People may take part in research trials for many reasons. For example, studies can be a way to help researchers advance science and medicine for the good of the public.
For the Ascension St. Vincent’s Clinical Trial, we are immediately seeking adults, at risk of contracting coronavirus, age 19 and older, who may be interested in participating in a research study for a coronavirus (COVID-19) vaccine.
Are you interested in taking part in a coronavirus (COVID-19) vaccine research study?
- Are you over 19?
- Do you have no known history of coronavirus (COVID-19) infection?
- Are you willing to participate in a study lasting over a 2 year period?
- Are you at high risk of contracting coronavirus?
If you answered yes to all four questions above, you might qualify to participate. Before you fill out the questionnaire to be considered, we encourage you to learn more about clinical trials and have a conversation with your primary care doctor to determine if this is the right decision for you and your health.
Please fill out the form at the link below if you want to be considered. Important note: The first in-person visit will be a longer time commitment and will last approximately 3 hours.
There is no cost to participate. Participants may be compensated for their time and travel.
Contact us if you have any questions
If you have any questions regarding clinical trials or research opportunities, or if at any time you are concerned about or have questions about your rights as a volunteer research subject, please contact us as firstname.lastname@example.org.
Frequently Asked Questions Related to the Ascension St. Vincent’s Clinical Trial
What is the purpose of this research study?
The reason for this study is to test a newly developed vaccine to see if it is safe and effective at protecting patients from coronavirus (COVID-19) infection.
How do I determine if I am a candidate for this research study?
If you are interested in participating in this research study, you must meet the following criteria:
- Must be 19 years of age or older
- Have no known history of coronavirus (COVID-19) infection
- Willing to participate in research study over a two-year period
- Be at high risk of contracting coronavirus
If you think you meet the criteria, we encourage you to have a conversation with your primary care doctor. They will listen and help you determine if this is the right decision for you and your health.
At what Ascension location(s) is this research study being conducted?
This research study will be conducted at the St. Vincent’s Birmingham campus.
How many appointments are required as part of this study?
The study will consist of up to seven outpatient visits and 24 phone calls for a period of 25 months. Please note that the first visit for this research study will be 3 hours long. If you develop coronavirus symptoms, there may be additional visits. And know that when an in-person appointment is required, we have strict precautions in place for your safety while in our care and participating as a volunteer.
How long will this study be conducted?
This research study will take place over the course of 25 months. In order to participate, you must be able to make yourself available for several scheduled outpatient appointments and phone calls. And know that when an in-person appointment is required, we have strict precautions in place for your safety while in our care and participating as a volunteer.
What is required of me as a participant in this study?
The study will consist of up to seven outpatient visits and 24 phone calls for a period of 25 months. Please note that the first visit will be 3 hours long. If you develop coronavirus symptoms, there may be additional visits. Participants will also be asked to complete an eDiary for seven days following each study vaccination, including the day of the vaccination.
Frequently Asked Questions about Clinical Trials
What are clinical trials?
Clinical trials are research studies to investigate health and medical treatments and devices to see if they are effective and safe for use in people.
Clinical trial volunteers are watched closely by healthcare teams for side effects or negative effects from the treatment or medicine being tested. Volunteers should fully understand the risks of participating in the research.
Who can participate in research or clinical trials?
Researchers make rules for who can take part in the trial to help make sure it is as safe as possible for volunteers to participate. They also make the rules for those who can participate and those who can’t (or are excluded) so that the results are based on the treatment being studied and not other factors. The things that may let a person be included in a trial or that may exclude or not allow them to be in a trial are things like: age, previous disease, current health condition, and gender.
How do I decide whether to volunteer for a clinical trial?
You should remember that clinical trials and research include unproven treatments and may not help you. Volunteering is a personal choice and may not be right for everyone. But the research can help advance medical science by helping researchers better understand possible treatments and their safety and effectiveness.
What questions should I ask before I volunteer for a clinical trial?
You should start by educating yourself about the clinical trial along with having a conversation with your doctor about your current health to help figure out if the research study is right for you. Some questions that may be answered when you volunteer could be:
- What is the reason for the study?
- What are the eligibility requirements (rules for who can participate) for the trial?
- If I want to opt out at any time, can I?
- How long is this trial? How often will I have to come for visits? How will this affect my daily life?
- Will this clinical trial have a placebo, meaning a control substance that does not include the medicine or therapy being tested?
- Who is the doctor or healthcare team that will take care of my health during the trial or research? Can I see my own doctor during that time?
- What are the risks, benefits and possible side effects?
- What kinds of tests and procedures will I have during this research?
- What happens if I get sick during the research study?
- Will I have to pay anything to participate in this trial?
- Do I get to have my personal results from the study?
- Who is sponsoring the study?
Is it safe for me to participate in a clinical trial?
Clinical trials are strictly reviewed to make sure they are as safe as possible and that they follow rigorous scientific processes. The U.S. Food and Drug Administration (FDA) approves and the Institutional Review Board (IRB) reviews the study and works to protect the volunteers. Our clinical trials committee also reviews the study for safety.
There are risks to volunteering for a clinical trial. The research team can help you understand those risks before you decide whether to participate. Before you participate, you will also be asked to fill out an informed consent form. This form gives you the information about the study and risks. And you can also ask questions to decide if the study if volunteering is right for you. You will sign the form before you can participate.
What happens to the information from the study?
The information from the study about you is private and kept confidential. Researchers must follow strict federal regulations, codes of ethics and other standards throughout the entire research process. You will need to ask the research team what results can be shared with you and what information you can share about your participation.