BUMC_IRB_validation study approval-8242011

Title of Study: Analyzing the SSA Disability Determination Proc ess -Validation Study
Protocol Number: H-31096
RE: New Protocol
Review Type: Expedited
Action: Approved
Date of Action: Date Revi sions: July 27, 2011
Were Accepted: August 24, 2011

Date of Expiration: July 26, 2012
Funding Source: NIH
Award #: HHSN269200900004C
Protocol Version #: 1. 2
Consent Version(s) #: N/A (collaborating site obtaining consent and IRB approval for all consent
activities, no consent or consent related findings necessary with this BUMC submission)

Dear Alan Jette, PhD,
The BUMC Institutional Review Board (IRB ) has reviewed the protocol referenc ed
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 protoc ol and consent form(s)
indicated above.
Protocol Specific Determinations and Findings
-Approved Expedited Ri sk Category 7 and HIPAA Exempt
PLEASE NOTE THAT THE APP ROVAL LETTER FOR POLIMETRIX MUST BE
SUBMITTED TO THE BUMC IRB AND APPROVED VIA THE AMENDMENT
PROCESS PRI OR TO THE START OF ANY ACTIVITIES INVOLVING
POLIMETRIX.

H-31096

PI Name: Alan Jette, PhD

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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 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 initiating this study. Once approved, validated HIPAA forms may be found
within INSP IR under Study Documents. It is the responsibility of the P I to ensure that
all required institutional approvals have been obtained prior to initiating any researc h
activities.
Sincerely yours,

Signature applied by Rita Cosgrove on 08/24/2011 10:00:36 AM EDT

[insert title e.g. Analyst, Board Member, etc.]

H-31096

PI Name: Alan Jette, PhD

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