Permission to Take Part in a Human Research Study
Title of research study: A Multicenter, Prospective Study of SARS COV-2 Infections Using At-Home Rapid Diagnostic Test Kits and Online Data Gathering
Investigators: William S. Weintraub, MD and Kristen Miller, DrPH
Key Information:
The following is a short summary of this study to help you decide whether or not to be a part of this study. More detailed information is listed later on in this form.
Why am I being invited to take part in a research study?
You are being asked to take part in this study because you live or work in the greater DC or Baltimore metro area or because you have received health care at a MedStar Health facility.
What should I know about a research study?
- Someone will explain this research study to you.
- Whether or not you take part is up to you.
- You can choose not to take part.
- You can agree to take part and later change your mind.
- Your decision will not be held against you.
- You can ask all the questions you want before you decide.
Why is this research being done?
The purpose of this research is to collect information about our community's coronavirus exposures, symptoms, and health care visits due to the virus.
How long will the research last and what will I need to do?
We expect that you will be in this research study for up to one year.
Participation in this study will involve completing a daily questionnaire which covers your coronavirus illness history or symptoms, your health care seeking behaviors and treatments, your contact with other sick people, and for health care workers, their use of personal protective equipment.
More detailed information about the study procedures can be found under "What happens if I say yes, I want to be part of this research?"
Is there any way being in this study could be bad for me?
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.
More detailed information about the risks of this study can be found under "Is there any way being in this study could be bad for me? (Detailed Risks)"
Will being in this study help me in any way?
You are not expected to receive any direct benefit from taking part in this research study.
What happens if I do not want to be part of this research?
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.
Your alternative to participating in this research study is to not participate.
Detailed Information:
The following is more detailed information about this study in addition to the information listed above.
Who can I talk to?
If you have questions, concerns, or complaints, or think the research has hurt you, you can reach the research team at 800-808-5759 or JoinTheFight@medstar.net or you can contact the study coordinator, Christopher Washington, at (443) 827-8241 or christopher.w.washington@medstar.net.
This research has been reviewed and approved by an Institutional Review Board ("IRB"). You may talk to them at (301) 560-2912 or MHRI-ORIHelpDesk@medstar.net if:
- Your questions, concerns, or complaints are not being answered by the research team.
- You cannot reach the research team.
- You want to talk to someone besides the research team.
- You have questions about your rights as a research participant.
- You want to get information or provide input about this research.
How many people will be studied?
This study is open to all volunteers at least 18 years of age. It is expected that tens of thousands of people will take part in the study, however the exact number is not known. Other participants are being recruited at other health systems.
What happens if I say yes, I want to be in this research?
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 antibodies to coronavirus. With your permission, we will also collect information from your medical record. Due to quarantines and social-distancing for infection prevention, an at home test kit will be used to test your blood.
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.
- Periodically for up to one year, you will receive a link to a very brief questionnaire about your coronavirus illness history or symptoms, your health care seeking behaviors and treatments, your contact with other sick people, and for health care workers, their use of personal protective equipment. The questionnaire can be completed on your smartphone, tablet or computer. Initially, you will receive the questionnaire every day. However, as the coronavirus pandemic diminishes, you will likely receive the questionnaire less often.
- The study will continue as long as there are concerns about the epidemic in our region.
- We will 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. Antibodies are markers in your blood that determine if you have been exposed to coronavirus. This test has NOT been approved by the FDA and is considered experimental in nature. You will be provided the results of this test, but since the test is not approved by the FDA, medical decisions should not be made based on the test results.
If you agree to take part in in-home testing:
- You will 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 the picture using an app on your smart phone/mobile device; orĀ
- 2) package the test stick in an enclosed return mailer and put into the US mail.
- You will receive an at-home test kit to complete and return every month for up to one year.
You can participate in the questionnaires even if you don't want to complete the in-home testing.
Test Results (for those participating in the testing section)
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.
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 are 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.
- 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.
What happens if I say yes, but I change my mind later?
You can leave the research at any time it will not be held against you. You can tell the study team that you want to take away your permission to use and share your Protected Health Information at any time. You can reach the study team at:
Christopher Washington, Project Manager
MedStar Health Research Institute
3007 Tilden Street NW, Suite 6N
Washington, DC 20008
christopher.w.washington@medstar.net
Mobile: 443-827-8241
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.
Is there any way being in this study could be bad for me? (Detailed Risks)
There are no physical risks to you from participating in the study. You may experience minor discomfort from the finger prick.
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, but 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.
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.
What happens to the information collected for the research?
Efforts will be made to limit the use and disclosure of 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.
The results of this research study may be presented at scientific or medical meetings or published in scientific journals. 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.
The purpose of this research study is to obtain data or information on the at-home test kit; the results will be provided to the sponsor, the Food and Drug Administration, and other Federal and regulatory agencies as required.
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.
If identifiers are removed from your identifiable private information or identifiable samples that are collected during this research, that information or those samples could be used for future research studies or distributed to another investigator for future research studies without your additional informed consent.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Federal law provides additional protections of your medical records and related health information. These are described in the HIPAA Authorization.
HIPAA Authorization
We are committed to respecting your privacy and to keeping your personal information confidential. When choosing to take part in this study, you are giving us the permission to use your personal health information including the health information in your medical records and information that can identify you. For example, personal health information may include your name, address, phone number or social security number. The health information we may collect from you and use for this research includes:
- All information in a medical record
- Results of physical examinations
- Medical history
- Lab tests
Once we have the health information listed above, we may share some of this information with the following offices or entities outside of MedStar Health and its clinical partners (or affiliates): the MedStar Health Research Institute Office for Research Integrity; the US Office of Research Integrity; the US Office for Human Research Protections; the US Food and Drug Administration.
Any research information shared with outside entities will not contain your name, address, telephone or social security number or any other personal identifier unless disclosure of the identifier is necessary for review by such parties or is required by law or MedStar Health policy [except that such information may be viewed by the Study sponsor and its partners or contractors at the Principal Investigator's office].
The following entities may receive your health information:
- Authorized members of the MedStar Health workforce, who may need to see your information, such as administrative staff members from the MedStar Health Research Institute, Office for Research Integrity and members of the Institutional Review Board.
- Laboratories and other individuals and organizations that may need to see your health information in connection with this study.
- Other MedStar Health research centers and MedStar Health contractors who are also working on the study.
- Study monitors and auditors who make sure that the study is being done properly.
- The Centers for Disease Control, who is sponsoring the study, and that company's contractors and partners.
- Government agencies and public health authorities, such as the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS).
The following individuals or organizations may also access, receive, or use your personal health information:
- Oracle Corporation
- The at-home test kit company(s)
- Investigators at other sites working on the research
Those persons who get your health information may not be required by Federal privacy laws (such as the Privacy Rule) to protect it. Some of those people may be able to share your information with others without your separate permission.
The results of this study may also be used for teaching, publications, or for presentation at scientific meetings.
Unless you revoke your consent, it will expire in 10 years. After the expiration date, MedStar Health may not gather new information about you, or use or disclose your personal health information collected in this study for any purpose other than the research study described in this consent unless MedStar Health obtains permission to do so from you.
Although you may revoke consent to participation in this research at any time and in any format, you must revoke authorization for use or disclosure of your health information in writing. To revoke your authorization, write to:
Kristen E. Miller, DrPH
MedStar Health Research Institute
3007 Tilden Street NW, Suite 6N
Washington, DC 20008
You do not have to authorize the use or disclosure of your health information; however, you will not be allowed to take part in this research study if you do not allow this. If you do not authorize the use or disclosure of your health information, it will not affect your treatment by health care providers, or the payment or enrollment in any health plans, or affect your eligibility for benefits.
A copy of this signed consent document, information about this study, and the results of any test or procedure done may be included in your medical records and may be seen by your insurance company.
Can I be removed from the research without my consent?
The person in charge of the research study or the sponsor can remove you from the research study without your approval. This could be because new information becomes available, or because the entire study has been stopped.
What else do I need to know?
This research is being funded by the Centers for Disease Control and Prevention. The sponsor is providing money or other support to MedStar Health to help conduct this study. The researchers do not, however, hold a direct financial interest in the sponsor or the product being studied.
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.
The at home test kit is an investigational device. 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.
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. 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.