IRB Approval

2021 and 2023 National Youth Risk Behavior Survey

Attachment J
IRB Approval Letters

DATE:

July 31, 2019

TO:

Alice Roberts

FROM:

Carole V. Harris, IRB Chair

SUBJECT:

Institutional Review Board (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.

Instructions on Reporting Adverse Events and Unanticipated Problems. Note—any event that could
be considered as an Unanticipated Problem or Adverse Event must be reported to the IRB within
2 business days. Failure to comply with the reporting requirements could result in the
suspension of IRB approval of this study and other consequences.

3.

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 study procedures.

The first two forms are for your files; the signed electronic copy of the third form must be sent to the IRB at
IRB@icfi.com and will be kept in the IRB files. Please maintain a copy of the third form for your records. If you
have any questions about these forms, please email IRB@icfi.com.

9300 Lee Highway • Fairfax, VA 22031 • 703-934-3000 • 703.934.3740 fax • icfi.com

National Youth Risk Behavior Survey
July 31, 2019

Institutional Review Board Findings Form
ICF IRB FWA00002349 Exp. 07/12/2023
Project Director(s): Alice Roberts
Project Title: National Youth Risk Behavior Survey
ICF Project Number: 171727

Type of Review:

☐ New Convened

☐ New Expedited

☐ Modification

☒ Continuing review

Findings of the Board:

☒ Project complies with all of the 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 Approved Until: July 30, 2020*
*All non-exempt studies require review at least annually. Continuing Review materials should be
submitted to the IRB no later than 6 weeks prior to expiration of approval.

July 31, 2019
Chair, Institutional Review Board

Date

(Revised 06/12/2018)

List of Approved Project Materials:
1. IRB Continuing Review Form

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National Youth Risk Behavior Survey
July 31, 2019

ICF International Institutional Review Board
Reporting Unanticipated Problems and Adverse Events
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 unanticipated problems or adverse events that occur
during the conduct of the research.
What Is an Unanticipated Problem 1?
An unanticipated problem is any event that meets all of the criteria below. The event:
a) was not expected (in terms of nature, severity, or frequency) given the research procedures described in
the study protocol and IRB documents, such as the consent form, and the subject population being
studied; and
b) was related or possibly related to participation in this research; possibly related means there is a
reasonable possibility that the study procedures may have caused or created the event; and
c) suggests that the research places the subjects or others at a greater risk of harm or discomfort than was
previously known or recognized. Risk of harm includes physical, psychological, economic or social
harm. Note – actual harm does not need to be confirmed.
*An unanticipated problem does not have to also qualify as an adverse event.
Unanticipated problems often involve the research team and relate to the execution of the research protocol.
For example:



A field interviewer has her laptop computer stolen. The study subjects may be at greater risk of
harm from breach in confidentiality of the study, so this must be reported to the IRB.
Unethical behavior on the part of a study team member when interacting with study participants or
using study data also qualifies as an unanticipated problem and must be reported to the IRB. Even
if the unexpected problem is unlikely to happen again.

What Is an Adverse Event?
As defined by OHRP Guidance2, adverse events are untoward or unfavorable occurrences in human subjects,
including abnormal medical findings, symptoms, diseases or activities that are temporally associated with the
subject’s participation in the research, even if they are not considered to be related to the subject’s participation.
Adverse events include physical and psychological harms and they can occur in biomedical, social or behavioral
research.
Some adverse events are expected to occur during research (e.g., a participant may feel sad when describing
past suicidal ideation), and these events are included among the risks of participating in the research. Other
adverse events are unexpected (e.g., a subject arrives for an interview intoxicated and unable to participate).
We may 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. Research protocols should include procedures
for dealing with expected adverse events (also called “risks”). 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.

1
2

https://www.hhs.gov/ohrp/sites/default/files/ohrp/policy/advevntguid.pdf
Same as above

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National Youth Risk Behavior Survey
July 31, 2019
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 does not need to be reported to the IRB.
Only adverse events that are unexpected (not identified as a risk of the study), serious (indicate a risk of harm
to a subject or research staff member) or occur at a higher than expected rate need to be reported to the IRB.





If a study subject reported feeling uncomfortable (but not suicidal) during an interview, and discomfort
was noted as a risk on the consent form and IRB protocol, the adverse event would not need to be
reported to the IRB.
If a study subject reported suicidal thoughts during the interview (even if suicidal ideation was listed as a
risk of participating in the interview), the suicidal ideation should be reported to the IRB because it is a
serious event. The IRB would confer with investigators to ensure participant protections were in place,
being followed by research staff, and adequate to address identified concerns.
If several subjects reported discomfort with interviews and discomfort was expected to occur at a low
rate, the event(s) should be reported to the IRB. In this case, the risk of emotional discomfort is greater
than expected or occurred at a higher rate than expected.

What If I’m Unsure If an Event or Problem Needs to Be Reported to the IRB?
If you are uncertain that an event or problem should be reported to the IRB, contact the IRB Chair by phone
(404) 929-8310 or email (Carole.Harris@icf.com or IRB@icfi.com). You may also contact the IRB Coordinator,
April Carswell, at April.Carswell@icf.com.
When Should the IRB Be Notified?
The IRB should be notified as soon as possible from the time an event occurs, but no later than 2 business days
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 go the IRB SharePoint site
(https://icfonline.sharepoint.com/sites/IRB/SitePages/Home.aspx) or email IRB@icfi.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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National Youth Risk Behavior Survey
July 31, 2019

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 Youth Risk Behavior Survey

Principal Investigator/Project Director(s):

Alice Robers

ICF Project Number:

171727

Approval Date:

July 31, 2019

As the responsible principal investigator/Project Director 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 the
IRB Chair, Carole V. Harris (Carole.Harris@icfi.com), to discuss your concerns.
Also, as the responsible principal investigator or project director, I agree to cooperate with the IRB continuing
review(s) of this project. I understand it is my responsibility to initiate the continuing review(s) process no later
than 4 weeks prior to the next review date listed above. The IRB Project Continuing Review Form can be found
on the IRB SharePoint site or obtained by contacting the IRB at IRB@icfi.com. The purposes of the IRB Project
Continuing 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)

5 August 2019

______________________
(date)

Please email an original signed copy of this form to the IRB at IRB@icfi.com. A copy of the signed form should
also be maintained with your study files.
(Revised-06/12/2018)

Page 5

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Memorandum
Date
d
From

November 7, 2019

Subject

**UPDATED** CDC IRB Approval of Continuation #21 of Protocol #1969.0, “National Youth
Risk Behavior Survey” (Expedited)

To

Nancy Brener, PhD
NCHHSTP/DASH

Denise M. Marshall, BS
IRB Administrator, Human Research Protection Office

CDC IRB Committee 1 has reviewed and approved the request to continue protocol #1969.0,
“National Youth Risk Behavior Survey”, for the maximum allowable period of one year. CDC
IRB approval will expire on 11/10/2020. The continuation action was reviewed in accordance
with the expedited review process outlined in 45 CFR 46.110(b)(1), category 4.
If other institutions involved in this protocol are being awarded CDC funds through the CDC
Procurement and Grants Office (PGO), you are required to send a copy of this IRB approval to
the CDC PGO award specialist handling the award. You are also required to verify with the
award specialist that the awardee has provided PGO with the required documentation and has
approval to begin or continue research involving human subjects as described in this protocol.
As a reminder, the IRB must review and approve all human subjects research protocols at
intervals appropriate to the degree of risk, but not less than once per year. There is no grace
period beyond one year from the last IRB approval date. It is ultimately your responsibility to
submit your research protocol for continuation review and approval by the IRB along with
available IRB approvals from all collaborators. Please keep this approval in your protocol file as
proof of IRB approval and as a reminder of the expiration date. To avoid lapses in approval of
your research and the possible suspension of subject enrollment and/or termination of the
protocol, please submit your continuation request along with all completed supporting
documentation at least six weeks before the protocol's expiration date of 11/10/2020.
Any problems of a serious nature must be brought to the immediate attention of the CDC
IRB, and any proposed changes to the protocol are required to be submitted as an
amendment to the protocol for CDC IRB approval before they are implemented.
If you have any questions, please contact your National Center Human Subjects Contact or the
CDC Human Research Protection Office at (404) 639-5256 or e-mail: huma@cdc.gov.
cc: NCHHSTP Human Studies (CDC)
Nicole (Nicky) Cohen, MD