FINAL_HCS_SSA_ATTACH 23_IRB APPROVAL_Jan 2013

Battelle Memorial Institute
100 Capitola Drive, Suite 200
Durham, NC 27713

Federalwide Assurance FWA00004696
Battelle Institutional Review Board: CPHRE Line of Review No.IRB00000284
Page 1 of 3

INSTITUTIONAL REVIEW BOARD NOTICE OF APPROVAL
Principal Investigator/Project Manager :
Proposal/Project Title :
Client/Funding Agency :

Howard Fishbein
Studying Community Programs to Reduce Childhood Obesity/The
Healthy Communities Study (HCS)
NHLBI (additional sources NICHD, NCI, NIDDK and OBSSR)

IRB No. :

N/A

Date of Submission to IRB :

Proposal No. :

N/A

Project No. :

10/31/2012

FG006608-TASK2

(including Task Order and/or Delivery Order)

Subcontract to Battelle from

N/A

(if applicable)

Subcontract from Battelle to

N/A

(if applicable)

Level of Review
__Expedited approval granted 11/8/2012_______ (Category/Reason)
Minimal risk. No change to risk/benefits.
Modifications include: revised study hypotheses, drawing replacement communities when needed, change
in subcontractors, new method to develop pool of potential families, new statistical plan and power
calculations, revised consent form, revised protocol for medical record abstraction, changes in school
observation and household data collection forms.

Type of Approval – See Page 2 of 3 for Requirements and Restrictions
Modifications

_________________________________________________
Signature
Official, Battelle Institutional Review Board, CPHRE Line of Review
__Margaret R. Pennybacker, PhD_____________________
Print or Type Name

___11/8/2012___________
Date

Battelle Memorial Institute
100 Capitola Drive, Suite 200
Durham, NC 27713

Federalwide Assurance FWA00004696
Battelle Institutional Review Board: CPHRE Line of Review No.IRB00000284
Page 2 of 3

Requirements and Restrictions
IRB Requirements: ____________________________________________________.
Per 45 CFR 46.109(e), the IRB has the authority to observe or to have a third party observe
the consent process and the research.
Per 45 CFR 46.113, the IRB has the authority to suspend or terminate approval of research
that is not being conducted in accordance with the IRB’s requirements or that has been
associated with unexpected serious harm to subjects.

Continuing Review/Approval. Federal regulations require that human subjects research
protocols maintain IRB approval for the entire duration of the research study, including data
analysis and report writing. Apply for continuing approval of FG006608 prior to_8/20/2013_,
the final day of approval.

Approval for Amendments. Seek the IRB’s approval for any proposed amendments/
revisions to the protocol, including changes to study documents and recruiting materials.
Federal regulations require that the IRB re-review and re-approve human subjects research
prior to implementing any proposed amendments or revisions. Complete and submit an
application for amendment to the IRB manager.

Reporting. The following events must always be reported to the IRB:
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Unforeseen events (within one (1) hour of discovery). If, during the course of the
research study, there are any unforeseen events (see definition of unforeseen event on
page 3), notify the IRB manager within one (1) hour of discovery, then follow IRB
instructions
Protocol violations that
o Placed a human subject at risk, or
o Were caused by the action or inaction of a researcher
New or changed risks to human subjects, including new findings
Failure to follow regulations or IRB requirements
Unresolved complaint by a human subject
Audit, inspection, or inquiry by a federal agency
Breach of confidentiality
Change to the protocol taken without prior IRB review to eliminate an apparent
immediate hazard to a human subject
Incarceration of a human subject.

Documentation Control Requirements. Study documents and records, e.g., informed
consent documents and data collection instruments, must be maintained in accordance with
established confidentiality measures. Federal regulations require that all documents and
records be retained for at least three (3) years after a study is formally closed. Battelle policy
or client requirements may require a longer retention.
Copy of approved informed consent document(s) on file.

Battelle Memorial Institute
100 Capitola Drive, Suite 200
Durham, NC 27713

Federalwide Assurance FWA00004696
Battelle Institutional Review Board: CPHRE Line of Review No.IRB00000284
Page 3 of 3

Definitions
Expedited Review – Review of proposed research by the IRB chair or a designated voting
member or group of voting members rather than by the entire IRB. Federal regulations at 45
CFR 46.110 permit expedited review for certain kinds of research involving no more than
minimal risk and for minor changes in approved research. Only the IRB can determine if a
proposed research activity meets the requirements for expedited review.
Adverse Event - An event or incident not previously known or not anticipated to result from:
• The interactions or interventions used in the research;
• The collection of privately identifiable information under the research;
• An underlying disease, disorder or condition of a human subject, and/or,
• Other circumstances unrelated to the research or any underlying disease, disorder or
condition of the subject.
Minimal Risk - The probability and magnitude of harm or discomfort anticipated in the research
are not greater in and of themselves than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests. Depending upon
applicable regulations, “minimal risk” may be defined differently for minors and other vulnerable
populations.
Nonconformance - A determination that some aspect of a research study has not been
performed in accordance with applicable laws and regulations, ethical standards, Battelle
policies, IRB requirements, or contractual obligations.
Unforeseen Event - An event that was unforeseen or unexpected, was related to the research,
and had the potential to adversely impact a human subject or the conduct of a human subjects
study. Unforeseen event(s) are reported to an IRB via an established reporting process and
may include incidents that could be categorized as: (1) adverse events; (2) unanticipated
problems; or (3) non-conformances.
Unanticipated Problem - An event in a human research study that is not expected given the
nature of the research procedures and the subject population being studied, and suggests that
the research places subjects or others at a greater risk of harm or discomfort related to the
research than was previously known or recognized.