The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is regulated by governments, with built in safeguards to protect the participants.
As a participant in a clinical trial:
- Your rights and welfare are a priority. Clinical researchers are following strict regulatory and ethical guidelines of the government and Ethics Review Board (a group comprised of varying backgrounds that is qualified through the experience and the expertise of its members to promote respect for its advice and counsel in safeguarding the rights and the welfare of human subjects).
- Your privacy will be respected. Research data is coded to help maintain your privacy.
- You will be in the know. Researchers have the obligation to inform you on the known risks and the benefits before your trial starts (informed consent – before joining, the study is explained to all participants and they are given the chance to ask questions. The purpose of the informed consent process is to protect the rights of study participants and to make sure they are adequately informed of important details about the clinical study).
- You can always ask. Ask as many questions as you want. We’ll always answer.
- You can stop participating at any time: You can withdraw from a trial at any time and for any reason.
- You are not alone. You will join a community of clinical trial and research participants.
- You will make a difference. Your participation helps pharmaceutical companies, universities and the research community to develop new treatments that can make lives better.
Ethics Review Boards (ERBs)
Every research study is reviewed by an ERB or Ethics Committee, which is made up of scientists, non-scientist professionals and members of the public. Its role is to make sure that the study is ethical and that the rights and welfare of participants are protected. This includes making sure that research risks are minimised, are reasonable in relation to any potential benefits, and are explained to the participants, among other things.
Before participating in a study, participants are provided information about the study and are given the chance to ask questions. This process is called Informed Consent. The purpose of the Informed Consent process is to make sure participants are adequately informed of important details about the clinical study so they can make an informed choice about their participation. Informed Consent begins before a research volunteer agrees to participate in a trial and continues throughout the study.
The Informed Consent document describes the study to research participants. It includes details about the study’s purpose, length, procedures, risks and benefits, and other information that all participants should know. Participants sign the document before they enter the study, but only after having read and discussed it with the research team and demonstrating an understanding of the information provided. In some cases, there will be multiple Informed Consent documents throughout the study as changes are made to the study or new safety information becomes available. Signing the document(s) and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over.