HEALTH & WELLNESS
YOUR HEALTH COMES FIRST
Participant safety and wellbeing is the most important part of our research. It’s our job to make sure you’re protected, comfortable, and confident when you participate. Still have questions? Feel free to reach out at any time!
FULLY INFORMED PARTICIPATION
We walk you through all the details, answer any questions, and ensure you feel confident about what’s involved before you decide to participate.
You can also take the time to discuss your choice with family or friends.
HEALTH & SAFETY
All our studies follow specific regulations that keep participants safe. Ethics and safety regulators carefully monitor everything we do – long before the study starts, and well after it ends.
How we protect participant health:
-
Our research team carefully chooses the disease and variant we’re testing to make sure it only causes relatively mild illness. If we think the illness could have a bigger impact on you, we won’t select you for the study.
Factors like age can affect your ability to fight off an infection, so we set strict criteria for who can sign up and screen every volunteer for potential health concerns.
-
In most challenge studies, you can expect mild symptoms or sometimes no symptoms at all. We monitor symptoms closely and provide treatment to stop the illness from progressing past a specific stage.
-
Throughout your stay, our team conducts daily tests and check-ins to carefully monitor your wellbeing. Your health is supported by qualified doctors and nurses.
Communicate with the study team at any time via secure online chat or the hospital call button by your bed. On-duty nurses are just down the hall.
-
You can choose to stop participating at any point, for any reason. If you decide to leave the study, we will give you an approved treatment to stop the infection and make sure you aren’t contagious. If you leave early, we may follow up with phone calls to monitor your health.
MENTAL & EMOTIONAL WELLNESS
Staying in the Challenge Unit for multiple days can be uniquely difficult. We don’t expect you to make that effort alone. Our team works hard to support every individual and make your stay as comfortable as possible.
Wellness support includes:
Mental health screening prior to participation
Check-ins with study staff trained in mental health management
When possible, accommodation of requests for specific items or groceries
Online social activities with other participants
Autonomy over your daily activities and meal choices
Medical tests are scheduled and consistent
You have the choice to receive antibiotics early and leave the study at any time.
ARE THERE ANY RISKS TO TAKING PART?
A challenge study has about the same risks as a regular clinical trial for a new vaccine.
Every research study involving people comes with some potential risks. These will always be thoroughly described before you agree to participate.
Some potential risks could include:
-
Medical procedures such as the inoculation (when you are administered the virus or bacteria), blood sampling, or EKG monitoring may cause mild discomfort. For example, you might experience skin irritation from stickers or tape, squeezing from a blood pressure cuff, or pinching from needles.
-
Antibiotic side effects can include an upset stomach or a rare risk of an allergic reaction.
-
Challenge studies are designed to make sure you only experience mild illness, but there is still a very low chance of developing more serious symptoms. The research team will make sure you know all potential symptoms of the disease and the likelihood of experiencing them.
-
Long periods away from your family, friends, and usual social activities is difficult and mentally taxing. We take steps to address these concerns, but there is still a possibility that you need to leave the study early. We provide a treatment to stop the infection if you do.
If any serious complications do develop, appropriate medical care will be provided immediately and the study will be interrupted until an evaluation is done.
