Safety and Your Rights as a Participant

Clinical research studies follow recognized standards and are reviewed by an independent ethics review board. Studies are conducted by qualified research professionals at accredited facilities. Before you decide whether to participate, the study team explains screening, informed consent, study visits, and safety procedures.

Independent ethics review

An independent ethics review board is a group of scientists, healthcare professionals, and community members who are not part of the study team. They review the study plan and consent materials to make sure risks are minimized, the study is fair, and participants receive clear, honest information.

Ongoing monitoring

During a study, the study team watch closely for anything that could affect your wellbeing. You'll be encouraged to report how you're feeling at every visit, and you can contact your study coordinator between visits whenever something comes up.

Your rights

• The right to take part voluntarily, and to say no without any consequence.
• The right to withdraw at any time, for any reason.
• The right to clear information about the study, including risks and possible benefits.
• The right to ask questions and receive understandable answers.
• The right to privacy and confidentiality of your personal information.
• The right to be told of new information that might affect your willingness to continue.

Privacy and confidentiality

The study team explains how your information is stored, protected, and accessed by authorized personnel. Study records are usually coded so that your name is not directly attached to the data used for research. If you ever have concerns about your rights or your experience, you can raise them with the study team or with the independent ethics review board listed on your consent form.