Consent to Participate in Research Study
Title: COVID Prevention Trials Registry
Principal Investigator: Karen Krueger, MD
Supported By: This research is supported by Northwestern University, Feinberg School of Medicine, Division of Infectious Diseases
Key Information about this research registry:
The following is a short summary of this study to help you decide whether to be a part of this registry.
The purpose of this registry is to recruit participants who are at risk for exposure to the coronavirus that causes COVID-19 and are interested in participating in vaccine and other studies to prevent infection and COVID-19 disease.
You will be asked to provide information through an online survey about yourself, how to contact you, your health, your COVID-19 risk and diagnosis and if you would be interested in being contacted about participating in vaccine and other prevention research that are not related to COVID.
We expect that you will be in this registry for about 5 years or until this registry is closed whichever is first.
The primary risk of participation is loss of privacy due to unauthorized access to the data.
The main benefit of participation is contribution to the understanding of vaccines for prevention of COVID-19 and other diseases and the opportunity to be recruited into clinical trials.
Why am I being asked to take part in this registry?
You are being asked to take part in this registry because you may be at risk for exposure to the virus that causes COVID-19 disease and/or belong to a group that has been associated with a higher risk of severe COVID manifestations.
How many people will be in this registry?
We expect about 5000 or more people will be in this registry.
What should I know about participating in a registry?
• 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 do not have to answer any question you do not want to answer.
What happens if I say, “Yes, I want to be in this registry”?
You will be asked to fill out an online survey which includes questions about your contact information (email, phone), your COVID risk and diagnosis, and your other health history. You will also indicate whether you would be interested in participating in future research studies that are not related to COVID. You may receive a brief survey via email for follow up annually.
After securing the proper approvals for research, investigators for other trials may contact us asking for potential matches from the registry. If you are a match for those criteria and have indicated your willingness to participate in other studies, we may provide your contact information to the investigators so that they can contact you about those studies. You always have the right to decline and opt out from further contact.
Will being in this registry help me in any way?
We cannot promise any benefits to you or others from your taking part in this research. However, possible benefits include being matched to a clinical trial or study that is relevant to you.
Is there any way being in this registry could be bad for me?
A possible risk for any research is that confidentiality could be compromised – that is, that people outside the study might get hold of confidential study information. We will do everything we can to minimize this risk, as described in more detail later in this form.
What happens if I do not want to be in this registry, or I change my mind later?
You can decide not to participate in this research or you can start and then decide to leave the registry at any time and it will not be held against you. To do so, simply exit the survey. Any data already collected will not be saved. If you decide to withdraw from this study, the researchers will ask you if information already collected from you can be used. If not, any data already collectd from you will be destroyed.
How will the researchers protect my information?
Efforts will be made to limit the use and disclosure of your personal information 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 institution.
This survey is being hosted by the Research Electronic Data Capture (REDCap) system. REDCap is a secure, web-based application designed exclusively to support data capture for research studies. REDCap provides: encryption between the data entry in your browser and the server; and audit trails for tracking data manipulation and export procedures. The application and data are housed on servers provided by the Northwestern University Feinberg School of Medicine (FSM). These servers are located within the FSM secure data center. All information will be kept on a password-protected device and only accessible by the research team.
Who will have access to the information collected during this research study?
There are reasons why information about you may be used or seen by other people beyond the research team during or after this study. Examples include:
• University officials, government officials, study funders, auditors, and the Institutional Review Board may need access to the study information to make sure the study is done in a safe and appropriate manner.
• The research team may give information to appropriate authorities for reasons of health and safety – for example, for public health reasons.
How might the information collected in this registry be shared in the future?
We will keep the information we collect about you in this registry for potential use in future research projects. Your name and other information that can directly identify you will be stored securely and separately from the rest of the research information we collect from you.
De-identified data from this study may be shared with the research community, with journals in which study results are published, and with databases and data repositories used for research. We will remove or code any personal information that could directly identify you before the study data are shared. Despite these measures, we cannot guarantee anonymity of your personal data.
We would like to contact you for future research studies. We will ask for your consent to do so at the end of this form. You can be in this current registry without agreeing to future research use of your identifiable information.
Will I be paid or given anything for taking part in this registry?
There is no payment or reimbursement for participating in this registry.
Who can I talk to?
If you have questions, concerns, or complaints, you can contact the Principal Investigator please email Karen.krueger@northwestern.edu or 312-694-0414.
This research has been reviewed and approved by an Institutional Review Board (“IRB”) – an IRB is a committee that protects the rights of people who participate in research studies. You may contact the IRB by phone at (312) 503-9338 or by email at irb@northwestern.edu 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.