Informed Consent
Before you begin participating in a research study, you will become involved in the informed consent process. As part of the process, you will receive an informed consent document that outlines the risks and benefits of participation. You may take all the time you need with this document and ask any questions you think of. You may also take the document home with you and share it with your loved ones. You will need to sign the informed consent document if you decide to participate in the study.
Ethical Rules & HREC Review
In addition to informed consent, researchers are bound by ethical guidelines that are designed to protect participants and uphold the integrity of science. Also, research studies involving humans are approved and monitored by an ethics committee. This committee makes sure that the risks of the study are reduced and that any potential benefits outweigh the risks.
Study Operations & Safety Monitoring
This study, like other clinical trials, follows a protocol. A protocol is a detailed written plan for how the research team should conduct their research. Protocols are written by scientific and medical experts with safety in mind and have been reviewed and approved by an ethics committee. Study activities are guided by this protocol.
An independent Data Safety and Monitoring Committee monitors the safety of study volunteers throughout the study. This committee is made up of research experts who review study information and make recommendations on the safety of study volunteers.