Sepsis IRB Letter

Institutional Review Board Findings Form
ICF IRB FWA00000845
(Expires 04/13/2019)

Project Directors: Ashani Johnson-Turbes
Project Title: Sepsis and Antibiotic Use Campaigns
ICF Project Number: 162691.0.001.01.000
Type of Review:

New

Findings of the Board:
 Project complies with all requirements of 45 CFR 46, “Protection of Human Subjects”.
□ Project is exempt from IRB review (See IRB Exemption Form).
□ Project does not comply with all of the requirements of 45 CFR 46.
Project is approved until: January 26, 2018
Annual Review due by: January 25, 2018

January 26, 2017
Chair, Institutional Review Board

Date

List of Approved Project Materials:
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Informed Consent Script for IDIs and Focus Groups
Healthcare Provider (HCP) Recruitment Screener
HCP Pre-Discussion Informational Survey (PDIS)
HCP In-Depth Interview Guide
Consumer Screener – Self Demander and Self-Expector Version
Consumer PDIS – Caregiver-Demander and Caregiver-Expector Version
Consumer PDIS – Self-Demander and Self-Expector Version
Consumer PDIS – Caregiver-Demander and Caregiver-Expector Version
Consumer Focus Group Moderator Guide

Sepsis and Antibiotic Use Campaigns
January 26, 2017
ICF Institutional Review Board
Reporting Adverse Events and Unanticipated Problems
Federal human subject protection regulations require the principal investigator (PI) or project director
(PD) of an IRB approved research study to report to the IRB any unexpected adverse events and
unanticipated problems that occur during the conduct of the research.
What is an unexpected Adverse Event?
Some adverse events are expected to occur during research, while others are unexpected. An
adverse event is considered an undesirable and unintended effect of the research occurring in study
subjects or others as a result of (a) the interventions and/or interactions used in the research; or (b)
the collection of identifiable private information under the research. Such events are included among
the risks of participating in the research. Even though an event is unintended, we often expect that a
certain number of adverse events will happen during the course of the research. For example, when
conducting telephone surveys, we expect some complaints from individuals who are called. Each
complaint is an adverse event and should be documented, but it is not unexpected. Research
protocols should include procedures for dealing with expected adverse events (risks). An unexpected
adverse event is one that was not anticipated in the research protocol. During the IRB review of a
research study, the IRB tries to make sure that all anticipated risks have been identified and included
in the informed consent form, and that there are procedures in place to minimize and address those
risks.
What Is an Unanticipated Problem?
An unanticipated problem is considered to be any event that (a) was not expected given the nature of
the research procedures and the subject population being studied; and (b) suggests that the research
places subjects or others at a greater risk of harm or discomfort than was previously known or
recognized. Note that it is only when both conditions (a and b) are present, that a problem is defined
as unanticipated. Unexpected adverse events are also unanticipated problems, but there can be
unanticipated problems that do not meet the definition of an unexpected adverse event.
What must be reported to the IRB?
Many adverse events are anticipated possible risks of participating in the research and do not need to
be reported to the IRB. For example, emotional discomfort may be a risk of participating in an
interview and is identified as a risk in the informed consent form. An interview that is terminated by a
subject because of emotional discomfort is an adverse event, but it is expected that some interviews
will be terminated for such reasons and it should not be reported to the IRB. Only adverse events that
are unexpected need to be reported to the IRB. If the study subject threatened suicide during the
interview and suicidal ideation is not identified in the study protocol and in the informed consent as a
risk of participating in the interview, the suicide threat would be an unexpected adverse event and
must be reported to the IRB. Also, if the researcher anticipated that very few interviews would be
terminated because of emotional discomfort, but finds that a higher number of interviews than
expected are being terminated for discomfort, the risk of emotional discomfort is greater than expected
and must be reported to the IRB.

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January 26, 2017
Many unanticipated problems are also adverse events in that the problems are unexpected
consequences of exposure to the research design and/or methods. However, there are some
unanticipated problems that are not related to the research but must be reported to the IRB. For
example, a field interviewer has her laptop computer stolen and the interview data are not encrypted.
The study subjects have been placed at greater risk of harm from breach in confidentiality of the study.
Another example of an unanticipated problem is unethical behavior on the part of a study team
member when interacting with study participants or using study data. Even if an unexpected problem
is not likely to happen again, it must be reported to the IRB.
Problems that do not place study subjects at increased risk of harm or discomfort do not need to be
reported to the IRB. For example, the termination of employment for a field data collector because he
reported administering surveys that were never administered. This problem does not have to be
reported to the IRB because it did not place the study subject(s) at greater risk.
What if I’m unsure if an event or problem needs to be reported to the IRB?
If it is unclear to you that an event or problem should be reported to the IRB, email the IRB at
IRB@icf.com. You may also contact the Chair, Janet Griffith, at Janet.Griffith@icf.com; or the IRB
Administrator, Rachelle Duke, at Rachelle.duke@icf.com. The IRB can also be reached toll-free at
(877) 556-2218.
When should the IRB be notified?
The IRB should be notified as soon as possible from the time a determination is made that an event
represents an unanticipated problem or unexpected adverse event. The notification must be made
within 2 weeks of the event or problem.
How should the IRB be notified?
If an adverse event occurs during an IRB approved study, the PI or PD must report the event to the
IRB using the IRB Adverse Event Report. Please email IRB@icf.com to obtain a copy of the IRB
Adverse Event Report.
Can I suggest changes in the Research Protocol when I report the adverse event?
Yes. You may suggest changes, and the IRB chair will consider your suggestions. Also, the
Adverse Event Report requires that you document any changes that were made as a result of the
event or problem. The IRB chair will determine if such changes are adequate or if other changes are
needed to protect the study subjects.
What does the IRB do when an adverse event or unexpected problem is reported?
The IRB reviews the research protocol to determine if changes are needed in the study procedures
to protect subjects from the identified risk or increase in risk. The IRB has the authority to require
changes in the study procedures to minimize the risk of harm to subjects. The IRB will send the PI or
PD an Adverse Event Findings Form that will document any required changes to the study
procedures. The IRB also submits a report to the Office of Human Research Protections (within
DHHS) that documents the event or problem and any actions taken by the IRB.

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Sepsis and Antibiotic Use Campaigns
January 26, 2017

Institutional Review Board
Agreement to Comply with Human Subject Protection Requirements

The following project has been found by the Institutional Review Board (IRB) to be in compliance with
the human subject protection requirements as specified in 45 CFR 46.
Project Title: Antibiotic Resistance and Sepsis: Raise the Dialogue, Prompt Action
Principal Investigator/Project Director(s): Ashani Johnson-Turbes
ICF Project Number: 162691.0.001.01.000
Approval Date: January 26, 2017
Annual/Continuous Review due by: January 25, 2018
As the responsible Principal Investigator/Project Director for this project, I agree to adhere to the human
protection procedures that were approved by the IRB and to inform the chair of the IRB when any
changes are made in the approved procedures. The approved procedures include all of the following:
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Subject selections and recruitment procedures
Data collection procedures
Informed consent procedures
Protection of privacy and confidentiality procedures
Data security procedures
Additional safeguards specified by the IRB

As the responsible Principal Investigator/Project Director, I agree to cooperate with the IRB Continuous
Annual Review(s) of this project. The purposes of the IRB Annual/Continuous Review Form are: (1) to
provide the IRB with updated information on the procedures used to protect the human subjects who are
involved in this project, and (2) to help the IRB determine if the project is in compliance with the
requirements stated in 45 CFR 46.

Ashani Johnson-Turbes
(Signature)

January 27, 2017
(Date)

Please email an original signed copy of this form to the IRB at IRB@icf.com. A copy of the
signed form should also be maintained with your study files.
If you have any questions regarding changes in procedures that are subject to IRB review, please
contact the IRB Chair, Janet Griffith (Janet.Griffith@icf.com) to discuss your concerns.
(Revised 12-29-16)

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