

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.
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.
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.
As a clinical trial participant, you have the right to:
What do I need to know before deciding to participate in a clinical trial?
What will happen if I decide to participate in a clinical trial?