Principal Investigator
Linda Simoni-Wastila, Ph.D. - lsimoniw@rx.umaryland.edu
University of Maryland Baltimore

React19 Study Staff:

Edoardo Galli, Ph.D. - edoardo.galli@react19.org
Danice Hertz, M.D. - danice.hertz@react19.org

Shaun Barcavage, FNP-BC - shaun.barcavage@react19.org

Brianne Dressen, Co-Founder React19 - brianne.dressen@react19.org

Joel Wallskog M.D., Co-Founder React19 - joel.wallskog@react19.org

Rachel Meier, Study Coordinator - rachel.meier@react19.org

Branden Nail, Data Protection Officer - branden.nail@react19.org

PARTICIPATION:

Thank you for considering participating in this study.

You are being asked to take part in a research study about COVID-19 vaccine adverse events conducted by the University of Maryland Baltimore (UMB) and React19. React19 is a science-based non-profit offering financial, physical, and emotional support for those suffering from long-term COVID-19 vaccine adverse events globally. Our mission is to bring healing to the moms, dads, friends, and loved ones who are facing life-altering side effects from their COVID-19 vaccine. We build bridges between patients and research institutions in order to develop a better understanding of our vaccine complications.

You are asked to be part of this study because you have or are currently still experiencing adverse reactions to the COVID-19 vaccines.

This consent form is for participation in a survey in the form of a questionnaire. We are only asking you to consent to participate in completing a questionnaire in this phase of the study. It is your choice to take part in this study. The study is entirely voluntary, and you are not required to participate. You may decline to answer any of the questions.

WHY IS THIS STUDY BEING DONE?

This study is being conducted to gather more information about COVID-19 vaccine reactions including symptoms, timing of adverse events, testing, and what diagnoses have been made as a result of the vaccine. The survey also investigates what treatments have been tried and their effect. We hope to use this data to publish patient-driven data about vaccine reactions in the hopes of educating the medical community and other vaccine injured individuals. As well, we hope findings provide preliminary data for future funding to allow larger surveys and to provide direction for analyses using larger, already-collected data (such as health insurance data).

ELIGIBILITY

You are being invited to participate in this research study because you have had an adverse reaction to a COVID-19 vaccine, or suspected adverse reaction to a COVID-19 vaccine (still suffering or suffered symptoms following vaccinations), and you are 18 years of age or older. English speaking participants with email and internet access will be able to access the online questionnaires.

WHAT WILL HAPPEN DURING THE STUDY?

The online questionnaire will include questions about your health prior to receiving your COVID-19 vaccine as well as symptoms, testing, diagnoses, and treatments made following the vaccination. We will also ask your COVID-19 vaccination history and related medical history as part of this study.

At the end of the survey, you will be able to follow a link where you will be able to subscribe to React19's newsletter. This email address cannot be linked with your responses. With your permission, we may reach out to you periodically if new studies are available.

HOW LONG WILL THE STUDY TAKE?

The survey typically takes about 60-90 minutes. It is possible to complete a portion of the survey and return to complete it at another sitting. You should answer the questions to the best of your ability.

HOW MANY PEOPLE WILL PARTICIPATE IN THIS STUDY?

Participation is open to eligible participants and the number of participants will vary based on enrollment. We aim to enroll 2,500 survey participants.

CONFLICT OF INTEREST:

The questions in this survey were created by the staff and investigator listed above. All staff and investigator have no conflicts of interests to disclose.

WHAT ARE THE BENEFITS OF BEING IN THE STUDY?

There is no direct benefit to you from participating in this research study; however, we hope to learn more about COVID-19 vaccinations including the range of adverse events and how people recover afterwards. There is no treatment offered by participating in this survey. There is a possibility that we will not learn anything from this study that may directly benefit you.

WHAT ARE THE RISKS AND DISCOMFORTS OF BEING IN THE STUDY?

You may find it difficult to answer questions about the impact that COVID-19 vaccination has had on yourself and your life. If so, you may refuse to answer any question or stop at any time by pressing the exit button.

In general, taking an online survey is safe and with no discomfort to the participant. Breach of confidentiality is a remote risk of this study. We will take every precaution to prevent this from happening.

There are rare possibilities of data breaches beyond the control of UMB's and React19’s internet security measures. If a data breach occurs, you will be notified immediately or within a reasonable time frame which allows UMB and React19 to investigate and confirm a breach of data. We will take extensive precautions to protect the confidentiality of your data.

STORAGE, SHARING AND FUTURE RESEARCH USING YOUR DATA

We will retain your anonymized responses in a secure server system for as long as necessary for this study and future studies. We will retain and use your anonymized data as necessary to perform the current study. The data may be used for future studies, presentations, reports, and publications. All data remains anonymous and does not include any information that may identify a participant.

CONFIDENTIALITY PROTECTIONS PROVIDED IN THIS STUDY

This study is performed using the QuestionPro survey software. This software will never present a respondent's email address linked to the response data in any of the analysis tools, reports, and data downloads.

In the exceptionally unlikely event that a breach occurs for any reason, technical or otherwise, QuestionPro will immediately notify the respondent as well as the survey researcher about the issue. If the respondent requests his response data to be removed from the servers as a result of the breach, QuestionPro will comply with the request even if the survey researcher does not agree. Furthermore, QuestionPro will make all reasonable efforts to make sure that such a breach does not occur again.

This study will also use the Respondent Anonymity Assurance feature of QuestionPro software which will completely hide any identifying information and in particular IP Address, Country Code, and Region of the device you are using to fill in the survey. Email addresses will not be stored with survey responses and will remain unknown to the research team. Any data exported cannot be linked to you and will be used by the above survey staff and investigators for the purpose of this study.

COMPENSATION

There is no compensation for participation in the study.

PROBLEMS OR QUESTIONS

Before the completion of the survey, you will have the opportunity to ask questions about the research study and the impact it may have on you and your privacy. Please let us know your questions and concerns.

If you have any problems or questions about this study or about your rights as a research participant, you may contact:

Principal investigator: lsimoniw@rx.umaryland.edu

CONSENT SUMMARY:

I voluntarily agree to participate in this study, and that I am free to withdraw at any time without giving a reason.
I understand that my data will be completely anonymous. I will be able to withdraw my answers after they have been submitted anonymously and can withdraw from the survey at any point.
I understand that the data gathered in this study will be stored securely and it will not be possible to identify me in any research presented publicly, either by written or oral presentation.
I understand that the data will not be shared with any commercial organization. It will only be used for the purpose of this research study and future studies.
I understand the direct/indirect benefits of participating.
I understand that I will not benefit financially from this study or from any possible outcome the study may result in.
I understand that the information I have submitted may be published as a report.
I am aware of whom I should contact if I have any questions or would like to file a complaint.
I have thoroughly read this information sheet and consent to all of the above.