Piloting a Motivational Interviewing Shame-Resilience Training
Phase: NA
Conditions: Shame
Sponsor: University of New Mexico

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PROTOCOL TITLE: 
Piloting a MI Informed Shame Resilience Intervention 
PRINCIPAL INVESTIGATOR: 
Jennifer Hettema  
Department of Family and Community Medicine  
ADMINISTRATIVE CONTACT:  
Cade Arnink 
clarnink@salud.unm.edu 
Department of Family and Community Medicine 
 
 
VERSION NUMBER: 
Version 3.4.0 
DATE: 
2/28/20 
REGULATORY FRAMEWORK: 
Please indicate all that apply: 
 
DOD (Department of Defense) 
 
DOE (Department of Energy) 
 
DOJ (Department of Justice) 
 
ED (Department of Education) 
 
EPA (Environmental Protection Agency) 
 
FDA (Food and Drug Administration) 
 
HHS (Department of Health and Human Services) 
 
VA 
 
Other:       
 
FUNDING: 
The protocol is awaiting funding. An UNM HSC RAC Grant has been applied for.  
 
CLINICAL TRIALS 
Is this a clinical trial per the NIH definition of a Clinical Trial?   
 Yes   
 No 
NIH Definition of a Clinical Trial:  
A research study in which one or more human subjects are prospectively assigned to 
one or more interventions. An "intervention" is defined as a manipulation of the subject 
or subject’s environment for the purpose of modifying one or more health-related 
biomedical or behavioral processes and/or endpoints. Examples include: drugs/small 
molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); 
delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change 
health-related behavior (e.g., diet, cognitive therapy, exercise, development of new 

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habits); treatment strategies; prevention strategies; and, diagnostic strategies (which 
may include placebo or other control) to evaluate the effects of those interventions on  
health-related biomedical or behavioral outcomes.  
Use the following four questions to determine the difference between a clinical 
study and a clinical trial:        
 
Does the study involve human participants? 
 Yes   
 No 
 
Are the participants prospectively assigned to an intervention? 
 Yes   
 No 
 
Is the study designed to evaluate the effect of the intervention on the 
participants? 
 Yes   
 No  
 
 Is the effect being evaluated a health-related biomedical or behavioral outcome? 
 Yes   
 No 
 
Note that if the answers to the 4 questions are yes, your study meets the NIH definition 
of a clinical trial, even if…  
• 
You are studying healthy participants 
• 
Your study does not have a comparison group (e.g., placebo or control) 
• 
Your study is only designed to assess the pharmacokinetics, safety, and/or 
maximum tolerated dose of an investigational drug 
• 
Your study is utilizing a behavioral intervention 
 
If yes to all 4 questions, please confirm that the research team is familiar with and 
agrees to comply with the investigator requirement to register the study on the 
ClinicalTrials.gov database. Additionally, the approved consent document(s) must be 
uploaded to the ClinicalTrials.gov database    
 Yes   
 No  
For any assistance with registration of your trial or the requirements, please contact 
HSC-CTSCResearchConcierge@salud.unm.edu  
 
  
 
 

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1. Objectives 
1.1 Shame is an emotion that can have significant negative impacts on health outcomes, 
including engagement in care. Feelings of shame are commonly experienced with 
stigmatized behaviors, such as substance misuse, and may be particularly strong among 
pregnant women who misuse substances. Rates of opioid misuse during pregnancy are 
dramatically rising, particularly in New Mexico, leading to negative health outcomes for 
mothers and fetuses. Shame has been found to decrease these patients’ willingness to 
attend and engage in care. Although a theoretical model is available to guide 
interventions to reduce shame, it has not been tested empirically. In the current study, 
we seek to evaluate the preliminary effectiveness and feasibility of a brief Shame 
Resilience Intervention among women seeking care in UNM’s Milagro program, a 
prenatal medical clinic for opioid using pregnant women. This research has the potential 
to significantly improve public health by generating a tool to reduce barriers to care. 
  
The specific aims of this project are as follows: 
  
Aim 1: Assess the feasibility of study methods (recruitment and retention), 
intervention fidelity, and treatment satisfaction. 
We will track rates of participation in the study as well as retention at follow-up. All 
intervention sessions will be audio-recorded and rated using the Motivational 
Interviewing Treatment Integrity tool. Participants will provide quantitative ratings of 
treatment satisfaction. In addition, a random sample of ten participants will be invited to 
complete qualitative interviews on treatment satisfaction. 
Hypotheses: The study sample will be recruited during the study timeline and a >85% 
follow-up rate will be attained. Coded intervention samples will meet benchmarks for 
proficiency on a validated treatment fidelity rating tool. Participants will report high 
satisfaction with the intervention. 
  
Aim 2: Examine the preliminary effectiveness of the intervention on well-being, 
shame, shame resilience, and treatment attendance. We administer a battery of 
validated questionnaires at baseline and 1-month follow-up. We will analyze within-group 
changes in effectiveness outcome variables. Standardized measures of effect size will 
be calculated. 
Hypotheses: The intervention will lead to significant improvements in well-being, shame, 
shame resilience, and treatment attendance. 
2. Background 
2.1 While the emotion of guilt entails “feeling bad” about a choice, shame involves the 
internalization of this emotion to a feeling of “I am bad.”1 While both emotions likely serve 
an adaptive function in helping individuals to modify behaviors,2 because of its 
internalized nature, shame is also often associated with negative behavioral health 
outcomes,3 and, based on our own preliminary data, lower overall well-being.4Specific to 
the current application, individuals who misuse substances have been found to have 
high levels of shame5 and women often experience shame during pregnancy,6 
particularly when there is a history of sexual or other trauma.7  The stigma associated 
with drug use during pregnancy is particularly high high8 and leads to extensive shame 
among affected patients.9 
Although it is difficult to estimate the prevalence of substance misuse during pregnancy 
because of the impact of shame on willingness to report accurately, available data 
suggests that more 5% of women report use drugs during pregnancy.8 Nationally, more 

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than ten thousand infants are born to opioid addicted mothers each year.10 New Mexico 
is among the highest with rates of pregnant opioid misuse exceeding 2.5 per 1000 
deliveries.11 The impact of substance use on the health of pregnant women and their 
fetuses is a significant public health concern.9 Opioid use during pregnancy can lead to 
preterm births, poor fetal growth, longer hospital stays, and birth defects.12  Opioid misuse 
during pregnancy can also lead to neonatal abstinence syndrome (NAS).13 NAS is a drug 
withdrawal syndrome that affects opioid-exposed infants shortly after birth. NAS can lead 
to respiratory complications, feeding difficulties, and seizures and accounts for upwards 
of half of all neonatal intensive care hospital unit stays. 14 
Shame has been found to function as a major barrier to care across a range of health 
behaviors.15 This effect is especially evident in populations of women dealing with 
stigmatized health issues, such as HIV/AIDS, depression, eating disorders, and 
domestic violence.16 Shame has been found to decrease the chance that patients will 
attend care and disclose unhealthy behavior to practitioners.10 For women who use 
substances during pregnancy, shame has been found to negatively impact participation 
and engagement in care, as it motivates efforts to avoid detection by not attending care, 
limits disclosure to providers, and decreases acceptance of front line recommended 
medication assisted treatments.9,10 
Despite the well documented impacts of shame on health outcomes, little empirical work 
has investigated interventions that may minimize shame or its negative impacts on 
health. Intervention development and evaluation could be guided by the prominent 
Shame Resilience Theory.17 Shame Resilience Theory posits that four behaviors may 
minimize the negative impact of shame on health outcomes, by improving understanding 
and encouraging vulnerability.17 These include: 
1)    Seeking to Understand Shame - Shame is an emotion that is often mistaken for other 
emotions. Shame can be difficult to identify and process, as the feelings of shame is 
often misattributed to other emotional processes.18  This behavior involved identifying 
shame as well as shame triggers. 
2)    Practicing Critical Awareness – This behavior serves to improve understanding and 
involves efforts to normalize and contextualize the thoughts coming from the shame 
response and process them. 
3)    Reaching Out – This behavior involves disclosing shame to others and asking for 
empathy from a support network. 
4)    Speaking Shame – This behavior involves speaking openly about the experience of 
shame and leading to desensitization and externalization. 
Shame Resilience Theory was developed through qualitative interviewing techniques17 
and has not been translated into a replicable behavioral health intervention or 
qualitatively evaluated to determine its impact on health outcomes. 
One means by which Shame Resilience Theory could be translated into 
clinical practice is through a widely utilized and evidence-based 
communication strategy known as Motivational Interviewing (MI).19 20 MI is 
a collaborative, goal-oriented style of communication with particular 
attention to the language of change. It is designed to strengthen personal 
motivation for and commitment to a specific goal by eliciting and exploring 
a person’s own reasons for change within an atmosphere of acceptance 
and compassion.21 MI is often implemented as a brief intervention in 
medical settings.22 In the current study, we seek to use MI as a 

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communication strategy to encourage behaviors thought to minimize the 
impact of shame on health as posited by Shame Resilience Theory. The 
goal of the current research is to evaluate the feasibility and preliminary 
effectiveness of an MI-Guided Shame Resilience intervention with 
pregnant, opioid misusing women attending UNM’s Milagro Treatment 
Programs. Identifying an effective and scalable intervention for managing 
shame in these settings, holds promise for significantly improving 
engagement in care, and consequent mother and fetus outcomes. 
2.2 The PI has dedicated her career to the development and evaluation of brief 
applications of MI, including a clinical trial focused on risky alcohol use in a 
recently completed K23 award (K23 AA020865;) and another soon to be 
completed multi-site clinical trial focused on unintended pregnancy prevention 
from an R01 level grant (TP2AH000028;). The current proposal bridges the PI’s 
background in addictions and pregnancy and targets a new health behavior in 
shame resilience. Pilot data demonstrating feasibility and initial efficacy will be 
needed in order to secure a larger grant. Co-Investigator Leeman is the Medical 
Director of the Milagro Clinic. He will shortly be conducting a sabbatical at X in 
which he will be focusing on treatments for shame and trauma with this clinical 
population. He has previously worked on treating infants who were exposed to 
substances during pregnancy as well as researching treatment programs of 
pregnant women with past trauma and substance abuse. Project Coordinator, 
Cade Arnink, also has extensive experience relevant to shame resilience and 
motivational interviewing, making him ideal to carry out the study intervention and 
evaluation aspects of the proposal. Mr. Arnink recently graduated with honors 
from UNM’s psychology department, where his senior thesis, which is currently 
under review for publication4 found a significant association between shame 
resilience and well-being, providing support for the theoretical mechanisms 
underlying shame resilience theory. Mr. Arnink has worked extensively with the 
PI for the past year and is skill MI interventionist. 
2.3. 
Mr. Arnink recently graduated with honors from UNM’s psychology 
department, where his senior thesis, which is currently under review for 
publication4 found a significant association between shame resilience and well-
being, providing support for the theoretical mechanisms underlying shame 
resilience theory. 
2.4. 
Based on the existing literature this research is the next reasonable step 
in establishing the efficacy of the shame resilience theory. To our knowledge this 
is the first shame resilience intervention to be established and examined. This 
project will add to the current literature by expanding our knowledge of shame 
and by providing quantitative evidence to the leading theory of managing shame. 
Continuing research with a pilot study is important to evaluate and formulate the 
intervention as well as how the intervention is administered. Participant feedback 
will be important in finalizing the intervention for a future clinical trial. A smaller 
group will allow for both quantitative and qualitative data. Allowing us to 
incorporate measurable changes and participant suggestions. 
3. Study Design 
3.3. 
This project will use a mixed methods research design to determine the 
feasibility and impact of a brief, MI-Guided Shame Resilience intervention on 
well-being, shame intensity, shame resilience, willingness to communicate, and 

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treatment attendance. Data will be collected in person by survey and interview at 
baseline and either in-person or over the phone at 1-month follow-up. Although a 
controlled, between group design was considered for the current study, in 
consultation with Co-Investigators and Milagro providers and staff, we elected to 
conduct a within groups evaluation, to maximize our ability to refine and 
investigate the acceptability of the intervention. Within group changes in 
outcomes can be used to estimate effect sizes for a larger trial. 
4. Inclusion and Exclusion Criteria 
4.3. 
20 Milagro participants will be recruited to participate in the intervention 
and follow-up. Participants will be screened and consented during regular 
medical visits at the South-East Heights clinic and the Family and Community 
Medicine (FCM) Clinic at 2400 Tucker Ave. NE. During recruitment, all patients 
attending the clinic for standard services will be approached by a research team 
member in the waiting or exam room. The research team member will ask the 
patient if they are interested in learning whether they are eligible to participate in 
a study.  
4.4. 
Inclusion criteria: Study participants will be Milagro patients, engaged in 
medication assisted treatment, at least 18 years of age, can read and speak 
English, are willing to be contacted for follow-up, are not incarcerated, and are 
within the first or second trimester of pregnancy  
4.3 We will be including pregnant women in the sample. 
4.5. 
Exclusion criteria: The study will not enroll non-English speaking Milagro 
patients, patients with obvious cognitive impairments, or those with the inability to 
provide informed consent.  
5. Number of Subjects 
5.1 This is not a multi-center study.  
5.2 We will recruit participants at the South-East Heights Clinic and the FCM 
Clinic 
We will recruit 20 participants for the pilot study.  
5.3 The sample size for this pilot study is based on the criteria set forth by Dr. 
Richard Browne in 1995. The South-East Heights and FCM clinics provides 
health services to the Milagro population. 
6. Study Timelines 
 
 6.1 Individual participants will participate for a duration of one month. After the 
initial encounter we will follow-up with participants at the end of a one-month 
period. The duration for enrolling all subjects will be ten months, the duration for 
investigators to complete the analysis will be twelve months. 
7. Study Endpoints 
7.1 The primary endpoint for the study is December 2020, the secondary 
endpoint is February 2021 

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7.2 
There are no safety endpoints to report. 
7.3. 
 There are no exploratory endpoints to report.  
8. Research Setting 
8.1 Research will be conducted in University of New Mexico South East Heights 
Family Medicine Clinic and the FCM Clinic. 
8.2 Potential subjects will be identified and recruited at the South East Heights 
Clinic and FCM Clinic. As described in section 4.1, recruitment strategy 1 will 
involve inviting patients at the clinic to complete an eligibility screening form.   
Research procedures will be performed at the South East Heights Clinic and 
FCM Clinic. Including: recruitment, screening, consent, baseline assessment, 
and completion of brief intervention. Follow-up interviews will be conducted either 
via telephone or in person. Analysis will be conducted in offices at the University 
of New Mexico Health Sciences Center.  
8.3. 
 We will not have a formal community advisory board, although 
throughout the project period, we will engage community groups and advocacy 
organizations for their support and input.      
8.4. 
 NA, no research will be conducted outside of UNM HSC or its affiliates. 
9. Resources Available 
9.1 
The PI and study staff have extensive experience which prepares them to 
conduct the proposed study. 
Principal investigator Jennifer Hettema, PhD, is an associate professor in the 
department of family and community medicine. She works closely with the 
research management team and is currently the PI on the TEMPO study, and as 
such has experience managing a multidisciplinary research team delivering a 
brief intervention using motivational interviewing. This research question is of 
high clinical relevance to her and will lay the groundwork for future research into 
establishing programs of care. Dr. Hettema will supervise all study activities.  
Lawrence Leeman, MD, MPH, will serve as a co-investigator and clinic liaison. 
Dr. Leeman is the medical director of the maternal child health program for the 
department of family and community medicine. Dr. Leeman has a proven track 
record for the coordination and care of maternal health research and patients. He 
has been the lead investigator on several studies that promote maternal health. 
Dr. Leeman will be responsible for medical-related issues should they arise.  
Cade Arnink, BS, will serve as research coordinator for the current project. Mr. 
Arnink is a research coordinator in the Department of Family and Community 
Medicine at the University of New Mexico Health Science Center. Mr. Arnink has 
a proven track record in the coordination, data collection, and analysis of shame 
research. He has participated in several studies that recruit, provide a brief 
intervention, and follow-up participants. Mr. Arnink currently serves as a research 
coordinator on the TEMPO study. This brief intervention research study includes 
motivational interviewing and multiple follow-up surveys, both telephone and in-
person. Mr. Arnink has also mentored family medicine residents in the UNM 
Department of Family and Community Medicine in motivational interviewing 
related activities. 

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9.2 
All medical procedures will be conducted as part of standard care by site 
clinicians. However, Dr. Leeman is a licensed physician and will be responsible 
for any emergent medical decision-making associated with the project. 
9.3 
Recruitment Feasibility: There are 250 potential subjects within the 
Milagro population. We need to recruit 8 percent over a ten-month period.  
Time Committed: The project is anticipated to take one year to complete.  
Facilities: The University of New Mexico Health Sciences Center (HSC) is the 
largest academic health complex in the state of New Mexico and has the only 
medical school in the state. With its internationally recognized track record for 
conducting cutting-edge and community engaged health research, the UNM HSC 
is an ideal setting for a research project of this size and scope. The UNM HSC 
provides extensive support for the management of projects including 
infrastructure, grants and contract management, IT and library service, and 
educational opportunities for faculty and staff. The project offices will be housed 
in the HSC Department of Family and Community Medicine (FCM). FCM is 
currently ranked 3rd nationally in federal funding among all departments of 
Family Medicine. The department is known for our commitment to increasing 
strategies to eliminate barriers to health equity. FCM will provide office space, 
desktop computers, grants management and other administrative support to 
facilitate the success of the project. The Department Chairman, David Rakel, MD 
is highly supportive of this project. 
Availability of Medical or Psychological Resources: All participants will have full 
access to all standard care services at South-East Heights Clinic. 
Process to Ensure Protocol Knowledge among Study Personnel: All study staff 
and investigators, will be asked to read this IRB proposal in its approved form. 
Weekly team meetings will be held for staff to review study procedures. All study 
personnel will complete required CITI training. 
10 
Prior Approvals 
10.1 
We obtained a letter of support from Dr. Lawrence Leeman, the Medical 
Director of the Milagro population. Which will be included with our supporting 
documents. 
10.2 
We have included the Departmental Review Form with our supporting 
documents 
10.3 
Ionizing radiation is not included in this study. 
10.4 
Biological specimens and drug attachment are not included in this study.  
11 
Multi-Site Research 
11.1 
This is not a multi-site research project. 
11.2 
Adverse events, problems, interim results, data and safety monitoring 
reports and study closure will be reported to the UNM HSC IRB 
11.3 
This is not an FDA regulated trial.  
12 
Study Procedures  
12.1 
There are no collaborating sites or investigators in this project.  

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12.2 The study procedures are described thoroughly below:  
Recruitment: Milagro patients presenting at the Southeast Heights and FCM 
Clinics will approached in the waiting room or an exam room following triage and 
asked if they would like to voluntarily screen for a confidential study. Patients 
who meet eligibility criteria will be informed about the study and their option to 
voluntarily participate in the study. Screening will be done through REDCap and 
completed screening forms will be maintained with other confidential study forms. 
Consent: Informed consent will be obtained from each participant before 
completing any research procedures. Each participant will read a document 
outlining the purpose and content of the research. Participants will fully 
understand what is expected of them throughout the research process. 
Participants will be made aware of potential risks, benefits, and incentives for 
participating in the initial meeting as well as the follow-up. During the consent 
process, phone numbers and other forms of contact information will be collected 
to perform the follow-up data collection. 
Baseline Assessment: Data will be entered directly into REDCap (Research 
Electronic Data Capture) software via a tablet device. REDCap is a secure, web-
based application designed to support data capture for research studies 
providing: 1) an intuitive interface for validated data entry; 2) audit trails for 
tracking data manipulation and export procedures; 3) automated export 
procedures for seamless data downloads to common statistical packages; and 4) 
procedures for importing data from external sources. REDCap is secure and 
HIPAA compliant and available for use to all UNM HSC faculty and staff.  
Baseline Assessment Questions can be found in the section on study forms. 
Questions are self-report and may be completed individually by participants or 
with the support of a study staff member. Questions will include demographic 
variables, including age and ethnicity. Contact and locator information will be 
gathered.  
Brief-Intervention: Twenty participants will receive a brief, MI-Guided Shame 
Resilience intervention. Participants will attend a one-on-one intervention with the 
research coordinator. The intervention will be 20-30 minutes and will be 
conducted in style consistent with MI. Participants will be invited to discuss their 
own experience with shame and how it affects them before moving into a 
collaborative discussion in which shame resilience strategies are introduced and 
practice. The interventionist will help guide the conversation and incorporate 
shame resilience into the participants' own life. 
All participants will receive the brief-intervention as there currently no alternative 
treatments or procedures for issues of shame.  
Follow-up Data Collection: Telephone or in-person follow-up surveys at one 
month after receiving the intervention. In-person follow-ups will occur at a 
patients’ scheduled visit to the clinic. Data collection will be surveys completed 
on a tablet device for privacy and security. If follow-up occurs over the phone, the 
interventionist will work with the participant to establish an adequate time, during 
the initial visit. 
12.3 
We are not collecting existing or prospective data. 

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12.4 
Participant recruitment, consent, baseline measurements, and 
intervention will occur at the South East Heights clinic. Participant follow-up will 
occur over the phone or at the South East Heights Clinic. Data analysis will occur 
at the department of Family and Community Medicine.   
12.5 
After completing the informed consent process participants will complete 
five instruments before the intervention to measure the preliminary effectiveness 
of the intervention. Participants will complete the instruments again during the 1-
month follow-up phone call.  
1.  
The Measure of Subjective Well-Being3031 is short, five-item survey with Likert 
response options for subjective quality of life based on positive mood, vitality, and 
general interest. The tool was developed by the World Health Organization and has 
strong psychometric characteristics. 
2.  
The Shame Inventory 32,33 is a two-part survey that looks measures an individual’s 
past month experience of shame. It provides an empirical measure for the extent and 
severity of overall shame experience and the severity of several possible shame events. 
Questions include items such as: How often do you typically experience shame? What is 
the intensity or severity of the shame you typically experience? To what extent does 
shame negatively affect your life? Response options are all on a 5-point Likert scale. 
3.  
The Shame Resilience Measure is a psychometrically valid measure examining 
healthy shame behaviors in response to potentially shame inducing events. Participants 
are asked to select from response options that are more or less consistent with the 
Shame Resilience Theory, including communication and self-compassion, negative self-
talk, and avoidance, on a 4-point Likert scale.34 
4.  
The Willingness to Communicate about Health34,35 is a survey made of 10 items 
that are rated on a 5-point Likert scale. It assesses individual’s willingness to 
communicate to both providers and non-providers about their health. High scores 
indicate a greater willingness to communicate. This scale is based off the Willingness to 
Communicate scale (WTC), a previously standardized scale, and demonstrated a 
Cronbach reliability coefficient of .91.   
5. 
The Trauma Checklist Adult39 (Modified) is a three part – self-report 
measure of symptomatic distress in adults arising from traumatic experiences. It 
measures aspects of post-traumatic stress as well as other symptoms found in 
some traumatized individuals.’s children and their families. In our analysis we are 
only interested in patient symptoms and are not asking them to report specific 
traumatic situations. Our modified checklist only includes the second and third 
part which asks about symptoms. 
    
 
13 Data Analysis 
13.3 
Descriptive statistics will be used to calculate rates of recruitment and retention, 
treatment fidelity scores, and quantitative treatment satisfaction. Detailed process notes 
regarding any unexpected study complications will be kept and analyzed using 
standardized qualitative methods.  Our qualitative analytic approach for open ended 
satisfaction questions will follow Gläser and Laudel’s framework for theory-driven 
qualitative content analysis to identify categories and patterns related to the main 
domains of the questions asked.36 Notes will be reviewed for systematic themes and 

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subthemes, and coded inductively. The extractions will be reduced, refined, 
summarized, and catalogued. To further explore patterns within each theme or sub-
theme, data will be examined and organized for coherence, and further interpretations 
will be developed. 
To address Aim 1: We will conduct a qualitative analysis to assess the feasibility of 
providing brief shame resilience training to the Milagro population. The feasibility of 
study methods and satisfaction with the intervention will be measured using the following 
measures. 
1.  
Recruitment Feasibility will include the number of patients approached, the 
proportion who agree to be screened, eligibility rates, and consent rates. 
2.  
Retention Feasibility will include rates of baseline completion, intervention 
completion, and follow-up rates at 1-month. 
3.  
Treatment Fidelity: Fidelity to the intervention will be measured by the MITI 
4.2.1.28 MITI is a one-pass behavioral coding system designed to measure treatment 
fidelity for motivational interviewing.  It can be used for clinician training or as a quality 
check in clinical trials.  The instrument has proficiency cut-points for a range of 
interventionist behaviors. 
4.  
The Treatment Satisfaction Questionnaire will measure treatment satisfaction 
using five, Likert style questions focused on quality and delivery.29 
5.  
The Treatment Satisfaction Interview will include an open-ended, interview-
guided discussion of treatment satisfaction. The interviews will be audio-recorded 
6.    
Treatment Attendance will be measured by comparing changes in past month 
proportion of Milagro appointments attended prior to and after the intervention, based on 
a medical record abstraction. 
To address Aim 2: Within group changes in targeted outcomes including well-being, 
shame, shame resilience, willingness to communicate about health, and treatment 
attendance. We will analyze the within-group data using one sample t-tests comparing 
baseline and follow-up means for each measure. In addition, we will calculate 
standardized effect sizes comparing baseline and follow-up scores, using Cohen’s d.37,38 
Exploratory analyses will compare all measures using a correlation matrix at both 
baseline and follow-up, particularly looking at the interaction between shame resilience 
and each measure. 
 
Fidelity and Quality: The research coordinator will meet with the study PI, a clinical 
psychologist, weekly for clinical supervision during the intervention phase of the study. 
All sessions will be audio-recorded and scored by the PI using an established MI fidelity 
rating tool called the Motivational Interviewing Treatment Integrity Scale 4.2.1.26 
13.4 
The main purpose of this Pilot is to assess feasibility for a future clinical 
trial. Data from this pilot will be used in a future power analysis. 
14 Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
The research does not involve more than Minimal Risk to subjects, however the 
study investigators will conduct a periodic review of the findings to ensure that no 
unanticipated events have occurred. Safety data will be evaluated monthly. The 
study lead will review participant transcripts to review for unanticipated events. 

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Additionally scientific literature was reviewed to inform the safety and conduct 
guidelines of the study.  
 
15 Withdrawal of Subjects 
15.3 
Subjects will only be withdrawn without their consent is if it becomes clear 
during other study procedures that the participant in fact did not meet inclusion 
criteria or if they fail to follow study instructions.  
15.4 
Termination or safe withdrawal is not applicable to the single session, 
brief, behavioral interventions that will be tested in the current study.  
15.3 There are no procedures that participants could withdrawal from but collect 
other forms of data. 
15.4 
  If a subject withdraws from the study and requests that their assessment 
data be withdrawn this will be possible. However, once aggregated data analysis 
is complete, it will no longer be possible for subjects to withdraw their data for 
that particular analysis. 
15.5      Participants can withdraw participation at any time for any reason.  
16 Data Management/Confidentiality 
16.1 
 Data will not be transferred or shared with an external entity  
16.2 
The research team is only permitted to access any source of information 
about the subjects through secure UNM verified tools. Such as REDCap and 
Powerchart. 
16.3 
Identifiers will be collected including participants names, dates of birth, 
and medical abstracts. 
16.4 
The research does require access, use, and disclosure of Protected 
Health Information. Protected Health Information being collected includes 
participant names, dates of birth, and medical abstracts.  
16.5 
The data being gathered is not publicly available.  
16.6 
Data includes sensitive information about the occurrence of shame 
experiences. We describe the procedures for managing data and protecting 
confidentiality below. 
16.7 
A Certificate of Confidentiality will be sought immediately following UNM 
IRB approval. 
16.8 
Many steps will be taken secure the data. All study staff will receive 
extensive training and monitoring in study procedures and complete required 
ethics trainings. For all study procedures, identifying information will be kept 
separate from study data. The Locator Form, Informed Consent, and Participant 
Information forms will be the only forms with identifying information. All 
participants will be assigned a unique identifier. This number will be used to 
identify patients on assessment and medical abstraction data. Identifying data 
will be stored separately from assessment and medical abstraction data. A key 
linking participants to their unique identifier will be kept in a password protected 
file that is only accessible to study staff. Hard copies of data will be kept in locked 
offices in locked filing cabinets at the study sties or in UNM offices. Data will be 
transferred from the study sites back to UNM approximately weekly. Data 

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transfer will involve a direct trip from the study site back to UNM in a vehicle. All 
electronic study data and brief intervention audio sessions will be stored on a 
secure, encrypted server that also requires password access. Brief intervention 
audio sessions will be checked for the presence of identifying information and 
such information will be muted or ‘beeped’ out before the audio sessions are 
accessed for the intervention fidelity and quality coding. Data will only be 
accessible by study staff. 
16.9 
Assessment and medical record abstraction data will be coded with a 
unique identifier. A key linking participants to their unique identifier will be kept in 
a password protected file that is only accessible to study staff. 
16.10  Intervention performance evaluations are measured by the MITI 
instrument.  A percentage of all interventions will be evaluated for quality, and 
regular feedback will be given to the study interventionists. Weekly meetings will 
take place between the study interventionists and the evaluator to facilitate 
communication and quality improvement 
16.11  
• 
We will collect demographics, age and ethnicity. We will include data 
gathered from each measure.  
• 
Data will be maintained and stored on REDCap with only necessary team 
members given access. 
• 
Data will be collected and stored electronically through REDCap 
• 
Data will be stored for six years following close of the study and will then be 
destroyed. 
• 
Only members of the research team will have access to data.  
16.12 Data will be collected, transmitted and stored via the internet, through use 
of secure software, REDCap. Data will be protected via a code to ensure 
participant data is not identifiable. This code will be kept in a secure file cabinet, 
separate from the data, with limited access via a single key controlled by the PI.   
16.13 Data will be collected by audio recording during the intervention. The 
purpose of this recording is to measure interventionist fidelity. The recordings will 
not be transcribed. All electronic study data and brief intervention audio sessions 
will be stored on a secure, encrypted server that also requires password access. 
Brief intervention audio sessions will be checked for the presence of identifying 
information and such information will be muted or ‘beeped’ out before the audio 
sessions are accessed for the intervention fidelity and quality coding. Data will 
only be accessible by study staff.  
16.14 The data will not include photographs.  
16.15 Research records and consent documents will be maintained for six years 
after the studies completion, following HIPAA Requirements for collecting 
identifiable health information. 
16.16 No minors will be included in the study. 
 
17 Data and Specimen Banking 
17.1 
This study does not involve banking.  

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17.2 
This is not a multi-center study.  
18 Risks to Subjects 
18. 1 Participants may experience discomfort when talking about 
engagement in a stigmatized behavior (shame surrounding opioid use) 
during intervention. In addition, potential psychological distress may also 
be caused by issues related to sexual health topics addressed. Lastly, 
inadvertent disclosure of confidential data to non-study staff could be 
damaging to patient’s reputation. Extra care will be taken to protect 
information during waiting room recruitment. Researchers will make no 
mention of shame behaviors or screening results in the waiting room. 
During telephone assessments, we will encourage participants to 
complete the brief follow-up call in a private location and explicitly ask 
about ability / comfort to discuss sensitive issues prior to commencing 
each assessment.  
18.2 
 We are not aware of any procedures with unforeseeable risks. 
18.3 
We are not aware of any procedures with risks to embryos or fetuses.  
18.4 
We do not anticipate risks to others who are not subjects.  
18.5 
Steps to ensure the confidentiality of data are described above. In the 
case that participants become psychologically distressed by participation in the 
study, referral to the clinic’s behavioral health care providers is available. 
Additionally, participants will be given the information for the Agora Crisis Center, 
a free crisis hotline, which can provide further support and resources. If a 
participant does experience psychological distress we will follow up with them 
over the phone the following day to ensure they are alright.  
19 Potential Benefits to Subjects 
19.1 
 Participants involved in the study will receive a brief intervention in 
addition to standard care and may benefit from the effects of either. However, no 
proven direct health benefits will accrue to the research participants. If this 
research is successful, then the patients may benefit from new program 
developments based on the findings, but this is in the future. 
20 Recruitment Methods 
20.1 
Recruitment methods are described extensively above. Briefly, during 
recruitment all patients attending the South-East Heights clinic for standard 
services will be approached by a research team member in the waiting or exam 
room. The research team member will ask the patient if they are interested in 
learning whether they are eligible to participate in a study. Interested patients will 
be given a brief self-administered screening instrument (see Screening Form) 
assessing inclusion criteria. Patients who do not meet inclusion criteria will be 
informed that they are not eligible and thanked for their willingness to be 
screened. Participants who do meet inclusion criteria will be informed they are 
eligible for participation. Patients will be informed of eligibility or ineligibility once 
they are in the exam room.   
20.2 
Potential subjects will be individuals who are attending the clinic for 
regularly scheduled medical visits or for behavioral health screening. No chart 
review or referral process will be used to recruit participants. 

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20.3 
We have included a recruitment script in our submission with 
supplementary materials.  
21 Provisions to Protect the Privacy Interests of Subjects 
21.1 
Potential subjects will be individuals who are attending the clinic for 
regularly scheduled medical visits or for behavioral health screening. No chart 
review or referral process will be used to recruit participants. No data collected as 
part of the study assessment or intervention will be shared with standard care 
providers.  
21.2 
With the exception of self-report written screening, all study procedures 
will take place in a private office space. In addition, measures to protect 
confidentiality are described above. 
22 Economic Burden to Subjects 
22.1 
Participants are not expected to accrue any costs as a result of 
participating in the study. Standard medical services will be billed using standard 
procedures. 
. 
Research 
Procedures 
Number of 
Samples/Procedures 
Responsible Party 
Study 
3rd Party 
Payer or 
Participant 
MI Guided 
Shame 
Resilience 
Intervention 
20 
 
 
      
      
 
 
      
      
 
 
      
      
 
 
      
      
 
 
      
      
 
 
      
      
 
 
      
      
 
 
Standard of 
Care 
Procedures 
Number of 
Samples/Procedures 
Responsible Party 
Study 
3rd Party 
Payer or 
Participant 
      
      
 
 
      
      
 
 
      
      
 
 
      
      
 
 
      
      
 
 
      
      
 
 
      
      
 
 
      
      
 
 
 
22.2 
There are not any costs to participants that are not described above.   

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22.3 
Participants will not be charged for investigational drugs, devices, 
procedures. 
22.4 
No adverse events are expected however participants or their insurer will 
be responsible for all standard medical procedures. 
22.5 
Costs have been addressed in the consent.  
23 Compensation 
23.1 
Participants will be reimbursed with $50 merchandise cards for their time 
at each assessment point. There will be two points of assessment so participants 
will receive $100 in total for their participation in the project. Each assessment 
point will last 20-30 minutes and will be incorporated into the participants regular 
schedule.  
24 Compensation for Research-Related Injury 
24.1 
The research does not involve more that Minimal Risk to subjects.  
25 Consent Process 
25.1. We will be obtaining informed consent. 
25.1.1 Study staff will be responsible for obtaining informed consent. These staff 
members have not yet been hired. All study staff will receive extensive training in 
research procedures including informed consent. For the purpose of screening 
we are requesting partial waivers of consent. 
25.1.2 The consent process will take place in a private exam room. 
25.1.3. The consent will emphasize the voluntary nature of research participation. 
The consent will highlight that decision to participate or not participate in the 
research trial will not affect the patients regular care at the clinic. Study staff will 
be trained in ethical consent procedures.  
25.1.4. We anticipate that most participants will decide to participate or not during 
the initial study contact. However, participants can have as much time as needed 
to decide regarding participation. Participants who need more time to think will be 
provided with the study team contact information and asked to follow-up with any 
questions or to participate.  
25.1.5 Participants will be provided with a copy of their consent upon signing. In 
addition, participants will be reminded at each follow-up that participation is 
voluntary. Comprehension quizzes will be administered following discussion and 
reading of the consent and, for any areas that potential participants are not able 
to answer correctly, additional time will be devoted to explanation to ensure 
comprehension. 
25.1.6 The consent will be written at or below the sixth-grade reading level. 
Participants will be asked to read the consent, which will also be paraphrased by 
a study staff member.  
25.1.7 To ensure that the prospective participant has sufficient knowledge and 
comprehension of all the elements of informed consent, a short open-ended quiz 
will be administered. Incorrect answers will be followed up with further 
explanation and the quiz will be re-administered.  
Subjects not fluent in English 

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25.1.8 English is the only language proficiently spoken by study staff.  
25.1.9 We will not enroll subjects with limited English fluency. 
25.1.10  We will not use short-form consent documents.  
Cognitively Impaired Adults/Adults Unable to Consent/Use of a Legally 
Authorized Representative 
25.1.11  Adults with cognitive impairments that limits their decision-making 
capacity will not be enrolled.  
25.1.12 - 25.1.25 Not applicable. 
26 
Documentation of Consent 
 
26.1. We will use a consent form, which is included in this protocol submission.  
26.2. We will not be collecting and/or storing tissue samples. 
26.3. We will use a standard HIPPA consent form.  
 
27 
Study Test Results/Incidental Findings 
27.1. Individual Results: Baseline and follow-up assessment results are based 
on self-reported behavioral data and will not be reported to participants. Any 
testing done as part of standard care will be reported to patients per standard 
medical care practice procedures. 
27.2. Incidental Findings: We do not anticipate any incidental findings.  
 
28 
Sharing Study Progress or Results with Subjects 
28.1. We do not anticipate providing summaries of trial progress. Data analysis 
will likely not occur until the study is complete. The study findings will be shared 
with interested participants at once results have been analyzed. These results 
will be written into an accessible information sheet that will be shared with 
community stakeholders and participants who indicated an interest in receiving 
such findings.  
28.2 Due to the confidential nature of the study, results will only be shared with 
participants who indicate a desire to receive them and then only via the channel 
of communication that they specify. Study results will also be presented in 
academic journals and at conferences.  
 
29 
Inclusion of Vulnerable Populations 
29.1 
Vulnerable populations are described below.  
29.1.1 
The research does not include students or employees.  
29.1.2 
The voluntary nature of the research will be made clear and reinforced 
across the informed consent process. The informed consent forms and process 
will emphasize that in no way will their decision to participate or not interfere with 
their receipt of services in their respective programs and medical staff will not 
have knowledge about their decision to participate. 

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29.1.3 
Due to their history of opioid, participants from both sites may be 
considered educationally disadvantaged. The informed consent materials will be 
written at an accessible reading level and a quiz will be administered to ensure 
understanding. 
29.1.4 
The research does not include seriously or terminally ill patients.  
29.1.5 
The research does include pregnant women. The checklist is 
completed below.  
29.1.6 
The research does not involve neonates.  
29.1.7 
The research does not involve prisoners.  
29.1.8 
The research does not involve children.  
29.1.9 
 The research does not involve cognitively impaired adults.  
30 
Community-Based Participatory Research 
30.1 
The Pilot Study will involve extensive engagement of the study population 
in the design of the research. In addition, as a research team, we will meet with 
relevant community members, advocacy groups, and site staff to ensure that our 
study methods remain sensitive to the needs of the community. 
31 
Research Involving American Indian/Native Populations 
31.1 
We do not anticipate Native American participants being largely 
represented in the Milagro population. If we do have a Native participant we will 
ensure that their feedback is incorporated and we seek out consultation of Native 
community groups to discuss the trial outside of the context of research aims. 
32 
Transnational Research 
32.1 
The study does not involve transnational research.  
33 
Drugs or Devices 
33.1 
The study does not involve the testing of drugs or devices.  
34 
Principal Investigator’s Assurance 
By submitting this study in the Click IRB system, the principal investigator of this 
study confirms that: 
☒ The information supplied in this form and attachments are complete and correct.   
☒ The PI has read the Investigator’s Manual and will conduct this research in 
accordance with these requirements.  
 ☒ Data will be collected, maintained and archived or destroyed per HSC Data 
Security Best Practices, including: 
1. Best Practice for data collection is for it to be directly entered onto a data 
collection form that is in a secured access folder on an HS drive behind a firewall, 
or in a secure UNM Data Security approved system such as RedCap. 
2. Data collection of de-identified data, if done in a clinical setting or other setting 
that does not allow direct entry into a secured system, may be done temporarily 
using a personal or university owned electronic storage device or hard copy 

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document. The important security safeguard is that no identifiers be include 
if the data is entered or stored using an untrusted device or storage. 
3. Permanent (during data analysis, after study closure) storage must reside on 
HSC central IT managed storage. Processing of data (aggregation, etc.) are to 
be carried out in such a way as to avoid creating/retaining files on untrusted 
storage devices/computers. Trusted devices are HSC managed and provide one 
or more of following safeguards: access logs, encryption keys, backups, 
business continuity and disaster recovery capabilities. 
4. Alternate storage media must be approved by HSC IT Security as meeting or 
exceeding HSC central IT provided security safeguards. 
 
 

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REFERENCES 
1.    Brown, B. Daring Greatly: How the Courage to Be Vulnerable Transforms the Way We Live, 
Love, Parent, and Lead. (Penguin UK, 2013). 
2. 
Evolution, Social Roles, and the Differences in Shame and Guilt on JSTOR. 
https://www.jstor.org/stable/40971967?seq=1#metadata_info_tab_contents. 
3. 
Van Vliet, K. J. Shame and resilience in adulthood: A grounded theory study. Journal of 
Counseling Psychology vol. 55 233–245 (2008). 
4. 
McDermott, E., Roen, K. & Scourfield, J. Avoiding shame: young LGBT people, homophobia 
and self‐destructive behaviours. Culture, Health & Sexuality vol. 10 815–829 (2008). 
5. 
McGaffin, B. J., Lyons, G. C. B. & Deane, F. P. Self-Forgiveness, Shame, and Guilt in Recovery 
from Drug and Alcohol Problems. Substance Abuse vol. 34 396–404 (2013). 
6. 
Dolezal, L. The Body and Shame: Phenomenology, Feminism, and the Socially Shaped Body. 
(Lexington Books, 2015). 
7. 
Slavič, T. R. & Gostečnik, C. The Experience of Pregnancy, Childbirth and Motherhood in 
Women with a History of Sexual Abuse. Sexology in Midwifery (2015) doi:10.5772/59085. 
8. 
Eggertson, L. Stigma a major barrier to treatment for pregnant women with addictions. 
Canadian Medical Association Journal vol. 185 1562–1562 (2013). 
9. 
Stone, R. Pregnant women and substance use: fear, stigma, and barriers to care. Health & 
Justice vol. 3 (2015). 
10. Koren, G., Chan, D., Klein, J. & Karaskov, T. Estimation of fetal exposure to drugs of abuse, 
environmental tobacco smoke, and ethanol. Ther. Drug Monit. 24, 23–25 (2002). 
11. Haight, S. C., Ko, J. Y., Tong, V. T., Bohm, M. K. & Callaghan, W. M. Opioid Use Disorder 
Documented at Delivery Hospitalization — United States, 1999–2014. MMWR. Morbidity and 
Mortality Weekly Report vol. 67 845–849 (2018). 
12. Schempf, A. H. Illicit Drug Use and Neonatal Outcomes: A Critical Review. Obstetrical & 
Gynecological Survey vol. 62 749–757 (2007). 
13. Kocherlakota, P. Neonatal Abstinence Syndrome. PEDIATRICS vol. 134 e547–e561 (2014). 
14. Soni, A. & Sehgal, A. Neonatal Abstinence Syndrome. Advances in Pediatrics 161–161 (2007) 
doi:10.5005/jp/books/10034_15. 
15. Kohler, P. K. et al. Shame, guilt, and stress: Community perceptions of barriers to engaging in 
prevention of mother to child transmission (PMTCT) programs in western Kenya. AIDS Patient 
Care STDS 28, 643–651 (2014). 
16. Shildrick, T. Poverty: discrimination, stigma and shame. Poverty Propaganda 113–130 (2018) 
doi:10.1332/policypress/9781447323976.003.0006. 
17. Brown, B. Shame Resilience Theory: A Grounded Theory Study on Women and Shame. 
Families in Society: The Journal of Contemporary Social Services vol. 87 43–52 (2006). 
18. Fessler, D. Shame in Two Cultures: Implications for Evolutionary Approaches. Journal of 
Cognition and Culture vol. 4 207–262 (2004). 
19. Miller, W. R. & Rollnick, S. Motivational Interviewing, Third Edition: Helping People Change. 
(Guilford Press, 2012). 
20. Hettema, J., Steele, J. & Miller, W. R. Motivational interviewing. Annu. Rev. Clin. Psychol. 1, 
91–111 (2005). 
21. Arkowitz, H., Miller, W. R. & Rollnick, S. Motivational Interviewing in the Treatment of 
Psychological Problems, Second Edition. (Guilford Publications, 2015). 
22. Lundahl, B. et al. Motivational interviewing in medical care settings: a systematic review and 
meta-analysis of randomized controlled trials. Patient Educ. Couns. 93, 157–168 (2013). 
23. Hettema, J., Wagner, C. C., Ingersoll, K. S. & Russo, J. M. Brief Interventions and Motivational 
Interviewing. Oxford Handbooks Online (2014) doi:10.1093/oxfordhb/9780199381708.013.007. 

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24. Hettema, J. E. et al. Development and differentiability of three brief interventions for risky 
alcohol use that include varying doses of motivational interviewing. Addict. Sci. Clin. Pract. 13, 6 
(2018). 
25. Sutter, M. B. et al. Group Prenatal Care for Women Receiving Medication‐Assisted Treatment 
for Opioid Use Disorder in Pregnancy: An Interprofessional Approach. Journal of Midwifery & 
Women’s Health vol. 64 217–224 (2019). 
26. Kramer Schmidt, L., Andersen, K., Nielsen, A. S. & Moyers, T. B. Lessons learned from 
measuring fidelity with the Motivational Interviewing Treatment Integrity code (MITI 4). J. Subst. 
Abuse Treat. 97, 59–67 (2019). 
27. Harvey, L. A. REDCap: web-based software for all types of data storage and collection. Spinal 
Cord vol. 56 625–625 (2018). 
28. Moyers, T. B., Rowell, L. N., Manuel, J. K., Ernst, D. & Houck, J. M. The Motivational 
Interviewing Treatment Integrity Code (MITI 4): Rationale, Preliminary Reliability and Validity. J. 
Subst. Abuse Treat. 65, 36–42 (2016). 
29. Hallis, L., Cameli, L., Bekkouche, N. S. & Knäuper, B. Treatment Satisfaction Questionnaire. 
PsycTESTS Dataset (2018) doi:10.1037/t65713-000. 
30. Subjective Well-Being Measure. Encyclopedia of Quality of Life and Well-Being Research 
6450–6450 (2014) doi:10.1007/978-94-007-0753-5_104074. 
31. Veenhoven, R. Subjective Measures of Well-being. Human Well-Being 214–239 (2007) 
doi:10.1057/9780230625600_9. 
32. Rizvi, S. L. Shame Inventory. PsycTESTS Dataset (2011) doi:10.1037/t00447-000. 
33. Rizvi, S. L. Development and Preliminary Validation of a New Measure to Assess Shame: The 
Shame Inventory. Journal of Psychopathology and Behavioral Assessment vol. 32 438–447 
(2010). 
34. Hauser, C. T. Shame and Resilience Among Mental Health Trainees: A Scale Construction 
Study. (2016). 
35. Wright, K. B., Frey, L. & Sopory, P. Willingness to Communicate about Health as an Underlying 
Trait of Patient Self-Advocacy: The Development of the Willingness to Communicate about 
Health (WTCH) Measure. Communication Studies vol. 58 35–51 (2007). 
36. Glaser, B. G. & Strauss, A. L. The Constant Comparative Method of Qualitative Analysis*. The 
Discovery of Grounded Theory 101–116 (2017) doi:10.4324/9780203793206-6. 
37. Mirzazadeh, A., Malekinejad, M. & Kahn, J. G. Relative risk reduction is useful metric to 
standardize effect size for public heath interventions for translational research. Journal of 
Clinical Epidemiology vol. 68 317–323 (2015). 
38. Saltychev, M. Measuring Effect Size. American Journal of Physical Medicine & Rehabilitation 
vol. 98 e4 (2019). 
39.  Elliott, D. M., & Briere, J. (1992). Sexual abuse trauma among professional women: validating 
the Trauma Symptom Checklist-40 (TSC-40). Child abuse & neglect, 16(3), 391–398. 
https://doi.org/10.1016/0145-2134(92)90048-v 
 
 
 
 
 
 
 
 
 
 
 
 

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35 
CHECKLIST SECTION 
This section contains checklists to provide information on a variety of topics that require special 
determinations by the IRB.  Please complete all checklists relevant to your research. 
36 
Partial Waiver of Consent for Screening/Recruitment 
Complete this checklist if you are requesting a partial waiver of consent so that you can review 
private information to identify potential subjects and/or determine eligibility prior to approaching 
potential subjects for consent or parental permission. 
A. Describe the data source that you need to review (e.g., medical records): 
Date of birth, medical records  
B. Describe the purpose for the review (e.g., screening): 
screening 
C. Describe who will conducting the reviews (e.g., investigators, research staff): 
Research staff 
D. Do all persons who will be conducting the reviews already have permitted access to the 
data source? 
 
      
 Yes 
            
 No. Explain:       
i. Verify that each of the following are true or provide an alternate 
justification for the underlined regulatory criteria: 
1. The activity involves no more than minimal risk to the subjects 
because the records review itself is non-invasive and the results of the 
records review will not be used for any purposes other than those 
described above. 
 True 
 Other justification:       
2. The waiver or alteration will not adversely affect the rights and welfare 
of the subjects because eligible subjects will be approached for 
consent to participate in the research and are free to decline.  Further, 
the information accessed during the records review will not be 
disclosed to anyone without a legitimate purpose (e.g., verification of 
eligibility). 
 True 
 Other justification:       

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3. The research could not practicably be carried out without the waiver 
or alteration because there is no other reasonably efficient and 
effective way to identify who to approach for possible participation in 
the research.   
 True 
 Other justification:       
4. Whenever appropriate, potentially eligible subjects will be presented 
with information about the research and asked to consider 
participation.  (Regulatory criteria: Whenever appropriate, the subjects 
will be provided with additional pertinent information after 
participation.) 
 True 
 Other justification:       
37 
Partial Waiver of HIPAA Authorization for Screening/Recruitment 
Complete the following additional questions/attestations if the records you will review to identify 
potential subjects and/or determine eligibility include Protected Health Information (PHI). 
A. Will you be recording any PHI when conducting the records review to identify potential 
subjects and/or determine eligibility? 
            
 Yes. Describe:  
            
 No 
B. If you answered “Yes” to question 6 above, please describe when you will destroy 
identifiers (must be the earliest opportunity consistent with the conduct of the research) 
or provide justification for why they must be retained: 
 
C. The PHI accessed or recorded for identification/screening purposes will not be reused or 
disclosed to (shared with) any other person or entity, except as required by law, for 
authorized oversight of the research study, or for other research for which the use or 
disclosure of the PHI would be permitted under the Privacy Rule. 
 
      
 True 
            
 False 
38 
Waiver of Documentation of Consent 
Complete this checklist if you intend to obtain consent verbally but will not be obtaining 
signatures from subjects on a consent form to document consent.  Waivers of documentation of 
consent are commonly requested when using scripts, information sheets, or email or survey 
introductions to present the elements of consent instead of using a traditional consent form. 
A. Are you requesting a waiver of documentation of consent for some or all 
subjects? 
 All 

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 Some. Explain:       
B. Provide justification for one of the following: 
i. 
That the only record linking the subject and the research would be the 
consent document and the principal risk would be potential harm 
resulting from a breach of confidentiality. Each subject will be asked 
whether the subject wants documentation linking the subject with the 
research, and the subject's wishes will govern. 
      
ii. 
That the research presents no more than minimal risk of harm to 
subjects and involves no procedures for which written consent is 
normally required outside of the research context. 
      
C. Do you intend to provide subjects with a written statement regarding the 
research in lieu of a traditional consent form? 
 Yes. Please attach a copy to your submission in Click. 
 No 
39 
Alteration of Consent 
Complete this checklist if you intend to obtain consent but will be eliminating or altering one or 
more of the required elements of consent. Alterations of consent are commonly requested for 
research involving deception or for minimal risk research when an abbreviated consent is 
desired and one or more of the required element are not relevant to the research. 
Note: FDA-regulated research is not eligible for an alteration of consent. 
A. Which element(s) of consent do you wish to eliminate and why? 
      
B. Which element(s) of consent do you wish to alter and why? 
      
C. Provide justification for each of the following regulatory criteria: 
i. 
The research involves no more than minimal risk to the subjects: 
      
ii. 
The waiver or alteration will not adversely affect the rights and welfare 
of the subjects: 
      

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iii. 
The research could not practicably be carried out without the waiver 
or alteration: 
      
iv. 
Whenever appropriate, the subjects will be provided with additional 
pertinent information after participation: 
      
40 
Full Waiver of Consent/Parental Permission 
Complete this checklist if you are requesting a full waiver of consent for all subjects or 
certain subject groups (e.g., retrospective cohort).  Full waivers of consent are commonly 
requested when the research does not include any opportunity for interaction with subjects 
(e.g., chart review). 
Note: FDA-regulated research is not eligible for a full waiver of consent using these criteria.  If 
you believe that your FDA-regulated research may be eligible for a waiver under another 
mechanism, such as planned emergency research, contact the HRPO for assistance in 
determining what information to provide to the HRRC. 
A. Are you requesting a waiver for some or all subjects? 
 All 
 Some. Explain:       
B. Provide justification for each of the following regulatory criteria: 
i. 
The research involves no more than minimal risk to the subjects: 
      
ii. 
The waiver or alteration will not adversely affect the rights and welfare 
of the subjects: 
      
iii. 
The research could not practicably be carried out without the waiver 
or alteration: 
      
iv. 
Whenever appropriate, the subjects will be provided with additional 
pertinent information after participation: 
      
41 
Full Waiver of Consent/Parental Permission (Public Benefit or Service Programs) 
Complete this checklist if you are requesting a full waiver of consent for all subjects or 
certain subject groups (e.g., retrospective cohort) and the research involves the evaluation 
of a public benefit or service program.   
A. Are you requesting a waiver for some or all subjects? 
 All 

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 Some. Explain:       
B. Provide justification for each of the following regulatory criteria: 
i. 
The research or demonstration project is to be conducted by or 
subject to the approval of state or local government officials and is 
designed to study, evaluate, or otherwise examine: (i) public benefit or 
service programs; (ii) procedures for obtaining benefits or services 
under those programs; (iii) possible changes in or alternatives to 
those programs or procedures; or (iv) possible changes in methods or 
levels of payment for benefits or services under those programs: 
      
ii. 
The research could not practicably be carried out without the waiver 
or alteration. 
      
42 
Full Waiver of HIPAA Authorization (Checklist) 
Complete this checklist if you are requesting a full waiver of the requirement to obtain 
HIPAA authorization for all subjects or certain subject groups (e.g., retrospective cohort).  
Full waivers of HIPAA authorization are commonly requested when the research does not 
include any opportunity for interaction with subjects (e.g., chart review). 
A. Are you requesting a waiver of authorization for some or all subjects? 
 All 
 Some. Explain:       
B. Describe your plan to protect health information identifiers from improper use 
and disclosure: 
      
C. Describe your plan to destroy identifiers at the earliest opportunity consistent 
with conduct of the research (absent a health or research justification for 
retaining them or a legal requirement to do so): 
      
D. Describe why the research could not practicably be conducted without the 
waiver or alteration: 
      
E. The PHI accessed or recorded for identification/screening purposes will not 
be reused or disclosed to (shared with) any other person or entity, except as 
required by law, for authorized oversight of the research study, or for other 
research for which the use or disclosure of the PHI would be permitted under 
the Privacy Rule. 
 True 
 False 

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43 
Other Waiver Types (Checklist) 
If you are seeking another waiver type (e.g., Planned Emergency Research, Waiver of 
Parental Permission to Protect Child Participants, Enforcement Discretion for In Vitro 
Diagnostics, etc. contact the HRPO office for assistance in determining what information to 
submit for the HRRC’s consideration. 
 
44 
Vulnerable Populations (Checklist) 
 
A. Adults with Cognitive Impairments 
Complete this checklist if the subject population will include adults with cognitive 
impairments.   
This checklist does not need to be completed if the research doesn’t involve 
interactions or interventions with subjects and will be conducted under a waiver of 
consent. 
1. Describe why the objectives of the study cannot be met without inclusion of 
adults with cognitive impairments. 
      
2. Describe how capacity to consent will be evaluated. 
      
3. If subjects may regain capacity to consent, or if subjects may have fluctuating 
capacity to consent, describe your plans to evaluate capacity to consent 
throughout the research and to obtain consent to continue participation if 
capacity is regained. 
      
4. Describe your plans, if any, to provide information about the research to 
subjects and the steps you will take to assess understanding. 
      
5. Describe your plans to obtain assent, including whether assent will be 
obtained from none, some, or all subjects. 
      
6. Describe why risks to subjects are reasonable in relation to anticipated 
benefits to the subjects. 
      
7. If this study involves a health or behavioral intervention, describe why the 
relation of the anticipated benefit to the risk of the research is at least as 
favorable to the subjects as that presented by alternative procedures. 

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8. Describe your plans for monitoring the well-being of subjects including any 
plans to withdraw subjects from the research if they appear to be unduly 
distressed. 
      
B. Children 
Complete this checklist if the subject population will include children. 
1. Select the category of research that you believe this research falls within and 
provide justification for any associated criteria.  If there are different 
assessments for different groups of children or arms (e.g., placebo vs. drug), 
include a memo to provide an assessment for each group.   
 Research not involving greater than minimal risk. (Minimal risk means 
that the probability and magnitude of harm or discomfort anticipated in 
the research are not greater in and of themselves than those 
ordinarily encountered in daily life or during the performance of routine 
physical or psychological examinations or tests.) 
 Research involving greater than minimal risk but presenting the 
prospect of direct benefit to the individual subjects. 
Provide justification for each of the following criteria: 
(1) The risk is justified by the anticipated benefit to the subjects: 
      
(2) The relation of the anticipated benefit to the risk is at least as 
favorable to the subjects as that presented by available 
alternative approaches: 
      
 Research involving greater than minimal risk and no prospect of direct 
benefit to individual subjects, but likely to yield generalizable 
knowledge about the subject's disorder or condition. 
Provide justification for each of the following criteria: 
(1) The risk represents a minor increase over minimal risk: 
      
(2) The intervention or procedure presents experiences to 
subjects that are reasonably commensurate with those 
inherent in their actual or expected medical, dental, 
psychological, social, or educational situations: 
      

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(3) The intervention or procedure is likely to yield generalizable 
knowledge about the subjects' disorder or condition which is of 
vital importance for the understanding or amelioration of the 
subjects' disorder or condition 
      
C. Pregnant Women and Fetuses 
Complete this checklist if the subject population will include pregnant women and 
fetuses. 
This checklist does not need to be completed if the research is both minimal risk and 
is not conducted, funded, or otherwise subject to regulation by DHHS, DOD, EPA, or 
VA. 
Provide justification for each of the following: 
1. Where scientifically appropriate, preclinical studies, including studies on 
pregnant animals, and clinical studies, including studies on non-pregnant 
women, have been conducted and provide data for assessing potential risks to 
pregnant women and fetuses. 
      
2. The risk to the fetus is caused solely by interventions or procedures that hold 
out the prospect of direct benefit for the woman or the fetus; or, if there is no 
such prospect of benefit, the risk to the fetus is not greater than minimal and 
the purpose of the research is the development of important biomedical 
knowledge which cannot be obtained by any other means. 
      
3. Any risk is the least possible for achieving the objectives of the research. 
      
D. Neonates of Uncertain Viability or Nonviable Neonates 
Complete this checklist if the subject population will include neonates of uncertain 
viability. 
Provide justification for each of the following: 
1. Where scientifically appropriate, preclinical and clinical studies have been 
conducted and provide data for assessing potential risks to neonates. 
      
2. Each individual providing consent is fully informed regarding the reasonably 
foreseeable impact of the research on the neonate. 
      
3. Individuals engaged in the research will have no part in determining the 
viability of a neonate. 

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4. The research holds out the prospect of enhancing the probability of survival 
of the neonate to the point of viability, and any risk is the least possible for 
achieving that objective, or, the purpose of the research is the development 
of important biomedical knowledge which cannot be obtained by other means 
and there will be no added risk to the neonate resulting from the research 
      
E. Nonviable Neonates 
Complete this checklist if the subject population will include nonviable neonates. 
Provide justification for each of the following: 
1. Where scientifically appropriate, preclinical and clinical studies have been 
conducted and provide data for assessing potential risks to neonates. 
      
2. Each individual providing consent is fully informed regarding the reasonably 
foreseeable impact of the research on the neonate. 
      
3. Individuals engaged in the research will have no part in determining the 
viability of a neonate. 
      
4. The purpose of the research is the development of important biomedical 
knowledge that cannot be obtained by other means. 
 
      
Verify each of the following: 
5. Vital functions of the neonate will not be artificially maintained 
 True 
 False 
6. The research will not terminate the heartbeat or respiration of the neonate 
 True 
 False 
7. There will be no added risk to the neonate resulting from the research 
 True 
 False 
F. Biomedical and Behavioral Research Involving Prisoners 

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Complete this checklist if the subject population will include prisoners. 
Note: Minimal risk for research involving prisoners is the probability and magnitude of 
physical or psychological harm that is normally encountered in the daily lives, or in 
the routine medical, dental, or psychological examination of healthy persons. 
1. Select and justify which allowable category of research involving prisoners 
this research falls within: 
 Study of the possible causes, effects, and processes of incarceration, and 
of criminal behavior, provided that the study presents no more than 
minimal risk and no more than inconvenience to the subjects 
      
 Study of prisons as institutional structures or of prisoners as incarcerated 
persons, provided that the study presents no more than minimal risk and 
no more than inconvenience to the subjects 
      
 Research on conditions particularly affecting prisoners as a class (for 
example, vaccine trials and other research on hepatitis which is much 
more prevalent in prisons than elsewhere; and research on social and 
psychological problems such as alcoholism, drug addiction, and sexual 
assaults) 
      
 Research on practices, both innovative and accepted, which have the 
intent and reasonable probability of improving the health or well-being of 
the subject 
      
 Epidemiologic studies in which the sole purpose is to describe the 
prevalence or incidence of a disease by identifying all cases or to study 
potential risk factor associations for a disease, the research presents no 
more than Minimal Risk and no more than inconvenience to the subjects, 
and Prisoners are not a particular focus of the research. 
      
2. Provide justification for each of the following regulatory criteria: 
a) Any possible advantages accruing to the prisoner through his or her 
participation in the research, when compared to the general living 
conditions, medical care, quality of food, amenities and opportunity for 
earnings in the prison, are not of such a magnitude that his or her 
ability to weigh the risks of the research against the value of such 
advantages in the limited choice environment of the prison is impaired 
      

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b) The risks involved in the research are commensurate with risks that 
would be accepted by nonprisoner volunteers 
      
c) Procedures for the selection of subjects within the prison are fair to all 
prisoners and immune from arbitrary intervention by prison authorities 
or prisoners. Unless justification is provided, control subjects must be 
selected randomly from the group of available prisoners who meet the 
characteristics needed for that particular research project 
      
d) The information is presented in language which is understandable to 
the subject population 
      
e) Adequate assurance exists that parole boards will not take into 
account a prisoner's participation in the research in making decisions 
regarding parole, and each prisoner is clearly informed in advance 
that participation in the research will have no effect on his or her 
parole 
      
f) When appropriate, adequate provision has been made for follow up 
examination or care after research participation, taking into account 
the varying lengths of individual prisoners' sentences, and for 
informing participants of this fact 
      
 
45 
Medical Devices (Checklist)  
Complete this checklist if the research evaluates the safety or effectiveness of a medical device.  
If more than one medical device is being evaluated, provide the requested information for each. 
A. Device Name:        
B. Manufacturer:        
C. Does the research involve a Significant Risk Device under an IDE? 
 Yes. Include documentation of the FDA approval of the IDE with your submission.  
Acceptable methods of documentation include: (1) FDA letter noting IDE number and 
approval status; (2) Industry sponsor letter noting IDE number and FDA approval 
status; or (3) FDA-approved industry sponsor protocol with IDE number noted  
 No 
D. Is the research IDE-exempt? 

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 Yes. Include a FDA letter with your submission noting the determination that the 
research is IDE-exempt or a letter from the sponsor (or sponsor-investigator) 
justifying why they believe the research is IDE-exempt*.   
 No 
E. Does the research involve a Non-Significant Risk (NSR) Device? 
 Yes. Include a FDA letter with your submission noting the determination that the 
research is NSR or a letter from the sponsor (or sponsor-investigator) justifying why 
they believe the research is NSR**.   
 No 
* This FDA guidance includes a description for when a device study is exempt from the 
IDE requirements: 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf  
**This FDA guidance includes information on how to differentiate between Significant 
Risk and Non-Significant Risk device studies: 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf  
46 
Export Control (Checklist) 
Indicate if there will be export control concerns (i.e., select agents or select toxins involved in 
the project, collaboration with foreign institution or foreign nationals, publication restrictions, 
foreign travel, etc.).  If so, please upload and complete Export Control Exclusion Screening 
Form.
 
47 
Data Transfer/Sharing (Checklist) 
Complete this checklist if the research involves transferring/sharing of data with an external 
entity (institution, company, etc.).  
A. Will data be transferred/shared with an external entity (institution, company, etc.)?   
 Yes 
 No. The remainder of this section does not apply.  
B. Indicate if the data is incoming and/or outgoing:         
C. Provide the name of the entity that data will be transferred/shared with:       
D. Provide the contact name, email and phone number with whom data is being             
transferred/shared with:       
E. Who is responsible for transmission of the data?            
F. Who is responsible for receiving the data?       
G. Describe how the data will be transferred/shared. Please note data cannot be 
transferred/shared without assistance from UNM HSC IT. Requesting HSC Central IT 
Transfer is detailed on the Sponsored Projects website:            

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H. For data being transferred/shared with outside locations or entities, describe the 
following: 
• 
Where is data storage and how will it be maintained in a secure manner (i.e. 
encryption, password protection, use of Qualtrics or REDCap, etc)?       
• 
What is method in which data will be collected and stored (i.e. electronic, hard 
copy, etc)?            
• 
How long will the data be stored?            
• 
Who will have access to data?         
I. 
 Please list all specific data elements, variables, etc. to be sent out and/or received. 
Indicate if the data contains identifiers and health information. Please note that identifiers 
that MUST be removed to make health information de-identified are as follows: Names, 
All geographic subdivision smaller than a State, All elements of year (except year), 
Telephone, Fax numbers, E-mail addresses, Social Security, Medical record number, 
Health plan beneficiary, Account numbers, Certificate/license numbers, Vehicle 
identifiers and serial numbers, Device identifiers and serial numbers, Web URLs, IP 
address numbers, Biometric identifiers, full face photographic images, and Any other 
unique identifying number, characteristic or code.)            
J. If the research requires the access, use, or disclosure of any of the 18 individually 
identifiable protected health information (PHI) identifiers that can be used to identify, 
contact, or locate a person (e.g., name, medical record number, etc.), are the subjects 
going to consent to or authorize the disclosure of their individually identifiable health 
information?        
a. Or is HIPAA authorization altered or waived?           
K. What is the classification of the data (de-identified, limited data set, protected health 
information, other).       
L. Does the request to transfer/share data include clinical data that belongs to the UNM 
Health Systems?       
M. Does the data to be transferred/shared include information about patients seen at 
external health system or at a third party medical provider?       
N. Is the external entity a “covered entity”?         
O. Is the data that is going to be transferred/shared owned or partially owned by another 
party or have any type of restrictions including regulatory restrictions (i.e. HIPAA, 
FERPA, etc.)?       
P. Is the data publicly available? If yes, please provide details:       
Q. Does the data include information about substance abuse treatment, sexually 
transmitted diseases, genetic testing results, HIV/AIDS testing results, and/or mental 
health?          
 
48 
Specimen Transfer/Sharing (Checklist) 
Complete this checklist if the research involves transferring/sharing of specimens with an 
external entity (institution, company, etc.).  
A. Will specimens be transferred/shared with an external entity (institution, company, etc.)?  
      
 Yes 
 No. The remainder of this section does not apply.  
B. Indicate if the specimens are incoming and/or outgoing:       
C. Provide the name of the entity that specimens will be being transferred/shared with: 
      

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D. Provide the contact name, email and phone number with whom specimens are being 
transferred/shared with:       
E. Who is responsible for sending out the specimens? Please note specimens cannot be 
sent out without a fully executed material transfer agreement.       
F. Who is responsible for receipt of the specimens? Please note specimens cannot be 
received without a fully executed material transfer agreement.             
G. For specimens being transferred/shared with outside locations or entities, describe the 
following: 
• 
Where is specimen storage and how will it be maintained in a secure manner?       
• 
What is method in which specimens will be collected and stored?       
• 
How long will the specimens be stored?       
• 
Who will have access to the specimens?