Attach #fram11

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 II COHORT
OF THE FRAMINGHAM HEART STUDY
H-22681
Contining Review
Full Board
Approved
11/4/2009
11/3/2010
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.
-Please note, since the IAA is still pending with MGH, no CTScans may be performed
until this is resolved.
-The COI issue regarding Dr. Mitchell is still pending, please contact the IRB when this
has been resolved.
-Please submit an amendment for an updated Spanish consent form when it has been
translated and attested.
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

https://braan.bumc.bu.edu/esp1/reports/Human/Approval.asp?protocol=757600&title_co...

11/30/2009

Human Approval Letter

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as External Attachments.
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,

SANFORD AUERBACH
IRB Chair

https://braan.bumc.bu.edu/esp1/reports/Human/Approval.asp?protocol=757600&title_co...

11/30/2009