Research participant FAQ

All patients at Advocate Aurora Health can be considered for a clinical trial, but not everyone is eligible to participate. We help you get the best possible care regardless of whether you are in a trial.

Each clinical trial has specific requirements and may limit participation based on:

• Age
• Gender
• Previous treatments received, such as major surgery or radiation therapy
• Diagnosis, including specific types of cancer
• Current medications and health history, which may include chronic conditions like diabetes or liver conditions

If you would like to know more, ask your doctor or contact us to ask a question.

Deciding whether to participate in a clinical trial is up to you. Our team includes dedicated clinical research coordinators who provide you with the information you need to make the decision that’s right for you.

This information includes:

• The treatment being studied and how it may help you
• Tests or treatments you may need in addition to the care you are already receiving
• Costs associated with participating in a clinical trial and who pays for them
• Benefits and risks of participating in a clinical trial
• Which Advocate Aurora location or locations you will need to visit for care during a clinical trial

The benefits of participating in clinical trials may include:

• Opportunity to potentially benefit from investigational treatments and advances in scientific knowledge
• One-on-one support you’ll receive from clinical research coordinators who provide prompt answers to any questions you may have
• Possibility of helping other people with the same condition in the future by advancing care

As with any medical treatment, the care you receive during a clinical trial carries some risks. The risks you may face and how serious they are depend on many factors. These factors may include the particular illness or condition and the type of treatment being tested.

Risks associated with participating in a clinical trial may include:

• Receiving a treatment that is not effective for your situation
• Experiencing unpleasant or serious side effects
• Spending time on additional office visits or other clinical trial requirements, such as writing down your daily symptoms

During the trial, our clinical research coordinators stay in close contact with you to help you avoid or minimize these risks.

Our research teams are deeply committed to maintaining the highest professional and ethical research standards.

Our Research Quality team is a second layer of protection and it carefully monitors all clinical trials. The team’s observations and suggestions help researchers maintain high standards and preserve our exceptional reputation.

The Research Quality team looks at:

• Regulatory compliance: We review all research documents for compliance with regulations governing research and clinical trials. These regulations include safeguards for research participants and protection of their privacy.
• Informed consent: Our team reviews consent documentation. We make sure research participants are fully informed about the purpose, risks and potential benefits of the clinical trial. See the next question – What is informed consent? – for more details.
• Accountability: We verify that the drugs or devices being studied are handled and controlled in accordance with federal regulations and the research protocol, which is the document that describes the rules and procedures for each clinical trial. These rules help achieve participant safety and maintain the integrity of the research.
• Documentation: Our researchers keep detailed and accurate records of all aspects of their research. These records verify the integrity of the data collected and validate the clinical trial results.
• Billing: Many participants in clinical trials do not pay for the drugs or devices being tested. We make sure services are billed appropriately.

Informed consent is the process of learning the key facts about a clinical trial. If you are considering joining a clinical trial, the research team will give you written informed consent documents that include details about the clinical trial, such as its purpose, duration, required procedures and key contacts. We encourage you to ask the research team any questions you may have about the clinical trial and consent forms before deciding if you’d like to participate. No research-related procedures will be performed until after a person has signed the written informed consent forms.

However, even after signing the forms, you may leave the clinical trial at any time. Informed consent for research is a process that continues throughout your participation in a clinical trial, and you are encouraged to ask questions every step of the way.

If the potential research participant is younger than 18 years of age, there is additional information you need to know. Learn more about special considerations for participation in child research.

When you come to Advocate Aurora as a patient, you always have a say in your care.

As a clinical trial participant, you also have rights, including the right to:

• Ask questions: You can ask our research team questions at any time during a clinical trial. We promise to give you answers as quickly as possible.
• Maintain your privacy: Your name and information related to your care (personal health information) are never shared outside Advocate Aurora unless required by law.
• Stop participating in the trial: Participating in a clinical trial is voluntary, and that means it is always acceptable to change your mind.
• Receive care that is best for your unique circumstances: We provide you with the best possible care regardless of whether you choose to participate in a clinical trial. Even if you leave a trial, you still receive care tailored to meet your needs from doctors you know and trust.

You are free to act on your rights at any time. Just let your clinical research coordinator or doctor know what you need and how we can help.

Before you agree to participate in a clinical trial, you’ll want to understand all aspects of the research. Below are some helpful questions to ask before participating. Because every study is unique, answers to these questions may vary. Our research coordinators are specially trained before joining a specific study team, so they’re excellent resources who can answer all your questions.

• What is the clinical trial about?
• What is the purpose of the clinical trial?
• Who is sponsoring the research?
• How long will the clinical trial last?
• What happens at each visit?
• How does the clinical trial differ from standard health care for the condition?
• Can I take my regular medication while I'm participating?
• Can I see my own doctor?
• How will the information gained by this research be shared?
• Are there financial costs to participating?
• How much will my insurance cover?
• Who is available to discuss insurance issues with me?

If you would like to know more, ask your doctor or contact us to ask a question.

In the eyes of the law, people under 18 years of age are not considered adults. Therefore, a parent or guardian must give legal permission during the informed consent process in order for a child to participate in a clinical trial.

However, our researchers believe children and teens should play a role in the decision to enter a research study. Supporting their involvement in decision-making respects children’s rights as individuals and gives them a sense of ownership in what happens during the clinical trial.

• Child assent: Even though children cannot give their consent to participate, children who are 7 years of age and older will be asked whether they agree (assent) or do not agree to participate. Like the informed consent process, the assent process is intended to be an ongoing, interactive conversation between the research team and the child or teen throughout clinical trial participation.

Parents or legal guardians and children are encouraged to ask the research team questions to make certain they know:

• The purpose of the clinical trial
• Any treatments given or procedures performed as part of the research
• Possible benefits and risks of participating
• The child's rights and responsibilities

Discussions with the research team will help parents and guardians decide whether to give or decline informed permission and supports children in deciding if they will or won’t give their assent to participate in the trial.