A Multicenter, Prospective Study of SARS COV-2 Infections Using At-Home Rapid Diagnostic Test Kits and Online Data Gathering
Informed Consent Form to Participate in Research
John Sanders, MD, Principal Investigator
Summary
You are invited to participate in a research study. The purpose of this research is to collect information about our community's coronavirus exposures, symptoms, and health care visits due to the virus. You are being asked to take part in this study because you have received health care at a Wake Forest Baptist Health facility. Participation in this study will involve completing a daily questionnaire which covers your coronavirus illness history, symptoms, treatments, as well as your contact with other sick people and use of personal protective equipment. You may also be asked to complete at home test kits (up to 12 times per year) for presence of antibodies to COVID-19 or an at-home test for the presence of the COVID-19 virus. As we learn more about this disease, we may contact you for additional information about COVID-19 or to offer you opportunities to participate in additional COVID-19 or related medical research. Your participation will last up to two, possibly, three years.
All research studies involve some risks. The risk of harm or discomfort that may happen as a result of taking part in this research study is not expected to be more than in daily life or from routine psychological examinations. You are not expected to receive any direct benefit from taking part in this research study.
Your participation in this study is voluntary. You do not have to participate in this study if you do not want to. You will not lose any services, benefits, or rights you would normally have if you choose not to participate.
The remainder of this form contains a more complete description of this study. Please read this description carefully. You can ask any questions if you need help deciding whether to join the study. The person in charge of this study is Dr. John Sanders If you have questions, suggestions, or concerns regarding this study or you want to withdraw from the study his contact information is: 336-716-2700 (336-716-7654 after hours). If you have any questions, suggestions or concerns about your rights as a volunteer in this research, contact the Institutional Review Board at 336-716-4542 or the Research Subject Advocate at Wake Forest at 336-716-8372.
Introduction
Research studies are designed to gain scientific knowledge that may help other people in the future. Please take your time in making your decision as to whether or not you wish to participate. You may also discuss the study with your friends and family. If you have questions about the study, you can reach study staff at the study call center at 336-70-COVID (336-702-6843).
Why Is This Study Being Done?
As you are aware, the coronavirus pandemic is a public health emergency. By studying the who, when, and where patterns of coronavirus infections researchers can help the medical community better understand the pandemic and develop strategies to fight it. This study involves the collection of information about our community’s coronavirus exposures, symptoms, and health care visits due to the virus. In addition to the information collected you may be asked to participate in at home testing for the presence of the coronavirus in saliva or the presence of antibodies to coronavirus in blood. With your permission, we will store any remaining blood or saliva after testing for other studies and collect information from your medical record. We may contact you to obtain additional information or specimens or to ask if you would be willing to participate in additional COVID-19 or related medical research.
The at home test kits for coronavirus infection or presence of coronavirus antibodies are investigational devices. This means it has not been approved by the U.S. Food and Drug Administration (FDA). Devices that do not have approval by the FDA cannot be sold or used by your physician. This test kit is being used for research purposes only
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this Web site at any time.
How Many People Will Take Part in the Study?
Everyone who has received health care at a Wake Forest Baptist Health care facility is invited to participate. It is expected that tens of thousands of people will take part in the study, however the exact number is not known.
What Is Involved in the Study?
If you agree to join the study, here is what will happen:
• You must read and complete this electronic consent document by providing your electronic signature. An electronic copy of the consent document will be provided after your signature.
• After completion of the online informed consent, you will be asked to complete a brief enrollment questionnaire.
• You will receive an email with a link to complete a brief on-line registration form. The questionnaire can be completed on your smartphone, tablet or computer.
• Each day for up to one year, you will receive a link to a very brief questionnaire about your coronavirus illness history, symptoms, treatments and your contact with other sick people, and use of personal protective equipment. The questionnaire can be completed on your smartphone, tablet or computer.
• We will also get certain information from your medical records. Examples include additional information about your health problems, health care visits, hospital stays, medical procedures, and lab results.
Some participants may also be asked to complete an in-home test kit for antibodies in your blood to the coronavirus and/or for the presence of coronavirus in your saliva. Antibodies are markers in your blood that determine if you have been exposed to coronavirus. These tests have NOT been approved by the FDA and are considered experimental in nature. You will be provided the results of these tests, but since the test is not approved by the FDA, medical decisions should not be made based only on the test results.
For detection of antibodies:
• You may receive an in home test kit by mail which detects antibodies to the coronavirus.
• Using the instructions and supplies in the at home test kit, you will prick your finger to produce a small amount of blood which you will place on a test stick. Your kit will instruct you to either:
1) take a picture of the test stick and send picture using an app on your smart phone/mobile device; or
2) package the test stick in an enclosed return mailer and put into the US mail.
• You will receive an at home test kit for antibodies up to 12 times in one year and a test for the coronavirus if there are clues that you have been exposed to the virus.
• As new resear ch questions arise over the course of the study, with your permission we may request additional information, blood, saliva, or other specimens from you.
For detection of coronavirus in saliva:
• You may receive an in home test kit by mail via USPS or UPS that detects the coronavirus in your saliva. This kit will come in a small box unmarked box from George Washington University.
• Using the instruction and supplies for the at home coronavirus detection kit, you will swab around the inside of your mouth until the swab is saturated with saliva and then place the swab into a capped tube and then into a return mailer. The kit can be mailed back at any USPS post office box.
• Once received and tested, you will receive an email from the Community Research Partnership and/or Oracle containing your results.
If you have any questions regarding your test results, please don’t hesitate to call 336-70-COVID
You can participate in the questionnaires even if you don't want to complete the in home testing.
TEST RESULTS FOR THOSE PARTICIPATING IN ANTIBODY TESTING
If you do an at home test kit for antibodies, you will receive one of the following messages regarding the results of your test via a secure email server:
Negative Test Result: Antibodies for COVID-19 were not detected suggesting that you may not have been previously infected. This is not a clinical test and should not be used to change your behavior. We encourage you to continue to follow guidance from the CDC and your physician concerning the best ways to prevent and manage COVID-19.
Positive Test Result: Antibodies for COVID-19 were detected suggesting that you may have been previously been infected. This is not a clinical test and should not be used to change your behavior. We encourage you to continue to follow guidance from the CDC and your physician concerning the best ways to prevent and manage COVID-19.
Invalid Test Result: your test was not able to be interpreted. There may have been technical difficulties with the test kit or the photo of your test stick. We will try to provide you more information and send you another test soon. We encourage you to continue to follow guidance from the CDC and your physician concerning the best ways to prevent and manage COVID-19.
TEST RESULTS FOR THOSE PARTICIPATING IN VIRUS TESTING
If you do an at home test kit for the SARS-CoV-2 virus, you will receive one of the following messages regarding the results of your test:
Negative Test Result: Virus was not detected in your saliva suggesting that you are not infected with the COVID-19 virus. This test was performed as part of researching the epidemiology of COVID-19, not as a clinical test. We encourage you to continue to follow guidance from the CDC and your physician concerning the best ways to prevent and manage COVID-19.
Positive Test Result: Virus was detected in your saliva that suggests an infection with COVID-19 virus. If you have symptoms, the US CDC recommends that you should isolate yourself from all others for at least 10 days, until your symptoms have improved, and until you have not had fever for three days. If you do not have symptoms, you should isolate yourself from others for at least 10 days. This test was performed as part of researching the epidemiology of COVID-19, not as a clinical test. If you have concerns about the accuracy of the test or the CDC recommendations concerning isolation, you may wish to contact your healthcare provider to discuss your result and symptoms. If you are experiencing trouble breathing, persistent pain or pressure in the chest, new confusion, inability to wake up or stay awake, or bluish lips or face, please seek medical care immediately. We also encourage you to continue to follow guidance from the CDC and your physician concerning the best ways to prevent and manage COVID-19.
Invalid Test Result: your test was not able to be interpreted. There may have been technical difficulties with the test kit. We will try to provide you more information and send you another test soon. We encourage you to continue to follow guidance from the CDC and your physician concerning the best ways to prevent and manage COVID-19.
Questionnaire Results
The information collected about you is for research purposes only. This information will not be used to guide your medical care. Your doctor or health care provider will not have access to this information.
What to do if you feel sick
The research study cannot provide medical care or coronavirus testing if you become sick. The questionnaires and at home testing is for research purposes only. If you begin to feel sick:
For mild illness:
Stay home and distance yourself from others.
Practice safe hygiene:
• Wash your hands, especially after touching any frequently used item or surface.
• Avoid touching your face.
• Sneeze or cough into a tissue or the inside of your elbow.
• Disinfect frequently used items and surfaces
If your illness worsens:
• Call your primary care provider.
• If you do not have a primary care provider, call 336-70-COVID to receive nurse advice.
• Your health care provider will direct you on next steps. It is important that you follow their instructions to keep you, your family and your community safe
How Long Will I Be in the Study?
You will be in the study for up to one year.
What Are the Risks of the Study?
There are no physical risks to you from participating in the study. You may experience minor discomfort from the finger prick or swabbing the inside of your mouth.
Participation in the study involves the potential risk of a breach of confidentiality of your health information that is collected in the questionnaires. Taking part in this research study may involve providing information that you consider confidential or private. Efforts, such as coding research records, keeping research records secure and allowing only authorized people to have access to research records, will be made to keep your information safe.
The study will use reasonable means to protect the security and confidentiality of information sent and received in this study, it may not be possible to completely secure the information. The use of text messaging and mobile applications can increase the risk of electronic information being disclosed to unauthorized individuals.
Are There Benefits to Taking Part in the Study?
If you agree to take part in this study, there may not be direct benefit to you. We hope the information learned from this study will benefit other people in the future.
What Other Choices Are There?
You do not have to be in this study to receive treatment for any coronavirus symptoms or illness. Your alternative is to not participate.
What Are the Costs?
There are no costs for participating in the study. The at home test kit is provided by the study sponsor and will not be billed to you or your insurance company. Costs for your regular medical care, which are not related to this study, will be your own responsibility.
Will Your Research Records be Confidential?
The results of this research study may be presented at scientific or medical meetings or published in scientific journals. Some data and results, for example maps of study participant coverage or tables of antibody or coronavirus testing results, may be available on public websites. However, your identity and/or your personal health information will not be disclosed unless it is authorized by you, required by law, or necessary to protect the safety of yourself or others. There is always some risk that even de-identified information might be re-identified.
Participant information may be provided to Federal and other regulatory agencies as required. The Food and Drug Administration (FDA), for example, may inspect research records and learn your identity if this study falls within its jurisdiction.
Participant acknowledges and agrees that the information provided pursuant to this Consent will become part of the COVID-19 national data registry operated, maintained, and provided by Oracle to the U.S. Department of Health and Human Services for its use, and potentially for use by other Government Agencies at HHS' direction, to address the imminent threat to the health and public welfare posed by the COVID-19 virus.
Will You Be Paid for Participating?
You will receive no payment or other compensation for taking part in this study.
The findings from this research may result in the future development of products that are of commercial value. There are no plans to provide you with financial compensation or for you to share in any profits if this should occur.
Who is Sponsoring this Study?
This study is being sponsored by the State of North Carolina with the use of funds from the Coronavirus Aid, Relief, and Economic Security Act or CARES Act. The sponsor is providing money or other support to Wake Forest University Health Sciences to help conduct this study. The researchers do not, however, hold a direct financial interest in the sponsor or the product being studied.
What About My Health Information?
In this research study, any new information we collect from you/or information we get from your medical records about your health or behaviors is considered Protected Health Information. The information we will collect for this research study includes: your name, address, email address, date of birth, medical record number, medical history, illness history, symptoms, health care visits and treatment information.
We will make every effort to keep your Protected Health Information private. We will store records of your Protected Health Information on a password protected computer.
Your personal health information and information that identifies you ("your health information") may be given to others during and after the study. This is for reasons such as to carry out the study, to determine the results of the study, to make sure the study is being done correctly, to provide required reports and to get approval for new products.
Some of the people, agencies and businesses that may receive and use your health information are:
• the research sponsor, CDC;
• George Washington University, where data analysis will be conducted and the GW University, Department of Global Health Laboratory where virology testing is completed;representatives of the sponsor assisting with the research
• Oracle Corporation;
• LabCorp, a corporation, conducting serology tests of blood specimens.
• the at home test kit company(s); • investigators at other sites who are assisting with the research;
• the Institutional Review Board;
• representatives of Wake Forest University Health Sciences and North Carolina Baptist Hospital; • SneezSafe staff;
• representatives from government agencies such as the Food and Drug Administration (FDA) or the Office of Human Research Protections (OHRP), the Department of Health and Human Services (DHHS), the Centers for Disease Control, or similar agencies in other countries.
Some of these people, agencies and businesses may further disclose your health information. If disclosed by them, your health information may no longer be covered by federal or state privacy regulations. Your health information may be disclosed if required by law. Your health information may be used to create information that does not directly identify you. This information may be used by other researchers. You will not be directly identified in any publication or presentation that may result from this study unless there are photographs or recorded media which are identifiable. Photographs or recorded media can only be used with your permission.
Monitors, auditors, IRB or other regulatory agencies will be granted direct access to the participant's original medical record for verification of clinical trial procedures or data, without violating confidentiality of the participant and to the extent permitted by other applicable laws.
If required by law or court order, we might also have to share your Protected Health Information with a judge, law enforcement officer, government agencies, or others. If your Protected Health Information is shared with any of these groups it may no longer be protected by federal or state privacy rules.
Any Protected Health Information and blood or saliva specimens collected from you in this study will be kept for an indeterminate period of time. This authorization does not expire. You will not be able to obtain a copy of your Protected Health Information in the research records until all activities in the study are completely finished.
You can tell Dr. John Sanders that you want to take away your permission to use and share your Protected Health Information at any time by sending a letter to this address:
Dr. John Sanders
Wake Forest University Health Sciences, Infectious Disease
Medical Center Blvd., Winston-Salem, NC 27157
However, if you take away permission to use your Protected Health Information you will not be able to be in the study any longer. We will stop collecting any more information about you, but any information we have already collected can still be used for the purposes of the research study.
By agreeing to be a part of this study you give us permission to use your Protected Health Information for this study.
What Are My Rights as a Research Study Participant?
Taking part in this study is voluntary. You may choose not to take part or you may leave the study at any time. Refusing to participate or leaving the study will not result in any penalty or loss of benefits to which you are entitled. The investigators also have the right to stop your participation in the study at any time. This could be because new information becomes available, or because the entire study has been stopped. Information that identifies you may be removed from the data collected as part of this study and could be used for future research or shared with others without additional consent.
You will be given any new information we become aware of that would affect your willingness to continue to participate in the study.
Confirmation
I agree to take part in this study. I authorize the use and disclosure of my health information as described in this consent and authorization form. If I have not already received a copy of the Privacy Notice, I may request one or one will be made available to me. I have had a chance to ask questions about being in this study and have those questions answered. By agreeing to take part in this study, I am not releasing or agreeing to release the investigator, the sponsor, the institution or its agents from liability for negligence.