IRB Letter

Attachment C1 Battelle IRB Approval Letter

Battelle Memorial Institute
Federalwide Assurance FWA0004696
DoD Addendum to Federalwide Assurance: DoD-NA3093
Battelle Institutional Review Board: No.IRB00000284
Page 1 of 3

INSTITUTIONAL REVIEW BOARD NOTICE OF APPROVAL
Principal Investigator/Project Manager :
Proposal/Project Title :
Client/Funding Agency :
IRB No. :
Proposal No. :

0566-100051149
Rev 0.0
OPP116214

IRB No. 0566-100051149 Rev 0.0

Betsy Payn
Conduct an Older Adult Mobility Assessment Tool Impact Evaluation
and Develop a Dissemination Plan (OAMAT)
U.S. Centers for Disease Control and Prevention (CDC)

Date of Submission to IRB:
Project No. :

6 March 2015

100051149-Task6

Subcontract to Battelle from

N/A

(if applicable)

Subcontract from Battelle to

N/A

(if applicable)

Level of Review
Expedited. 45 CFR 46.110 (b)(1) Category 7, “Research on individual or group characteristics or behavior
(including, but not limited to, research on perception, cognition, motivation, identity, language, communication,
cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group,
program evaluation, human factors evaluation, or quality assurance methodologies”

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

Full approval of study. Human Subjects’ informed consent must be documented for PHASE 1: Cognitive
Interview, but documentation is waived for PHASE 2: Evaluation Study “Survey Telephone Interview”.
This approval continues to 9 March 2016.

Gary M. Sapp for Margaret Pennybacker *
_________________________________________________
Signature
Co-Chair, Battelle Institutional Review Board

11 March 2015
______________
Date

Margaret Pennybacker, Ph.D.
Print or Type Name

*Approved per e-mail (Pennybacker to Sapp); 11 March 2015 at 12:52 p.m.

Battelle Memorial Institute
Federalwide Assurance FWA0004696
DoD Addendum to Federalwide Assurance: DoD-NA3093
Battelle Institutional Review Board: No.IRB00000284
Page 2 of 3

Requirements and Restrictions
A. Any problems of a serious nature resulting from implementation of this protocol should be brought
to the attention of the Battelle IRB, and any proposed changes should be submitted for IRB
approval before they are implemented.
B. 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.
C. 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. If the formal study remains pending approval by 9 March 2016 (the final day of approval),
apply for continuing approval of IRB No. 0566-100051149 Rev 0.0

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 four (4) hours of discovery). See definition of unforeseen event on
page 3 of 3.
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.

*Approved per e-mail (Pennybacker to Sapp); 11 March 2015 at 12:52 p.m.

Battelle Memorial Institute
Federalwide Assurance FWA0004696
DoD Addendum to Federalwide Assurance: DoD-NA3093
Battelle Institutional Review Board: 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 regulation.
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, 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: (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.

*Approved per e-mail (Pennybacker to Sapp); 11 March 2015 at 12:52 p.m.