Virus Shedding & Face Mask Study Consent Form

Purpose of the Study

This research is conducted by Donald Milton, MD, DrPH and researchers at the University of Maryland. It is funded by the University and federal government sources including the U.S. Department of Health and Human Services. The purpose is to find out how people transmit COVID-19 and how to prevent transmission. This research will answer several important questions. How much airborne virus does an infected person exhale? How much virus is released into the air when an infected person breathes, talks, or sings? How well do masks block release of airborne virus? This work will help us understand whether airborne transmission is important and how to prevent it. Another goal is to gather samples that can be used to better understand how the body fights the infection. This will help with future research to develop new medications and vaccines to treat and prevent COVID-19. We invite you to participate because you have recently tested positive for the virus, or you were recently identified by a medical provider based on your symptoms and fever as a likely COVID-19 case.

Procedures

➢Study Overview

We will ask you to come to one of our research clinic sites (School of Public Health in College Park or Laurel Regional Medical Center or Express Healthcare / Med-Ped Healthcare) for up to 2 visits, approximately 1-2 days apart to evaluate your infection. We want to see if you are shedding virus in the air. This is a critical part of the research because there is little information about whether infected persons spread the virus through their exhaled breath. We also want to see how well masks can help to prevent spread of the virus. After you have recovered, we will ask you to return for a short follow-up visit, in approximately one month. For this study, you will:

  • Answer online questionnaires

  • Have your temperature, heart rate and oxygen level measured

  • Provide swabs of your nose and cell phone

  • Provide saliva

  • Provide blood

  • Provide breath sample(s)

We will also ask you to give or email a flyer to your household contacts so that we can test them to see if they have the infection.

➢Factsheet and Consent Form

Please read this consent form and the “Factsheet – Understanding Your COVID-19 Test Results”. The fact sheet explains what the testing means and how the results will be handled.

Most of our tests cannot be used to diagnose you or make treatment decisions. The results are for research only. However, if you haven’t had a diagnostic test, we can collect an extra swab and perform a diagnostic rapid test.

If you decide to participate, you must correctly answer a few questions at the bottom of this consent form to make sure you understand. After you complete the short quiz we will ask you to sign this form online. We will email you a copy of the signed form.

➢Enrollment Questionnaire

Immediately after you agree to participate (by signing this form) we will ask you to complete a secure online survey if you are new to the study. This survey asks for your:

  • Social Security number (for your compensation)

  • Contact information: name, email address, affiliation with UMD and UID (if any), mobile phone number, local residential address, and emergency contact including primary medical provider

  • Demographic information: date of birth, sex, race, ethnicity, education, employment, and income category

  • Medical history and health behaviors such as tobacco and alcohol use

  • Residential conditions

  • Up-to-date vaccination status

  • Current symptoms and medications

  • Close contacts within the last 48 hours

We may ask you to provide confirmation of your diagnosis or positive test for COVID-19. We will email a separate link to some of these questions so you can answer them just before coming to your visit.

➢Initial Study Visit

We will contact you to make an appointment with us. We will give you directions to the School of Public Health research clinic or the Laurel Regional Medical Center or another site and instructions on how to prepare for your visit. The site will either be in the School of Public Health or another location that is convenient for you.

Please call us when you arrive outside for your appointment and a research staff member will meet you and escort you to the testing area. We will ask you to wear a well-fitting mask before bringing you inside the building and exam room. If you don’t have one or yours is not well fitted, we will provide you with a well-fitting mask. You will wear a mask during the entire visit, except when it must be removed for sample collection. Study staff will review this form with you and give you a chance to ask questions before starting the visit.

During this visit we will measure and collect the following from you:

  • Height, weight, oral temperature, heart rate and oxygen level

  • Nasal swabs and a swab of your cell phone

  • A saliva sample

  • A blood sample (up to 25 mL, a little less than 2 tablespoons)

  • Up to two 30-minute breath samples

Details of each type of collection are given below. We estimate this visit will take approximately 1-2 hours (60 to 120 minutes), plus an additional 30 minutes if you have not completed the enrollment questionnaire before coming to the clinic, depending on the number of breath samples you provide.

We will also give you a flyer and email that you can give/send to your household contacts. We want to tell them about the study and that they are eligible to come into the clinic for testing.

➢Repeat Study Visit

We may ask you to return to the study clinic approximately 1-2 days later for a second visit to assess your illness. Whether we ask you to return depends on our testing capacity, where you are in the course of the infection, and if you are feeling well enough to come for the visit. If we schedule you for a repeat visit, we will call or text you to ask if your symptoms have changed. We will also ask you to complete an online questionnaire before you arrive.

The questionnaire will ask about your:

  • Current symptoms and medications

  • Close contacts within the last 48 hours

  • Time spent in your home or room and bedroom

We will make the same measurements and collections as at the first visit except that we will not repeat the height and weight and will not collect another blood sample.

The repeat visit will take approximately 50-110 minutes, depending on the number of breath samples collected.

We will not ask you to come to the research clinic if your symptoms suggest you may meet CDC or Maryland Department of Health criteria for triage to urgent medical care. If a supervising clinician determines that you require urgent medical intervention, we will instead advise you to seek medical attention, possibly by calling 911..

➢ Immune Response Follow-up Visit

We will ask you to return to us for a follow-up visit approximately 3-5 weeks after the start of your infection. If you are unable to come then or are still ill, we will ask you to return as soon as possible after you have recovered. We will send you an online survey and ask you to complete it just before coming to the visit. This survey will ask about your symptoms, medications and treatment, and information about the course of your illness.

At the visit trained study personnel will measure your oral temperature, heart rate, and oxygen level and will collect two nasal swabs, saliva, and a blood sample. We estimate the follow-up visit will take approximately 20-30 minutes.

Schedule of Procedures

*time depends on the number of breath samples you provide

➢ Oral Temperature

We will place the tip of the standard oral thermometer probe under your tongue on one side of your mouth next to the back molar. We will repeat this on the other side of your mouth.

➢ Oxygen Saturation and Heart Rate

We will place a small clip on the end of one of your fingers for approximately 30 seconds. The clip shines a light through your finger and is attached to a device that measures your oxygen level and heart rate.

➢ Phone Swab

Trained study personnel will use a swab dampened with universal transport medium to swab the four sides and the front surface of your phone. This is to test for infectious agents.

➢ Saliva Samples

We will ask you to stop eating and drinking for 30 minutes before your visit. Just before saliva collection, we will ask you to clean your hands with hand sanitizer. Then we will hand you a collection tube. We will ask you to collect approximately 0.5-1 mL of saliva from the back of your throat. This amount of saliva can usually be collected by spitting into the cup 2-3 times. Saliva will be tested for the virus that causes COVID-19.

➢ Nasal Swabs

We will use a small penlight to look inside your nostrils, and then collect 2 mid-turbinate nasal swabs. This swab is small, soft, contoured, and made specifically for this procedure. We will gently insert the swab approximately 1.5-2” into your nostril (stopper ensures proper depth). We will rotate the swab once and then withdraw it. A second swab will be collected from the other nostril, unless there is an obstruction or other reason to avoid sampling one side. In that case both swabs may be collected from the same nostril.

Depending on the availability of supplies, we may collect two nasopharyngeal or anterior nasal swabs instead. A nasopharyngeal swab is smaller than the mid-turbinate swab described above. It is inserted slightly deeper into the nasal passage but in a similar manner. The anterior nasal swab is larger but less invasive. It is inserted approximately 3/4" inside the nostril and firmly pressed against the nasal membrane by rotating the swab for 10-15 seconds.

Nasal swabs will be tested for the virus that causes COVID-19. They may also be tested for other viruses and bacteria that cause respiratory infections. If rapid testing is available and indicated, one additional swab may be collected and tested by using a rapid COVID-19 diagnostic kit for immediate results. For this testing, we will insert a nasal swab approximately 1 inch into one of your nostrils until resistance is met. We will gently rotate the swab several times, remove it, and repeat the procedure in the other nostril.

➢ Blood Sampling

We will use a small butterfly needle and standard sterile technique to collect a relatively small amount of your blood from a vein in your arm. We will collect up to 25 mL (less than 2 tablespoons) at the first visit and at the immune response follow-up visit. The blood samples will be used to test for antibodies and biomarkers of infection and to develop countermeasures to control the SARS-CoV-2 virus.

Exhaled Breath Sample (s)

If your condition allows, and we have testing capacity, we will ask you to give us up to two breath samples at your initial study visit and two additional breath samples at a repeat study visit if you are eligible. At each visit, we will collect one sample while you are wearing a mask and the other without wearing the mask. We will provide the masks for you to wear. At one visit we will give you a surgical mask and at the other we will provide a KN95.

We will ask you to sit in a booth with clean, filtered, warm humidified air and to breathe normally into a large funnel or cone. The cone is part of an apparatus that collects particles in your exhaled breath, coughs, and sneezes. You will sit in the booth for 30 minutes for each breath sample. During each session you may be asked periodically to talk and/or sing loudly. We will count the number of times you cough and sneeze while you are providing the exhaled breath sample. We will do this either by direct observation or by asking you to wear a microphone so that we can count your coughs and sneezes later. We will ask you to put a mask back on before leaving the booth. Breath samples will be tested for COVID-19 and possibly other viruses or bacteria.

Potential Risks and Discomforts

TThere is a risk of incorrect test results. We believe the risk is fairly small, but we don’t know for sure. The University of Maryland research lab performing the tests has years of experience with similar tests. We use a commercial test kit that is used by many clinical laboratories.

However, our research lab is not a certified clinical laboratory. Please see the “Factsheet – Understanding Your COVID-19 Test Results” for a detailed description of the tests and what to expect from the results.

Your participation in this study may take time away from other activities or time you may have spent resting and recovering. We will try to keep your study visit as short as possible and to minimize wait times through efficient scheduling of appointments. You may not feel well while participating in the study due to symptoms of your illness. Study participation will not worsen your symptoms any more than a visit to a health care provider. You may feel some embarrassment when providing information about your medical history or habits. We will minimize your potential embarrassment by allowing you to answer the questions in a private setting. There is a small risk to your privacy and confidentiality because we 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. All data will be transmitted between the electronic device used to enter your data (a computer, tablet, or your phone) and the server via encrypted connections. The server will be housed in a high security data center as described below under confidentiality.

You may experience some mild pressure or discomfort, a tickling sensation, occasional eye watering, or sneezing when the nasal swabs are collected. In rare instances swabbing inside the nose may cause very minor bleeding. 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. The staff members who will collect your nasal swab and blood sample are trained to minimize these risks. The total maximum amount of blood that will be drawn for the study (if you complete an initial shedding visit and the immune follow-up) is 50 mL. This is much less than the amount typically removed at one time for blood donation (450-500 mL).

When providing a breath sample in the G-II booth, you may feel uncomfortable sitting in the booth with your face at the entrance to the large funnel. You are more likely to feel uncomfortable if you suffer from claustrophobia. You may wear headphones and listen to your own entertainment during this session. There is no known risk from breathing warm, humidified HEPA (High Efficiency Particulate Arresting -- removes ≥ 99.94% of particles in the air) filtered air when sitting in the booth.

Potential Benefits

It is unlikely that you will benefit from participating. We hope that, in the future, other people might benefit from this study through improved understanding of COVID-19. We want to find out whether mild early infection is associated with shedding airborne viruses. This will help develop better ways to reduce the spread of the infection. Your blood samples will be used to study the body’s immune response to the virus and may assist in the development of medical treatments.

Confidentiality

Any potential loss of confidentiality will be minimized by storing all data in an encrypted database maintained on a secure server in a high security data center. Only essential study personnel have access to this data. Access to data is limited. Only staff with an operational need for particular information will have access to sensitive information (for example social security numbers). Undergraduate research assistants only have access to the database while working in the clinic under senior staff supervision. You have been assigned a subject ID number which will be used by research staff to access your records in the database.

All biologic samples will be labeled with a unique sample ID number. The number can only be linked to your personally identifiable information by Dr. Milton and his designated research staff. The sample labels will not contain your name or other personally identifiable information.

Samples will be stored in laboratories with controlled access at the School of Public Health. Some samples may be deposited in a secured storage system maintained by the University of Maryland or the National Institutes of Health. This system is for long term storage and distribution of samples to other laboratories for research on respiratory infections, especially COVID-19. Samples will be retained indefinitely until used up or there is no longer sufficient scientific justification for the cost of maintaining them in storage.

We will not disclose any personally identifiable information about you to anyone outside of the research team, unless you test positive for COVID-19 or another infection where public health reporting is required. If you test positive for COVID-19 and did not have a previous positive test, we will notify the State and/or County Health Departments. We will also refer you to the University Health Center or your medical provider for follow-up. Decisions about testing, treatment, and isolation will be made by the Health Department, University Health Center, or your medical provider.

Collaborators within and outside the University of Maryland will conduct analyses on your samples or data for research purposes. All such samples or data will always be de-identified. We may report a summary of group results on our study website. If we post information on the website or write a report about this research project, your identity will be protected to the maximum extent possible.

Your information may be shared with representatives of the University of Maryland, College Park or governmental authorities in certain special situations. We must share your information if you or someone else is in danger or if we are required to do so by law. The Code of Maryland Regulations (COMAR) 10.06.01.03 C, requires reporting certain infectious diseases to the Maryland Department of Health and Mental Hygiene. This includes reporting personally identifiable information in the event of any disease outbreak that poses a danger to public health, such as COVID-19. It also requires reporting of cases of Measles, Mumps, Pertussis and Legionellosis, which may be tested for in samples that we collect. Measles is a highly contagious virus that causes respiratory infection and rash. Mumps is a somewhat less contagious viral illness that typically causes swollen tender salivary glands. Pertussis, also known as whooping cough, is a highly contagious bacterial respiratory infection. Legionellosis (also known as Legionnaire’s Disease) is a bacterial infection that can cause pneumonia or flu-like illness. Measles, Mumps, and Pertussis can all be prevented through proper vaccination.

Any unanticipated problems involving risks to participants or others such as unexpected or serious adverse events, non-compliance, audits, and investigation reports will be promptly reported to the University of Maryland Institutional Review Board.

Medical Treatment

The University of Maryland does not provide any medical, hospitalization or other insurance for participants in this research study. The University of Maryland will not 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 have the potential to receive up to $275 if you are eligible for and complete two Shedding Assessment Visits and a Follow-up Visit as specified in the chart below.

  • We will provide compensation using one of the following methods:

    • A University issued debit card onto which funds will be electronically transferred.

    • A virtual gift card.

    • If you are UMD affiliated, through your Terrapin Express account.

  • Payment methods will depend on the logistical capabilities of the University of Maryland Student Financial Services and Cashiering Office.

  • We will collect the information required by UMD Student Financial Services and Cashiering to make payments which may include but not be limited to your date of birth, address, and social security number. If you decline to provide this information you can still participate in the study, but you will not be able to receive compensation.

  • Payment will be made as soon as logistically possible, and may take up to 7-10 days.

  • If you earn $100 or more as a research participant in this study, we will be required to provide your name, address, and social security number to the Comptroller of the State of Maryland.

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

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, you will not be penalized. You will not lose any benefits to which you otherwise qualify. Your academic standing as a student or employability at UMD will not be affected by your participation or non-participation in this study.

Special notice for research assistants: If you are a student working on the study and are earning course credit for your work, your grade will not be affected by your decision to participate (or not participate) in this study.

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

Telephone: 301-405-0389

Email: dmilton@umd.edu

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

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

Statement of Consent or Assent and Permission

Your signature indicates the following:

  • You are age 18 or older. If you are younger, your signature indicates that you are either enrolled as a student at the University of Maryland or that your parent will also sign to give permission.

  • You have read this consent form or have had it read to you.

  • Your questions have been answered to your satisfaction.

  • You voluntarily agree to participate in this research study.

You will be sent a copy of this signed consent form via email, which you may print.

Use of samples: Your signature also indicates that you agree to use of your samples for research on COVID-19 and other infections, immune response to infections, and for similar future research studies for which they may be helpful. Your samples may be used by researchers both inside and outside of the University of Maryland. For example, researchers at the University of California, Irvine may measure antibody levels in your blood samples. We may also send your samples to the Walter Reed Army Institute for Research for viral DNA sequence analysis. Please note that no personally identifiable information will be provided to researchers outside of Dr. Milton’s laboratory. If you do not want us to use your samples in this manner you should not sign this consent form.