IRB Review

Title of Study: SSA Test Retest Study
Protocol Number: H-32407
RE: New Protocol
Review Type: Expedited
Action: Approved
Date of Action: September 20, 2013
Date Revisions Were Accepted: January 13, 2014
Date of Expiration: September 19, 2014
Funding Source: NIH (ARRA)
Award #: HHSN269201200005C
Protocol Version #: 1.4
Consent Form(s):
Study Consent From
Title
Functional Assessment
Study
Functional Assessment
Study

Version Number
Version 1.1

Version Date
07/03/2013

Outcome
Approved

Version 1.0

07/03/2013

Void

Dear Dr. Alan Jette,
The BUMC Institutional Review Board (IRB) has reviewed the protocol referenced above. It has been
determined that the study meets the requirements set forth by the IRB and is hereby approved. This
protocol was approved by the expedited review process in accordance with 45 CFR 46.110 and 21 CFR
56.110.
This protocol is valid through the expiration date indicated above.
This approval corresponds with the versions of the protocol and consent form(s) indicated above.
Protocol Specific Determinations and Findings
- This protocol is minimal risk.
- This protocol will be expedited in the future.
Please Note: No research activities can begin by the NIH external investigators until you receive
confirmation from IRB coordinator Roz Schomer that the fully signed IAA agreement is attached to the
protocol.

H-32407

PI Name: Dr. Alan Jette

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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 implementation unless the change is necessary for the safety of subjects.
You must report to the IRB unanticipated 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.
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 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 Anderson on 01/13/2014 02:26:43 PM EST

IRB Analyst

H-32407

PI Name: Dr. Alan Jette

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