Preventing Alcohol and Other Drug Use and Violence Among Latino Youth
Phase: NA
Conditions: Alcohol Drinking, Violence in Adolescence
Sponsor: Boston College

(For ORP use only) BC IRB 
Protocol#: 
22.037.01
INITIAL IRB APPLICATION FORM
For Initial IRB Review Only
Boston College Institutional Review Board
Office for Research Protections
140 Commonwealth Ave., Waul House
Chestnut Hill, MA 02467
(617) 552-4778 Fax: (617) 552-0498 E mail: 
irb@bc.edu 
I. Study Title:
(If funded must
match the sponsored
title)
Preventing Alcohol and Other Drug Use and 
Violence among Latino Youth - Clinical Trial 
Today's Date: 06/30/21
II. Principal Investigator Information
A. Name of Principal Investigator 
  Christopher    Salas-Wright
B. Are You? (Please check)
 Faculty 
C. Mailing Address: 
140 Commonwealth Ave
McGuinn Hall, #218
Chestnut Hill, MA 02467 
 Staff 
 Undergraduate Student 
D. Department: 
Social Work/ Graduate School of Social Work 
 Graduate Student 
E. E-mail address: 
wrightcu@bc.edu 
F. Primary Phone Number: 
(617) 552-4020 
G. Alternate Phone:
8572124049
III. Research Risk
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of 
themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological 
examinations or tests (45 CFR 46. 102). Research must present no more than minimal risk to human subjects in order to qualify 
for exempt or expedited review. Research must fit within one of the categories of review in order to qualify for that level of review. 
Projects that propose greater than minimal risks to human subjects are considered full board protocols and they must be reviewed 
by the IRB at a convened meeting. The IRB meetings are held every third Wednesday of the month. Full board protocols must be 
submitted ten business days in advance of an IRB meeting in order to be reviewed at that month's meeting. NOTE: Research 
involving prisoners is always considered a full board protocol and must be reviewed at an IRB meeting.
A. Does the research propose greater than minimal risk to participants? 
 Yes 
 No 
B. Does the research include prisoners? 
 Yes 
 No 

C. Level of Review
Please select a level of review and the appropriate category that corresponds to that level of IRB review: 
 Exempt 

 Expedited 
Category Number: 6, 7
 Full Board 
IV. General Study Information
Is this project a Clinical Trial? 
 Yes 
 No
A. Funding 
1. 
None (Go on to Section B)
2. 
University Funded
3. 
External
4. 
Federal : List agency: NIAAA 

 Sponsor Award Number (if known) 
1 K01 AA026645-02
 BC Project Number (if known) 
Not known
5. Is BC the primary awardee for the grant? 
 Yes 
 No 
6. Are there subcontracts? 
 Yes 
 No 
B. Participant Recruitment Numbers: This number must be the maximum 
number you intend to recruit. You will not be allowed to recruit more than this 
number without first coming back to the IRB to seek approval. 
Total # of participants: 50
Do you plan to include a larger proportion of one gender group, or omit any 
gender groups? 
 Yes 
 No 
C. Participant Ages (please check)
 0-7 (parental consent and oral child assent)

 8-11 (parental consent and child written consent)

 12-17 (parental consent and written consent)
 18-65
 65+
D. Estimated Project Duration
Start Date: 07/01/21 End Date: 08/31/23 
E. Why is this Project being conducted? (please 
check)

 Faculty/Staff Research
 Undergraduate Coursework
 Master's Thesis
 Doctoral Dissertation
 Other: 
F. Will This Study Involve Long-Term Follow-Up with participants: 
 Yes 
 No 
If Yes, please describe: 
There will be a 6-month post-intervention survey data collection and follow-up focus group. 
G. Special Study Populations 

 Minors (under 18 years) If including minors, also complete Research with Minors Form
 Pregnant Women/Fetuses or products of labor & delivery
 Prisoners
 Physically or mentally challenged
 Diminished capacity for consent 
 Other: 
 No Special Study Populations 

H. Does this study involve any of the following? 
 Deception or Punishment 
 Use of drugs 
 Covert observation 
 Induction of mental and/or physical stress
 Procedures which may risk physical/mental harm to the participant 
 Materials/issues commonly regarded as socially unacceptable
 Information relating to sexual attitudes, sexual orientation or practices

 Information relating to the use of alcohol, drugs or other addictive products
 Procedures that might be regarded as an invasion of privacy 
 Information pertaining to illegal conduct 
 Genetic information that may be linked to a participant's health status, such as genetic markers for cancer, heart disease, etc. 
 Information normally recorded in a patient's medical record, and the disclosure of which could reasonably lead to social 
stigmatization or discrimination.

 Information pertaining to an individual's psychological well being or mental health.
 Information that if released could reasonably damage an individual's financial standing, employability, or reputation within the 
community.
 None of the above Procedures
Please provide details on all procedures checked above: How are they integral to the study? 
The study is an substance use intervention study; thus collecting information about AOD use is important to measure 
effectiveness of the intervention. Additionally, anxiety and depression will be measured as they are commonly comorbid with 
substance misuse and are important cofounding variables to determine the effectiveness of the intervention.  
V. Research Summary: 
Instructions: A research summary is a narrative that provides the IRB with important information about a study. Please provide a 
thoughtful response to each section using simple language and avoid technical jargon. If a specific question is not applicable to your 
study, please state not applicable  or n/a . 
A. Introduction and Background: 
1. State the problem and hypothesis
There are currently no interventions aimed at preventing both alcohol and other drug (AOD) use and interpersonal violence that 
have been adapted for Latino adolescents. This study hypothesizes that a cultural adaptation of a validated AOD use 
prevention program (Keepin' it REAL) that also integrates violence prevention content will both amplify the AOD use effects of 
that intervention for Latino adolescents and lead to reductions in youth violence.
2. Provide the scientific or scholarly reason for this study and background on the topic
Adolescent alcohol and other drug (AOD) use and interpersonal violence impose major social costs. These behaviors are also 
profoundly interrelated. Youth substance users are more likely to enact violence and prospective studies have shown that youth 
involvement in violence predicts later AOD use. It is believed that both are connected to similar underlying biosocial processes. 
Latino adolescents have been found to be disproportionately at risk for involvement in both substance use and violence. Latinos 
are also the fastest growing segment of the adolescent population, and it is predicted that the proportion of the youth population 
that is Latino will continue to rise in the foreseeable future. Certain Latino populations, such as Venezuelan immigrants, are 
rising especially quickly. There is a thus a need for culturally-concordant interventions to  prevent or delay initiation of both AOD 
use and interpersonal violence among this population. 
Furthermore, the cultural adaptation literature indicates a need for more finely-grained adaptations and has encouraged 
focusing on more specific groups, as Latinos represent a large and diverse array of cultural backgrounds. To this end, this 
project will focus on Venezuelan immigrant youths. Due to the political and socioeconomic changes in Venezuela over the past 
several years, over 5 million Venezuelans have left their country since 2015. Cross-sectional research has found elevated 
psychosocial risk factors and rates of alcohol misuse among that population, indicating that they are priority population for youth 
prevention efforts. The initial phase of this project, which consisted of qualitative focus groups with Venezuelan migrant youth, 
indicated that interpersonal aggression for this population is frequently mediated through social media and online platforms, 
so special attention to interpersonal violence in the cyberspace will be integrated into the intervention.

B. Specific Aims/Study Objectives: 
1. List the purpose(s) of the study (what are you hoping to learn as a result of the study)
The purpose of this study is to conduct a pilot-test randomized controlled trial (RCT) of a youth AOD use prevention intervention 
that has been adapted to integrate interpersonal violence content and has been culturally adapted for a specific Latino 
population (Venezuelan migrant youth). The goals of the pilot test are to determine feasibility, acceptability, and preliminary 
effects of the intervention for future testing.
The intervention will be an adaptation of Keepin' it REAL (KiR). KiR is a 10-week intervention for early adolescents that is 
considered a model evidence-based AOD use prevention program by SAMHSA. It based on communications theory and the 
importance of aligning cultural values with AOD outcomes. Weekly sessions focus on teaching youth communications strategies 
to enhance their ability to navigate situations where substance use may be present.  It incorporates a student workbook, videos, 
and in-session discussions and exercises. We will be adapting the intervention for an online platform so that it can be delivered 
virtually. We will also be integrated interpersonal aggression content to expand the logic and program theory of KIR to apply to 
situations in which violence may arise. The goal is to both delay initiation of AOD use/aggressive behaviors and change the 
youth's norms around the appropriateness of AOD use and interpersonal aggression. The intervention will delivered for the pilot 
study by members of the research team (PI and/or GRAs). The intervention materials will be translated into Spanish by a 
research team member who is a native speaker of Spanish and checked for accuracy by other members of team. Adaptations 
will be made in consultation with a community advisory board that consists of Venezuelan migrants to check for cultural fit, 
language appropriateness, and overall concordance with the target population. All members of the research team are either 
fluent or proficient in Spanish. 
A three-armed RCT design will be used. In addition to a control group that will receive an abbreviated, one-session workshop, 
one group will receive a version of the intervention that has been adapted for Venezuelan youths and the other will receive a 
version of the intervention that has been adapted for Venezuelan youths and includes interpersonal violence content. The 
purpose of this design is to determine the effectiveness of the the culturally adaption of KiR for the original intended outcome 
(reduced AOD use) and the separate effect of integrating interpersonal violence content on reducing aggressive behaviors.
C. Materials, Methods and Analysis (quantitative and qualitative)
1. Describe data collection methods (Procedures) (be specific): 
Data will be collected both prior to and after the intervention. Data will be collected a pre-test prior to the intervention, 
which is a 10-week program consisting of weekly online sessions to provide psychoeducation and skills training 
regarding avoiding substance use and interpersonal aggression. The control group will participate in a one-time skills-
building workshop but data will be collected at the same timepoints. Please see intervention materials included as 
supporting documents for more details. Data will then be collected at two time points following the intervention - 
immediately after and at 3 months follow-up. 
Data will be collected via self-report survey using Qualtrics. The survey will be administered via Qualtric's email function and 
each participant will receive a unique link. The survey will be administered in Spanish although an English version will be 
available if preferred. The survey will be translated into Spanish by a research team member who is a native speaker of 
Spanish and checked for accuracy by other team members who are also fluent in Spanish. Cognitive interviews will be 
conducted with community advisory board members to determine intelligibility and cultural sensitivity of the survey. Only 
approved members of the research team will have access to the Qualtrics account and downloaded data will be kept in a 
secure database.
Focus groups will be conducted with participants after the final wave of data collection. Focus groups will focus on 
understanding how youth experienced the intervention program. This will be based on three core questions: What did you 
like/dislike about the program?  What parts of the program were especially helpful/unhelpful? What would you suggest we 
change? Focus groups will be conducted online and recorded for transcription. Zoom settings will be adjusted to ensure 
audio recordings of focus groups will be downloaded directly onto the researcher's device rather than to cloud 
storage. All data collection - including surveys and focus groups - and the intervention itself will be implemented by research 
staff who are either qualified social workers or social work students and all of whom are either native speakers of Spanish or 
fluent Spanish-speakers with experience using Spanish in professional settings.
2. Describe the specific materials or tools that will be used to collect the data (be specific):
Survey will consist of items to gather information related to: demographics; technology access & use; cigarette, alcohol, and 
cannabis use; interpersonal aggression; depression & anxiety; norms regarding AOD use; and norms regarding interpersonal 
aggression. These items have been adapted from previous evaluation studies of KiR.
Focus groups will be conducted over Zoom and recorded for transcription. The computer where the Zoom recordings will be 
temporarily stored will be password-protected. 
3. Describe timeline of the procedures and how long each procedure will last
Survey data will be collected at baseline, immediately following the intervention, and at 3 months post-intervention follow-up. 

The same survey instrument will be used at all three data points. The intervention is anticipated to take place in fall 2021, with 
post-intervention data being collected in spring 2022. This timeline may be earlier depending on the speed of recruitment. The 
survey takes approx. 30 minutes to complete.
Participants will be invited to participate in a focus group after the final wave of data collection in spring 2022.
4. Describe how you will analyze your data (be specific):
Exploratory descriptive analyses will be performed initially to examine variable distributions, confounding variables, and missing 
data. The primary analysis will be determining retention rates across all three data collection timepoints in order to establish 
feasibility of the intervention. The secondary analysis will examine the effect sizes between the two intervention groups and the 
control group will be determined regarding changes in AOD use, interpersonal violence, and norms for AOD use/interpersonal 
violence across the three waves of data collection.
Transcriptions will be open-coded for thematic analysis using grounded theory techniques.
D. Research Population & Recruitment Methods:
Describe:
1. Inclusion and Exclusion Criteria (what participant traits are needed to be included, what traits exclude participants?)
Inclusion criteria are 1) being born in Venezuela, 2) currently residing in the U.S., and 3) being between the ages of 11-14 at the 
time of recruitment. Participants will also need access to the internet and technology to complete the surveys and participate in 
the intervention. AOD use and/or engagement in interpersonal aggression will not be considered for purposes of 
inclusion/exclusion, unless the participant is intoxicated to the point of being unable to successfully complete a survey or 
participate in the intervention. Participants will also be excluded if they are otherwise cognitively unable to successfully engage 
in the intervention. The GRA who is consenting the participant will determine capacity. All GRAs who will be consenting 
participants will be either clinical MSW students who have experience performing mental health assessments or 
licensed mental health professionals. The GRAs who are licensed mental health professionals will also be available to 
consult with the student GRAs as needed. If there are questions or concerns about capacity to consent, final 
determination will be made by the PI.
2. What is the scientific or scholarly justification for the number, gender, age, or race of the population you intend to 
recruit? 
Early adolescence is a critical developmental window. AOD use and aggression in early adolescence have been linked to 
higher risks for later negative psychosocial outcomes, including substance use disorders, thus making it an important life stage 
in which to intervene. Furthermore, the empirically-validated intervention that is being adapted (KiR) is aimed at early 
adolescents (specifically 7th graders), so a similar age group will be recruited to maintain treatment fidelity.
3. How did you choose the source of participants or data? (census records, BC students, Mass General Hospital records, 
etc.)
Participants will be recruited via a community partner in Miami, FL, that provides social services for Venezuelan immigrants 
(Raices Venezolanos). Our community partner will be asked to refer local youth to the study. 
4. Recruitment procedure; including who will recruit participants and, if applicable, how any conflict of 
interest/coercion/undue influence will be mitigated
The research team will recruit participants in conjunction with the community partner in Florida. Specifically, our community 
partner will inform parents about the opportunity to participate and the research team will then communicate with parents and 
kids. We will then select participants in the order that they express interest, enrolling only those who have received informed 
consent and provide assent. Our point of contact is with parents who will be told about the study and will then have the 
discretion to proceed with informing their children about the possibility of participation. We will specifically instruct our 
community partners that participation must be voluntary and free of coercion, and we too will communicate this verbally and in 
our consent documents. We will communicate to our community partner that it is critical that youth have the freedom to tell 
partner agencies that they prefer not to participate. Please note that our community partner will NOT be consenting participants-
-as such, we are in a position to ensure that all youth participate without coercion. Although the our primary community partner 
is not a member of the research team for this project, she has completed CITI training and has previously received instruction 
from the PI concerning human subjects research, coercion, etc. All recruitment is via word-of-mouth. Recruited participants may 
also be asked to refer other potential participants.

5. Tools that will be used to recruit (payment, advertisements and flyers attach copies to this application)
A recruitment flyer will be used to facilitate recruitment by the community partner and to provide essential details of participation 
in the study.
6. Research Incentives and Payments: Please specify what form of payment you will be using and how it will be 
documented. (Note: participant payment beyond $600 must be reported to the IRS, and this requirement must be added to the 
consent form)
Participants will receive incentives for both completing the surveys and participating in the intervention. Participants will receive 
a $30 gift card for each survey completed, for up to $90 total per participant. Gift cards will be distributed via Tango Card, a 
third-party vendor that integrates into Qualitrics, which will document who has completed the survey and received a gift card. 
Participants will receive a Boston College item (such as a teeshirt) worth approx. $30 for their participation in the intervention 
itself. If participants withdraw early from the intervention they will still receive the item in appreciation for their time. Distribution 
will be tracked by the PI/GRAs using a spreadsheet. Research team members will manage to the greatest extent possible the 
incentive distribution process. Program administrative staff will only be involved if needed and only be provided de-identified 
information.
Participants will also receive a $30 gift card for participating in the focus group. They will receive the gift card even if they leave 
the group before it finishes.
E. Informed Consent Procedure: 
1. Who will perform the informed consent procedure, and how will that person be trained? (Note: undergraduates should 
specify their qualifications and describe how the faculty research supervisor will closely monitor.)
Informed consent will be performed by the PI/GRAs. PI will train the GRAs in best practices for consenting the participants and 
their parent/guardian and oversee the informed consent process. 
2. How will the prospective participant's competence or understanding of the procedures be assessed; will 
participants be asked questions about the procedures, or encouraged to ask questions?
Parents/guardians and the child will have the study explained to them verbally and be encouraged to ask questions. They will 
receive an electronic copy of the informed consent document in Spanish via email. The document will be translated into 
Spanish using the same process as the survey and intervention materials, first by a member of the research team who is a 
native speaker of Spanish and then checked by other members of the research team who are fluent in Spanish  (or also native 
speakers). 
3. Please describe the process by which informed consent will be obtained. Note: research involving minors requires 
consent from a parent/legal guardian and assent from the child.
A research team member will meet with each participants and his/her parent/guardian(s) prior to the initiation of the intervention 
to screen for appropriateness and to collect informed consent. These meetings will be conducted in either English or Spanish as 
preferred by the participant and their family. Informed consent will include both the survey data collection and participation in the 
intervention itself. Informed consent will be documented via Qualtrics due to public health guidelines around social distancing 
and the virtual nature of the intervention. They will indicate verbally and via Qualtrics that they understand the study procedures 
and agree to participate.  
F. Confidentiality:
Describe the Provisions for participant and data confidentiality:
1. Where will the data be stored, and who will have access to the data and the area? (Please refer to the References Tab for 
the latest BC Research Data Policy.)
The data will be stored on a secure departmental server administered by BC. Only IRB-approved members of the research 
team will have access to the password-protected server.
2. How will the data be stored, and in what format (hard or electronic copy, identifiable or de-identified)
Data will be stored electronically. It will be identifiable since participant data will need to be linked across the three waves of 
data collection. Survey data and focus group transcripts will be de-identified. Focus groups recordings will be deleted after 
transcription. 
3. Will you collect the names, email addresses, phone numbers, student ID numbers, and/or any other data elements 
that individually identify the subjects of the research? Will the participant's identity be coded? Will the codes to 

identify participants be stored with the data? 
Participant's names and emails will be collected. Participants will be assigned a unique, randomized code by Qualtrics upon 
completion of the informed consent. The sheet with names and codes will be kept in a password-protected spreadsheet that will 
be stored separately from other data. Only two members of the research team (the GRA handling survey distribution and the PI 
as a back-up) will have access to the spreadsheet with names and emails. 
All data will be deleted one year after the end of the study (August 2024).
4. Will you collect any identifiable information from any organizations or individuals other than the subjects (or 
potential subjects) themselves? (e.g., a hospital or school)
 Yes* 
 No
G. Statement of potential research risks to subjects (e.g. breach of confidentiality, treatment complications)
1. Indicate the type of risk that may result from participation. Consider psychological or emotional risks, social stigma, 
change in status or employment, physical risks or harms, information risks-breach of confidentiality and any effect 
loss of confidentiality may have on status, employment, or insurability. If the protocol involves treatment, what are the 
risks compared to other treatments in terms of "standard of care"? Please consider any populations who may be 
particularly vulnerable and may be triggered by this research topic and the risks they may face. Please check section IV.H. to 
ensure that you have considered how sensitive topics might lead to risks for some populations.
We anticipate minimal risk to participation in both the survey data collection and the intervention. Participants may have feelings 
of discomfort in providing information requested on the survey. The research team cannot provide a secure space for to 
complete the survey so there is a chance that others may see their responses. For participants in the intervention, they may feel 
social pressure to share information they do not want to and what is shared in the groups may divulged by other group 
members. There is no reasonable risk of loss of employment or insurability. 
2. Consider the likelihood and magnitude of the risks or discomforts occurring? Are they unlikely, or likely to occur 
and what effect would the discomforts or risks have on the individual should they occur?
The magnitude of risks are minimal and overall unlikely to occur. The most likely main effect would be feelings of 
embarrassment on the part of the participant. However, we take seriously the possibility of breach of confidence and will do 
everything possible to minimize this risk. 
3. How will you minimize the risks? Some examples include informed consent, adequate staff training and experience, 
debriefing, and monitoring adverse effects on participants
The intervention will focus on skills-development and hypothetical scenarios to avoid having the participants feel pressured to 
share personal experiences. The need for privacy to complete the surveys will be stressed in the informed consent process. 
Intervention facilitators (who will be members of the research team) will be trained to not pressure participants into sharing more 
than they feel comfortable. Intervention facilitators will also stress the importance of confidentiality with group members. The PI 
is a trained social worker with experience overseeing research teams who will train and supervise intervention facilitators on 
recognizing and managing participant distress. One of the GRAs is also a licensed mental health clinician will extensive crisis 
intervention experience who will be available for consultation and support as needed.
H. Statement of potential research benefits to subjects (Please note that compensation/ payments are considered a 
recritment tool and should not be listed as a benefit)
1. Indicate the type of benefit that may result from participation. Consider psychological or emotional benefits, 
learning benefits, physical benefits and discuss if participant will benefit directly or if the benefit is largely to gather 
generalizable knowledge or provide scientific or social information on a topic that may benefit society. DO NOT 
OVERSTATE the benefit. 
For the participants receiving one of the versions of the intervention, they will benefit directly by learning new communication 
strategies to help navigate social situations where AOD use is present and to avoid interpersonal violence. The participants in 
the control group should benefit from the one-time psychoeducation workshop. All participants may benefit indirectly by 
contributing to the scientific development of an intervention for their community.
2. Consider the likelihood of the benefits. Will all or some participants benefit?
All participants are equally likely to gain benefit from participation in the various interventions, although those randomized to the 
full intervention may receive greater benefit. All can potentially benefit from feeling like they are contributing to an intervention to 
help their community.
I. Investigator experience. Please attach a current copy of your C.V. unless a current copy is on file. Note: the IRB 
only needs the C.V. from the PI, not the faculty advisor.

VI. Informed Consent 
1. If this project qualifies for Exempt review, category 4 (previously collected data), or Informed Consent is otherwise not 
applicable click here 
 and skip to section IX. 
2. Are you requesting an alteration or waiver? 
 Yes* 
 No 
 Both - I have a consent form, but will be asking for a waiver 
for some cases 
A. Standard Elements of Consent
The informed consent document should include all required elements of consent (See BC Consent Guide for informed consent 
samples https://www.bc.edu/content/bc-web/research/sites/vice-provost-for-research/research-protections/forms---
templates.html) . Confirm that each element is included in your consent form :

 A.1. A statement that the study involves research 

 A.2. The purpose of the research in lay terms (in language understandable to the participant)

 A.3. A statement that they are being asked to participate in research, and how they were selected to participate 

 A.4. The expected duration of the participant's participation "You will be asked to complete a survey every month for 1 year" 

 A.5. The total time commitment of participation in the procedures "the survey will take 20 minutes to complete" 

 A.6. A brief but complete description of all procedures to be followed (if research includes treatment describe which procedures 
are experimental and alternatives to those procedures)

 A.7. The risks or discomforts that are reasonably expected from the research, and a statement that "There may be unknown 
risks" 

 A.8. The benefits to the participant or others that are reasonably expected from the research 

 A.9. A statement of confidentiality that provides the participant a contact at the institution who may be reached if injury occurs 
or confidentiality is breached (this should be someone other than the researcher)

 A.10. A statement that participation is entirely voluntary and may be discontinued at any time 

 A.11. A statement that withdrawal from participation will not result in denial of entitled benefits 
 A.12. Invasive biological, clinical or behavioral interventions require specific descriptions of the procedure (Do NOT check this 
box if your study does not involve invasive biological, clinical, or behavioral interventions) 

 A.13. The consent form must be signed and dated, or oral consent must be witnessed and signed and dated by the witness 

 A.14. A statement and check box that indicates the participants have a copy of the informed consent document 
Note: Individuals with added protections require both permission of a legal representative and assent of the individual.
B. Consent Waiver/Alteration: In rare circumstances, the IRB may consider altering the informed consent requirements. In order 
for the IRB to approval a waiver of the informed consent process or a partial waiver of any of the required elements of consent, 
require that: ( Federal Regulations: 45 CFR 46.116(d)(1-4)
1. The research involves no more than "minimal risk;" 
2. The waiver will not adversely affect the rights and welfare of the research participants;
3. The research could not practicably be carried out without the waiver; and
4. Whenever appropriate, the research participants will be provided with additional pertinent information after participation. 
B.1. Are you asking for a partial waiver of consent: 
 Yes 
 No 
Please indicate which elements you are asking to waive::
 B.1.a. A statement that the study involves research 
 B.1.b. The purpose of the research in lay terms (in language understandable to the participant)
 B.1.c. A statement that they are being asked to participate in research, and how they were selected to participate 
 B.1.d. The expected duration of the participant's participation "You will be asked to complete a survey every month for 1 
year" 
 B.1.e. The total time commitment of participation in the procedures "the survey will take 20 minutes to complete" 
 B.1.f. A brief but complete description of all procedures to be followed (if research includes treatment describe which 
procedures are experimental and alternatives to those procedures)
 B.1.g. The risks or discomforts that are reasonably expected from the research, and a statement that "There may be 
unknown risks" 
 B.1.h The benefits to the participant or others that are reasonably expected from the research 
 B.1.i. A statement of confidentiality that provides the participant a contact at the institution who may be reached if injury 
occurs or confidentiality is breached (this should be someone other than the researcher)
 B.1.j. A statement that participation is entirely voluntary and may be discontinued at any time 
 B.1.k. A statement that withdrawal from participation will not result in denial of entitled benefits 
 B.1.l Invasive biological, clinical or behavioral interventions require specific descriptions of the procedure 


 B.1.m. The consent form must be signed and dated, or oral consent must be witnessed and signed and dated by the 
witness 
 B.1.n. A statement and check box that indicates the participants have a copy of the informed consent document 
Note: Individuals with added protections require both permission of a legal representative and assent of the individual.
B.2. Are you asking for a total waiver of consent: 
 Yes 
 No 
B.3. Are you asking for a waiver of the documentation of consent 
 Yes 
 No 
B.3.a. Are you asking for a waiver of the documentation of consent to waive the requirement for signature and name because 
this study will be conducted online: 
 Yes 
 No 
B.4. Please describe what elements of consent you wish to waive and provide a strong rationale for this alteration/waiver. 
We wish the waive the requirement for a physical signature. The study will be conducted online and our target population has 
limited access to printers/scanners. We will document informed consent via Qualtrics instead will all the required elements.
C. The PI is responsible for ensuring that the consent form is written at a reading level that is appropriate to the population being 
studied. The comprehension level of the consent document must be verified by choosing one of the three readability tools below. 
Mark which tool you used to check the readability level of the consent form and insert the readability comprehension level (the 
grade level, 8.0,8.1, not the larger number) in the box below: 
C.1. http://www.readability-score.com/
C.2. http://www.online-utility.org/english/readability_test_and_improve.jsp
C.3. Microsoft Word Readability Statistics 
C.4. Insert Readability Comprehension Level 5.8
VII. Research with Minors
Instructions: Please complete this section only if you are using minors in your research. Otherwise, you may proceed to the next 
section. Research with minors requires either expedited or full board review. 
Federal regulations recognize children as vulnerable subjects in research and require that special consideration be given to 
protecting their welfare. IRBs consider the potential benefits, risks, and discomforts of the research to children as well as their 
circumstances (e.g. age, health status, ability, etc.) and assess the justification for their inclusion in the research (www.hhs.gov). 
Please provide a scientific or medical rationale for the inclusion of minors: 
Early adolescence is a critical developmental period and substance use initiation or interpersonal violence in this period can have 
serious ramifications for the adolescent's development and future psychosocial outcomes. Furthermore, early adolescence is 
when peer influences play a more prominent role in decision-making underscoring the importance of teaching communication 
strategies for navigating social situations that may lead to AOD sue and/or aggression. It is important to intervene during this age 
range to prevent more serious problems occurring later. Furthermore, the intervention being adapted (KiR) was developed and 
validated with early adolescents, so it is important to implement this study with the same age group to ensure treatment fidelity. 
Federal regulations classify research with minors into four categories based on the degree of risk. Please pick the appropriate 
category for your research. 

 Category 1 (45 CRF 46.404): Research involving minimal risk to minors
My research falls under this category because: 
Survey data collection does ask about substance use and aggressive behaviors but that information is confidential and only 
accessible by the research team. The intervention itself uses examples and hypothetical scenarios to teach skills and does not 
ask participants to disclose their own experiences with substance use or interpersonal violence. Participants will be encouraged to 
actively participate in the intervention but will not be pressured to share personal details that may make them uncomfortable. 
Are the risks involved in participating in this research those that parents would allow their minors to experience in the course of 
their everyday lives? 
 Yes 
 No 
Are adequate provisions in place for soliciting the assent of the minors and consent from the parents? (45 CFR 46.408)
 Yes 
No 
 Category 2 (45 CFR 46.405): Research involving greater than minimal risk to minors with the prospect of direct benefit to the 
child: 
 Category 3 (45 CFR 46.406): Research involving greater than minimal risk with no direct benefit to the minors but it is likely to 
yield generalizable knowledge about the subject's disorder or condition 
 Category 4 (45 CFR 46.407): Research not meeting the criteria for Categories 1-3 that involves greater than minimal risk to 
healthy minors and presents no direct benefit to them but presents an opportunity to understand, prevent, or alleviate a serious 
problem affecting the health and welfare. Please note: this fourth category of research with minors requires a special level of 
DHHS review after BC IRB review. 

Guidance on Remuneration: Minors may receive small gifts of appreciation for participation. Gifts should rarely be cash and 
should never be contingent upon study completion. Parents and guardians may be compensated for travel or time lost from work. 
VIII. Performance Sites: 
If you are conducting research at a site, (e.g. hospital, school, organization), the site must provide the BC IRB with evidence that 
they support the research being conducted at their location. If the site has an IRB, you should consult with that IRB to determine 
whether they require IRB approval from their institution in addition to IRB approval through BC. If they do not have an IRB, please 
provide a site permission letter. Site permission letters should be written on the letterhead of the institution and signed by a 
Principal or Administrator. 
A. Are you conducting research at a site? 
 Yes 
 No 
IX. Acknowledgement 
SUBMISSION OF A PROPOSAL TO THE BC IRB REQUIRES THAT THE PRINCIPAL INVESTIGATOR (AND MENTOR IF 
THE PI IS A STUDENT OR FELLOW) SIGN THIS PAGE AND READ COMPLETELY THE DEFINITION OF "SCIENTIFIC 
MISCONDUCT" AND ANSWER ALL "CONFLICT OF INTEREST" QUESTION GIVEN BELOW.
A. Scientific Misconduct
"Scientific Misconduct" shall be considered to include:
1. Fabrication, falsification, plagiarism or other unaccepted practices in proposing, carrying out or reporting results from 
research;
2. Material failure to comply with Federal requirements for the protection of human participants, researchers and/or the Public;
3. Failure to meet other material legal requirements governing research;
4. Failure to comply with established standards regarding author names on publications;
5. Failure to adhere to issues of confidentiality as provided in the participant consent form, the study protocol, and as outlined 
in the Code of Federal Regulations (45 CFR 46).
Conflict of Interest
1. Are you or any member of your immediate family (spouse or domestic partner and/or dependent children) an officer, director, 
partner, trustee, Employee, advisory board member, or agent of (a) the external organization funding this Sponsored Project or (b) 
any external organization from which goods and services will be obtained under this Sponsored Project (including those to which 
you may be subcontracting a portion of the project work), (c) any external organization whose financial condition could benefit 
from the results of this Sponsored Project, or (d) any external organization having business dealings in an area related to the work 
under this Sponsored Project?
 Yes (if so, describe in detail the nature and extent of the association on an attached sheet).
 No 
2. Publicly-Traded Entities: Have you or any member of your immediate family derived income within the past year of $5,000 or 
more in a publicly-traded entity, or in the past year have you or any member of your immediate family owned equity interests in a 
public-traded interest, the fair market value of the equity being $5,000 or more? 
 Yes (If any of the following pertain, provide a full description on a separate sheet):
(a) The entity is co-funding this Sponsored Project; 
(b) The income or equity is related the your university responsibilities (e.g. research, teaching, and service);
(c) The entity may provide goods and services under this Sponsored Project (including those to which you may be 
subcontracting a portion of the project work);
(d) The entity's financial condition may benefit from the results of this Sponsored Project; or 
(e) The entity has business dealings in an area related to the work under this Sponsored Project? 
 No 
3. Non-Publicly Traded (i.e. Privately Held) Entities: Have you or any member of your immediate family derived income within the 
past year of $5,000 or more in a non- publicly traded entity, or in the past year have you or any member of your immediate family 
owned any equity interests in a non-publicly traded entity?
 Yes (If any of the following pertain, provide a full description on a separate sheet):
(a) The entity is co-funding this Sponsored Project; 
(b) The income or equity is related the your university responsibilities (e.g. research, teaching, and service);

(c) The entity may provide goods and services under this Sponsored Project (including those to which you may be 
subcontracting a portion of the project work);
(d) The entity's financial condition may benefit from the results of this Sponsored Project; or 
(e) The entity has business dealings in an area related to the work under this Sponsored Project? 
 No
Research Staff 
Added Personnel
Staff Type
EPPN
Date of IRB Training Certificate
Hodges, James
Research Assistant
hodgesjb
05/03/20
Email
hodgesjb@bc.edu
Added Personnel
Staff Type
EPPN
Date of IRB Training Certificate
LESTER MCSWEENEY, MAURA R
Research Assistant
lestermc
01/26/21
Email
MAURA.LESTERMCSWEENEY@BC.EDU
Added Personnel
Staff Type
EPPN
Date of IRB Training Certificate
Familiar-Bolanos, Marcela
Research Assistant
familiam
02/04/21
Email
marcela.familiar-bolanos@bc.edu
Added Personnel
Staff Type
EPPN
Date of IRB Training Certificate
Palacios Pizarro, Estefania
Research Assistant
EPalaciosPizarro
05/31/21
Email
ecpalacios@uc.cl
Added Personnel
Staff Type
EPPN
Date of IRB Training Certificate
Mendez Campos, Barbara
Research Assistant
BMendezCampos
12/04/19
Email
mendezba@bc.edu
SIGNATURE OF PRINCIPAL INVESTIGATOR
The undersigned accept(s) responsibility for the study, including adherence to the ethical guidelines set forth in the Belmont 
Report, Declaration of Helsinki, the Nuremberg Code, the ethical principles of your discipline, the Common Rule and Boston 
College policies regarding protection of the rights and welfare of human participants participating in this study. In the case of 
student protocols, the faculty supervisor and the student share responsibility for adherence to policies.
Signed by Christopher Salas-Wright on Oct 07, 2021  

SIGNATURE OF FACULTY RESEARCH SUPERVISOR- REQUIRED FOR STUDENT RESEARCH
By signing this form, I certify that: