IRB Approval Determination Memo

FWA #00000287

JHSPH Institutional Review Board Office
615 N. Wolfe Street / Room E1100
Baltimore, Maryland 21205-2179
Phone: 410-955-3193
Toll Free: 1-888-262-3242
Fax:
410-502-0584
Email:
[email protected]
Website: www.jhsph.edu/irb

APPROVAL/DETERMINATION MEMO
Amendment Approval

Date:

July 19, 2021

To:

Meghan Moran, PhD
Department of Health Behavior and Society

From:

Katherine C. Smith, PhD
Chair, IRB- X

Study Title:

How Consumers use Flavors to Make Inferences about Electronic Nicotine
Delivery System (ENDS) Product Qualities and Intentions to Use (Phase 2)

IRB No.:

11186/MOD1313

Approved

Approval/Determination Date: July 10, 2021

Approved, minor change (single reviewer)

Approval Lapse Date: March 30, 2022

Approved Expedited Cat:
Determined to be Exempt Cat: (2)(i)

As Principal Investigator for this IRB approved study, you are responsible for conducting
the study in accordance with the ethical principles of the Belmont Report, in compliance
with all relevant laws and regulations, and in accordance with JHU institutional policy.
This approval includes the following:

1). To add a new recruitment method to recruit youth participants 13-17
years old by contacting parents who are a survey panelists and inviting
them to have one of their children join the study.
This approval is inclusive of the following documentation:
Research Plan/Sponsor’s Protocol:
•

Research Plan (PI version #4, June 28, 2021)

Approval-Determination Template
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Recruitment Material:
•

*DHHS

Parental Recruitment Email (PI version #2, June 21, 2021)
(IRB version #1, July 10, 2021)

45 CFR 46
CR

FDA

Revised CR

21 CFR 50, 56
IND, 21 CFR 312
IDE, 21 CFR 812

IND/IDE held by JHSPH PI
Dept. of Defense Funding
Min. Risk

*Consent/Parental Permission
Required From:

Written Consent

Written Permission

Waiver of Signature

Waiver of Signature

LAR

Exempt (Electronic)

Exempt (Electronic)

Two Parents 46.406, 50.53

Alteration of Consent; meets
46.116 (f)(3) criteria

Alteration of Permission;
meets 46.116 (f)(3) criteria

Legal Guardian of Children in
Foster Care

Waiver of Informed Consent;

Waiver of Permission;

One Parent

Minor Consent as Adult
*Vulnerable Populations:

GWAS

Children

Reliance Agreement

Foster Care Children

Clinical Trial/GCP
*Study Site(s):

DHHS

FDA

46.404

50.51

U.S.

46.405

50.52

International

46.406

50.53

*List Country(ies):

*Parental Permission:

Adult Participant

Greater than min.
risk

*Adult Consent:

Preg. Women/Fetuses 46.204
Neonates

Prisoners

meets 46.116 (f)(3) criteria

Meets 46.116 (f)(3)
46.408, with Substitute
Mechanism provided

*Assent:
Written (signed)

*Sample Size:

Oral

(screened plus enrolled)

Statement in Parent Permission
Form

5,000

Electronic
Waived for all children

*Final Enrollment:

Waived for children
*HIPAA:

JHM

Non-JHM

Authorization

*Secondary Data Analysis:

Prep. To Research

(specimens/participants)

HIPAA Alteration/Waiver
JHM Data Tracking
Limited Data Set

DUA

*Complete for Exempt Studies for operational purposes to help track documents; HSR code provisions do not apply.

As principal investigator of IRB approved research, you are responsible for meeting the
following requirements of approval:
1) Informing the co-investigators listed on the application of the status of the research.
2) Submitting an Amendment Application or Administrative Amendment for any changes
in research. These changes in research are required to be reviewed and approved prior
to the activation of the changes, unless you are correcting or clarifying language in
approved instruments.

Approval-Determination Template
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3) Reporting Unanticipated problems involving risk of harm to participants or others that
are related to the study procedures to the JHSPH IRB within 10 days of the time that the
PI learns of such problems. Submit a Problem Event Report Form must be submitted to
the IRB immediately.
4) Using only the most recently approved JHSPH IRB approved consent forms, with the
JHSPH stamp or logo, unless otherwise approved by the IRB. All consent forms signed
by subjects enrolled in the study should be stored securely, in paper or electronic form,
until 3 years following study completion unless otherwise approved by the IRB.
5) Submitting in a timely fashion Continuing Review Applications or Progress Reports.
The Approval Lapse Date above marks the end of this approval; no study activity may
take place after that date without new IRB approval. Submit your report to the IRB
Office no later than six weeks prior to the approval lapse date to allow time for IRB
review to be completed prior to that date.
6) If your study is an NIH funded clinical trial, e.g., “A research study in which one or
more human participants are prospectively assigned to one or more interventions
(which may include placebo or other control) to evaluate the effects of those
interventions on health-related biomedical or behavioral outcomes”, it must be
registered on clinicaltrials.gov, and one IRB approved consent form used in the study
must be posted on a publicly available Federal website.
7) If your research involves international travel, please don’t forget to register with the
International Travel Registry https://travelregistry.johnshopkins.edu/Travel so that the
school may locate you in the event of an emergency.
KS/sro

Approval-Determination Template
V9_18May2021