Roommate Study Informed Consent and Registar Release Forms

For a full explanation of what this study involves and why we are doing this research, please read the informed consent and registrar release forms below.

Purpose of the Study

Donald K. Milton, MD, DrPH is conducting this research at the University of Maryland, College Park. We invite both you and your roommate to participate in this research project. Your involvement with your roommate will provide valuable insights into various factors that impact transmission risk of respiratory viruses. The purpose of this research project is to collect prospective data and study the factors influencing the spread of respiratory viruses, such as influenza, in shared living spaces. The study will also evaluate the ventilation of buildings to determine if it contributes to virus transmission between people.   

Procedures

To be eligible for this study, you must have a roommate who shares a sleeping space with you. To continue and maintain your participation in this study, your roommate must also join and maintain participation.

If you agree to participate in this study, you will sign and submit this consent form. We will then assign you a study ID number. You will be asked to complete the following procedures:

• Complete two short online surveys: one at the beginning and one at the end of the study year.

• If you are a UMD student, grant permission to get your class schedule from the UMD Registrar. 

• Complete daily symptom surveys. 

• Attend two clinic visits: one at the beginning and one at the end of the study year.

• When your room is randomly selected, place an indoor air quality monitor, such as a CO2 monitor, in your shared bedroom for approximately one week each month.

• Submit nasal swabs twice per week. 

• Provide exhaled breath samples during cold and flu season.

Short online survey:
Each survey will take 10 to 15 minutes to complete. We will record all of your answers directly into a secure electronic study database. The initial survey will ask you:

• Your name and contact information.

• Basic information about yourself such as age, sex, race, and ethnicity. 

• Medical history, health behaviors, and past influenza and COVID vaccinations.

• The type of mask you use and where you wore it in the past 48 hours.

• The last name of your roommate (or roommates, if you have more than one), who may also enroll in the study. Their records will be connected to yours to form pairs for the study. 

Daily symptom survey:
After you and your roommate(s) have signed this consent form and completed the first survey, you will receive a daily message to report your symptoms.

Baseline clinic visit:
Each visit will take no more than 30 minutes to complete.
Once you and your roommate(s) have both signed this consent form and completed the first survey, we will ask you to come to the SPH clinic for a joint clinic visit. During this visit, a research staff will review the procedures with you and answer any questions you may have. The research staff will then measure your height and weight, assess your temperature, and collect a nasal swab, and a small amount (5 mL, or 1 tsp) of blood sample from each of you in separate exam rooms to ensure privacy.
We will also provide you with home sample kits for self-collecting nasal swabs twice per week. Instructions for self-collection and sample drop-off are included in the kits. 

Indoor air quality monitor:
We will also ask you to place an indoor air quality monitor, such as a CO2 monitor, in your shared room for approximately one week each month to gather environmental data. 

Nasal swabs twice per week:
We will ask you to use the provided home kits to self-collect samples from your nose twice per week. We will let you know which two days each week to take samples.

Sample and Monitor Drop-off/Pick-up:
We offer multiple options for submitting your samples and returning indoor air monitors, including designated drop-off boxes on campus, direct submission to our research clinic, and scheduled pick-ups from agreed-upon locations. We will coordinate with you and your roommate to arrange the drop-off or pick-up process. We will ask you some questions about your surroundings in the shared bedroom when you return the monitors.

Exhaled Breath Sample Visit:
When cold and flu season is active, we might ask you to breathe into a special device if you tell us you have new onset of flu-like symptoms in your daily symptom survey. This involves you sitting in a warm, moist booth for 30 minutes. While in the booth, you will complete procedures such as talking or singing at different times, following the research staff’s instructions.  Also during this visit, we will assess your temperature, and may collect nasal swabs, saliva, and a small amount (5 mL, or 1 tsp) of blood. We will have you fill out a more detailed symptom survey at this visit. During your visit, we will ask you to wear an N95 mask that we provide. We will colelct the mask from you near the end of the visit and test it for virus.

End-of-year survey and visit:
At the end of the study year, we will invite you to complete the End-of-Year questionnaire to update relevant information and attend another clinic visit. During this visit, the same procedures as the previous clinic visit will be performed. We will collect your height, weight, temperature, a nasal swab, and a small amount (5 mL, or 1 tsp) of blood samples.

Potential Risks and Discomforts

There may be some risks or discomfort from participating in this research study.

• Your participation in this study may require time that could have been spent on other activities such as studying or resting. However, you will have the flexibility to complete the initial consent and questionnaire during any free time you may have. 

• You may feel some embarrassment when providing information about your medical history or habits. However, since you will be answering the survey on your own electronic device, you can do so privately.

• You may experience some mild pressure or discomfort, a tickling sensation, occasional eye watering, or sneezing when you collect the nasal swabs. The self-collected nasal swab only enters the front part of the nose. 

• When having your blood drawn, you may feel some discomfort from having the tourniquet placed around your arm. You will likely experience a small amount of pain at the site where the needle enters the skin. There is also a very small risk of bruising or infection at the site where the blood is taken. Some people become lightheaded or feel faint at the sight of blood or when blood is drawn. Our research staff who will collect your blood sample are trained to minimize these risks. 

• You may feel a bit uncomfortable while sitting in the booth to provide an exhaled breath sample, if you are invited to do so. There are no known risks associated with breathing the warm, humidified air filtered by HEPA (High Efficiency Particulate Air) filters in the booth.

• There is a small risk to your privacy and confidentiality because our team will be collecting a variety of personal data from you. We will do our best to keep your personal information confidential and limit access to only essential study personnel. 

Potential Benefits 

There are no direct benefits from participating in this research.  We hope that, in the future, other people might benefit from this study through improved understanding of the role of building ventilation in transmitting respiratory infections. 

Confidentiality

If you decide to participate in the study, our team will assign you a subject ID number which will be used to access your records in the database. We will label all samples with a unique sample ID that can only be linked to your subject ID number by Dr. Milton and his designated research staff. The sample labels will not contain your name or other personally identifiable information.

We will use end-to-end encryption from your phone to our servers to protect the confidentiality of your answers to our questions. We will minimize any potential loss of confidentiality by storing all data in a secure server in a high security data center. Only staff with a specific need for particular information will have access to sensitive information (for example social security numbers). Undergraduate research assistants only have access to the database during the hours that they are working under senior staff supervision. 

If we write a report or article about this research project or post information on the study website, we will protect your identity to the maximum extent possible. We may share your information with representatives of the University of Maryland, College Park, or governmental authorities if you or someone else is in danger or if we are required to do so by law. 

We will store your samples in labs with controlled access at the School of Public Health. We may deposit your samples in a secure long-term storage facility. Long-term storage may be at the University of Maryland Baltimore, the National Institutes of Health, or another similar institution. We will keep your samples until used up or until there is no longer a good scientific justification for the cost of keeping them. 

Your samples and data will be used for research on respiratory infections, especially COVID-19 and influenza. We may share your samples and data with other scientists at the University of Maryland and elsewhere. All shared samples and data will always be de-identified.

This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that: 

• The researchers cannot release or use information, documents, or samples that may identify you in any action or suit unless you say it is okay.

• They cannot provide your personal information as evidence in federal, state, or local civil, criminal, administrative, legislative, or other proceedings unless you have agreed to it. (for example, a court subpoena)

However, the Certificate does NOT PREVENT:

• Reporting on child or elder abuse, some communicable diseases, and threats to harm yourself or others.

• A sponsoring United States federal or state government agency from checking records or evaluating programs.

• Disclosures required by the federal Food and Drug Administration.  

• Your information from being used for other research if allowed by federal regulations.

Researchers may release information about you, when you say it is ok to do so. For example, you may give them permission to release information to insurers, medical providers or any other persons not connected with the research. The Certificate of Confidentiality does not stop you from willingly releasing information about your involvement in this research. It also does not prevent you from having access to your own information.

Medical Treatment

The University of Maryland does not provide any medical, hospitalization or other insurance for participants in this research study, nor will the University of Maryland provide any medical treatment or compensation for any injury sustained as a result of participation in this research study, except as required by law.

Compensation

You will receive compensation for your participation in this study. We will pay your through Terrapin Express, virtual gift card, or other similar mechanism. 

• We will give you compensation when you complete each study procedure listed in the table below. 

• You will be responsible for any taxes assessed on the compensation.

If you have a roommate enroll and you continue on to the initial clinic visit, you will likely earn more than $100 as a research participant in this study. In that case you will need to provide your permanent address and social security number to receive compensation. This is required for tax purposes.

Right to Withdraw and Questions

Your participation in this research is completely voluntary. You may choose not to take part at all. If you decide to participate in this research, you may stop participating at any time. If you decide not to participate in this study or if you stop participating at any time, our team will not penalize you or take away any benefits to which you otherwise qualify. If you are affiliated with UMD, your participation or non-participation in this study will not affect your academic standing as a student or employability at UMD.

If you decide to stop taking part in the study, if you have questions, concerns, or complaints, or if you need to report an injury related to the research, please contact the investigator:

Dr. Donald Milton
Room 2234V
SPH Building 255
University of Maryland
College Park, MD 20742

Participant Rights 

If you have questions about your rights as a research participant or wish to report a research-related injury, please contact: 

University of Maryland College Park
Institutional Review Board Office
1204 Marie Mount Hall
College Park, Maryland, 20742
E-mail: irb@umd.edu
Telephone: 301-405-0678

For more information regarding participant rights, please visit: https://research.umd.edu/irb-research-participants 

This research has been reviewed according to the University of Maryland, College Park IRB procedures for research involving human subjects.

Future Studies

There may be opportunities for you to enroll in future studies, and we would like to be able to notify you if such an opportunity develops. Please indicate whether we have permission to contact you for future studies.

I agree to be contacted for possible future studies:

☐Yes ☐No

Registrar Release Form

Please also sign a Registrar Release Form so that we can request a copy of your class schedule. This information will help us understand how you might be exposed to flu and colds on campus.

Statement of Consent:

Your signature indicates that you authorize the University of Maryland Office of the Registrar to release your class schedules for the current academic year to the study. If you agree to the Registrar Release, please sign your name below.

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