Volunteer Guidance for Human Challenge Trial Informed Consent Procedures
One of the most important parts of being in any medical trial is informed consent. That means that a participant not only consents, but does so with all the knowledge and awareness they need to make the decision. If the participant can’t understand the relevant information (or if relevant information were withheld from them), their consent would not truly informed, and it would be unethical (and sometimes even illegal!) to enroll them in a study.
For a medical study of any kind, the informed consent process will help you to understand the risks and benefit so you make a decision about whether to take part in the trial or not. As part of this, you have the opportunity to ask any questions that you might have of the trial team. They will provide you with a lot of information already, but we would draw your attention to a few important aspects and potential consequences of challenge trial participation.
General Advice
- Feel empowered to ask the trial personnel to repeat, rephrase, or clarify any information that is unclear to you, whether written down or verbal. Medical studies can be complex, and if you need to have information repeated, that’s not your fault (if anything, it might be the study’s for not being clear enough)!
- Don’t feel pressed for time to review the informed consent materials. The information sheet for a challenge trial will be quite lengthy, and you should feel comfortable taking it home to process and to discuss it with friends and family. Take time to reflect on the information you are receiving, what is being asked of you, and how it fits with your own values, desires, and beliefs.
- Even after the official informed consent process for entry into the trial is completed, you should feel free to ask additional questions throughout the course of the trial, such as about the tests and exams being conducted.
Things to think about in a challenge study
Questions you may wish to ask for an inpatient study:
- What items can I bring with me? What items (e.g. bedding, scrubs/clothing, earplugs) are provided in the facility?
- What activities am I allowed to do or restricted from doing? For example, some studies may allow participants to go outdoors on balconies or restricted-access patios, etc.
- What sort of amenities do the facilities have? Some studies may have kitchenettes, exercise equipment, or other common areas, especially if participants aren’t required to stay in a single room.
- What kinds of contact can I have with other people, including other trial participants?
- Can I receive deliveries from the outside world?
- Will I have the option of leaving early if I choose to or feel that I need to? There may be special protocols involved if you absolutely must leave.
Quarantine
Challenge trials often will require participants to stay in secured facilities to prevent the spread of the disease to others (this depends on the disease, though). For airborne illnesses like the flu or COVID-19, this generally means quarantine in an individual room with no outside visitors besides medically trained study staff. For other diseases, you may live in a more dorm-like facility with other participants who you can interact with. Some studies may be completely outpatient if the disease is very hard to spread to others.
Long-Term Effects
Challenge trials are designed to minimize the risk of long-term negative impacts on participants, but no one can ever guarantee that nothing bad will ever happen. Study coordinators will inform you about possible long-term consequences of infection by a disease. Do not be afraid to ask any questions you may have about long-term consequences for any sickness.
The long-term risks of COVID-19 challenge trials are higher than those of Phase III vaccine trials. Long term risks include illness immediately after the trial (lingering symptoms), as well as prolonged illness, commonly referred to as “long COVID”, which could leave you feeling ill for a few months after the trial ends. (1Day Sooner’s summary of research on the long-term effects of COVID-19 is available here.)
Even if they are rare, long-term risks should be a factor in your personal decision to participate in a challenge trial, and you should consider the mechanisms in place for protecting you as much as possible, and possibly compensating you.
Questions you may wish to ask:
- What are the provisions for insurance in case of long-term consequences resulting from the trial?
- What are your obligations to me after the trial ends?
- Would the compensation and long term health security coverage be affected if I chose to leave the trial early?
- Who is overseeing and monitoring the trial, both the present run of the trial and possible future consequences of trial participation?