Belongingness in Nursing Through Mindfulness - BEING Mindful: A Pilot Study
Phase: NA
Conditions: Mindfulness, Sense of Belonging
Sponsor: University of New Mexico

PROTOCOL COVER PAGE 
 
PROTOCOL TITLE: Belongingness in Nursing through Mindfulness – BEING Mindful: A Pilot Study  
PRINCIPAL INVESTIGATOR: Sharon L. Ruyak, PhD, CNM, RN, FACNM Department  
VERSION NUMBER: Version 02 DATE: 07/14/25 
Identifiers: NCT06866288   Unique Protocol ID: 25-036 

Page 1 of 62
Version Date: 07/14/25
PROTOCOL TITLE:
Belongingness in Nursing through Mindfulness – BEING Mindful: A Pilot Study
PRINCIPAL INVESTIGATOR:
Sharon L. Ruyak, PhD, CNM, RN, FACNM
Department
VERSION NUMBER:
Version 02
DATE:
07/14/25
REGULATORY FRAMEWORK (The federal regulatory framework 
governing human subjects research is found in the US Department of 
Health and Human Services Policy for the Protection of Human 
Subjects (45 CFR 46).):
Please indicate all that apply (please note that the regulatory framework does not 
mean the funding source):
☐
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:
Indicate if the protocol is funded.  If so, provide sponsor and SPO Huron ERA record 
number (FPXXXXX). 
This protocol is not funded
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 

Page 2 of 62
Version Date: 07/14/25
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 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.” (https://grants.nih.gov/policy/clinical-trials/definition.htm)
Use the following four questions to determine the difference between a clinical study 
and a clinical trial:       
1)
Does the study involve human participants? ☒ Yes   ☐ No
2)
Are the participants prospectively assigned to an intervention? ☒ Yes   ☐ No
3)
Is the study designed to evaluate the effect of the intervention on the participants? 
☒ Yes  ☐ No 
4)
 Is the effect being evaluated a health-related biomedical or behavioral outcome? 
☒ Yes   ☐ No
Note that if the answers to all 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 

Page 3 of 62
Version Date: 07/14/25
Table of Contents
1.
Objectives.....................................................................................................................6
2.
Background ..................................................................................................................6
3.
Study Design ................................................................................................................6
4.
Inclusion and Exclusion Criteria ..................................................................................6
5.
Number of Subjects......................................................................................................7
6.
Study Timelines............................................................................................................7
7.
Study Endpoints ...........................................................................................................7
8.
Research Setting...........................................................................................................7
9.
Resources Available.....................................................................................................8
10.
Prior Approvals.........................................................................................................8
11.
Multi-Site Research ..................................................................................................9
12.
Study Procedures ......................................................................................................9
13.
Data Analysis..........................................................................................................10
14.
Provisions to Monitor the Data to Ensure the Safety of Subjects...........................10
15.
Withdrawal of Subjects...........................................................................................11
16.
Data Management/Confidentiality..........................................................................11
17.
Data and Specimen Banking...................................................................................13
18.
Risks to Subjects.....................................................................................................13
19.
Potential Benefits to Subjects .................................................................................14
20.
Recruitment Methods..............................................................................................14
21.
Provisions to Protect the Privacy Interests of Subjects ..........................................14
22.
Economic Burden to Subjects.................................................................................15
23.
Compensation .........................................................................................................16
24.
Compensation for Research-Related Injury............................................................16
25.
Consent Process......................................................................................................16
26.
Documentation of Consent .....................................................................................19
27.
Study Test Results/Incidental Findings ..................................................................20
28.
Sharing Study Progress or Results with Subjects...................................................20
29.
Inclusion of Vulnerable Populations ......................................................................21
30.
Community-Based Participatory Research.............................................................22
31.
Research Involving American Indian/Native Populations .....................................22
32.
Transnational Research...........................................................................................22
33.
Drugs or Devices ....................................................................................................23
34.
Principal Investigator’s Assurance .........................................................................23
35.
CHECKLIST SECTION ........................................................................................25
36.
Partial Waiver of Consent for Screening/Recruitment ...........................................25
37.
Partial Waiver of HIPAA Authorization for Screening/Recruitment.....................26
38.
Waiver of Documentation of Consent ....................................................................26
39.
Alteration of Consent..............................................................................................27
40.
Full Waiver of Consent/Parental Permission..........................................................28
41.
Full Waiver of Consent/Parental Permission (Public Benefit or Service Programs)
29
42.
Full Waiver of HIPAA Authorization (Checklist)..................................................29
43.
Other Waiver Types (Checklist).............................................................................30

Page 4 of 62
Version Date: 07/14/25
44.
Vulnerable Populations (Checklist)........................................................................30
45.
Medical Devices (Checklist)...................................................................................36
46.
Export Control (Checklist) .....................................................................................37
47.
Data Transfer/Sharing (Checklist)..........................................................................37
48.
Specimen Transfer/Sharing (Checklist)..................................................................38

Page 5 of 62
Version Date: 07/14/25
1. Objectives
1.1. Describe the purpose, specific aims, or objectives.
Our long-term goal is to develop a mindfulness-based intervention (MBI) 
program that significantly decreases stress/burnout and increases 
belongingness and connectedness among  nurse faculty and staff. The overall 
objective of this pilot project, which is the next step in toward achievement of 
our long-term goal, is to examine the feasibility and preliminary efficacy of 
MBIs as an intervention for University of New Mexico (UNM) Health 
Sciences Center (HSC) nurse faculty and staff. Our central hypothesis is that 
this MBI intervention will improve the psychosocial outcomes (sense of 
belonging) and physiological outcomes (HRV) among HSC nurse faculty and 
staff. To test our central hypothesis and attain the overall objective, we will 
pursue the following specific aims:
Aim 1. To evaluate the feasibility and acceptability of MBIs (meditation or 
yoga) for HSC nurse faculty and staff. Acceptability will be assessed 
qualitatively from analyses of interviews with participants. Feasibility will be 
assessed as rates of recruitment, retention, and adherence to the MBI (% 
training sessions attended).
Aim 2. To evaluate the preliminary effect of MBI (meditation; yoga) in HSC nurse 
faculty and staff on: psycho-social outcomes (burnout; sense of belonging, stress, 
anxiety) and physiological outcomes (HRV evaluated by wearable electronics). We 
hypothesize that: a) psycho-social outcomes will improve post-intervention and b) 
physiologic measures (HRV) will improve post intervention compared to 
preintervention.
1.2. State the hypotheses to be tested.
Our central hypothesis is that this MBI intervention will improve the psychosocial 
outcomes (sense of belonging) and physiological outcomes (HRV) among HSC nurse 
faculty and staff.
2. Background
2.1. Describe the relevant prior experience and gaps in current knowledge.
Background: Nurses are the foundation of health care in the United States (US). 
Critically, there is a growing shortage of academic nurse faculty resulting in 
limited capabilities to enroll future nurses and thus increase the nursing 
workforce. Factors attributed to this shortage include stress and burnout,1–3 lack of 
collegiality and non-inclusive environment.4 These factors lead to significant adverse 
behavioral, psychological and physiological outcomes.1,5 Staff, who are critical to the 
foundation for learning and innovation in academic nursing,6 likely experience 
similar outcomes.7 Notably, the American Association of Colleges of Nursing 
(AACN; 2024) states a sense of belonging is imperative for successful achievement 
of academic nursing’s mission and priorities which focus on preparing the next 

Page 6 of 62
Version Date: 07/14/25
generation of nurses. A sense of belonging goes beyond the subjective feeling of 
connectedness with a community to a sense of a shared mission and ownership of 
common outcomes. There is emerging literature surrounding the role of faculty and 
staff in increasing belonging among students as well as strategies for leaders to create 
and sustain a culture of belonging. However, a notable gap in the science is the 
absence of clinical trials examining the integration of interventions, such as 
mindfulness-based interventions (MBI), aimed at improving a sense of belonging 
and connectedness in academic nursing faculty and staff. This study addresses this 
critical gap by examining the effect of MBIs on psychosocial and physiological 
outcomes in faculty and staff, thus directly addressing the number one 
recommendation from the AACN Leading Across Multidimensional Perspectives 
(LAMP) Culture and Climate survey to increase belongingness through community 
connectedness and cohesion. 
2.2. Describe any relevant preliminary data.
Preliminary Data: The AACN LAMP Culture and Climate Survey was developed to 
assess the experiences of students, faculty and staff at nursing schools across the 
nation.7 The survey provides a means to gather input from all constituents (students, 
faculty, staff) regarding what is working well at an organization and where there are 
opportunities for improvement. Results are grouped into 5 thematic areas: Perceptions 
of Culture and Climate, Fair Treatment and Observations of Discrimination, 
Belongingness, Value of Diversity, Equity and Inclusion, and Campus Services and 
Clinical Training. Of specific interest to this project is the thematic area of 
Belongingness. 
The UNM AACN LAMP Survey was deployed to all University of New Mexico 
(UNM) College of Nursing (CON) students, faculty, and staff from March 2023 to 
April 2023. In total, 47 (57%) faculty and 36 (48%) administrators/staff completed 
the survey. Faculty and staff responded to 10 items focused on perception of 
connection to others and feelings of isolation. Approximately 28% of faculty reported 
when they interacted with other people at the CON, they did not feel included. 
Roughly 30% of faculty reported they felt their campus did not care about them. 
Thirty-nine percent of faculty reported they felt isolated from others on their campus 
and 38% reported they lacked a sense of belonging with their campus community. 
Finally, an alarming 49% of faculty reported feeling like a stranger when they where 
with other people from their campus. 
Answers by faculty and staff to the question “to improve the campus climate at my 
nursing program we need to do more of” included multiple comments related to: 
1) “promoting a sense of belonging”, 2) “building community”, and 3) “fostering 
cohesiveness and collaboration”. Thus justifying the focus of this project. 
2.3. Provide the scientific or scholarly background for, rationale for, and 
significance of the research based on the existing literature and how will it add 
to existing knowledge.

Page 7 of 62
Version Date: 07/14/25
It is long been established that mindfulness practices like meditation and yoga are 
associated with positive mental health outcomes.8,9 In addition, mindfulness practices 
are known to support interpersonal relationships.10 In the workplace, mindfulness 
practice improves communication, builds a sense of shared goals leading to greater 
productivity and retention, and helps to decrease burnout.11,12 Furthermore, 
mindfulness practices foster resilience. Mindfulness practices are also associated with 
improved physiologic function including autonomic nervous system (ANS) 
function.13 Peripheral ANS activity, including cardiac vagal activity (indexed by heart 
rate variability [HRV]), regulates dynamic fine-tuning of feedback loops between 
emotion-related brain circuitry and the heart.14  HRV is known to be a robust 
biomarker of health, wellness, stress, and the ability to self-regulate.15 By instructing 
individuals in MBIs homeostasis in brain-heart feedback loops is promoted leading to 
autonomic stability.16 Given the potential impact of MBI to promote individual and 
workplace wellness, investigation of this intervention to improve wellness in 
academic faculty and staff is critical.
3. Study Design
3.1. Describe the study design (e.g., observational; randomized placebo-controlled 
clinical trial, etc.)
This study is a minimal-risk, single site, quasi-experimental study.
3.2. Describe blinding, if applicable
4. Inclusion and Exclusion Criteria
4.1. Describe how individuals will be screened for eligibility.
The UNM CON currently employs 71 faculty and 71 staff. In addition there are 
nurses who hold appointment with other departments and the UNM hospital. Using 
convenience sampling we will recruit and enroll 60 participants into two study 
groups: 1) mindfulness mediation and 2) yoga. Interested study participants will be 
contacted by study staff and screened to determine study eligibility (See Attachment 
A). The screener is approximately 1-page in length and takes approximately 5 
minutes to complete. The screener includes queries related to inclusion and exclusion 
criteria. Participants will also complete an Exercise Participation Screening (see 
Attachment B).17
4.2. Describe the criteria that define who will be included or excluded in your final 
study sample, including age. “Age” can be part of a de-identified data set 
provided ages over 89 are not included.  In order to maintain a de-identified 
classification, all ages over age 89 may be aggregated into a single category of 
“age 90 or older”.  If specific ages over 89 are included, then this would be 
considered a Limited Data Set.
Inclusion criteria for the study include: 1) 18 years of age or older, 2) in general good 
health, 3) employed as HSC nurse faculty or  staff, 4) reside in the state of New 
Mexico and able to attend 6 weeks of in-person research sessions, 5) willing to 
complete research assessments, 6) own a smart phone.

Page 8 of 62
Version Date: 07/14/25
Exclusion criteria for the study include: 1) major medical illness making individual 
unable to participate in the research.
Additional Screening Criteria: Vigorous-intensity exercise is accompanied by a small 
risk of cardiovascular complications, however, proper screening minimizes these 
risks.17 The American College of Sports Medicine’s (ACSM) guidelines are designed 
to eliminate barriers for an individual to begin a regular exercise program. Additional 
screening criteria will include completion of the Preparticipation Exercise 
Participation Screening (See Attachment B).  
4.3. Special Populations: Will any of the following populations be included in this 
study? Indicate specifically whether or not you will include each of the following 
special populations below.

Adults unable to consent: ☐Yes ☒No

Pregnant women: ☒Yes ☐No or ☐Not targeted nor is pregnancy screened 
for

Minors (individuals who are under the age of 18):  ☐Yes ☒No

Mothers who are minors cannot enroll their child into a research study 
without the consent of their parent or parents, as applicable. Clarify if 
applicable. 

Minors in foster care must be excluded from research per NM state law. 
Please state minors in foster care will be excluded, if applicable. 

Minors that are wards of the state must have additional safeguards met; 
Please consult with the HRPO if not excluding minors who are wards of the 
state. Otherwise state that wards of the state will be excluded. 

Prisoners ☐Yes ☒No; If yes, please contact HRPO; Inclusion of prisoners 
requires approval from the Office for Human Research Protections (OHRP) 
and from the NM Corrections Department.

Non-English speakers ☐Yes ☒No; If yes, please clarify specific languages 
enrolling:       Note: State congruently in section 25. Consent Process, 
subsection, Subjects not fluent in English.
4.4. Indicate if you excluding any particular populations (e.g., women, children, 
persons not fluent in English, a particular racial or ethnic group, etc.) and 
provide justification. 
This study excludes individuals under that age of 18 due to the focus on 
adult faculty and staff employed at the UNM HSC. We will exclude 
pregnant individuals due to specific activity modifications that would be 
required to assure the safety of these individuals during yoga. We will not 
recruit individuals unable to provide written consent in English. 
4.4.1. If excluding pregnant women, please indicate how investigators will 
screen for pregnancy. 
5. Number of Subjects

Page 9 of 62
Version Date: 07/14/25
5.1. If this is a multicenter study, indicate the total number of subjects to be accrued 
across all sites.
N/A. this study is not a multicenter study. 
5.2. Indicate the number of subjects to be recruited at this site.  
We will enroll 60 faculty and staff in this study. Once we have enrolled 30 
participants, we will waitlist individuals for a second six-week intervention session 
after the completion of the first session. This will result in a possible enrollment 60 
individuals.
5.3. Provide sample size justification
The planned overall sample size of 30 is consistent with recommendations for pilot 
studies seeking to build evidence in the context of medium effect size differences 
between two groups.18
6. Study Timelines
6.1. Describe:

The duration of an individual subject’s participation in the research

The duration anticipated to enroll all subjects

The expected duration for the investigators to complete the study (complete 
analysis)
Participants will be enrolled until the allotted 30 participants for the first 6 weeks of 
the study is reached. The study is comprised of a pre-intervention assessment, 
followed by 6 weeks of meditation/yoga attendance (twice/week). Upon completion 
of the 6-week intervention, participants will complete a post intervention assessment 
(See Table 1.).
Table 1. Study Timeline
Months
1
2
3
4
5
6
7
8
9
10
Prepare research and data 
management tools.
Session 1
Recruitment
Intervention 
Data Collection
Preliminary Data Analyses
Session 2
Intervention
Data Collection
Analyses
Prepare R01 proposal
Dissemination

Page 10 of 62
Version Date: 07/14/25
7. Study Endpoints: Primary endpoint(s) are typically efficacy measures that 
address the main research question. Secondary endpoints are generally not sufficient 
to influence decision-making alone, but may support the claim of efficacy by 
demonstrating additional effects or by supporting a causal mechanism.
7.1. Describe the primary and secondary study endpoints.
Primary outcomes of interest of this study include the feasibility and acceptability of 
mindfulness-based interventions (MBI) (Aim 1). We will also examine the 
preliminary effect of these interventions on psychosocial outcomes (primary: sense of 
belonging; secondary: burnout, stress) and physiologic outcomes (HRV) (Aim 2).
7.2. Describe any primary or secondary safety endpoints.
This is a minimal risk study. 
7.3. Describe any exploratory endpoints.
N/A There are no anticipated exploratory endpoints.
8. Research Setting
8.1. Describe the sites or locations where your research team will conduct the 
research.
Potential participants will be recruited from the UNM HSC. The UNM HSC currently 
employs 71 faculty and 71 staff in the CON, plus nurse faculty and staff in other HSC 
programs. Study personnel will conduct all screenings in the private clinical research 
rooms housed within the CON Research Laboratory suite. 
8.2. Identify where your research team will identify and recruit potential subjects.
Potential participants will be identified and recruited from the UNM CON.
8.3. Identify where research procedures will be performed including any laboratory 
analytics
Informed consent and research visit interviews will occur in private clinical research 
rooms housed within the UNM CON Research Laboratory suite. Questionnaires will 
be administered via secure REDCap survey. Garmin devices will be distributed 
and/or collected after completion of questionnaires. Meditation and yoga sessions will 
occur in the Collaborative Research Space housed within the CON Research 
Laboratory suite. 
8.4. Describe the composition and involvement of any community advisory board
N/A, this study does not involve a community advisory board. 
8.5. For research conducted outside of UNM HSC and its affiliates describe:

Site-specific regulations or customs affecting the research

Local scientific and ethical review structure/requirements (Note: include any 
approvals (IRB, facility, or other) with your submission)
N/A, this is a single site study. 

Page 11 of 62
Version Date: 07/14/25
9. Resources Available
9.1. Describe the qualifications of the PI and study staff (e.g., training, experience, 
oversight) as required to perform the research. When applicable describe their 
knowledge of the local study sites, culture, and society. 
The PI, Dr. Sharon Ruyak, has been a registered nurse for the past 37 years. In 
addition, Dr. Ruyak is an Associate Professor in the UNM CON and has been 
a faculty member of the UNM CON since 2013. She has extensive experience 
in the evaluation of stress and collection of both biological and behavioral 
research data. Additionally, Dr. Ruyak has successfully conducted research 
employing mobile ecological momentary assessment.19,20 Dr. Ruyak is also a 
Registered Yoga Teacher (RYT) 200 and will lead the yoga intervention. 
Dr. Roberta Lavin (Co-Investigator) has been a registered nurse for the past 
35 years, a professor for 14 years and at the UNM CON for 4 years. She is 
part of a fellowship in contemplative medicine. In addition, she has 15 years 
of mindfulness practice and is an ordained Soto Zen Priest. 
Dr. Mary Pat Couig (Co-investigator) has been a registered nurse for the past 
47 years and faculty at the UNM CON for 5 years. Dr. Couig has expertise in 
new registered nurse graduate transition to practice residency programs and 
faculty mentoring programs. She is part of the leadership team that developed 
and implemented a new facilitated peer group mentoring program for new 
CON faculty.
Dr. April Tafoya (Co-investigator) has been a registered nurse for the past 10 
years. Dr. Tafoya is a Lecturer II in the UNM CON and has been a faculty 
member for the past four years. Dr. Tafoya is a Registered Yoga Teacher 
(RYT) 200 and will work with Dr. Ruyak to lead the yoga intervention. 
Clinton Mitch Irvin, MSN, RN, (Co-investigator) has been a registered nurse 
for 14 years and a UNM CON faculty member for the past 4 years. In 
addition, Mr. Irvin is a Lecturer II at the UNM CON. Mr. Irvin also has a BA 
in Religious Studies. He will work closely with Dr. Lavin to facilitate 
meditation sessions.
Stephen Van Roper, PhD, RN, FNP-BC, FAANP (C0-investigator) Has been 
a registered nurse for 30 years and a UNM CON faculty member for the past 
12 years. Dr. Roper is a Clinical Professor and is a certified yoga instructor. 
He will work closely with Dr. Ruyak to facilitate yoga sessions.
9.2. When applicable, describe which licensed physicians/providers will be 
responsible for medical decision-making and ordering and evaluation of 
necessary diagnostics and therapeutics. 
N/A, this is a minimal risk study that does not involve medical decision making. 
9.3. Describe other resources available to conduct the research: For example, as 
appropriate:

Page 12 of 62
Version Date: 07/14/25

Justify the feasibility of recruiting the required number of suitable subjects 
within the agreed recruitment period. For example, how many potential 
subjects do you have access to? What percentage of those potential subjects 
do you need to recruit?

Describe the time that will be devoted to conducting and completing the 
research.

Describe the facilities available to conduct the research.

Describe the availability of medical or psychological resources that subjects 
might need as a result of an anticipated consequences of the human research.

Describe the process to ensure that all persons assisting with the research are 
adequately informed about the protocol, the research procedures, and their 
duties and functions.

If CTSC resources are being accessed, please provide the IRB submission and 
approval deadline dates on the CTSC Submission page in Huron IRB.
Feasibility of recruitment: The UNM CON currently employs 71 faculty members and 71 
staff members with additional nurse faculty in other HSC schools and colleges and the 
hospital. The planned overall sample size of 30 per cohort is consistent with 
recommendations for pilot studies seeking to build evidence in the context of medium 
effect size differences between two groups.18 Furthermore, objectives of pilot studies 
include assessment of recruitment and retention rates.18
The UNM College of Nursing is housed in the College of Nursing/College of Population 
Health Building. The UNM College of Nursing has a state-of-the-art Research 
Laboratory suite that includes private clinical research rooms as well as a large 
collaborative research space to conduct the intervention. 
This is a minimal risk study that is not expected to have adverse psychological or medical 
consequences for participants.  However, if needed there are providers available for 
referral and referral procedures are described below in Section 18 - Risks to Subjects.
Prior to beginning recruitment and enrollment, all study personnel will be trained on the 
protocol as well as consent and interview procedures for the study. All study personnel 
will have completed training for the ethical conduct of research. Study coordinators will 
routinely monitor the approved study team member list to ensure all team members 
remain current in their training. 
10.Prior Approvals
10.1. Describe any approvals that will be obtained prior to commencing the research. 
(e.g., school, external site. funding agency, laboratory, radiation safety, or 
biosafety approval.) N/A
10.2. Upload the required Departmental Review Form signed by your Department 
Chair (or authorized designee if the PI is the Department Chair) into Huron 
IRB under “supporting documents.” The signed, required Departmental Review 
form has been uploaded under “supporting documents”.

Page 13 of 62
Version Date: 07/14/25
10.3. If a study includes ionizing radiation, the Radiation Safety Attachment (HUS-
FORM_1) must be uploaded (attached) in Huron IRB with your submission.  
The consent should include radiation exposure information in the Risks section.
N/A
10.4. If applicable to the study, include the signed “Biological Specimens” and/or 
“Drug Attachment” in Huron IRB with your submission.
N/A
11.Multi-Site Research
11.1. If this is a multi-site study where the UNM HSC PI is the lead investigator, or 
UNM HSC is the coordinating site, describe the processes to ensure 
communication among sites, such as:

All sites have the most current version of the protocol, consent document, and 
HIPAA authorization.

All required approvals have been obtained at each site (including approval by 
the site’s IRB of record).

All modifications have been communicated to sites, and approved (including 
approval by the site’s IRB of record) before the modification is implemented.

All engaged participating sites will safeguard data as required by local 
information security policies.

All local site investigators will conduct the study appropriately.

All non-compliance with the study protocol or applicable requirements will 
reported in accordance with local policy.
11.2. Describe the method for communicating to engaged participating sites:

Adverse events

Problems

Interim results

Data and safety monitoring reports

The closure of a study
11.3. If the UNM HSC investigator is serving as the “sponsor-investigator” of a 
FDA-regulated trial, describe how sponsor responsibilities will be fulfilled, 
including, but not limited to:

Trial Monitoring

Investigational Product Accountability

Safety and other interim reporting to investigators and FDA

Unanticipated Problem reporting to investigators, IRBs, and FDA
N/A
12.Study Procedures 

Page 14 of 62
Version Date: 07/14/25
12.1. List any collaborating site where human subject research will be performed and 
describe the role of those sites and collaborating investigators in performing 
the proposed research (if applicable). N/A
12.2. Provide a thorough description of all study procedures, assessments and subject 
activities in a logical and sequential format.
The UNM CON currently employs 71 faculty and 71 staff and the HSC has additional 
nurse faculty and staff. We will employ a quasi-experimental design to assess 
feasibility, acceptability, and preliminary efficacy of MBIs (meditation; yoga) to 
increase a sense of belonging and connectedness in academic nursing faculty and 
staff. Using convenience sampling we will recruit and enroll 60 participants in to two 
study groups: 1) mindfulness mediation and 2) yoga. Interested study participants will 
be contacted by study staff and screened to determine study eligibility (See 
Attachment A). The screener is approximately 1-page in length and takes 
approximately 5 minutes to complete. The screener includes queries related to 
inclusion and exclusion criteria. Participants will also complete an Exercise 
Participation Screening (see Attachment B).17
Pre-data collection:
We will assign 15 individuals to each condition. Across both conditions, all 
participants will participate in one baseline assessment/training session, 6 weeks 
of MBIs (participants will be required to attend 2 sessions per week), and a post-
intervention assessment session.  Following screening for inclusion/exclusion 
criteria, eligible participants will complete the BEING Mindful Exercise 
participation screening. Eligible participants will provide informed consent. 
After informed consent is obtained, research staff will allocate individuals to meditation 
vs yoga on 1:1 basis. If an individual is unable to participate in the yoga arm based on the 
BEING Mindful Exercise participation screening, they will be assigned to meditation and 
the next two participants will be assigned to yoga.
All participants will be given an anonymous study ID number once they are
enrolled in the study. The only link between the study ID number and any identifier will 
be stored in a secure N:\Research-Studies network drive, in a folder to which only the 
investigators will have access. Any link between the study ID and identifiers will be 
destroyed when data analysis is complete. 
Once we have enrolled 30 participants we will waitlist individuals for a second six-week 
intervention session after the completion of the first session. This will result in a possible 
enrollment 60 individuals.
12.3. For studies that collect existing or prospective data, describe the source of 
information, whether collected prospective or retrospectively.
Data collection: 
Participants who express interest and meet inclusion criteria will meet with the PI or 
trained research personnel to review the study protocol, including risks and benefits. 
Participants will be asked to read and sign the informed consent (Attachment C) and 
HIPPA agreement following the procedure described in Section 25 – Consent Procedure.

Page 15 of 62
Version Date: 07/14/25
Baseline Assessment session: During the baseline assessment session, participants will 
be administered a structured questionnaire with a research team member via the secure 
REDCap system. Baseline self-report questionnaires will be completed: 1) Sense of 
Belonging Scale (SBS); 2) Mindfulness Attention Awareness Scale (MASS) 15-item; 3) 
Generalized Anxiety Disorder-7 (GAD-7); 4) NIH toolbox measure of perceived stress
Sample Descriptors: Sociodemographic characteristics (age, sex, physical ability, staff vs 
faculty, years in profession, years employment at HSC, previous mindfulness practice) 
will be assessed at the baseline session.
Assessment of belonging: Belonging will be assessed using the 8-item Sense of 
Belonging Scale (SBS). The SBS measures the sense of belongingness or feelings of 
acceptance and inclusion in a community experienced by an individual.21 The SBS was 
developed to be adapted to specific contexts.21 Using the method described by Mellinger 
and Park (2023), we adapted the scale to be specific to UNM HSC nurse faculty and staff. 
Response categories range from 1 (Strongly disagree) to 5 (strongly agree). Responses 
are summed and the mean is calculated with higher scores corresponding to a stronger 
sense of belonging.22 The SBS-8 demonstrated high levels of reliability with a 
Cronbach’s alpha coefficient of .96.21
Assessment of mindfulness: Trait mindfulness: Trait mindfulness will be assessed using 
the 15-item Mindfulness Attention Awareness Scale (MAAS).23 The MAAS was 
designed to assess core characteristics of mindfulness. The MAAS has demonstrated 
consistent reliability with Cronbach’s alpha coefficients ranging from .80 to .90 in 
undergraduate, community, and nationally sampled adult populations.23
Assessment of burnout: The Copenhagen Burnout Inventory is a valid and reliable, 19-
item, self-report measure of burnout.24 Originally designed to measure burnout in among 
human service workers, it includes 3 scales. The personal burnout scale has six items and 
measures prolonged physical and emotional exhaustion. The work-related burnout scale 
has seven items that measure prolonged physical and emotional exhaustion secondary to 
work. The third scale, client-related burnout, has six items that measure burnout related to 
working with clients (client may be patients, students, service recipients). Each subscale 
can be scored separately.24 The three subscales have demonstrated good reliability and 
criterion related validity in a variety of samples.24,25
Assessment of anxiety and stress: The Generalized Anxiety Disorder-7 screener (GAD-7) 
is a 7-item self-report-measure of generalized anxiety disorder.26 Response categories 
range from 0 (Not at all) to 3 (Nearly every day). Responses are summed (range, 0 to 21) 
with higher scores corresponding to more severe levels of anxiety. Using a cut-off of 8, 
the GAD-7 has a sensitivity of 92% and specificity of 76% for diagnosis of generalized 
anxiety disorder.27,28 The NIH toolbox measure of perceived stress is a 10-item fixed 
form. Responses are measured on a 5-point Likert scale ranging from 1 (Never) to 5 
(Very Often) with higher scores indicating higher levels of perceived stress.29,30
Brief Reflective Feedback: At the end of each mindfulness session, participants will be 
given a card on which to write two words that embody how they are feeling right now (no 

Page 16 of 62
Version Date: 07/14/25
identifying information will be on the card). Participants will be asked to share their two 
words with the group if they feel comfortable.
Mobile Ecological Momentary Assessment (mEMA): Ambulatory assessment via 
mEMA allows for real time sampling within the individual’s natural environment at 
multiple time points throughout the day. The Ilumivu mEMA (https://ilumivu.com) 
platform (iOS and Android compatible) is HIPPA compliant. The platform does not 
require any personally identifying information from participants. The platform 
automatically generates a unique identifying code. A research team member will provide  
this code to the participant to enter into their mobile app. Data are sent from the sensor to 
the mEMA app on the phone directly via Bluetooth. Data are then uploaded to Ilumivu’s 
servers when the individual is within range of WiFi.  Surveys are timestamped upon 
completion. All data are encrypted on transmission and stored securely. Datasets are only 
available to authorized research team members. 
Following completion of baseline surveys, participants will be instructed to install the 
Ilumivu mEMA application on their smart-phone. The participants will be trained on how 
to access and respond to mEMA surveys. Participants will be asked to complete three 
mEMA assessments per day (morning, afternoon, and evening). An alert will be 
programmed to be sent at pre-determined times to remind the participant to complete the 
survey. All questions will be multiple choice (see MAAS-State below).
mEMA outcome: State mindfulness will be measured using the 5-item MAAS-State scale 
completed on the IlumiIvu mEMA app. The MAAS-State was designed to assess the 
expression of the core characteristic of mindfulness in real-time.23 
Physiologic Outcome Measures. Ambulatory assessment of physiological processes 
within the context of an individual’s daily life will occur through use of a wearable wrist 
electronic sensor. This platform provides direct, real-time data which is sent from the 
wearable sensor to the mEMA app, by Bluetooth.
Physiologic measures: inter-beat-interval will be collected via a Garmin Vivosmart5® 
device. This device has been shown to produce reliable heart rate data with the mean 
absolute percentage error below the designated acceptable 10% threshold.31 Each 
participant will receive training for use of the sensor and written instructions will be 
provided for future reference. Participants will wear the device on their non-dominant 
hand in their daily environment every day for six weeks. Daily reminders to wear the 
device and to check the battery level will be delivered via the mEMA to increase 
compliance with the protocol. 
HRV outcome measures: Garmin Vivosmart5® uses optical technology in which a series 
of lights emitted by photoplethysmography (PPG) sensors against the skin illuminate 
capillaries to detect changes in blood volume and providing heart rate data in real time.31  
Raw data is collected from the device and sent to the phone via Bluetooth. Using the 
pulse to pulse (P-P) interval, inter-beat-interval (IBI) is derived via Ilumivu software. HR 
epochs of five-minute intervals immediately preceding and corresponding to each mEMA 
survey will be selected for analysis. Time and frequency domain analysis will be 
performed by Ilumivu using proprietary software. Time Domain measures: Time domain 
measures are based on the time difference between easily detectable QRS complexes. 

Page 17 of 62
Version Date: 07/14/25
Using PPG technology, these measures are derived from the P-P interval (distance in 
milliseconds between each P). Simple time domain measures (standard deviation of P-P 
interval, mean HR) will be calculated. Frequency domain measures estimate frequency 
spectrum. The general bands are low frequency (LF; 0.04–0.15 Hz) and high frequency 
(HF; 0.15–0.40 Hz). Low frequency measures, high frequency measures, and LF/HF ratio 
of HRV will be computed.32 
Long-term HRV, 24 hour time windows, will be determined by dividing the 24 hour time 
period into consecutive 5 minute epochs and averaging the individual values of the HRV 
metrics to obtain the mean of the value within the 24 hour time window.32,33 Five-minute 
heart rate epochs immediately following completion of each mEMA survey will also be 
selected for analysis.20,34 Between subject variability, in which relatively stable variation 
is compared between individuals, and within-subject (WS) variability, in which variation 
within the same individual across time will be examined.
12.4. Indicate what study activities happen when and where.
12.5. Describe, in chronological order, all research procedures and interventions 
being performed and when they are performed. Include:

Each specific intervention, procedure, examination, imaging, laboratory test, 
etc. that subjects will undergo for the purposes of the research and the 
purpose of it.

Each drug, biologic, device, or other such product used in the research, the 
purpose, and the regulatory status (e.g., investigational, marketed – on label, 
marketed – off label, etc.)

Each survey, questionnaire, interview, focus group, etc., that subjects will be 
asked to complete or participate in for the research and the purpose of it.

Each data source that will be used to gather information about subjects and 
the purpose of it (confidentiality will be addressed later.

Indicate whether subjects would already be expected to undergo any of the 
procedures for clinical, diagnostic, or other non-research purposes

Include all referenced study instruments, such as questionnaires, scripts, 
diaries, and data collection forms with your submission as separate 
attachments.

For HUDs, provide a description of the device, a summary of how you 
propose to use the device, including any screening procedures, the HUD 
procedure, and any patient follow-up visits, tests, or procedures.  Note 
whether the HUD is being used for clinical purposes only or if you are 
proposing to study the safety or effectiveness of the device.

Whole genome sequencing (WGS) or whole exome sequencing (WES) requires 
the following: (1) Subjects must opt-in or opt-out in the consent form for the 
WGS and/or WES. (2) Clinically actionable findings from WGS or WES must 
be confirmed in a CLIA certified laboratory. (3) Subjects must be given the 
option in the consent to receive the CLIA certified laboratory test results. (4) 
If the subject would like to be informed of clinically actionable CLIA certified 
findings, they must be given option for genetic counseling, and the genetic 

Page 18 of 62
Version Date: 07/14/25
counseling must be paid by the researchers. All of these steps must be detailed 
in the protocol and congruently stated in lay-terms in the consent form.  
Alternatively, subjects can be informed in the consent form that there are no 
identifiers linking to their samples where WGS and/or WES will be 
performed, and as such, clinically actionable findings will not be reported 
back to them. If applicable, state in the protocol and congruently in lay-
terms in the consent form. 
Description of Intervention Delivery
These guidelines detail the procedures used to conduct Mindful Meditation or Yoga 
sessions. 
We will employ a quasi-experimental design to assess feasibility, acceptability, and 
preliminary efficacy of MBIs (meditation; yoga) to increase a sense of belonging and 
connectedness in academic nursing faculty and staff. We will assign 15 individuals to 
each condition. Across both conditions, all participants will participate in one baseline 
assessment/training session, 6 weeks of MBIs (participants will be required to attend 2 
sessions per week), and a post-intervention assessment session.  Following screening for 
inclusion/exclusion criteria, eligible participants will complete the BEING Mindful 
Exercise participation screening. Eligible participants will provide informed consent. 
Assignment of Participants:
After informed consent is obtained, research staff will allocate individuals to meditation 
vs yoga on a 1:1 basis. If an individual is unable to participate in the yoga arm, they will 
be assigned to meditation and the next two participants will be assigned to yoga.
Retention:
To promote retention, we will reach out to participants with frequent reminders via text 
messages and emails. 
Baseline Assessment session: During the baseline assessment session, participant 
characteristics will be collected. Baseline self-report questionnaires will be completed: 1) 
Sense of Belonging Scale (SBS); 2) Mindfulness Attention Awareness Scale (MASS) 15-
item; 3) Generalized Anxiety Disorder-7 (GAD-7); 4) NIH toolbox measure of perceived 
stress.
Intervention Delivery:
The meditation and yoga interventions are 6-week protocols. We will offer meditation 
sessions 4 times per week and yoga sessions 4 times per week. We will require 
participants to attend two sessions per week. Attendance will be tracked via the Ilumivu 
platform. Participants will be requested to log attendance at each session via the app.
The meditation intervention will be led by Dr Roberta Lavin and Mr. Mitch Irvin. 
Meditation is a practice of mental exercises designed to increase focus and cultivate a 
desire to relieve suffering in self and other.35,36 The practice dates back millennia to 
Buddhist and Hindu sages, but more recent work focuses on stress.37 More recently, the 
term mindfulness has been used which means awareness, attention, and remembering.37 
Many religious traditions have a form of meditation based practice. This study will focus 

Page 19 of 62
Version Date: 07/14/25
on two forms of meditation both of which are focused on right mindfulness: 1) zazen 
which is a seated meditation primarily focused on the breath, posture, and sensation 
without attaching judgment. This is meant to develop awareness, equanimity, and insight, 
and 2) kinhin which is a walking meditation which is meant to connect mindfulness in 
one’s movement by synchronizing breath and movement. It also focuses on development 
of awareness, equanimity, and insight. The two activities combined help the individual to 
nurture a thread of mindfulness. Instructors have developed a protocol (see attachment 
E).  to standardize the delivery of the meditation intervention. The protocol includes a 
description of the amount of time for each phase of the practice. The protocol also 
includes suggested cues and dialogue which can be expressed or paraphrased in the 
instructors’ own words. 
The yoga intervention will be led by certified, 200-hour registered yoga instructors, Drs 
Sharon Ruyak, Dr. Van Roper, andApril Tafoya. Yoga is a wholistic, multidimensional 
practice.  There are three fundamental limbs of yoga: 1) breathwork (pranyanma), 2) 
physical postures  with breathing techniques (asanas), and 3) meditation and visualization 
(Dhyana).38 Yoga practice unites the mind, body and spirit leading to 
psychophysiological changes within the individual including improved self-regulation 
ability and stress response, mood, well-being, and quality of life.8,9,13 Yoga instructors 
will offer modifications and props such as blocks to ensure sessions are accessible to 
individuals of various abilities and minimize the risk of injury. Instructors have 
developed a detailed manual to standardize the delivery of the yoga intervention (see 
Attachment F). The manual includes photos and descriptions of how to perform the pose. 
The manual also includes suggested cues and dialogue which can be expressed or 
paraphrased in the instructors’ own words. Additionally, the manual includes suggested 
modifications or amplifications for poses so the participant can practice to their level. 
This allows for personalization of the yoga flow while preserving treatment fidelity.
For each yoga class, the instructor will lead the student through a series of yoga poses. 
Class will begin with centering and breathwork (pranayama) for 5-10 minutes. This will 
be followed by a series of warm-up poses (~5-10 minutes). After the warm-up sequence, 
students will flow through traditional sun salutations (~10-15 minutes). This will be 
followed by a series of standing poses (~ 15 minutes). Students will then be guided to 
flow through a series of cool-down poses on the floor (~10 minutes). Class will conclude 
with traditional Savasana during which affirmations or meditation are provided (~5-10 
minutes).
Treatment fidelity:
Delivery: Standard treatment manuals and checklists have been developed. To ensure that 
the interventions are delivered as intended, yoga instructors will complete standardized 
checklists after each in-person session.39 In addition, we will select one yoga session 
every 2 weeks for rating by trained research personnel. The PI and interventionists will 
meet to discuss results and problem solve. We will track participant’s completion of 
study components using summary sheets for each visit. Participants will log attendance at 
intervention sessions using the mEMA app. 

Page 20 of 62
Version Date: 07/14/25
Post-intervention session: During the post-intervention assessment session, participants 
be administered a structured questionnaire with a research team member via the secure 
REDCap system. Self-report questionnaires will be completed: 1) Sense of Belonging 
Scale (SBS); 2) Mindfulness Attention Awareness Scale (MASS) 15-item; 3) Generalized 
Anxiety Disorder-7 (GAD-7); 4) NIH toolbox measure of perceived stress. Participants 
will complete semi-structured (See Attachment G) interviews to help us collect data 
pertaining to the MBIs and delivery preferences. Interview responses will be transcribed 
in the REDCap system. These data will be used to adjust the content and format of the 
intervention based on feedback from participants who are our intended users. 
13.Data Analysis
13.1. Describe the data analysis plan, including any statistical procedures.
Consistent with the scope of pilot projects, the proposed study will allow us to 
examine barriers to successful completion of the study, evaluation of acceptability of 
methods to participants, and estimates for future power analysis for a subsequent NIH 
R01 application. Numerical and graphical summaries will be computed for all 
measurements.
Aim 1: To assess precision of estimates, 95% confidence intervals will be calculated 
for rates of recruitment into study, retention to end of study, and participants 
completing all training sessions. Overall adherence will also be described by 
calculating the mean and standard deviation of the number of completed training 
sessions per participant. Qualitative Analyses: Qualitative descriptive analysis40 will 
be used to create a comprehensive summary of the acceptability of the MBI to 
participants. Deductive analysis will be used to determine common themes related to 
acceptability in the domains of affective attitude, burden, ethicality, intervention 
coherence, opportunity costs, perceived effectiveness, and self-efficacy.41 Interview 
responses will be reviewed by two members of the research team to identify themes. 
Themes and preliminary interpretations will be regularly presented to the larger 
research team to resolve any discrepancies or disagreements and check for alternative 
interpretations.
Aim 2: Participant characteristics and baseline survey responses will be described 
using means and standard deviations (SD) for continuous variables and number 
(percentage) for categorical variables. Continuous intervention outcomes will be 
described using means and standard deviations and, due to sample size, difference 
scores from baseline for intervention outcomes will be compared between groups 
using non-parametric statistical tests. Cohen’s d, as a descriptive statistic, will be used 
as an effect size measure to quantify the extent of within group and between group 
differences in means over time.42 Long-term HRV (time domain and frequency 
domain measures derived for each 5 minute epoch within a 24 hour period will be 
averaged) measures will be compared between meditation and yoga groups by t-test. 
EMA and HRV data will be merged into a single dataset, matching upon timestamp. 

Page 21 of 62
Version Date: 07/14/25
Five-minute heart rate epochs immediately following completion of each mEMA 
survey will be selected for analysis.20,34
13.2. Provide a power analysis, if applicable.
14.Provisions to Monitor the Data to Ensure the Safety of Subjects
This section is required when research involves more than Minimal Risk to subjects. 
Describe:
N/A – The PI believes this study constitutes no more than minimal risk for potential 
participants. Therefore, a Data and Safety Monitoring Plan is not required.
14.1. The entity (e.g., DMC, DSMB) or individuals (e.g., medical monitor) who will 
perform data and safety monitoring.  Describe whether they are independent of 
or affiliated with the sponsor or investigator.  If a DMC or DSMB is planned, 
describe the composition of the committee or board. Generally, a DSMB or 
DMC should be composed of experts in all scientific disciplines needed to 
analyze and interpret the data (e.g., epidemiologists, biostatisticians, subject 
matter experts).
14.2. The safety information that will be collected and monitored.
14.3. The frequency or periodicity of review of data, such as specified points in time 
or after a specific number of participants have been enrolled.
14.4. The plans for review of scientific literature and data from other sources that 
may inform the safety or conduct of the study.
14.5. The procedures for analysis and interpretation of the safety data.
14.6. The conditions that would trigger a suspension or termination of the research 
(i.e., stopping rules), if appropriate.
14.7. The plan for reporting findings to the sponsor, investigators, and HRRC.
15.Withdrawal of Subjects
15.1. Describe any anticipated circumstances under which subjects may be 
withdrawn from the research without their consent.
A study investigator may withdraw a participant from the study if, in the
investigator’s judgment, it would be in the participant’s best interest not to
continue participating in the study.
15.2. Describe any procedures for orderly termination/safe withdrawal (e.g., tapering 
of meds, physical exams, laboratory or other tests, etc.). N/A
15.3. Describe any procedures for partial withdrawal (e.g., from procedures but 
allowing continued data collection by record review, phone contact, etc.).
Participants are allowed to withdraw from the study at any time without penalty.
At the time of withdrawal, the participant will be asked if he or she wishes to

Page 22 of 62
Version Date: 07/14/25
withdraw authorization for use of the data collected to that point. However, any data 
that has already been deidentified and analyzed cannot be withdrawn.
15.4. Describe the disposition of existing data/specimens when a subject withdraws.  
Describe any restrictions on a subject’s ability to withdraw any already 
gathered data or specimens (e.g., unable to retrieve because it has been 
stripped of identifiers and no code exists to allow re-linking).  (Note: FDA 
requires that existing data be maintained for studies subject to FDA oversight.)
Participants are allowed to withdraw from the study at any time without penalty.
At the time of withdrawal, the participant will be asked if he or she wishes to
withdraw authorization for use of the data collected to that point. However, any data 
that has already been deidentified and analyzed cannot be withdrawn.
15.5. Describe withdrawal procedures and any limitations in the consent document.
16.Data Management/Confidentiality
If data or specimens will be transferred/shared with an external entity (institution, 
company, etc.), please complete Checklist sections 47 and 48, as applicable.
16.1. All electronic research data and electronic research records MUST be stored 
on the N:\Research-Studies network drive. This drive is not the same as the N: 
departmental drive. 
The N:\Research-Studies network drive is established by the Information 
Security Office (ISO), and it is Part 11 compliant. The N:\Research-Studies 
network drive must be established after the protocol is approved. If you do not 
have this network drive setup, contact the ISO at HSC-ISO@salud.unm.edu. 
All data files will be stored on the N:\Research-Studies network drive.
16.2. Indicate how the research team is permitted to access any sources of 
information about the subjects. 
Participants will be administered a structured questionnaire with a research team 
member via the secure REDCap system. Data collected will be stored on the 
secure REDCap server at the UNM HSC CTSC and on the N:\Research-Studies 
network drive. Data will be accessible to the PI and other trained research 
personnel. Both REDCap and the UNM HSC N:\Research-Studies network or 
VPN support multi-factor authentication. Any paper records, will be stored in a 
locked file cabinet in the UNM HSC locked office of the PI after retrieval. Only 
the PI or designated research coordinator will have access to any identifiers. The 
REDCap data collection tool is both encrypted and password protected. The PI 
has undergone the introductory training and has established an account. All data 
files used during the data analysis will be stored on the N:\Research-Studies 
network drive. Only de-identified data in aggregate will be exported from 
REDCap and used in analyses. All data will be kept for a minimum of six years 
and then destroyed.  
16.3. Note whether the research requires the access, use, or disclosure of Protected 
Health Information including direct identifiers (e.g., name, medical record 

Page 23 of 62
Version Date: 07/14/25
number etc. or a limited data set. See Data Classification definitions in section 
47, after question P. 
Protected health information will not be collected. 
16.4. Several zip codes are below the 20,000-census mark, and HIPAA regulations 
require that the three first digits of the zip code are replaced with “000” in 
order to create a de-identified data set.  Based on the 2010 Census, the sparsely 
populated zip codes in New Mexico are as follows: 878, 879, and 884 pre-fixes. 
Please indicate if these zip codes will be included, and if so, indicate they will 
be replaced with “000” in order to create a de-identified data set. If utilizing 
these zip codes, the data set would be a limited data set.
These zip codes will not be collected.  
16.5. If data will be coded, describe the nature of the code and mechanisms that will 
be used to protect the code (e.g., secure storage, limited access, separate 
location from research data). A subject list linking the unique subject code with 
the subject identifier needs to be kept in a separate location from the data 
collection sheets. Please indicate if such a list will be maintained and where it 
will be maintained separately from the data collection sheets. Please indicate 
where in N:\Research-Studies network drive the link will be stored when storing 
electronically. 
All surveys, and study materials will be coded with a unique study ID number 
assigned at enrollment. The link to study ID numbers will be stored on the secure 
REDCap server at the UNM HSC CTSC and only authorized, IRB approved 
study team members will have access to the information. The link will be 
destroyed when the study is complete. Only de-identified data labeled with the 
unique study ID will be exported from REDCap and used in analyses. All data 
files used during the data analysis will be stored on the N:\Research-Studies 
network drive. Only de-identified data in aggregate will be exported from 
REDCap and used in analyses.
All data collected via mEMA are de-identified. The mEMA platform does not 
require collection of any personal identifying information. The system 
automatically generates a unique identifying code that is assigned to participants 
to enter into the mEMA App. The key linking this code to the unique participant 
study ID is stored outside of the Ilumivu mEMA system in the secure HSC 
REDCap database and only authorized study personnel will have access. Data are 
sent from the wearable Garmin sensor to the mEMA app on the participant’s 
smart phone and then uploaded to Ilumivu’s servers when the participant is within 
WiFi range. All data are encrypted before being pushed to the Ilumivu cloud-
based storage database. Access to the database is restricted to authorized research 
personnel. Only research personnel authorized by the PI can directly access the 
secure cloud-based storage database to download data in CSV file format. All 
data files will be stored on the N:\Research-Studies network drive
16.6. Note whether the data is publicly available. If the data is publicly available a 
data use agreement is not required. “Publicly available” refers to data and/or 

Page 24 of 62
Version Date: 07/14/25
biospecimens that are accessible to anyone in the general public, without the 
need for special qualifications, permissions, or privileges. Examples include 
data/biospecimens available for public purchase, searchable online, or 
available at a library. 
N/A
16.6.1. Examples of types of identifiable data/biospecimens that are not 
considered publicly available are as follows:

Data in the electronic medical record;

Social media data labeled as "private" by the data owner, or not 
readily available without permission of the site 
Owner/Administrator under the Terms of Service of the site; 

Data protected by Copyright; and

Data or biospecimens that have access restrictions (e.g. are only 
available to clinicians or qualified researchers or may only be 
accessed on a secure server. 
16.7. Note whether the data includes information that may be considered sensitive or 
require additional protections such as HIV, genetic test results, mental health 
information, substance abuse information, criminal records, etc. If HIV records 
are being accessed, the protocol must contain the following language: The data 
does include information on HIV. This information has been disclosed from 
records whose confidentiality is protected by state law. State law prohibits 
investigators from making any further disclosure of this information without the 
specific written consent of the person to whom this information pertains or as 
otherwise permitted by law. A person who makes an unauthorized disclosure of 
this information is guilty of a petty misdemeanor and shall be sentenced to 
imprisonment in the county jail for a definite term not to exceed six months or 
the payment of a fine of not more than five hundred dollars ($500), or both.
The data will include information related to participants mental health. 
16.8. Indicate whether a Certificate of Confidentiality (CoC)will be used to protect 
data from forced release (e.g., subpoena) and whether the certificate is in 
place or will be applied for once IRB approval is in place. Please note: NIH 
funded studies are automatically covered under a CoC.  More information on 
Certificates of Confidentiality is available here: 
http://grants.nih.gov/grants/policy/coc/index.htm 
N/A
16.9. Describe the steps that will be taken to secure the data (e.g., training, 
authorization of access, password protection, encryption in transmission and 
at rest, physical controls, certificates of confidentiality, and separation of 
identifiers and data) during storage, use, transmission and transport.
16.9.1.  The UNM Health Sciences REDCap system managed by Clinical and 
Translational Science Center (CTSC) is also considered a secure method for 

Page 25 of 62
Version Date: 07/14/25
data collection and maintenance during the life of the study. The UNM 
Hospital REDCap cannot be used for human subjects research.  Also note 
that multi-factor authentication (MFA), which UNM Health Sciences 
REDCap supports, is required when using another institutions REDCap. 
The data cannot be stored in REDCap after the study closure, and the 
protocol must indicate where data will be stored after the study closes. 
16.9.2. After study closure, long-term data storage must be in the N:\Research- 
Studies network drive. Please indicate this in this section. 
NOTE: Email HSC-ISO@salud.unm.edu to set up the N:\Research-Studies 
network Drive, if needed. For any questions regarding REDCap, please 
contact the UNM Health Sciences Clinical and Translational Center 
(CTSC). 
All surveys, and study materials will be coded with a unique study ID number 
assigned at enrollment. The link to study ID numbers will be stored on the secure 
REDCap server at the UNM HSC CTSC and only authorized, IRB approved 
study team members will have access to the information. The link will be 
destroyed when the study is complete. Only de-identified data labeled with the 
unique study ID will be exported from REDCap and used in analyses. All data 
files used during the data analysis will be stored on the N:\Research-Studies 
network drive. Only de-identified data in aggregate will be exported from 
REDCap and used in analyses.
All data collected via mEMA are de-identified. The mEMA platform does not 
require collection of any personal identifying information. The system 
automatically generates a unique identifying code that is assigned to participants 
to enter into the mEMA App. The key linking this code to the unique participant 
study ID is stored outside of the Ilumivu mEMA system in the secure HSC 
REDCap database and only authorized study personnel will have access. Data are 
sent from the wearable Garmin sensor to the mEMA app on the participant’s 
smart phone and then uploaded to Ilumivu’s servers when the participant is within 
WiFi range. All data are encrypted before being pushed to the Ilumivu cloud-
based storage database. Access to the database is restricted to authorized research 
personnel. Only research personnel authorized by the PI can directly access the 
secure cloud-based storage database to download data in CSV file format. All 
data files will be stored on the N:\Research-Studies network drive
Research records will be maintained for at least 6 years after study completion 
and then destroyed per the following policy: HSC-R-801 PR.1 “Research Data 
and Materials Retention Policy” and then destroyed. After study closure, long-
term data storage must be in the N:\Research- Studies network drive. 
16.10.Describe any procedures that will be used for quality control of collected data 
and/or specimens.

What information will be included in the data or associated with the 
specimens?

Page 26 of 62
Version Date: 07/14/25

How will data be collected and what is the data type (i.e. electronic, hard copy, 
specimen, etc.)?
Data will collected via survey using the secure REDCap server at the UNM 
HSC CTSC and only authorized.
All data collected via mEMA are de-identified. The mEMA platform does not 
require collection of any personal identifying information. The system 
automatically generates a unique identifying code that is assigned to 
participants to enter into the mEMA App. Data are sent from the wearable 
Garmin sensor to the mEMA app on the participant’s smart phone and then 
uploaded to Ilumivu’s servers when the participant is within WiFi range. All 
data are encrypted before being pushed to the Ilumivu cloud-based storage 
database. Access to the database is restricted to authorized research personnel. 
Only research personnel authorized by the PI can directly access the secure 
cloud-based storage database to download data in CSV file format. All data 
files will be stored on the N:\Research-Studies network drive.
The PI has completed the HSC-ISO Cloud Bases Security System Review (see 
attachment H) as well as the required User Policy (see Attachment I)

How long will the data or specimens be stored? See sections 16.15 – 16.17 for 
data storage requirements. 
Research records will be maintained for at least 6 years after study completion 
and then destroyed per the following policy: HSC-R-801 PR.1 “Research Data 
and Materials Retention Policy” and then destroyed. After study closure, long-
term data storage must be in the N:\Research- Studies network drive. 

Who will have access to each method of data collection and/or specimens?
Only authorized, IRB approved study team members will have access to the 
information.
16.11.How will the data and specimens be transported. Describe if data will be 
collected, transmitted, and/or stored via the internet, the identifiability of the 
data, and the security measures that will be employed to protect it (if data is 
de-identified, explicitly state that).
All data collected via mEMA are de-identified. The mEMA platform does not 
require collection of any personal identifying information. The system 
automatically generates a unique identifying code that is assigned to participants 
to enter into the mEMA App. Data are sent from the wearable Garmin sensor to 
the mEMA app on the participant’s smart phone and then uploaded to Ilumivu’s 
servers when the participant is within WiFi range. All data are encrypted before 
being pushed to the Ilumivu cloud-based storage database. Access to the database 
is restricted to authorized research personnel. Only research personnel authorized 

Page 27 of 62
Version Date: 07/14/25
by the PI can directly access the secure cloud-based storage database to download 
data in CSV file format. All data files will be stored on the N:\Research-Studies 
network drive.
The PI has completed the HSC-ISO Cloud Bases Security System Review (see 
attachment H) as well as the required User Policy (see Attachment I)
16.12.Describe if data will be collected by audio or video recording, how the 
recordings will be secured, whether and when recordings will be transcribed, 
if the transcription will include identifiers, if, when, and how the recordings 
will be deleted.  Describe if the subjects will have the opportunity to review the 
recordings and request full or partial deletion. If the recordings may include 
persons other than the subjects, describe how this will be managed. 
N/A
16.13.Describe if the data will include photographs, what will be included in the 
photographs, and how the photographs will be secured.  Describe if subjects 
will have the opportunity to review the photographs and request destruction.  If 
the photographs may include persons other than the subjects, describe how this 
will be managed.
N/A 
16.14.The National Institutes of Health (NIH) has issued the Data Management and 
Sharing (DMS) policy effective January 25, 2023, to promote the sharing of 
scientific data. The NIH Policy for Data Management and Sharing (NOT-OD-
21-013) requires researchers to include a data management and sharing 
(DMS) plan in funding applications. The DMS Policy applies to all research, 
funded in whole or in part by NIH, that results in the generation of scientific 
data.  If applicable, complete HRP – 234 – FORM – NIH Data Management 
and Sharing Policy and upload to the study record at time of initial new study 
submission. At time of study closure, complete HRP-235 – FORM – NIH Data 
Management  & Sharing Policy_Study Closure Form. Clarify if this policy 
applies. 
N/A
16.15.State how long research record will be maintained. Note: Federal regulations 
require that research records will be maintained for at least 3 years after study 
completion and then will be destroyed. 
Research records will be maintained for at least 6 years after study completion 
and then destroyed per the following policy: HSC-R-801 PR.1 “Research Data 
and Materials Retention Policy” and then destroyed. After study closure, long-
term data storage must be in the N:\Research- Studies network drive. 
16.16.Research records of minors (under 18) must be retained until the minor turns 
22 years old per the following policy: HSC-R-801 PR.1 “Research Data and 
Materials Retention Policy” and then will be destroyed. 

Page 28 of 62
Version Date: 07/14/25
N/A
16.17.HIPAA Requirements: Any research that involved collecting identifiable health 
information is subject to HIPAA requirements. As a result, records must be 
retained for a minimum of 6 years after each subject signed an authorization, 
and then will be destroyed.
17.Data and Specimen Banking
17.1. If data or specimens will be banked or archived locally for future use, provide 
the name and study number of the repository that they will be deposited into.  
Describe exactly what data or specimens will be banked and for what purposes, 
and whether the data or specimens will include identifiers, be coded, or be fully 
stripped of all identifiers with no code or key that would allow relinking.  Be 
certain to describe the banking in the primary consent.  A separate consent and 
authorization, if applicable, will be necessary for the banking activity itself and 
is typically provided by the repository.  If you need to establish a repository for 
the purposes of banking or archiving data or specimens, a separate submission 
for the repository is needed as this is considered to be a distinct research 
activity under the regulations. 
N/A: we will not be banking data or specimens. All data will be stored in the 
HSC-maintained and secured REDCap data base or on the N:\Research-Studies 
network Drive.
17.2. If this is a multi-center study, and/or if data or specimens will be banked or 
archived elsewhere, identify who the holder of the data or specimens will be, 
exactly what data or specimens will be banked and for what purposes, and 
whether the data or specimens will include identifiers, be coded, or be fully 
stripped of identifiers with no code or key that would allow relinking.  A 
Materials Transfer or other agreement may be necessary, please consult with 
the HSC Sponsored Projects Office at 505-272-6264 or by email at hsc-
preaward@salud.unm.edu. Material Transfer Agreement procedures may be 
found at http://hsc.unm.edu/financialservices/preaward/ancillary-
agreements/material-transfer-agreements/procedures.html.   Be certain to 
describe the banking in the consent and authorization, using opt-in procedures, 
and the procedures for subjects to request withdrawal of their data or 
specimens and any limitations on their ability to do so. 
18.Risks to Subjects
18.1. List the reasonably foreseeable risks, discomforts, hazards, or inconveniences 
to the subjects related the subjects’ participation in the research.  Describe the 
probability, magnitude, duration, and reversibility of the risks. Consider 
physical, psychological, social, legal, and economic risks.  Note that almost all 
research includes the risk of a breach of confidentiality and/or privacy.
18.2. If applicable, indicate which procedures may have risks to the subjects that are 
currently unforeseeable.

Page 29 of 62
Version Date: 07/14/25
There are minimal risks to participants from this research. Since breach of 
confidentiality is the most likely risk, participants will be administered informed 
consent privately in order to insure anonymity. All data collected as part of the study 
will be identified with a study number. Any forms and survey results that are obtained 
will be securely stored in either an encrypted database or on the N:\Research-Studies 
network Drive. Any links between personal identifying information and study ID will 
be destroyed upon completion of the study. 
Each participant will complete surveys regarding mental well-being (e.g. anxiety, 
stress). These surveys may cause discomfort or stress. To minimize stress, all 
interviews will be conducted in a private room in a non-judgmental manner by trained 
research personnel. We will encourage all study participants to discuss concerns 
about mental health or other health issues with their health-care provider. 
Additionally, meditation is generally not considered harmful, however, it is possible a 
participant may experience some discomfort while participating in meditation. 
Meditation can reveal uncomfortable thoughts or emotions. If a participant 
experiences distress, a trained research team member will provide the participant with 
information related to the UNM Counseling, Assistance, & Referral Services 
(CARS).
Yoga is generally considered to be a safe form of physical activity when performed 
properly under the guidance of trained instructors. However, as with other forms of 
physical activity, there is always a chance that an injury may occur. Most common 
discomforts include muscle soreness, pain, fatigue, or emotional discomfort. We will 
ask participants to complete an Exercise Participation Screener to determine exercise 
readiness. The certified yoga instructors are trained to provide guidance on 
modifications to make sure everyone can participate safely. In the rare event of an 
injury, research personnel will assist the participant to make an appointment at the 
UNM LoboCare Clinic. 
18.3. If applicable, indicate which procedures may have risks to an embryo or fetus 
should the subject be or become pregnant.  If pregnancy testing or birth control 
provisions are required, describe these.
N/A
18.4. If applicable, describe risks to others who are not subjects.
N/A
18.5. Describe the steps being taken to minimize the probability or magnitude of 
risks.
Note: All risks described here should also be described in the consent document.
19.Potential Benefits to Subjects
19.1. Describe the potential benefits that individual subjects may experience from 
taking part in the research. Include as may be useful for the IRB’s 
consideration, the probability, magnitude, and duration of the potential 

Page 30 of 62
Version Date: 07/14/25
benefits. Note: Compensation for research participation is not considered a 
benefit.
19.2. Indicate if there is no direct benefit. Do not include benefits to society or others 
in this section.
Note: All potential benefits described here should also be described in the consent 
document.
Participants will be participating in either meditation or yoga which may provide them 
with direct individual benefits. It has long been established that mindfulness practices 
like meditation and yoga are associated with positive mental health outcomes.8,9 
Mindfulness practices are also associated with improved physiologic function including 
autonomic nervous system (ANS) function.13
20.Recruitment Methods
20.1. Describe when, where, and how potential subjects will be recruited.
20.2. Describe the methods that will be used to identify potential subjects (e.g., chart 
review, referral, etc.). 
20.3. Describe materials that will be used to recruit subjects (e.g., emails, scripts, 
advertisements, brochures, flyers, etc.). Attach draft copies of the documents or 
audio or video recordings with the application. Once the draft has been 
approved, the final copy of the printed material, audio or video recording must 
be submitted for review and approval prior to implementation.  Please see 
Worksheet HRP-315 for information on advertisement standards. The 
preference is recruitment materials are submitted on Word document(s), 
however, this is not required when not possible. Clarify accordingly in this 
section. 
We will recruit participants from the UNM HSC. The UNM CON currently employs 
71 faculty and 71 staff with additional nurse faculty and staff within the HSC. 
Participants will be recruited in-person during monthly faculty, staff, and all college 
meetings. We will also recruit participants through college email listservs using IRB 
approved flyers (see Attachment D) and by posting IRB approved fliers in common 
areas of the CON and Public Health Excellence Building. Interested participants will 
be contacted by study staff and screened for eligibility.
21.Provisions to Protect the Privacy Interests of Subjects
21.1. Describe the steps that will be taken to protect subjects’ privacy interests. 
“Privacy” refers to persons and their interest in controlling the access that 
others have to themselves.  For example, based on their privacy interests, 
people may want to control:

The time and place/setting where they are examined or provide information

The nature of the information they provide

The nature of the experiences they are exposed to 

Page 31 of 62
Version Date: 07/14/25

Who may observe or have access to information about them
For example, individuals may not want to be approached for participation, 
provide responses to a research interview, or undergo a research procedure 
in a location where they may be seen or overheard.
The risk of loss of privacy is the greatest risk in this study. All reasonable attempts to 
maintain the privacy of participants will be taken. 
Screening for study eligibility will take place in a private room with a closed door. 
This will occur in the Clinical Research Rooms housed within the CON Research 
Laboratory suite.
21.2. Describe the steps that will be taken to protect subjects’ privacy including 
privacy protections during recruitment, consent, and data collection. Issues 
related to data are addressed in the Data Management/Confidentiality Section. 
The consent process and the study visit will take place in a private room with a closed 
door in the Clinical Research Rooms housed within the CON Research Laboratory.
Only study members who have completed training will be authorized to administer 
informed consent and interviews. 
22.Economic Burden to Subjects
22.1. Describe any costs that subjects may be responsible for because of participation 
in the research.  Clearly stipulate what procedures are standard of care and 
what procedures are research-related in the table below. Please place an X in 
the box for the responsible party for each procedure involved.
List any costs to participants (or their 3rd party payer); include any charges for 
study procedures, visits, or drug/devices.
There is no cost to participants to participate in this study. 
Responsible Party
Research Procedures
Number of 
Samples/Procedures
Study
3rd Party Payer 
or Participant
     
     
☐
☐
     
     
☐
☐
     
     
☐
☐
     
     
☐
☐
     
     
☐
☐
     
     
☐
☐
     
     
☐
☐
     
     
☐
☐
Standard of Care Procedures
Number of 
Responsible Party

Page 32 of 62
Version Date: 07/14/25
Samples/Procedures
Study
3rd Party Payer 
or Participant
     
     
☐
☐
     
     
☐
☐
     
     
☐
☐
     
     
☐
☐
     
     
☐
☐
     
     
☐
☐
     
     
☐
☐
     
     
☐
☐
22.2. List any other costs to participants not already described above. 
22.3. Indicate whether subjects will be charged for investigational drugs, devices, 
procedures
22.4. Explain who will be responsible for paying for treatment of adverse events
22.5. Ensure that the cost section of the consent form reflects the cost that are 
covered by the sponsor and the costs for which the subjects (or 3rd party 
payers) are responsible.
23.Compensation
23.1. Describe any plans for compensation or reimbursement for subjects (amounts, 
methods (e.g., merchandise card), and payment schedule; cash and checks are 
institutionally prohibited).  Describe why the proposed amount is reasonable 
and appropriate for the subjects’ time and inconvenience.  Credit for payment 
should be prorated and not be contingent upon the participant completing the 
entire study.  Any amount paid as bonus for completion of the entire study 
should not be so great that it could unduly induce subjects to remain in the 
study when they otherwise would have withdrawn.  Note: Consult with your 
department official for reporting requirements associated with merchandise 
cards distributed to research subjects. De-identified reporting of the 
distribution of merchandise cards to department officials is preferred. 
Participants will not receive compensation other than the meditation or yoga 
sessions they are allocated to as part of the study.
24.Compensation for Research-Related Injury
24.1. If the research involves more than Minimal Risk to subjects, describe the plan 
for compensation in the event of research related injury.
There is no compensation for costs related to treating any injuries incurred during the 
course of the study
24.2. If subjects are responsible for seeking their own form of care for research-
related injury, describe how this will be communicated and what options are 
available to participants.

Page 33 of 62
Version Date: 07/14/25
Each participant will complete surveys regarding mental well-being (e.g. anxiety, stress). 
These surveys may cause discomfort or stress. To minimize stress, all interviews will be 
conducted in a private room in a non-judgmental manner by trained research personnel. 
We will encourage all study participants to discuss concerns about mental health or other 
health issues with their health-care provider. Additionally, meditation is generally not 
considered harmful, however, it is possible a participant may experience some discomfort 
while participating in meditation. Meditation can reveal uncomfortable thoughts or 
emotions. If a participant experiences distress, a trained research team member will 
provide the participant with information related to the UNM Counseling, Assistance, & 
Referral Services (CARS).
Yoga is generally considered to be a safe form of physical activity when performed 
properly under the guidance of trained instructors. However, as with other forms of 
physical activity, there is always a chance that an injury may occur. Most common 
discomforts include muscle soreness, pain, fatigue, or emotional discomfort. We will ask 
participants to complete an Exercise Participation Screener to determine exercise 
readiness. The certified yoga instructors are trained to provide guidance on modifications 
to make sure everyone can participate safely. In the rare event of an injury, research 
personnel will assist the participant to make an appointment at the UNM LoboCare 
Clinic. 
25.Consent Process
25.1. Indicate whether you will you be obtaining consent, and if so describe:
25.1.1. Who will be responsible for obtaining consent and their 
qualifications/training to do so.  Be certain to identify which study team 
members will obtain consent in Huron IRB under Project Contacts.
Study personnel with training and experience related to consenting participants 
will be authorized to obtain participant consent for this study. All study team 
members will be current in their HIPAA and CITI trainings.
25.1.2. Where will the consent process take place and the provisions for privacy.
Study participants will meet with a member of the study team in a private room 
Clinical Research Room housed within the CON Research Laboratory suite.
25.1.3. The steps that will be taken to minimize the possibility of coercion or 
undue influence
Participants will be informed, both in writing and verbally, that their participation 
in the study is voluntary. They will also be informed that they may discontinue 
the study at any point in time and that their decision to participate or decline will 
not affect their employment at UNM HSC or their ability to participate in the 
yoga and meditation sessions.
25.1.4. The waiting period available between reviewing the study and consent 
with the potential subject and obtaining the consent.

Page 34 of 62
Version Date: 07/14/25
Participants who are eligible will be given the opportunity to take the consent 
form home for review prior to deciding whether to participate or not in the study. 
Potential participants will be encouraged to think about their decision and will be 
provided with contact information to schedule an appointment at their 
convenience.
25.1.5. Processes to ensure ongoing consent throughout the study.
25.1.6. Any steps that will be taken to enhance understanding
All participants will be provided a copy of the informed consent to read along 
with the research personnel throughout the consent discussion processes. 
Participants will be encouraged to ask questions throughout the process. As 
consent is administered, research personnel will periodically stop to ask 
participants to provide their understanding of what was just discussed. If the 
participant does not indicate understanding, information will be reviewed and 
questions answered until the participant states they fully understand.  Every 
participant will be asked if all of their questions about volunteering in the study 
have been answered prior to completing the consent form.
25.1.7. Any procedure/testing for ensuring that the consent is understood by the 
potential subject (e.g., teach back)
See above
25.1.8. There are no provisions for a waiver of consent for FDA regulated 
research.  
25.1.9. NOTE: For adults and per NM state law, consent and HIPAA 
authorization are required in order to access their mental health 
information or developmental disabilities information if access is before 
July 1, 2019. For adults records only, information can be accessed from 
July 1, 2019 onwards without consent and HIPAA authorization. 
Subjects not fluent in English
25.1.10.Indicate what language(s) other than English speakers will be enrolled as 
participants. 
25.1.11.If you anticipate enrolling subjects who do not understand or have 
limited fluency in English, describe the process to ensure that the oral 
and written information provided to those subjects initially and 
throughout their participation will be in the language they understand 
(e.g., use of translations and interpreters). Please note that translations 
of consent documents and subject materials will likely be required once 
the content of the English-language version is approved.
25.1.12. Short-form consent documents are available for unanticipated 
enrollments of persons who don’t understand or have limited fluency in 
English.  However, based upon the nature of the research (e.g., clinical 
trials) subsequent translation of the consent document may be required so 

Page 35 of 62
Version Date: 07/14/25
that the subject has access to written information about the research in a 
language they understand. Clarify that the English consent will be used as 
the summary of the research in combination with the short form consent. 
This study will only enroll participants fluent in English. Non-English speaking            
individuals are excluded because the ability to accurately and completely 
communicate study information, answer questions about the study, and obtain consent 
are necessary. 
Cognitively Impaired Adults/Adults Unable to Consent/Use of a Legally 
Authorized Representative
N/A. This study will not enroll cognitively impaired adults unable to provide 
consent
25.1.13. The HRRC must specifically approve the enrollment of adults unable to 
consent and adults with cognitive impairment or limited decision-making 
capacity.  Complete the applicable checklist in the Checklists Section of 
this Protocol Template.
25.1.14. Describe whether the entire subject population or a portion of it is 
expected to have limited or no ability to provide legally effective consent.
25.1.15. Describe the process to determine whether an individual is capable of 
consent. 
25.1.16. Describe the process to determine whether a prospective subject is 
capable of providing consent.  Include who will be responsible for 
determining capacity and how it will be documented.
25.1.17. Describe how the participant’s decisional capacity will be assessed as 
the study proceeds in order to evaluate any fluctuation in the participant’s 
level of capacity to consent. 
25.1.18. If it can be anticipated that some or all subjects will regain capacity to 
provide consent, describe the provisions to provide them with information 
about their participation in the research and to seek their consent for 
ongoing participation, if applicable.
25.1.19. For research conducted in New Mexico, review “SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013)” to be 
aware of which individuals in the state meet the definition of “legally 
authorized representative.”
25.1.20. For research conducted outside of the New Mexico, provide information 
that describes which individuals are authorized under applicable law to 
consent on behalf of a prospective subject to their participation in the 
procedure(s) involved in this research. 
25.1.21. Describe how the representative’s authority to provide consent will be 
confirmed. 
25.1.22. Describe the process for assent of the subjects. Indicate whether:

Page 36 of 62
Version Date: 07/14/25

Assent will be required of all, some, or none of the subjects. If some, 
indicated, which subjects will be required to assent and which will not.

If assent will not be obtained from some or all subjects, an explanation of why 
not.

Describe whether assent of the subjects will be documented and the process to 
document assent.
Minor Subjects (individuals who are under the age of 18)
N/A/ This study will not enroll individuals under the age of 18. We are recruiting 
individuals employed as nurse faculty or staff at the UNM HSC. 
25.1.23. Provide the age range of the children anticipated to be enrolled in the 
research.
25.1.24. Describe the criteria that will be used to determine whether a 
prospective subject has not attained the legal age for consent to 
treatments or procedures involved in the research under the applicable 
law of the jurisdiction in which the research will be conducted. 

For research conducted in New Mexico, review “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013)” to be aware of which 
individuals in the state meet the definition of “children.”

For research conducted outside of New Mexico, provide information that 
describes which persons have not attained the legal age for consent to 
treatments or procedures involved the research, under the applicable law of 
the jurisdiction in which research will be conducted. 
25.1.25. Describe whether parental permission will be obtained from:

One parent (may be permissible, if the HRRC approves, for (1) research not 
involving greater than minimal risk, or (2) research involving greater than 
minimal risk but presenting the prospect of direct benefit to individual 
subjects)

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. (Permissible for research involving greater than 
minimal risk and no prospect of direct benefit to individual subjects.)
25.1.26. Describe whether permission will be obtained from individuals other 
than parents, and if so, who will be allowed to provide permission. 
Describe the process used to determine these individuals’ authority to 
consent.
25.1.27. Indicate whether the children to be enrolled in the research should be 
capable of providing assent.
25.1.28. Indicate if assent will be obtained from all, some, or none of the children 
and provide justification.  If assent will be obtained from some children, 
indicate which children will be asked for assent.

Page 37 of 62
Version Date: 07/14/25
25.1.29. When assent of children will be obtained describe the proposed assent 
process and whether and how assent will be documented.  The assent 
process and documentation of assent should be age-appropriate and may 
consist of different procedures for different age groups.
25.1.30. NOTE: For minors (less than 18 years of age) and per NM state law, 
consent and HIPAA authorization are required in order to access their 
mental health information and/or developmental disabilities information. 
Waiver or Alteration of Consent Process (consent will not be obtained, required 
element of consent will not be included, or one or more required elements of 
consent will be altered) 

Complete the applicable checklists in the Checklists section of this Protocol 
Template if you are requesting a waiver or alteration of consent for this 
research

Consent can be waived for all of some subjects (e.g., the research includes a 
retrospective cohort)

Consent can be waived in full or in part (e.g., partial waiver for recruitment 
purposes)
26.Documentation of Consent
26.1. Describe if you plan to use a consent form to document consent.  Use one of the 
consent templates available on the HRPO website.  Attach consent documents 
as fully editable Word documents (i.e., please don’t submit protected documents 
or pdfs).  Please include page numbers in the footer (e.g., Page 1 of XX).
A written consent form will be used to document consent for the study. Please see 
the attached consent form (Attachment C). 
26.2. If the study is collecting and/or storing tissue samples, include a Tissue Banking 
Consent Form (and Authorization if the specimens will be accompanied by 
PHI).
26.3. Describe if you plan to obtain consent but will be using a script, information 
sheet, or other mechanism.  If you will obtain consent verbally, attach a consent 
script and information sheet, if you will be providing one.  If you will be 
obtaining consent via an on-line survey, please use the survey cover letter 
consent template on the HRPO website and include your email script with your 
submission. 
Complete the checklist for “Waiver of Documentation of Consent” in the 
Checklists section of this Protocol Template.  If you will be excluding or 
modifying one or more of the required elements of consent you will also need to 
request an Alteration of Consent.
NOTE: If FDA regulated, there is no provision for waiver of written 
documentation of consent. 

Page 38 of 62
Version Date: 07/14/25
27.Study Test Results/Incidental Findings
27.1. Individual Results: Indicate whether you intend to share study test or 
procedure results with study participants. If so, describe which results will be 
shared, whom the results will be shared with (e.g., subjects, parents, primary 
care physicians), and how the findings will be communicated (e.g., in person 
consultation, posting in medical record, etc.).  If the findings are the results of 
laboratory tests, indicate whether the tests will be processed in a CLIA-certified 
lab.  
Specific results of questionnaires and physiologic data will not be shared with 
individual study participants.
27.2. Incidental Findings: Based upon the nature of the research, and the tests that 
will be performed, indicate if you anticipate that the research may result in 
incidental findings (traditionally defined as results that arise that are outside 
the original purpose for which the test or procedure was conducted (for 
example, a potential tumor is identified but this is not the reason imaging was 
obtained).  If so, please describe your plans for communication of such results 
to subjects and their health care providers, if appropriate.  If there are 
limitations on the accepted validity of the results (e.g., test performed in non-
CLIA lab, test available in the context of research only), please describe and 
provide a plan for confirmatory testing or justification for why it is not 
recommended, not necessary, or not possible.  If you do not plan to provide 
results, provide justification.  

Be certain to describe your plans for provision of study results and incidental 
findings in your consent documents.

For more information on incidental findings, please consult the President’s 
Bioethics Commission Report “Anticipate and Communicate: Ethical 
Management of Incidental and Secondary Findings in the Clinical, Research, 
and Direct-to-Consumer Contexts”: 
https://bioethicsarchive.georgetown.edu/pcsbi/node/3183.html

For information specific to Whole Genome Sequencing, please consult the 
President’s Bioethics Commission Report “Privacy and Progress in Whole 
Genome Sequencing”: https://bioethicsarchive.georgetown.edu/pcsbi/node/764.html
Incidental Findings: It is possible that during this study unexpected findings 
may arise during structured interviews and we acknowledge these in the consent 
form. Anticipated potential findings may include clinically significant symptoms 
of anxiety. A trained research team member will provide the participant with 
information related to the UNM Counseling, Assistance, & Referral Services 
(CARS). 
28.Sharing Study Progress or Results with Subjects
28.1. Describe whether you intend to provide subjects with a summary of the trial 
progress while the study remains underway.  If so, describe your plans and the 
mechanisms that you will use (e.g., newsletter, handouts, mailings, etc.).  Please 

Page 39 of 62
Version Date: 07/14/25
note that all written materials that will be provided to subjects need to be 
reviewed and approved by the HRRC prior to use.
While the study is underway, we will not provide summaries of progress. 
28.2. Describe whether you intend to provide subjects with a summary of the study 
results after the study is complete.  If so, indicate if the information will include 
study arm assignment if the study involved blinding.  Please describe your plans 
for dissemination of results and the mechanisms that you will use.  Please note 
that HRRC review of materials may be required, consult with the HRPO prior 
to distribution.
After completion of the study, de-identified, aggregate results will be 
disseminated through presentations and publications. 
29.Inclusion of Vulnerable Populations
29.1. If the research involves individuals who are vulnerable to coercion or undue 
influence, describe who will be included, why their participation is necessary or 
warranted, and any additional safeguards included to protect their rights and 
welfare. The following is not intended to serve as a comprehensive list, rather to 
provide some examples for your consideration.
29.1.1. If the research includes students or employees, describe protections to 
promote the voluntary nature of participation and minimize the risks 
associated with access to or use of data by persons in a position of 
actual or perceived authority. 
In order to promote the voluntary nature of participation of UNM HSC 
employees, during the consent process, potential participants will be informed, 
both in writing and verbally, that their participation in the study is voluntary and 
that they may participate in the program without being part of the study. They 
will also be informed that they may discontinue the study at any point in time and 
that their decision to participate or decline will not affect their employment at 
UNM HSC or their ability to attend the yoga and meditation sessions.
29.1.2. If the research includes economically disadvantaged persons, describe 
the mechanisms to promote the voluntary nature of participation and 
to minimize economic risks associated with participation.
29.1.3. If the research includes educationally disadvantaged persons, describe 
the mechanisms to ensure that they are provided information and 
materials that enhance their ability to understand the research initially 
and throughout their participation in the research.
29.1.4. If the research includes seriously or terminally ill patients, describe 
the mechanisms to ensure that they understand the true purposes of the 
research, the risk it entails, and what is known or not understood 
about the likelihood of individual benefit

Page 40 of 62
Version Date: 07/14/25
29.1.5. If the research involves pregnant women, note this here and complete 
the Pregnant Women Checklist in the Checklist Section of this 
Protocol Template.  
29.1.6. If the research involves neonates of uncertain viability or non-viable 
neonates, note this here and complete the applicable checklist in the 
Checklist Section of this Protocol Template.  
Note: For the purposes of the federal research regulations, viability is 
established shortly after delivery. “Viable, as it pertains to the 
neonate, means being able, after delivery, to survive (given the benefit 
of available medical therapy) to the point of independently 
maintaining heartbeat and respiration.” Once a neonate has been 
determined viable, they are considered a child under the regulations.
29.1.7. If the research involves prisoners, note this here and complete the 
Prisoners Checklist in the Checklist Section of this Protocol Template.  
29.1.8. If the research involves persons who have not attained the legal age 
for consent to treatments or procedures involved in the research 
(“children”), note this here and complete the Children Checklist in the 
Checklist Section of this Protocol Template.  
29.1.9. If the research involves cognitively impaired adults, note this here and 
complete the Cognitively Impaired Adults Checklist in the Checklist 
Section of this Protocol Template.
30.Community-Based Participatory Research
30.1. Describe involvement of the community in the design and conduct of the 
research.  If members of the community will fulfill key research responsibilities 
such as recruitment and consent, describe what research activities community 
members will be responsible for, how they will be trained, and the plan for 
quality oversight.  When relevant, please include information regarding the 
approval of the research at collaborating sites (e.g., Albuquerque Public 
Schools).
Note: “Community-based Participatory Research” is a collaborative approach 
to research that equitably involves all partners in the research process and 
recognizes the unique strengths that each brings. Community-based 
Participatory Research begins with a research topic of importance to the 
community, has the aim of combining knowledge with action and achieving 
social change to improve health outcomes and eliminate health disparities.
N/A. This study is not community-based participatory research.
31.Research Involving American Indian/Native Populations
31.1. Please provide detailed information of the local research context including how 
the research questions are sensitive to community attitudes and how the PI has 
ascertained that the proposed research is acceptable to the local population in 
terms of tribal regulations, applicable law and standards of professional 

Page 41 of 62
Version Date: 07/14/25
conduct and practice.  Attach any supporting documents from tribal officials or 
entities addressing the status or requirements for review of the research activity 
from tribal officials or tribal entities (for example, Indian Health Services, the 
Navajo Nation IRB).  
This research does not specifically sample American Indian/Native Populations.
32.Transnational Research
32.1. When conducting transnational research, you must ensure that subjects are 
provided equivalent and appropriate protections for human subjects located 
outside of the United States.  Please refer to the following website for current 
OHRP interpretations of research standards, equivalent protections, and for a 
current compilation of international research standards and regulatory 
agencies. http://www.hhs.gov/ohrp/international/index.html 
N/A
32.2. Location: Describe the research locale and how and why the setting was 
chosen.  Describe significant cultural norms, local laws, and differences with 
U.S. culture with respect to autonomy, perception of research, recruitment, 
consent, age of majority, parental permission, etc.  
32.3. Study Personnel: Describe the qualifications of the researcher and research 
team to perform research in the community/culture where it will occur.  Indicate 
the research team’s ability to speak, read, and write the language of the 
subjects.  Describe the researcher’s knowledge of or expertise in local or state 
laws, culture, and community norms. Indicate if the researcher was invited into 
the community (provide documentation, if available).  If not invited, then 
describe how the researcher will have culturally appropriate access to the 
community.
32.4. Consent: Describe the consenting procedure that you intend to use for the 
research and why it is appropriate for the community where the research will 
occur.  Describe how you will ensure that potential subjects understand the 
research, and the voluntariness of their participation.
32.5. Community Consultation: Describe any plans for community consultation to 
assess receptiveness to the proposed research and to obtain feedback on how it 
should be conducted and any limitations or boundaries that should be 
respected.  Describe plans for dissemination of results to subjects and to the 
community. 
33.Drugs or Devices
33.1. If the research involves drugs or devices, describe your plans to store, handle, 
and administer those drugs or devices so that they will be used only on subjects 
and be used only by authorized investigators.
This study will use a commercially available Garmin device. Garmin 
Vivosmart5® uses optical technology in which a series of lights emitted by 

Page 42 of 62
Version Date: 07/14/25
photoplethysmography (PPG) sensors against the skin illuminate capillaries to 
detect changes in blood volume and providing heart rate data in real time.31  
33.2. If the drug is investigational (has an IND), identify the holder of the 
IND/IDE/Abbreviated IDE.
33.3. For research involving drugs, complete and attach a signed “Drug 
Attachment”, available in Huron IRB or the HRPO website
33.4. For research involving devices, complete the “Device Checklist” in the 
Checklist Section of this template.
N/A
34.Principal Investigator’s Assurance
By submitting this study in the Huron 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. 
☒ The PI attests that all electronic research records/data will be locally stored on the 
N:\Research-Studies network drive. This drive is established by the Information Security 
Office (HSC-ISO@salud.unm.edu).
☒ Data will be collected, maintained and archived or destroyed per HSC Data Security Best 
Practices, including:
1. Best Practice for data collection is to be directly entered onto a data collection 
form that is stored in a secured access folder on HSC central IT managed network 
storage (N:\Research-Studies network drive), or in a secure HSC Information 
Security approved system such as REDCap during the data collection phase. At 
the time of the study closure, the data needs to be transferred to the N:\Research-
Studies network drive.
2. Temporary storage -- de-identified data collection, if done in a clinical setting 
or other setting that does not allow direct entry into a secured system, may be 
temporarily stored using encrypted removable (e.g. CD-ROM (a compact disc 
used as a read-only optical memory device for a computer system), USB 
flash/thumb drive (a small external flash drive that can be used with any computer 
that has a USB port), etc.) media or a university owned electronic storage device 
or hard copy document. This temporarily stored data must be transferred to HSC 
central IT managed network storage and deleted from the temporary device as 
soon as possible.  The important security safeguard is that no identifiers be 
included if the data is entered or stored using a storage container that is not 
managed by HSC central IT.
3. Permanent (during data analysis, after study closure) storage must reside on 
HSC central IT managed network storage (N:\Research-Studies network drive). 
Processing of data (aggregation, etc.) are to be carried out in such a way as to 
avoid creating/retaining files on untrusted or unsecure storage devices/computers 

Page 43 of 62
Version Date: 07/14/25
(an example of an unapproved storage location would be storing the data locally 
on your HSC computer hard drive rather than on the HSC network drives). 
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.

Page 44 of 62
Version Date: 07/14/25
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):
     
B. Describe the purpose for the review (e.g., screening):
     
C. Describe who will conducting the reviews (e.g., investigators, 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:      

Page 45 of 62
Version Date: 07/14/25
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.

Page 46 of 62
Version Date: 07/14/25
A. Are you requesting a waiver of documentation of consent for some or all 
subjects?
☐All
☐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 Huron IRB.
☐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 elements 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:
     

Page 47 of 62
Version Date: 07/14/25
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:
     
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:
     

Page 48 of 62
Version Date: 07/14/25
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
☐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):
     

Page 49 of 62
Version Date: 07/14/25
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
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.
     

Page 50 of 62
Version Date: 07/14/25
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.
     
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:
     

Page 51 of 62
Version Date: 07/14/25
(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:
     
(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.

Page 52 of 62
Version Date: 07/14/25
     
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.
     
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.
     

Page 53 of 62
Version Date: 07/14/25
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
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
     

Page 54 of 62
Version Date: 07/14/25
☐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
     
b) The risks involved in the research are commensurate with risks that 
would be accepted by non-prisoner 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
     

Page 55 of 62
Version Date: 07/14/25
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.
Ambulatory assessment of physiological processes will occur through use of a wearable wrist 
electronic sensor, Garmin Vivosmart5®, which uses optical technology. The Garmin device is 
commercially available and being used for the intended purpose. The Garmin device is not being 
used as a medical device it is only a research measurement tool and the data that it records is not 
being monitored in real-time by the study team. Safety and effectiveness of this device are not 
being evaluated. 
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?
☐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

Page 56 of 62
Version Date: 07/14/25
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.).  
47.Data Transfer/Sharing/Storage (Checklist) (required –do not delete even if 
the answer is “No”) 
Data Use Agreement (DUA) Contacts: 
Sponsored Projects Office 

HSC-PreAward@salud.unm.edu
Privacy Office 

HSC-Privacy@salud.unm.edu
Information Security Office

HSC-ISO@salud.unm.edu 
NOTE: For any data transfer/sharing questions or for help filling out this section, please 
email all contacts listed above. 
All information stated in this section must be congruently stated in all other applicable 
sections of the protocol.  
Provide all information requested, meaning all questions must be answered, if the research 
involves transferring/sharing of data with an external entity (institution, company, etc.). 

Page 57 of 62
Version Date: 07/14/25
A. Will UNM data be transferred/shared with an external entity (i.e. another institution, 
company, etc.) or will an external entity’s data be transferred/shared with UNM?  
☐Yes. If yes, all questions must be answered congruently based on protocol 
provisions.

If yes, does this research involve federal funding: ☐Yes ☐No

If yes, provide the name of the funder:        
☐ No. If no, the remainder of this section does not apply. 
☐ The data is publicly available. If the data is publicly available a data use 
agreement is not required and the remainder of this section does not apply. 
“Publicly available” refers to data and/or biospecimens that are accessible to 
anyone in the general public, without the need for special qualifications, 
permissions, or privileges. Examples include data/biospecimens available for 
public purchase, searchable online, or available at a library. 
Examples of types of identifiable data/biospecimens that are not considered 
publicly available are as follows:
Data in the electronic medical record;
Social media data labeled as "private" by the data owner, or not readily available 
without permission of the site Owner/Administrator under the Terms of Service of 
the site; 
Data protected by Copyright; and
Data or biospecimens that have access restrictions (e.g. are only available to 
clinicians or qualififed researchers or may only be accessed on a secure server. 
B. Indicate if the data is incoming, outgoing or both:        
C. Provide the name of the entity(s) that data will be transferred/shared with, if incoming: 
     
D. Provide the name of the entity(s) that data will be transferred/shared with, if outgoing: 
     
E. Provide the external entity(s) contact name, email and phone number with whom the data 
agreement is going to be negotiated and executed with (i.e. Sponsored Projects Office 
contact or contracts department as applicable). List contact information for each external 
entity(s) that are involved with the project. 
Contact Name
External Entity
Email
Phone Number

Page 58 of 62
Version Date: 07/14/25
F. Who is responsible for transmission of the data (include name, email address and phone 
number)?         
  
G. Who is responsible for receiving the data (include name, email address and phone 
number)?      
H. Describe how the data will be securely transmitted/shared. If using an externally 
managed data transfer system, please include details about the system such as the URL 
for the site and information about who manages the security and maintenance. Please 
note data cannot be transmitted/shared without assistance from UNM HSC Central 
IT. Request UNM HSC Central IT transfer from the ISO office at HSC-
ISO@salud.unm.edu.  This means data cannot be transferred via email, cloud 
storage services such as Dropbox, OneDrive, and fax.    
☐ UNM HSC Secure File Transfer Protocol (SFTP)
☐ UNM HSC REDCap
☐ Other External Solution, and clarify:      
I.
For data being received/shared with non-HSC locations or entities, describe the 
following:
1. Where will data be stored and how will it be protected? UNM HSC requires data 
storage on the N:\Research -Studies network drive (i.e. encryption, password 
protection, access controls, use of REDCap, etc)?       
o
If REDCap, who manages/owns REDCap (i.e. UNM HSC or other 
external entity)?      
o
If REDCap or other external system is not UNM HSC REDCap 
managed/owned, please provide the name and contact information of 
owner and the access (login) link?           
Provide IT security point of contact details for externally 
managed/owned REDCap:      
2. What is the method being used for data collection and storage (i.e. electronic, hard 
copy, etc.)?           
3. How long will the data be stored? Must be congruent with section 16.       
4. Who will have access to data?        
J.
Please list all specific data elements to be sent out (outgoing) and/or received (incoming) 
in the table below. If there are extensive data elements being shared, please summarize in 
the table below, and provide the document file name that contains the full list of data 
elements.  
List Sponsor or 
Outside Entity
What is the 
classification of the data? 
Please indicate which of the 
following applies: 
List Incoming 
Data Elements
List Outgoing 
Data Elements

Page 59 of 62
Version Date: 07/14/25
 De-identified Data; 
 Limited Data Set; 
 Protected Health Information 
See definitions after question “P”. 
K. 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?
 ☐Yes (If yes, ensure section 25. Consent Process completed)
 ☐No. If no, is HIPAA authorization altered or waived? If altered or waived, provide           
details:               
 
L. Does the request to transfer/share data include clinical data that belongs to the UNM 
Health System? If data originates from the UNM Health System medical records, this 
question should be answered “Yes”. ☐Yes ☐No
M. Is the external entity a “covered entity”? (HIPAA-covered entities include health care 
providers (i.e. hospitals, doctors, academic health centers), health plans, and 
clearinghouses.):  ☐Yes ☐No
N. For outgoing data, is the data that is going to be transferred/shared owned or partially 
owned by another party? ☐Yes ☐No ☐NA, data is incoming only
If yes, please provide details:        
O. Does the data have any restrictions other than HIPAA? ☐Yes ☐No
If yes, please provide details:      
P. Does the data include information about substance abuse treatment, sexually transmitted 
diseases, genetic testing results, HIV/AIDS testing results, and/or mental health?  
 ☐Yes ☐No
If yes, please provide details:      
DEFINITIONS
DE-IDENTIFIED DATA: Identifiers That Must Be Removed to Make Health 
Information De-Identified:

Page 60 of 62
Version Date: 07/14/25
(i) The following 18 identifiers must be removed  of the individual or of relatives, 
employers or household members of the individual must be removed: (A) Names; (B) All 
geographic subdivisions smaller than a State, including street address, city, county, 
precinct, zip code, and their equivalent geocodes, except for the initial three digits of a 
zip code if, according to the current publicly available data from the Bureau of the 
Census: (1) The geographic unit formed by combining all zip codes with the same three 
initial digits contains more than 20,000 people; and (2) The initial three digits of a zip 
code for all such geographic units containing 20,000 or fewer people is changed to 
000.(C) All elements of dates (except year) for dates directly related to an individual, 
including birth date, admission date, discharge date, date of death; and all ages over 89 
and all elements of dates (including year) indicative of such age, except that such ages 
and elements may be aggregated into a single category of age 90 or older; (D) 
Telephone numbers; (E) Fax numbers; (F) Electronic mail addresses; (G) Social security 
numbers; (H) Medical record numbers; (I) Health plan beneficiary numbers; (J) Account 
numbers; (K) Certificate/license numbers;(L) Vehicle identifiers and serial numbers, 
including license plate numbers; (M) Device identifiers and serial numbers; (N) Web 
Universal Resource Locators (URLs); (O) Internet Protocol (IP) address numbers; (P) 
Biometric identifiers, including finger and voice prints; (Q) Full face photographic 
images and any comparable images; and (R) Any other unique identifying number, 
characteristic, or code; and (ii) The covered entity does not have actual knowledge that 
the information could be used alone or in combination with other information to identify 
an individual who is a subject of the information.
LIMITED DATA SET: A “limited data set” is a limited set of identifiable patient 
information as defined in the Privacy Regulations issued under the Health Insurance 
Portability and Accountability Act (HIPAA). A “limited data set” is information from 
which “facial” identifiers have been removed. A “limited data set” is information from 
which “facial” identifiers have been removed. Specifically, as it relates to the individual 
or his or her relatives, employers or household members, all the following identifiers 
must be removed in order for health information to be a “limited data set”: names;
street addresses (other than town, city, state and zip code); telephone numbers;
fax numbers; e-mail addresses; Social Security numbers; medical records numbers;
health plan beneficiary numbers; account numbers; certificate license numbers;
vehicle identifiers and serial numbers, including license plates; device identifiers and 
serial numbers; URLs; IP address numbers; biometric identifiers (including finger and 
voice prints); and full-face photos (or comparable images).
The health information that may remain in the information disclosed includes: dates 
such as admission, discharge, service, DOB, DOD;
city, state, five digit or more zip code; and
ages in years, months or days or hours.
It is important to note that this information is still protected health information or “PHI” 
under HIPAA. As a limited data set the information is still subject to the requirements of 
the federal and state privacy and security regulations.
PROTECTED HEALTH INFORMATION (PHI): PHI is defined as any individually 
identifiable health information collected or created as a consequence of the provision of 

Page 61 of 62
Version Date: 07/14/25
health care by a covered entity, in any form, including verbal communications. PHI is 
information that can be linked to a particular person and that is created, used, or disclosed 
in the course of providing a health care service (i.e., diagnosis or treatment). There are 18 
PHI identifiers as listed in the de-identified data definition section. 
48.Specimen Transfer/Sharing (Checklist) (required –do not delete even if the 
answer is “No”)
Please submit your material transfer agreement (MTA) request through Click ERA 
Agreements module so that Sponsored Projects Office (SPO) can begin working with you on 
the MTA. For any questions contact SPO via HSC-PreAward@salud.unm.edu. 
Provide all requested information 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. If yes, all questions must be answered congruently based on protocol   
         provisions.
☒No. If no, the remainder of this section does not apply. 
B. Indicate if the specimens are incoming and/or outgoing:      
C. Provide a description of the material/specimen that will be transferred/shared with the 
external entity:      
D. Provide the name of the entity that specimens will be being transferred/shared with: 
     
E. Provide the contact name, email and phone number with whom specimens are being 
transferred/shared with:      
F. Who is responsible for sending out the specimens? Please note specimens cannot be sent 
out without a fully executed material transfer agreement.      
G. Who is responsible for receipt of the specimens? Please note specimens cannot be 
received without a fully executed material transfer agreement.            
H. For specimens being transferred/shared with outside locations or entities, describe the 
following:

Page 62 of 62
Version Date: 07/14/25
1. Where is specimen storage and how will it be maintained in a secure manner?      
2. What is method in which specimens will be collected and stored?      
3. How long will the specimens be stored?      
4. Who will have access to the specimens?