Attach #fram10

Human Approval Letter

Title of Study:
Protocol Number:
RE:
Review Type:
Action:
Date of Action:
Date of Expiration:
Funding Source:

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EVALUATION OF THE OMNI GENERATION I COHORT
OF THE FRAMINGHAM HEART STUDY
H-24583
Contining Review
Expedited
Approved
2/5/2010
2/4/2011
Government: Pending NIH/NHLBI Supplement to
Framingham Heart Study N01-HC-25195 1910G IRB
Protocol #H-22762
Government Award #: N01-HC-25195

BU Source # or Record
337-30975
#:

Dear EMELIA BENJAMIN, MD, ScM:
The Institutional Review Board (IRB) has reviewed the above referenced protocol and
has determined that it meets the requirements set forth by the IRB and is hereby
approved. This protocol is valid through the date indicated above.
NOTE: The IAA between MGH and BUMC is still pending. Subjects may not participate
in study activities to be conducted at MGH until this agreement is signed. MGH
Investigators may not participate in human subejcts research activities for this study until
this agreement is signed.
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 may be used when
informed consent is required. Only consent forms validated with current approval dates
(either generated by the INSPIR system or by a manual stamp by the IRB office) may be
used. Manually stamped consent forms may be found under External Attachments in
INSPIR.
Any changes to the protocol or informed consent must be reviewed and approved prior to
implementation unless the change is necessary for the safety of subjects. In addition, you
must report to the IRB unanticipated problems involving risk to subjects or others
according to the process posted on the IRB website. The IRB must be informed of any
new or significant information that might impact a research participant's safety or
willingness to continue in your study.
Investigators are required to ensure that all HIPAA requirements have been met prior to
initiating this study. Once approved, validated HIPAA forms may be found within INSPIR
as External Attachments.

https://braan.bumc.bu.edu/esp1/reports/Human/Approval.asp?protocol=759567&title_code=0 2/8/2010

Human Approval Letter

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It is the responsibility of the PI to ensure that all required institutional approvals have
been obtained prior to initiating any research activities.
Please note that the IRB is no longer stamping attachments, subject letters, recruitment
materials, etc. These documents are each associated with this approved version of the
protocol. They can be found by going to Letters/Protocol History in INSPIR and clicking
on the highlighted (linked) word "Approved" and then clicking on the paperclip icon in the
upper left corner. *This does NOT apply to consent forms, which must be validated.
Sincerely yours,

DANIELLE DELOSH
IRB Board Member

https://braan.bumc.bu.edu/esp1/reports/Human/Approval.asp?protocol=759567&title_code=0 2/8/2010