Attach-1_IRB_Approval_EXACT_Pro00008535

Attachment 1
IRB Approval: Chesapeake IRB (EXACT)

Rapid Throughput Standardized Evaluation of
Transmissible Risk for Substance Use Disorder in Youth
(NIDA)

Chesapeake IRB
_____________________________________________________________

Providing Human Research Protections Services
IRB Services • Consultation • Education
7063 Columbia Gateway Drive, Suite 110
Columbia, MD 21046-3403
410.884.2900

PROTOCOL APPROVAL
DATE:

19 Jun 2013

TO:

Barry Tarter, MBA
EXACT Sports

PROTOCOL:

National Institute on Drug Abuse / National Institutes of Health - no protocol
number, Rapid Throughput Standardized Evaluation of Transmissible Risk for
SUD in Youth: Validation Study (Pro00008535)

IRB APPROVAL:

18 Jun 2013

IRB EXPIRATION:

18 Jun 2014
IRB APPROVED DOCUMENTATION:

Consent
Templates:




Adult Twins Informed Consent Form (REVIEW ONLY).
Parental Informed Consent Form (REVIEW ONLY).

Other
Materials:










University of Pittsburgh Approval (Dated 4/11/2013).
University of Pittsburgh Protocol (Print Date 4/12/2013).
Rutgers University Approval (Dated May 30, 2013).
Rutgers Protocol Review (Print Date 4/17/2013).
Rutgers Protocol (Dated 11/27/12).
About your Twin Questionnaire (Not Dated).
Short Survey (Not Dated).
Award/Contract (Effective Date 09/17/2012).

The IRB approved the above referenced protocol on 18 Jun 2013.
The IRB reviewed the project in accordance with the 45 CFR Part 46, Subpart D Federal Regulations which
provide for additional protections for children as research subjects.
The IRB determined that the research study meets the criteria found in the risk category described as follows:


45 CFR 46.404: “Research not involving greater than minimal risk.” Permission of one parent is
required.

It is the understanding of the IRB that EXACT Sports will act as a coordinating center and local IRBs
(Rutgers and Pittsburgh) will have oversight of the informed consent process and informed consent forms.

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Please review the Sponsor and CRO Handbook by accessing CIRBI™ (www.cirbi.net). Log on to your
CIRBI homepage (“My Home”) and select the “Reference Materials” tab for IRB requirements and
guidance. A copy of the most recent IRB roster is also available under “Reference Materials”.
Thank you for selecting Chesapeake IRB to provide oversight for your research project.

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