Rigorous Evaluation of the READY to Stand Curriculum as a Tool to Prevent the Commercial Sexual Exploitation of Children Among Racially and Ethnically Diverse Urban Youth (PHASE II: OPEN PILOT TRIAL)
Phase: NA
Conditions: Sex Trafficking, Sex Crimes, Commercial Sex, Sexual Violence, Child Abuse, Sexual, Sex Offense
Sponsor: University of Nebraska Lincoln

ClinicalTrials.gov Data Entry Cover Sheet  
 
Protocol ID: 22811 Clinical Trials.gov ID: NCT05988398 
Project Title: Preventing Commercial Sexual Exploitation of Children (Project LIVE) 
Principal Investigator: Katie M. Edwards, PhD, University of Nebraska-Lincoln 
 
 

University of Nebraska-Lincoln
Institutional Review Board (IRB)
402-472-6965
irb@unl.edu
FOR OFFICE USE ONLY
IRB #: 20221122322EP
IRB Decision Date: 11/09/2022
Date Received: 09/30/2022
NUgrant Project ID: 22322
Form ID: 59444
Status: Approved by the IRB
The UNL Human Research Protection Program policies and procedures along with guidance documents and templates are available
for your reference and use during the completion of this application.
Only projects that meet the deﬁnition of research 
 AND human subjects 
If your project does not require IRB approval, you are not required to submit this application; however, please be aware, IRB
approval may not be granted if the research has already started or been conducted and the determination of IRB applicability
was made incorrectly by the investigator.
If your project does require IRB approval, the decision charts may not be used for exemption determinations, expedited review,
or continuing review. Certain state laws and institutional policies, not taken into account within the decision charts, may aﬀect
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Protection Program staﬀ members and are required to be submitted for oﬃcial review and certiﬁcation by completion of this
application.
Contact the IRB at irb@unl.edu for further guidance.
Any general comments regarding this form can be added to the "Comments" button at the top of this page.
Basic Project Information
* 1. Project Title:
If this project corresponds with a current grant, contract, and/or award, use the same proposal
title to allow for eﬃcient communication between all necessary UNL oﬃces including Research
Compliance Services, the IRB and the Oﬃce of Sponsored Programs.
Rigorous Evaluation of the READY to Stand Curriculum as a Tool to Prevent the Commercial Sexual Exploitation of Children
Among Racially and Ethnically Diverse Urban Youth (PHASE I: FOCUS GROUPS AND COG INTERVIEWS)
* 2. Principal Investigator is:
Faculty
* Principal Investigator:
Katie Edwards - katie.edwards@unl.edu - 6034223207
* Principal Investigator's Department
Nebraska Center for Research on Children, Youth, Families and Schools
3. Secondary Investigator is:
Faculty
Secondary Investigator:
Rochelle Dalla - rdalla1@unl.edu - 4028810091

Secondary Investigator's Department
Department of Child, Youth and Family Studies
Description of Multi-Institutional Study Coordination
* 4. Are external person(s) not aﬃliated as a faculty, staﬀ or student with the University of
Nebraska-Lincoln working on the project?
Yes
* 4.a. Please list all external persons working on the project along with their email address,
role (e.g., research assistant, Co-Investigator, consultant, etc.), and institutional aﬃliation, if
applicable.
Yes, there are numerous people working on this project who are not aﬃliated with UNL. These include:
Stephanie Olson, CEO and Founder of The Set Me Free Project, will implement the curriculum in the schools;
stephanie@setmefreeproject.net
Jennifer Stalder, SUCCESS specialist, Des Moines Public Schools, consultant; jennifer.stalder@dmschools.org
Stacie Nessa, Social Worker with Des Moines Public Schools, consultant; Stacie.Nessa@dmschools.org
Dr. Justin Ingels, Research Associate Professor, University of Georgia-- will serve as a consultant on cost documentation
portion of the study; ingels@uga.edu
* 5. Is this a multi-institutional study? (i.e., colleagues from other institutions are on the research
team)
No
Project
* 6. Will the project involve an external performance site other than the University of Nebraska-
Lincoln where data collection will occur?
Yes
6.a. Please list all other institutions or agencies:
Institution/Agency
* 1. Name of Institution/Agency:
Des Moines Public Schools
* 2. Contact Information for the site:
Stacie Nessa
Educational Liaison Consultant
stacie.nessa@dmschools.org
* 3. Does the site have an IRB?
No
* 4. Has the site granted permission for the research to be conducted?
Yes
* 5. Is this site supported through a subaward?
No
* 7. Does this project involve any international sites where the PI will either conduct or supervise

the study?
No
* 8. The European Union’s ('EU') General Data Protection Regulation (‘GDPR’), regulates the
processing by an individual, a company or an organization of personal data relating to individuals
located (i.e., geographically and not to be confused with citizenship) in the EU. Will this project
process/control any personal data, monitor the behavior of individuals, and/or oﬀer good/services
(paid or free) to or from someone who is located in an applicable country within the EU?
No
The GDPR applies to persons located in the following countries Iceland, Liechtenstein, Norway, Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy,
Ireland, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Spain, Slovakia,
Slovenia, Sweden and the United Kingdom. To learn more about the EU GDPR, including possible additional
consent requirements, please visit the IRB Guidance webpage and reference the topic titled, European Union
General Data Protection Regulation (EU GDPR).
* 9. Does this project require review by Lincoln Public Schools (LPS)?
No
Note
Research can only begin at each performance site after the IRB receives and accepts the site's approval or
agreement document.
* 10. Describe the location(s) where recruitment and participation will take place (e.g., UNL,
UNMC, UNO, UNK, at home, in a community building, schools, hospitals, clinics, prisons, unions,
online, etc.).
Recruitment and participation will take place within eight public (5 traditional and 3 alternative) high schools within the Des
Moines Public School System (DMPS).
* 11. Describe the facilities available to conduct the research (e.g., there will be a quiet room in
the school to conduct interviews, a private research space, a participant will use their personal
computer, etc).
Data will be collected in a private oﬃce, in an empty classroom, and/or within a private area of the library or gym of one of
the DMPS high schools.
Funding
* 12. Funding source:
Present source
* 12.a. Funding source type:
Federal
* 12.b. Name or describe the funding sponsor. (e.g., NIH, NSF, USDA, name of company, name
of non-proﬁt, department funds, start-up funds, etc.) Along with the name, list the Oﬃce of
Sponsored Programs NUgrant project ID number or the assigned WBS number, if available.
Centers for Disease Control and Prevention.
RCS Update: 11/09/2022: Federal, Centers for Disease Control and Prevention (CDC), Sponsor Award Number: 1

U01CE003405-01-00; UNL OSP project ID #55872, OSP form #143481. Grant congruency review conducted by RW on
10/10/2022. NOTE: This project approves only a portion of the proposed research in the grant referenced here. The
approval only oversees Component A, Phase I. Future phases are expected to be submitted for review and approval
building upon what is learned in this phase. No human subjects research related to future phase may begin until UNL IRB
approval has been completed.
12.c. Related OSP Projects
ID :55872 click for more details
Title : Rigorous Evaluation of the READY to Stand Curriculum as a Tool to Prevent the Commercial Sexual Exploitation
of Children Among Racially and Ethnically Diverse Urban Youth
Lead PI : Katie Edwards - katie.edwards@unl.edu - 6034223207
Department : Department of Educational Psychology
Sponsor : DHHS-Ctr for Disease Control
* 12.d. Will this project be funded through a subaward and not the primary award?
No
* 12.e. If this project is associated with a federal award, have you been contacted by a program
oﬃcer with a speciﬁc timeline required for IRB review and approval?
No
Note
The protocol must be updated via a change request form when a new and/or additional funding source is
received so the project can be reviewed based on the speciﬁc source's policies and procedures.
Project Dates
Note
The dates identiﬁed below are intended to be estimates of when the project will start and end and not when the
application process begins.
* 13. Project start date:
(Start date is dependent upon approval)
11/01/2023
* 14. Project end date:
12/31/2023
Clinical Trials
The conduct of a clinical trial per any of the deﬁnitions below, requires certain language speciﬁc to the
description of a clinical trial to be included in the consent form(s). Template language for this requirement can
be found on the IRB website under the heading ClinicalTrials.gov (CT.gov) Template Language.
* 15. Is this project a clinical investigation that is regulated by the Food and Drug Administration

(FDA)?
No
* 16. Is this project a clinical trial that is funded or supported by a Federal Awarding Agency that
follows the Common Rule at 45 CFR 46?
No
* 17. Is this project categorized as a clinical trial per the deﬁnitions provided by the National
Institutes of Health (NIH)?
(Note: The NIH deﬁnition is only applicable if your funding source is from the NIH.)
No
* 18. Is this project categorized as a clinical trial per the deﬁnition 
 provided by the International
Committee of Medical Journal Editors (ICMJE) AND are you planning on submitting results of this
project to journals that follow the ICMJE's recommendations for the Conduct, Reporting, Editing
and Publication of Scholarly Work in Medical Journals? A full list of journals that follow ICMJE
recommendations is provided below. Please be aware some journals or sponsors may follow
guidelines requiring ct.gov registration but are not listed. Please check with the speciﬁc journal or
sponsor if you have questions regarding applicability of ct.gov registration.
Journals Following the ICMJE Recommendations
No
Page 2 of the New Project Form is used to assign a preliminary review type (Exempt, Expedited or Full Board) upon submission to
the IRB. Your selection of categories below will assist IRB staﬀ in the assignment and initial review process. This assignment is
only preliminary. IRB staﬀ will also conduct an initial pre-review upon submission to conﬁrm the most appropriate review type
and applicable categories.
Before completing this page there are a few items you might ﬁnd helpful to know:
More than one category in the review type of Exempt and Expedited can be selected. The higher review level (i.e., Expedited)
will be the default if this occurs.
Question marks 
 appear throughout this page to assist you in making an informed decision about the category selection.
Each question mark contains category speciﬁc information, general information, and intended use.
Review at an IRB meeting is only required if a project will be reviewed under the Full Board review category. The IRB meets
at least monthly throughout the year. Be aware of submission deadlines.
Exempt and Expedited projects are reviewed on an ongoing basis with no submission deadline requirements.
If there questions about any of the categories or review types, please contact the IRB at irb@unl.edu or 402-472-6965 or visit
our website at https://research.unl.edu/researchcompliance/human-subjects-research/.
Full Board Category
Any categories selected at the proposal stage are only preliminary. The IRB Coordinator will conﬁrm the appropriate review type and
respective category upon initial review with ﬁnal decision authority reserved by the IRB.
* Is this project greater than minimal risk?
No
* Will the project involve prisoners?
No
Exempt Category
Any categories selected at the proposal stage are only preliminary. The IRB Coordinator will conﬁrm the appropriate review type and

respective category upon initial review with ﬁnal decision authority reserved by the IRB.
Exempt Category 1: Research conducted in established or commonly accepted
educational settings that speciﬁcally involves normal educational practices that are not
likely to adversely impact students’ opportunity to learn required educational content or
the assessment of educators who provide instruction. This includes most research on
regular and special education instructional strategies, and research on the eﬀectiveness
of or the comparison among instructional techniques, curricula, or classroom
management methods.
Exempt Category 2: Research that only includes interactions involving educational tests
(cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures,
or observation of public behavior (including visual or auditory recording) if at least one
of the following criteria is met:
(2a) The information obtained is recorded by the investigator in such a manner that
the identity of the human participants cannot readily be ascertained, directly or
through identiﬁers linked to the participants; or
(2b) Any disclosure of the human participants' responses outside the research would
not reasonably place the participants at risk of criminal or civil liability or be
damaging to the participants' ﬁnancial standing, employability, educational
advancement, or reputation; or
(2c) The information obtained is recorded by the investigator in such a manner that
the identity of the human subjects can readily be ascertained, directly or through
identiﬁers linked to the subjects, and an IRB conducts a limited IRB review to make
the determination required by §46.111(a)(7).
Exempt Category 3: Research involving benign behavioral interventions in conjunction
with the collection of information from an adult (19 or older in the State of Nebraska)
subject through verbal or written responses (including data entry) or audiovisual
recording if the subject prospectively agrees to the intervention and information
collection and at least one of the following criteria is met:
(3a) The information obtained is recorded by the investigator in such a manner that
the identity of the human participants cannot readily be ascertained, directly or
through identiﬁers linked to the subjects; or
(3b) Any disclosure of the human participants' responses outside the research would
not reasonably place the subjects at risk of criminal or civil liability or be damaging to
the participants' ﬁnancial standing, employability, educational advancement, or
reputation; or
(3c) The information obtained is recorded by the investigator in such a manner that
the identity of the human participants can readily be ascertained, directly or through
identiﬁers linked to the participants, and an IRB conducts a limited IRB review to
make the determination required by §46.111(a)(7).

Regulatory Requirements for use of this category (3) and any of the criteria:
For the purposes of this category, benign behavioral interventions are brief in duration, harmless, painless, not
physically invasive, not likely to have a signiﬁcant adverse lasting impact on the subjects, and the investigator
has no reason to think the subjects will ﬁnd the interventions oﬀensive or embarrassing. Provided all such
criteria are met, examples of such benign behavioral interventions would include having the subjects play an
online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a
nominal amount of received cash between themselves and someone else.
If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption
is not applicable unless the subject authorizes the deception through a prospective agreement to participate in
research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding
the nature or purposes of the research.
Exempt Category 4: Secondary research for which consent is not required: Secondary
research uses of identiﬁable private information or identiﬁable biospecimens, if at least
one of the following criteria are met:
(4a) The identiﬁable private information or identiﬁable biospecimens are publicly
available; or
(4b) Information, which may include information about biospecimens, is recorded by
the investigator in such a manner that the identity of the human participants cannot
readily be ascertained directly or through identiﬁers linked to the participants, the
investigator does not contact the participants, and the investigator will not re-
identify participants; or
(4c) The research involves only information collection and analysis involving the
investigator's use of identiﬁable health information when that use is regulated under
the Health Insurance Portability and Accountability Act (HIPAA) at 45 CFR parts 160
and 164, subparts A and E, for the purposes of health care options or research as
those terms are deﬁned at 45 CFR 164.501 or for public health activities and
purposes as described under 45 CFR 164.512(b); or
(4d) The research is conducted by, or on behalf of, a Federal department or agency
using government-generated or government-collected information obtained for
nonresearch activities, if the research generates identiﬁable private information that
is nor will be maintained on information technology that is subject to and in
compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note,
if all of the identiﬁable private information collected, used, or generated as part of
the activity will be maintained in systems or records subject to the Privacy Act of
1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was
collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
Exempt Category 5: Research and demonstration projects which are conducted or
supported by a Federal department or agency, or otherwise subject to approval of
department or agency heads (or the approval of the heads of bureaus or other
subordinate agencies that have been delegated authority to conduct the research and
demonstration projects), and that are designed to study, evaluate, improve, or
otherwise examine public beneﬁt or service programs, including procedures for
obtaining beneﬁts or services under those programs, possible changes in or alternatives
to those programs or procedures, possible changes in methods or levels of payment for

beneﬁts or services under those programs. Such projects include, but are not limited to,
internal studies by Federal employees, and studies under contracts or consulting
arrangements, cooperative agreements, or grants. Exempt projects also include waivers
of otherwise mandatory requirements using authorities such as sections 1115 and 1115A
of the Social Security Act, as amended.
Regulatory Requirements for use of this category (5):
Each Federal department or agency conducting or supporting the research and
demonstration projects must establish, on a publicly accessible Federal website or in
such other manner as the department or agency head may determine, a list of the
research and demonstration projects that the Federal department or agency conducts or
supports under this provision. The research or demonstration project must be published
on this list prior to commencing the research involving human subjects.
Exempt Category 6: Taste and food quality evaluation and consumer acceptance studies
if wholesome foods without additives are consumed, or if a food is consumed that
contains a food ingredient at or below the level and for a use found to be safe, or
agricultural chemical or environmental contaminant at or below the level found to be
safe, by the Food and Drug Administration, or approved by the Environmental Protection
Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Note
The following Exempt categories 7 & 8 would allow the storage, maintenance and/or use of identiﬁable private
information and/or biospecimens if broad consent was used. The current categories are included in the
application to gauge the interest of the UNL research community in implementing the use of broad consent
under the Exempt categories.
At this time, it is the intention of the UNL IRB to potentially oﬀer these Exemptions in the future as a way to
reduce regulatory burden for investigators; however, there is also a considerable amount of work to be done to
be able to ensure that the exemptions are implemented in a manner that meets all regulatory requirements,
including the tracking of all non-consent for all projects using Exempt categories 7 & 8 at the institutional level.
Although, the UNL IRB will not be approving the use of broad consent at this time under the Exempt categories,
all previous regulatory requirements through traditional informed consent for non-exempt (i.e., Expedited or Full
Board) storage, maintenance, and research use involving identiﬁable information and biospecimens are still
available.
Exempt Category 7: Storage or maintenance for secondary research for which broad
consent is required: Storage or maintenance of identiﬁable private information or
identiﬁable biospecimens for potential secondary research use if an IRB conducts a
limited IRB review and makes the determinations required by §46.111(a)(8).
Exempt Category 8: Secondary research for which broad consent is required: Research
involving the use of identiﬁable private information or identiﬁable biospecimens for
secondary research use, if all of the following criteria are met:
(8a) Broad consent for the storage, maintenance, and secondary research use of
identiﬁable private information or identiﬁable biospecimens was obtained in
accordance with 45 CFR 46.111(a)(8); and the reviewer conducts a limited IRB review
and makes the determination in accordance with 45 CFR 46.111(a)(7); and the
reviewer makes the determination that the research to be conducted is within the
scope of broad consent; the return of individual research results to subjects is not
part of the study plan (this provision does not prevent an investigator from abiding
by any legal requirements to return individual research results); and documentation
of informed consent was obtained in accordance with 45 CFR 46.117.

(8b) Waiver of documentation of consent was obtained in accordance with 45 CFR
46.117.
Expedited Category
Any categories selected at the proposal stage are only preliminary. The IRB Coordinator will conﬁrm the appropriate review type and
respective category upon initial review with ﬁnal decision authority reserved by the IRB.
Expedited Category 1: Clinical studies of drugs and medical devices only when one of the
two conditions is met:
Research on drugs for which an investigational new drug application (21 CFR Part
312) is not required.
Research on medical devices for which (i) an investigational device exemption
application (21 CFR Part 812) is not required; or (ii) the medical device is
cleared/approved for marketing and the medical device is being used in accordance
with its cleared/approved labeling.
Expedited Category 2: Collection of blood sample by ﬁnger stick, heel stick, ear stick, or
venipuncture as follows:
From healthy, non-pregnant adults who weigh at least 110 pounds. In studies in
which more than 400 ml of blood is to be drawn within an 8 week period, the
participant must have a baseline hemoglobin level of 12.0 grams. After 250 ml of
blood has been drawn, the hemoglobin level must be retested; anyone whose
hemoglobin has fallen below 11.0 grams must be withdrawn from the study; or
From other adults and children, considering the age, weight, and health of the
participants, the collection procedure, the amount of blood to be collected and the
frequency with which it will be collected. For these participants, the amount drawn
may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection
may not occur more frequently than 2 times (or research sessions) per week.
Expedited Category 3: Prospective collection of biological specimens for research
purposes by non-invasive means.
Expedited Category 4: Collection of data through non-invasive procedures (not involving
general anesthesia or sedation) routinely employed in clinical practice (excluding
procedures involving x-rays or microwaves). Where medical devices are employed, they
must be cleared or approved for marketing. (Studies intended to evaluate the safety and
eﬀectiveness of the medical device are not generally eligible for expedited review,
including studies of cleared medical devices for new indications.)
Expedited Category 5: Research involving materials (data, documents, records, or

specimens) that have been collected, or will be collected solely for non-research
purposes (such as medical treatment or diagnosis).
Expedited Category 6: Collection of data from voice, video, digital, or image recordings
made for research purposes.
Expedited Category 7: Research on individual or group characteristics or behavior
(including, but not limited to, research on perception, cognition, motivation, identity,
language, communication, cultural beliefs or practices, and social behavior) or research
employing survey, interview, oral history, focus group, program evaluation, human
factors evaluation, or quality assurance methodologies.
Description of Participants
* 1. Estimate the number of participants per category via the table provided:
 
 Male
 Female
 Unspeciﬁed
 Totals
Adults
 
28
 
28
 
4
 
60
Children
 
45
 
45
 
10
 
100
Totals
 
73
 
73
 
14
 
160
* 2. Please indicate all special groups who will be purposefully recruited for the project. Please check all that apply.
Adults, non students
Employees
UNL Students
Persons currently serving in the
military
Students attending external
institutions (i.e., not UNL)
Veterans
Children (under age 19)
Persons with language impairment(s)
Persons who are institutionalized
Persons with mental disabilities
Prisoners
Persons with physical disabilities
Pregnant women/fetuses/neonates
Persons with psychological
impairment
Persons who are experiencing
restricted or inequitable civil rights
(including parolees and LGBT people
in certain states)
Persons who are decisionally-
impaired
Persons with HIV/AIDS
Persons with neurological
impairment

Adults and/or children with legal
representatives
Wards of the state
Other
Inclusion Criteria
* 3. Will both male and female participants be recruited?
Yes
* 4. Will participation be limited to certain racial or ethnic groups?
No
* 5. Describe the inclusion criteria that will be followed to select the participants to be enrolled in
the research, including the lower and upper age range of participants. If the project will include
various stages of recruitment, please describe the selection or inclusion criteria for each phase.
We are collecting focus group data from school personnel and high school students. We are collecting cognitive interview data
with youth only.
School personnel will include anyone who working in administration (e.g., principal), teaching (e.g., academic subject matter
instructor) or support service (e.g., counselor) capacity within any of the eight high schools encompassed within Des Moines
Public School (DMPS) system.
All youth/student participants will be enrolled in one of eight high schools (grades 9 - 12) within DMPS. The ﬁrst youth who
express interest from each school, who meet eligibility criteria and who have parental consent will be included.
Note
Nebraska age of majority is 19 years of age, with exceptions. If any participants below the age of 19 years will
be included in the research, additional requirements may be necessary based on the inclusion of minors, the
research review level and the category in which the project will be reviewed under.
* 6. Describe the process that will be followed to screen and determine the participant’s eligibility.
For example, eligibility determinations could be completed through a participant self-
determination process, screening questions included in a survey, pre-screening interview
questions, or through access of private information or biospecimens.
Eligibility will be determined by a verbal screening process conducted by the Project Coordinator or member of the research
team when potential participants contact him/her/them to learn more about the study. (See recruitment script, attached)
The ﬁrst who express interest and meet eligibility criteria will be selected for inclusion. In terms of youth, the ﬁrst who express
interest, meet criteria, and have parental consent will be included.
* 7. Describe your access to the population that will allow recruitment of the necessary number of
participants. For example, if you are an employee of an organization that will allow for the
research to occur, are the instructor of the classroom in which the research will take place, or you
have a professional/personal relationship with someone in the targeted population, etc., describe
that in your response.
The PIs (Drs. Edwards and Dalla) have a professional relationship with the DMPS administration including the superintendent
(see Letter of support), Executive Director of Student Services, Jake Troja, Director of School Climate Transformation, Mike
Vukovich, Director of High Schools, and Mary Grinstead, Executive Director of Data and Assessment. We are working directly
with Stacie Nessa (DMPS Educational Liaison Consultant), and Jennifer Stalder (DMPS SUCCESS Supervisor ). This group will
work with us to coordinate recruitment.
* 8. Describe the process that will be followed, facilities available, or locations that will be used
during the conduct of research to protect the privacy of participants, if applicable. In this

question, privacy refers to procedures such as how a participant will complete a sensitive
research questionnaire in private without having the possibility of someone reading their
responses over their shoulder or possibly having someone overhear responses during an
interview.
We will be collecting focus group discussions (FGD) with school personnel (n=60) and youth (n=80) and cognitive interviews
with youth (n=20). All FGD will include groups of ~10 people and occur in a private space in a DMPS library or empty
classroom. Responses from FG participants will be anonymized (no names associated with responses). All FGD participants will
be asked to maintain privacy of all information shared within the discussion--however, there is no guarantee that FG
participants will not share information outside the discussion (and this is in the consent/assent forms). Cognitive interviews
(n=20) will occur one-on-one (between participant and research staﬀ member trained by Dr. Edwards). These will occur in a
private room in a DMPS library, oﬃce or an empty classroom. Cognitive interview data/transcripts will be de-identiﬁed by a
member of the research team.
In terms of youth: the ﬁrst from each school who express interest, meet inclusion criteria, and have parental consent will be
included.
Exclusion Criteria
* 9. If not already described above, will any groups or categories of participants be excluded from
the project?
No
* 10. Speciﬁcally, will females of child-bearing potential or pregnant females be excluded?
No
* 11. Will subjects be vulnerable to coercion 
 or undue inﬂuence? 
 This question must be
answered as yes, if a member of the research team or an immediate family member are in or
perceived to be in a position of authority over potential participants. For example, this may be a
boss/director of an organization, or the instructor of classroom in which research takes place.
No
Research Methodology and Data Sources
* 1. Will the project involve audio recording?
Yes
* 1.a. What will be recorded? How long will the recordings be stored? How will they be stored?
Where will they be stored? Who will have access to the recordings? When will the recordings be
destroyed? How will the recordings be destroyed?
Focus group discussions and cognitive interviews will be recorded using a digital audiotape. Recordings will be saved in a
restricted UNL OneDrive folder that only the PI, Co-I, trained research assistants (RAs) will have access to. The recordings
will be deleted after they are transcribed by Rev.
* 1.b. Will the audio recordings be transcribed?
Yes
* 1.b.1. How will the audio and transcripts be transferred between the research team and
the transcriptionist or transcription services organization? Will the audio and/or transcripts
contain identifying information? Who is completing the transcription? If being completed by
an online service, what protocols are in place to ensure data security? As a
recommendation, transcriptionists external to the research team should complete a
conﬁdentiality agreement.

Note
Depending on the sensitivity of the data and the vulnerability of the participants,
additional requirements for transcription services may be necessary. A template
conﬁdentiality agreement is available on the IRB website.
FG and cognitive interview recording ﬁles will be uploaded to REV (a professional transcription service). The
recordings will be de-identiﬁed by research staﬀ before uploading to Rev. All REV professionals have signed NDAs and
conﬁdentiality agreements (see attached).
* 2. Will information be obtained from study participant(s) utilizing web, mobile or online data
transmission procedures? For example, this question would be answered "yes" if the project
involves the use of Qualtrics as an online survey provider or a mobile application.
Yes
* 2.a. What web, mobile, or online program will be used? Will the data be sent to a secure
server? Will the data be encrypted while in transit? Will IP addresses be collected by the online
program? If IP addresses will be collected by the program, will they be stored in the research
records external to the web, mobile or online program? If so, what is the purpose of storage
and use as it relates to the purpose of the research? If applicable, will a third-party or external
organization also have access to the data?
Demographic surveys will be completed using qualtrics; data will be sent to a secure UNL onedrive folder. IP addresses
will not be collected. Names or other identifying information will not appear on the demographic forms (see Demographic
Forms- youth and school personnel). No one but members of the research team [PI, Co-I, research assistants trained by PI
Edwards] will have access to the data.
* 2.b. Based on the nature of web-based studies and global accessibility, participants from an
EU GDPR regulated country could be incidentally included and the GDPR may be applicable if
the project processes/controls any personal data, monitors the behavior of individuals, and/or
oﬀers good/services (paid or free) to or from someone who is located in an applicable country
within the EU. Will participants from a regulated country be targeted for inclusion or will
responses be restricted to those only in the United States and those in non-regulated
countries?
Restricted to US and non-regulated countries only
Note
The GDPR applies to persons located in the following countries Iceland, Liechtenstein, Norway, Austria,
Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Italy, Ireland, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania,
Spain, Slovakia, Slovenia, Sweden and the United Kingdom. To learn more about the EU GDPR, including
possible additional consent requirements, please visit the IRB Guidance webpage and reference the topic
titled, European Union General Data Protection Regulation (EU GDPR).
According to the European Commission, personal data is any information that relates to an identiﬁed or
identiﬁable living individual. Diﬀerent pieces of information, which collected together can lead to the
identiﬁcation of a particular person, also constitute personal data.
Personal data that has been de-identiﬁed, encrypted or pseudonymised but can be used to re-identify a
person remains personal data and falls within the scope of the GDPR.
Personal data that has been rendered anonymous in such a way that the individual is not or no longer
identiﬁable is no longer considered personal data. For data to be truly anonymised, the anonymisation must
be irreversible.
The GDPR protects personal data regardless of the technology used for processing that data – it’s
technology neutral and applies to both automated and manual processing, provided the data is organized in
accordance with pre-deﬁned criteria (for example alphabetical order). It also doesn’t matter how the data is
stored – in an IT system, through video surveillance, or on paper; in all cases, personal data is subject to the
protection requirements set out in the GDPR.
Examples of personal data:

a name and surname;
a home address;
an email address such as name.surname@company.com;
an identiﬁcation card number;
location data (for example the location data function on a mobile phone);
an Internet Protocol (IP) address;
a cookie ID;
the advertising identiﬁer of your phone;
data held by a hospital or doctor, which could be a symbol that uniquely identiﬁes a person.
Examples of data not considered personal data:
a company registration number;
an email address such as info@company.com;
anonymous data.
To learn more about the EU GDPR, including possible additional consent requirements, please visit the IRB
Guidance webpage and reference the topic titled, European Union General Data Protection Regulation (EU
GDPR).
* 2.b.i. Describe how the project will restrict responses from those in an applicable EU GDPR
country if you are collecting personal data?
Recruitment, as it relates to GDPR, is restricted to the US only and does not apply.
* 3. Will the project obtain, use, study, or analyze Protected Health Information (PHI) (i.e.,
information obtained from or provided to a covered entity or business associate such as a doctor's
oﬃce, hospital, nursing home, insurance company, etc.)? If this project uses PHI, training is
required to be completed by PIs, Supervising Investigators and participating personnel who
conduct research applicable to the Health Insurance Portability and Accountability Act (HIPAA).
Information Privacy and Security – Information for Researchers: Basic Course is completed through
the Collaborative Institutional Training Initiative (CITI).
Note
Self-reported health information provided directly to the investigator is not covered by the
Privacy Rule if that investigator is not part of the workforce of a covered entity.
No
* 4. Will the project ask questions about illegal drug use or criminal activity that could place
participants at risk for legal action?
No
* 5. Does a Certiﬁcate of Conﬁdentiality apply to this project?
Note
Certiﬁcates of Conﬁdentiality are obtained from federal agencies, such as the National
Institutes of Health or the Department of Justice.
Learn more about Certiﬁcates of Conﬁdentiality on the UNL IRB webpage. If a project involves
a Certiﬁcate of Conﬁdentiality, speciﬁc information must be present in the consent form
informing participants of the certiﬁcate. See the IRB website for more information.
Yes
* 6. Will the project involve photography?
No

* 7. Will the project involve videography?
No
* 8. Will the project use, or analyze archival or secondary data?
No
* 9. Will the project collect, use, study, analyze, or generate bio-specimens such as cells, tissues,
saliva, blood, serum, human excreta, tissue, hair, teeth, etc.?
No
* 10. Will this project store, maintain, use or generate identiﬁable private biospecimens or
information, including participant contact information, for the purposes of future use by the study
team or others outside of the study team? Typically information or biospecimens for future use
are stored in a biorepository, data repository or registry.
Note
Biospecimens or information are considered identiﬁable if identiﬁer(s) are readily accessible
to at least one member of the study team, including a master list linking names and codes.
No
* 11. Does this project utilize human embryonic stem cells (hESC) and/or their derivatives?
No
* 12. Does this project utilize human fetal cells, fetal tissue (hFT) and/or their derivatives?
No
* 13. Does this project involve the use of ionizing radiation or ionizing radiation-emitting device(s)
that is not part of a clinical patient’s standard of care?
Note
A magnetic-resonance imaging (MRI) machine does not emit ionizing radiation.
No
* 14. Will the project ask participants to perform physical tasks (e.g. climbing a ladder, doing a
push-up, contracting a muscle, running on a treadmill, etc.)?
No
* 15. Does this project involve a medical device and it is the object of the investigation?
Note
Even some smartphone applications could be regulated by the FDA if they meet the deﬁnition
of a medical device. Always consult with your IRB coordinator if you are unsure how to
answer this question. Be aware, all projects regulated by the FDA are referred to the UNMC
IRB for review under the FDA regulations.
No

* 16. Does this project involve a FDA-approved and marketed device and it is NOT the object of the
investigation?
No
Purpose, Methods & Procedures
1. Indicate the project’s design by checking the appropriate box(es):
Action research
Case-control
Class Project
Cohort
Correlational
Cross-sectional
Ethnography
Exploratory
Evaluation
Intervention
Longitudinal
Pilot
Randomized
Other
* 2. What is the signiﬁcance/purpose of the project? (Provide a brief description in lay terms
including a brief literature justiﬁcation and objectives/aims of the research.)
The overall goal of the 5-year project is to conduct both a process and rigorous outcome evaluation of The Set Me Free
Projects (SMFP) READY to Stand (RTS) curriculumwith an eye toward widespread dissemination to other U.S. communities, if
deemed eﬀective.
The overall project is divided into Components A and B, and three diﬀerent IRB Phases for IRB approval as follows:
1. Component A, Phase I: Focus groups with students (n = 80) and school personnel (n = 60); cognitive interviews with
students (n = 20)
2. Component A, Phase II (Open Pilot Trial/OPT): Survey data from students (n = 878) and school personnel (n = 78) to further
reﬁne the surveys and procedures; and
3. Component B, Phase III (RCT): quasi experimental study
The current application is for Component A, Phase 1 aimed at planning and reﬁnement of instruments through FG and
cognitive interview data.
To date, no comprehensive, rigorously evaluated primary prevention programs for CSEC exist. Although a handful of programs
have been developed to prevent CSEC, they are often awareness-based only programs (rather than skills-based programs),
target select groups of youth (e.g., system-involved), seek to prevent revictimization (rather than initial perpetration) or focus
on reducing victimization risk only (rather than focusing on perpetrators and/or bystanders), and are rarely (and never
rigorously) evaluated. Experts have suggested that CSEC programming focus on healthy and unhealthy relationships, provide
youth with general information about sex traﬃcking, factors related to sex traﬃcking, and identiﬁcation of safe people and
needed resources. Additionally, programs that include bystander intervention training as well as promoting social norms that
protect against violence may help to reduce the incidence of CSEC. Further school personnel are likely critical partners in the
prevention of CSEC.
The READY to Stand (RTS) Curriculum (which stands for Report anything dangerous; End the communication; Ask for help;
Dont engage; and Your safety ﬁrst) is a commercial sex traﬃcking prevention program created for 3rd to 12th grade students
and includes programming for school personnel. The RTS for high school students provides students four, 45-minute modules
with psychoeducation on CSEC, healthy relationship skills training, identiﬁcation of safe people and resources, and
programming components to enhance valuing of self and others. The RTS will be enhanced with two additional 45-minute
modules that focus on bystander intervention training in situations of CSEC and shifting school and community norms to be
intolerant of all forms of violence, including CSEC and glamorization of pimp culture.
* 3. Describe the data collection procedures sequentially. (Upload all interview questions,
measurements, images, examples, etc. on page nine. Do not just provide a list of procedures, but
rather this section must include enough information for the IRB to understand what the
participants will be asked to complete.)
For this phase of the research project (Component A, Phase I: Reﬁnement and Planning), will we collect focus group data from

youth (n = 80 or until saturation is reached) and school personnel (n=60 or until saturation is reached), and cognitive
interview data from youth (n=20).
High school students and school personnel associated with one of the eight public high schools (5 traditional and 3 alternative
schools) in Des Moines will be included. We will conduct approximately one focus group per school for youth (10 participants
per school x 8 schools) and one focus group per school for school personnel (10 participants per school x 5 regular high
schools and an additional focus with school personnel from each of the 3 alternative schools.
The focus groups with youth will last approximately 90 minutes and engage youth in a discussion regarding perceptions of
commercial sexual exploitation of children (CSEC) in their school and more speciﬁcally opportunities for bystander action in
situations of CSES as well as social norms regarding the acceptability of CSEC. Youth will also be asked their ideas for how to
enhance students engagement in bystander action in situations of CSEC as well as how to create school and community
norms that are intolerant of CSEC and foster the belief that everyone has a role to play in ending CSEC. The role of
glamorization of pimp culture in CSEC will also be examined as well as perceptions of survey research inquiring about CSEC
(after explaining to youth why it is important to ask these questions and how they are used in research). Youth will be asked
to provide ideas for ways to enhance safety of youth participation in CSEC research and ways to enhance enrollment and
retention of youth in CSEC research (see Focus Group Script_Youth, attached).
The focus groups with school personnel will last approximately 90 minutes and engage school personnel in discussion
regarding perceptions of how CSEC impacts students in DMPS and their ideas for the role that school personnel can play in
preventing CSEC in DMPS, speciﬁcally around modeling programming messages speciﬁc to bystander action and shifting
community norms to be intolerant of all forms of violence, including CSEC (see Focus Group Script_School Personnel,
attached).
After the initial item pools for the survey instruments have been created following focus groups, research advisory input, and
an updated and extensive literature review, the researchers will conduct cognitive interviews with students (N=20 across all 8
high schools).These will be used: to ensure that students understand the survey questions, to determine if questions need
modifying to be more salient/relevant to the age group and local context, to ensure that the response options are meaningful,
etc. More speciﬁcally, participants will be asked to read each question and response options aloud. We will ask probing
questions such as, tell me in your own words what this means, does this question make sense and if not why, how could we
make this question better, etc (see Cognitive Interview Script_Youth, attached).
[The measures that are to be used in the cognitive interview procedures will be submitted via a change request form once
they are conﬁrmed through the FG data analyses, lit review, and consultation with the research advisory board].
* 4. Brieﬂy describe the data analysis plan.
All data will be transcribed (by Rev) and then analyzed by trained research assistants/project staﬀ (supervised by Drs.
Edwards and Dalla) using thematic analysis. Speciﬁcally, More speciﬁcally, audio ﬁles will be transcribed (using Rev, a speech
to text on-line transcriptions service), deidentiﬁed by a member of the research team, and then read thoroughly to become
familiar with the data. Initial codes are then created that represent the meaning and patterns evident in the data. A codebook
is created simultaneously to keep track of the codes. The next step involves reading data again and applying codes to
excerpts/passages that correspond to codes. Excerpts that represent the same meaning(s) receive the same code. Next, all
excerpts with the same code are grouped together. The codes are then grouped into potential themes; with some themes
having sub-themes. Themes are then reviewed and revised, ensuring that each theme has enough data to support it as a
distinct concept. Themes are then arranged in narrative communicating results of analysis. Although school personnel data
will be analyzed separately from student data, we will examine similarities and diﬀerences in themes across these
populations. We will also examine variations in themes across subpopulations of students as well as subpopulations of school
personnel. Themes will be shared with the research advisory board and their input on how to use this data to inform
programming and research will be solicited.
* 5. Does this project involve deception?
No
* 6. Describe how long, in terms of time, the procedures will take a participant to complete. The
description should include the duration of a session, the number of sessions, over what period of
time and the total time required to complete the procedures.
Each focus group participant (youth or school personnel) will engage in one ~90-minute group discussion.
Each cognitive interview participant will engage in one ~90-minute one-on-one interview.
* 7. Will there be any follow-up with the participant or will reminders be sent to the participant?
Yes
* 7.a. Describe how the follow-up/reminder(s) will be completed (e.g. in-person, email, text-
message, etc.). Describe the number of follow-up/reminder(s) that will be completed. (Upload
all applicable scripts, templates, email, etc. on page nine.)
Participants will each receive two reminders (via email or text) at one week and 3 days before their upcoming focus group
or cognitive interview (see reminder script, attached).

* 8. Describe any procedure not being done solely to achieve the project's proposed purpose. For
example, a student will always complete the assignment described in the procedures during their
classtime but the survey evaluating the assignment is done strictly for the project.
None
* 9. Describe the research team's available time allocated to conduct and complete the project.
Essentially, the IRB would like to know if your time available would be suﬃcient to achieve the
results successfully in a responsible manner.
The PIs (Drs. Edwards and Dalla) have time allocated speciﬁcally for this project; research assistants will hired for the project
as well as a project coordinator.
* 10. Describe the process followed to ensure that all persons assisting with the research (e.g.
data collectors, transcriptionists, research assistants, etc.) are adequately trained, have the
qualiﬁcations and appropriate training to perform the procedures included in the research.
Describe the communication plan that the research team will follow to ensure that all personnel
members , are informed about the protocol, any changes to the protocol, research-related duties
and functions, etc.
Dr. Edwards will take lead on implementing data safety procedures. Regular study team meetings (e.g., PI, Co-Is, Project
Coordinator) will dedicate time to the data safety and monitoring to ensure that all data quality and IRB policies and
procedures are being followed. We will ensure that any study staﬀ are following best practices for data storage. The research
materials as part of Component A consist of focus group transcripts and interview transcripts. No identifying information will
be included in the data. Focus group and individual interviews will be recorded and transcribed. Neither recordings nor
transcripts will include names or other identifying information. Upon completion of transcription and data checking, all audio
recordings will be destroyed.
We will ensure that all study staﬀ complete CITI training prior to study participation, are aware of appropriate procedures, and
are aware that we limit access to data to only study staﬀ that are necessary. As needed, we will consult with IRB for help to
ensure that best practices for ethical and safe practice of research are being followed.
Recruiting Procedures
* 1. Describe how potential participant names and contact information will be obtained. For
example, a list of names will be obtained from the telephone directory.
Students and school/district personnel for the focus groups and cognitive interviews will be recruited through word of mouth,
ﬂiers posted throughout the schools including staﬀ break-rooms, announcements in school outlets (e.g., school newspapers /
school social media), and targeted recruitment through diverse student groups (e.g., Gay Straight Alliance) (see Recruitment
Flyer, attached).
The recruitment ﬂier indicates that students and school personnel are both needed for the project. Those interested are asked
to contact the project coordinator (PC) who will provide more information, conﬁrm that the individuals are eligible to
participate, and then--
IF SCHOOL PERSONNEL:
If the caller is school personnel the project coordinator would move forward to schedule the FC (refer to PC_School Personnel
Recruitment script).
IF YOUTH:
PC will determine if they are intersted in the FG or the cognitivie interview, obtain parental/guardian contact information and
youth contact information. The PC will then contact the parent/guardian, explain the study, and then send a link to the
parental consent form. Once this is received, the PC will contact the youth, schedule the FG or cognitive interview, and send a
link to complete the youth assents. (refer to PC_Youth Recruitment script).
* 2. Describe how potential participants will be approached or told about the opportunity to
participate in the project. Ensure all phases of recruitment are described. Upload all applicable
recruitment documents such as scripts, ﬂyers, templates, etc. on page nine.
Potential participants will contact the Project Coordinator (PC; see above)
The PC will:
1. Conﬁrm eligibility (i.e., high school student at one of the 8 DMPS schools) or high school personnel aged 18 or more.
2. Answer questions about study.
If potential participant is school personnel, Project Coordinator will then (see PC_School Personnel Recruitment Script):
3a. Schedule the FG with the person;
3b. Obtain preferred contact method for reminder (text or email);
3c. Send link to qualtrics consent form.

If potential participant is a youth, Project Coordinator will then (see PC_Youth Recruitment Scrip):
3a. Determine if youth wants to be involved in Focus Group or Cognitive Interview;
3b. Obtain contact information for parent/guardian; obtain contact information for youth;
3c. Contact parent (via phone; see Parental Contact and Permission Script) to explain the study and their youth's interest in
participating (in FG or cognitive interview) and answer questions. If parent is interested in having their child participate,
Project Coordinator will send a link (via text or emial) to parent;
3d. Once the parental consent form is received, the Project Coordinator will contact the youth, schedule the FG or interview,
and then email or text a link to the youth assent (see Youth_ParentPermissionReceived(PPR) Script).
Beneﬁts and Risks
* 3. Describe any direct beneﬁts to participants, if any.
Note:
Payments or incentives (including credit) should be discussed in section 6.9.a.
There are no direct beneﬁts of this research. However, participants may enjoy being part of the study and discussing the
topics with others.
* 4. Will any individual results of the research or procedures/tests completed, be provided back to
the participant?
No
* 5. Describe the beneﬁts of the research to society, if any.
The information provided in this research will strengthen the surveys and procedures for Component B-- the evaluation of the
prevention program curriculum. Results will be valuable to help keep youth healthy and to prevent the CSEC.
* 6. Describe all risks to the participant including a breach of conﬁdentiality, if applicable. What
will be done to minimize the risk(s)? If there are no known risks, this should be stated.
The risks of this study are minimal. Participants may feel sad or anxious or award when we discuss sensitive topics however,
none will be asked about their personal experiences. Instead, this study is intended to obtain perceptions about the issues in
Component B (e.g., perceptions of CSEC in their school, school norms regarding the acceptability of CSEC; Focus group data)
and to see if the surveys make sense (e.g., "does this question make sense and if not why?", cognitive interviews). A resource
page for services in the Des Moines area related to, for example, sex traﬃcking, sexual violence, homelessness,
physical/domestic violence etc... will be provided to each participant. (see Resource Sheet, attached).
Information has been included at the lead in to the FGs indicating that we will not be asking about personal experiences and
asking that participants not provide information on personal experiences. If infomation is provided that requires mandatory
reporting the following steps will be made:
1. the researcher will contact the PI
2. the PI will report the incident to the proper authorities (most likely Iowa Department of Public Health and/or law
enforcement);
3. PI will report incident to IRB
An additional risk is that there is no guarantee that a member of a focus group won't share what is said as part of the focus
group. However, we will stress that all information discussed in the FG is conﬁdential and stress the importance of maintaining
that conﬁdentiality after the FG is over. Language to this eﬀect has been included in all FG consent forms/assent forms.
Because we are not asking about personal experiences, there are no negative consequences or known risks if a breach of
conﬁdentiality should occur.
* 7. Does this research involve procedures, equipment or tests that could reasonably result in an
incidental ﬁnding?
No
* 8. Describe the availability of medical or psychological resources that participants might require
as a consequence of the research and/or in the case of incidental ﬁndings, if applicable.
Data will be collected within the DMPS school system (library, gym, oﬃce, empty classroom). There are counselors on site at
each school, as well as trained personnel (teachers, special education instructors, etc...). In addition, we will provide all
participants with a list of resources available within the Des Moines community.

Compensation/Incentives and/or Cost for Participation
* 9. Will compensation or incentives (including money, gift certiﬁcates, extra credit, books, t-
shirts, etc.) be provided to participants?
Yes
* 9.a. Describe the amount and form of compensation. If providing research or course credit,
please describe the alternate activity that will be available for students who choose not to
participate in the project and still want to receive credit. If a lottery/raﬄe is oﬀered, please
describe the odds of winning and when the winning participant(s) is expected to be notiﬁed.
If the project is supported through a form of funding, including department, internal, or start-
up funds UNL accounting requirements must also be met when documenting receipt of
participant payments. Describe how UNL accounting requirements will be met, speciﬁcally
when handling payment receipts that include individual identifying information.
Each person will be provided a $25 gift card; they will sign a form indicating they received the gift card (see attached).
These receipts will not be attached to any of the collected data.
* 10. Will the research require the participant to pay for any aspects of the study or cost for
participation, including cost for travel and transport to and from the study site?
No
Informed Consent Process
* 1. Describe how informed consent/assent will be obtained and the process that will be followed
to ensure the participant understands the information presented. (Upload age appropriate
consent/assent forms, if applicable, on page nine.)
YOUTH:
1. Project coordinator will go over the key parts of the study (purpose, risks, procedures) with the parent (while on the phone)
to make sure they understand, answer all questions, and then email or text a link to the parental consent form.
2. Once the parental consent form is obtained, the PC will contact the youth, schedule the FG or cogn. interview, and send a
link to the youth assent form via email or text. Phone number of PI and PC are included on the form with instructions to
contact if they have questions.
SCHOOL PERSONNEL:
1. Project coordinator will send (via text or email) the consent form to school personnel.
* 2. Describe the person(s) who will obtain participant consent/assent.
The project coordinator will obtain consent, parental consent, and youth assent.
* 3. Describe who will provide consent/assent. If you have identiﬁed the inclusion of either child or
adult wards or persons with a legally authorized representative (LAR) within section 3.2 of the
protocol, describe the process that will be followed to ensure the LAR is providing the consent for
the participant.
School Personnel (18+) provide consent for themselves (see attached).
Parents/guardians will provide parental informed consent for their youth. On the consent form, the parent/guardian conﬁrms
that they are legally responsible for the youth they are consenting (see attached). After parental consent is obtained, youth
will be contacted by PC, questions answered about the study, and then a link to the assent will be emialed or texted.
* 4. Describe the waiting period, if any, between when the potential participant will be informed of
the study and when consent will be obtained. If multiple data collection points are included within
the project, describe the amount of time between each period.
SCHOOL PERSONLEL: All school personnel interested in the project will contact the Project Coordinator (PC) who will provide
more information about the study and schedule the FG if s/he wants to participate. At that time, a link to the informed consent

form will be emailed (or texted) to the person to complete and submit. (no waiting period).
*If consent has not been received, the PC will remind of this and send a new link when the PC calls for the reminder of the
scheduled FG.
*The PC will provide the researchers leading the FG a list of people who have provided consent and who are scheduled for that
FG
YOUTH: All youth nterested in the project will contact the Project Coordinator (PC) who will provide more information about the
study and determine whether the youth is interested in the FG or cognitive itnerview. The youth will provide contact
information for his/her parent/guardian. The PC will then contact the parenta/guardian and explain the study and then email or
text a link to the parental consent form if they are willing to allow their youth to participate. Once that has been completed,
the PC will contact the youth, schedule data collection, and then send the link (text or email) to the youth to obtain youth
assent. (minimal waiting period)
*Cognitive interviews & FG are scheduled after receiving parental consent. The PC will provide the researchers leading the FG
a list of youth who have recieved parental consent and provided assent and who are scheduled for that FG. Anyone who
arrives without the required documentation completed will be asked to leave.
*The PC will remind the youth about the assent form when s/he calls to remind about the scheduled interview/FG. If the youth
still does not complete the assent by the day prior to the interview, it will be cancelled.
* 5. Describe the primary language that will be used by those obtaining consent.
English*
*Component A is planning and reﬁnement (information gathering) if it is necessary to obtain consent/parental consent/youth
assent in another language (e.g., Spanish) a modiﬁcation will be sent to IRB in advance.
* 6. Describe the primary language understood by the participant. If translation services (verbal
and/or written) are needed, please describe that here. If written materials are necessary a
Translation Certiﬁcation Form is required.
English*
*Component A is planning and reﬁnement (information gathering) if it is necessary to conduct a FG (or one-on-one interview);
in another language (e.g., Spanish) modiﬁcations will be submitted to IRB in advance.
* 7. Will any subjects be decisionally impaired so that they do not have the capacity to give
consent?
No
* 8. In certain cases involving non-exempt research (i.e. Expedited or Full Board), a waiver of
informed consent or a waiver of an element of informed consent may be requested. Additionally,
for projects including UNL students who are 17 or 18 years of age, a waiver of parental consent
may be requested. Would you like to request a waiver of consent or a waiver of a consent
element?
No
9. In certain cases involving non-exempt research (i.e., Expedited or Full Board), a waiver of informed consent documentation may be
requested. Electronic consent may be a typical process where consent documentation might be waived.
Note
In the state of Nebraska, electronic signature must be individually identiﬁable to the person signing to constitute
electronic signature.
* Will this project request to waive consent documentation (e.g. signature)?
No
Note
Consent documentation cannot be waived when an authorization to access Protected Health Information is
required under the HIPAA regulations.

Conﬁdentiality
* 1. The project should make adequate provisions to maintain the conﬁdentiality of the data.
Describe how conﬁdentiality of all records will be maintained.
Audio recordings will be uploaded to a private UNL OneDrive/Sharepoint folder. Only those associated iwth the projec (PI, Co-I,
project coordinator or research assistants/staﬀ ON THIS IRB PROTOCOL) will have access to these. Audio recordings will be
uploaded to Rev where they will be transcribed. Once transcribed, all audio-recordings will be deleted. Transcript ﬁles will be
uploaded to a private UNL OneDrive/Sharepoint folder. Only those associated with the project (e.g., PI, Co-I, project
coordinator or research assistant) will have access to these.
* 2. Will participants be identiﬁable during data collection or in the results? (This question should
be answered "yes" if data collection is completed in an in-person setting or if data will be coded
throughout the research process and a link is maintained between the code and participant
identiﬁers.)
Yes
* 2.a. Describe how participants will be identiﬁed during the data collection procedures and in
the data.
The Project Coordinator will maintain a list of all youth and school personnel who participate (as well as contact
information-- this is necessary to arrange the Focus Groups and cognitive interviews as well as to send reminders). After
participating, all youth and school personnel will also sign a "Research Participant Compensation Conﬁrmation" form.
However, none of these identiﬁers will be associated with the data provided by the research participants.
* 2.b. If the data are coded, describe if a list linking names and codes will be used. The
description should include the process that will be followed to keep the list secure during and
after data collection and when the list will be destroyed. If the list will continue to be stored
after all data collection procedures are complete and data has been veriﬁed, a justiﬁcation for
long-term storage must be provided.
A list of names associated with each focus group will be maintained by the Research Team members coordinating the
focus groups (to identify who shows up/who does not). However, identifying information will not be associated with any of
the focus group data collected. Lists of participants will be kept in separate ﬁles from the audio-recordings or transcripts.
Lists of participants will be destroyed after data collection (other than participant payment forms kept on ﬁle).
The research conducting the one-on-one interviews will also know the name of the youth they are interviewing. However,
this information will not be associated with the interview data, but in a separate ﬁle for record keeping purposes only.
Data will be stored online 7 years post publication.
* 3. Describe how long the project records and data will be kept. The description should
diﬀerentiate between the length of storage time for identiﬁable and de-identiﬁed records, if
applicable.
Audio recordings will be kept only until they are transcribed (no more than one year). De-identiﬁed transcripts will be kept for
seven years and then destroyed.
* 4. Describe where and how records and data collected will be stored. The description should
include how both electronic and/or paper/physical records and data will be stored. Speciﬁcity
regarding secure UNL servers vs. external servers possibly utilizing cloud computing must be
provided, if applicable.
A list of names associated with each focus group will be maintained by the Research Team members coordinating the focus
groups (to identify who shows up/who does not). However, identifying information will not be associated with any of the focus
group data collected. Lists of participants will be kept in separate ﬁles from the audio-recordings or transcripts. Lists of names
will be destroyed following the completion of data collection although they will be maintained in payment and consent/assent
forms).
The research conducting the one-on-one interviews will also know the name of the youth they are interviewing. However, this
information will not be associated with the interview data, but in a separate ﬁle for record keeping purposes only.
Lists of participants will be kept in a password protected computer by the Project Coordinator and in a private UNL onedrive
folder with access limited to project personnel. Participant lists will be kept for 7 years and then destroyed.
Signed consent forms / youth assent forms will be scanned and uploaded to a private UNL Onedrive folder; once scanned the
original paper copies will be shredded; parental permission forms will kept in a private UNL Onedrive folder.

* 5. Describe all persons or entities planning to have access to the records and/or data.
Only project personnel will have access to the data: Project Coordinator, PI, Co-I, research assistants/staﬀ on this IRB protocol.
Rev will have access to the audio-recordings as well in order to transcribe.
* 6. Describe how data and/or research results will be reported. The description should include
whether the data will be reported individually, identiﬁable, or in summary (aggregate) format.
This description should also consider the possibility of deductive disclosure when reporting results
or describing the research in a manuscript. If applicable, describe if masking procedures or certain
descriptions would or would not be used. Also, describe if the data/results will be reported at
conferences, in journals, in a thesis, in a dissertation, to the funding agency, back to the project
site, etc.
All data will be reported in aggregate form only; names or particpant identifying information will not be used.
Data Monitoring & Sharing
* 7. Does the project require data safety monitoring?
Yes
* 7.a. Describe the provisions for monitoring the data to ensure the safety of participants. For
example, in a clinical drug trial study, the data is monitored as it is collected to detect adverse
side eﬀects. If participants are having serious reactions to the study drug, then the study is
adjusted to protect the participants. A second example would be in a study on teen suicide, if a
teen exhibits signs of suicidal tendencies, a process is in place to notify the appropriate people
immediately rather than realizing the problem at the end of the study.
At this point in the project, the research team will be monitoring the data for safety. This will involve de-brieﬁng with all
data collectors for both the FGs and cogntive interviews; having at least 2 researchers present at each FG; contacting the
PI immediately if any problems or unexpected events arise at the FG or cogn. interviews.
* 7.b. Identify what data will be reviewed.
Information provided at the FG and cogntive interviews.
* 7.c. Describe how often the data will be reviewed.
The research team will be monitoring the data provided by participants for as the data are being collected (during FG or
interviews). The PI will be contacted if any problems are detected (e.g., personal disclosures; individuals showing up
without proper consent/parenal consent/assent; upset at the questions or emotional distress).
* 7.d. Describe what actions would be considered during the review of the data.
The PI will be contacted immediately. Actions will result depending on what the issue is (e.g., informing that a person was
asked to leave a FG because he/she showed up without having received parental consent; pausing the cogntive interview
if a break is needed, etc...). All incidents will be recorded. IRB will be notiﬁed in cases including, but not limited to:
mandatory reporting required, person stopping the FG or cogn. interview because of being upset; person not allowed to
participate in FG bc parental consent not obtained.
* 8. Do you plan to share the data collected during this project through public-use ﬁles,
repositories or other means outside of your approved research team and/or sites?
No
Note
If data sharing plans change at any time, please contact your IRB coordinator to discuss the necessary
steps, as applicable.

Questionnaires, Surveys, and Testing Instruments
* Please list all questionnaires, surveys, and/or assessment instruments/measures used in the
project.
Focus group script- school personnel
Focus group script- youth
Cognitive interview- youth
Demographics (school personnel and youth)
*Please note that we will come back with a change request form with the surveys for the cognitive interviews, branding for
ﬂiers/consents, and other edits after working more with our school partners to obtain their input. We are also in the process of
discussing plans for putting together adult and youth advisory boards and will let the IRB know about these as well. Just like
other boards in PI Edwards work, these individuals will provide guidance/input on all study protocols that are submitted to the
IRB.
**The funded grant proposal is also uploaded.
Uploaded Attachments
Please submit copies of the following:
Funding application
Institutional Approval letters
Data sharing plans
Recruitment ﬂyers, ads, phone scripts, emails, etc.
Informed Consent Forms, emails, and/or letters
If transcriptions are required, Conﬁdentiality Agreement that transcriptionists will sign
If this is a study utilizing PHI, Release of Authorization that will be used to obtain permission
from the participant for the agency/institution to release protected health information for
project purposes or a letter from the agency/institution documenting agreement to provide
protected health information for project purposes
All Instruments/Measures used in the project
Please upload all documents that would include the IRB approval stamp as a PDF. These
documents could include recruitment materials AND informed consent/assent forms.
letter of support (2) from Tom for SMF-UNL project TA signed.pdf
Edwards CDC proposal 2-1-22.pdf
Rev.com Information Security Privacy Overview.pdf
Resource Sheet - Des Moines, IA.docx
Cogntive Interview Script_Youth.docx
Demographics, School Personnel.docx
Demographics, Youth.docx
PC_Youth Recruitment Script.docx
Recruitment Flyer.docx
Research Participant Compensation Conﬁrmation.docx
Focus Group Scripts_School Personnel (2).docx
Focus Group Scripts_Youth.docx
Reminder Script.docx
Youth_ParentPermissionReceived(PPR) Script.docx
Parental Contact and Permission Script.docx
Caregiver Consent_Cognitive Interview_11.8.22.docx
Caregiver Consent_Focus Group_11.8.22.docx
Consent_School Personnel_11.8.22.docx
Youth Assent_Cognitive Interview_11.8.22.docx
PC_School Personnel Recruitment Script_11.8.22.docx
Youth Assent_Focus Group_11.8.22_RWedits.docx
Youth Assent_Focus Group_11.8.22_RWedits-Approved.pdf
Youth Assent_Cognitive Interview_11.8.22-Approved.pdf
Caregiver Consent_Cognitive Interview_11.8.22-Approved.pdf
Consent_School Personnel_11.8.22-Approved.pdf
Caregiver Consent_Focus Group_11.8.22-Approved.pdf