Testing Climate Impact Menu Labels Influence on Nutrition Quality of Fast-Food Selections: A Pilot Study
Phase: NA
Conditions: Food Selection
Sponsor: Johns Hopkins Bloomberg School of Public Health

Climate impact label design and fast-food meal selection 
 
NCT06678178 
 
Study Protocol 
Version Date:  10/18/2024 

BSPH IRB Research Plan for New Data Collection 
IRB Version:  01Sep2023 
 
For new data collection, new data collection plus secondary data analysis, 
biospecimen repositories, and data coordinating center protocols. 
 
DO NOT DELETE ANY QUESTIONS FROM THIS TEMPLATE 
 
PI Name:     Dr. Julia Wolfson 
Study Title:   Testing climate impact menu labels inﬂuence on nutrition quality of fast food 
selections: a pilot study   
IRB No.:  IRB00030419  
PI Version No. / Date:  V1/October 18, 2024 
 
I. Aims of the Study:  Describe the aims/objectives of the research and/or the 
project’s research questions or hypotheses.  
Our primary objective of this study is to compare the e5ects of di5erent climate-label menu 
designs on the healthfulness of hypothetical fast-food meal orders. We hypothesize that: (1) 
compared to orders from menus with control labels, participants ordering from menus with all 
other climate-impact labels will select more healthiful meal, and (2) the e5ect of healthifulness 
of meal orders will di5er by climate-impact label condition, with high-impact warning labels 
performing best, followed by the tra5ic light labeling scheme, then by the grade labeling 
scheme, and ﬁnally the numeric labels.  
 
As a secondary outcome, we will also seek to compare perceived message e5ectiveness (PME) 
of di5erent climate-label menu designs to communicate the environmental impact associated 
with fast-food menu items. We hypothesize that: (1) participants will perceive climate-impact 
labels as more e5ective compared to control labels, and (2) PME will di5er by climate-impact 
label condition, with high-impact warning labels performing best, followed by the tra5ic light 
labeling scheme, then by the grade labeling scheme, and ﬁnally the numeric labels. 
 
Additional secondary outcomes will include examining total greenhouse gas emissions per 
meal order, total calories per meal order, and selection of a sugar-sweetened beverage within 
order. 
 
This is a pilot study to help us determine the label types we will include in our next study using 
the NORC AmeriSpeak panel (IRB00027451). A separate application exists and will be amended 
for the next study for IRB approval, prior to its initiation.  
 
 
II. Background and Rationale: Explain why this study is being done.  Summarize 
briefly what is already known about the issue and reference previously published 
research, if relevant. 

Climate change and diet-related non-communicable diseases (including many cancers, 
obesity, diabetes, and heart disease) are among the most pressing global public health issues. 
The modern food system is responsible for more than 30% of global anthropogenic Greenhouse 
Gas Emissions (GHGE), including 14.5% of global GHGE from food animal production alone. In 
the United States (U.S), meat consumption, and red meat consumption in particular, is 
consistently far above recommended levels based on national Dietary Guidelines. On a typical 
day, more than one-third of Americans eat out in fast-food restaurants which are a common 
source of red meat in American’s diets and are associated with numerous adverse health 
outcomes. Therefore, fast-food restaurants will be a key environment for any e5orts to shift 
Americans towards a ‘win-win’ ‘planetary-health’ diet that beneﬁts both climate change and 
individual health. Similar to calorie menu labels, which have been a key public health tool to 
facilitate healthier choices in restaurant settings, menu labels that either provide a negative 
signal that an item is environmentally unsustainable (i.e. high GHGE), or menu labels that 
provide a positive signal that an item is an environmentally sustainable choice (i.e., low GHGE) 
are a potential tool to shift consumer food choices towards a ‘planetary-health’ diet. Evidence 
suggests that products labeled as environmentally sustainable receive a ‘health halo’ even in 
unrelated domains, like improved perceptions of health and tastiness. Whether sustainability-
focused menu labels (either negative or positive) are e5ective at encouraging sustainable food 
choices in fast-food restaurants, and whether such labels also encourage healthier food 
choices, has never been tested. Therefore, in this study we will test whether sustainability 
labels on a fast-food restaurant menu nudge consumers towards healthier food choices by 
comparing four labeling schemes on main menu items:  
(1) Red negative nudge labels [WARNING: HIGH CLIMATE IMPACT] displayed on high-GHGE 
items 
(2) A tra5ic light nudge labeling scheme [HIGH CLIMATE IMPACT; MED. CLIMATE IMPACT; 
LOW CLIMATE IMPACT] displayed on high-, medium-, and low-GHGE items in red, 
yellow and green, respectively 
(3) A grade labeling scheme [A; B; C; D; F] on all items by level of impact, with A indicating 
the lowest level of impact and F indicating the highest level of impact 
(4) A numeric labeling scheme that demonstrates the estimated climate-impact 
associated with the life cycle of each menu item in kilograms of carbon dioxide 
equivalent (kg CO2e).  
 
We will also compare e5ects of these labels against a control condition with a Quick Response 
(QR) code label on all menu items.  
 
III. Study Design: 
A. Provide a BRIEF overview of your study design and methods.  The study design 
must relate to your stated aims/objectives.  DETAILS WILL BE REQUESTED 
LATER.  If your study also involves analysis of existing data, please complete 
Section XI, “Secondary Data Analysis of Existing Data” in the last part of this 
research plan.  If your study ONLY involves analysis of existing data, please use 
the research plan template for secondary data analysis (BSPH IRB Research 
Plan for Secondary Data Analysis of Existing Data/Specimens).   
 

We will conduct a randomized controlled experiment in which participants are randomly 
assigned to view one of five versions of a fast-food menu based on a well-known burger-
focused fast-food chain, and instructed to select an entrée they would hypothetically like to 
order for lunch. Each menu version will differ by labeling condition assigned to main menu 
items to demonstrate the climate impact associated with each item. Climate-impact label 
menu designs in the study will include a QR code label (control), a high-impact warning 
label, traffic-light labeling of high, medium, and low impact, grade labeling (five-tiers; 
grades A-F) and a numeric label describing the estimated amount of kg CO2e associated 
with each menu item. Following the meal ordering task, we will also ask questions about 
the perceived message effectiveness of the label for which each participant was 
randomized, their perception of the relative effectiveness of all labels in this experiment, 
and their personal values, dietary patterns, and other demographic information. 
 
This trial will ﬁrst be conducted as a pilot study via CloudResearch, an online panel 
provider, before ﬁelding a larger study with NORC AmeriSpeak, another online panel 
provider. A separate application (IRB00027451) exists and will be amended for the next 
study for IRB approval, prior to its initiation.  
 
 
 
B. Provide a sample size and a justification as to how you arrived at that number.  If 
you use screening procedures to arrive at a final sample, distinguish the 
screening sample size from the enrolled sample size; a table may be helpful.   
For electronic survey studies involving online recruitment and survey completion: 
consider how you will set controls on how many people will join your study. 
The CloudResearch initial sample will be 6,250 people, evenly divided with approximately 
1,250 people in the control arm and each of the four experimental arms, respectively. This 
sample size will give us >80% power to detect a small e5ect size (d=0.12) with a 
conservative Bonferroni adjusted alpha of 0.0125, which was determined based on our 
prior research would be su5icient to see di5erences between all label arms. The 
CloudResearch sample will be broadly representative of the U.S general population, but 
carry the possibility of a 25% skew tolerance across demographic lines. We will recruit 
individuals until the target sample size has been reached by working with the managed 
research partner with CloudResearch.  
 
 
C.  Does your study meet the NIH definition of “clinical trial”: ““A research study in 
which one or more human subjects are prospectively assigned to one or 
more interventions (which may include placebo or other control) to evaluate the 
effects of those interventions on health-related biomedical or behavioral 
outcomes”?  If yes, the study must be listed on clinicaltrials.gov, study personnel 
must complete GCP training, and federally funded studies must post consent 
forms on approved sites, like clinicaltrials.gov. 
Yes.  
 

IV. Participants: 
Describe the study participants and the population from which they will be drawn.  
Specify the inclusion and uusion criteria.  If you plan to include children, note their 
ages and whether you will include children in foster care or who are wards of the 
State. Note if the participants are particularly vulnerable in terms of cognitive 
limitations, education, legal migration status, incarceration, poverty, or some 
combination of factors.  
 
A. Inclusion Criteria:  
- 
18 years of age or older 
- 
Residing in the United States 
- 
Member of the CloudResearch panel 
 
B. Exclusion Criteria:  
 
- 
Under 18 years of age 
- 
Not residing in the United States 
- 
Completed the survey implausibly quickly based on the distribution of the time to 
complete the survey among all participants 
- 
Failed the built-in Qualtrics survey fraud detection measures 
NOTE: If you are recruiting participants or receiving, accessing, or using data from a 
U.S. health care provider, HIPAA review is likely to be required.  If you plan to 
bring identifiable health information from a foreign country to a U.S. covered 
entity (e.g., lab at the Hopkins SOM), HIPAA may be triggered. Check “yes” to 
the HIPAA question in the PHIRST application. 
 
V. Study Procedures:  
      In this section, provide details of your procedures, particularly as they relate to 
human subjects. If this is a  
      multi-center study, make the role of BSPH clear. If you will collaborate with other 
institutions or     
      organizations, or plan to subcontract BSPH responsibilities to others, make clear 
their responsibilities in 
      the Study Oversight section of this document. Be aware that all recipients of federal 
funding for non-exempt  
      human subjects research must have a Federal Wide Assurance (FWA), which is a 
promise to comply with  
     human subjects research regulations.   
 
If the BSPH will serve as a data coordinating center, indicate in the sections below 
which procedures BSPH will not be performing.  Additional information regarding 
data coordinating centers is requested in a later section.   
If your study will develop in phases, address each item below by phase. 

A. Recruitment Process: 
1. Describe how you will identify, approach, and inform potential participants 
about your study.  Include details about who will perform these activities and 
their qualifications. 
The survey job will be posted on CloudResearch and participants will be able to click on 
it and complete the survey. CloudResearch panel members have an internal ID and 
can only take each survey once. Individuals not in CloudResearch panels will not 
be able to take the survey.  
 
 
2. Address any privacy issues associated with recruitment.  If recruitment itself 
may put potential participants at risk (if study topic is sensitive, or study 
population may be stigmatized), explain how you will minimize these risks. 
There are no privacy concerns associated with this study. We will have no interaction 
with participants. All surveys are anonymous, and we will not collect any identifying 
information. 
 
B. Consent Process:   
1. Describe the following details about obtaining informed consent from study 
participants.  If a screening process precedes study enrollment, also describe 
the consent for screening. 
a. Who will obtain informed consent, and their qualifications: 
We will seek consent through a written prompt at the start of the CloudResearch survey. We 
provide a brief description and o5er participants the opportunity to consent or not by 
responding to a question. For those who do not consent, the survey will will end at that 
point.   
 
b. How, where, and when the consent discussion(s) will occur: 
N/A 
c. The process for determining whether a potential participant meets 
eligibility criteria.  If you will collect personally identifiable information for 
screening purposes, collect only data needed for this purpose and explain 
what will happen to the data for individuals who are not eligible: 
CloudResearch engages tens of millions of participants worldwide. We will provide 
our study inclusion criteria, which is solely demographic, to CloudResearch, and 
they will recruit from their pool of participants based on these requirements.            
d. Whether you will obtain a signature from the participant or will use an oral 
consent process: 
No 

e. Whether you will obtain a legally authorized representative’s signature for 
adults lacking capacity: 
 
No 
f. If children are included in the study, if and how you will obtain assent from 
them: 
N/A 
 
 
g. If children are included in the study, how you will obtain permission for 
them to participate from their parent, legal guardian, or other legal 
authority (if child is in foster care or under government supervision).  If any 
of the children are “wards of the state”, additional regulatory requirements 
will apply: 
 
N/A 
h. If you are seeking a waiver of informed consent or assent, the justification 
for this request: 
N/A 
i. Whether you will include a witness to the consent process and why: 
N/A 
 
j. If the language is unwritten, explain how you will communicate accurate 
information to potential participants and whether you will use props or 
audio materials: 
N/A 
2. Identify the countries where the research will take place and the languages 
that will be used for the consent process.   
 
 
 
 
 
 
 
 
 
 
C. Study Implementation:  
Country 
Consent Document(s) 
(Adult Consent, Parental Permission, 
Youth Assent, etc.) 
Languages 
United States 
Written adult consent will be included 
electronically at the beginning of the 
survey 
English 
      
      
      
      
      
      

1. Describe the procedures that participants will undergo.  If complex, insert a 
table below to help the reviewer navigate.   
Participants will complete an approximately 3-minute anonymous online survey. 
The survey will begin with a written consent statement to which participants can 
select a multiple choice option to agree and proceed with the survey. Alternatively, 
participants can opt to decline to provide consent and end the survey. Participants 
who consent will be automatically randomized into one of five trial arms and 
presented with a survey, which mimicks a fast-food menu based on a well-known 
burger-focused fast-food chain, and instructed to select an entrée they would 
hypothetically like to order for lunch. Participants in each trial arm will be exposed 
to a menu version that differs by labeling condition assigned to main menu items 
(e.g., burgers, wraps, salads, etc.) that describes the climate impact associated 
with each item. Climate-impact label menu designs in the study will include a QR 
code label (control), a high-impact warning label, traffic-light labeling of high, 
medium, and low impact, grade labeling (five-tiers; grades A-F) and a numeric label 
describing the estimated amount of kg CO2e associated with each menu item. 
Following the meal ordering task, participants will be presented with several 
questions about the label for which each participant was randomized to view, 
followed by a question about relative effectiveness of all labels in the experiement. 
Finally, participants will answer several demographic questions, after which the 
survey will conclude. CloudResearch will provide information about participants’ 
age, sex, and race and ethnicity, so these questions will not need to be asked.  
 
 
 
2. Describe the number and type of study visits and/or contacts between the 
study team and the participant, how long they will last, and where/how they 
will take place. 
Participants will take the survey, online on a computer or cell phone, at a place of 
their choosing. They will only take the survey once. The survey is expected to last 
approximately 3 minutes or less. There is no direct contact between the study team 
and the participant. 
 
3. Describe the expected duration of the study from the perspective of the 
individual participant and duration overall. 
The survey is expected to last approximately 3 minutes or less. 
 
4.   Provide a brief data analysis plan and a description of variables to be 
derived.  
The primary outcome measure will be the healthfulness of the fast-food meal 
selections, measured with a modiﬁed Nutrient Proﬁle Index (NPI) score. NPI scores 
are based on the UK Ofcom Nutrient Proﬁling Model, which is used to score 

individual foods in the U.K. to determine which ones can be marketed to children. 
For this study, we will generate a modiﬁed NPI score to evaluate the healthfulness of 
full meals comprised of multiple food items. This measure will be determined by 
calculating the weighted mean NPI score of all food items selected per meal, with 
each item’s NPI score weighted by its proportionate contribution of mass in grams 
to the total mass of the meal. Beverages will be excluded from the modiﬁed score 
and assessed through secondary outcomes. 
The key independent variable will be a ﬁve-category indicator of the experimental 
arm to which the participant is randomized. Using logistic regressions, we will 
explore diTerences in primary outcome between climate-impact label conditions 
(arms 2, 3, 4, and 5) vs. the QR label control, and between the label conditions (arm 
2 vs. arm 3; arm 2 vs. arm 4; arm 2 vs. 5; arm 3 vs. arm 4; arm 3 vs. 5; arm 4 vs. 5).  
As secondary outcomes, we will also compare total greenhouse gas emissions (kg 
CO2e) associated with hypothetical orders across labeling conditions, perceived 
message eTectiveness, total calories per meal order, and selection of a sugar-
sweetened beverage within order. 
 
5. Answer the following if they are relevant to your study design: 
 
A. If the study has different arms, explain the process for assigning 
participants (intervention/control, case/control), including the sequence 
and timing of the assignment. 
 
Randomization will be enabled as a function of the survey software (Qualtrics). 
Participants will be randomized into one of ﬁve study arms, as described above.  
 
B. If human biospecimens (blood, urine, saliva, etc.) will be collected, provide 
details about who will collect the specimen, the volume (ml) and frequency 
of collection, how the specimen will be used, stored, identified, and 
disposed of when the study is over.  If specimens will be collected for use 
in future research (beyond this study), complete the “Biospecimen 
Repository” section below. 
 
N/A 
 
 
 
C. If genetic/genomic analyses are planned, address whether the data will be 
contributed to a GWAS or other large dataset.  Address returning 
unanticipated incidental genetic findings to study participants. 
 
N/A 
 

D. If clinical or laboratory work will be performed at JHU/JHH, provide the JH 
Biosafety Registration Number. 
 
N/A 
 
E. If you will perform investigational or standard diagnostic laboratory tests 
using human samples or data, clarify whether the tests are validated 
and/or the lab is certified (for example is CLIA certified in the U.S.).  For 
clinical tests of human biospecimens, no results may be returned 
unless completed in a certified lab. Explain the failure rate and under 
what  
circumstances you will repeat a test.  For all human testing (biomedical, 
psychological, educational, etc.), clarify your plans for reporting test 
results to participants and/or to their families or clinicians.  Address 
returning unanticipated incidental findings to study participants. 
 
N/A 
 
F. If your study involves medical, pharmaceutical or other therapeutic 
intervention, provide the following information: 
 
a. Will the study staff be blind to participant intervention status?   
N/A 
 
 
b. Will participants receive standard care or have current therapy 
stopped? 
N/A 
 
c. Will you use a placebo or non-treatment group, and is that justifiable? 
       N/A 
 
 
d. Explain when you may remove a participant from the study. 
N/A 
 
e. What happens to participants on a study in which there is a medical 
intervention when the study ends?  Will participants continue to have 
access to the study intervention?  What happens if they leave the 
study early? 
 
N/A 
 
 

f. Describe the process for referring participants to care outside the 
study, if needed. 
N/A 
 
VI.  Data Custody, Management, Security, and Confidentiality Protections:  Data 
security and management plans must meet institutional standards.  If you need 
assistance, contact [bsph_cybersecurity@jhu.edu] 
Investigators are responsible for ensuring the security of data from the time of 
collection, through any transfers from one system to another, analysis, sharing, storage, 
and ultimate archiving and disposal.  The questions below seek to elicit your plans for 
these protections.  Feel free to add information. 
1. Data Sources:  Identify the source(s) of data. 
     ☒   Participant/Parent-Guardian/Legally Authorized Representative                                                       
     ☐   JHM Medical Records (from Epic)   
Note for JHM Data Users Only:  Please complete the Data Trust Risk Tiers Calculator available on the 
Applications and Forms page on the BSPH IRB website: [https://tinyurl.com/2p96md3s] and upload a copy of the 
documents to the “Miscellaneous- Other” section of your PHIRST application. 
  
In addition, review the Data Protection Attestation for Research and/or Healthcare Operations at: 
[https://tinyurl.com/yszfkuur] and certify your attestation of compliance to those requirements. 
               ☐   I certify my attestation of compliance to JHM Data Protection Requirements 
☐   Non-JHM Medical Records  
☐   Outside Data Pprovider (CMS, National Death Index, Insurance Co., etc.)                                                           
☐   Other Existing Records (please specify):         
2. Data Content:  Will you collect, use, and/or record personal identifiers about study participants for any 
purpose?  Please look at the list of identifiers in Question 3 to help answer this question. Note:  Limited Data 
Sets (including dates, ages, and zip codes) are considered to be “identifiable”. 
☐   Yes:  Continue with Question 3 
☒   No:  Skip to Question 6 
3. Data Identification:  Identify the Personally Identifiable Information (PII)/Protected Health Information (PHI) 
you will access/collect by checking the box(es) below for “Recruitment” and “Study Data” needs. 
 Recruitment Study Data 
PII/PHI to be Accessed/Collected 
 
☐  
☐   
Name, signature, initials or other identifiable code 
 
☐   
☐   
Geographic identifier (address, GPS location, etc.) 
 
☐   
☐   
Dates (birth, death, clinical service, discharge, etc.) 
 
☐   
☐   
Contact information (phone number, email address, etc.) 
 
☐   
☐   
Identification numbers (SSN, driver’s license, passport, etc.) 

 
☐   
☐   
Health records identifiers (medical record #, insurance plan, etc.) 
 
☐   
☐   
Text of clinical record notes 
 
☐   
☐   
Device identifiers (implants, etc.) 
 
☐   
☐   
Internet identifiers (IP address, social media accounts, etc.) 
 
☐   
☐   
Biometric identifiers (fingerprints, retinal scan, voice print, etc.) 
 
☐   
☐   
Audio Recordings 
 
☐   
☐   
Video or full-face photographic images 
 
☐   
☐   
Genomic / Genetic data 
 
☐   
☐   
Other identifiers (list here):          
4. Identifiers:  If you have checked any of the boxes above, how will you protect personal identifiers? 
☐   Will delete all identifiers (explain when you will delete identifiers):        
☐   Will separate identifiers from analytic data and will store the link/code.  Please explain where you will  
store the link/code:        
☐   Will use a method to make it harder to connect the data with the study participant (jiggering date, use 
other methods to obfuscate, etc.).  Please explain:        
5. Data Transit Plans and Protections:  Identifiable data may transfer, sometimes with multiple steps, from 
mechanisms for collection to storage.  For example, participants may complete a web-based survey, which is 
then downloaded to a storage platform.  Briefly identify these steps and the protections for each step (including 
encryption used at each step). 
☐   Will delete all identifiers prior to transfer. 
       ☐   Will separate identifiers from analytic data and will store the link/code prior to transfer.  Please explain   
where you will store link/code:        
  ☐   Other (please specify):        
6. Device(s) used for data collection:  Identify the computing device(s) being used for identifiable data 
receipt/collection.  Check all that apply. 
We understand that resources in low resource countries may require use of systems that are not pre-approved.  
The following are examples of platforms/storage solutions that are not pre-approved to store identifiable 
information and require a risk assessment from BSPH Data Security.  Do not hesitate to contact 
[bsph_cybersecurity@jhu.edu] for an assessment. 
• JHU Independent Departmental Servers 
• Local Computer owned by JH 
• Other computers or devices owned/managed by study team members and used for other than secure 
web access 
• USB/Portable data storage device 
• Other solutions not managed by IT@JH, e.g., commercial cloud storage (Box, Dropbox, iCloud, personal 
OneDrive, Google Drive, Amazon storage, etc.) 
  
 ☐   Provided or managed by BSPH IT 
     ☐   Study-provided, and not managed by BSPH IT.  These must include the following protective controls: 
• Data  encrypted while “at rest” (on a storage device) 

•   Security patches and updates are routinely or automatically applied 
•   Devices have access controls so that: 
o   Each person accessing the device is uniquely identified (username) 
o   Passwords are sufficiently strong to prevent compromise 
o   All access is logged and recorded 
o   Unauthorized access is prevented 
• Approved access list is reviewed periodically for correctness 
      ☐   Other (please specify):        
7. Data Collection:  Describe the format of data received/collected.  Check all that apply. 
☐   Paper/Hard Copy (must be secured in transit and placed in a secure cabinet/room)                                    
☐   Audio recording   
☐   Video recording                                               
☐   Received directly by research team member and entered into file/database 
☐   Mobile or Web App (custom developed).  Review [guidance] and provide attestation of compliance 
☐   Mobile or Web App (purchased).  Specify product and version:        
☒   Online survey.  Specify mechanism/platform:  Qualtrics via CloudResearch 
☐   3rd party collector (please specify):         
☐   Existing data shared with BSPH by data provider via electronic access/transfer 
☐   Duplicate and backup copies will be secured with same rigor as original data            
☐   Other (please specify):         
 
8. Devices/Platforms used for Analysis, Storage, Processing:  Identify where the identifiable or de-identified 
data will be analyzed/stored.  Check all that apply. 
☒   Pre-approved storage and analysis platforms managed by JH/BSPH for which security and risk mitigation 
measures are known. 
       Identify pre-approved storage platform(s) being used: 
JHM Preferred: 
 ☐   JH SAFE Desktop    ☐   JH PMAP  
 
Other Approved Platforms: 
☒   JH One Drive/BSPH OneDrive     ☐   JH IT-Managed Network Storage     ☒   JHM/BSPH Qualtrics 
☐   BSPH HPCC     ☐   BSPH SharePoint     ☐   BSPH Shares     ☐   JHU REDCap  
☐   MARCC-Secure Environment 
 
☐   Platform(s) not managed by JH/BSPH, not pre-approved, and require a risk assessment review from BSPH 
Data Security.   
• Describe the not pre-approved platform(s) you plan to use:        

• Describe the technologies you intend to use (software, hardware, connectivity) with a focus on the 
measures taken to secure collected data along the continuum of data collection, storage, transmittal 
and access:        
 
9. Access to Data and Access Controls:  How will you ensure that only authorized individuals can access the 
data?  What access controls will you put into place to ensure that only authorized individuals may access and 
use the data.  (For example, OneDrive [guidance] illustrates how to share files with “people you specify”.  
[BSPH Shares] addresses providing permissions to individual people.)  Check all that apply.  Note:  If you need 
assistance implementing secure access controls, contact [bsph_cybersecurity@jhu.edu] 
 
☒   Will provide access to data in accordance with OneDrive/BSPH-Shares guidance posted on JHU IT websites 
☐   Will use secure access controls to limit access to individual-level data  
☐   Will use secure access controls to provide other researchers controlled access only to aggregated study data 
 
10. Data Sharing:  Clarify if data are to be shared externally with third parties, including sponsors and other 
investigators, and whether only aggregated data will be shared, or if you will share individual-level data.  
Describe sharing and protection plans for that sharing, including the proposed use of data agreements.   
Consider the following: 
• 
Information about your data sharing in the consent forms 
• 
Information about data sharing laws in the country where data will be collected, and if they limit sharing, 
how you will comply with those limitations? 
• 
Whether data will be shared in aggregate only, or individual level data 
• 
Whether you plan to make the data publicly available, and in what form. 
☐  Will not share data with outside investigators 
☐  Will make publicly available 
☐  Will share with restrictions/controls 
☐  Will share aggregated data only 
☒  Will share individual-level data without identifiers 
☐  Will deposit data into an existing data repository for future research.  Please explain:         
☐  Future research use and data sharing will have limited purposes.  Please explain:         
☐  Other sharing information:         
 
11. Duration and Destruction:  Explain how long data will be retained and the plan for eventual return, 
deidentification or destruction of data, including moving data to an archive. 

A. Certificate of Confidentiality: 
All NIH studies include Certificate of Confidentiality (C of C) protections with the 
grant; the consent form must include the C of C language provided in our 
template.  Other funders may obtain C of C protections through NIH.  
[https://grants.nih.gov/policy/humansubjects/coc.htm]  
 
Does the study have Certificate of Confidentiality protections?  Yes ☒   No ☐ 
 
VII. Risks of the Study: 
A. Describe the risks, discomforts, and inconveniences associated with the study 
and its procedures, including physical, psychological, emotional, social, legal, or 
economic risks, and the risk of a breach of confidentiality.  Include risks beyond 
individuals to include the study population as a group and community risks. 
Ensure that the risks described in the consent documents are consistent with the 
risks outlined in the research plan. 
 
Breach of conﬁdentiality is a potential risk, but it is very low, given data security 
procedures at CloudResearch and the fact that they will only share de-identiﬁed 
data with JHU. 
 
B. Describe steps you will take to mitigate or minimize each of the risks described 
above.  Include a description of your efforts to arrange for care or referral for 
participants who may need it. 
We are not collecting any identifying information, including IP address information. 
We will have no way of identifying the participant or their location. 
 
C. Describe the anticipated frequency and severity of the harms associated with the 
risks identified above; for example, if you are performing “x” test/assessment, or 
dispensing “y” drug, how often do you expect an “anticipated” adverse reaction to 
occur in a study participant, and how severe do you expect that reaction to be?   
This risk of conﬁdentiality breach could only occur at the point of participant 
engagement with CloudResearch, as no identifying information will be collected or 
received by JHU. 
 
D. Describe the research burden for participants, including time, inconvenience, 
invasion of privacy in the home, out of pocket costs, etc.  
Participants will take an online survey that will span approximately 3 minutes, at a 
time that is convenient to them.  
 
 
We will retain data for a minimum of 7 years. All data is deidentified. 

E. Describe how participant privacy, and if relevant – family privacy - will be 
protected during data collection if sensitive questions are included in interviews, 
or if study visits occur in the home setting.  
 
N/A 
 
F. Levels of COVID-19 community transmission will vary considerably by geography 
and over time, and therefore, the responses to the pandemic may also vary.  The 
risk of COVID-19 to study staff and participants from in-person research activities 
can be mitigated by appropriate study procedures.  If you are conducting in-
person research activities, please indicate the protections you plan to implement 
at your research site(s): 
 
☒   Not applicable 
☐   COVID testing of staT                                       
☐   COVID testing of study participants 
☐   Indoor masking/wearing PPE 
☐   Social distancing for indoor activities 
☐   Symptom screening of staff 
☐   Symptom screening of study participants 
☐   Vaccination of research team members 
☐   Other procedures/comments:        
 
VIII. Direct Personal and Social Benefits: 
A. Describe any potential direct benefits the study offers to participants (“payment” 
for participation is not a direct personal benefit). 
 
Participation in the study may increase participant awareness of and knowledge 
about the connection between food choices and climate change. 
 
B. Describe potential societal benefits likely to derive from the research, including 
value of knowledge learned. 
This research supports a larger inquiry about the potential usage of fast-food menu 
labeling to promote healthier and more environmentally sustainable food choices at-
scale. If effective, thereby improving dietary quality and lessening demand for foods 
that disproportionately contribute to greenhouse gas emissions, this pilot study and 
the research it scaffolds will meaningfully contribute to strategies that address diet-
related disease and climate change. The implications could include increased 
consumer awareness and knowledge to support healthier and more sustainable 
choices, efficient leveraging of cross-sectoral resources to simultaneously address 
two major public health crises, the adoption of voluntary practices within industry, 
and considerations for regulatory and policy action.  
 

IX.  
Payment or Token of Appreciation:   
A. Do you plan to provide a non-monetary token of appreciation (food, soap, tea, 
chlorine tablets, etc.) to study participants?  If no payment is provided, the BSPH 
IRB strongly encourages providing such tokens. If yes, please describe below. 
 
Participants will be compensated through CloudResearch according to their 
guidelines.  
 
Should we determine that a participant’s response is not valid, we will alert 
CloudResearch and they will determine, per their guidelines, whether a 
participant receives compensation. Participants we exclude due to our eligibility 
criteria will be replaced by CloudResearch.  
 
B. If you plan to provide a monetary payment, describe the form, amount, and 
schedule of payment to participants. Reimbursement for travel or other expenses 
is not “payment,” and if the study will reimburse, explain. 
 
The level of compensation is set by CloudResearch, per their guidelines.   
 
C. Include the possible total remuneration and any consequences for not completing 
all phases of the research. 
None 
X. Study Management: 
A. Oversight Plan: 
1. Describe how the study will be implemented.  List all parties, including 
collaborators and subcontractors, who will be “engaged” in the human 
subjects research project and their roles . 
Dr. Julia Wolfson, Associate Professor in International Health, SPH, is the PI of the study, 
and Nina Carr, MPH, MBA, Senior Research Program Coordinator is the the study 
coordinator. Their roles will be to lead implementation including study design, data 
collection, and analysis without actively being involved with participants. We will provide a 
link to the survey, programmed in Qualtrics) to CloudResearch and respondents will be able 
to access the survey without any contact or interaction with the study team. 
Dr. Alexandra Reimold, a postdoctoral scholar in the Department of Human Ecology at the 
University of California, Davis. She will conduct data analysis under the oversight of Dr. 
Jennifer Falbe, Associate Professor in the Department of Human Ecology at the University of 
California, Davis. Dr. Falbe will also serve as a consultant on study design and 
interpretation of results. Neither will be engage in data collection or have any interaction 
with participants.  
 
2. What are the qualifications of study personnel implementing the project? 
 

Dr. Julia Wolfson, has a PhD in public health policy and 10 years of experience 
conducting online survey research. The research team has extensive expertise in online 
experiments testing e5ects of food labels on food choices.  
 
Nina Carr is a Senior Research Program Coordinator II in the Human Nutrition Program 
within the Department of International Health. As a direct report of Dr. Wolfson, she 
assists with the coordination of studies aimed at food systems change. Ms. Carr holds 
master’s degrees in public health and business administration and has 9 years of 
professional experience managing projects focused on health promotion. 
 
 
3. How will non-professional personnel (data collectors) involved with the data 
collection and analysis be trained in human subjects research ethical 
protections?  (Use the BSPH Ethics Field Training Guide available on the 
BSPH IRB website. If the study is a clinical trial, consider using the BSPH 
Good Clinical Practice (GCP) For Social and Behavioral Research Field 
Guide).  
 
N/A 
 
4. If the BSPH PI is responsible for data collection and will not personally be on-
site throughout the data collection process, provide details about PI site visits, 
the supervision over consent and data collection, and the communication plan 
between the PI and study team. 
N/A 
 
B. Protocol Compliance and Recordkeeping:   
Describe how you plan to ensure that the study team follows the protocol and 
properly records and stores study data collection forms, IRB regulatory 
correspondence, and other study documentation (for assistance, 
contact:  [housecalls@jhu.edu]). 
Please provide information about study oversight to ensure compliance with IRB 
approval and regulatory and institutional requirements.  If the study team does 
not follow study procedure, what is your plan for reporting protocol non-
compliance?   
The study team will have a shared OneDrive folder in which all study documents and 
protocols will be saved. The study team will have weekly meetings, and every person 
brought on to the study team will have an orientation meeting with Dr. Wolfson. Dr. Wolfson 
will be responsible for all correspondence with the IRB and all other study documentation. 
 
C.  Safety Monitoring: 

1. Describe how participant safety will be monitored as the study progresses, by 
whom, and how often.  Will there be a medical monitor on site?  If yes, who 
will serve in that role and what is that person’s specific charge? 
Participation in this study does not pose any safety risks. The study engages 
participants in a very brief, 3-minute survey task that asks non-sensitive 
questions.  
2. If a Data Safety Monitoring Board (DSMB), or equivalent will be established, 
describe the following: 
a.   The DSMB membership, affiliation and expertise. 
N/A 
b. The charge or charter to the DSMB. 
N/A 
c.   Plans for providing DSMB reports to the IRB. 
N/A 
3. Describe plans for interim analysis and stopping rules, if any. 
N/A 
 
D. Reporting Unanticipated Problems/Adverse Events (AEs) to the IRB (all 
studies must complete this section):   
 
NOTE: The IRB does not require PROMPT reporting of all AEs, only those that 
are unanticipated, pose risk of harm to participants or others, and are 
related to the study.  Anticipated AEs may be reported with the Continuing 
Review/Progress Report. 
 
Describe your plan for reporting to the BSPH IRB, local IRBs, and (if applicable) 
to the sponsor.  Include your plan for government-mandated reporting of child 
abuse or illegal activity.  
While we do not expect any adverse events, should any occur we will report them 
immediately to the IRB.  
 
E.  Other IRBs/Ethics Review Boards:   
If other IRBs will review the research, provide the name of each IRB/ethics 
review board and its Federal Wide Assurance number, if it has one (available on 
[OHRP's Website]).  For federally funded studies, subrecipients  MUST have 
a Federal Wide Assurance (FWA) number from the OHRP.  The IRB 
overseeing the subrecipient should be registered with the OHRP.  The 
BSPH IRB will not have oversight responsibility for international 
subrecipients, and generally will not oversee data collection at external 
U.S. institutions  Please contact the [BSPH IRB Office] with questions. 

 
 
 
F. “Engaged” in Human Subjects Research:  
For studies that involve collaboration with non-BSPH institutions, complete the 
chart below by describing the collaboration and the roles and responsibilities of 
each partner, including the BSPH investigator.  This information helps us 
determine what IRB oversight is required for each party. Complete the chart for 
all multi-collaborator studies. 
 
Insert collaborator names and FWA numbers, if available.  Note who will be 
“engaged” in human subjects research by filling in the following table: 
 
BSPH 
      
      
For federally funded studies, 
collaborators’ FWA 
00000287 
      
      
Primary Grant/Contract 
Recipient 
      
      
      
Grant/Contract Subrecipient 
      
      
      
Hiring Data Collectors 
      
      
      
Training Data Collectors 
      
      
      
Obtaining Informed Consent 
and/or Identifiable Data 
      
      
      
Accessing/Analyzing 
Identifiable Data 
      
      
      
Overseeing storage, access 
and use of biospecimens 
      
      
      
 
COMPLETE THE FOLLOWING SECTIONS WHEN RELEVANT TO YOUR 
STUDY:  
 
XI. Secondary Data Analysis of Existing Data: 
 
 
A. Study Design: 
1. Describe your study design and methods.  The study design must relate to 
your stated aims/objectives.   
      
 
2.  Provide an estimated sample size and an explanation for that number. 
Non-BSPH  IRB/REC 
FWA Number 
      
      
      
      
      
      

 
      
3. Provide a brief data analysis plan and a description of variables to be derived. 
      
 
 
 
 
B. Participants: 
1. Describe the subjects who provided the original data and the population from 
which they were drawn.  
  
      
 
Note: If you are receiving, accessing, or using data from a U.S. health care 
provider, the need for HIPAA review is likely.  If you plan to bring identifiable 
health information from a foreign country to a U.S. covered entity (e.g., lab at 
the Hopkins SOM), HIPAA may be triggered.  If either of these conditions is 
met, check “yes” to the HIPAA question in the PHIRST application.   
 
 
2. If you plan to analyze human specimens or genetic/genomic data, provide 
details about the source of those specimens and whether they were collected 
using an informed consent document.  If yes, explain whether your proposed 
use is “consistent with” the scope of the original consent, if it potentially 
introduces new analyses beyond the scope of the original consent, and/or if it 
introduces new sensitive topics (HIV/STDs, mental health, addiction) or 
cultural/community issues that may be controversial. 
      
 
3. Explain whether (and how) you plan to return results to the participants either 
individually or as a group. 
      
 
XII. Oversight Plan for Student-Initiated Studies: 
A. For student-initiated studies, explain how the PI will monitor the student’s 
adherence to the IRB-approved research plan, such as communication frequency 
and form, training, reporting requirements, and anticipated time frame for the 
research.  Describe who will have direct oversight of the student for international 
studies if the PI will not personally be located at the study site, and their 
qualifications. 
      

 
B. What is the data custody plan for student-initiated research?  (Note:  Students 
may not take identifiable information with them when they leave the institution.)   
      
 
XIII. Creation of a Biospecimen Repository: 
Explain the source of the biospecimens, if not described above, and what kinds of 
specimens will be retained over time.  Clarify whether the specimens will be 
obtained specifically for repository purposes, or will be obtained as part of the core 
study and then retained in a repository. 
 
A. Describe where the biospecimens will be stored and who will be responsible for 
them. 
      
 
B. Describe how long the biospecimens will be stored, and what will happen at the 
end of that period. 
      
 
C. Explain whether the biospecimens will be shared with other investigators, inside 
and outside of JHU, how the decision to share will be made, and by whom.  
Include your plans, if any, for commercial use.  Also explain how downstream use 
of the specimen will be managed, and what will happen to left-over specimens.   
      
 
D. Describe whether future research using the biospecimens will include specimen 
derivation and processing (cell lines, DNA/RNA, etc.), genomic analyses, or any 
other work which could increase risk to participants. Explain what additional 
protections will be provided to participants. 
      
 
E. If future research could yield unanticipated incidental findings (e.g., an 
unexpected finding with potential health importance that is not one of the aims of 
the study) for a participant, do you intend to disclose those findings to the study 
participant?  Please explain your position. 
      
 
F. Explain whether the specimens will be identifiable, and if so, how they will be 
coded, who will have access to the code, and whether the biospecimens will be 
shared in linked (identifiable) form. 
      

 
G. Explain whether the repository will have Certificate of Confidentiality protections.  
      
 
H. Explain whether a participant will be able to withdraw consent to use a 
biospecimen, and how the repository will handle a consent withdrawal request. 
      
 
I. Describe data and/or specimen use agreements that will be required of users.  
Provide a copy of any usage agreement that you plan to execute with 
investigators who obtain biospecimens from you. 
      
 
XIV. Data Coordinating Center: 
Complete if BSPH serves as the Data Coordinating Center. 
    
A. How will the study procedures be developed?   
      
 
B. How will the study documents that require IRB approval at each local site be 
developed?  Will there be some sort of steering or equivalent committee that will 
provide central review and approval of study documents, or will template consent 
forms, recruitment materials, data collection forms, etc. be developed by and 
provided to the local sites by the coordinating center without external review?  
      
 
C. Will each local clinical site be overseen by its own IRB with an FWA, or will a 
Single IRB review the study?  State whether the coordinating center will collect 
IRB approvals and renewals from the clinical centers; if not, explain why. 
      
 
D. How will the coordinating center provide each local site with the most recent 
version of the protocol and other study documents?  What will be the process for 
requesting that these updates be approved by local clinical center IRBs? 
      
 
E. What is the plan for collecting data, managing the data, and protecting the data 
at the coordinating center?  
      
F. What is the process for reporting and evaluating protocol events and deviations 
from the local sites? Who has overall responsibility for overseeing subject safety: 
the investigators at the recruitment site, the Coordinating Center, the Steering 

Committee, or a Data and Safety Monitoring Board (DSMB)? Is there a DSMB 
that will evaluate these reports and provide summaries of safety information to all 
the reviewing IRBs, including the coordinating center IRB?  Please note that if 
there is a DSMB for the overall study, then the coordinating center PI does not 
have to report to the coordinating center IRB each individual adverse 
event/problem event that is submitted by the local site PIs. 
      
 
G. Some FDA regulated studies have different AE reporting criteria than that 
required by the IRB (IRB Policy No. 103.06).  How will you reconcile the different 
requirements, and who is responsible for this reconciliation?  
 
       
 
H. Who is responsible for compliance with the study protocol and procedures and 
how will the compliance of the local sites be monitored and reviewed?  How will 
issues with compliance be remedied? 
      
 
XV. Drug Products, Vitamins, Food and Dietary Supplements: 
Complete this section if your study involves a drug, botanical, food, dietary 
supplement or other product that will be applied, inhaled, ingested or otherwise 
absorbed by the study participants.  If you will be administering drugs, please upload 
the product information. 
A. List the name(s) of the study product(s), and the manufacturer/source of each 
product. 
Name of Study Product 
Manufacturer/Source 
 
      
      
      
      
      
      
 
B. List each study product by name and indicate its approved/not approved status. 
Approved by the FDA 
and Commercially Available 
Approved by Another Gov’t 
Entity (provide name) 
Cleared for Use at Local 
Study Site 
 
      
      
      
      
      
      
      
      
      

 
C. If your study product has an Investigational New Drug (IND) application through 
the U.S. Food and Drug Administration, provide the IND number, and the 
Investigators Brochure.  
 
       
 
 
Who will hold the IND? 
      
 
D. If your study product is a marketed drug, provide the package inserts or other 
product information.  If the study product WILL NOT be used for its approved 
indication, dose, population, and route of administration, provide a detailed 
rationale justifying the off-label use of the study product.  
 
      
 
E. If the study product does not require FDA approval (e.g., dietary supplements, 
botanicals, products not subject to the U.S. FDA, etc.), provide safety information 
(as applicable) and a certificate of analysis. 
 
      
 
F. Explain who will be responsible for drug management and supply, labeling, 
dispensing, documentation and recordkeeping.  Complete and upload into 
PHIRST the Drug Data Sheet available on the [BSPH IRB Website] 
      
  
G. What drug monitoring and/or regulatory oversight will be provided as part of the 
study? Please describe.   
      
XVI. Medical Devices: 
Complete this section if your study will involve an approved or investigational 
medical device (diagnostic, non-significant risk, significant risk). 
    
A. List the name(s) of the study product(s), the manufacturer/source of each 
product, and whether or not it is powered (electric, battery).  Provide product 
information.  If it is electric, upload documentation of clinical engineering approval 
or its equivalent from a local authority, to ensure that the device is in good 

working order. 
 
 
Name of Study Product 
Manufacturer/Source 
Powered? 
 
      
      
      
      
      
      
      
      
      
 
B. List each study product by name and indicate its status as approved by a 
government authority or not approved. 
 
Approved by the FDA and 
Commercially Available 
Approved by Another Gov’t 
Entity (provide name and 
approval information) 
 
Not Approved  
 
      
      
      
      
      
      
      
      
      
 
C. If your investigational device is Exempt from the FDA IDE regulations, explain 
which section of the code applies to your device and why it meets the criteria 
provided.  If it is a diagnostic device, provide pre-clinical information about the 
sensitivity and specificity of the test and the anticipated failure rate.  If you plan to 
provide the results to participants or their physicians, justify doing so, and explain 
how those results will validated (or not) against the current “gold standard”.   
      
 
D. If you believe the investigational device is not IDE exempt under 21CFR 
812.2(c), but is a “Non-Significant Risk” device considered to have an approved 
IDE application, provide information from the manufacturer supporting that 
position. 
       
 
E. If you are using an investigational device that is a Significant Risk Device, 
provide the IDE number given by the FDA, or if not under FDA jurisdiction, 
explain why it is appropriate to use this device in this study.  Provide a description 
of the device, and upload a picture or manufacturing schematics into PHIRST.  
Provide any other information relevant to a determination of its safety to be used 
for the purposes outlined in this research plan.