The World Medical Association’s “Declaration of Helsinki” is the cornerstone for human research ethics across the world. It was first developed post-WWII as a result of the Nuremberg trials, to ensure that human subjects would forever have their rights, safety and well-being placed above all other priorities in clinical research. the Declaration of Helsinki was used to develop international standards of Good Clinical Practice (GCP). GCP governs the standards by which clinical trials are undertaken at the UQDI and across the world to ensure both the well-being of the patient and the quality of the research findings.
The UQDI undertakes clinical trials in accordance with the Australian Government’s Therapeutic Goods Administration (TGA). This body protects and promotes public health and patient safety in Australia by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely.
Trials conducted at the UQDI are first reviewed by an ethics committee. The committee includes members of the public, researchers and health care professionals. A trial cannot go ahead if an ethics committee has not approved it, and any changes to the trial protocol cannot occur without the approval of the ethics committee.
Patients are recruited to clinical trials on a volunteer basis, irrespective of background, and only after they agree to do so. In order for patients to decide whether to participate, researchers first ensure that patients are fully informed about the purpose of the trial, what treatments are being compared, what it involves for the patient and the possible risks and benefits. Patients are given as much time as they need to consider participating and are encouraged to consult with whomever they wish – family, their GP and/or other learned members of society.