Informed Consent Form (ICF)

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

Protocol Title: Screening protocol to establish a registry of healthy adults for potential influenza transmission studies (EMIT-2b Registry Protocol)

Introduction To The Registry

You are being asked to participate in a research registry. This consent form details the screening procedures and provides context for your participation in the registry. Please read this consent form carefully and take as much time as you need.

Before you decide if you want to participate in this registry, you should know the following:

• This is a registry for the purpose of making people available for a future influenza transmission study.

• Signing this consent form allows for screening to see if you are eligible for the registry but does not enroll you in the future influenza transmission study automatically.

• A separate consent form for the future influenza transmission study will be provided to explain the research study and your part in it in detail.

• Eligibility is based on being healthy and not having any health conditions for serious complications with an influenza infection.

• Participation in this registry is completely voluntary. You can decide not to join this registry, or you may quit at any time without fear of penalty or loss of benefits.

• We anticipate having up to 1000 people in this registry.

• This registry is being assembled at the Public Health Aerobiology Lab (PHAB Lab) at the University of Maryland School of Public Health, University of Maryland, College Park (UMD).

• If you do not understand any words or terms in this informed consent form or in the consent form for the influenza transmission study, you should ask the study staff to explain what they mean. You may have an unsigned copy of this consent form (digital or physical) to think about or discuss with family or friends before making your decision.

Who Is Funding The Study?

This study was started with funding from the National Institutes of Health (NIH). This means that the University of Maryland College Park (UMD) received funding from NIH to cover the costs related to setting up the registry. Costs of running the registry may be covered by NIH, foundation gifts, and other funders. The NIH is a federal health research organization that supports research for many infectious diseases and vaccines. The principal investigator from the UMD is ultimately responsible for the conduct of the registry.

Purpose Of The Registry

The purpose of this registry is to place eligible people into future influenza transmission studies.  To be in this registry you must be a healthy adult with no health conditions that would put you at risk for more serious influenza or complications of influenza. Once you have consented to be in this registry, we will have you come back to the clinic at least once per year. At each in-person visit you will update your medical information, and we will collect your blood. You will also receive an online survey invitation every month asking you to provide updates (if there are any) to your health and vaccination status. Meanwhile, we may contact you during the influenza season about participating in the influenza transmission study that takes place in a controlled research environment.  

Why Study Influenza Transmission?

Influenza is a virus that can cause infection of the nose, throat, and lungs. Influenza infection can cause fevers, weakness, body aches, muscle aches, sore throat, and cough. A severe influenza infection can cause people to be hospitalized, require intensive care, and can cause death.  Transmission studies are to examine how the infection is passed from one person to another person. We plan to do these future transmission studies in a research building on the College Park campus with research physicians and nurses to carefully monitor illness and manage symptoms. If you developed symptoms that require immediate medical attention, we will refer you to local urgent care or Emergency Room.

Special Note for Public Health Emergencies. While there is a declared Public Health Emergency for a contagious respiratory disease, there is a risk of exposure to infected individuals at in-person visits and will be some additional measures that will be required for all study participants and research staff. We will minimize this risk by contacting participants the day prior to visit and screening for relevant symptoms associated with the circulating pathogen. If you were to develop any illness symptoms before a clinic visit, then we ask that you contact the clinic before you arrive so that we can discuss whether the clinic visit will be postponed or cancelled. The completion of a valid COVID-19 vaccination will be required before entry into the influenza transmission study.

Are There Requirements For Joining The Registry?

To take part in the registry, you must be between 18 and 49 years old and in good health. If you are pregnant or breastfeeding, you cannot participate in this registry. There may be other reasons why you cannot be in the registry. The study doctor will tell you if and why you do not qualify for the registry.

How Many People Will Take Part In This Registry?

Up to 1000 people may be enrolled for participation in this registry.

What Is Involved In This Registry?

If you agree to be screened for this registry, you will be asked to read, sign, and date this consent form. We will collect your medical history, vaccination and infections history, and ask about what medications you may be taking. We will also measure your vital signs, height, and weight.  This information will inform on whether you are healthy enough to stay in the registry. We will also collect a blood sample from you. The blood will be analyzed to see if you are vulnerable to some influenza viruses. 

There are risks to participating in the future influenza transmission study. It is important to be completely honest with your study doctor and the study staff during the visit and throughout the entire study.

Study Procedures

Online:

• Ask you to read this consent form with detailed information about the study, and sign this consent form, if you agree to participate.

• Collect demographic information from you, such as age, sex, and how to contact you.

• Collect your medical and health history and ask you for a list of medications you are taking

• The online survey will take about 20-30 minutes.

Initial Visit:

At this visit, we will do the following:

• Give you a description of the registry.

• Ask you to review this consent form and confirm if you agree to participate.

• Review your demographic information from you, such as age, sex, and confirm how to contact you.

•  Review your medical history, ask you for a list of medications you are taking.

• Measure your height, weight, blood pressure, pulse, temperature, breathing rate, and oxygen.

• We might conduct a physical examination.

• Collect a blood sample, by a needle stick in your arm.

  • Less than 1 tablespoon (12.5 mL), for routine tests to look at your overall health and to screen you for Hepatitis B, Hepatitis C, and HIV. HIV is the virus that causes AIDS. Hepatitis B and C are viruses that affect the liver.

Note: We are required to follow state law and report positive test results for HIV and hepatitis to the local health agency. We will notify you if any of your screening tests are abnormal and refer you to counseling and for follow-up care.

•  Less than 2 teaspoons (8.5 mL), for tests of antibodies (a substance that is in your blood that fights germs) to influenza.

• We might provide you with a home kit if supplies are available.

  • The home kit includes an at-home flu rapid test with self-testing instructions, a factsheet explaining the test, and a recruitment flyer for the future transmission study.

Note: The at-home flu rapid test is intended for research purposes only and cannot be used for treatment. Please read the full explanation provided in the factsheet included in the home kit.

• We might provide you with a flyer for the future influenza transmission study.

• This visit should take approximately an hour and a half.

Follow-up Clinic Visits (Yearly)

If you continue to be eligible and funding to extend the study becomes available, during the Fall and Winter months you will be given an appointment date and time for a follow-up visit. At the follow-up visit, we will do the following:

•  Ask you to provide an updated medical history, vaccination history, and list of any medications you have taken since your last visit.

•  Measure your weight, blood pressure, pulse, temperature, breathing rate, and oxygen.

• Conduct a physical examination (if needed, if any changes in your medical history).

• Collect a blood sample, less than 2 teaspoons (8.5 mL), for tests of antibodies to influenza.

• If the at-home flu rapid test kit is available and you have an expired kit, we may provide you with another home kit.

• We may provide you with a flyer for the future influenza transmission study.

• This visit may take between 30-60 minutes to complete.

Follow-up Survey (Monthly)

Following the clinic visit, we will send you a follow-up survey each month during the flu season to: 

• Confirm your ongoing consent to participate.

• Ask if you received any vaccines since your last visit or survey.

• Ask if you had a respiratory illness in the last month.

• This survey should take 2-3 minutes to complete.

You may also have unscheduled outpatient visits and/or blood tests if the study doctor thinks they are needed.

During the flu season

While you are in the registry, you can expect that we may contact you to ask if you can participate in the future influenza transmission study. If you agree to participate as a recipient in a transmission study, you may be asked to take part in activities that increase your risk of infection. When you are not part of the study activities, we will ask you to make special efforts to avoid catching the flu for a period of about two weeks. There will be a separate consent form that will fully explain this study.

How Long Will I Be In The Registry?

You may be in this registry for up to one year. You can choose to stop participating at any time without penalty or loss of any benefits to which you are entitled. If the study is extended beyond one year, you may continue to participate by completing the yearly follow-up visit.

What Will You Do With My Samples At The End Of The Registry?

By agreeing to be in this registry, you are agreeing to allow for the indefinite storage of your samples. After your blood samples are used for testing as part of the registry, we will keep any remaining samples for future research studies. These samples will be coded, meaning they will be labeled with your subject code number and will not contain your name or any other identifying personal information. Your samples may be tested for other antibodies against bacteria or viruses or other immune responses. The samples will not have genetic testing, will not be used to generate cell lines, and will not be sold for commercial use (for profit). The results from the research tests will not be reported back to you or your doctor, as they will not affect your healthcare. If at any point in the future, you decide that you do not want your samples stored indefinitely, then you must write a letter to the principal investigator to make this request. Then, your samples will be destroyed after your written request has been received. The samples will not be returned back to you.

The risk of storing your samples or using them in future research studies is a loss of confidentiality. This risk is low, because your name is not on the samples - only your study subject number is used. These coded samples will be stored in laboratories with controlled access and may be shared with investigators at other institutions. If these samples are tested in the future, the results may be published; however, the publication will not contain any information about you that would allow someone to find your identity.

If you have not withdrawn your consent for secondary research use, your samples and data may be de-identified and made available for secondary (other) research. This means the codes are removed and no one can trace the data and samples back to you. Information from the data and samples may be posted in a database for data sharing with other researchers.

What Are My Responsibilities If I Take Part In This Research?

If you take part in this research, it is your responsibility to:

• Tell us your complete medical history, including vaccinations and infections. You are also voluntarily deciding to not complete an influenza vaccination, as part of participation in this registry.

• Agree to consider possibly being available, during the flu season, to participate in the influenza transmission study.

What Are The Risks Of The Registry?

Blood Draws

Drawing blood may cause pain, bruising, lightheadedness, fainting, bleeding, and rarely infection. The research team will clean the blood draw area and will use gloves and sterile equipment to decrease any risk of infection.

Confidentiality

If you decide to participate in the registry, 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.

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. 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.

Any publications from this registry will not identify you personally. Organizations that may inspect and/or copy your research records for quality assurance and data analysis include groups, such as the NIH.

Rapid Flu Test

Rapid diagnostic tests may not always be accurate, as they can produce false positive and false negative results. It is recommended that you always discuss your test results with your doctor for further guidance and treatment, if necessary.

Unknown Risks

There may be additional risks in this registry which are not yet known, but if they happen, we will tell you about them.

Potential Benefits 

There is no direct benefit from your participation in this registry.

Alternatives To Participation

You do not have to join this registry; your participation is completely voluntary. Your alternative is to not join this registry. If you do not join this registry, your healthcare will not be affected.

Costs And Compensation

All procedures for the registry will be provided at no cost to you. However, your participation may cost you the time and travel required for the completion of each clinic visit. You will be compensated for your time in the registry. You will be reimbursed $75 for the initial clinic visit, and $50 for each annual follow-up visit. You will be compensated $5 for each completed monthly survey. Bus tokens and/or parking vouchers will be provided for clinic visits if you to campus shuttles and/or parking.

Confidentiality And Access To Records

Efforts will be made to limit your personal information, including research study and medical records, to people who have a need to review this information. We cannot promise complete secrecy. Organizations that may inspect and copy your information include the IRB and other representatives of this organization. All of the information you give during the registry will be considered confidential and kept in locked areas and/or on secured database. The only people who will have access to your information are those involved in the registry. Others who may see your information are the groups of people who review the registry for legal and ethical reasons. These groups may include:

• Audit and compliance officers and legal counsel

• Department of Health and Human Services (DHHS) agencies and governmental agencies to which HIV and hepatitis testing must be reported

• The UMD Institutional Review Board (IRB)

• Study funder, DMID of NIAID of NIH

• Study monitor

When we contact you for potential participation in the influenza transmission study, we will use encrypted email or text messages to minimize the risk of loss of confidentiality.

Maryland state law requires us to report some diseases and information about you. If reported, this information may not remain confidential. Otherwise, the information that identifies you will not be given out to people not working on the registry unless you give us permission.

The data from the registry may be published. However, you will not be identified by name. People designated from the institutions where the registry is being conducted and people from the sponsor will be allowed to inspect sections of your medical and research records related to the study. Everyone using registry information will work to keep your personal information confidential. Your personal information will not be given out unless required by law.

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.

Right to Withdraw

Your participation in the registry is completely voluntary. You are free to withdraw from this registry at any time. You must inform the research team immediately if you intend to withdraw. Your decision will not result in any penalty or loss of benefits to which you are entitled or influence your ability to get regular medical care. If you leave the registry, information collected up to the date you leave the registry can be used only as outlined in the confidentiality section of this consent form.

Whom To Contact About This Registry

If you have questions about study clinic policies or the conduct of the registry, please call the UMD PHAB Lab Clinic phone number (301) 405-3142 Monday-Friday during the day.

University Statement Concerning Research Risks

The University is committed to providing participants in its research all rights due them under State and federal law. You give up none of your legal rights by signing this consent form or by participating in the research project. This research has been reviewed and approved by the Institutional Review Board (IRB). Please contact the Institutional Review Board (IRB) if you have questions about your rights as a research participant.

The contact information for the IRB and the Human Rights Protection Office at the University of Maryland, College Park is:

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