The factors that allow someone to participate in a clinical study are called inclusion criteria, and the factors that disqualify someone from participating are called exclusion criteria. They are based on characteristics such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
How are participants protected?
Participation in a clinical trial is voluntary - it is up to you to decide if you want to take part.
Informed consent is a process used by researchers to provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll or continue to participate in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study.
In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions, and activities to measure participant understanding.
In general, a person must sign an informed consent document before joining a study to show that he or she was given information on the risks, potential benefits, and alternatives and that he or she understands it.
In some cases, a legally appointed guardian will be asked to provide informed consent, for example the parent of a child or a guardian of someone who cannot make their own decisions.
Participants may withdraw from a study at any time, even if the study is not over.
As part of Lawson’s research review process, all research involving humans must be submitted for approval to one of the Research Ethics Boards.
This ensures that all health research activities involving human subjects or materials that are being conducted within or on behalf of Lawson meet current scientific, regulatory and ethical standards for the protection of research participants.
- Western University’s Health Sciences Research Ethics Board: Western University’s Office of Human Research Ethics manages the review process and ethical oversight for human participant research at Lawson.
- Ontario Cancer Research Ethics Board: For multi-centre Ontario oncology clinical trials, managed through the Ontario Institute for Cancer Research.
- CTO Qualified Research Ethics Boards: Used as Lawson’s Board of Record through Clinical Trials Ontario.
There is scientific and medical oversight of the clinical trial throughout the time that is being carried out. There are also several regulations and guidelines that apply to clinical research.
What are you rights?
As a clinical trial participant, you have the right to:
- Decide if you wish to take part of continue to take part in the clinical trial or not
- Withdraw at any time for any reason without having to provide a reason and without this affecting your medical care
- Confidentiality of your information. Any personal or health information about you that is collected is protected by law.
What to expect
What do I need to know before deciding to participate in a clinical trial?
- The research team will give you a detailed letter of information about the study.
- The research team will not do any tests or procedures for the study before you’ve provided your written consent.
- The study protocol provides the criteria that determines if a participant is eligible.
- Be sure that you can attend all study visits and commit to the requirements of participation.
- Discuss your intent to participate with family/friends and/or other health care providers if desired.
- Participation is completely voluntary, you do not have to participate if you don’t want to.
- Your usual medical care will not be affected by your decision to participate or not.
What will happen if I decide to participate in a clinical trial?
- The research team will schedule a visit to go through the letter of information with you.
- You should read the letter of information completely and ask the study doctor or research team any questions that you may have.
- The study doctor will answer all of your questions and ensure you fully understand.
- You will be asked to sign a consent form to participate and be given a copy.
- You will be scheduled for a screening visit to determine eligibility, and if you are eligible you will be scheduled for follow up visits according to the protocol.
- You will be provided with any new information that becomes available throughout the study that may impact your decision to continue in the study.
- You can withdraw your consent at any time for any reason without affecting your usual medical care.