IRB approval

Battelle Memorial Institute
Federalwide Assurance FWA0004696
Battelle Institutional Review Board: No.lRB00000284
Page 1 of 3

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

IRB No.:
Proposal No.:

ji RB

No. 0652-100086358 Rev O.O!

Gary Chovnick

Client/Funding Agency :

Evaluation of the SAMHSA Naloxone Education and Distribution
Program
NIH/National Centers for Disease Control and Prevention

0652-100086358 Rev O.O

Date of Submission to IRB:

OPP204267

Project No.:

16 May 2017
100086358-Task2

Subcontract to Battelle from

NIA

(if applicable)

Subcontract from Battelle to

NIA

(if applicable)

Level of Review - Initial IRB Review and Approval

C8J

Expedited. Minimal risk to participants. 45 CFR 46.11 O (b)(I) 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"
HIP AA not indicated. Controls to assure privacy and data confidentiality for data collected from key informants,
stakeholders, and laypersons are adequate. The Batte lle IRB does not require that the study solicit or obtain a NIH
Certificate of Confidentiality.
IA W 45 CFR 46. l l 7(c), the Battelle IRB waives the requirement for the Investigator to obtain a signed informed
consent form for ALL human subjects in the research. The Battelle IRB has found that the only record linking the
subject and the research would be the consent document and the principal risk would be potential harm resulting
from a breach of confidentiality.
The Investigator will ask each human subject if he/ she wants documentation linking the subject with the research,
and the subject's wishes will govern. However, since many study interactions with human subjects will occur
remotely, e.g., as telephone conversations, the IRB does not require the Investigator to provide subjects with a
written statement regarding the research.

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

C8J

Requires prior U.S. 0MB review and approval before engaging any human subjects in research. Battelle
IRB's approval continues to 16 May 2018.

Signature ~ ~
Co-Chair, Battelle Institutional Review Board
Rosalee Meyer, Ph.D.
Print or Type Name

Battelle Memorial Institute
Federalwide Assurance FWA0004696
Battelle Institutional Review Board: No.lRB00000284
Page 2 of 3

Requirements and Restrictions
A. All study documentation requires prior review and approval by U.S. Office of Management and

Budget (0MB) before the study may engage ANY Human Subjects in research
B. Any problems of a serious nature resulting from implementation of this protocol should be brought to the
attention of the Batte lle IRB, and any proposed changes should be submitted for IRB approval before they
are implemented.
C. 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.
D. 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 stud , including data analysis and re ort
writing. If the formal study remains pending approval by 16 Ma 2018 (the final da of a rovai),
apply for continuing approval of lRB No. 0652-100086358 Rev O.O

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:
•
•

•
•
•
•
•
•
•

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.

Battelle Memorial Institute
Federalwide Assurance FWA0004696
Battelle Institutional Review Board: No.lRB00000284
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 46.11 O 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 - A Battelle-coined term that has no regulatory equivalent, but that may
summarize one or more of the following terms: (1) adverse events; (2) unanticipated problems
involving subjects or others; or (3) non-conformances. Unforeseen Events must be reported to
an IRB via an established reporting process
Unanticipated Problem Involving Subjects or Others - 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.