WHO CAN PARTICIPATE IN A CLINICAL TRIAL?
Each clinical trial has guidelines drawn up that specify which patients are suitable (inclusion criteria) or unsuitable (exclusion criteria) for the particular study. These criteria are based on factors such as age, type of disease, medical history and current medical condition. The purpose is to make sure that the study is suitable for the patients who are enrolled in it and that the risks are minimised.
WHAT IS THE ROLE OF THE ETHICS COMMITTEE?
All clinical trials must be reviewed and approved by an ethics committee before they begin. The ethics committee provides ongoing oversight and protection of the interests of the participants. The membership, responsibilities and operating procedures of ethics committees are governed by a set of guidelines called the National Statement on Ethical Conduct in Human Research (2007, updated March 2014).
There are two ethics committees within the SLHD - one based at Royal Prince Alfred Hospital and one at Concord Repatriation General Hospital. They are widely representative committees with up to half the members being non-medical, several of whom are not associated with the hospital in any other respect.
The committees have reporting responsibilities to:
- The Board of the Sydney Local Health District
- The NSW Department of Health
- The Australian Health Ethics Committee (of NHMRC)
- The Therapeutic Goods Administration (TGA)
When a new clinical trial is submitted for ethics approval, an expert sub-committee first examines the scientific, technical and safety aspects of the trial, and may request modifications to the research plan if it has any concerns.
Once the expert sub-committee is satisfied with the study plan, all other aspects of the trial are scrutinised by the ethics committee, including:
- The risks and benefits of the trial
- The process of recruiting and enrolling patients
- The plain language information statement which is given to those considering joining the trial
- The consent procedures
- Privacy and confidentiality issues
- Financial arrangements and potential conflicts of interest
- Insurance and compensation arrangements
- Safety monitoring arrangements
The ethics committee may require additional modifications, and will only give approval for recruitment to begin when it is satisfied with all aspects of the trial.
WHAT ARE THE RESPONSIBILITIES OF SPONSORS AND RESEARCHERS?
Clinical trial sponsors and researchers have a responsibility to ensure that:
- The resources for running the trial are in place, including adequate funding, experienced professional and support staff, and suitable facilities
- Ethical approval has been obtained
- Relevant regulatory guidelines are followed
- High research standards are maintained
- Careful safety monitoring is undertaken
- Any unexpected or serious adverse events are dealt with and reported promptly
- There are appropriate provisions for compensation if anyone is seriously injured as a result of their participation in a clinical trial
Large international trials often have an independent Data & Safety Monitoring Board which conducts regular reviews and can recommend that a trial be stopped if unacceptable risks are identified. In addition, if there are local concerns the TGA can stop a trial, or can suspend it and require that changes be made to protect the participants before it can continue.
WHAT ARE THE RISKS AND BENEFITS OF BEING IN A TRIAL?
The main risks of clinical trials are:
- The treatment you receive may turn out to be ineffective
- Unforeseen side-effects or adverse reactions to the trial treatment
- Pain or discomfort associated with tests required by the trial
- Time and inconvenience associated with frequent trips to clinics, hospital stays, complex treatments, tests, etc.
Direct benefits may include:
- Gaining access to new treatments that are not available to the general public
- Obtaining expert medical care at a leading research centre. (Even being in the 'control' group of a trial can lead to better health outcomes.)
Other benefits are less tangible:
- A sense of empowerment from becoming well informed about your illness, and playing an active part in your own health care
- Helping others in the future by contributing to a global research effort
WHAT ARE MY RESPONSIBILITIES AS A TRIAL PARTICIPANT?
If you decide to participate in a clinical trial, you will be expected to:
- Accurately report your medical history
- Let your doctor know if you're taking anything else (including herbal medications, vitamin supplements, oral contraceptives, illicit drugs etc.)
- Adhere to all safety and monitoring requirements
- Attend all scheduled appointments
- Take trial medications exactly as prescribed
- Keep all trial medications out of the reach of children
- Inform your study doctor promptly if you develop any unexpected symptoms or new problems
WHAT ARE MY RIGHTS AS A TRIAL PARTICIPANT?
Participation in a clinical trial is entirely voluntary.
You cannot be enrolled without giving your written informed consent. Researchers are under an obligation to answer all your questions honestly; to make your welfare their primary concern; not to apply pressure or coercion to get you to join or stay in a trial; and to protect your privacy and keep all personal information about you confidential. If you decide to participate, and later change your mind, you can withdraw at any time. Whatever your decision, it will not affect your relationship with your health care team or with the hospital. You will be given a copy of the plain language information about the trial to keep. This has contact details for the researchers as well as the ethics committee.
If there are any irregularities, or you have concerns or complaints about a trial you're involved with, you can contact the ethics committee. Your concerns will be dealt with speedily and confidentially.