IRB Approval (1)

DATE:

June 5, 2009

TO:

Dan Geller

FROM:

Jack Hermann, IRB Chair

SUBJECT:

IRB Review Forms

Attached are the following forms for the recent IRB review of your research project:
1.

IRB Review Findings Form, which documents the review and approval of the project.

2.

IRB Members list, which identifies the board members who reviewed the project.

3.

Instructions on Reporting Adverse Events and Unanticipated Problems, which defines
unexpected adverse events and unanticipated problems, and details when and how the
IRB should be notified of such events and problems. Note—any problem or incident
that could be an adverse event must be reported to the IRB according to the
instructions in this form. Failure to comply with the adverse event reporting
requirements could result in the suspension of your right to submit studies to the
IRB and/or the suspension of IRB approval of this study.

4.

Agreement to Comply with Human Subject Protection Requirements, which must be
signed by you and returned to the IRB. By signing this form, you agree to adhere to
the human subject protection procedures that were approved by the IRB, and to inform
the IRB chair of any changes made to the approved procedures.

The first three forms are for your files; the signed copy of the fourth form must be sent to the
IRB Secretary, Rená Agee, and will be kept in the IRB files. Please maintain a copy of the
fourth form for your records. If you have any questions about these forms, please contact me
at [email protected] or Rená at (301) 572-0340 ([email protected]).

(Revised 04/08/09)

ICF Macro
Institutional Review Board
IRB Review Findings Form

Name of Project Director(s):
Title of Project:

Daniel Geller

National Survey of WIC Participants II

ICF Macro Project Number:

35214.00.000.00

Type of Review:
X

New
Renewal

Findings of the Board:
Project is exempt from IRB review
X

Project complies with all of the requirements of 45 CFR 46, "Protection of
Human Subjects"
Project does not comply with all of the requirements of 45 CFR 46

Project Approved Until:

September 30, 2011

Next Annual Review Date:

May 29, 2010

Chair, Institutional Review Board

(Revised 04/08/09)

06/05/09
Date

INSTITUTIONAL REVIEW BOARD MEMBERS
DATE: 06/05/09
ICF Macro
11785 Beltsville Drive, Suite 300
Calverton, MD 20705
NAME
(voting members only)2,3
Last, First

HIGHEST DEGREE
EARNED

Hermann, John A.*
Arnold, Fred
Baum, Herbert M.
Belcher, Frances
Duffy Jr., Thomas
Gilford Jr., John
Iachan, Ronaldo
Jones, A. Billy S.
Matsakis, Aphrodite
Morgan, Mark
Pacqué, Michel
Ross, James G**
Walrath-Greene, Christine
Yee, Eugene B.

PhD
PhD
PhD
PhD
MA
PhD, MSW
PhD
MSW
PhD
PhD
MD, MPH
MS
PhD
JD

PRIMARY SCIENTIFIC
OR NONSCIENTIFIC
SPECIALITY

Social Welfare
Economics/Demography
Population Dynamics/Biostatistics
Community Psychology
Political Science
Social Work
Statistics
Social Work/Criminal Justice
Psychology
Political Science
Medicine/Public Health
Psychology
Community-Social Psychology
Finance

** Alternate Chair

AFFILIATION WITH
INSTITUTION ABOVE
(YES/NO)

Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes

ATTESTATIONS OF IRB
CHAIRPERSON
FOR ALL RESEARCH CONDUCTED UNDER THIS ASSURANCE, THE IRB CHAIRPERSON HEREBY
ATTESTS THAT, EXCEPT WHERE SPECIFICALLY WAIVED OR ALTERED BY THE IRB UNDER 45 CFR
46.116(c), 46.116(d), 46.117(c), THE IRB WILL UPHOLD THE REQUIREMENTS OF 45 CFR 46 FOR
WRITTEN INFORMED CONSENT, IN NONEXCULPATORY LANGUAGE UNDERSTANDABLE TO THE
SUBJECT (OR THE SUBJECT'S LEGALLY AUTHORIZED REPRESENTATIVE), INCLUDING THE
FOLLOWING BASIC ELEMENTS PER 45 CFR 46.116(a/b):
(1) IDENTIFICATION AS RESEARCH; PURPOSES, DURATION, AND PROCEDURES; PROCEDURES
WHICH ARE EXPERIMENTAL;
(2) REASONABLY FORESEEABLE RISKS OR DISCOMFORTS;
(3) EXPECTED BENEFITS TO THE SUBJECT OR OTHERS;
(4) ALTERNATIVE PROCEDURES OR TREATMENTS;
(5) EXTENT OF CONFIDENTIALITY TO BE MAINTAINED;
(6) WHETHER COMPENSATION OR MEDICAL TREATMENT ARE AVAILABLE IF INJURY OCCURS (IF
MORE THAN MINIMAL RISK);
(7) WHOM TO CONTACT FOR ANSWERS TO QUESTIONS ABOUT THE RESEARCH, SUBJECT'S RIGHTS,
AND RESEARCH-RELATED INJURY;
(8) PARTICIPATION IS VOLUNTARY; REFUSAL TO PARTICIPATE WILL INVOLVE NO PENALTY OR
LOSS OF BENEFITS TO WHICH SUBJECT IS ENTITLED; SUBJECT MAY DISCONTINUE AT ANY TIME
WITHOUT PENALTY OR LOSS OF BENEFITS TO WHICH SUBJECT IS ENTITLED;
(9) WHEN APPROPRIATE, ADDITIONAL ELEMENTS PER 45 CFR 46.116(b).

AS IRB CHAIRPERSON, I HEREBY SO ATTEST.

SIGNATURE:
DATE: 06/05/09
PHONE: (301) 572-0340

E-MAIL: [email protected]

ADDRESS: ICF Macro
11785 Beltsville Drive, Suite 300
Calverton, MD 20705

*DENOTES CHAIRPERSON
**DENOTES ALTERNATES (IF ANY, DENOTE MEMBER FOR WHOM ALTERNATE WILL SERVE)
(1) WHERE REVIEW IS CONDUCTED BY ANOTHER INSTITUTION'S IRB, THE IRB MUST ENSURE ADEQUATE KNOWLEDGE OF LOCAL CONDITIONS, INCLUDING COMMUNITY ATTITUDES, RELEVANT
CULTURAL SENSITIVITIES, INSTITUTIONAL POLICIES/ COMMITMENTS, APPLICABLE LAW, AND STANDARDS OF PROFESSIONAL CONDUCT/PRACTICE.
(2) NO IRB MEMBER MAY PARTICIPATE IN THE REVIEW OF ANY PROJECT IN WHICH THE MEMBER HAS A CONFLICTING INTEREST.
(3) IRBs MUST BE CONSTITUTED SO AS TO ENSURE APPROPRIATE REVIEW AND ADDITIONAL SAFEGUARDS FOR RESEARCH INVOLVING VULNERABLE CATEGORIES OF SUBJECTS.
(4) AFFILIATION MAY TAKE THE FORM OF EMPLOYMENT, MEMBER OF GOVERNING BOARD, STOCKHOLDER, OR PAID/UNPAID CONSULTANT (FOR PURPOSES OTHER THAN IRB FUNCTIONS).

ICF MACRO
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 to be 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.
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.

(rev 04-08-09)

Page 1

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, contact the IRB chair at
[email protected] or the IRB Secretary, Rena Agee at [email protected] or
(301) 572-0340.

When Should the IRB Be Notified?
The IRB should be notified as soon a 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 principal investigator (PI) or project director
(PD) must report the event to the IRB using the online IRB Adverse Event Report. The online IRB Adverse
Event Report is located on ICF MacroNet (https://intranet.macrointernational.com/) [under the main page,
Project Resources, Institutional Review Board]. Once you press submit, the report and any accompanying
documentation will be automatically sent to the IRB Secretary. A copy of the submission can be accessed
by selecting the output/view link.
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.

(rev 04-08-09)

Page 2

ICF Macro
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:

National Survey of WIC Participants II

Project Director(s):

Daniel Geller

ICF Macro Project Number:

35214.00.000.00

Approval Date:

May 29, 2009

Next Annual Review Date:

May 29, 2010

As the responsible principal investigator for this project, I agree to adhere to the human subject
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:







Subject selection and recruitment procedures
Data collection procedures
Informed consent procedures
Protection of privacy and confidentiality procedures
Data security procedures
Additional safeguards specified by the IRB.

If you have any questions regarding changes in procedures that are subject to IRB review, please
contact Jack Hermann ([email protected]) to discuss your concerns.
Also, as the responsible principal investigator, I agree to cooperate with the IRB annual review(s) of this
project. Several weeks prior to the next annual review date listed above, the IRB secretary will send
you an IRB Project Annual Review Form to complete and submit to the IRB before the annual review
date. The purposes of the IRB Project Annual 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 in 45 CFR 46.

_______________________________________
(signature)

______________________
(date)

Make a copy of the signed form for your files, and return the original copy to Rená Agee, IRB secretary.
(Revised 04/08/09)