IRB Approval

IRB APPROVAL CERTIFICATION
Modification - Study
Salus IRB Board 5 #IRB00013544
Roster dated 16September2022

IRB Signature
Signature
Jean Taylor-Woodbury, RN, MS, ANP-BC, Chair

By
Leslie Wilson

11/14/2022
Date

Review and Approval Information
Salus IRB Study Number 22095 - 01A
Expedited
Review Process

Approval Date Sunday, November 13, 2022
Expiration Date Friday, June 2, 2023 at 11:59 PM

This document certifies the IRB's approval of the bolded items identified under "Documents Approved" to be
conducted by the named Principal Investigator.
A waiver of the requirement for documentation of informed consent is granted according to 45 CFR 46.117(c)(2).
In accordance with 45 CFR §46.404, the IRB made the following determinations:
• No greater than minimal risk to children is presented (§46.404).
• Assent is required of some of the children, as defined in the protocol (§46.408(c)).
• Assent will be documented, using the approved assent form or as outlined in the protocol (§46.408(g)).
• Permission of one parent/guardian is sufficient even if the other parent/guardian is alive, known, competent,
reasonably available, and shares legal responsibility for the care and custody of the child, unless restricted by
state law (§46.408).
• Permission by parents/guardians shall be documented in accordance with §46.117(a).
• Wards may not be included (§46.409).
All translated documents must be submitted to the IRB, including certifications, prior to enrollment of Non-English
speaking subjects.
In accordance with §46.109(f), the requirement for continuing review does not apply to this study. IRB approval
will not expire on the stated expiration date, however a continuing review check-in process must be completed on
or before the stated expiration date. Any changes to research activity continue to require IRB approval prior to
implementation, except when necessary to eliminate apparent immediate hazards to the subject.
NOTE: Subjects must be asked for their consent using the most recently approved, stamped version(s). All IRB
approved consent documents are version controlled and may not be modified in any way without prior IRB
approval. Use of an unapproved document may constitute non-compliance.

Study
2022 Hispanic/Latino Youth and Young Adult Tobacco
Use Online Survey Study

Principal Investigator

Client
Sponsor

IQ Solutions, Inc.
US Food and Drug Administration

Address

Everly Macario, Sc.D, MS, Ed.M
E&I PI Number 16705 - 001

IQ Solutions, Inc.
11300 Rockville Pike, Suite 901
Rockville, MD 20852

Performance Sites
IQ Solutions, Inc., 11300 Rockville Pike, Suite 901, Rockville, MD 20852

Documents Approved

Document # Version

Protocol

Date

3

11/2/2022

Web-Assent/Consent Form

E&I 06/07/2022

2

May 18, 2022

Web-Cognitive Interview Consent Form

E&I 06/07/2022

2

May 18, 2022

This is a multi-sided document.
Salus IRB • 2111 W. Braker Lane • Suite 100 • Austin, Texas 78758
P: 512-380-1244 • F: 512-382-8902
salus@salusirb.com • www.salusirb.com

IRB APPROVAL CERTIFICATION
Modification - Study
Salus IRB Board 5 #IRB00013544
Roster dated 16September2022
Web-Parental Opt-Out Form

E&I 06/07/2022

3

June 1, 2022

Survey Screener

Attachment C

11.2.22

Survey Instrument

Attachment D

11/2/2022

Cognitive Interview Recruitment Screener

Attachment E

4.18.22

Cognitive Interview Screener Contact Sheet

Attachment F

4.18.22

Cognitive Interview Guide

Attachment K

4.18.22

Stipulations of Approval
1. No subjects may be involved in any study procedure prior to the IRB approval date or after the expiration
date, unless otherwise stated in this letter. Investigators and sponsors are responsible for initiating
Continuing Review proceedings.
2. All protocol modifications must be IRB approved prior to implementation. This includes any addition or
change of recruitment materials, change of investigator, or performance site address. (Exception: If
necessary to eliminate apparent immediate hazard to subjects.)
3. Report to Salus IRB within ten working days of learning if any of the following occur:
- Unanticipated problems involving risk to human subjects or others;
- Unanticipated Serious Adverse Events and Safety Reports;
- Protocol deviations, violations, and exceptions that impact subject welfare or safety or study integrity
including changes intended to reduce immediate risk to subjects;
- Use of an investigational product in an emergency situation; and
- Claims for compensation or for medical care for research-related injury.
4. Advertising and recruitment materials must be approved by Salus RIB prior to use or publication.

END

This is a multi-sided document.
Salus IRB • 2111 W. Braker Lane • Suite 100 • Austin, Texas 78758
P: 512-380-1244 • F: 512-382-8902
salus@salusirb.com • www.salusirb.com

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