs pring Examination 9
1-Generation III Exam 2- may 9
1-Blood Draw Consent for Cell Line
Creation
1-New Offs pring Spouse Exam 2

Version Number
Version
1.769333.11
Version 1.769333.4
Version 1.769333.5

Version Date
05/09/2012

Outcome
Approved

05/09/2012
05/09/2012

Approved
Approved

Version 1.769333.4 05/09/2012

Approved

Dear Dr. Philip A. Wolf:
At the May 9, 2012th Panel Purple Institutional Review Board (IRB) meeting, chaired by Sanford
Auerbach, 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 a nd 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
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.

H-22762

PI Name: Philip A. Wolf, MD

Page 1

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

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 05/ 17/2012 09:26: 45 AM EDT
IRB Analyst

H-22762

PI Name: Philip A. Wolf, MD

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