A Randomized Controlled Trial of a College Human Physiology Course With Integrated Mindfulness Practice on Student Applied and Trait Mindfulness, Well-being, and Physiological Stress Reactivity (2026)
Phase: NA
Conditions: Mindfulness, Stress, Well-being
Sponsor: Trustees of Dartmouth College

Date 2/19/2026 
 
 
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Dartmouth College  
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS 
CPHS@Dartmouth.edu • 603-646-6482 
 
                  MINIMAL RISK CLINICAL RESEARCH PLAN    v. 2/18/2026 
 
Please complete: CPHS#         STUDY00032944        PI: Dr. Diane Gilbert-Diamond 
 
 
Important Note:  The CPHS Department (Chair & Scientific) Review Form is required with this 
application.  Find the form in the RAPPORT Library or on the CPHS Website.  
 
• DO NOT USE this form for retrospective chart review studies.  Please use the Data Specimens 
Registries Research Plan. 
• Respond to each item, even if to indicate N/A or not applicable 
• Attach and/or upload this form as your ‘Investigator Protocol’ in Rapport 
• If you are completing this form on a Mac, indicate your answer to any checkboxes by bolding or 
highlighting, or by deleting any incorrect options. 
 
 
 
1. Introduction and Background 
 
College students show rising stress levels and report challenges in maintaining physical and mental health. In a 
2018 health survey conducted on 605 undergraduate students at Dartmouth College, 90% responded that they 
felt overwhelmed by what they had to do, 88% felt exhausted (not from physical activity), and 76% experienced 
loneliness sometime in the past year (Dartmouth Office of Institutional Research, 2018). Nearly 20% were 
diagnosed with depression or anxiety. 57% reported experiencing tremendous stress within the last 12 months. 
Only half of the respondents were able to get three or more servings of vegetables or fruits each day. Every one 
in four respondents reported having episodes of overeating in the past three months. 50% reported binge or 
high-risk drinking (having 5+ drinks in one sitting) in the past two weeks. More effective preventative strategies 
are needed to support college students’ well-being.  
 
Mindfulness-based interventions (MBIs) show promise in improving mental and physical health in college 
student populations (Dawson et al., 2020). A systematic review meta-analyzed 51 randomized controlled trials 
on MBIs and college student health and found that compared with passive controls, MBIs reduce stress, 
depression, and trait anxiety and increase self-compassion post-intervention with medium effect sizes (SMD > 
0.4 with p <.00001) (Dawson et al., 2020). This review and others (Black, 2015; Dawson et al., 2020; Shapiro 
& Jazaieri, 2015) also highlight the lack of stringent intervention studies that use objective markers to inform 
training effects on mental and physical health states. Another limitation is the absence of follow-up beyond the 
conclusion of the interventions to investigate long-term health benefits. Third, as existing literature (88%) 
primarily assessed health changes, little is known about how MBIs influenced academic outcomes (Dawson et 
al., 2020). Fourth, the review indicates that 55% of studies used passive controls (i.e., usual care) and 
recommends further studies to compare mindfulness interventions with active controls, such as health education 
and nutritional counseling, to examine if MBIs are equally or more efficacious than existing intervention 
programs (Dawson et al., 2020). Lastly, existing MBIs designed for college students often encounter high 
attrition rates. In an 8-week mindfulness program adapted for university students in the UK, 41% (127 out of 
309) discontinued halfway through the program (Galante et al., 2018). In a review of qualitative studies with 
college student participants in MBIs, many found it challenging to find time to practice mindfulness (Bamber & 
Schneider, 2022). It is thus essential to design interventions that adapt to college student lifestyles to encourage 
consistent practice and investigate intervention efficacy with longer follow-ups beyond course completion. 
 

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2. Objectives and Hypotheses 
 
The proposed study aims to evaluate whether integrating mindfulness practice into an undergraduate biology 
course (Mindful Physiology) will enhance applied mindfulness and stress regulation capacity. We hypothesize 
completing this ten-week course will (1) increase applied mindfulness, (2) increase trait mindfulness, (3) 
increase well-being, and (4) decrease physiological stress response to an acute social-evaluative test.  
 
3. Study Design 
 
Describe all study procedures, materials, and methods of data collection: 
 
3.1 Study Design The study is a two-arm randomized controlled trial. The intervention group will consist of 
students enrolled in the Mindful Physiology course (Biology 3) at Dartmouth College in the spring 2026 term. 
(3/30/2026-6/3/2026). The control group will enroll students waitlisted for the course over the same period.  
The waitlist controls will receive university wellness support (i.e., treatment as usual, TAU). TAU includes 
access to counselors, mental health advisors, and psychiatrists at the university’s counseling center, wellness 
advising at the student wellness center, and campus-wide wellness programs such as weekly group yoga and 
meditation sessions and a free subscription to the Headspace app. We anticipate enrolling 37 students enrolled 
in the course and 52 waitlisted students for the study.  
 
3.2 Eligibility Criteria 
Students who participated in the 2025 version of the study will not be eligible to enroll, as we are administering 
the same questionnaires and the same video procedure during the TSST-OL.   
 
3.3 Intervention Description 
The intervention, Mindful Physiology, is an undergraduate-level biology course embedded with mindfulness 
practices. There will be 19 class sessions, each 1 hour and 50 minutes long, over 10 weeks. Students will be 
taught human physiology through didactic lectures, laboratory activities, and written quizzes typical for a 
college course. Each class meeting will have ~20 minutes of mindfulness practice in Thích Nhất Hạnh’s Plum 
Village tradition (Hanh, 1992). Students will also be encouraged to practice mindfulness for 15 minutes daily 
outside the class and to attend a weekly mindfulness event (e.g. Student Wellness Center activities). Students 
will complete a daily log of their mindfulness practice and be given credit for each log completion regardless of 
the minutes of mindfulness practice. Students will be asked to download a secure phone application to complete 
their daily log, as well as self-report their weekly phone screen use. The phone app will only be accessible by 
students enrolled in the class. The application will also display university wellness resources and mindfulness 
opportunities on campus. Students will be assigned a weekly written reflection on the physiology course content 
and/or their mindfulness practice. All students in the class are required to attend a 4.5-hour or a two-day (16-
hour) mindfulness retreat. The retreats will also be advertised to and open to all Dartmouth students, including 
those in the control group. Students in the control arm will receive university wellness resources as usual. 
 
3.4 Data Collection  
Trained research staff will email eligible participants with informed consent forms two weeks before the 
intervention start date and over the first week of classes (3/16/2026 to 4/3/2026). After signing the consent 
form, participants will receive a baseline survey remotely via RedCap and will be asked to complete the survey 
no later than the end of the first week of class (3/16/2026 to 4/3/2026). This questionnaire will be administered 
again at intervention completion (week 10, 6/3/2026 to 6/7/2026). 
 
Over weeks 8 and 9 (5/18/2026 to 5/29/2026), participants will be invited for an in-person lab visit for a Trier 
Social Stress Test (TSST-OL). Since they have already provided written informed consent, at the beginning of 
the in-person visit, participants will verbally consent and state whether they still want to engage in the study 
visit. During the TSST-OL, participants will be invited to give a 5-minute speech in front of a virtual panel of 
judges to mimic a real-life stressful situation. Perceived stress, heart rate (HR), heart rate variability (HRV), and 

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respiration rate will be collected to assess physiological reactivity to this acute stressor (please read section 
4.1.3. on stress reactivity assessment).  
 
4. Analysis 
  
Describe any qualitative tests and measures as well as quantitative methods: 
 
4.1 Primary Outcomes 
4.1.1 Physiological stress response to an acute stressor 
At intervention completion, physiological stress reactivity will be evaluated using the online variant of 
the Trier Social Stress Test (TSST-OL) in our laboratory (Heyers et al., 2025). The TSST-OL is a 
computerized stress induction protocol with three components: 5 minutes of brief preparation, 5 minutes 
of public speaking (job interview), and 5 minutes of math test in front of a panel of evaluators online. 
Our protocol will be modified to use a pre-recorded video of the panel of evaluators to give the 
impression of a live audience and minimize research assistant time while maintaining the conditions of 
the established TSST-OL. We will also not administer the math test during the TSST-OL, as our study 
design does not employ in-person actors administering the math test for real-time feedback. 
 
During the TSST, heart rate will be measured using a chest-worn Polar H10 (Polar Electro Oy, 
Kempele, Finland) (Schaffarczyk et al., 2022) and video-based photoplethysmography (PPG) (Pirzada et 
al., 2023). Wrist collected PPG heart rate data will also be measured during the TSST-OL (ActiGraph 
LEAP; Ametris, Pensacola, Florida). Raw inter-beat intervals will be recorded via a Bluetooth pairing to 
an accelerometer nearby (ActiGraph wGT3X-BT; Ametris, Pensacola, Florida).  
 
The mean heart rate (MHR) will be computed during the baseline resting phase and during the TSST 
(speech preparation and speaking), and during the recovery (Nyklíček et al., 2013). Reactivity to the 
acute stressor will be operationalized as differences in heart rate parameters during the TSST compared 
to the baseline.  
  
 
4.1.2 Well-Being  
Psychological well-being will be assessed with the 5-item World Health Organization Well-Being Index 
(WHO-5) (Topp et al., 2015). Participants will rate five positively phrased items on subjective well-
being, i.e., “I have felt cheerful and in good spirits.” Responses are anchored from 0 (none of the time) 
to 5 (all the time). The total score is the sum of item responses ranging from 0 to 25, with 25 indicating 
the maximum possible well-being. The index has shown high internal consistency with α = 0.86 and 
test-retest reliability of r = 0.77 in 903 college students (Downs et al., 2017). 
 
4.1.3. Applied Mindfulness 
Students will complete the Applied Mindfulness Process Scale (AMPS) at baseline and post-intervention 
completion (Roemer & Medvedev, 2022). The scale consists of 15 questions that quantify the 
application of mindfulness skills to navigate difficult situations and stressors in life. The AMPS 
encompasses three subscales: decentering, negative emotion regulation, and positive emotion regulation. 
The total scores are the sum across items. Total possible scores range from 0 to 60. Higher scores reflect 
more active use of mindfulness practice in everyday life. The scale showed high internal validity with a 
Cronbach’s α of 0.91 in 134 adults in the original study (Roemer & Medvedev, 2022). Additionally, lab-
observed application of mindfulness in stressful situations will be assessed during the Trier Social Stress 
Test (TSST). Participants will report whether they have used mindfulness techniques during the stress 
challenge. 
 
4.1.4. Trait Mindfulness  

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Trait mindfulness will be assessed with the Five Facet Mindfulness Questionnaire (FFMQ), a 39-item 
questionnaire evaluating five distinct components of mindfulness (R. Baer, 2019; R. A. Baer et al., 
2006). The five facets are observation, description, aware actions, non-judgmental inner experience, and 
non-reactivity. (7 items). The total score is the average across the five subscales. Possible scores range 
from 1 to 5, with higher scores indicating higher dispositional mindfulness. 
 
4.2 Other Outcomes  
 
 
4.2.1. Stress Management Self-Efficacy  
Participants will evaluate their confidence in managing stress with the Stress Management Self-Efficacy 
Scale (α = 0.86, N = 2292) (Sawatzky et al., 2012). The scale has four items, e.g., “I believe I have the 
ability to cope with the demands of my life.” All items will be rated on a four-point Likert scale from 1 
(strongly disagree) to 4 (strongly agree). A global score will be computed with the mean across the four 
items (range: 1 to 4), with higher scores indicating greater self-efficacy in identifying and managing 
stress.  
 
4.2.2. Heart rate variability response to TSST  
Heart rate variability response to the TSST will be assessed with the change in the Root Mean Square of 
Successive Differences (RMSSD) during the presentation task from the baseline.  
 
 
 
4.2.3. Harmful Alcohol Consumption 
Harmful alcohol consumption behavior will be assessed via the Consumption subscale from the Alcohol 
Use Disorders Identification Test (AUDIT-C) (Bush et al., 1998). The AUDIT-C has three items on the 
frequency and quantity of alcohol use (US Preventive Services Task Force, 2018). The total score is the 
sum across items, which range from 0 to 12, with higher scores indicating a higher risk of alcohol abuse 
or dependence. A score of 3 and above is indicative of possible risky drinking that warns of clinical 
concerns. Questions include asking on how often you have a drink containing alcohol, how many 
alcoholic drinks are consumed on typical day and how often six or more alcoholic drinks are consumed 
on any occasion. This survey was modified to include the option “I choose to not answer” given the 
nature of asking about potential illegal behaviors. Responses from these questionnaires are identifiable 
but will be coded for participant anonymity and stored securely on Dartmouth College’s encrypted 
server. 
 
 
4.2.4. Social Connectedness 
Social connectedness will be measured via the Social Connectedness Scale, revised (SCS-r) (R. M. Lee 
& Robbins, 1995). Participants will rate 20 items on a six-point Likert scale from 1 (strongly disagree) 
to 6 (strongly agree), e.g., “I am able to relate to my peers.” A total score will be computed by taking the 
sum across items. Possible scores range from 20 to 120, with 120 indicating the strongest sense of 
belongingness.  
 
 
4.2.5. Learning-Related Anxiety  
Anxiety around learning will be assessed with the learning-related anxiety subscale from the 
Achievement Emotions Questionnaire-Short Form (AEQ-S) (Bieleke et al., 2021). Participants will rate 
four five-point Likert scales on feelings of anxiousness when studying, e.g., “I get tense and nervous 

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while studying.” The subscale showed adequate internal validity in the original study with an α of 0.72 
in 180 adults (71% female, 58% White) (Bieleke et al., 2021).  
 
4.2.6. Social Media Addiction 
Social media use will be assessed with the Bergen Social Media Addiction Scale (BSMAS) (Shin, 
2022). This is a brief 6-item self-assessed questionnaire evaluating individuals’ reliance on social media. 
The scale has been validated and previously used for understanding young adults’ social media use 
(Meynadier et al., 2023). Participants will also be asked to estimate the minutes spent on social media on 
a typical weekday and weekend day separately.  
 
 
4.2.7. Perceived Stress During the Last Month 
Subjective stress will be measured with the 10-item Perceived Stress Scale (PSS), which evaluates 
individuals’ perception of how uncontrollable and overloaded their lives have been in the past month 
(Cohen et al., 1983). Participants will complete the 10-item version at baseline and post-class 
assessments. Participants will rate items on a five-point Likert scale from 0 (never) to 5 (very often). 
The possible scores range from 0 to 50; higher scores reflect more perceived stress. The scale has shown 
strong internal validity (α > 0.70) and test-retest reliability (r > 0.70) in a systematic review (E.-H. Lee, 
2012). 
 
4.2.8. Anxiety 
Anxiety will be assessed with the seven-item Generalized Anxiety Disorder Scale (GAD-7) (Spitzer et 
al., 2006). The scale had high internal validity (α = 0.92) and test-retest reliability (interclass correlation 
= 0.83) in the original study. Item responses are anchored on a four-point Likert scale from 0 (not at all) 
to 3 (nearly every day). A total score will be computed by taking the sum of item responses. Possible 
scores range from 0 to 21, with higher scores reflecting more severe anxiety. A score of 8 and above 
indicates possible cases of GAD with a sensitivity of 83% and specificity of 84% (Plummer et al., 2016). 
 
4.2.9 Emotional Eating 
Emotional Eating will be assessed with the 13-item Emotional Eating Subscale from the Dutch Eating 
Behavior Questionnaire (DEBQ) (Van Strien et al., 1986). The Emotional Eating scale has shown a 
strong internal validilty (α > 0.98) in English speaking populations (Mason et al., 2019). Items are 
scored on a five-point Likert scale from 1 (never) to 5 (very often). A total score with be computed by 
taking the average across all items. Possible scores range from 1 to 5, with higher scores indicating 
higher rates of emotional eating (Mason et al., 2019; Van Strien et al., 1986). 
 
4.3. Covariates 
 
4.3.1. Demographics 
Sociodemographic information will be self-reported via a questionnaire, including questions on age, 
biological sex, gender, race, ethnicity, class year, major, parental education (i.e., highest education attained 
by either parent: doctoral degree, master’s degree, bachelor’s degree, or no college degree). 
 
4.3.2. Self-Reported Screen Use 
Students will be asked to self-report their daily average screen use over 1 week as posited within their phone 
“Screen Time” report in the baseline and follow-up questionnaire. Students will have the option to include a 
screen-capture of this on the survey if they wish but it is not required.  
 
4.3.3. Self-Reported Mindfulness Practice 

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Students will be asked to self-report their average daily amount of mindfulness practice over 1 week in the 
baseline and follow-up questionnaire.  
 
4.3.4. Post-Term Question 
Students will be asked whether they attended a Plum Village mindfulness retreat hosted by Dartmouth over 
the spring term in the follow-up questionnaire. 
 
4.3.5. Daily Logs, Weekly Course Material and Attendance, Class 
Students in the intervention arm of this study will be asked for their consent to use their course materials 
and questionnaire data to be used for research purposes. Students in the intervention arm of this study will 
also be asked for their permission to quote from their submitted writing for research anonymously. 
 
4.4. Statistical Analysis 
  
Participant baseline characteristics will be compared between the intervention and control groups to ensure a 
balance between the intervention arms. Any demographic variables that significantly differ between the two 
groups will be adjusted in all models. Second, summary statistics will be computed for primary and other 
outcomes and covariates. Means with standard deviations will be reported for continuous variables. Counts 
with proportions will be reported for categorical variables. Normality will be examined for continuous 
variables via Shapiro-Wilk tests and visual inspections of histograms and quantile-to-quantile (Q-Q) plots. 
Outcomes that do not follow a normal distribution will be log-transformed in all models. 
 
For the primary outcomes, we will examine the between-group differences in changes in applied 
mindfulness, trait mindfulness, heart rate response to the TSST, and the WHO-5 Index, using linear 
regression models with change scores in each outcome as the dependent variable and the group status as the 
independent variable, adjusted for age and sex. We will report Cohen’s d to estimate the effect sizes.  
 
As exploratory analyses, we will examine the dose-response relationship between practice time (assessed 
with self-report practice time) and changes in primary and other outcomes over the term. Further, we will 
explore any between-group differences in changes in heart rate and heart rate variability during the TSST 
preparation and speaking task, separately, with linear regression models, adjusted for age and sex. All 
analyses will consider a p-value > 0.05 as statistical significance.  
 
 
5. Study Progress Monitoring 
 
Note:  appropriate monitoring may include periodic assessment of the following: 
• data quality 
• timelines   
• recruitment and enrollment  
 
Provide a description of the methods which will be used to determine the progress of the study, 
including periodic assessments of data quality, timelines, recruitment, and enrollment as appropriate: 
 
5.1. Data Management  
Trained research staff will download data within two weeks of the data collection period and examine data 
for incompletion and errors. Data will be de-identified and stored in a private, secure server hosted at 
Dartmouth College. Data quality will be assessed by examining missingness of questionnaire items and 
missing heart rate data from study visits. 
 
5.2. Timeline 

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Study recruitment and enrollment will occur two weeks before the spring term begins and will proceed into 
the first week of the class (3/16/2026 to 4/3/2026). Baseline questionnaires will be administered online up to 
one week after enrollment (3/16/2026 to 4/3/2026). In-person lab assessments will occur during weeks 8 and 
9 of the intervention period (5/18/2026 to 5/29/2026). Follow-up questionnaires will be administered within 
a week after intervention completion (6/2/2025 to 6/9/2026).  
 
6. Risks & Benefits 
 
Note: Risks may be physical, psychological, social, legal, economic, to reputation, or others.  
 
 
a. Describe any potential risks, their likelihood and seriousness: 
Psychological distress due to survey questions: Some questionnaires administered screen for mental health 
disorders. Participants filling out these questionnaires may perceive this as an appropriate avenue to call for 
help if they are experiencing mental health problems. The likelihood of this is low, provided the informed 
consent makes it explicitly clear that the surveys administered do not provide a mental health diagnosis, and in 
the event of certain scores, mental health professionals will not be contacted. 
Psychological distress due to in-person stress test: Participants are expected to experience an acute increase in 
feelings of stress during the virtual Trier Social Stress Test. This amount of stress is expected to be comparable 
to what students experience during typical public speaking activities in classes or during a job interview. The 
risk that the TSST-OL impacts participants outside the study visit is low. Participants will be debriefed at the 
end of data collection, explaining that they were not being judged on their performance of tasks in the virtual 
setting within the lab. A copy of the written debrief is in the supplementary materials.  
Discomfort related to wearing the heart rate monitors: Participants may experience mild skin irritation at the 
wear site related to the activity tracker or heart rate monitors. Any participants who experience skin irritation 
because of this is directed to discontinue wearing either device. 
Loss of confidentiality: Participants risk a loss of confidentiality. Information collected from surveys, logs, 
wearables and video will be stored in on a private secure Dartmouth server, with several methods for mitigating 
this risk of privacy loss, providing some of the data collected in this research is identifiable. To further ensure 
data security, identifiable video data will be recorded and stored on a secure Dartmouth server in a password 
protected folder. Some of the questionnaires disclose potentially illegal behaviors related to alcohol use. The 
likelihood this risk occurs is low, however if loss of confidentiality were to occur it would be serious. When the 
data is no longer needed, electronic data will be permanently deleted from the database, and any paper files will 
be securely shredded and destroyed. 
 
b. Confirm that risks to subjects have been minimized, by use of procedures which are consistent 
with sound research design, and which do not unnecessarily expose subjects to risk: 
To reduce the risk of student mental health going unchecked, an overview of all mental health and wellness 
services available to all Dartmouth students will be provided to all participants at the time of going over the 
informed consent document, as well as via email after study enrollment. This document provides a 
comprehensive overview of resources available to students and was developed by the Student Wellness Center 
at Dartmouth. 
Provided some collected data in this research is identifiable to participants, it will be coded and stored with a 
random study ID, on a secure, encrypted Dartmouth server. Only the research team members who directly 
contact participants will have access to the information necessary to link them to their identified data from 

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surveys and other data measures collected. The encrypted database on a secure Dartmouth server will be 
password protected and only accessed by research staff while connected to the eduroam network on the 
Dartmouth campus. Further, video data collected that is identifiable will also be securely stored on the 
Dartmouth server, in a password protected folder.  
Health information collected in this research will be kept confidential unless its disclosure is permitted by law. 
Information created or collected by the study team will only be shared with other researchers after it is stripped 
of identifiers, and no information can be traced back to participants. Currently, there is no plan to share any 
data. Additionally, no names will be used in any publications presentations that may come from this research. 
A Certificate of Confidentiality from the NIH has been obtained to further protect participants related to any 
information that is disclosed in this research.  
 
c. Describe why all the risks to subjects are reasonable in relation to both anticipated benefits 
and the knowledge expected to be gained from the study: 
College students experience high levels of stress, which is linked to poor health outcomes, so understanding 
whether Mindfulness practice integrated into the classroom improves health outcomes in college students can be 
beneficial to college student populations. 
 
7. Unexpected Events or Incidental Findings 
 
Note: It may be important to consider the potential for certain unanticipated events to occur, for example: 
• finding an anomaly in a MRI 
• discovering child abuse 
• causing distress in interviews of a sensitive nature 
 
Describe potential events and provide a plan of action: 
 
Should any participant experience discomfort during the study, the participant will be encouraged to contact 
the Committee for the Protection of Human Subjects at Dartmouth College (603) 646-3053. Student 
participants can receive physical health and mental health support resources that are available to them 
throughout the study. 
 
In the event of a breach confidentiality, participants and the Dartmouth College IRB would be informed of 
the context and the extent of the breach. 
 
8. Deception 
  
Does any part of this study involve deception or withholding of information from participants? 
  
☒  Yes                  ☐  No 
  
If Yes, provide an explanation which addresses the following: 
· 
A description of the deception being used 
· 
Why the deception is necessary 
A plan for debriefing, or providing subjects with the pertinent information after participation 
  
Participants are invited to attend an in-person study visit for a stress reactivity assessment (Trier Social 
Stress Test, TSST-OL) (Heyers et al., 2025). In the consent process, this protocol will be introduced to the 
participants as a mock interview in front of a live panel of evaluators evaluating their speaking ability and 

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facial expressions. In fact, the panel of evaluators will be a pre-recorded video to simulate a live audience 
while reducing research staff effort, and no one will be assessing participants' facial expressions or speaking 
ability. The deception during the TSST-OL intends to elicit a more natural stress response from the 
participants. Participants will be informed that the assessment is an established stress induction after all 
participants have completed the in-person study visit. A copy of the debrief is included in the supplementary 
materials. 
 
9. Placebo Use or Inconsistency with Standard of Care 
 
Does any part of this study involve the use of a placebo or procedures that are inconsistent with the 
standard of care? 
 
☒  No 
 
 
 
If Yes, explain how the use of placebo or non-standard of care therapy may affect risks for 
participants, addressing the following: 
• The safety and efficacy of other available therapies 
• The maximum total length of time a participant may receive placebo on study 
• The greatest potential harm that may result from not receiving or delaying effective therapy  
• Safeguards for the participants receiving placebo or non-standard of care therapy 
 
 
10. Genetics 
 
Does any part of the study involve genetic analysis of biological specimens? 
 
☒  No 
 
 
☐  Yes, the study is based on the premise that a link between a genotype or a biomarker and a specific 
disease or condition is clinically useful in predicting the development of that specific disease or condition.  
Please complete the Genetic Research Form and upload it to the ‘Supporting Documents’ page in 
Rapport. 
 
 
-OR -  
 
☐  Yes, the study is looking for an association between a genotype or a biomarker and a specific disease or 
condition, but at this point it is not clear if the genetic marker has predictive value. The uncertainty 
regarding the predictive value of the genetic marker is such that studies in this category will not involve 
referral of participants to genetic counseling; however, participants will be informed of genetic testing in the 
consent form.  Please comment: 
 
 
 
11. Equitable Participant Selection 
 
a. Estimated number of participants at Dartmouth CPHS reviewed sites:  
 
89 (control: n = 52; class: n = 37) 
 
b. Provide a justification of the proposed sample size 

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The proposed sample size is based on preliminary data and feasibility. Our preliminary data 
indicated that the class had statistically significant lower increase in heart rate during TSST 
preparation and speaking tasks (preparation: Cohen’s d = -0.74; speaking: d = -0.73), suggesting 
medium to large effect sizes. Based on last year’s recruitment rate, we expect that 52 students from 
the control group and 37 from the class would complete both baseline and follow-up assessments. 
This sample size is powered to detect an effect size of d of 0.61 or above, sufficient to detect a 
significant effect for our primary outcomes.  
 
c. Define the target population: 
College Students 
 
d. Vulnerable populations 
 
Note: Certain populations are considered vulnerable to coercion and undue influence and are 
provided with additional protections when participating in a research study.   
 
Identify any of the below populations which you plan to recruit for this study.  In addition, 
complete the form(s) linked with each population as necessary and upload on the ‘Supporting 
Documents’ page in Rapport.  
☐ Pregnant Women, Fetuses and Neonates 
☐ Children 
☐ People with impaired decision-making capacity 
 
The following populations may also be considered vulnerable to coercion or other undue 
influence: 
• Prisoners 
• People who are economically disadvantaged  
• The elderly  
• People who are illiterate or do not speak English 
• Students and employees 
 
Describe any other potentially vulnerable population(s) and the additional protections 
provided to them: 
 
Students are only being recruited by convenience sampling within the registered waitlists and class 
lists. The professor will not know the students participating in the study and will not have access to 
the collected surveys and objective outcome measures until class grades have been submitted. 
 
 
 
12. Recruitment 
 
Describe method(s) of recruitment.  Associated advertisements and other materials to be used for 
recruitment should be uploaded to the ‘Consent Forms and Recruitment Materials’ page in Rapport. 
 
All students who registered in Biology 3: Mindful Physiology at registration were randomly assigned to the 
class or waitlist by the Dartmouth College registrar. Students on the original class list and waitlist will be 
contacted up to 5 times via email over 3 weeks during the enrollment phase (3/16/2026 – 4/4/2026). Study 
recruitment will begin 2 weeks prior to class commencement; students will be sent the recruitment 
documents provided in the submission. We anticipate enrolling 52 individuals from the class (intervention 
group), and 37 individuals from the waitlist (control). A research assistant will post flyers around the 

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Dartmouth campus over the recruitment period of the spring term, which can be viewed in the 
supplementary materials. 
 
 
13. Informed Consent, Assent, and Authorization 
 
All forms discussed in this section should be uploaded to the ‘Consent Forms and Recruitment 
Materials’ page in Rapport 
 
a. Please describe the consent and/or assent process, addressing the following: 
• Who will obtain consent/assent from participants 
• Where the consent/assent process will take place 
• The timeframe for providing information potential participants about a study, having the consent 
form signed, and beginning study activities 
• Any precautions taken to minimize the possibility of coercion or undue influence 
• The forms which will be used as well as any aids used to simplify scientific or technical 
information 
• How comprehension will be ensured 
 
Participants will be offered the opportunity to discuss any questions with a research assistant during 
the recruitment process. This will be by email request and occur up to two weeks prior to the class 
beginning. A consent form will be provided to all students who respond to recruitment via RedCAP.  
Upon a signed informed consent document, a research assistant will administer the baseline survey 
online via RedCAP. 
 
No mention of the project will occur within the classroom. 
 
Comprehension of the study will be ensured by way of verbal consent before any study activity 
ensues. Students will be invited to schedule their in-person study visit via email in the middle of the 
term for an appointment over weeks 8 and 9 (5/18/2026 – 5/29/2026). Trained research staff will 
debrief the study aims and procedures at the beginning of the lab visit. Participants will verbally 
state whether they still want to engage in the study activities. 
 
b. Waiver(s) or alteration(s) may be requested for research that involves no more than minimal 
risk.   
Indicate requested waiver(s) or alteration(s) below.  In addition, complete the corresponding 
section of the Waivers and Alterations Request Form and upload it to the ‘Consent Forms and 
Recruitment Materials’ page in Rapport.      
☐  For the informed consent process 
☐ For the documentation of informed consent 
☐  For the HIPAA Authorization to use and/or disclose PHI 
☐ For a waiver of the requirement for medical record documentation 
 
 
14. Financial impact on participants 
a. List the tests, visits, and procedures performed for only research purposes and specify who will 
pay: 
 
Note: Research procedures may not be billed to a health insurance plan 
 
N/A 

Date 2/19/2026 
 
 
12 
 
 
15. Compensation or Gifts 
 
Please describe any payments, gifts or reimbursements participants will receive for taking part in the 
study: 
 
Participants will be compensated with a $30 gift card for completing the baseline survey, a $60 gift card for 
completing an in-person stress induction lab visit, and a $60 gift card for completing the second survey.  
 
Those who complete all three study tasks will be entered into a raffle for an additional $200 gift card. 
 
 
16. Privacy of Participants  
 
Note: Methods used to obtain information about participants may have an effect on privacy.  For example: 
• Consent discussions or interviews held in public which concern sensitive subjects or behaviors 
• Observations of behavior, especially illicit behavior, in quasi-public settings 
 
Describe any activities or interactions which could lead to a breach of privacy and provide a plan to 
protect participant privacy: 
 
Since a portion of data is operating out of Dr. Diane Gilbert-Diamond’s lab, there is potential of an 
unforeseen breach of privacy of participants who are enrolled in Biology 3. Because of this, surveys will be 
administered to participants remotely. The course instructor (D.G.D.) will remove herself from the lab 30 
minutes before a study visit to ensure participant privacy and primarily work out of her offices in the Life 
Sciences Building for visits to be conducted at the lab. 
 
17. Confidentiality of Data 
 
Note: Any person engaged in research collecting information that could cause financial, social or legal harm 
to participants may apply for a Certificate of Confidentiality.  Certificates of Confidentiality are issued by 
the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. 
They are intended to allow the investigator and others who have access to research records to refuse to 
disclose identifying information on research participants in any civil, criminal, administrative, legislative, or 
other proceeding, whether at the federal, state, or local level.    
 
a. If disclosed, could any of the data collected be considered sensitive, with the potential to 
damage financial standing, employability, insurability, or reputation? 
 
☐  No 
 
☒  Yes 
 
 
If Yes, describe the data or information, the rationale for their collection, and whether a 
Certificate of Confidentiality will be obtained: 
 
 
Information relates to potential engagement in illegal activities, specifically alcohol use. Asking this 
data is necessary, as it may be linked to applied mindfulness. Additionally, alcohol use is a measured 
health outcome in this study. A certificate of confidentiality has been obtained from the NIH. 
 

Date 2/19/2026 
 
 
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b. Describe the safeguards employed to secure, share, and maintain data during the study, 
addressing any of the following which may apply:  
• Administrative, ie. coding of participant data  
• Physical, ie. use of locked file cabinets 
• Technical, ie. encrypted data systems 
 
Participant data will be coded and stored with a random study ID on the encrypted Dartmouth server. 
Researchers on this project will only access the Dartmouth server while connected to a secure 
Dartmouth network or VPN. Additionally, the database where data is stored will be password protected.  
c. Describe the plan for storage or destruction of data upon study completion: 
 
All files collected will be in digital format. Physical copies with any data collected will be destroyed 
after the study is complete. Data in a digital format will be stored on the encrypted, secure Dartmouth 
College server for a minimum of 5 years.