Participating in clinical trials
When conducting clinical trials, the researcher’s most important responsibility is to protect patients through well-designed protocols, a dedicated Institutional Review Board (IRB) and a careful informed consent process.
A protocol is a detailed plan that explains what will be done in a clinical trial and why. It outlines how many patients will participate, what medical tests they will receive and how often, and the treatment and monitoring plan. Researchers must follow the protocol approved by the local ethics committee or Institutional Review Board (IRB).
When the trial protocol is ready it is given to the relevant research ethics committee for approval. The research ethics committee is an independent group of people that includes doctors, nurses, medical staff, members of the public and sometimes lawyers. They decide whether the trial is ethical. In particular, they check that:
- the trial is looking at an important question in cancer care that cannot be answered using existing evidence from previous or current research
- the researchers are qualified to carry out the trial
- the protocol is suitable for the needs of the trial
- the probable benefits of a new treatment are likely to outweigh the side effects
- there is enough information for patients to decide whether they want to go into the trial
- the way in which people will be entered into the trial (recruited) is correct
- there will be compensation for people in the trial if something goes wrong, although it is unlikely that anything will go wrong
- the local health services have the resources to carry out the trial
- extra travel expenses will be offered to patients taking part
- the hospital research and development process has all the facilities to support the research
When the ethics committee has approved the trial it can begin
The Informed Consent Process
If your doctor offers you the option to participate in a clinical trial, you will first take part in a process called informed consent. In this process you will learn details about a specific clinical trial so that you may decide whether you want to participate. The informed consent process is designed to make sure patients understand the clinical trial’s plan before agreeing to participate.
The researcher or nurse from the clinical trial team will review the informed consent form in detail with you. This form explains a specific clinical trial’s purpose, procedures, risks and benefits.
You will be encouraged to ask questions about terms or ideas that are confusing. A family member or friend may be helpful by listening to the explanation, asking questions and recording answers. Some doctors encourage patients to bring tape recorders so they can review the information afterwards.
You can take the informed consent form with you to think about whether you would like to participate in the clinical trial.
Informed consent forms should include:
- The reason for the clinical trial (what the researchers hope to learn)
- What is known about the type of treatment being studied
- The possible risks and benefits (based on what is known so far)
- Other treatments that may be options
- The clinical trial’s design (randomised, single blind, double blind, etc.)
- Types of tests, the number of tests and doctor’s visits required
- Who is responsible for the costs of the clinical trial (tests, doctor’s visits, etc.)
- Who is responsible for the costs if a patient needs additional care as a result of the clinical trial
- A statement about protecting the patient’s privacy
- A statement about the clinical trial being voluntary and the patient’s rights to leave the clinical trial at any time
- Contact information for further questions
It is important that you are satisfied that you have enough information to make an informed decision. You should feel free to ask any questions that you believe are important in helping you to reach a decision. You should also feel satisfied that you have been given enough time to think about the trial and what it will mean to you before you decide.
Signing the Form
If you want to participate in a clinical trial after learning all that is involved and what you would be expected to do, then you, the trial’s principal investigator (or nurse, if called for in the protocol) will sign and date the informed consent form. A witness may also be present to sign the form with you. A copy of the form will be given to you.
The informed consent process does not end once you sign the form. If new benefits, risks or side effects are found during a trial, the doctor must inform all of the participants in the trial. You will be encouraged to keep asking questions throughout the trial.