Efficacy of a Web-Based Alcohol Intervention for High School Students
Phase: NA
Conditions: Underage Drinking
Sponsor: Boise State University

 
 
Study Protocol for Human Subjects Research and Statistical Analysis Plan 
Efficacy of a Web-Based Alcohol Intervention for High School Students 
January 27, 2021 
 

ORC Form, Revised 11.03.15 
FOR ORC USE ONLY 
DATE RECEIVED:  
PROTOCOL #:  
 
Page 1
 
DIVISION OF RESEARCH & ECONOMIC DEVELOPMENT 
Office of Research Compliance |Institutional Review Board 
(phone) 208.426.5401 | (fax) 208.426.2055 
humansubjects@boisestate.edu | MS 1138 
 
 
EXPEDITED/FULL BOARD PROTOCOL APPLICATION   
 
INSTRUCTIONS 
• 
The application must be typed. Handwritten applications will not be accepted. 
• 
Spellcheck will not work on this application. Proofread before submitting.   
• 
SUBMIT COMPLETED APPLICATION AND ALL SUPPORTING APPENDICES TO: HUMANSUBJECTS@BOISESTATE.EDU 
• 
The second page must be signed by all applicable investigators and must be submitted to the Office of Research 
Compliance via: 
 Email—humansubjects@boisestate.edu (as a scanned PDF); 
 Campus Mail—Mail Stop 1138; 
 Mail—Office of Research Compliance, 1910 University Drive, Riverfront Hall 311, Boise, ID 83725-1138; or 
 Fax—208.426.2055 
 
SECTION A: General Information 
1. 
Project Title:  
Efficacy of a Web-Based Alcohol Intervention for High School Students (Capital and Boise High) 
 
2. 
Anticipated Start Date: 
7/1/2017 
Anticipated End Date: 
6/30/2019 
 
3. 
PRINCIPAL INVESTIGATOR (PI) (Refer to the IRB PI Eligibility requirements. IRB staff will confirm your eligibility. Graduate thesis or 
dissertation students MUST list an eligible PI as their co-investigator) 
 Name: Diana Doumas 
 
Title: 
 Full Professor 
 
Associate Professor 
 Assistant Professor 
 
 
 If you fall into any of the titles in the grey box below, you must have an eligible PI listed as your Co-Investigator. 
 
 Adjunct Faculty 
 Visiting Faculty  
 
 Instructor/Lecturer 
 Staff 
 
 Graduate Student—Thesis 
 Graduate Student—Dissertation 
 
Department: 
Counselor Education 
Phone:   
6-2646 
 
E-mail:   
dianadoumas@boisestate.edu 
 
Roles and responsibilities in this study: 
As the Principal Investigator, I will be overseeing the entire project including the participant recruitment, 
collection of data, supervision of the research team, analyzing data, reporting data at conferences, and writing 
manuscripts for publication. 
 
CITI Training Completed: 
 Social & Behavioral Researchers 
 Biomedical Researchers 
 
4. CO-INVESTIGATOR (IRB staff will confirm your title with the directory.) 
 Name: 
Susan Esp 
 
 Full Professor 
 Associate Professor 
 Assistant Professor 
 
 Adjunct Faculty 
 Instructor 
 Staff 
 
 Graduate Student 
 Undergraduate Student 
 
 Other: 
      
 
Department: 
Social Work 
Phone: 
6-3970 
 
E-mail: 
susanesp@boisestate.edu 
 
Roles and responsibilities in this study: 
As co-investigator, Dr. Esp will assist in overseeing participant recruitment, data collection, and 
implementation of the intervention program.  Dr. Esp will also assist in analyzing data, reporting data at 
conferences, and writing manuscripts for publication. 
 
CITI Training Completed: 
 Social & Behavioral Researchers 
 Biomedical Researchers 
 

ORC Form, Revised 11.03.15 
FOR ORC USE ONLY 
DATE RECEIVED:  
PROTOCOL #:  
 
Page 2
5. Do you have additional research personnel (Co-Investigators, key personnel, student research assistants, etc.)? 
 
 NO 
 
 YES  
 
To list additional investigators and/or key personnel, complete and attach an ADDITIONAL PERSONNEL form. 
 
6. 
Is this research supported in whole or in part by a grant or contract?  
 
 NO 
 
 YES:  
 
Sponsor Name: 
National Institute on Alcohol Abuse and Alcoholism 
 
PI on Grant: 
Diana Doumas 
 
Grant Title/Contract: 
Efficacy of a Web-Based Alcohol Intervention for High School Students  
 
Project Period: 
From: 
7/1/2017 
To: 
6/30/2019 
 
 Grant Project Summary Attached 
 
OSP Proposal Number (if known): 
this grant is pending - it has received a score in funding range - IRB 
required for JIT information for Advisor Council meeting in May 
2017 
 
7. 
Has this protocol previously been considered by Boise State University’s IRB? 
 
 NO 
 
 YES:  
IRB Number:  
      
Date Approved: 
      
 
 
SECTION B: Financial Conflict of Interest Disclosure 
Conflicts of interest must be disclosed in accordance with the Boise State Conflict of Interest and Commitment Policy #1110.  
1. 
Do any investigators (PI, Co-Investigator) or research team members (key personnel) have any relationship or 
equity interest with any institutions or sponsors related to this research that might present or appear to present a 
conflict of interest with regard to the outcome of the research?  
 
 NO POTENTIAL CONFLICTS EXIST  
 
 YES: 
2. Name of the person(s) with the potential COI:         
 
 This potential conflict has been disclosed to the Boise State Conflict of Interest Office via the electronic 
disclosure form: https://web.boisestate.edu/conflictofinterest/app.html. 
 
 This conflict has not been disclosed to the Boise State COI Office. 
 
 
Note: If a significant conflict of interest exists, you must also attach the Boise State COI Committee approved 
management plan. If you have questions about conflicts of interest, contact the Boise State Conflict of Interest 
Officer at (208) 426-1252. 
 

ORC Form, Revised 11.03.15 
FOR ORC USE ONLY 
DATE RECEIVED:  
PROTOCOL #:  
 
Page 3
 
 
SECTION C: Signatures 
Principal Investigator Assurance and Acknowledgement  
I certify that the information provided in this application is complete and accurate.  As the principal investigator, I have ultimate 
responsibility for the conduct of this study, the ethical performance of the project, the protection of the rights and welfare of human 
participants, and strict adherence to any stipulations designated by the IRB.  I accept and will conform to all federal, state, and 
institutional provisions concerning the protection of human participants in research.  I will ensure all personnel involved in the 
research will be appropriately trained for all procedures used in this project.   
 
I agree to conduct the research involving human participants as presented in this protocol application as approved by the Boise State 
Institutional Review Board (IRB), and am qualified to perform the procedures described herein.  I will submit any proposed 
changes/modifications for review and approval before they are implemented.  I agree to notify the IRB and Office of Research 
Compliance of any adverse events that may occur during the study.  I also assure that I will follow through with the storage and 
destruction of data as outlined in the protocol.  I understand that Boise State owns the research data.  If I choose to transfer to 
another institution, I will need departmental approval to take the data with me. 
 
If I am a graduate student investigator on this research application, I further agree to meet with my faculty adviser on a regular 
basis to discuss the progress of the study.  I agree to meet with my faculty adviser to solve protocol issues as they arise.   
 
I understand that data collection (including recruitment) is not permitted until final approval is granted by the IRB. 
 
Diana Doumas 
 
 
 
3-8-17 
 
Principal Investigator (PRINT) 
 
Signature 
 
Date 
 
 
 
Co-Investigator/Faculty Advisor Assurance and Acknowledgement  
I certify I have read this protocol application and that the information is complete and accurate.  I ensure that the principal 
investigator is qualified to perform the procedures described. I understand that I will be included in all email correspondence related 
to the protocol application including questions from the IRB committee and approval notifications. 
 
I further agree to meet with the principal investigator on a regular basis to monitor the progress of the study. I agree to be available 
and to personally supervise the student investigator in solving problems as they arise.  I will arrange for an alternate Co-Investigator 
to assume responsibility if I become unavailable, as when on sabbatical leave or vacation, and will notify the IRB of this change.  I 
assure that the PI will follow through with the storage and destruction of data as outlined in the protocol. 
 
Susan Esp 
 
 
 
3-8-17 
 
Co- Investigator (PRINT) 
 
Signature 
 
Date 
 

ORC Form, Revised 11.03.15 
FOR ORC USE ONLY 
DATE RECEIVED:  
PROTOCOL #:  
 
Page 4
 
SECTION D: Review Category 
Indicate the applicable review category for your research: 
 
 FULL BOARD Review:  
 
Any research or training project involving the use of human participants which does not fall into an 
exempt or expedited review category must be submitted for full board IRB review.  Research involving 
more than minimal risk requires full board review. 
 
 
 EXPEDITED Review (Indicate category(ies) below): 
 
 1. 
Clinical studies of drugs and medical devices only when condition (a) or (b) is met. 
 
 a. 
research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.  
(Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of 
the risks associated with the use of the product is not eligible for expedited review). 
 
 b. research on medical devices for which (i) an investigational device exemption application (21 CFR Part 
812) is not required; or (ii) the medical device cleared/approved for marketing and the medical device is 
being used in accordance with its cleared/approved labeling. 
 
 2. 
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: 
 
 a. 
from healthy, nonpregnant adults who weigh at least 110 pounds.  For these participants, the amounts 
drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 
times per week; or 
 
 b. from other adults and children1 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 per week. 
 
 3. 
Prospective collection of biological specimens for research purposes by noninvasive means. 
 
 
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of 
exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine 
patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) 
uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or 
wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic 
fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and 
subgingival dental plaque and calculus, provided the collection procedure is not more invasive than 
routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted 
prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or 
mouth washings; (j) sputum collected after saline mist nebulization. 
 
 4. 
Collection of data through noninvasive 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/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.) 
 
 
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do 
not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; 
(b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, 
electroencephalography, 
thermography, 
detection 
of 
naturally 
occurring 
radioactivity, 
electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; 
(e) moderate exercise, muscular strength testing where appropriate given the age, weight, and health of 
the individual. 
 
 5. 
Research involving materials (data, documents, records, or specimens) that have been collected, or will 

ORC Form, Revised 11.03.15 
FOR ORC USE ONLY 
DATE RECEIVED:  
PROTOCOL #:  
 
Page 5
be collected solely for nonresearch purposes (such as medical treatment or diagnosis).  (NOTE: Some 
research in this category may be exempt from the HHS regulations for the protection of human 
participants.  45 CFR 46.101(b)(4).  This listing refers only to research that is not exempt.) 
 
 
 6. 
Collection of data from voice, video, digital, or image recordings made for research purposes. 
 
 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.  (NOTE: Some research in this category 
may be exempt from the HHS regulations for the protection of human participants.  45 CFR 46.101(b)(2) 
and (b)(3).  This listing refers only to research that is not exempt.) 
 
 8. 
Continuing review of research previously approved by the convened IRB as follows: 
 
 a. 
where (i) the research is permanently closed to the enrollment of new participants; (ii) all participants 
have completed all research-related interventions; and (iii) the research remains active only for long-
term follow-up participants; or 
 
 b. where no participants have been enrolled and no additional risks have been identified; or 
 
 c. 
where the remaining research activities are limited to data analysis.  
 
 9. 
Continuing review of research, not conducted under an investigational new drug application or 
investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has 
determined and documented at a convened meeting that the research involves no greater than minimal 
risk and no additional risks have been identified. 
 
SECTION E:  Purpose 
1. 
Provide a summary of the purpose of your project.  Include information about the background and rationale for 
the study and goal(s) of the proposed study.  Use language understood by a person unfamiliar with this area of 
research.  Specific jargon should be avoided or explicitly explained. 
Underage drinking and the negative associated consequences represent a significant problem in the United 
States.  Drinking in adolescence significantly increases the risk for developing alcohol dependence and heavy 
drinking in high school is associated with multiple negative interpersonal, academic, legal, and neurocognitive 
consequences. A significant body of literature supports the use of brief interventions based on social norming 
theory and motivational enhancement models to reduce heavy drinking and the associated consequences 
among college students.  Recent reviews of the literature also indicate brief interventions are effective when 
delivered in a web-based format. In spite of the compelling need to provide alcohol interventions to high 
school students, application of evidence-based interventions is limited.  Further research examining the 
efficacy of brief interventions delivered to seniors through the high school curriculum is warranted. The 
proposed project will address this gap by examining the efficacy of a web-based intervention for this high 
school age group. 
 
The goal of this study is to reduce underage drinking. This study builds upon research conducted over the past 
five years in the school district. We evaluated the efficacy of a web-based intervetnion, eCHECKUP TO GO (San 
Digo State University Research Foundation, n.d), shown to be effective with college students (Doumas, Kane, 
2011; Doumas, Workman, Smith, 2011; Doumas, Workman, Navarro, 2011; Doumas, Haustveit, 2010; Doumas, 
Anderson, 2009). Results of this evaluation with 9th grade students were promising, but results were not 
sustained over time.  Because high school seniors' drinking patterns are more similar to those of college 
students than 9th grade students, this approach may be more useful with high school seniors. We evaluated 
this hypothesis with pilot data collected in the Boise School District in 2015-2016.  Results suggest that the 
eCHECKUP TO GO was effective in reducing risk factors associated with alcohol use (Doumas, Esp, Trull, & 
Shearer, 2017) and alcohol use (Doumas, Esp, Flay, & Bond, in press) at a short-term follow-up. 
 
The proposed study extends the literature by examining the eCHECKUP TO GO wiht high school seniors over a 
longer follow-up period, as well as examining mediators and moderators of interveniton effects.  All 12th 
grade students at the two participating school sites will be given the opportunity to participate in the study. 
All participants will complete an assessment packet containing questionnaires including demographic 

ORC Form, Revised 11.03.15 
FOR ORC USE ONLY 
DATE RECEIVED:  
PROTOCOL #:  
 
Page 6
informaiton, the quantity and frequency of their drinking, beliefs about both the quantity and frequency of 
their peers' drinking, alcohol beliefs and expectancies, problems associated with drinking, personality 
characteristics, and future goals  (see attachment 1). Classrooms within the high school schools will be 
randomly assigned to the following groups: eCHECKUP TO GO and control group.   
 
 
What is your research question? State your hypothesis. 
The project is designed to evaluate the following hypothesis:  Participants in the eCHECKUP TO GO 
intervention condition will report a reduction in their quantity of alcohol consumption and alcohol-related 
consequences relative to those in the control group. We are also interested in mechanisms of change (e.g. 
changes in estimates of peer drinking and/or drinking expectancies) and if this program is more effective for 
some students than others (e.g. gender, baseline drinking status, social-emotional maturity, college-bound 
status). 
 
 
What will you do with the results of your study (e.g. contributing to generalizable knowledge, publishing, 
sharing at conference, etc.)?  If this project is only for internal evaluation or to complete a class assignment, IRB 
may not be required.  Please contact the ORC for additional information. 
Results of this study will be presented at conferences via oral or poster presentations and through publication 
in peer-reviewed journals. In addition a project summary report will be sent to the partipating schools and/or 
school district.  
 
SECTION F: Participant Population 
1. 
Provide a description of the participant population you intend to recruit and collect data from.  Describe the 
characteristics of the participant population such as gender, age ranges, ethnic background and health status, as 
applicable to the research. 
 
Participants (12th grade students; N = 1000) will be recruited from Capital High School and Boise High School 
in the Boise School District.  All 12th grade students will be given the opportunity to participate in the study.    
 
We anticipate the demographics to be as follows: 
47% male; 53% female 
Ages 16-18 
91% Caucasian,  .03% African American, . 05% Asisan American, .002% Native American, . 06 % Hispanic and . 01% 
other 
 
We anticipate the student participants will be healthy. 
 
2. 
Will your research involve vulnerable populations, such as children or adolescents under the age of 18, pregnant 
women, prisoners or cognitively, economically, or educationally impaired participants? 
 
 NO  
 YES (indicate population):  
      
 
If yes, describe additional safeguards planned to protect the rights and welfare of this population(s): 
Student participants recruited to this research study will be approximately 1000 high school seniors (ages 
16-18) from Capital High School and Boise High School in the Boise School District. Classrooms within the 
schools will be randomized to intervention or assessment-only control conditions. Participants will be 
recruited from classes. A letter will be sent by the schools to parents and their students prior to the study 
explaining the research. Parents will be asked to return consent forms using a self-addressed stamped 
postcard. Students will be invited to participate in the research study during class. Those students who 
decline participation will participate in an alternate academic activity under the supervision of the 
teacher. Consent procedures will be the same for minors and 18 year old students as the Boise School 
District requires parental consent for 18 year old students. 
 
The surveys will ask student participants about their own alcohol use/non-use and any negative 
consequences, attitudes and beliefs about alcohol use, reasons for using alcohol use, norms for alcohol 
use, personality characteristics, future plans, and demographic information. Similar procedures have 
been used in previous research with 9th grade students and high school seniors without adverse incident. 
Psychological risks posed by the research are primarily related to the content of the assessment 
measures. Items include thoughts and feelings that may be private and personal behavior such as alcohol 
use. These questions may make participants uncomfortable, or be perceived as an intrusion on their 
privacy. Although it is important to consider there potential risks, and it is important to point out the 
potential for these risks, we have not observed any indications of these risks materializing in all of our 
previous research using procedures similar to those we will use in the proposed study. 

ORC Form, Revised 11.03.15 
FOR ORC USE ONLY 
DATE RECEIVED:  
PROTOCOL #:  
 
Page 7
 
All data and other information in this study will be maintained confidentially, but data will not be 
anonymous due to the longitudinal nature of participation. In order to protect against risks posed by the 
potential loss of confidentiality, we will take the following steps: 1) participants will be assured that they 
are free to refrain from answering any questions they do not wish to answer; 2) all data will be identified 
only by a unique personal identifier (PIN), which will be randomly generated for study purposes; 3) a 
master list of names and code numbers will be stored in locked file cabinets under the supervision of the 
PI and will be available only to research staff on this project. Data will be retained on computers with 
restricted and password protected access, without links to the master code list. All data based on this 
research will be reported in aggregate form. 
 
3. 
Will you be recruiting students from a class that you teach? (See IRB guidelines for using your own students.) 
 
 NO  
 YES 
 
If yes, explain why this population is necessary to the study, and how you will ensure participants do not feel 
coerced to participate.  Coercion is a significant concern. 
      
 
4.  
Will you be recruiting employees who report to you?  
 
 NO 
 YES  
 
If yes, explain why this population is necessary to the study, and how you will ensure participants do not feel 
coerced to participate.  Coercion is a significant concern. 
      
 
5. 
Indicate any exclusion criteria for participants. 
There are no exclusion criteria for recruitment other than not meeting inclusion criteria other than not being a 
senior at one of the two school sites.  
 
6. 
How many participants do you anticipate are needed for this research? 
We anticipate a 45% response rate (students with parental acitve consent, student assent, and who are 
present the day of data collection) - this will yeild 450 student participants in this study which will provide a 
large enough sample to adequately power this study. 
 
SECTION G: Recruitment and Informed Consent 
1.  
Attach copies of all applicable recruitment materials: 
 
Recruitment Scripts (what will be said to participants during recruitment) 
 
Recruitment Emails 
 
Cover Letters 
 
Flyers 
 
Advertisements 
 
Other:       
  
2. 
Who will recruit potential participants? 
We have recruited Capital High School and Boise High School in the Boise School District by contacting the 
principal. Participants will be recruited through the high schools from 12th grade classes. Student participants’ 
names will be obtained from the registrar’s list of seniors, which have the names, street addresses, and 
current phone numbers for all students. This information can be obtained directly from the registrar’s 
computer database. Recruitment letters to parents will be sent directly from the school. 
 
3. 
Describe how, when, and where individuals will be first contacted about their interest in participating in the 
study (e.g., face-to-face, email, flyers, advertisements, phone call, etc.). 
A pre-notification letter will be sent by the school to parents early in the academic year. A second letter will 
be sent explaining the study, include the consent form and a project-addressed stamped envelope for return 
of the consent form.  A reminder letter and consent form with project-addressed stamped envelope will be 
sent to parents who do not return the initial consent form. All letters will be sent to parents’ permanent 
addresses, provided to us via the registrar's office. Additionally, letters with consent form with a project-
addressed stamped envelope will be sent home with students.  
 

ORC Form, Revised 11.03.15 
FOR ORC USE ONLY 
DATE RECEIVED:  
PROTOCOL #:  
 
Page 8
Students with parental consent will be invited to participate in the research study during class. Students will 
be given an assent form which will address the voluntary nature of participation, participants’ rights, the risks 
of participation, the availability of referral options outside the study for help with alcohol use prevention or 
treatment, data retention and storage information, protections for and limits to confidentiality, a description 
of the interventions, and procedures for reporting complaints and/or adverse events to the investigators and 
to the University Human Subjects Review Committee. Participants will be given a copy of the consent 
document. Students who elect not to participate will be given an alternative academic activity to complete 
under the supervision of the teacher during the assessment and intervention class periods.  
 
4. 
Are you are directly emailing or mailing participants? 
 
 NO 
 
 YES 
 
If yes, how are you obtaining emails and/or mailing addresses? 
 
  
Participants' parents will be mailed, although recruitment letters to parents will be sent directly from 
the school, not from Boise State.  Student participants’ names will be obtained from the registrar’s list of seniors, 
which have the names, street addresses, and current phone numbers for all students. This information can be 
obtained directly from the registrar’s computer database.  
 
RECRUITING BOISE STATE STUDENTS 
Recruiting Boise State students may require additional internal and departmental permissions, in addition to IRB 
approval. It is the PIs responsibility to obtain these permissions before moving forward with recruitment. The Boise State 
Office of the Vice President for Student Affairs (VPSA) provides guidelines for sending mass emails to students. It is the 
PI’s responsibility to be familiar with these guidelines and any additional departmental, college or unit processes. 
5. 
Are you recruiting Boise State students? 
 
 NO, skip to #6 
 
 YES: 
 
Indicate which students or employees you are targeting: 
 
      
 
  Approval(s) obtained and attached, if applicable. 
 
6.  
Attach copies of all applicable informed consent materials: 
 
Informed Consent Form 
 
Cover Letter 
 
Web-based Cover Letter 
 
Assent Form 
 
Parent/Guardian Informed Consent Form 
 
Verbal Consent Script 
 
Debriefing Statement 
 
7. 
Are you requesting an alteration or waiver to any informed consent requirements, including documentation of 
informed consent (signed consent)? 
 
 NO 
 YES  
 
If YES, complete the section below.  If NO, skip to question 4. 
 
INDICATE THE TYPE OF WAIVER YOU ARE REQUESTING: 
 
I am requesting to waive the required documentation of informed consent (i.e. waive obtaining the signature for 
anonymous internet-based survey, telephone survey, mailed survey, etc.). COMPLETE SECTION A 
 
 
I am requesting to waive or alter the required elements of the informed consent process.COMPLETE SECTION B 
 
 
SECTION A 
 
 
Check the box next to the condition that best fits your research study and justify how your research study meets 
that condition.  If waiving the signature, you must still submit a verbal script or cover letter for participants that 
addresses the eight required elements of consent as stated in 45 CFR 46.116 (a)(1-8).   
 
 
 CONDITION 1 
 

ORC Form, Revised 11.03.15 
FOR ORC USE ONLY 
DATE RECEIVED:  
PROTOCOL #:  
 
Page 9
 
 
The only record linking the participant and the research would be the consent document and the principal risk 
would be potential harm resulting from a breach of confidentiality.  Each participant will be asked whether the 
participant wants documentation linking the participant with the research, and the participant’s wishes will 
govern. 
 
 
 
Justify why your study meets this condition:  
      
 
 
 
 CONDITION 2 
 
 
 
The research presents no more than minimal risk to the participant and involves no procedures for which 
written consent is normally required outside the research context (i.e. no questions are being asked that could 
result in potential embarrassment, personally or professionally.) 
 
 
 
Justify why your study meets this condition:  
      
 
 
 
 
SECTION B 
 
 
 I am requesting to waive the informed consent process. 
 
 
 
 
 I am requesting alteration of the informed consent process. 
Describe which elements of consent will be altered and/or omitted: 
      
 
You must justify your request to waive or alter the informed consent process in accordance with each of the following 
four criteria established under 45 CFR 46.116 (d) (1-4).  Provide supporting information for ALL FOUR criterion: 
 
1. 
The research involves no more than minimal risk to the participants. 
 
Justify:       
 
2. 
The waiver or alteration will not adversely affect the rights and welfare of the participants. 
 
Justify:       
 
3. 
The research could not practicably be carried out without the waiver or alteration. 
 
Justify:       
 
4. 
Whenever appropriate, the participants will be provided with additional pertinent information after 
participation.  (If a debriefing statement is used, submit a copy with this application.) 
 
Explain:       
 
8. 
Describe the consent process.  Do not answer, “see attached consent form,” as this does not describe the 
process of obtaining informed consent.  Describe how, when and where the informed consent process will take 
place and who will obtain informed consent. 
A pre-notification letter will be sent by the school to parents early in the academic year. A second letter will 
be sent explaining the study, include the consent form and a project-addressed stamped envelope for return 
of the consent form.  A reminder letter and consent form with project-addressed stamped envelope will be 
sent to parents who do not return the initial consent form. All letters will be sent to parents’ permanent 
addresses, provided to us via the registrar's office. Additionally, letters with consent form with a project-
addressed stamped envelope will be sent home with students.   
 
9. 
If the participants are not able to give legal consent (e.g., minors), explain how assent will be secured.   
Students will be invited to participate in the research study during class. Students will be given an assent form 
which will address the voluntary nature of participation, participants’ rights, the risks of participation, the 
availability of referral options outside the study for help with alcohol use prevention or treatment, data 
retention and storage information, protections for and limits to confidentiality, a description of the 
interventions, and procedures for reporting complaints and/or adverse events to the investigators and to the 
University Human Subjects Review Committee. This will be presented by Dr. Susan Esp. It will be clearly stated 
to the participants that participation is voluntary. Students who elect not to participate will be given an 
alternative activity to complete during the assessment and intervention class periods. 
 
10. 
Into what languages will the consent be translated?  (NOTE: Translated consent documents must be reviewed 
and approved by the IRB prior to use.) 
None 
 

ORC Form, Revised 11.03.15 
FOR ORC USE ONLY 
DATE RECEIVED:  
PROTOCOL #:  
 
Page 10
11. 
If your research involves collecting a combination of demographic data (e.g., a combination of gender, age, 
race, and ethnicity) that may make a participant identifiable, you must inform the participants the following: 
“For this research project, the researchers are requesting demographic information.  Due to the make-up of 
Idaho’s population, the combined answers to these questions may make an individual person identifiable.  The 
researchers will make every effort to protect your confidentiality.  However, if you are uncomfortable answering 
any of these questions, you may leave them blank.”   
 
If applicable, indicate where and how participants will be informed of this. 
This information will be included in the informed consent and assent. 
 
SECTION H: Data Collection 
1. 
Attach copies of all data collection tools and methods to be used.  Check all that apply.  
 
Questionnaire/Survey (attach questions) 
Videotaping  
 
Observation 
Photographing 
 
Interviews (attach questions and scripts) 
Audiotaping  
 
Focus Groups (attach questions and scripts) 
Using direct quotes 
 
Reviewing Medical/Education Records 
Deception 
 
Other:       
 
2. 
Indicate all biomedical procedures that apply to your research:  
 
Physical Activity 
Body Mass Index 
 
Venipuncture 
X-rays 
 
Magnetic resonance imaging (MRI) 
Anthropomorphic evaluations 
 
Electrocardiograms (EKGs) 
Intravenous catheter insertion 
 
Collection of blood samples by finger stick, heel stick, ear stick or venipuncture 
 
Other:       
 
3. 
If applicable, describe the procedures being performed already for diagnostic or treatment purpose.   
N/A 
 
4. 
What are you going to ask participants to do?  Provide a step-by-step description of each procedure, including 
the frequency and duration of each procedure.  This question is mandatory and may not be skipped. 
Applications missing this section will not be accepted. 
All student participants will be asked to complete an online survey during class time. This will take no longer 
than 20 minutes. Participants in the classrooms randomly assigned to the intervention group will be asked to 
complete an online intervention program which will occur during class time. The program involves a 
comprehensive assessment of the participant's drinking and drinking-related behaviors, followed by 
systematic personalized feedback to the participant about their alcohol use feedback in relation to their peer 
group. The program will take about 30 minutes to complete. Participants will then be asked to complete a 
brief exit survey regarding the intervention. Participants will be asked to complete the surey at 6 weeks and 6 
months in the computer lab at their school. This survey will completed online during class periods and will 
take no longer than 20 minutes to complete. Participants will also complete a very brief survey to assess help 
seeking. This will occur at the 6 week and 6 month follow-up assessments. 
 
5. 
Where will the data collection and data analysis procedures take place? (i.e., explain where you are distributing 
surveys, conducting interviews, etc.)  
Onsite at Capital High School and Boise High School in the computer lab via electronic methods. 
 
6. 
Does your study include plans to conduct research at an external site? (i.e., off Boise State campus. For example, 
an elementary school, hospital, prison, etc.) 
 
YES  
NO 
 
If YES, indicate the external site(s) and you must attach an acknowledgement (letter or email) indicating 
you have permission to use their facility and personnel.   
Capital High School, Boise, ID and Boise High School, Boise, ID 
 
 
If YES, does your study include plans to conduct research at external sites that are engaged in the research?  
If so, will that site’s IRB approve this research or will it rely upon the BSU IRB? 

ORC Form, Revised 11.03.15 
FOR ORC USE ONLY 
DATE RECEIVED:  
PROTOCOL #:  
 
Page 11
The external site is not engaged in the research other than in facilitating the process and sending parental 
informed consent letters. Additionally, a school counselor may help facilitate data collection in the 
computer lab with the research team. We do, however, have approval from the Boise School District 
Research Board to conduct the study. 
 
7. 
Will monetary or other compensations be offered to the participants (e.g., gift certificates, raffle, cash payment 
or class extra credit?)   
 
YES  
NO 
 
If YES, identify the amount of compensation and method of payment.  Explain how participants would earn 
compensation if their participation is anonymous.  If students are offered extra credit, you must provide 
other options to fulfill the research component if they do not wish to participate. 
Classroom incentives will be given to classrooms with at least a 60% response rate. These will include a 
$100 gift certificate to the teacher for classroom supplies and a pizza party for the class. 
 
SECTION I: PARTICIPANT PRIVACY 
Privacy refers to persons during data collection.  It is the control over the extent, timing, and circumstances of sharing oneself 
(physically, behaviorally, or intellectually) with others (e.g., surveys are completed in the privacy of their own home; interviews 
will be done in a location of their choosing where it is unlikely they will be overheard). 
1. 
Describe the provisions to protect the privacy of the participants during the data collection procedures.   
Participants will complete all questionnaires and the intervention on a computer situated so no other person 
can see the computer screen. The participants will be given a code number to use during each assessement. 
The research staff will have a master list that links the code number to the participant. Once the 6 month 
follow-up data is collected the master list will be destroyed.   
 
SECTION J: CONFIDENTIALITY OF DATA 
CONFIDENTIALITY: Confidentiality refers to how DATA is handled after collection.  It is the treatment of information already 
revealed and states that there is an expectation that it will not be divulged to others in ways that are inconsistent with the 
understanding of the original disclosure without permission (e.g., data is secured on a password-protected computer or locked 
file cabinet, data is de-identified or coded, only the researchers have access to the data). 
1. 
Provide details as to how you plan to protect the data while on site and during travel (e.g. from data 
collection site back to the office). When traveling (especially overseas) or just with portable devices, data 
security is vital, especially if the device or data is lost or stolen. Address the storage and security of electronic 
data as well as any physical data, such as paper consent forms or surveys, during travel. 
All data will be collected via online surveys  - it will not be transported as it is electronic. 
 
2. 
Describe how you will maintain confidentiality of the data after it has been collected, including measures to 
protect the identity of the participants and their responses (coding procedures, encryption, etc.).  
Confidentiality of data will be maintained through the use of a code number. All data collected through 
electronic means will be delivered directly to the research database upon completion of the survey. The 
master list of volunteer names and their corresponding code numbers will be confidential and will only be 
accessible by the principal investigator at BSU. After completion of the post-intervention surveys, the master 
list will be destroyed.  
 
3. 
Where will you store the data? A copy of the data must be kept within the campus departmental area, not 
stored at home. OIT offers virtual servers and storage for BSU researchers, click for more details. Describe 
procedures for both electronic and hard copy data. 
Survey data are collected online and will be kept on a password protected computer in a locked office. The 
data will be stored on a password protected computer in a locked office at Boise State and will be kept for a 
minimum of three years.  
 
4. 
Who will have access to the data?   
Only members of the research team will have access to the data through permission from the PI.  
 
5. 
In what format will the data be stored (e.g., paper or electronic copy)? 
The data will be stored in electronic format. 
 
SECTION K: Risks and Benefits 

ORC Form, Revised 11.03.15 
FOR ORC USE ONLY 
DATE RECEIVED:  
PROTOCOL #:  
 
Page 12
1. 
What are the risks and inconveniences to the participants?  Describe all known anticipated psychological, 
physical, sociological, financial, economic risk to participants: 
 
Examples include, but are not limited to: 
 
Loss of confidentiality  
 
Identifiable links to individual participants 
 
Feeling guilty for lying in study requiring deception 
 
Emotional stress or discomfort (describe below)  
 No physical, psychological, legal or economic risks or consequences to the participants are 
anticipated. Any potential psychological risks posed by the research are primarily related to the 
sensitivity of some of the measures. Items include thoughts, feelings, and personal difficulties that 
may be private and personal behavior such as alcohol and other drug use. These questions may 
make participants uncomfortable, or be perceived as an intrusion on their privacy. Participants are 
also asked to report on potentially illegal behaviors, such as drinking under the legal drinking age 
or driving after drinking. However, there is no risk of coercion of individuals, as individuals are free 
to delete the invitation email should they choose to do so and may discontinue involvement in the 
study at any time. 
 
Physical injury or discomfort (describe below)  
      
 
 
Other: 
      
 
2. 
How will you minimize these risks and their impact to the participants? 
The primary procedure for guarding against this risk is to fully inform them of their right to refuse to 
participate in any portion of the study or to discontinue the study altogether. Dr. Susan Esp is a Licensed 
Clincial Professional Counselor and will be with the students during all assessments and the online 
intervention will also be prepared to respond in an appropriate and caring manner to any querries by a 
participant. Participants will also be provided information about follow-up counseling services.  
 
3. 
Describe how you are able to identify and handle the risks above.  Provide a brief description of all relevant 
training, experience, education, and credentials.   
The intervention will be administered by Dr. Susan Esp who is a Licensed Clinical Professional Counselor and is 
fully trained and licensed to work with students experiencing distress and provide appropriate resources for 
participants. In addition, this project is similar to several projects conducted by this PI and Dr. Susan Esp with 
no adverese events. The PI and Co-I have extensive experience working with this population.   
 
In addition, program staff are licensed mental health professionals and are trained to manage any crisis that 
might occur. Dr. Doumas is a licensed psychologist with over 10 years experience in clinical work. Dr. Esp is a 
Licensed Clinical Professional Counselor with 15 years experience in clinical work.  
 
4. 
Describe your plan for an emergency situation. Even if you feel this situation is unlikely, please have a plan in 
case of emergency (e.g., the researcher will carry a cell phone, etc.).  
If a participant were so distressed as to represent a harm to themselves, the participant  would be walked to 
school counselor's office where arrangements would be made to have the police escort the participant to an 
appropriate facility for an evaluation. Dr. Susan Esp is a Licensed Clinical Professional Counselor - she will be 
administering the survey and intervention and is trained to evaluate and manage crisis situations. The PI will 
be available by cellular phone to supervise and manage any crisis that might occur.   
 
5. 
What are the potential direct benefits to the research participants? (This may not be applicable to your 
research.) 
Participants in the study who are using alcohol may decrease their drinking. Interventions such as those used 
in this study have been shown in the literature to decrease high-risk drinking and alcohol initiation. Thus, 
participating in this study has the potential to positively impact students, including those who are at high-risk 
for alcohol-related consequences.   
 
6. 
What are the potential broader benefits of the study? 
n addition to benefits for participants, the development and implementation of intervention programs for 
high school students has the potential for reducing the serious public health problem of underage drinking and 
the negative associated consequences. Given the relatively high rates of heavy drinking in high school, the 
relationship between high school drinking and drinking in college students and non-college attending young 

ORC Form, Revised 11.03.15 
FOR ORC USE ONLY 
DATE RECEIVED:  
PROTOCOL #:  
 
Page 13
adults, and the relationship between underage drinking and the development of alcohol use disorders, 
dissemination of efficacious intervention programs has the potential for significant societal benefits. Given the 
potential benefit to both individual participants and society, the risks of participation are outweighed.  
 
SECTION L: Unanticipated Problems/Adverse Events 
Unanticipated Problem: includes any information that is unexpected, related or possibly related to the research, or 
indicates that participants or other individuals may be placed at greater risk of harm than initially anticipated by the 
IRB. 
 
Adverse Event: Any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign 
(for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the 
subject’s participation in the research, whether or not considered related to the subject’s participation in the 
research. 
 
If an unanticipated problem or adverse event should occur, you must immediately complete and submit the IRB 
Incident Report Form to HumanSubjects@boisestate.edu, and contact the Office of Research Compliance at 
208.426.5401. 
 
 

Statistical Analysis Plan 
To identify reductions in alcohol use and negative alcohol-related consequences among high school 
seniors over the duration of the study, we will evaluate each outcome using analysis of variance in a linear 
or generalized linear mixed model framework, with random effects of repeated observations on students, 
students nested in classes, periods or teachers, and within school. We will address the appropriateness of 
the model for non-normal outcomes and apply the appropriate distribution as necessary, and we will 
assess models for the necessity of all random effects using AICC. The fixed effects will include treatment 
(intervention, control), time (baseline, 6-weeks, and 6-months), and their interaction.