Community Wise: An Innovative Multi-level Intervention to Reduce Alcohol and Illegal Drug Use
Phase: NA
Conditions: Substance Use Disorders
Sponsor: University of Illinois at Urbana-Champaign

 
 
 
 
Notice of Approval: Continuing – Data Analysis Only 
 
November 15, 2021 
 
Principal Investigator 
Liliane Windsor 
CC 
Ellen Benoit, Carol Lee 
Protocol Title 
Community Wise: An Innovative multi-level intervention to reduce 
alcohol and illegal drug use 
Protocol Number 
16574 
Funding Source 
National Institute on Minority Health & Health Disparities 
Grant Number: 5U01MD010629 
Review Type 
Expedited 8 
Approved Subparts 
BB 
Status 
Data Analysis Only 
Risk Determination 
No more than minimal risk 
Approval Date 
November 15, 2021 
Expiration Date 
November 14, 2022 
 
 
This letter authorizes the use of human subjects in the above protocol. The University of Illinois at Urbana-
Champaign Institutional Review Board (IRB) has reviewed and approved the research study as described.  
 
The Principal Investigator of this study is responsible for: 
• 
Conducting research in a manner consistent with the requirements of the University and federal 
regulations found at 45 CFR 46. 
• 
Using the approved consent documents, with the footer, from this approved package. 
• 
Requesting approval from the IRB prior to implementing modifications. 
• 
Notifying OPRS of any problems involving human subjects, including unanticipated events, 
participant complaints, or protocol deviations. 
• 
Notifying OPRS of the completion of the study. 
 
 

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University of Illinois 
at Urbana–Champaign 
Office for the Protection of Research 
Subjects [OPRS] 
528 East Green Street, Suite 203, MC-
419 
Champaign, IL 61820 
tel: 217-333-2670      fax: 217-333-0405 
E-mail: irb@illinois.edu Web:
www.irb.illinois.edu 
IRB Application 
Application for Review of Research Involving Human Subjects 
This Section is for Office Use Only 
UIUC IRB Protocol No. 16574 
Track: 
Exempt under 45 CFR §46.101(b)  
(1)   
(2)   
(3)   
(4)   
(5)   
 (6) 
Reviewer 1: 
Expedite, Category 
(1)  
(2)  
(3)  
(4)  
(5)  
(6)  
(7)  
(8)  
(9) 
Reviewer 2: 
All forms must be completed, signed by the RPI, and submitted by FAX, Email, or single-
sided hard copy.  
Please type responses, handwritten forms will not be accepted. 
Please, no staples! 
  Initial Submission, date of submission 
  Revised IRB-1, date of revised IRB-1 1/15/2020 
1. RESPONSIBLE PROJECT INVESTIGATOR (RPI) The RPI must be a non-visiting member
of UIUC faculty or staff who will serve as project supervisor at UIUC. For other research team
members [including those from other institutions], please complete the Research Team
Attachment and provide with the completed application. Include all persons who will be 1)
directly responsible for the project’s design or implementation, 2) recruitment, 3) obtain informed
consent, 4) involved in data collection, data analysis, or follow-up.
Last Name:  Windsor 
First Name: Liliane 
Academic Degree(s):  PhD 
Dept. or Unit:  School of Social 
Work 
Office Address:  1010 W. Nevada St. 
Mail Code:  
Street Address:  1010 W. Nevada St. 
City:  Urbana 
State:  IL 
Zip Code:  61801 
Phone:  217-300-1782 
Fax:  
E-mail:  lwindsor@illinois.edu
UIUC Status:  Non-visiting member of (Mark One)  
 Faculty      
  Academic 
Professional/Staff 
Training 
 CITI Training, Date of Completion,  02/10/21 
Additional training, Date of Completion1,     
2. PROJECT TITLE
1 Additional CITI modules may be required depending on subject populations or types of research. These include: (i) research enrolling 
children; (ii) research enrolling prisoners; (iii) FDA regulated research; (iv) data collected via the internet; (v) research conducted in 
public elementary/secondary schools; and, (vi) researchers conducted in international sites 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
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Community Wise: An innovative multi-level intervention to reduce alcohol and illegal drug use 
3. FUNDING Indicate whether this research is funded by, or application has been made for, a grant,
contract, or gift.
3A. STATUS 
  Research is not funded and is not pending a funding decision (Proceed to 
Part 4). 
  Research is funded (funding decision has been made). 
  Funding decision is pending.  Funding proposal submission date:  
3B.  SOURCE(S)  If the research is funded or pending a funding decision, mark and name all sources: 
Type of Funding—check all that apply 
Name of Source 
UIUC Department, College, or Campus 
(includes Research Board and Campus Fellowship 
Training Grants) 
Federal 
(from federal agencies, offices, departments, 
centers) 
National Institute on Minority Health & 
Health Disparities 
Commercial Sponsorship & Industry23 
(from corporations, partnerships, proprietorships) 
State of Illinois Department or Agency 
(from any state office or entity) 
Gift or Foundation (including UIF) 
(public or private foundations, not-for-profit 
corporations, private gifts) 
 Check here if the funding is through a Training Grant:  
 
3C. PROPOSAL Attach a complete copy of the funding proposal or contract.  
 Attached     
Sponsor-assigned grant number, if known:   1U01MD010629 - 01  
Title of Funding Proposal or Contract, if different from Project Title in Part 2: 
3D.  FUNDING AGENCY OFFICIAL, IF ANY, TO BE NOTIFIED OF IRB APPROVAL 
Last Name:  Griffith 
First Name: 
 Carla 
Salutation:  Ms. 
Agency:  National Institute on 
Minority Health & Health 
Disparities 
Office Address:  6707 Democracy 
Boulevard, Suite 800 
Mail Code:  
Street Address:  
City:  Bethesda 
State: MD  Zip Code:  
20892-5465 
2 Clarify whether or not sponsor requires specific language in the contractual agreement that impacts human subjects 
research 2 
3 Clarify whether or not the sponsor requires the protocol adhere to ICH GCP (E6) standards 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
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Phone:  (301) 594-8944 
Fax:  (301) 480-4049 
E-mail:  Griffithcp@mail.nih.gov 
 
 
4.  FINANCIAL INTERESTS: Indicate below if any investigators or any members of their immediate 
families have any relationships, commitments, or activities with the sponsor of this research that might 
present or appear to present a conflict of interest with regard to the outcome of the research. (If a 
financial conflict of interest exists, please submit the UIUC approved conflict management plan. If you 
have questions about conflict of interest contact the Office of the Vice Chancellor for Research at 217-
333-0034.) 
  
  Ownership, equity or stock options  
  Has been disclosed to the UIUC campus  OR    
  has not been disclosed to the UIUC 
campus 
 
  Personal compensation such as royalties, consulting fees etc. 
  Has been disclosed to the UIUC campus  OR    
  has not been disclosed to the UIUC 
campus 
 
 
 Intellectual property such as patents, trademarks, copyright, licensing, etc. 
 Has been disclosed to the UIUC campus  OR     
  has not been disclosed to the UIUC 
campus  
 
 Other conflict of interest:  
 Has been disclosed to the UIUC campus  OR    
  has not been disclosed to the UIUC 
campus  
 
 No conflicts exist 
5.  SUMMARIZE THE RESEARCH.  In LAY LANGUAGE, summarize the objectives and 
significance of the research. 
 
Rates of alcohol and illicit drug use (AIDU) among residents of distressed communities with 
concentrations of African Americans (DCAA- i.e., localities with high rates of poverty and crime) are 
similar to the general population. Yet AIDU has significantly higher consequences for residents in 
DCAAs (e.g., higher incarceration and HIV/HCV infection rates), who also have considerably less 
access to effective treatment of substance use disorders. This project will continue to develop and test 
Community Wise, an innovative multi-level intervention created in partnership with service providers, 
residents of DCAAs and individuals with histories of substance use disorders and incarceration, to 
reduce health inequalities related to AIDU. We used community-based participatory research (CBPR) 
to develop and pilot test Community Wise, achieving 75% intervention completion rates, despite great 
participant challenges (such as homelessness, AIDU, and poverty). Note that substance use disorder 
intervention completion rates in the literature are much lower among populations with fewer 
challenges (often 30 to 40%). We believe that this success is due to the CBPR model used to develop 
an intervention that is relevant to participants’ needs.  
 
 
Community Wise addresses social determinants of health (e.g., stigma, poverty, lack of treatment 
access, housing, and meaningful employment) and inequalities related to AIDU at the micro level 
(e.g., cognitive and behavioral processes), meso level (e.g., relationships with individuals and 
organizations) and macro level (e.g., political and cultural processes). Community Wise builds on 
critical consciousness theory, which empowers individuals, organizations, and communities to address 
social determinants of health while changing individual behaviors (e.g., reducing AIDU). We propose 
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to apply the Multiphase Optimization Strategy (MOST) - an innovative and rigorous framework that 
employs factorial designs - to optimize Community Wise. Specifically, using MOST we will identify 
the most efficient, scalable, and sustainable components of Community Wise so that we can refine the 
intervention protocol by including only components that significantly reduce AIDU. The long-term 
goal of Community Wise is to reduce health inequalities related to AIDU between men with substance 
use disorders and a history of incarceration residing in DCAAs and the general population through an 
intervention that is congruent with DCAA world views and grounded in scientific and indigenous 
knowledge. Data from this study will culminate in an optimized Community Wise manual; enhanced 
methodological strategies to develop multi-component scalable interventions using MOST and CBPR; 
and a better understanding of the application of critical consciousness theory to the field of health 
inequalities related to AIDU.  
 
 
 
6.  PERFORMANCE SITES 
Including UIUC sites, describe ALL the research sites for this 
protocol. For each non-UIUC site, describe:   Whether the site has 
an IRB.  Whether the site has granted permission for the research to 
be conducted.  Contact information for the site. If the site has an 
IRB, whether the site’s IRB has approved the research or planned to 
defer review to a UIUC IRB. 
For non-UIUC sites, 
documentation of IRB approval 
is: 
 
 
1
. 
National Development & Research Institutes, Inc. FWA00002853 
Carol Tarzian: 212-845-4405; tarzian@ndri.org 
 Attached    
 Will Follow    
 N/A 
3
. The University of Michigan FWA00004969 
 Attached    
 Will Follow    
 N/A 
4 North Jersey Community Research Initiative (NJCRI) 
FWA00001870 
 Attached    
 Will Follow    
 N/A 
List and describe any additional Performance Sites information on an attachment and check here:  
 
 
 
7.  DESCRIBE THE HUMAN SUBJECTS 
 
7A.  SECONDARY DATA ONLY?  If this research only involves the analysis of data that has 
already been collected from human subjects and no new data collection will occur, check here:  
 
 
7B.  MATERIALS OF HUMAN ORIGIN?  Will this research involve the collection, analysis, or 
banking of human biological materials (e.g., cells, tissues, fluids, DNA)?    
 Yes   
 No       If yes 
attach Appendix C, the Biological Materials Form. 
 
7C.  ANTICIPATED NUMBERS  How many subjects, including controls, will you study in order to 
get the data that you need? 
 If you plan to study disproportionate numbers of a given sex, race, or minority group, provide scientific 
rationale in Part 11. 
Performance Site 
# Male 
# Female 
Total 
1. 
NJCRI - RCT 
592 
0 
592 
2. 
NJCRI - NCCB 
08 
12 
20 
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3. 
      
      
      
      
TOTALS 
600 
12 
612 
List Anticipated Numbers for additional Performance Sites on an attachment and check here:  
 
 
 
7D.  AGE RANGE  Mark all that apply. Researchers planning to include children in research projects 
involving more than minimal risk must provide written documentation of the benefits that are likely to 
accrue to a child participating in the project. This should include information gathered on adults, if it 
exists, or an explanation about why it does not exist. 
 
  0–7 years 
  8–17 years 
 
  18–64 years 
 
  65+ years 
  If applicable, written documentation of benefits for including children in more than minimal 
risk research is attached. 
 
 
 
 
7E. SPECIAL OR VULNERABLE POPULATIONS Mark groups that will be targeted by design. 
Also indicate groups likely to be involved in the research even though they are not targeted by design.  
 
 
  None of the following special populations will be targeted  
 
 Children (age < 18 
 
 Neonates 
 Mentally disabled or cognitively impaired persons 
 Fetuses (in utero) 
 Adults with legal guardians 
 in vitro fertilization 
 Persons with limited civil freedom (e.g., prisoners) 
 Pregnant or lactating 
 Specific racial or ethnic group(s)— 
      
 Inpatients 
 Low income or economically disadvantaged persons 
 Outpatients 
 UIUC Students—name subject pool, if 
      
 Elderly (age > 65 
 Other College Students—name subject 
      
 Other (describe here):        
 
7F. If you checked any of the groups in question 7E, describe additional safeguards included in the 
protocol to protect the 
      rights and welfare of special or vulnerable populations. 
To avoid possible violations of confidentiality, project staff are trained to carefully follow detailed 
procedures designed to assure that no information about any participant (or others they may mention) 
will be given to law enforcement, other government agencies, or anyone but research staff.  Every 
member of the research team and all Newark Community Collaborative Board (NCCB) members will 
be required to undergo human subject protection training and provide a certificate of completion to the 
IRB prior to any contact with human subjects. Standards of confidentiality include the use of code 
numbers and code names for participants and other individuals they may mention. The only place 
participants’ names or other identifying information will appear is on informed consent forms and 
locator forms (used for follow-up interviews after the baseline). These forms will be kept 
electronically in box, in a folder separate from the data. Only full time, trained staff in the project 
including the outreach works, group facilitators, PD and PIs will have access to these files. Peer 
facilitator and licensed facilitator will not have access to data from the individuals that are randomized 
into their groups. 
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The electronic files generated through data collection will be identified by code numbers and 
codenames only and kept in password-protected devices/servers, separate from identifying 
information and available only to project staff. This helps to ensure that no identifying information 
will be disclosed in the unlikely event that computerized data are stolen or otherwise seen by 
unauthorized persons.) All identifying electronic data will be destroyed immediately after data 
analysis is completed. Signed consent forms will be kept for 3 years after study completion. De-
identified electronic data will be kept indefinitely. NCCB participants may ask at any time to have 
recordings of their interview destroyed by calling/e-mailing one of the Principal Investigators at the 
numbers provided in the informed consent forms. RCT voice recordings will be kept indefinitely for 
data analysis. However, if we have reason to believe that any of these recordings contain information 
that can put any of our participants in danger of being hurt or being incarcerated, we will destroy the 
recording.  
 
Our interviewers are trained to watch participants carefully and will stop questioning if an individual 
appears uneasy. At every interview, participants will be informed that they may ask the interviewer to 
stop if they are feeling uncomfortable. Referrals to counselors are available if participants wish and 
trained clinical counselors are available at NJCRI in the event that someone may need immediate 
assistance, whether it is during data collection or during the intervention sessions.  
 
Dr. Windsor, Dr. Benoit, and project director will be available by phone at all times in case an 
emergency occurs. Any adverse event will be reported to the IRB and funding agency within 24 hours. 
Through our NCCB collaboration, we have excellent relationships with the community, including 
community members and agencies that we can mobilize in case the need arises (e.g., access to 
providers that provide detox and emergency services, legal support clinic at Rutgers University, 
Newark campus, community members who learned from participants about their engagement in the 
study may reach out to us for help in case they know one of our participants may be in trouble). 
 
In addition to this extensive network, we will collect data during the baseline and follow-up 
assessments to monitor participant safety. For instance, we will conduct the MINI suicidality screen 
and if we find anyone at risk, we will have the appropriate group clinician reach out to the participant 
individually and make sure they are linked to the mental health services they need. 
 
Finally, the research team and the clinical team will engage in weekly project meetings to discuss the 
progress of the study and identify, discuss, and address any potential issues. 
 
 
 
8.  RECRUITMENT 
 
8A-1  RECRUITING PROCEDURES  Specifically describe the systematic procedures for finding 
and recruiting subjects or requesting pre-existing data or materials. 1) State whether any of the 
researchers are associated with the subjects (e.g., subjects are students, employees, patients). 2) Name 
any specific agencies or institutions that will provide access to subjects or subject data. 3) Who will 
contact the prospective subjects? 4) Who gives approval if subjects are chosen from records? 5) 
Describe solicitation through the use of advertising (e.g., posters, flyers, announcements, newspaper, 
radio, television, Internet), face-to-face interaction, direct mail or phone contact, classrooms, subject 
pools, health care registries, patient referrals, and institutional “gatekeepers,” as applicable.  
 
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This study will include up to 20 participants who will serve a dual role as researchers and human 
subjects through their membership in the Newark Community Collaborative Board (NCCB). All 
NCCB members are also research participants because NCCB meetings are recorded and board 
members complete an anonymous annual survey, both to monitor the study for compliance with 
principles of community-based participatory research and satisfaction. No NCCB member will be a 
participant in the Community Wise clinical trial. No NCCB member except the project director and the 
principal investigators, will have access to any identifying information about participants. 
The NCCB is a diverse group of service providers, consumers of substance abuse treatment, 
individuals with a history of incarceration, researchers, and government employees who work together 
to improve health conditions in the City of Newark, NJ. The NCCB developed and pilot tested 
Community Wise and they will oversee all phases of the current study. At this time we have a total of 
15 members. Anyone can apply to become a NCCB member at any time. Since the NCCB will 
oversee the research (e.g., recruitments, data collections, analysis, dissemination) all members are 
required to complete the CITI training prior to engaging in any study activities. 
 
NCCB members bring a variety of skills to the table. Together, the NCCB is the overall directing 
body or the research, but outside of monthly meetings to get a big picture update on the research, it 
will function through sub-committees. All activities are voluntary (meaning no one is required to 
participate in any given activity). Subcommittees are formed to conduct specific and time limited 
research tasks. Membership in subcommittees is based on individual members’ skills and interest in 
participating. For instance, clinical screening for the clinical trial requires that screeners have clinical 
training at the master level. Hence, only NCCB members who are clinicians are eligible to join the 
clinical screening sub-committee. In the event that NCCB clinicians are not interested in conducting 
clinical trial screens, we can hire and train outside clinicians to perform that task. Thus, NCCB 
members participate in all aspects of the research; however, not every NCCB member participates in 
every task. This is done on a case by case basis under the supervision of the project director and PIs.  
 
Our clinical trial participants will be recruited from various venues in the community and using a 
variety of approaches. We will post fliers at reentry, substance abuse, and HIV/HCV service agencies 
throughout the community (e.g., Integrity House; La Casa de Don Pedro; NJCRI). Individual service 
providers and Community Wise alumni will be asked to help disseminate information about the study 
by distributing study fliers to people who may meet the eligibility criteria. These agencies and 
Community Wise alumni will not engage in recruitment; they will simply distribute fliers about the 
study.  We will train the partner agency staff not to answer any questions that their clients may have 
about the study. We will provide them with the partner agency flier dissemination instruction sheet so 
that they can help us avoid potential coercion. We will pay NCCB members $5 per eligible participant 
referred into the project who successfully enrolls. NCCB members will distribute the fliers and 
encourage people they believe may be eligible and interested to contact the study outreach worker 
to complete the phone screening. During the screening, we ask participants to tell us who referred 
them to the study. NCCB members will receive a lump sum per wave for the number of people that 
name them as a referral source and that were admitted into the study. NCCB members will not have 
access to the information about who did not enter the study and why. Once the wave sample is 
randomized, the outreach worker will cross check the list of  referee names in  the phone screen 
with the list of people enrolled and submit the dollar amount that is due to each NCCB member. The 
outreach worker is not a member of the NCCB and only the outreach worker will have contact with 
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potential study participants which will include conducting the phone screen, and scheduling the 
clinical screen, the orientation session, and the baseline.  
 
In addition, research staff will encourage potential participants to help distribute the study’s fliers in 
their neighborhoods, churches and other meeting places. Men interested in participating will call the 
study’s cell phone number to receive information about the study. A trained master’s level clinician 
will conduct a brief phone screening to obtain self-reported eligibility information including substance 
use disorder, date of last prison release, age and contact information. Those meeting phone screening 
eligibility will be invited to complete the clinical screen. Those meeting the clinical screen eligibility 
criteria (see below) will be consented into the study. In this process we will explain the randomization 
process, the study risks and benefits, what we will ask them to do and their rights as research 
participants. Those consenting will be randomized into one of the eight experimental conditions.  
 
It is possible the NCCB members may know some of the potential clinical trial participants as these 
individuals live and work in Newark, NJ. Potential clinical trial participants may be clients, family 
members, or a friend of any NCCB member. The standard protocol for such situations is to ensure that 
any NCCB member or staff person who has a personal relationship with a potential participant does 
not recruit or interact with that person in any capacity as part of the study. This is acknowledged in the 
NCCB informed consent which will be signed by NCCB members.  
 
NJCRI will be the main recruitment and performance site where experimental groups will run and all 
data will be collected. NJCRI has been our partner for over 6 years and it has served as a site for the 
intervention during our pilot testing. NJCRI is New Jersey’s largest and most comprehensive 
HIV/AIDS community-based organization.  NJCRI’s mission is “to help people with HIV/AIDS and 
those at risk for HIV/AIDS.” NJCRI conducts state-wide HIV clinical trials, and HIV treatment, care 
and prevention services in the Greater Newark Area.  Populations served include youth and adults, 
men and women, men who have sex with men, people who acquire or who are at risk for HIV through 
injection drug use, and others. NJCRI also seeks to address the concerns and disparities of access to 
health care faced by minority populations.  Some of the non-HIV related services offered include 
behavioral research, chronic illness management education, street outreach, substance abuse 
treatment, transportation, food pantry, and technical assistance to other community-based 
organizations.  Approximately 5,000 people avail themselves of NJCRI’s free and confidential 
services each year. NJCRI is located in a predominantly low-income African-American neighborhood 
in Newark, NJ. Another advantage of partnering with NJCRI is that they offer HIV/STDs counseling, 
testing and referrals services at no charge to people in the community. They house 1 of 5 syringe 
exchange programs in the state along with a drop-in center. Our participants will have access to all of 
these services at NJCRI. 
We will also recruit participants through New Jersey parole officers. Specifically, parole officers will 
share the Community Wise study flier with their clients and inform them that they may choose to contact 
the study staff and participate in Community Wise as an optional and additional treatment service. 
Parole officers will not have access to information about who enrolled and who did not enroll unless 
the participant chooses to disclose this information themselves.  
 
8 A-2 Attach final copies of recruiting materials including the final copy of printed advertisements 
and the final version of any audio/taped advertisements and check here:     Attached  
       Will 
Follow 
         
 
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8B. WITHHELD INFORMATION Do you propose to withhold information from subjects prior to or 
during their participation? 
 
  
  Yes 
  No 
 
If yes, describe what will be withheld, justify the withholding (address risks, provide rationale), 
describe the debriefing plan, and attach a labeled copy of a written debriefing form, to be provided to 
subjects.    
  Debriefing Attached      
  Will Follow 
      
 
 
8C.  PROTECTED HEALTH INFORMATION (PHI)  The IRB must address the privacy and use of 
health information that is created, received, or housed by health care providers, health plans, or health 
care clearinghouses and that identifies or could be used to identify an individual. During either 
recruiting or data collection, will you use or have access to such information that is related to the past, 
present or future health or conditions of a living or deceased individual, provision of health care to the 
individual, or the payment for the provision of health care to the individual? 
    
  Yes 
  
No 
 
 
8D.  SCHOOL-BASED RESEARCH  If subjects will be recruited from Illinois public or private 
elementary or secondary schools, additional deadlines and procedures apply. Criminal background 
clearances might be required. Special consideration must be given to the exclusion of protected 
populations. Please contact the Office of School–University Research Relations (OSURR) 
(217.244.0515 or http://www.ed.uiuc.edu/BER/OSURR.html) for more information. Mark one: 
 
 
  Illinois schools will be used 
 
  Illinois schools will not be used 
 
 
9.  INCLUSION AND EXCLUSION CRITERIA  Address all four of the following items in 
explaining who will and will not qualify for participation and how that determination will be made:  (1) 
Describe procedures to assure equitable selection of subjects. Justify the use of any special or 
vulnerable groups marked in Part 9E. Selection criteria that target one sex, race, or ethnic group require 
a clear scientific rationale. (2) List specific criteria for inclusion and exclusion of subjects in the study, 
including treatment groups and controls. (3) Name and attach copies of measures and protocols that will 
be used to screen applicants. (4) Explain how the inclusion/exclusion criteria will be assessed and by 
whom. If special expertise is required to evaluate screening responses or data, tell who will make this 
evaluation and describe their training and experience. 
 
All experimental participants will be males over the age of 18 and predominantly African Americans. 
Because we are dealing with health disparities related to AIDU and the intervention was developed at 
a DCAA and will take place in Newark, NJ, we anticipate that the vast majority of participants will be 
African American. However, we are not imposing race as an eligibility criterion.  
 
Our pilot study included a balanced sample of men and women and our preliminary findings showed 
great improvements among the women. While we had hoped to conduct this experiment with both 
men and women, the reality of the population in Essex County made this impossible at this time. 
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Women represent only 6% of the populations being released from incarceration in Essex County, NJ. 
Therefore, unless we expanded the study to additional sites (which is unrealistic given the budgetary 
constraints), recruiting enough women would not be feasible. We discussed this challenge at our 
NCCB meeting and collaboratively made the difficult decision to exclude women from the current 
study. Once the intervention is optimized using a male sample, we will be in a better position to 
design a larger, multi-site study where we will be able to adapt and test the intervention with women.    
 
We do not anticipate that we will have enough power to conduct significant racial comparisons as we 
expect that approximately 80% of our sample will be African American. We will, however, conduct 
valid analysis and explore potential moderation effects on the AIDU outcome to inform planning of 
future studies that could adapt Community Wise for use with other populations.  
 
Women currently make up the majority of the NCCB. The NCCB is racially diverse with African 
Americans, Latinos, and Whites represented. The only female participants in the study will be 
members of the NCCB. 
 
Participants in this study are not expected to be under custody, court order to attend the treatment, or 
any form of limited civil freedom; thus this is not part of the inclusion or exclusion criteria. No 
research will be conducted with any subject who becomes incarcerated after enrollment until a 
research amendment discussing the specific procedures of access to the facility is filed and 
approved by the IRB. 
Master or doctoral level social workers or psychologists will conduct the clinical screens to assess 
participant eligibility. All recruitment will take place at Integrity House. Staff will be supervised by 
our co-investigator project director and the PI Ellen Benoit. 
 
Inclusion criteria for the factorial experiment participants in the study will include: 
• 
Men age 18 or older 
• 
Residence in Essex County, NJ 
• 
Willingness to be voice recorded during group sessions 
• 
Ability to speak English  
• 
Having a substance use disorder measured by the Global Appraisal of Individual Needs-
Substance Problem Scale (GAIN-SPS).  
• 
Having been released from incarceration in the past 4 years. This is due to research that shows 
that people are more likely to be re-incarcerated within the first 4 years of release from 
incarceration. 
 
Exclusion criteria for RCT participants will include: 
• Severe psychiatric disorders in the prior 6 months not stabilized (schizophrenia, depression 
with psychotic features, bipolar disorder, any psychosis), as measured by the MINI 
International Neuropsychiatric Interview 6 psychoticism and suicidality modules 
• Gross cognitive impairment as measured by the Mini Mental State Exam. 
• Sexual identification as female 
 
Inclusion criteria for the focus group participants in the study will include: 
 
• Being randomly selected from the study’s intent to treat sample 
• Being willing to be voice recorded 
• Having attended at least one intervention session 
 
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Inclusion criteria for the NCCB members include: 
• Men and women age 18 or older 
• Knowledge about Essex County, NJ 
• Ability to speak English  
• Being invited to become a NCCB member after a majority favoring vote  
 
We will use a screening script and a signed consent form to obtain permission to conduct the 
screening and use the data as part of the study, regardless of establishment of final eligibility. 
Participants will be informed that the information will be confidential and they can choose to stop 
participating at any time and we will destroy their data upon receiving their request. Note that voice 
recordings of Community Wise are exceptions as this will include data from entire groups of 
participants. We will only destroy voice recordings if there is reason to believe the recording has 
content that can put participants in danger of being hurt or re-incarcerated. 
 
 
10.  RESEARCH PROCEDURES:  Using LAYMAN’S LANGUAGE, specifically describe what 
the participants (treatment groups and controls) will do and where the research activities will take place. 
Give approximate dates and durations for specific activities, including the total number of treatments, 
visits, or meetings required and the total time commitment.  
(For schools-based research where class time is used, describe in detail the activities planned for 
nonparticipants and explain where (e.g., in a classroom, in a private area) both participants and 
nonparticipants will be located during the research activities. Include a concise description of 
procedures, locations, time commitments, and alternate activities on the relevant consent and assent 
forms.) 
All research activities will take place at NJCRI. Drug screening will take place at baseline and 
follow-up assessments conducted by trained full time staff supervised by the project director. 
Participants will be told by the RA that they have a right to refuse to complete the drug screen and 
that results will not be shared with staff at NJCRI. Results will be used to enhance the rigor of the 
study as an added source of information about drug use.  
 
Intervention groups will be held at NJCRI. The research team is being hired through NJCRI and will 
have offices in the building. Mr. Morris and Mr. Iwuala will be the contact people at NJCRI. NJCRI 
will provide the research team with an office space for each project full time employee (project 
director, outreach worker, and group facilitators) in addition to conference rooms where the research 
groups will take place.  
 
The project applies community based participatory research (CBPR) principles to the multiphase 
optimization strategy (MOST) framework in implementing a 2x2x2 factorial design in which 592 
men with substance use disorders and a history of incarceration residing in Essex County, NJ will be 
randomized into one of sixteen conditions: 1) Critical Dialogue (CD) only, facilitated by a licensed 
facilitator (LF). 2) Critical Dialogue (CD) only, facilitated by a peer facilitator (PF). 3) Quality-of-
Life-Wheel (QLW) only, facilitated by LF. 4) Quality of Life Wheel only, facilitated by PF. 5) 
Capacity building project (CBP) only, facilitated by LF. 6) CBP only, facilitated by PF. 7) 
CD+QLW facilitated by LF. 8) CD+QLW facilitated by PF. 9) CD+CBP facilitated by LF. 10) 
CD+CBP facilitated by PF. 11) QLW+CBP facilitated by LF. 12) QLW+CBP facilitated by PF. 13) 
CD+QLW+CBP facilitated by LF. 14) CD+QLW+CBP facilitated by PF. 15) Core Component 
facilitated by LF and 16) Core Component facilitated by PF. All groups will receive the core 
component of the intervention which includes introduction, critical thinking session and graduation. 
 
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Facilitators, whether licensed or peer, may or may not be members of the NCCB. In the event a 
NCCB member is selected to be a group facilitator, they will not have access to any of the research 
data collected in the groups they are facilitating and they will need to leave any portion of the 
NCCB meetings where we may discuss their groups. This will be done to avoid bias in the group 
facilitation and in the data.    
 
Core component includes an introduction session, a critical thinking session, and the graduation. 
This is designed to give participants tools to assess their own thinking and hence, their assumptions 
that may contribute to substance use; 
 
Critical Dialogue consists of group conversations prompted by thematic images. It aims to help 
participants develop a deeper understanding of how marginalizing processes (e.g., systematic 
stigma; feelings of rage as victims of discrimination) impact their lives and behavior;  
 
Quality-of-Life-Wheel consists of individual and group exercises to develop individual goals. It 
aims to increase self-efficacy and help participants develop a vision for their future, breaking this 
vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. 
quitting smoking, improving relationships with family members, paying down debt);  
 
Capacity Building Projects consist of projects created by the groups to address a community 
problem. The capacity building projects are designed to create collaborative efforts to overcome and 
dismantle marginalizing processes by building positive social and organizational relationships and 
community capacity through the development and implementation of community projects aiming to 
address social determinants of health. 
 
Facilitation by both licensed clinician and peer facilitator will provide an opportunity to test not only 
the efficacy of delivering the intervention through peers but will also determine the cost 
effectiveness of peer delivery vs. licensed facilitators. 
 
Prior to the being consented into the study at baseline, participants will have the opportunity to 
attend an orientation session where we will explain the research design, the different conditions 
available, the randomization process, and the risks and benefits of participation in the study. We will 
emphasize the difference between the intervention and the research (mainly group sessions and data 
collection sessions). We hope that this make the participants better informed about the study and 
minimize contamination by explaining the importance to keep their activities in each group private. 
Data will be collected in six waves and will include a baseline and five monthly follow-up 
interviews. These interventions were developed and pilot tested by our team. We will also randomly 
select 24 groups to participate in focus groups and provide their feedback about their experience 
participating in the intervention. We will randomly select one group per intervention condition and 
only participants who attended at least one intervention session will be eligible to participate. We 
will keep track of other services that participants seek during follow-up assessments and we will 
control for the impact of these services statistically. 
 
Below is a table displaying research activities. Note that for follow-up, depending on which 
condition someone is randomized into, they may complete between 1 to 5 follow-ups post 
intervention, receiving $20 per follow-up plus $2.50 for each intervention session they attend. This 
occurs because of the variance in the number in intervention sessions among the different 
conditions.: 
 
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Activity 
Cost per participant 
Time 
Professional 
Assigned 
Clinical screens 
$10 
30 
minutes 
Licensed NCCB 
clinicians 
Baselines 
$20 
90 
minutes 
NCCB, research 
assistants 
Follow-ups during 
intervention 
$20 + $2.50 per intervention group attended 
in the past month for a maximum of $30 per 
follow-up 
90 
minutes 
Focus groups 
$20 
90 
minutes 
NCCB Meetings 
$50 
120 
minutes 
Online survey 
NCCB retreat 
$100 
4 hours 
Research 
assistants 
 
Below is a table summarizing the participation of 592 men in the different experimental conditions. 
Note participants may stop participating at any time or skip any sessions without penalty: 
 
 
*LF = Licensed facilitator; PF = Peer facilitator 
 
Below is a table describing the research process: 
 
Study condition with number of sessions and total cost estimate to deliver each 
condition 
Experimental  
Condition 
Critical 
Dialogue 
(CD) 
Quality of 
Life Wheel 
(QLW) 
Capacity 
Building 
Project (CBP) 
Facilitated 
By* 
 
# 120 
minute 
sessions 
1: CD alone 
Present 
Absent 
Absent 
LF 
9 
2: CD alone 
Present 
Absent 
Absent 
PF 
9 
3:QLW alone 
Absent 
Present 
Absent 
LF 
6 
4:QLW alone 
Absent 
Present 
Absent 
PF 
6 
5:CBP alone 
Absent 
Absent 
Present 
LF 
6 
6:CBP alone 
Absent 
Absent 
Present 
    PF  
6 
7: CD+QLW 
Present 
Present 
Absent 
LF 
12 
8: CD+QLW 
Present 
Present 
Absent 
PF 
12 
9: CD+CBP 
Present 
Absent 
Present 
LF 
12 
10: CD+CBP 
Present 
Absent 
Present 
PF 
12 
11: QLW+CBP 
Absent 
Present 
Present 
LF 
9 
12: QLW+CBP 
Absent 
Present 
Present 
PF 
9 
13: Full 
intervention 
Present 
Present 
Present 
LF 
15 
14: Full 
intervention 
Present 
Present 
Present 
PF 
15 
15: Core 
component 
Absent 
Absent 
Absent 
LF 
0 
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Measures: 
 
Clinical Screen: Mini Mental State Exam, MINI International Neuropsychiatric Interview 6 
psychoticism and suicidality modules, and the Global Appraisal of Individual Needs-Substance 
Problem Scale (GAIN-SPS). 
 
Baseline and follow-ups: Timeline Follow Back to measure drug use, a urine toxicology screen, the 
Crime and Violence Scale (part of the GAIN scale), the States of Engaged Awareness about Health 
Inequalities (SEAHI-unpublished and developed by us-see baseline and follow-up packet). The 
SEAHI will be administered through the computer along will all the other measures. During the 
baseline assessment, we will ask participants permission to take a digital photograph of them during 
the baseline to assist with finding them during follow-ups.  The photo will be in the master file 
along with the name and identifying information, but not linked to any data. Photographs will be 
used by the outreach workers to recognize participants on the streets and they will be destroyed as 
soon as the participant completes follow up 5. Participants will have the option to refuse without 
penalty and they may ask us to destroy their photo at any time during the study.  
 
Additional follow-up measures:  Use of Treatment Skills measure to track participants’ use of 
specific tools learned; measures of participants’ perceptions of helpful intervention components, and 
the Treatment Service Review. 
 
A trained research assistant (most likely a MSW student) will schedule the data collection with up to 
eight participants at a time.  Participants will be asked to take a urine collection sterile cup when 
they are ready to use the restroom. The RA will ask them to collect ½ inch of urine privately in the 
restroom, close the container and hand it to the RA who will be working near the data collection 
room. The RA will use rubber gloves to handle the sample. A drug test will be inserted in the urine 
and the results can be read within 3 minutes. The RA will empty the cup in a toilet and dispose the 
cup and gloves in a dedicated trash bin in a private area. The results will be recorded directly into 
redcap using the participant’s codename. No identifying information will be attached to the results 
or the discarded materials. The RA will pay the participant when they complete the survey and they 
will be free to go. While she is in collecting the drug test, she will tell participants still working on 
the computer to wait for her to return in case they finish or have questions. The urine drug test 
procedure takes 5 minutes to complete. We used this strategy successfully in our pilot study.  
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Facilitators complete a checklist at the end of each Community Wise group session to list the activities 
completed and group attendance. Facilitators will upload the checklists directly to a facilitator-
assigned folder in Box, the study’s secured server, where they will be reviewed by the PIs and the PD. 
 
Participants will use both codenames and code numbers, which will be connected in the electronic 
key list, but not in the database. We use this strategy to facilitate (and humanize) participants as we 
talk about them in meetings (including clinical supervision, NCCB meetings, and in Community 
Wise groups). Participants can request that we destroy their data (except group voice recordings) at 
any time until data collection is completed by notifying one of the PIs by phone or e-mail. After that 
we will destroy the electronic key and we will be unable to determine what data belongs to whom. 
Note that voice recordings will be kept indefinitely. 
 
The clinical screen will be an in-person interview conducted by the study local PI, the licensed 
facilitator, or the project director who will be properly trained by Dr. Windsor.  
Urine screens will be collected in person by a trained staff person. Baseline and follow-up will be 
administered through Redcap on the laptop during the small group sessions and administered by 
trained full time staff. The peer facilitator will only be allowed to collect data from participants in 
the licensed facilitator groups and vice versa.   
 
Focus groups will be facilitated in person by the local PI or trained staff members who did not 
facilitate the group being interviewed.  
 
NCCB members and project staff will recuse themselves from interacting with anyone they 
personally know as a part of study activities. We will have study interviewers review the name of 
the person they are interviewing prior to the interview to make sure they do not personally know 
them. If they do, we will find someone else to conduct the interview. If a NCCB member 
unexpectedly encounters someone they know at a study related activity, they will recuse themselves 
and notify the project director and the principal investigators. The project director will keep a list of 
participants that we identify as having a personal relationship with NCCB members or staff and we 
will make sure these individuals are not booked together for any study related activities.  
 
Due to randomization, we cannot schedule the group time and date before the participant enrolls in 
the study. Thus, it is likely that many participants will be randomized into a group that is being held 
during a time when they are no available. Thus, we will offer, as a courtesy, The opportunity for 
people who are enrolled in the study to participate in a  full intervention group after they complete 
their participation in the study. These groups will be provided by the licensed facilitator and it will 
not be a part of the study. No data will be collected and this will be offered solely to give 
participants the option to engage in the intervention. 
 
11.  EQUIPMENT  Will any physical stimulation or physiological data acquisition equipment be used 
with the subjects? 
 Yes   
 No If yes, attach Appendix A, the Research Equipment Form. 
 
12.  DEVICES Will any devices be used with the subjects? 
 Yes   
 No If yes, attach Appendix B-1.  
 
13. DRUGS AND BIOLOGICS  Will any drugs or chemical or biological agents be used with the 
subjects? 
 Yes   
 No If yes, attach Appendix B-2.  
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14. MRI AT BIC  To use the Beckman Institute Biomedical Imaging Center (BIC) in human subject’s 
research, you must obtain prior approval from the BIC (217.244.0600; bmrf@bmrl.bmrf.uiuc.edu)  
and use BIC-approved screening and consent forms. Attach: 
 
  
 
BIC approval  
  Attached 
 
 
 
BIC screening form 
  Attached 
 
 
 
BIC consent form 
 
  Attached 
 
 
 
15.  MEASURES  If subjects will complete questionnaires, surveys, interviews, psychological 
measures, or other measures, however administered, the IRB must review and approve the measures.  
List all such measures here and attach complete,  labeled copies (including translations, if applicable) to 
this application: 
CLINICAL SCREEN  
  Attached      
Measure 
1: 
Mini Mental 
Measure 
2: 
Mini suicidality screen 
Measure 
3: 
Mini Psychotic Assessment 
Measure 
4: 
GAIN 
BASELINE  
  Attached      
Measure 
5: 
Demographics 
Measure 
6: 
Timeline Follow-back 
Measure 
7: 
Crime and violence scale (part of GAIN) 
Measure 
8: 
States of Engaged Awareness about Health Inequalities(developed by us) 
FOLLOW-UP 
  Attached      
Measure 
9: 
Demographics 
Measure1
0: 
Timeline Follow-back 
Measure1
1: 
Crime and violence scale 
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Measure 
12: 
States of Engaged Awareness about Health Inequalities (developed by us) 
Measure 
13: 
Treatment Services Review (TSR) 
Measure 
14: 
Yalom Group Scale 
Measure 
15: 
Use of Treatment Skills (UTS- developed by use) 
Measure 
16: 
End of treatment questionnaire (ETQ- Developed by us) 
List additional Measures on an attachment and check here:  
 
 
16.  SUBJECT REMUNERATION 
 
Will subjects receive inducements or rewards before, during, or after participation? 
 Yes   
 
No 
If yes, will payment be prorated for partial participation? 
 
 
 
 Yes   
 
No 
 
If remuneration will be given, for each subject group: 
(1) specify the form of remuneration, including $, course credit, lottery, gift certificate, or other; 
(2) state the $ amount or the approximate $US value, or the course credit and its percentage of 
the final grade; 
(3) explain the remuneration plan, including whether and how prorating will be made for partial 
participation;  
(4) for lotteries, include (a) the number of prizes, (b) the nature and value of each prize, (c) the 
approximate odds of winning, (d) the date(s) of the drawing(s), and (e) how winners will be 
notified, by whom, and by when; and 
(5) include all this information on the relevant consent forms. 
 
Incentives will be distributed in cash at the completion of each study tasks described in the table 
above. Participants may earn as much as $187.5 over 5 months if they complete all study activities. 
For instance, someone randomized into condition 14 (full intervention) who completes all study 
activities will receive: $10 for clinical screen, $20 for baseline, $20 for the all follow-ups plus $10 for 
each of the first 3 follow-ups for attending 4 intervention sessions per month, $7.50 for attending 3 
intervention sessions in follow up 4 $20 for focus group if they are randomized to complete the focus 
group = $187.5. Someone randomized to receive condition 15 (core component only)  and 
randomized not to complete the focus group who completes all study activities will receive $10 for 
clinical screen, $20 for baseline, $20 for each follow-up, in addition to $7.50 for follow-up 1 only will 
earn $137.50 over the course of the study. 
 
NCCB members will receive $20 per hour worked, generally in meetings of 2 hours each. They will 
also receive $100 per 4 hour long retreat they attend. NCCB retreats are, for the most part, long 
NCCB meetings. Retreats can be more informal and build in opportunities for members to simply 
engage with one another, bring family and friends, and increase our bond. No confidential materials 
are discussed during open session retreats where non-NCCB members are present. If there is an 
agenda of items we need to discuss more formally, we use the same exact procedures as those 
described for meetings and collect the same data (video recording of the meeting). NCCB members 
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may also receive compensation for referring participants to the Community Wise randomized 
controlled trial. They will receive $5 per enrolled participant they refer. NCCB members will not 
know the identity of those they referred who successfully enrolled. Participants will contact the 
outreach worker directly and during the phone screen, we will ask them who referred them to the 
study. Those NCCB members who are named by the enrolled participants will receive a lump sum 
once recruitment is ended.  
 
 
17. SUBJECT OUTLAY  Will subjects incur costs for research-related procedures (e.g., longer 
hospitalization, extra tests), use of equipment, lost compensation, or transportation (over 50 miles)?        
 Yes     
 No 
       If yes, describe here: 
 
      
 
 
18.  CONFIDENTIALITY OF DATA  Answer each of the following to describe methods that will 
ensure the confidentiality of individually identifiable data. Confidentiality is required unless subjects 
give express, written permission to have their identifiable information published, presented, or shared. 
 
 
18A. CHECK IF USED IN DATA COLLECTION:  
 Audio tapes/     
 Video tapes     
 Still 
photos     
 Other imaging 
                                                                                     Digital voice 
 
 
18B.  DATA COLLECTION  Explain how the data will be collected. If anonymous data collection is 
proposed, provide details of how investigators will not have the ability to trace responses to subject 
identities.  For multiphase data collection or if multiple contacts will be made with subjects, specifically 
explain the subject tracking and coding systems.  
 
Address the confidentiality of data collected via e-mail, databases, Web interfaces, computer servers, 
and other networked information, as applicable. 
Data will be generated and collected through face-to-face computer assisted interviews, computer 
assisted self-interviews, focus groups, and group session audio recordings. This will include brief 
telephone screenings, clinical screenings, baseline, five post baseline follow-ups, focus groups and 
intervention sessions.  Interested individuals will call the study’s confidential phone number and 
complete a brief telephone screen with a research assistant who will obtain self-reported identifying 
and eligibility information such as birth date, complete name, last incarceration date and place, 
gender, current AIDU, and whether they reside in Essex County, NJ. Before completing the phone 
screen, participants will be given a brief description of the study and they will be informed that the 
information they release on the phone will be kept confidential and will be used only to verify 
eligibility (including verification of their last incarceration place and date based on public records). 
This information will be kept in a password secured Excel file in a password secured laptop at a 
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locked office at NJCRI. Those found to be eligible will be invited to complete the clinical screen with 
a licensed clinician at NJCRI. Prior to completing the clinical screen, participants will learn more 
about the study and the clinical screen. They will sign an informed consent to participate in the 
clinical screen which will include Mini Mental State Exam, MINI International Neuropsychiatric 
Interview 6 psychoticism and suicidality modules, and the Global Appraisal of Individual Needs-
Substance Problem Scale (GAIN-SPS).  Those found to be eligible will learn about the randomization 
process and the study procedures. The clinician will go through the informed consent and those who 
agree will be randomized into one of eight experimental conditions and we will schedule the baseline. 
Participants may take the informed consent with them and think about whether to participate or not, as 
long as we are still recruiting. Paper data will be kept at a locked file cabinet at NJCRI. A code 
number and a codename will be assigned to each participant completing the clinical screen and only 
this code number and codename will be used in the paper and electronic data collection. A master list 
will be created linking names with code numbers and this list will be kept in a password protected 
excel file in the PD’s computer in a locked office at NJCRI.  
 
Baseline and follow-up data will be collected at NJCRI by assistant staff member. Community Wise 
group participants will be scheduled to complete the data collection on the same day and time. Each 
participant will work independently on a private tablet using RedCap data collection management 
software. We will collect outcome, process, and safety monitoring measures (e.g. MINI suicidality) 
including AIDU, use of treatment skills measure, and their perceptions about helpful components. 
This electronic data will only contain the code numbers and codenames and it will be stored in a 
secured server at the University of Illinois at Urbana Champaign. Data will be securely uploaded into 
the server immediately after data collection. Only authorized personnel will have access to it.  
 
During the baseline assessment, we will ask participants permission to take a digital photograph of 
them during the baseline to assist with finding them during follow-ups.  The photo of those who 
consent will be taken by the RA and immediately uploaded into the master file along with the name 
and identifying information, but not linked to any data. Photographs will be used by the outreach 
workers to recognize participants on the streets and they will be destroyed as soon as the participant 
completes follow up 5. Participants will have the option to refuse without penalty and they may ask 
us to destroy their photo at any time during the study.  
 
No research will be conducted with any subject while they are incarcerated. 
 
Focus groups 
Sixteen out of 48 Community Wise groups of up to eleven participants each will be randomly selected 
in advance during year 1 to be included in the focus groups throughout the six waves. Participants 
from selected groups who attended at least one Community Wise session will be invited to attend the 
focus group at the end of each data collection wave. The focus groups will be conducted at NJCRI by 
a trained RA, and will be audio-recorded and transcribed for analysis. Focus group sessions will be 
structured and the RA will be trained to keep the discussion focused on clients’ satisfaction with the 
intervention. If a participant starts to talk about personal issues, the RA will stop them and offer to 
refer them to talk to an Integrity House counselor if appropriate (see focus group script). Data will be 
uploaded into a password-secured server at the University of Illinois at Urbana-Champaign. Only 
code numbers will be included with the electronic data. 
 
Audio Recordings 
All Community Wise sessions will be voice-recorded for the purposes of treatment fidelity and quality 
control. Agreement to be voice-recorded is a requirement for eligibility and it will be fully explained 
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during the informed consent process. Session audio files will be kept in a password secured server at 
the University of Illinois at Urbana-Champaign. The files will be accessed only by and the PIs, the 
PD, and research assistants who will listen to randomly selected sessions to complete the treatment 
fidelity and participant safety measures. These measures will only include code numbers and they will 
be stored in the server at the University of Illinois where the data analysis will take place.  
 
NCCB meetings 
The NCCB is a diverse community collaborative board of up to 20 community residents, consumers, 
researchers, service providers and government representatives working together to build a safer and 
healthier city through the implementation of a comprehensive community based health program that 
fosters advocacy of health and community reentry issues at the government level. Over the past 5 
years, the NCCB has developed and pilot tested Community Wise. The NCCB will meet as a full 
board 6 times each year for 2 hours each time, to monitor the current research progress including 
training, recruitment, data collection, services delivery, data analysis, and dissemination. Members 
will also meet in committees, to work on specific aspects of the study (e.g., revising manuals, 
developing capacity building projects). Only NCCB members who are not listed in the current 
research budget will be compensated for attending meetings ($20 per hour). NCCB meetings will be 
video recorded so that detailed minutes can be taken and the research team can collect data on how 
decisions were made among NCCB members.  Detailed meeting minutes are taken and approved each 
meeting. Videos are available at a private Blackboard virtual collaboration site to be reviewed by any 
NCCB member.  Each NCCB member has a password and login ID to access the collaboration site. 
NCCB members will also participate in annual evaluations of the NCCB and its chair, which will be 
overseen by Dr. Pinto, the project’s co-investigator. Dr. Pinto is at the University of Michigan and he 
is responsible for evaluating our adherence to CBPR principles and the quality of communication and 
satisfaction among NCCB members. Anonymous evaluation data will be collected via Qualtrix and 
only Dr. Pinto will have access to it. Results will be used to gage the health of collaboration within the 
NCCB and the application of CBPR principles. Participation will be voluntary. 
We will use a REDCap to track participants’ progress throughout the project. We will keep one 
password protected file that will contain participants’ names, phone number, e-mail address, residence 
address, Facebook page, permission to contact them, and specific instructions about what type of 
message we may or may not leave. We will also collect information about friends and family 
members that we may contact if we lose communication with participants.  
We will find out about participants being incarcerated in one of three ways: 1) someone tells us about 
it while we are attempting to contact the person, 2) the person themselves find a way to notify us, 3) 
we run a public search for incarceration in state and federal websites. Once we find someone who was 
incarcerated, we will check to see if they granted authorization for us to pursue them. If authorization 
was given, we will find out who is the appropriate authority and we will call them to make a formal 
request to visit the participant. We will simply state that the person is a participant in a health research 
study and that we would like to schedule a time to collect the follow up data in the facility. We will 
explain that the data will be collected using the REDCap and that once it is submitted by the 
participants in the tablet, it is encrypted. The data is completely confidential and protected by the 
COC. We will only schedule the interview if the responsible official grants us permission and agrees 
to provide us with a private room (incarceration officers can see us, but not hear us) for up to 1.5 
hours, and agrees that the data collected will be confidential. The tablet does not have internet 
connection and it will not have any other programs or information installed outside of the Redcap 
interview. We will not conduct the urine drug screen as that is not safe or feasible in an incarceration 
setting. These interviews will be conducted personally by the local PI or the PD. 
 
 
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18C. DATA SECURITY Describe how and where the data be kept so that the data remain 
confidential. 
We will use the same strategy we developed during our pilot study to store hard paper data, 
including informed consent forms, papers completed during the clinical screen, and incentive 
receipts. This data will be organized into separate folders and locked into file cabinets that will be 
in the project director’s locked office. Forms containing identifying information will not contain 
either the codename or the code numbers and they will be stored separately from the data. All 
paper forms will be kept for at least 3 years after study completion.  
 
Electronic files containing identifying information will be stored in Box . A master list will be 
created linking code numbers to identifying information. Only fulltime staff will have access to 
participants identifying information. Participants will have the choice to use their real names in the 
group or request that they only use their codenames. This information will be deleted at study 
completion (once analysis is complete). 
 
Facilitators will have contact information for the participants so that they can contact them to 
schedule/cancel meetings/ data collection, and check in during the week if needed. This 
information will be kept in the facilitator’s password protected study cell phone and will include 
instructions on whether it is all right to leave a message and under what circumstance for each 
participant.  
 
All de-identified electronic data, including NCCB videos and focus group and Community Wise 
session group voice recordings will be stored in a Box cloud contracted through the University of 
Illinois (see https://www.box.com/business/). Folders for specific content will be created and 
permissions will be assigned accordingly to members of the NCCB who are assigned to work with 
specific data files. The PIs and the project director will have access to all files. Other team 
members will gain access based on the tasks they are assigned and cleared to complete. All team 
members will receive training on each task they are to perform by the PIs or the PD and they will 
not receive access to data until they have been cleared by one of the PIs or the PD. Dr. Windsor 
will be responsible for tracking who has access to what at any given time. This data will be kept 
indefinitely for the purposes of data analysis.  
 
The University of Illinois at Urbana-Champaign has applied for a single Certificate of Confidentiality, 
which will apply to all collaborating institutions. With this Certificate, the researchers cannot be 
forced to disclose information that may identify a participant, even by a court subpoena, in any 
federal, state, or local civil, criminal, administrative, legislative, or other proceedings. However, the 
Certificate cannot be used to resist a demand for information from United States Government 
personnel that is used for auditing or evaluation of federally funded projects. Researchers may also 
disclose the identity of participants who report intentions to harm themselves or others or if 
researchers have knowledge those participants are abusing children or elderly persons. 
 
 
 
 
 
18D.  STAFF TRAINING  Describe the training and experience of all persons who will collect or 
have access to the data.  
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All members of the research team (including all members of the NCCB) will complete IRB 
certification training prior to starting to work on the project. Drs. Windsor and Benoit will be 
responsible for training NCCB members on project specific tasks, and on human subjects protocol. 
Both Dr. Windsor and Dr. Benoit are experienced researchers who have worked with this population 
before and who have conducted several projects that were higher than minimal risk. Dr. Windsor 
served as a member of the IRB at Rutgers University for 3 years and Dr. Benoit is currently a member 
of the IRB at National Development & Research Institutes, Inc.  project director and Dr. Windsor will 
train clinicians on the delivery of the intervention on IRB protocol.  
 
We recognize that peer facilitators will need enhanced training, supervision, and support. The NCCB 
is currently reviewing the literature on peer group facilitation and we have created a committee who 
will be responsible for developing the peer training. This will include an all-day training conducted by 
a member of the NCCB who is a licensed practitioner. The training will cover our safety and ethical 
protocols, training on group facilitation techniques, and role play where they will be able to practice 
these skills. Peer and licensed facilitators will participate in weekly supervision with Dr. Windsor to 
discuss each group and address potential problems. We will hire and train four peer facilitators to 
ensure that if someone needs to be replaced, we will have a back up facilitator.   
 
No research will be conducted with any subject while they are incarcerated. 
 
 
18E.  DATA RETENTION How long will the data be kept? 
 
All paper forms will be kept for at least 3 years after study completion.  
 
Electronic files containing identifying information and focus group voice recordings will be deleted at 
study completion (once analysis is complete). 
 
Facilitators will have contact information for the participants in their groups so that they can contact 
them to schedule/cancel meetings and check in during the week if needed. Once the group is 
completed, the information will be deleted by the facilitator.  
 
All de-identified electronic data, including NCCB videos and Community Wise session group voice 
recordings will be stored in a Box cloud contracted through the University of Illinois (see 
https://www.box.com/business/). This data will be kept indefinitely for the purposes of data analysis. 
 
An identity key along with participants photo in electronic form will be kept until data collection is 
completed. At that time, the electronic key will be destroyed. Participants will be able to request that 
their data be destroyed (with the exception of voice recordings) as long as the electronic key is stored 
by the project director. Once the electronic key is destroyed at the conclusion of data collection, we 
will no longer be able to destroy any data because we will no longer be able to track what part of the 
data belongs to what participant.  
 
 
 
18F. DISSEMINATION OF RESULTS  What is(are) the proposed form(s) of dissemination (e.g., 
journal article, thesis or academic paper, conference presentation, sharing within industry or 
profession)? 
 
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Research context, findings, and interpretation will be disseminated to policymakers, clinicians, 
members of the community, and researchers through publication of study results in peer-reviewed 
journals, periodicals, professional presentations at conferences (e.g., CPDD, APHA, ASA, SSWR, 
Paulo Freire Institute), and the media. However, individuals may want to access the data directly, 
either for the purpose of replicating published findings or to use the data to explore new or related 
research questions. 
 
UIUC and NDRI researchers are bound by professional ethics and maintenance of professional 
standards overseen by an Institutional Review Board. The investigators have historically made data 
from previous projects available to other researchers, including graduate students, and other early-
career individuals. We will continue to make every effort to comply with reasonable requests for 
access. The investigators in collaboration with members of the Newark Community Collaborative Board 
(NCCB) will develop a plan for sharing data and associated documentation with outside researchers. 
Regardless of specifics, will require a data- sharing agreement that provides for the following 
conditions at minimum: (1) a commitment to using the data only for research purposes and not to 
identify any individual participant; (2) a commitment to securing the data using appropriate tools and 
computer technology; and (3) a commitment to destroying or returning the data after analyses are 
completed. 
 
All data will be stripped of personal identifiers so as to be suitable for use by other investigators. Even 
though the database will be stripped of identifiers prior to any sharing, however, we will make the data 
and associated documentation available to users only under a data-sharing agreement that provides for 
the above-stated commitments. 
 
 
 
 
 
18G. PRIVACY Describe provisions to protect the privacy interests of subjects. 
Participation is voluntary and participants may stop participation at any time. Our interviewers are 
trained to watch participants carefully and will stop questioning if an individual appears uneasy. At 
every interview, participants will be informed that they may ask the interviewer to stop if they are 
feeling uncomfortable. Referrals to counselors are available if participants wish and trained clinical 
counselors are available at NJCRI in the event that someone may need immediate assistance, whether 
it is during data collection or during the intervention sessions.  
 
It is possible the NCCB members or group facilitators may know some of the potential clinical trial 
participants as these individuals live and work in Newark, NJ. Potential clinical trial participants may 
be clients, family members, or friends of any NCCB member. The standard protocol for such 
situations is to ensure that any NCCB member who has a personal relationship with a potential 
participant does not interact with that person as part of the study or does not have access to data that 
includes their family/friend/client. To further protect privacy, NCCB members will not have access to 
the session voice recordings. Before assigning facilitators to specific groups, we will make sure that 
the facilitator does not personally knows any of the group members. 
 
Session voice files will be stored in the secured server and only the PIs, PD, and RAs at the University 
of Illinois coding the files for analysis will have access to them.  
 
 
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18H.  INDIVIDUALLY IDENTIFIABLE INFORMATION  Will any individually identifiable 
information, including images of subjects, be published, shared, or otherwise disseminated?      
 Yes     
 No Only NCCB members whose membership in the NCCB will be public and displayed in our 
website. 
 
If yes, subjects must provide explicit consent or assent for such dissemination.  Provide appropriate 
options on the relevant consent documents. 
 
 
 
19.  INFORMED CONSENT:  University policy requires the execution of a comprehensive, written 
document that is signed by the subject (or the subject’s authorized representative) as the principal 
method for obtaining consent from subjects.  The language in the document must be understandable to 
the subject or the subject’s legally authorized representative.  
 
An investigator may request a Waiver or Alteration of Informed Consent or a Waiver of Documentation 
of Informed Consent (e.g., online consent, oral consent). If requesting a waiver please complete the 
appropriate waiver form at: www.irb.illinois.edu and submit it with the IRB Application for review. 
 
Children must assent (or, voluntarily agree) to participation and a parent must separately consent on 
behalf of their child (i.e., two different forms are generally required). Children under age 8 may assent 
either orally or passively, depending on their level of maturity. Children 8–17 years old should sign a 
written form unless the UIUC IRB approves a different process.  
 
19A. TYPE OF CONSENT Check all that apply and attach one copy of each relevant form, letter, or 
script on university letterhead. Include translations, if consent will be obtained in a foreign language. 
Use headings, headers, or footers to uniquely identify each document and associate it with the subject 
group for which it will be used. 
 
 Written informed consent (assent) with a document signed by 
 adult subjects 
 parent(s) or guardian(s)  
 adolescents aged 8–17 years 
 
 Waiver or Alteration of Informed Consent (Attach waiver form.) 
       
 adult subjects 
 parent(s) or guardian(s)      
 adolescents aged 8–17 years 
 
 Waiver of Documentation (signature) of Informed Consent (Attach waiver form.) 
       
 adult subjects 
 parent(s) or guardian(s)      
 
 adolescents aged 8–17 years 
 
 
 
19B. USE OF PROXY  Will others (e.g., next of kin, legal guardians, powers of attorney) act on 
behalf of adult subjects in giving consent to participate in this research?  
 Yes    
 No  if yes, 
describe in Section 20D. 
 
19C. USE OF PROXY OUTSIDE THE UNITED STATES If a proxy is used in research conducted 
outside Illinois, provide justification (e.g., statement of an attorney or copy of applicable law) that the 
proxy is authorized under the laws of the jurisdiction in which the research will be conducted to consent 
to the procedures involved in this protocol. 
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19D.  CONSENT PROCESS Describe when and where voluntary consent will be obtained, how often, 
by whom, and from whom. If cognitively impaired subjects (including children under age 8) will be 
involved, explain how the subject’s understanding will be assessed and how often; include the questions 
that will be asked or actions that will be taken to assess understanding. 
 
Describe any waiting period between informing the prospective subject and obtaining the consent.  
Describe steps taken to minimize the possibility of coercion or undue influence. Indicate the language 
used by those obtaining consent.  
Indicate the language understood by the prospective subject or the legally authorized representative. 
 
If the research involves pregnant women, fetuses, or neonates, indicate whether consent will be 
obtained from the mother, father, or both. If the research involves children, indicate whether consent 
will be obtained from:  Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for the care and custody of the 
child; or from one parent regardless of the status of the other parent. 
 
We will obtain 4 separate consents: 
1) NCCB members will be asked to sign a consent to participate in the study 
2) RTC participants will be asked to sign a consent to complete the clinical screen 
3) RTC participants will be asked to sign a consent to participate in the study (including focus 
groups) 
4) Half of RCT participants will be randomly selected and asked to sign a consent to participate 
in a focus group about the intervention 
 
Participants will be recruited by project staff in the field and by referral from NCCB members and 
participants themselves. We will post study fliers throughout the city including parks, health service 
agencies, and places that provide services to people with histories of incarceration and substance 
abuse treatment. NCCB members will promote the study in the community and help encourage 
potential participants to consider participating. We will also attend community events where we will 
distribute flyers and ask participants themselves to encourage others to participate. Those interested 
will be able to call or e-mail the study’s private phone or e-mail to complete the phone screen. All 
potential participants will be screened for eligibility and will provide written informed consent before 
answering any questions. Project staff will inform each research subject in detail about the nature of 
the study, its sponsors, sources of funding, objectives, and goals, duration of the study, and the extent 
of participation sought.  The purpose and sponsorship of the research will be thoroughly explained 
and procedures for confidentiality will be clearly understood by respondents prior to beginning 
interviews. 
 
It will be stressed that participation is voluntary and that participants are able to withdraw their 
consent and participation at any time during study data collection without explanation or repercussion, 
that respondents will be eligible to receive payments for their participation, and that payment is not 
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linked to completion of the interviews or complete abstinence from AIDU. The data provided by the 
participants will be used for research purposes only and will be kept confidential and not shared 
except among research staff. Respondents will be assured that their participation in the research will 
not lead to investigations by welfare or social workers, law enforcement and other governmental 
agencies unless there is reason to suspect imminent harm to oneself (i.e., suicidal ideation with intent 
or plan) or immediate danger to another individual (i.e., homicidal idea) that is reported during a 
session or at the intake interview.  Such clinical emergencies will be handled by the appropriate 
NJCRI staff in accordance with their guidelines for triage and needs assessment of high-risk behavior 
(see Data and Safety Monitoring Plan below for more detail on handling clinical emergencies). 
Participants will sign informed consent forms prior to engaging in any research activities. 
 
Participants will be asked to grant permission for us to take a digital photograph of them during the 
baseline when they are enrolled in the study and sign the informed consent. Their photo will be stored 
in connection to the real names and separate from the data. Only the PIs, project director, and outreach 
worker will have access to the photos. These will be used to help project staff identify participants 
that lose contact with the study. Participants can request that their photo be destroyed at any time and 
the project staff will destroy the photos with 24hours of the participant’s request. A separate request 
for the photo was added to the informed consent.  
 
Participants will also be asked to provide consent for us to contact them to complete the follow-up in 
the event they are re-incarcerated. Those refusing to consent to this will not be contacted. Participants 
will be informed that if they provide consent for us to contact them in case they become re-
incarcerated, we may disclose their participation in the study to prison officials in order to obtain 
permission to complete the follow-up. The exact procedures will depend upon the facility’s policies 
and will be cleared with the IRB prior to any data collection taking place. Data will be collected by 
trained NCCB members and research assistants. No research will be conducted with any subject who 
becomes incarcerated until a research amendment discussing the procedures is filed and approved by 
the IRB. A new consent document will be used for re-consent for incarcerated subjects. A letter of 
permission from the relevant correctional facility (local, state, federal jail or prison) will also be 
submitted prior to conducting research with incarcerated subjects. 
 
 
 
20.  RISKS 
20A.  DESCRIPTION  Specifically describe all known risks to the subjects for the activities proposed 
and describe the steps that will be taken to minimize the risks. Include any risks to the subject’s 
physical well-being, privacy, dignity, self-respect, psyche, emotions, reputation, employability, and 
criminal and legal status. Risks must be described on consent forms. 
 
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Potential risks of this study include 1) inadvertent violation of confidentiality, 2) emotional distress on 
the part of participants, 3) potential discord during group sessions, given the sensitive topics we 
discuss. The use of code names and numbers along with other procedures described below are 
intended to prevent violations of confidentiality. It is important to be aware that participants may be 
disturbed by sensitive questions raised during data collection and intervention sessions. Questions and 
discussions regarding drug use, HIV risk behavior including sexual activity, HCV infection, social 
and family relationships, and discrimination may cause anxiety, anger, suspicions, or other emotions.  
While this is a predominantly African American sample, there will be some White and Latino 
participants as well and talking about racism in the group will elicit strong emotions. We welcome 
homosexual participants and discuss sexuality in groups that may include members who are opposed 
to homosexuality. Each of these differences has the potential to harm or cause discomfort for the 
participant or revive psychological dynamics that could threaten to renew old conflicts. We designed 
Community Wise very carefully so that these discussions happen in a safe way, where everyone is 
encouraged to challenge their own assumptions by analyzing the evidence they have that supports or 
challenges their positions. This starts with operational components where the intervention is clearly 
described so that people know what to expect, and ground rules are collaboratively created and 
enforced during group discussions. In the pilot, there were many instances where the critical questions 
posed led to a heated dialogue where people were able to express their conflicting views while 
respecting each other and considering the possibility of changing their point of view. In half of the 
conditions, we are using licensed facilitators who have a great deal of experience dealing with these 
sensitive topics and with this marginalized population. The other half will be facilitated by trained 
peers. We will carefully select peers that show a deep understanding about the challenges of managing 
a group discussion and we will carefully train them on how to handle potential conflict in the group. 
The hiring process will be conducted by Drs. Benoit and Windsor, and project director. Facilitators 
will participate in weekly supervision meetings where we will process any challenges they may 
experience and sessions will be taped so that we can provide them with feedback on how to improve 
their performance. In the unlikely event a discussion escalates to the point that it may challenge the 
safety of the group, or if during a session something happens and the facilitator needs assistance, there 
are trained NJCRI staff that include licensed clinicians and security in place who can intervene and 
deflect potential violence.  Moreover, during the Community Wise pilot study and first year of the 
current study no adverse events occurring as a result of study participation were observed.  
 
Another risk to confidentiality refers to the fact that participants who participate in Community Wise 
groups will learn information about other participants that are shared in the group.  Group participants 
will make a pledge in the first group meeting to maintain confidentiality.  While we hope that people 
will abide by this pledge, it is possible that group members share information about you with other 
individuals. We disclosed this risk to participants in the informed consent noting this risk for 
Community Wise Groups and research focus groups. 
 
It is possible the NCCB members and group facilitators may know some of the potential clinical trial 
participants as these individuals live and work in Newark, NJ. Potential clinical trial participants may 
be clients, family members or friends of any NCCB member. The standard protocol for such 
situations is to ensure that any NCCB member or group facilitator who has a personal relationship 
with a potential participant does not interact with that person as part of the study or does not have 
access to data that identifies their family/friend/ client.  
 
Clinical trial participants will be randomized into the 16 conditions. It is possible that participants 
may not be randomized into their study condition of choice (e.g., some people prefer peer facilitators 
while others prefer a licensed clinician). We will clearly explain to participants at the orientation 
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session that we do not know which condition is the most effective since this research has not been 
done before. We will describe each condition with a great amount of detail and emphasize the 
importance to conduct the research properly so that we can find out what is best possible intervention 
package. We will ensure that prior to consenting to the study, participants will be fully aware that they 
will not be able to choose what condition they will receive and that they will agree to participate in 
whatever condition they are randomized to. Those who are set on only participating in a specific 
condition will be discouraged from entering the study prior to the randomization. 
 
Because NCCB members may have multiple roles in the study, we will employ procedures to manage 
power differentials and role boundaries.  We address issues of power imbalance by ensuring 
transparency (e.g., budgets are shared and collaboratively developed), anonymous evaluations (which 
include measures of trust) and adherence to the bylaws, which were developed collaboratively by the 
NCCB and which require decision-making by consensus and voting. We maintain role boundaries 
through subcommittees dedicated to performing specific research tasks. Roles are selected for NCCB 
members based on their expertise, interest, availability and performance. Some roles automatically 
preclude others (e.g., group facilitators may not collect data from their groups).  Finally, each task 
assigned to the NCCB includes training specific to that task. The PIs and PD are responsible for 
developing and conducting all research-related training. 
 
 
20B.  RISK LEVEL:   
 No more than minimal risk 
(the probability and magnitude of harm or discomfort anticipated for participation in 
the proposed 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). 
 
 
 More than minimal risk 
 
20C. Data Monitoring Plan: If you checked that the research is more than minimal risk, describe the 
provisions for monitoring the data to ensure the safety of subjects (Who will periodically monitor harms 
and benefits experienced by subjects to ensure that the relationship of risks to potential benefits remains 
unchanged? How often will monitoring occur? What analyses will be performed? If appropriate, what 
criteria will be used to stop the research based on monitoring of the results?) 
 
The DSMP was reviewed and approved by the assigned Project Officer and the University of Illinois 
at Urbana-Champaign IRB, who will continue to monitor the study as it progresses.  Data will be 
collected at NJCRI.  All data will be stored in password protected devices and/or locked in a filing 
cabinet in a locked office space where only authorized members of the research team have access.  A 
database will be set up at a password protected University of Illinois at Urbana-Champaign server in 
such a way that all authorized members of the research team will be able to access specific files 
remotely.  Each member will be assigned a password protected account that will allow them to access 
the database.  Immediately after data entry, all data will be filed at University of Illinois at Urbana-
Champaign for safekeeping.  Project director and Drs. Benoit and Windsor will be responsible for 
overseeing all data collection and processing. All identifying electronic data will be destroyed 
immediately after data analysis is completed. Signed consent forms and session videos will be kept for 
3 years after study’s completion. De-identified electronic data will be kept indefinitely. 
 
While the proposed study does not seek to test the effectiveness of drugs or a medical devise delivered 
in multiple sites, the proposed study will be testing a new intervention in the community with a 
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marginalized population and there is potential for harm. Thus, we developed a Data and Safety 
Monitoring Plan (DSMP) and will create a Data Safety and Monitoring Board (DSMB) in keeping 
with the protocol as approved by the designated NIH Program Official to conduct periodic 
independent analyses of the pilot evaluation data in the data collection phase.  The DSMP is as 
follows:  
 
1.  The participants are fully informed of the study requirements throughout the evaluation and are 
allowed the opportunity to withdraw from participation, at no penalty to themselves or their ability to 
receive other treatment that we suggest at regular cost to them.  This is written in the consent form, 
which will be approved by the IRBs. 
 
2. Risks of the study and steps taken to minimize risk and protect the participants as outlined in the 
consent form are as follows: 
 
a. Possible discomfort from answering personal questions.   If the participants experience such 
discomfort at any time, they are free to inform the interviewer or facilitator, and are free to 
withdraw from the program. Interviewers will be trained to observe signs of discomfort and check 
with participants if they want to continue. Licensed facilitators and peer facilitators are trained to 
address discomfort during the sessions and participants are able to leave whenever they need. 
 
b. Discomfort or risk of minor or major substance withdrawal symptoms. This will be carefully 
assessed at the Clinical Screen and throughout the intervention.  Monthly assessments will test 
levels of AIDU and suicidality. Staff at Integrity House, Inc. and NJCRI, as well as group 
facilitators are highly trained to recognize and recommend courses of action for current or 
potential withdrawal symptoms, and will consult with project director at Integrity House, Inc. 
Integrity House, Inc. offers a variety of substance abuse treatment services and staff there are 
fully trained to recognize and address signs of withdrawal. Dr. Windsor will be available to 
consult with project director and the group facilitators via phone and e-mail, and she will provide 
on-going, remote clinical supervision and monitoring of each case.  In the event of acute 
withdrawal symptoms or high risk behaviors (i.e., suicidal or homicidal ideation, intent, or plan), 
the facilitator will refer the participant to the appropriate staff at NJCRI. for admission to 
inpatient or ambulatory detoxification.  Dr. Windsor and the project director will review each 
intake for risk of withdrawal symptoms, level of care needs, and appropriate action plan.  
Members of the NCCB who are service providers will be available to provide consultation to any 
challenges that may arise with participants. Member service providers include social workers 
experienced in the field of substance abuse. 
 
c. Clinical emergencies will be handled by the NJCRI treatment team of experienced staff under 
supervision of project director and at NJCRI under the supervision of Henry Iwuala and Corey 
DeStefano, who will be available by phone to all facilitators.  Appropriate assessments will be 
conducted; treatment options will be recommended and followed through as necessary.  NJCRI 
routinely provide services to individuals with substance use disorders and they are fully equipped 
to address any potential emergencies either themselves or via referrals.  NJCRI, project director, 
and the NCCB have longstanding relationships with all substance abuse treatment facilities in 
Newark, NJ. NJCRI project director or on-call service providers will be available 24 hours a day 
to handle health-related emergencies.  Any adverse event will be reported to the appropriate 
authorities within 48 hours and immediate action will be taken to minimize the likelihood of it 
occurring again.  
 
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d. Non-Response to Intervention. Close monitoring during the intervention allows us to determine 
if a participant develops increased risk or withdrawal symptoms or need of a higher level of care.  
At any time during the course of the intervention, any acute medical issues, non-response to 
treatment, or reported or observed withdrawal symptoms will result in the facilitator’s consultation 
with project director and/or Dr. Windsor regarding appropriate course of action using NJCRI 
guidelines.   
 
e. Relapse and Referral for Further Treatment.  As the participant nears the end of the intervention, 
our intervention will include relapse prevention, and what to do in the event of relapse. Each 
participant therefore will leave the intervention with a plan for handling relapse during the follow-
up period and beyond. If further treatment is indicated, we will provide the participant with several 
outpatient referrals.  After the intervention, should the participant request a referral for treatment, 
study personnel will refer the participant to NJCRI where staff can provide appropriate care or 
referrals.   
 
f. Deterioration. Clients who are deteriorating during treatment will be reviewed by project 
director and Dr. Windsor. Clients may be withdrawn from the study and/or referred to a higher 
level of care if they meet specific indicators of deterioration that will be discussed during clinical 
supervision (e.g., become suicidal, regularly arrives high to participate in group discussions, 
consistently displays disruptive behavior during group).  
 
g. Potential harm done by involvement in Community Wise groups.  Typically intervention groups 
lead to a positive outcome. However, given the sensitive nature of the topics we discuss, the 
diversity of the groups, and the innovative nature of the intervention, harm as a result of 
participation in Community Wise is possible. The facilitators, project director, and Dr. Windsor 
will closely monitor the course of the intervention through ongoing data collection, observations, 
and weekly supervision and staff meetings to monitor and address any issues that may arise.  
 
h. All cases will be monitored closely on a weekly basis by the responsible members of the 
research team (Dr. Windsor, project director, Dr. Benoit, NCCB, research assistants) and the 
facilitators.  All participants will be supervised by the facilitators, at least one other clinical expert 
(including Dr. Windsor), and by research assistants through coding of video sessions, ongoing 
data analysis, and weekly clinical and staff meetings.   
 
i. Any research staff member who learns of an adverse event is responsible for reporting the event 
to the Principal Investigators (PI), who are in turn responsible for discussing the event to make a 
joint decision about whether the event is serious or non-serious.  Events will be categorized as 
adverse or serious adverse according to NIH guidelines: “Adverse events (AEs) are defined as any 
untoward medical occurrence that may present itself during treatment or administration of an 
intervention, and which may or may not have a causal relationship with the treatment. Serious 
adverse events (SAEs) are defined as any medical occurrence that results in death; is life-
threatening; requires inpatient hospitalization or prolongation of existing hospitalization; creates 
persistent or significant disability/incapacity, or a congenital anomaly/birth defects.”  As such, 
adverse events (AEs) occurring during the course of the study will be collected, documented, and 
reported to the PIs or a designated co-investigator. The occurrence of AEs will be assessed during 
the intervention phase of the study at baseline and each group visit through clinical observation. 
Each week a study investigator will review the AE Forms from the previous week for events that 
were reported as new or continuing. The study investigators will follow all AEs to the point of a 
satisfactory resolution. A study participant may be withdrawn from the study if the responsible 
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investigator or group facilitators determine it is the best decision in order to protect the safety of a 
participant. All AEs will be assessed to determine if they meet criteria for an SAE. If an AE meets 
criteria for serious adverse event (SAE), as defined by the FDA, they will be systematically 
evaluated at each clinic visit and treated in a similar fashion as AEs with regards to monitoring and 
reporting. 
 
Any SAE will be reported to each of the three IRB’s and to the assigned NIH Project Officer 
within 48 hours of the occurrence. The report of SAEs will include whether they were expected or 
unexpected, a rating of severity of the event, a brief narrative summary of the event, a 
determination of whether a causal relationship existed between the study procedures and the event, 
whether the informed consent should be changed as a result of the event and whether all enrolled 
participants should be notified of the event. Finally, as part of the annual progress report 
(noncompeting continuation application) to NIH, we would provide summary information on all 
SAEs that have occurred during that year.  
 
j. Any actions taken by any of the IRBs will be reported promptly to NIH via the Project Officer 
or appropriate parties. 
 
k. The PIs and Dr. Smith will closely monitor the validity and integrity of the data on an on-going 
basis. The DSMB with also conduct biannual monitoring of the data through spot checks and 
independent preliminary analysis of the data. For instance, the PIs and the Project Director will 
meet regularly with project interviewers to review assessments and coding of incoming data. The 
PIs will be responsible for ensuring that data are being coded, entered and cleaned appropriately. 
The full research team will meet every week for 120 minutes to review all aspects of the research 
study.  
 
l. Data collected from NCCB members is anonymous and does not include sensitive information. 
It will be reviewed by the IRB, but this data will not be included in the oversight of the DSMP  
 
 
 
21.  BENEFITS  Describe the expected benefits of the research to the subjects and/or to society. 
 
The potential benefits to participants in this study and other members of the community are significant 
and long lasting if the proposed research results in a manual-based optimized intervention that is truly 
community-based, culturally congruent, effective, and scalable. In the near term, participants may 
experience increased feelings of empowerment, connection with their community, sense of purpose in 
life and self-esteem, all of which have been associated with reduced health-risk behaviors. The 
community itself is likely to benefit from the various capacity building projects that participants will 
implement during the intervention. In the near term, participation itself can be beneficial when 
individuals are able to share their lived experiences and concerns about health needs and community 
problems in a secure and unthreatening environment. Community member participants will also be 
compensated materially for participating in interviews, focus groups and the pilot intervention.  In 
addition, if participants express a need for professional assistance at any time, the project team and the 
NCCB are well equipped to either provide service or make appropriate referrals. 
 
Knowledge to be gained from this investigation is important for deepening our understanding of 
structural environmental challenges as contributors to racial and economic health inequalities between 
distressed communities with concentrations of African Americans (DCAA) and their wealthier and 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

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IRB-1 04/08/2013 
                             
 
predominantly White counterparts. Major obstacles to the adoption of evidence-based interventions by 
DCAAs include distrust and differences between community culture and the theoretical frameworks 
of many evidence-based interventions. Knowledge produced by community-based participatory 
research (CBPR) such as that proposed here can address these challenges while building community 
capacity and empowerment. This is the first study to apply the Multiphase Optimization Strategy 
(MOST) under CBPR principles to optimize a multi-level intervention. This cutting edge research will 
help increase the number of rigorous methodologies available that can be used with CBPR principles 
to develop multi-level interventions targeting myriad health inequalities. 
 
 
 
 
22.  RISK/BENEFIT ASSESSMENT  Weigh the risks with regard to the benefits. Provide evidence 
that benefits outweigh risks. 
The value of the knowledge to be gained far outweighs the potential risks of participation described 
above, particularly when considering the precautions we have taken to minimize these risks. As 
explained earlier in this section, project staff will employ every effort to maintain confidentiality and 
to minimize any other potential risks; should a serious adverse event occur, it will be reported to the 
DSMB, Project Officer, funding agencies and the IRBs of the University of Illinois at Urbana-
Champaign, NDRI, NJCRI, and Michigan University within 48 hours. Adverse events will be tracked 
in a database and reviewed at each DSMB meeting. Our CBPR pilot research shows significant 
community support for this application and community members themselves are committed to 
assisting us in the successful and safe implementation of this project. 
 
If additional Risk/Benefit information is attached, check here:  
 
 
 
23. Is this a multi-center study in which the UIUC investigator is the lead investigator of a multicenter 
study, or the UIUC is the lead site in a multi-center study.       Yes 
       No
 
 
If yes, describe the management and communication of information obtained that might be relevant to 
the protection of subjects, such as: unanticipated problems involving risks to subjects or others, interim 
results and protocol modifications. 
 
To avoid possible violations of confidentiality, project staff are trained to carefully follow detailed 
procedures designed to assure that no information about any participant (or others they may mention) 
will be given to law enforcement, other government agencies, or anyone but research staff.  Every 
member of the research team and all NCCB members will be required to undergo human subject 
protection training and provide a certificate of completion to the IRB prior to any contact with human 
subjects. Standards of confidentiality include the use of code numbers and code names for participants 
and other individuals they may mention. The only place participants’ names or other identifying 
information will appear is on informed consent forms and locator forms (used for follow-up interviews 
after the baseline). These forms will be kept in a locked filing cabinet at NJCRI, which will be kept 
separate from data. The Project Director, and Dr. Benoit, a Principal Investigator, are the only people 
who will have access to the filing cabinet. 
 
The electronic files generated through data collection will be identified by code numbers only and kept 
in password-protected devices/servers, separate from identifying information and available only to 
project staff. This helps to ensure that no identifying information will be disclosed in the unlikely 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

33 of 35 
IRB-1 04/08/2013 
                             
 
event that computerized data are stolen or otherwise seen by unauthorized persons.) All identifying 
electronic data will be destroyed immediately after data analysis is completed. Signed consent forms 
and session videos will be kept for 3 years after study completion. De-identified electronic data will be 
kept indefinitely. NCCB participants may ask at any time to have recordings of their meetings 
destroyed by calling/e-mailing one of the Principal Investigators at the numbers provided in the 
informed consent forms.    
 
Our interviewers are trained to watch participants carefully and will stop questioning if an individual 
appears uneasy. At every interview, participants will be informed that they may ask the interviewer to 
stop if they are feeling uncomfortable. Referrals to counselors are available if participants wish and 
trained clinical counselors are available at NJCRI in the event that someone may need immediate 
assistance, whether it is during data collection or during the intervention sessions.  
 
Dr. Windsor, Dr. Benoit, and project director will be available by phone at all times in case an 
emergency occurs. Any adverse event will be reported to the IRB and funding agency within 24 hours. 
Through our NCCB collaboration, we have excellent relationships with the community, including 
community members and agencies that we can mobilize in case the need arises (e.g., access to 
providers that provide detox and emergency services, free legal support clinics, community members 
who learned from participants about their engagement in the study may reach out to us for help in case 
they know one of our participants may be in trouble). 
 
In addition to this extensive network, we will collect data during the baseline and follow-up 
assessments to monitor participant safety. For instance, we will conduct the MINI suicidality screen 
and if we find anyone at risk, we will have the appropriate group clinician reach out to the participant 
individually and make sure they are linked to the mental health services they need. 
 
Finally, the research team and the clinical team will engage in weekly project meetings to discuss the 
progress of the study and identify, discuss, and address any potential issues. 
 
 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

34 of 35 
IRB-1 04/08/2013 
                             
 
24.  INVESTIGATOR ASSURANCES:  The signature of the Responsible Project Investigator is 
required (scanned or faxed signatures are acceptable). Other investigators are also responsible for these 
assurances and are encouraged to sign.  
 
I certify that the information provided in this application, and in all attachments, is complete and 
correct. 
 
I understand that I have ultimate responsibility for the protection of the rights and welfare of human 
subjects, the conduct of this study, and the ethical performance of this project. 
 
I agree to comply with all UIUC policies and procedures, the terms of its Federal Wide Assurance, and 
all applicable federal, state, and local laws regarding the protection of human subjects in research. 
 
I certify that 
 
• the project will be performed by qualified personnel according to the UIUC IRB-approved protocol. 
 
• the equipment, facilities, and procedures to be used in this research meet recognized standards for 
safety. 
 
• no change will be made to the human subjects protocol or consent form(s) until approved by the 
UIUC IRB. 
 
• legally effective informed consent or assent will be obtained from human subjects as required. 
 
• Unanticipated problems, adverse events, and new information that may affect the risk–benefit 
assessment for this research will be reported to the UIUC IRB Office (217.333.2670; 
irb@illinois.edu) and to my Departmental Executive Officer. 
  
• I am familiar with the latest edition of the UIUC Handbook for Investigators, available at 
www.irb.illinois.edu, and I will adhere to the policies and procedures explained therein. 
 
• student and guest investigators on this project are knowledgeable about the regulations and policies 
governing this research. 
 
• I agree to meet with the investigator(s), if different from myself, on a regular basis to monitor study 
progress. 
 
• if I will be unavailable, as when on sabbatical or other leave, including vacation, I will arrange for 
an alternate faculty sponsor to assume responsibility during my absence. I will advise the UIUC 
IRB by letter of such arrangements. 
 
 
 
 
 
 
 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

35 of 35 
IRB-1 04/08/2013 
                             
 
I further certify that the proposed research has not yet been done, is not currently underway, and will 
not begin until IRB approval has been obtained. 
 
03/03/2019  
      
      
Responsible Principal Investigator 
Date 
 
Investigator 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator 
Date 
 
Investigator 
Date 
 
25.  (OPTIONAL) DEPARTMENTAL ASSURANCE  To be completed by the RPI’s Departmental 
Executive Officer or their designee. 
 
The activity described herein is in conformity with the standards set by our department and I assure that 
the principal investigator has met all departmental requirements for review and approval of this 
research. 
 
 
      
      
Departmental Executive Officer (or designee) 
Date 
 
*  For units that conduct scientific merit review, the signature above documents the following: 
 
 1. The research uses procedures consistent with sound research design. 
 2. The research design is sound enough to yield the expected knowledge.  
 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

 
 
Research Team  
 
 
1 of 8 
                             
 
Revised: 4/11/2019 
 
For Listing Additional Researchers who are Involved in the Project 
All forms must be typewritten and submitted via email to irb@illinois.edu. 
 
When to use this form: If there are collaborating researchers participating in a research study, including 
those from other institutions, complete this form by listing all collaborating researchers. Include all 
persons who will be: 1) directly responsible for project oversight and implementation, 2) recruitment, 3) 
obtaining informed consent, or 4) involved in data collection, analysis of identifiable data, and/or follow-
up. Please copy and paste text fields to add additional research team members.  
Note:  
• 
Changes made to the Principal Investigator require a revised Protocol Form and an Amendment 
Form. 
• 
A complete Research Team form with all research team members included needs to be submitted 
every time the research team is updated.  
 
Section 1. PROTOCOL INFORMATION 
1A. Principal Investigator: Liliane Windsor 
1B. Protocol Number: 16574 
1C. Project Title:    Community Wise: An Innovative multi-level intervention to reduce alcohol and 
illegal drug use    
 
Section 2. ADDITIONAL INVESTIGATORS 
Full Name: Carol Lee 
Degree: MSW 
Dept. or Unit: School 
of Social Work 
Professional Email: carolal2@illinois.edu 
Phone: 5184773204 
Campus Affiliation:  
 University of Illinois at Urbana-Champaign 
 Other, please specify:       
Campus Status: 
 Faculty 
 Academic Professional/Staff  
 Graduate Student 
 Undergraduate Student  
 Visiting Scholar 
 Other, please specify: Research staff 
Training: 
 Required CITI Training, Date of Completion (valid within last 3 years): 05/28/2020 
 Additional training, Date of Completion:       
Role on Research Team (check all that apply): 
 Recruiting 
 Consenting 
 Administering study procedures 
 Handling identifiable data 
 Other, please specify: Handling deidentified data 
 This researcher should be copied on OPRS and IRB correspondence.   
 This researcher is no longer an active research team member.       
Date added to research team:   05/2016                           Date removed from research team:         
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

 
 
Research Team  
 
 
2 of 8 
                             
 
Revised: 4/11/2019 
 
Full Name: Dora Watkins 
Degree: LLMSW 
Dept. or Unit: School 
of Social Work 
Professional Email: dnw6@illinois.edu 
Phone: 313-463-0093 
Campus Affiliation:  
 University of Illinois at Urbana-Champaign 
 Other, please specify:       
Campus Status: 
 Faculty 
 Academic Professional/Staff  
 Graduate Student 
 Undergraduate Student  
 Visiting Scholar 
 Other, please specify: Research staff 
Training: 
 Required CITI Training, Date of Completion (valid within last 3 years): 07/2021 
 Additional training, Date of Completion:       
Role on Research Team (check all that apply): 
 Recruiting 
 Consenting 
 Administering study procedures 
 Handling identifiable data 
 Other, please specify: Handling deidentified data 
 This researcher should be copied on OPRS and IRB correspondence.   
 This researcher is no longer an active research team member.       
Date added to research team:   07/2021                            Date removed from research team:         
 
 
Full Name: Peter Treitler 
Degree: MSW 
Dept. or Unit: IFH 
Professional Email: peter.treitler@rutgers.edu 
Phone: 848-932-6896 
Campus Affiliation:  
 University of Illinois at Urbana-Champaign 
 Other, please specify: Rutgers University 
Campus Status: 
 Faculty 
 Academic Professional/Staff  
 Graduate Student 
 Undergraduate Student  
 Visiting Scholar 
 Other, please specify:       
Training: 
 Required CITI Training, Date of Completion (valid within last 3 years): 4/5/2018 
 Additional training, Date of Completion:       
Role on Research Team (check all that apply): 
 Recruiting 
 Consenting 
 Administering study procedures 
 Handling identifiable data 
 Other, please specify: Secondary analysis of de-identified data 
 This researcher should be copied on OPRS and IRB correspondence.   
 This researcher is no longer an active research team member.       
Date added to research team:   12/21/2020                      Date removed from research team:   11/9/2021 
 
Full Name: Sierra Wollen 
Degree: MSW 
Dept. or Unit: Social 
Work 
Professional Email: slwollen@uw.edu 
Phone: 253-569-7271 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

 
 
Research Team  
 
 
3 of 8 
                             
 
Revised: 4/11/2019 
Campus Affiliation:  
 University of Illinois at Urbana-Champaign 
 Other, please specify: University of Washington 
Campus Status: 
 Faculty 
 Academic Professional/Staff  
 Graduate Student 
 Undergraduate Student  
 Visiting Scholar 
 Other, please specify:       
Training: 
 Required CITI Training, Date of Completion (valid within last 3 years): 1/31/19 
 Additional training, Date of Completion:       
Role on Research Team (check all that apply): 
 Recruiting 
 Consenting 
 Administering study procedures 
 Handling identifiable data 
 Other, please specify: Secondary analysis of de-identified data 
 This researcher should be copied on OPRS and IRB correspondence.   
 This researcher is no longer an active research team member.       
Date added to research team:   12/21/20                                   Date removed from research team:         
 
Full Name: Sophia Gawron 
Degree: BS 
Dept. or Unit: School 
of Social Work 
Professional Email: sgawron2@illinois.edu 
Phone: 319-457-0885 
Campus Affiliation:  
 University of Illinois at Urbana-Champaign 
 Other, please specify:       
Campus Status: 
 Faculty 
 Academic Professional/Staff  
 Graduate Student 
 Undergraduate Student  
 Visiting Scholar 
 Other, please specify:       
Training: 
 Required CITI Training, Date of Completion (valid within last 3 years): 12/01/2020 
 Additional training, Date of Completion:       
Role on Research Team (check all that apply): 
 Recruiting 
 Consenting 
 Administering study procedures 
 Handling identifiable data 
 Other, please specify: Cleaning deidentified data 
 This researcher should be copied on OPRS and IRB correspondence.   
 This researcher is no longer an active research team member.       
Date added to research team:   12/26/2020                      Date removed from research team:   10/21/2021 
 
Full Name: Ashley Masengale 
Degree: BSW 
Dept. or Unit: School 
of Social Work 
Professional Email: amasen2@illinois.edu 
Phone: 217-497-0511 
Campus Affiliation:  
 University of Illinois at Urbana-Champaign 
 Other, please specify:       
Campus Status: 
 Faculty 
 Academic Professional/Staff  
 Graduate Student 
 Undergraduate Student  
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

 
 
Research Team  
 
 
4 of 8 
                             
 
Revised: 4/11/2019 
 Visiting Scholar 
 Other, please specify:       
Training: 
 Required CITI Training, Date of Completion (valid within last 3 years): 12/01/2020 
 Additional training, Date of Completion:       
Role on Research Team (check all that apply): 
 Recruiting 
 Consenting 
 Administering study procedures 
 Handling identifiable data 
 Other, please specify: cleaning deidentified data 
 This researcher should be copied on OPRS and IRB correspondence.   
 This researcher is no longer an active research team member.       
Date added to research team:   12/26/2020                      Date removed from research team:   10/21/2021 
 
Full Name: Kang Sun 
Degree: PhD 
Dept. or Unit: School 
of Social Work 
Professional Email: kangsun2@illinois.edu 
Phone: 419-494-2123 
Campus Affiliation:  
 University of Illinois at Urbana-Champaign 
 Other, please specify:       
Campus Status: 
 Faculty 
 Academic Professional/Staff  
 Graduate Student 
 Undergraduate Student  
 Visiting Scholar 
 Other, please specify:       
Training: 
 Required CITI Training, Date of Completion (valid within last 3 years): 09/29/2018 
 Additional training, Date of Completion:       
Role on Research Team (check all that apply): 
 Recruiting 
 Consenting 
 Administering study procedures 
 Handling identifiable data 
 Other, please specify: Cleaning deidentified data 
 This researcher should be copied on OPRS and IRB correspondence.   
 This researcher is no longer an active research team member.       
Date added to research team:   12/26/2020                      Date removed from research team:   10/21/2021 
 
Full Name: Kimberly Garcia 
Degree: High 
School 
Dept. or Unit: School 
of Social Work 
Professional Email: kimberlyg_christina@yahoo.com 
Phone: 7324875646 
Campus Affiliation:  
 University of Illinois at Urbana-Champaign 
 Other, please specify:       
Campus Status: 
 Faculty 
 Academic Professional/Staff  
 Graduate Student 
 Undergraduate Student  
 Visiting Scholar 
 Other, please specify: Research staff 
Training: 
 Required CITI Training, Date of Completion (valid within last 3 years): 12/2020 
 Additional training, Date of Completion:       
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

 
 
Research Team  
 
 
5 of 8 
                             
 
Revised: 4/11/2019 
Role on Research Team (check all that apply): 
 Recruiting 
 Consenting 
 Administering study procedures 
 Handling identifiable data 
 Other, please specify: Handling deidentified data 
 This researcher should be copied on OPRS and IRB correspondence.   
 This researcher is no longer an active research team member.       
Date added to research team:   12/26/2020                            Date removed from research team:         
 
Full Name: Julia Gold 
Degree: BFA 
Dept. or Unit: School 
of Social Work 
Professional Email: juliarg2@illinois.edu 
Phone: 847-769-8152 
Campus Affiliation:  
 University of Illinois at Urbana-Champaign 
 Other, please specify:       
Campus Status: 
 Faculty 
 Academic Professional/Staff  
 Graduate Student 
 Undergraduate Student  
 Visiting Scholar 
 Other, please specify: 
Training: 
 Required CITI Training, Date of Completion (valid within last 3 years): 12/2020 
 Additional training, Date of Completion:       
Role on Research Team (check all that apply): 
 Recruiting 
 Consenting 
 Administering study procedures 
 Handling identifiable data 
 Other, please specify: Handling deidentified data 
 This researcher should be copied on OPRS and IRB correspondence.   
 This researcher is no longer an active research team member.       
Date added to research team:   12/26/2020                       Date removed from research team:   10/21/2021 
 
Full Name: Marlene Pena 
Degree: BS 
Dept. or Unit: School 
of Social Work 
Professional Email: mpena21@illinois.edu 
Phone: 872-233-5308 
Campus Affiliation:  
 University of Illinois at Urbana-Champaign 
 Other, please specify:       
Campus Status: 
 Faculty 
 Academic Professional/Staff  
 Graduate Student 
 Undergraduate Student  
 Visiting Scholar 
 Other, please specify: 
Training: 
 Required CITI Training, Date of Completion (valid within last 3 years): 09/2020 
 Additional training, Date of Completion:       
Role on Research Team (check all that apply): 
 Recruiting 
 Consenting 
 Administering study procedures 
 Handling identifiable data 
 Other, please specify: Handling deidentified data 
 This researcher should be copied on OPRS and IRB correspondence.   
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

 
 
Research Team  
 
 
6 of 8 
                             
 
Revised: 4/11/2019 
 This researcher is no longer an active research team member.       
Date added to research team:   12/26/2020                            Date removed from research team:         
 
Full Name:      Vitalis Im 
Degree: 
    MSW  
Dept. or Unit: 
     School of Social 
Work and Department 
of Anthropology 
Professional Email:      vitalis@umich.edu 
Phone:      7348001961 
Campus Affiliation:  
 University of Illinois at Urbana-Champaign 
 Other, please specify: University of Michigan 
Campus Status: 
 Faculty 
 Academic Professional/Staff  
 Graduate Student 
 Undergraduate Student  
 Visiting Scholar 
 Other, please specify:       
Training: 
 Required CITI Training, Date of Completion (valid within last 3 years): 11/04/2020 (PEERS Certification) 
 Additional training, Date of Completion:  
Role on Research Team (check all that apply): 
 Recruiting 
 Consenting 
 Administering study procedures 
 Handling identifiable data 
 Other, please specify: Analyzing deidentified data 
If administering biomedical study procedure (e.g., blood draws, scans, etc.), please specify the 
procedure(s):       
 This researcher should be copied on OPRS and IRB correspondence.   
 This researcher is no longer an active research team member.       
Date added to research team:   10/21/2021                                   Date removed from research team:       
 
Full Name:      Evan Hall 
Degree: BS 
Dept. or Unit: 
     School of Social 
Work 
Professional Email:      ejdhall@umich.edu 
Phone:      248-882-7113 
Campus Affiliation:  
 University of Illinois at Urbana-Champaign 
 Other, please specify: University of Michigan 
Campus Status: 
 Faculty 
 Academic Professional/Staff  
 Graduate Student 
 Undergraduate Student  
 Visiting Scholar 
 Other, please specify:       
Training: 
 Required CITI Training, Date of Completion (valid within last 3 years): 3/22/2021 
 Additional training, Date of Completion:  
Role on Research Team (check all that apply): 
 Recruiting 
 Consenting 
 Administering study procedures 
 Handling identifiable data 
 Other, please specify: Analyzing deidentified data 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

 
 
Research Team  
 
 
7 of 8 
                             
 
Revised: 4/11/2019 
If administering biomedical study procedure (e.g., blood draws, scans, etc.), please specify the 
procedure(s):       
 This researcher should be copied on OPRS and IRB correspondence.   
 This researcher is no longer an active research team member.       
Date added to research team:   10/21/2021                                   Date removed from research team:   
      
 
Full Name:      Annabella Vidrio 
Degree: BS 
Dept. or Unit: 
     School of Social 
Work 
Professional Email:      bellanv@umich.edu 
Phone:      562-977-7308 
Campus Affiliation:  
 University of Illinois at Urbana-Champaign 
 Other, please specify: University of Michigan 
Campus Status: 
 Faculty 
 Academic Professional/Staff  
 Graduate Student 
 Undergraduate Student  
 Visiting Scholar 
 Other, please specify:       
Training: 
 Required CITI Training, Date of Completion (valid within last 3 years): 3/22/2021 
 Additional training, Date of Completion:  
Role on Research Team (check all that apply): 
 Recruiting 
 Consenting 
 Administering study procedures 
 Handling identifiable data 
 Other, please specify: Analyzing deidentified data 
If administering biomedical study procedure (e.g., blood draws, scans, etc.), please specify the 
procedure(s):       
 This researcher should be copied on OPRS and IRB correspondence.   
 This researcher is no longer an active research team member.       
Date added to research team:   10/21/2021                                Date removed from research team:         
 
Full Name:      Marc Arthur 
Degree: PhD 
Dept. or Unit: 
     School of Social 
Work 
Professional Email:      marcarth@umich.edu 
Phone:      415-425-4690 
Campus Affiliation:  
 University of Illinois at Urbana-Champaign 
 Other, please specify: University of Michigan 
Campus Status: 
 Faculty 
 Academic Professional/Staff  
 Graduate Student 
 Undergraduate Student  
 Visiting Scholar 
 Other, please specify:       
Training: 
 Required CITI Training, Date of Completion (valid within last 3 years): 3/22/2021 
 Additional training, Date of Completion:  
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

 
 
Research Team  
 
 
8 of 8 
                             
 
Revised: 4/11/2019 
Role on Research Team (check all that apply): 
 Recruiting 
 Consenting 
 Administering study procedures 
 Handling identifiable data 
 Other, please specify: Analyzing deidentified data 
If administering biomedical study procedure (e.g., blood draws, scans, etc.), please specify the 
procedure(s):       
 This researcher should be copied on OPRS and IRB correspondence.   
 This researcher is no longer an active research team member.       
Date added to research team:   10/21/2021                                Date removed from research team:         
 
 
Full Name: Ellen Benoit 
Degree: PhD 
Dept. or Unit: NJCRI 
Professional Email: e.benoit@njcri.org 
Phone: 973-483-3444 ext. 281 
Campus Affiliation:  
 University of Illinois at Urbana-Champaign 
 Other, please specify:       
Campus Status: 
 Faculty 
 Academic Professional/Staff  
 Graduate Student 
 Undergraduate Student  
 Visiting Scholar 
 Other, please specify: 0% employee 
Training: 
 Required CITI Training, Date of Completion (valid within last 3 years): 02/17/2020 
 Additional training, Date of Completion:       
Role on Research Team (check all that apply): 
 Recruiting 
 Consenting 
 Administering study procedures 
 Handling identifiable data 
 Other, please specify:  
 This researcher should be copied on OPRS and IRB correspondence.   
 This researcher is no longer an active research team member.       
Date added to research team:     05/2016                                  Date removed from research team:         
 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

Date: Mon, Mar 11, 2019 at 1:43 PM
Subject: eResearch Notification: Scheduled Continuing Review Approved
To: <ropinto@umich.edu>, <krber@umich.edu>, <yunch@umich.edu>
 
  Health Sciences and Behavioral Sciences Institutional Review Board (IRB-HSBS) • 2800 Plymouth Rd., Building 520, Room 1170, Ann Arbor, MI
48109-2800 • phone (734) 936-0933 • fax (734) 998-9171 • irbhsbs@umich.edu
 
To: Dr.  Rogerio Pinto
From:
Thad
Polk
 
 
Cc:
Rogerio
Pinto
Kathryn
Berringer
Yun
Chen
 
 
Subject: IRB HSBS Acknowledgement of Scheduled Continuing Review for Study Conducted Under
a Non-UM IRB (University of Illinois), [CR00074677] for [HUM00115022] 
SUBMISSION INFORMATION:
Study Title: Community Wise 
Full Study Title (if applicable): Community Wise: An Innovative multi-level intervention to reduce
alcohol and illegal drug use.
Study eResearch ID: HUM00115022 
SCR eResearch ID: CR00074677 
SCR Title: HUM00115022_Continuing Review - Wed Jan 30 10:37:25 EST 2019
Date of this notification from IRB HSBS: 3/11/2019 
Review: Expedited 
Date of  IRB HSBS Registration Review: 3/11/2019
Non-UM IRB ID Number: 16574
Current Non-UM Approval Period: **Staff Insert Approval Date** - **Staff Insert
Expiration Date** 
Current UM Acknowledgement Period: **Staff Insert UM Acknowledgement Period**
UM Federalwide Assurance: FWA00004969 (For the current FWA expiration date, please visit the
UM HRPP Webpage) 
NOTICE OF IRB APPROVAL AND CONDITIONS:
Following applicable internal review(s), this application to conduct human subjects research is
acknowledged as meeting the criteria of the University of Michigan for ceding oversight to a non-UM
IRB and is considered to be registered with IRB HSBS for purposes of institutional record-keeping.
You must conduct this study in accordance with the approval criteria of the external IRB.
APPROVAL PERIOD AND EXPIRATION DATE:
The updated UM acknowledgement period for this study is listed above. Please note the UM
expiration date as it may differ from the IRB approval period of the non-UM IRB. If the external IRB
approval lapses, you may not conduct work on this study until appropriate approval has been re-
established, except as necessary to eliminate apparent immediate hazards to research subjects or
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

others. Should the latter occur, notify the external IRB and the IRB HSBS Office as soon as
possible.
IMPORTANT REMINDERS AND ADDITIONAL INFORMATION FOR INVESTIGATORS
AMENDMENTS, RENEWALS, AND TERMINATIONS:
The non-UM IRB is now the IRB of Record for the conduct of this study at the University of
Michigan. However, you must utilize eResearch to:
Submit amendments to the registered application if any changes to the protocol will require
re-review by an ancillary committee (e.g., IDS, CRAO, RDRC/SHUR)
Annually renew (SCR) the registration of this research study with IRB HSBS
Terminate the IRB HSBS registration of this study when the study is terminated at the non-
UM IRB
AEs/ORIOs:
Although the non-UM IRB is now the IRB of Record for the conduct of this study, you must report
related Serious Adverse Events and Unanticipated problems in accordance with the division of labor
as agreed upon by the University of Michigan and the non-U-M IRB.
This should be done through eResearch following the same procedures as for an IRB HSBS-
approved study. These include, but are not limited to, events and/or information that may have
physical, psychological, social, legal, or economic impact on local research subjects.
APPROVED STUDY DOCUMENTS:
You must use the study documents approved by the non-UM IRB.
SUBMITTING VIA eRESEARCH:
The online forms for continuing review, amendments, and AE/ORIO reporting can be accessed in
the eResearch workspace for this Non-UM IRB-approved, IRB HSBS-accepted study, referenced
above.
MORE INFORMATION:
You can find additional information about UM’s Human Research Protection Program (HRPP) in the
Operations Manual and other documents available at http://research-
compliance.umich.edu/human-subjects.
Thad Polk
Chair, IRB HSBS
 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

Up to 15 WEEKLY 
GROUP 
SESSIONS OF  
COMMUNITY 
WISE 
1 to 2-Hours  
$2.50 per session 
SCREENING 
$10 Dollars 
20 Minutes 
Orientation 
Session 
Bus ticket 
45 Min 
Up to 5 Follow ups 
$20 Dollars 
1.5 Hours 
FOCUS GROUP 
$20 Dollars 
1 Hour 
Baseline 
 $20 Dollars 
1 Hour 
Randomization 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

Seeking men with a history of substance use disorders transitioning into 
Newark from incarceration (up to 4 years since release date) to 
participate in the evaluation of Community Wise, a new community 
based intervention to reduce substance use: 
THE INTERVENTION: You will be randomized into receiving all or a combination of: 
1) Group dialogue.
2) Personal goal development and implementation.
3) Engagement on community capacity building projects.
Participants must be 18 or older, speak English, live in Essex County, NJ, and 
be willing to be voice recorded. 
Participation is confidential and voluntary 
Participants may receive anywhere from $10 to $187.50 over 5 
 months depending upon the number of study interviews  
completed. Participants will also receive the potential benefits of 
 the free intervention which may include improved health, mental 
 health, networking opportunities, and community engagement. 
Email: outreach@newarkccb.org 
Tel.: (973) 803-1927 
Email: outreach@newarkccb.org 
Tel.: (973) 803-1927 
Email: outreach@newarkccb.org 
Tel.: (973) 803-1927 
Email: outreach@newarkccb.org 
Tel.: (973) 803-1927 
Email: outreach@newarkccb.org 
Tel.: (973) 803-1927 
Email: outreach@newarkccb.org 
Tel.: (973) 803-1927 
Email: outreach@newarkccb.org 
Tel.: (973) 803-1927 
Email: outreach@newarkccb.org 
Tel.: (973) 803-1927 
Email: outreach@newarkccb.org 
Tel.: (973) 803-1927 
Email: outreach@newarkccb.org 
Tel.: (973) 803-1927 
Email: outreach@newarkccb.org 
Tel.: (973) 803-1927 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

Thank you for agreeing to help spread the word about the Community 
Wise study. We are currently seeking men with a history of substance 
use disorders transitioning into Newark from incarceration (up to 4 years 
since release date) to participate in the evaluation of Community Wise, a 
new community based intervention to reduce substance use.  
We are asking you to help distribute our study fliers to your client who 
may meet our eligibility criteria. In an effort to minimize potential 
coercion (e.g. a client may want to please you by participating in in the 
study when in fact they do not want to), we ask you to follow the 
recommendations below:  
If you have any questions about this request, please contact the project 
director at the e-mail or phone number below: 
Leticia Mcbride 
Email: outreach@newrkccb.org 
Tel.: (973)803-1927 
• Hand in fliers at the end of your session with your client
• Do not encourage clients to participate in the study, rather
mention to them that there is a study going on that they can
consider joining if they want to. 
• Do not answer any of their questions about the study. Simply
tell them to call the study number if they have any questions.
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

Incentive and Study Activities 
Condition 1 or 2 – Full Intervention 
Session 
# of 
sessions 
Length in 
minutes 
Who 
Where How much per 
session 
Phone screen 
1 
5 
Research 
Assistant 
Phone 
$0 
Clinical Screen 
1 
20 
Clinician 
NJCRI 
$10 
Baseline 
1 
90 
Research 
Assistant 
NJCRI 
$20 
Community Wise 
Sessions 
15 
120 
Group 
facilitators 
NJCRI 
$2.50 each attended session 
(paid at month follow-up) 
Follow-up during 
intervention 
5 
60 
Research 
Assistant 
NJCRI 
$20 
Focus group 
1 
90 
Research 
Assistant 
NJCRI 
$20 
Total earned over 
5 months 
--- 
--- 
--- 
--- 
$187.50 
Group #: 
Group Meeting Dates: 
Group Meeting Time: 
Name of Group Facilitator: 
Meeting place address: 
Office Phone Number: 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

 
 
 
Incentive and Study Activities 
Condition 3 or 4 – Critical Dialogue (CD) and Quality of Life Wheel (QLW) 
 
  
Group #:  
Group Meeting Dates: 
Group Meeting Time: 
Name of Group Facilitator:  
Meeting place address: 
Office Phone Number: 
 
Session 
 
# of 
sessions 
Length in 
minutes 
Who 
Where How much per  
session 
Phone screen 
 
1 
5 
Research 
Assistant 
Phone 
$0 
Clinical Screen 
 
1 
20 
Clinician 
NJCRI 
$10 
Baseline 
 
1 
90 
Research 
Assistant 
NJCRI 
$20 
Community Wise CD 
and Core Sessions 
9 
120 
Group 
facilitators 
NJCRI 
$2.50 each attended session 
(paid at month follow-up) 
Community Wise QLW 
Sessions 
6 
60 
Group 
facilitators 
NJCRI 
$2.50 each attended session 
(paid at month follow-up) 
Follow-ups 
5 
60 
Research 
Assistant 
NJCRI 
$20 
Focus group (possible) 
 
1 
90 
Research 
Assistant 
NJCRI 
$20 
Total earned over  
5 months 
--- 
--- 
--- 
--- 
$187.50 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

Incentive and Study Activities 
Condition 5 or 6 – Critical Dialogue (CD) and Capacity Building Project (CBP) 
Group #:  
Group Meeting Dates: 
Group Meeting Time: 
Name of Group Facilitator: 
Meeting place address: 
Office Phone Number: 
Session 
# of 
sessions 
Length in 
minutes 
Who 
Where 
How much per 
session 
Phone screen 
1 
5 
Research 
Assistant 
Phone 
$0 
Clinical Screen 
1 
20 
Clinician 
NJCRI 
$10 
Baseline 
1 
90 
Research 
Assistant 
NJCRI 
$20 
Community Wise CD 
and Core Sessions 
9 
120 
Group 
facilitators 
NJCRI 
$2.50 each attended session 
(paid at month follow-up) 
Community Wise CBP 
Sessions 
6 
60 
Group 
facilitators 
NJCRI 
$2.50 each attended session 
(paid at month follow-up) 
Follow-ups 
5 
60 
Research 
Assistant 
NJCRI 
$20 
Focus group (possible) 
1 
90 
Research 
Assistant 
NJCRI 
$20 
Total earned over 
5 months 
--- 
--- 
--- 
--- 
$187.50 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

 
 
 
Incentive and Study Activities 
Condition 7 or 8 – Critical Dialogue 
 
  
Group #:  
Group Meeting Dates: 
Group Meeting Time: 
Name of Group Facilitator:  
Meeting place address: 
Office Phone Number: 
 
Session 
 
# of 
sessions 
Length in 
minutes 
Who 
Where How much per  
session 
Phone screen 
 
1 
5 
Research 
Assistant 
Phone 
$0 
Clinical Screen 
 
1 
20 
Clinician 
NJCRI 
$10 
Baseline 
 
1 
90 
Research 
Assistant 
NJCRI 
$20 
Community Wise 
Sessions 
9 
120 
Group 
facilitators 
NJCRI 
$2.50 each attended session 
(paid at month follow-up) 
Follow-ups 
5 
60 
Research 
Assistant 
NJCRI 
$20 
Focus group 
(possible) 
1 
90 
Research 
Assistant 
NJCRI 
$20 
Total earned over 5 
months 
--- 
--- 
--- 
--- 
$172.50 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

Incentive and Study Activities 
Condition 9 or 10 – Quality of Life Wheel (QLW) and Capacity Building Projects (CBP) 
Group #:  
Group Meeting Dates: 
Group Meeting Time: 
Name of Group Facilitator: 
Meeting place address: 
Office Phone Number: 
Session 
# of 
sessions 
Length in 
minutes 
Who 
Where How much per 
session 
Phone screen 
1 
5 
Research 
Assistant 
Phone 
$0 
Clinical Screen 
1 
20 
Clinician 
NJCRI 
$10 
Baseline 
1 
90 
Research 
Assistant 
NJCRI 
$20 
Community Wise 
Sessions 
9 
120 
Group 
facilitators 
NJCRI 
$2.50 each attended session 
(paid at month follow-up) 
Follow-ups 
5 
60 
Research 
Assistant 
NJCRI 
$20 
Focus group 
(possible) 
1 
90 
Research 
Assistant 
NJCRI 
$20 
Total earned over 5 
months 
--- 
--- 
--- 
--- 
$172.50 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

 
 
 
Incentive and Study Activities 
Condition 11 or 12- Quality of Life Wheel (QLW) 
 
  
Group #:  
Group Meeting Dates: 
Group Meeting Time: 
Name of Group Facilitator:  
Meeting place address: 
Office Phone Number: 
 
Session 
 
# of 
sessions 
Length in 
minutes 
Who 
Where 
How much per  
session 
Phone screen 
 
1 
5 
Research 
Assistant 
Phone 
$0 
Clinical Screen 
 
1 
20 
Clinician 
NJCRI 
$10 
Baseline 
 
1 
90 
Research 
Assistant 
NJCRI 
$20 
Community Wise Core 
Sessions 
3 
120 
Group 
facilitators 
NJCRI 
$2.50 each attended session 
(paid at month follow-up) 
Community Wise 
QLW 
Sessions 
6 
60 
Group 
facilitators 
NJCRI 
$2.50 each attended session 
(paid at month follow-up) 
Follow-ups 
5 
90 
Research 
Assistant 
NJCRI 
$20 
Focus group (possible) 
 
1 
90 
Research 
Assistant 
NJCRI 
$20 
Total earned over  
5 months 
--- 
--- 
--- 
--- 
$172.50 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

 
 
 
Incentive and Study Activities 
Condition 13 or 14 – Capacity Building Projects (CBP) 
 
  
Group #:  
Group Meeting Dates: 
Group Meeting Time: 
Name of Group Facilitator:  
Meeting place address: 
Office Phone Number: 
 
Session 
 
# of 
sessions 
Length in 
minutes 
Who 
Where How much per  
session 
Phone screen 
 
1 
5 
Research 
Assistant 
Phone 
$0 
Clinical Screen 
 
1 
20 
Clinician 
NJCRI 
$10 
Baseline 
 
1 
90 
Research 
Assistant 
NJCRI 
$20 
Community Wise 
Core Sessions 
3 
120 
Group 
facilitators 
NJCRI 
$2.50 each attended session 
(paid at month follow-up) 
Community Wise 
CBP Sessions 
6 
60 
Group 
facilitators 
NJCRI 
$2.50 each attended session 
(paid at month follow-up) 
Follow-ups 
5 
60 
Research 
Assistant 
NJCRI 
$20 
Focus group 
(possible) 
1 
90 
Research 
Assistant 
NJCRI 
$20 
Total earned over  
5 months 
--- 
--- 
--- 
--- 
$172.50 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

 
 
 
Incentive and Study Activities 
Condition 15 or 16- Core 
 
  
Group #:  
Group Meeting Dates: 
Group Meeting Time: 
Name of Group Facilitator:  
Meeting place address: 
Office Phone Number: 
 
Session 
 
# of 
sessions 
Length 
in 
minutes 
Who 
Where 
How much per  
session 
Phone screen 
 
1 
5 
Research 
Assistant 
Phone 
$0 
Clinical Screen 
 
1 
20 
Clinician 
NJCRI 
$10 
Baseline 
 
1 
90 
Research 
Assistant 
NJCRI 
$20 
Community Wise 
Core Sessions 
3 
120 
Group 
facilitators 
NJCRI 
$2.50 each attended session 
(paid at month follow-up) 
Follow-ups 
5 
90 
Research 
Assistant 
NJCRI 
$20 
Focus group 
(possible) 
1 
90 
Research 
Assistant 
NJCRI 
$20 
Total earned over  
5 months 
--- 
--- 
--- 
--- 
$157.50 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

Script for terminating the Clinical Screen: 
If they do not qualify: 
I am sorry but the screen is showing you are not eligible. The intervention has some components that 
could be more harmful to some people. Since the program is still new, we are not taking any risks and 
making sure your safety comes first.   If ineligible due to MINI, let them know the screen captured a 
cognitive deficit and encourage them to contact their doctor for further screening. If they ask what that 
means, say they do not seem to be processing information properly. This could be due to an injury, age, 
genetics, drug use, or other illnesses. Thus, they should follow up with a doctor. If they are ineligible due 
to their drug use level, tell them their level of substance use disqualified them but do not provide 
further information. Refer them appropriately with the referral list. 
If they say they are seeking residential treatment, let them know they do not qualify for the study. If 
they say they tried to get into residential but were unable to, ask how long the waiting list is. If longer 
than 5 months, admit them. If not, let them know they are not eligible.  
 
If they qualify: 
Congratulations, you qualify for the study. The next step will be to attend an orientation session where 
we will explain the study in detail to you. We will not pay you to attend but we will provide 
transportation tickets at the end. The orientation will last 30 minutes and we will offer light 
refreshments. You can only proceed in the study after you attend the orientation. There are several 
dates available and this card includes all of the information. After the orientation, if you are still 
interested, you will be invited to complete another questionnaire on the computer and after that you 
will start the intervention. We plan on starting Community Wise groups in two weeks or so. [Give them 
one copy of the full informed consent letter and encourage them to read it and write down their 
questions to ask at orientation]. Do you have any questions? [if they ask about the study, tell them to 
read the consent and attend the orientation]. Ask them if they would like a copy of our referral list. 
 
 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

1 
__________ 
Initials 
NAME OF LEAD RESEARCHERS:  Dr. Liliane Windsor, MSW and Dr. Ellen Benoit 
RESEARCH STUDY: We invite you to participate in a research study that seeks to evaluate 
Community Wise, a new program seeking to reduce substance use. We want to develop the best 
program we can by identifying and keeping only the activities that work to reduce substance use. 
To decide if you want to take part in this study, you need to know about its risks and benefits. I 
will go over this informed consent form with you. Once all your questions have been answered, I 
will ask you if you want to participate in the study. If you want to participate, you and I will sign 
this document.  You will get a copy of it.  
This research is confidential. The research records will include some information about you but 
this information will be stored in such a manner that will keep your identity separate from your 
responses.  Some of the information collected about you will include your name, address and 
phone number. You will also be asked some personal questions and to share some of the 
personal experiences you’ve had. For example, questions and discussions may relate to mental 
health issues, substance use or experiences you’ve had in Essex County since your release. 
Please note that we will limit access to the research data and keep it stored in a password secured 
online server. 
PURPOSE:  The purpose of this research study is to refine the Community Wise program so 
that it is as efficient as it can be. This study seeks to test if three different components of 
Community Wise reduce substance use. 
DURATION:  If you agree to participate in this study you will complete up to 9 research 
interviews (each lasting between 30 minutes and 90 minutes) and attending up to 15 weekly 
group meetings (2 hours each). It will take approximately 5 months to complete the meetings and 
all of the interviews.  
PROCEDURES: If you agree to participate, we will ask you to take part in up to 15 weekly 
group sessions (approximately 2 hours each) led either by a peer or a licensed facilitator where 
you will meet with other people in Essex County who have had similar experiences as you. The 
number of sessions you will be asked to attend will depend upon which version of the program 
you are randomly selected to join. Thus you will not be able to choose which group you will be 
joining. This means you could be randomized (picked by chance or luck) to join the “Core” 
group that includes 3 sessions. You also may be randomized to attend a group that is only offered 
at a time that is inconvenient for you. If this is the case, you will have to wait 5 months before 
you will be able to participate in Community Wise. However, if this is the case, you will have 
the opportunity to receive the full version of Community Wise after you complete the study. The 
shortest version of the program consists of 3 weeks of meetings. But your participation in the 
study will take approximately 5 months, regardless of which group you were randomly selected 
for. 
Informed Consent to Participate 
Community Wise 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

2 
 
 
 
 
 
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Initials 
 
 
All study groups will consist of weekly group meetings led by a group facilitator. In these 
groups, you and the other group members will talk about your feelings and experiences. 
Examples of discussion topics include racism, sexism, classism, mental health issues, substance 
use, incarceration, and your relationship with your community. You may also learn tools that you 
can use to improve your health.  
 
The group conversations will be voice recorded. You will use your codename and no identifying 
information about you will be included in the recording. You must consent to be audio recorded 
in order to participate in this study. We will ask you to make a pledge to respect the privacy of 
the session, we hope everybody will abide by this pledge but please understand that we can’t 
guarantee that some group members won’t reveal information about you to others after the 
session is over. 
 
In addition to attending these group sessions, your participation in this study will involve the 
following interviews:  a brief phone talk, an individual interview, up to 6 monthly computer 
interviews, and possibly a focus group (for a total of 9 research interviews). Each interview will 
include a urine drug screen, meaning we will ask you for a sample of urine and will test it for 
certain substances. In the baseline interview we will ask your permission to take a digital photo 
of you. You may refuse to take the photo without penalty. The information you give us, 
including results from saliva screens and photo, will be kept private. There are no consequences 
to having positive or negative urine drug screens and no one outside of this study, including 
parole officers or the providers at NJCRI, will be informed of the results. Your answers to any 
questions that will be asked throughout this study will be completely confidential. If, at any time, 
you do not want to answer a question or participate in a certain part of the study, you may refuse 
without penalty. You should know that some of the interviews include questions about suicide. If 
we find that you are thinking about killing yourself, your group facilitator will be notified and 
asked to offer you assistance. 
PARTICIPANTS:  592 men will be recruited from Essex County, NJ. All participants will be 
adults with a history of substance use disorder transitioning from incarceration into Essex 
County.  
 
RISKS/DISCOMFORTS: Discussing issues related to mental health, substance use, 
incarceration and other personal experiences can be painful and uncomfortable. You always have 
the right to stop participating in the research study and program at any time without penalty. If 
you feel upset during any part of the study, for example, during the group sessions or during an 
interview, you may stop participating. At that time we can let you speak with our project 
manager or a trained counselor at NJCRI. If necessary, we will refer you to affordable services in 
the community that can help address emotional issues that may arise during your participation in 
this study.  
 
While we will take several steps to protect your identity and the confidentiality of your responses 
(see details below), there is a small chance that confidentiality may be lost. For instance, data 
could be stolen while the researcher transports your consent form to the office.  We will take 
every precaution to prevent this from happening, including the use of a locked file and password 
protected secured server to safeguard your information. The only instance where the 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

3 
 
 
 
 
 
__________ 
 
 
Initials 
 
researcher will reveal information you provide is if during the interview you tell us about 
child abuse or about yourself or someone else being in danger that is about to happen.  In 
these circumstances, the researcher will notify the appropriate authorities. If you begin to 
reveal this information during the interview, the researcher will remind you that such information 
cannot be kept confidential or secret. 
 
BENEFITS: We hope that the group sessions in this study will help you with issues you may be 
having with substance use and returning to the community from incarceration. However, we 
cannot guarantee that these sessions will have a positive effect or any effect at all. In 
participating, however, you are helping us gather information that could potentially improve the 
lives of individuals who have had similar experiences as you. You may also find that the group 
discussions may help you think about some issues in new and more useful ways. You may feel 
empowered by having the opportunity to share your stories, relate to others and gain a voice that 
can be used to help your community. 
 
ALTERNATIVES: Participating in this study is completely voluntary. It is your choice to 
participate in this study and all of its components. Choosing not to be part of the study will not 
involve any penalty or loss of benefits to you. Your participation or nonparticipation in this study 
will not have any effect on your parole, parole decisions, or your relationship with providers in 
the community, the University of Illinois at Urbana-Champaign or NDRI. It will not have any 
effect on the services provided to you at NJCRI.    
 
CONFIDENTIALITY:  To make sure that your privacy and confidentiality are protected, your 
name will not appear on any records or results. We will ask you for contact information (e.g., 
phone number, address) so that we can reach you to schedule follow-up interviews, but that 
information will be kept in a locked file cabinet in the project manager’s office. There will be a 
code number placed on all of the documents related to your interviews and the urine screens and 
you will use a code name during the interviews and group sessions. Only the project manager 
and Dr. Benoit will have access to the only document that links your name to your code number. 
Your comments will be kept confidential. Only researchers working on this study will have 
access to the information you provide, and they will know only your code name and number. 
Faculty, students, and staff at the University of Illinois who may see your information will 
maintain confidentiality to the extent of laws and university policies. Things that you say 
throughout the study will be reported in ways that will protect your identity. If we use specific 
things you say, we will not refer to you by name or number. For example, we might report that 
during one group session, "four people mentioned needing help finding housing."  
 
Once the study is completed, other researchers may ask to use the data. Sharing data is an 
important way to create opportunities for new discoveries. Thus we will make every effort to 
make the data available to others, but only if we believe your identity and privacy are protected. 
In order to share the data, we will require an agreement that provides for the following 
conditions at minimum: (1) a commitment to use the data only for research purposes and not to 
identify any individual participant; (2) a commitment to secure the data using appropriate tools 
and computer technology; and (3) a commitment to destroy or return the data after analyses are 
completed. We will remove all personal identifiers from the data before we will allow it to be used 
by other researchers.  
 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

4 
 
 
 
 
 
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Initials 
 
To help us protect your privacy, we obtained a Certificate of Confidentiality from the National 
Institutes of Health. With this Certificate, researchers cannot be forced to disclose information 
that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, 
administrative, legislative, or other proceedings. We will use the Certificate of Confidentiality to 
resist any demands for information that would identify you, with the following exceptions:  
1) The certificate cannot be used to resist a demand for information from personnel of the agency 
sponsoring the project and that will be used for auditing or program evaluation of agency-funded 
projects.  
2) You should understand that a Certificate of Confidentiality does not prevent you or a member 
of your family from voluntarily releasing information about yourself or your involvement in this 
research.  
3) If you give another person or organization your written permission to receive research 
information, then we may not use the Certificate to withhold that information.  
4) Mandated reporting of ongoing child maltreatment or imminent danger. 
 
All project staff will be trained in how to protect confidentiality and will sign a pledge of 
confidentiality. Utmost care will be taken when contacting participants about enrollment and 
participation.  Only study staff will talk with you directly unless you ask another authorized staff 
person to leave a message. In general, we will not tell anyone any information about you. When 
this research is discussed or published, no one will know that you were in the study.   
 
You must also be warned that peers who participate in your Community Wise group will learn 
information about you that you choose to share in the group.  Group participants will make a 
pledge in the first group meeting to maintain confidentiality. While we hope that people will 
abide by this pledge, it is possible that group members will share information about you with 
other individuals.  
 
FINANCIAL COSTS/PAYMENTS TO THE PARTICIPANT: You will not receive 
payments for the weekly group discussions. However, you will receive compensation for each 
interview activity you participate in, ranging from $10 for 30 minutes and $20 for 90 minutes 
depending on the interview and the group you will be in. You have the opportunity to receive a 
minimum of $157.50 to a maximum of $187.50 if you are eligible and choose to participate in all 
possible research interviews over the period of 5 months.  
 
RIGHT TO REFUSE OR WITHDRAW:  Your participation is voluntary. You may refuse to 
participate, or stop participating at any time, without any penalty or loss of benefits, and without 
any impact on past or future incarceration. You have the right to refuse to answer any question or 
participate in any aspect of the study. Additionally, we have the right to dismiss you from the 
study, including the group sessions, at any time. Finally, if you decide to stop participating, you 
may request that we destroy your data at any time during the study. At the end of the study we 
will destroy all identifying data and we will no longer be able to tell what data belongs to whom. 
We will keep group session voice recordings indefinitely and that is the only part of the data you 
may not request to be destroyed because it has data from other participants included in the 
sessions. 
 
CONTACTS:  If you have questions or suggestions about the study or the procedures, you may 
contact Dr. Benoit at (212) 845-4425 (benoit@ndri.org) or Dr. Liliane Windsor at (217) 300-
1782 (lwindsor@illinois.edu).  If you feel you have not been treated according to the 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

5 
 
 
 
 
 
__________ 
 
 
Initials 
 
descriptions in this form, or if you have any questions about your rights as a research participant, 
including questions, concerns, complaints, or to offer input, you may call the Office for the 
Protection of Research Subjects (OPRS) at 217-333-2670, e-mail OPRS at irb@illinois.edu, or 
contact NDRI's Research Integrity Officer, Lisa Bernhard at (212) 845-4567. 
 
 
 
 
 
 
 
I have read this entire form, or it has been read to me, and I understand it completely. All 
of my questions regarding this form or this study have been answered to my complete 
satisfaction. I agree to participate in this study, Community Wise.  
 
Participant Name: _____________________________________________________   
Participant Signature: ___________________________________           Date:  ________________ 
Researcher Signature: ___________________________________       Date: _______________ 
 
 
 
CONSENT TO AUDIO RECORD PARTICIPANT:  We are asking your permission to make 
audio recordings of the weekly group sessions that you will be participating in as part of this 
study. The recording(s) will be used for data analysis by the research team and will not be 
disseminated.  
 
The recording(s) will include the voices of you, your fellow participants and the group facilitator. 
We will ask you not to use real names for anyone you talk about or talk to during the group 
session. The group facilitator will remind you of this rule during the group sessions.  If you 
accidentally use your real name, or someone else’s real name, the interviewer will edit the name 
out of the audio file before submitting it for analysis. The recording(s) will be stored in a 
password protected server with no link to your real identity. We will keep the audio recordings 
indefinitely for possible further data analysis. 
 
If you do not consent to allowing yourself to be audio recorded during the group sessions, you will 
not be able to participate in this study. Please check your corresponding choice: 
 
 
 
I consent to having myself audio recorded during this study 
 
 
I refuse to consent to having myself audio recorded during this study 
 
 
 
Signature:    _________________________________       Date:  _____________________ 
CONSENT TO BE CONTACTED IN JAIL OR PRISON TO COMPLETE THE 
FOLLOW-UP IN CASE OF RE-INCARCERATION 
 
In the event you are re-incarcerated, we would like your permission to attempt to find you and 
obtain permission from the appropriate authorities to complete the follow-up interview while you 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

6 
 
 
 
 
 
__________ 
 
 
Initials 
 
are incarcerated.  Note that this means we will need to disclose to the relevant authorities that 
you are a participant in the current study. We will only give them a general description of the 
study (e.g., “a health study”) and no personal information about you will be disclosed other than 
that you are a study participant. Note we will only conduct the data collection during 
incarceration if the relevant authority agrees to grant us complete privacy and confidentiality of 
the data that we will collect from you.  
 
Please check your corresponding choice: 
 
 
I consent to study staff attempting to contact me in the event I am re-incarcerated so that I 
can complete the study follow-ups while incarcerated. 
 
 
I refuse to consent to study staff attempting to contact me in the event I am re-incarcerated 
so that I can complete the study follow-ups while incarcerated. 
 
 
Signature:    _________________________________       Date:  ____________________ 
 
 
CONSENT TO BE PHOTOGRAPHED AT BASELINE:  
 
We are asking your permission to take a digital photograph of you today. Your photo will assist 
us with finding you in case we lose touch during follow-ups.  The photo will be in a master key 
file along with your name and contact information. The outreach worker, project coordinator, 
and principal investigators will be the only people with access to your photo. These information 
will be used to help outreach workers to recognize you on the streets. You may refuse to take 
your photo without penalty. You may also ask us to destroy your photo at anytime by asking any 
member of the research team to do it.  
 
Please check your corresponding choice: 
 
 
I consent to study staff to take my photo. 
 
 
I refuse to consent to study staff to take my photo. 
 
 
 
Signature:    _________________________________       Date:  ____________________ 
 
 
CONSENT TO ADD YOUR CONTACT INFORMATION TO THE COMMUNITY WISE 
COURTESEY GROUP CONTACT LIST 
 
If you are randomized to the short version of the intervention or if you are unable to attend your 
group meetings for any reason, you can have the opportunity to participate in the full 
intervention after you complete the study, 5 months from now. You will not be paid to 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

7 
 
 
 
 
 
__________ 
 
 
Initials 
 
participate in these groups and there is not transportation reimbursement.  Please check your 
corresponding choice: 
 
 
I consent to study staff to add my contact information to the Community Wise courtesy 
group list. They will contact me 5 months from now to offer me the opportunity to complete the 
full intervention. 
 
 
I am not interested in the courtesy group. 
 
CONSENT TO ADD YOUR CONTACT INFORMATION TO THE COMMUNITY WISE 
ALUMNI GROUP 
 
Please check your corresponding choice: 
 
 
I consent to study staff to add my contact information to the Community Wise.alumni 
group so that I can have the opportunity to stay involved in community projects with my peers. 
 
 
I am not interested in the Community Wise alumni group. 
 
CONSENT TO ADD YOUR CONTACT INFORMATION TO A FUTURE STUDIES 
RECRUITMENT LIST 
 
Please check your corresponding choice: 
 
 
I consent to study staff to add my contact information a recruitment list for future studies. 
 
 
I am not interested in being contacted about future studies. 
 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

This questionnaire will be entered into REDCap The clinical screen will be completed by /he RA 
directly in REDCap. 
Clinical Screen Consent 
Total administration time: 32 minutes 
Screening Script and Documentation of Consent 
I would like to tell you about a research study taking place at NJCRI. This research study is 
being conducted by the University of Illinois at Urbana-Champaign and by the National 
Development and Research Institutes, Inc. It was funded by the National Institute on Minority 
Health and Health Disparities. We are evaluating a new program called Community Wise, which 
is expected to prevent substance use among people returning from incarceration to communities 
in Essex County. We are testing several forms of Community Wise, ranging from 6 to 15 weekly 
group meetings that will take place at NJCRI. We will also ask you to complete a few research 
interviews, for which you will be paid, over a period of about 5 months. 
If you are interested, the first step is to answer a few questions to see if you might be eligible to 
participate. We call this a clinical screen and will ask you about your demographic background 
and mental health. This will take up to 32 minutes. Your name will not appear with any of these 
answers and your answers will not be available to staff of NJCRI. The researchers will be the 
only ones to have access to the information, however in the event that other faculty, students, and 
staff see your information, they will maintain confidentiality to the extent of laws and university 
policies. Identifying information will not be published or presented. You can refuse to answer 
any of the questions or stop participating at any time. If you agree to complete the screening, we 
will include the information you give us in our database and use it in the study's analysis whether 
you are found to be eligible or not. Your identifying information (e.g., name, address) will not be 
included with the data and it will be destroyed once data collection is completed. You may 
request that we destroy all of your information at any time during the study by notifying the 
project director or the principal investigators. After the study is completed we will destroy all 
identifying information and we will no longer be able to tell what information belongs to whom. 
To help us protect your privacy, obtained a Certificate of Confidentiality from the National 
Institutes of Health. With this Certificate, researchers cannot be forced to disclose information 
that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, 
administrative, legislative, or other proceedings. We will use the Certificate of Confidentiality to 
resist any demands for information that would identify you, with the following exceptions: 
1) The certificate cannot be used to resist a demand for information from personnel of the agency
sponsoring the project and that will be used for auditing or program evaluation of agency-funded
projects.
2) You should understand that a Certificate of Confidentiality does not prevent you or a member
of your family from voluntarily releasing information about yourself or your involvement in this
research.
University of Illinois at Urbana-Champaign 
Institutional Review Board 
Approved March 26, 2018 
Expires March 25, 2019 
IRB #16574 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

1 
 
 
 
 
 
__________ 
 
 
Initials 
 
 
 
 
 
 
 
 
NAME OF LEAD RESEARCHERS:  Dr. Liliane Windsor, MSW and Dr. Ellen Benoit 
 
RESEARCH STUDY: We invite you to participate in a research study that seeks to evaluate 
Community Wise, a new program seeking to reduce substance use. We want to develop the best 
program we can by identifying and keeping only the activities that work to reduce substance use. 
To decide if you want to take part in this study, you need to know about its risks and benefits. I 
will go over this informed consent form with you. Once all your questions have been answered, I 
will ask you if you want to participate in the study. If you want to participate, you and I will sign 
this document.  You will get a copy of it.  
 
This research is confidential. The research records will include some information about you but 
this information will be stored in such a manner that will keep your identity separate from your 
responses.  Some of the information collected about you will include your name, address and 
phone number. You will also be asked some personal questions and to share some of the 
personal experiences you’ve had. For example, questions and discussions may relate to mental 
health issues, substance use or experiences you’ve had in Essex County since your release. 
Please note that we will limit access to the research data and keep it stored in a password secured 
online server. 
 
PURPOSE:  The purpose of this research study is to refine the Community Wise program so 
that it is as efficient as it can be. This study seeks to test if three different components of 
Community Wise reduce substance use. 
 
DURATION:  If you agree to participate in this study you will complete up to 9 research 
interviews (each lasting between 30 minutes and 90 minutes) and attending up to 15 weekly 
group meetings (2 hours each). It will take approximately 5 months to complete the meetings and 
all of the interviews.  
 
PROCEDURES: If you agree to participate, we will ask you to take part in 15 weekly 
group sessions (approximately 2 hours each) led either by a trained facilitator where you 
will meet with other people in Essex County who have had similar experiences as you. Your 
participation in the study will take approximately 5 months. In these groups, you and the 
other group members will talk about your feelings and experiences. Examples of discussion 
topics include racism, sexism, classism, mental health issues, substance use, incarceration, and 
your relationship with your community. You may also learn tools that you can use to improve 
your health. Note that this will be an open group, thus you may see the same people or new 
people in each group session. The group conversations will be voice recorded. You will use your 
codename and no identifying information about you will be included in the recording. You must 
consent to be audio recorded in order to participate in this study. We will ask you to make a 
pledge to respect the privacy of the session, we hope everybody will abide by this pledge but 
Informed Consent to Participate 
Community Wise 
 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

2 
 
 
 
 
 
__________ 
 
 
Initials 
 
please understand that we can’t guarantee that some group members won’t reveal 
information about you to others after the session is over. 
 
In addition to attending these group sessions, your participation in this study will involve the 
following interviews:  a brief phone talk, an individual interview, up to 6 monthly computer 
interviews, and possibly a focus group (for a total of 9 research interviews). Each interview will 
include a urine drug screen, meaning we will ask you for a sample of urine and will test it for 
certain substances. In the baseline interview we will ask your permission to take a digital photo 
of you. You may refuse to take the photo without penalty. The information you give us, 
including results from saliva screens and photo, will be kept private. There are no consequences 
to having positive or negative urine drug screens and no one outside of this study, including 
parole officers or the providers at NJCRI, will be informed of the results. Your answers to any 
questions that will be asked throughout this study will be completely confidential. If, at any time, 
you do not want to answer a question or participate in a certain part of the study, you may refuse 
without penalty. You should know that some of the interviews include questions about suicide. If 
we find that you are thinking about killing yourself, your group facilitator will be notified and 
asked to offer you assistance. 
PARTICIPANTS:  631 men will be recruited from Essex County, NJ. All participants will be 
adults with a history of substance use disorder transitioning from incarceration into Essex 
County.  
 
RISKS/DISCOMFORTS: Discussing issues related to mental health, substance use, 
incarceration and other personal experiences can be painful and uncomfortable. You always have 
the right to stop participating in the research study and program at any time without penalty. If 
you feel upset during any part of the study, for example, during the group sessions or during an 
interview, you may stop participating. At that time we can let you speak with our project 
manager or a trained counselor at NJCRI. If necessary, we will refer you to affordable services in 
the community that can help address emotional issues that may arise during your participation in 
this study.  
 
While we will take several steps to protect your identity and the confidentiality of your responses 
(see details below), there is a small chance that confidentiality may be lost. For instance, data 
could be stolen while the researcher transports your consent form to the office.  We will take 
every precaution to prevent this from happening, including the use of a locked file and password 
protected secured server to safeguard your information. The only instance where the 
researcher will reveal information you provide is if during the interview you tell us about 
child abuse or about yourself or someone else being in danger that is about to happen.  In 
these circumstances, the researcher will notify the appropriate authorities. If you begin to 
reveal this information during the interview, the researcher will remind you that such information 
cannot be kept confidential or secret. 
 
BENEFITS: We hope that the group sessions in this study will help you with issues you may be 
having with substance use and returning to the community from incarceration. However, we 
cannot guarantee that these sessions will have a positive effect or any effect at all. In 
participating, however, you are helping us gather information that could potentially improve the 
lives of individuals who have had similar experiences as you. You may also find that the group 
discussions may help you think about some issues in new and more useful ways. You may feel 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

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Initials 
 
empowered by having the opportunity to share your stories, relate to others and gain a voice that 
can be used to help your community. 
 
ALTERNATIVES: Participating in this study is completely voluntary. It is your choice to 
participate in this study and all of its components. Choosing not to be part of the study will not 
involve any penalty or loss of benefits to you. Your participation or nonparticipation in this study 
will not have any effect on your parole, parole decisions, or your relationship with providers in 
the community, the University of Illinois at Urbana-Champaign or NDRI. It will not have any 
effect on the services provided to you at NJCRI.    
 
CONFIDENTIALITY:  To make sure that your privacy and confidentiality are protected, your 
name will not appear on any records or results. We will ask you for contact information (e.g., 
phone number, address) so that we can reach you to schedule follow-up interviews, but that 
information will be kept in a locked file cabinet in the project manager’s office. There will be a 
code number placed on all of the documents related to your interviews and the urine screens and 
you will use a code name during the interviews and group sessions. Only the project manager 
and Dr. Benoit will have access to the only document that links your name to your code number. 
Your comments will be kept confidential. Only researchers working on this study will have 
access to the information you provide, and they will know only your code name and number. 
Faculty, students, and staff at the University of Illinois who may see your information will 
maintain confidentiality to the extent of laws and university policies. Things that you say 
throughout the study will be reported in ways that will protect your identity. If we use specific 
things you say, we will not refer to you by name or number. For example, we might report that 
during one group session, "four people mentioned needing help finding housing."  
 
Once the study is completed, other researchers may ask to use the data. Sharing data is an 
important way to create opportunities for new discoveries. Thus we will make every effort to 
make the data available to others, but only if we believe your identity and privacy are protected. 
In order to share the data, we will require an agreement that provides for the following 
conditions at minimum: (1) a commitment to use the data only for research purposes and not to 
identify any individual participant; (2) a commitment to secure the data using appropriate tools 
and computer technology; and (3) a commitment to destroy or return the data after analyses are 
completed. We will remove all personal identifiers from the data before we will allow it to be used 
by other researchers.  
 
To help us protect your privacy, we obtained a Certificate of Confidentiality from the National 
Institutes of Health. With this Certificate, researchers cannot be forced to disclose information 
that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, 
administrative, legislative, or other proceedings. We will use the Certificate of Confidentiality to 
resist any demands for information that would identify you, with the following exceptions:  
1) The certificate cannot be used to resist a demand for information from personnel of the agency 
sponsoring the project and that will be used for auditing or program evaluation of agency-funded 
projects.  
2) You should understand that a Certificate of Confidentiality does not prevent you or a member 
of your family from voluntarily releasing information about yourself or your involvement in this 
research.  
3) If you give another person or organization your written permission to receive research 
information, then we may not use the Certificate to withhold that information.  
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

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Initials 
 
4) Mandated reporting of ongoing child maltreatment or imminent danger. 
 
All project staff will be trained in how to protect confidentiality and will sign a pledge of 
confidentiality. Utmost care will be taken when contacting participants about enrollment and 
participation.  Only study staff will talk with you directly unless you ask another authorized staff 
person to leave a message. In general, we will not tell anyone any information about you. When 
this research is discussed or published, no one will know that you were in the study.   
 
You must also be warned that peers who participate in your Community Wise group will learn 
information about you that you choose to share in the group.  Group participants will make a 
pledge in the first group meeting to maintain confidentiality. While we hope that people will 
abide by this pledge, it is possible that group members will share information about you with 
other individuals.  
 
FINANCIAL COSTS/PAYMENTS TO THE PARTICIPANT: You will receive $2.50 for 
each intervention weekly group discussions. You will receive compensation for each research 
interview activity you participate in, ranging from $10 for 30 minutes and $20 for 90 minutes. 
You have the opportunity to receive a maximum of $167.50 if you choose to participate in all 
possible research interviews over the period of 5 months.  
 
RIGHT TO REFUSE OR WITHDRAW:  Your participation is voluntary. You may refuse to 
participate, or stop participating at any time, without any penalty or loss of benefits, and without 
any impact on past or future incarceration. You have the right to refuse to answer any question or 
participate in any aspect of the study. Additionally, we have the right to dismiss you from the 
study, including the group sessions, at any time. Finally, if you decide to stop participating, you 
may request that we destroy your data at any time during the study. At the end of the study we 
will destroy all identifying data and we will no longer be able to tell what data belongs to whom. 
We will keep group session voice recordings indefinitely and that is the only part of the data you 
may not request to be destroyed because it has data from other participants included in the 
sessions. 
 
CONTACTS:  If you have questions or suggestions about the study or the procedures, you may 
contact Dr. Benoit at (212) 845-4425 (benoit@ndri.org) or Dr. Liliane Windsor at (217) 300-
1782 (lwindsor@illinois.edu).  If you feel you have not been treated according to the 
descriptions in this form, or if you have any questions about your rights as a research participant, 
including questions, concerns, complaints, or to offer input, you may call the Office for the 
Protection of Research Subjects (OPRS) at 217-333-2670, e-mail OPRS at irb@illinois.edu, or 
contact NDRI's Research Integrity Officer, Lisa Bernhard at (212) 845-4567. 
 
 
 
 
 
 
 
I have read this entire form, or it has been read to me, and I understand it completely. All 
of my questions regarding this form or this study have been answered to my complete 
satisfaction. I agree to participate in this study, Community Wise.  
 
Participant Name: _____________________________________________________   
Participant Signature: ___________________________________           Date:  ________________ 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

5 
 
 
 
 
 
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Initials 
 
Researcher Signature: ___________________________________       Date: _______________ 
 
 
 
CONSENT TO AUDIO RECORD PARTICIPANT:  We are asking your permission to make 
audio recordings of the weekly group sessions that you will be participating in as part of this 
study. The recording(s) will be used for data analysis by the research team and will not be 
disseminated.  
 
The recording(s) will include the voices of you, your fellow participants and the group facilitator. 
We will ask you not to use real names for anyone you talk about or talk to during the group 
session. The group facilitator will remind you of this rule during the group sessions.  If you 
accidentally use your real name, or someone else’s real name, the interviewer will edit the name 
out of the audio file before submitting it for analysis. The recording(s) will be stored in a 
password protected server with no link to your real identity. We will keep the audio recordings 
indefinitely for possible further data analysis. 
 
If you do not consent to allowing yourself to be audio recorded during the group sessions, you will 
not be able to participate in this study. Please check your corresponding choice: 
 
 
 
I consent to having myself audio recorded during this study 
 
 
I refuse to consent to having myself audio recorded during this study 
 
 
 
Signature:    _________________________________       Date:  _____________________ 
CONSENT TO BE CONTACTED IN JAIL OR PRISON TO COMPLETE THE 
FOLLOW-UP IN CASE OF RE-INCARCERATION 
 
In the event you are re-incarcerated, we would like your permission to attempt to find you and 
obtain permission from the appropriate authorities to complete the follow-up interview while you 
are incarcerated.  Note that this means we will need to disclose to the relevant authorities that 
you are a participant in the current study. We will only give them a general description of the 
study (e.g., “a health study”) and no personal information about you will be disclosed other than 
that you are a study participant. Note we will only conduct the data collection during 
incarceration if the relevant authority agrees to grant us complete privacy and confidentiality of 
the data that we will collect from you.  
 
Please check your corresponding choice: 
 
 
I consent to study staff attempting to contact me in the event I am re-incarcerated so that I 
can complete the study follow-ups while incarcerated. 
 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

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Initials 
 
 
I refuse to consent to study staff attempting to contact me in the event I am re-incarcerated 
so that I can complete the study follow-ups while incarcerated. 
 
 
Signature:    _________________________________       Date:  ____________________ 
 
 
CONSENT TO BE PHOTOGRAPHED AT BASELINE:  
 
We are asking your permission to take a digital photograph of you today. Your photo will assist 
us with finding you in case we lose touch during follow-ups.  The photo will be in a master key 
file along with your name and contact information. The outreach worker, project coordinator, 
and principal investigators will be the only people with access to your photo. These information 
will be used to help outreach workers to recognize you on the streets.You may refuse to take 
your photo without penalty. You may also ask us to destroy your photo at anytime by asking any 
member of the research team to do it.  
 
Please check your corresponding choice: 
 
 
I consent to study staff to take my photo. 
 
 
I refuse to consent to study staff to take my photo. 
 
 
 
Signature:    _________________________________       Date:  ____________________ 
 
University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574

University of Illinois at Urbana-Champaign 
Institutional Review Board
Approval Date: November 15, 2021 
IRB #16574