Informed Consent for Participation in the COVID-19 Genomic Study
Purpose of the study
You are invited to participate in a research study COVID-19. This study intends to identify genomic factors that alter either the rate of infection or the severity of the disease in response to exposure to the virus causing COVID-19. While we are not determining whether you have or been exposed to COVID-19 in the past, or what is your risk. Your information will help us better understand possible vulnerability or resistance to the virus in a population. It must be noted that while participating in a survey may help others, it does not give you health advice.
Your participation in this study is entirely voluntary. Your decision not to participate will not have any negative effect on the service that is provided to you. You can decide to participate now, but withdraw your consent later and stop being in the study without any effects.
Duration Of Study Involvement
This research study is expected to take approximately 2-3 years.
We will ask you to participate in the study by performing tasks as simple as answering online questions and/or providing some information about your lifestyle or other health information. By answering a relatively short survey (20-45 minutes), you will participate in our health and wellness studies to better understand the correlation between genetic predispositions and actual conditions of the body. During the study, data about your lifestyle and habits will be combined with your genetic data (if provided) so we can offer more individualized results and actionable recommendations. By participating in the study, you allow us to contact you in the future to follow up questions. If you decided to opt-out of the study, you can email [email protected] at any time to be removed from future follow-ups.
As part of the analysis of your saliva samples, we will do genetic testing. The tests we plan to do will allow us to study the role of genetic mediators on the response to possible exposure to the SARS-CoV2 causing COVID-19. Genetic research may include looking at information, such as personal appearance and biochemistry, gene sequences, genetic landmarks, individual and family medical histories, reactions to medications and responses to treatment. You will be asked to provide a DNA sample (your saliva contains this DNA), or upload your existing DNA file if it is compatible with the format we can use in the study.
Genetic research raises certain questions about informing you of any results. Possible risks of knowing results include anxiety; other psychological distress; and the possibility of insurance and job discrimination. Possible risk of not knowing includes being unaware of the need for treatment. These risks can change depending on the results of the research and whether there is a treatment or cure for a particular disease. Sometimes volunteers have been required to furnish information from genetic testing for health insurance, life insurance, and/or a job. A Federal law, the Genetic Information Nondiscrimination Act of 2008 (GINA), generally makes it illegal for health insurance companies, group health plans, and employers with 15 or more employees to discriminate against you based on your genetic information.
Withdrawal From Study
If you first agree to participate and then you change your mind, you are free to withdraw your consent and stop your participation at any time. If you decide to withdraw from the study, you will not lose any benefits to which you would otherwise be entitled and your decision will not affect your service. If you want to stop being in the study you should notify us at: [email protected] and describe your wish to be excluded from this study.
We may also withdraw you from the study without your consent for one or more of the following reasons:
- Failure to follow the instructions of the study.
- The study is canceled.
- Other administrative reasons.
- Unanticipated circumstances.
There are no direct benefits to you for participation in this study. Your participation may help us to learn more about specific genetic markers that WE CANNOT AND DO NOT GUARANTEE OR PROMISE THAT YOU WILL RECEIVE ANY DIRECT BENEFITS FROM THIS STUDY.
At the end of this study, you will not be given any health advice. Your participation combined with others may contribute to the advancement of our understanding of COVID-19 or similar viruses.
Potential Issues and Risks
We don’t expect you to experience any risks or discomfort by participating in this study. If you felt uncomfortable answering the questions, you may stop at any time and also withdraw from future follow-ups. While we take all security precautions, there is a minor risk that information shared with us be accessed by others that are not mentioned in this consent form.
Your participation is voluntary. You should not feel obligated to agree to participate. Your questions should be answered clearly and to your satisfaction.
We will keep your name and all the information you tell us in this study as confidential as possible. We will protect the confidentiality of your samples and information about you. Your samples will be stored in a locked area and all information about you will be stored in a locked file cabinet or on a password protected secure computer.
No payment will be provided to you for participation in this study.
The data provided by you will be combined and analyzed by our expert scientists. Your answers combined with the DNA sample (if a DNA test is taken by Silverberry) is extracted and analyzed at our partner lab. Combining your genetic data with provided data from other tasks, we will look for the genes and genetic predispositions affecting your health and/or wellness. Your data will also be combined with that of other participants to make new discoveries in the area of genomics science.
Protecting Your Data
We do our best to ensure your data is protected from the point that we collect, analyze, and store it. For instance, we store your information in a secure database and replace your name with a random code not linked to your personal information (also known as protected health information or PHI).
Aside from legal consideration, at Silverberry, we consider ethical and social implications of our study, supervised by our own internal IRB. The Silverberry Institutional Review Board (IRB) is a committee composed of individuals that can provide legal, scientific expertise, nonscientific oversight, and support to ensure both the responsibility and ethical use of genomic data derived from our human participants.
All human studies conducted by Silverberry will comply with federal regulations that protect the rights and welfare of the participants and require that scientists clarify the benefits and risks of participating in the study through the use of Informed Consent. All studies will be subject to the Federal Policy for the Protection of Human Research Subjects, or ‘Common Rule’ (Code of Federal Regulations, Title 45, Part 46) to ensure the safety of study participants.
Questions, Concerns, or Complaints: If you have any questions, concerns or complaints about this research study, its procedures, risks and benefits, or alternative courses of treatment, contact [email protected]
Experimental Research Subject’s Bill Of Rights
As a research participant you have the following rights. These rights include but are not limited to the participant’s right to:
- Be informed of the nature and purpose of the experiment.
- Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized.
- Be given a description of any attendant discomforts and risks reasonably to be expected;
- Be given an explanation of any benefits to the subject reasonably to be expected.
- Be given a disclosure of any appropriate alternatives, drugs or devices that might be advantageous to the subject, their relative risks and benefits;
- Be informed of the avenues of medical treatment, if any available to the subject after the experiment if complications should arise.
- Be given an opportunity to ask questions concerning the experiment or the procedures involved.
- Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation without prejudice;
- Be given a copy of the signed and dated consent form.
- Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject’s decision.
Point of Contact for Questions
For questions about Silverberry Genomix and its services, contact:
In US and Canada: 1-800-552-4730
International Inquiry: +1 (415) 949-6257
You agree that you understand the terms and are legally bound by User Consent described above.