A clinical study -
Through these clinical studies, clinicians find new and alternative ways to prevent, detect, diagnose, control and treat illnesses.
If you are keen to participate in a clinical trial or study, it is important for you to be aware of your rights. You are also encouraged to seek advice from your doctor before participating in a clinical trial or study.
You can find a clinical trial/study to participate in through the following avenues:
To find out more on how you can participate in a clinical trial or study at NUHS, or to provide feedback, please email [email protected].
By participating in clinical research, you will contribute and play a part in the understanding of diseases which will accelerate medical science by providing valuable insights into potential treatments and methods of prevention.
Participants with an illness who have exhausted conventional treatment options also participate in clinical research to receive the newest or alternative treatments that are otherwise not available to them.
You may want to speak to both your doctor and the Principal Investigator (PI) of the clinical study to learn more about the study.
Some examples of questions you may want to ask:
It is important to fully understand and have all your queries answered before agreeing to take part in the clinical study.
Researchers (Principal Investigators - PI) follow clinical studies' guidelines when deciding who can participate in a study. These guidelines are inclusion/exclusion criteria based on factors such as age, gender, the type and stage of a disease, treatment history, and other medical conditions. Trial coordinators can provide additional information on individual trials.
If you fit the criteria and decide to participate in a clinical study, the PI and/or his/her team will need to obtain your informed consent.
Obtaining informed consent is the process in which the PI provides adequate information to a potential participant for him/her to make an informed decision on whether to participate in the clinical study.
The PI will provide you an 'Informed Consent' form, which will include all relevant information, such as the details about the purpose, duration, required procedures, potential risks and benefits of the clinical study, for your consideration.
Please take your time to read and understand the information in the form. If you are uncertain about the information provided, you may wish to consult your family members or another doctor, or simply decline to participate.
Once you have decided to participate in the clinical study, you will be required to sign and date on the 'Informed Consent' form. The PI and/or his staff will provide you with a copy of the signed form and inform you of any further administrative details.
An 'Informed Consent' form is not a binding contract. You may withdraw from participating in the clinical study at any time. It will not affect your ongoing standard treatment of care with your doctor.
You are entitled to your rights as a participant in a clinical study. Knowing your rights allows you to be in control of your welfare when participating in a clinical study.
Your rights include -
If you wish to seek an independent opinion of your rights as a participant, you may contact the NHG Domain Specific Review Board Secretariat at +65 6471 3266.
As an Academic Medical Centre, NUHS has a robust 'Human Research Protection Programme' to protect the safety and well-being of research participants.
All clinical studies, involving human participants and conducted in NUHS, are reviewed by independent institutional review boards (IRB) appointed by NUHS. The IRB is an independent committee constituted of medical, scientific and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human participants involved in a clinical study by reviewing, approving and providing continuing review of clinical studies and amendments, and of the methods and materials to be used in obtaining and documenting informed consent of the research participants.
Clinical studies, such as clinical trials, that are regarded as more than minimal risk to participants are reviewed by a 'Full Board Review' process. Full Board Review means that a group of members from the IRB gather at a convened meeting to collectively review clinical studies to ensure that the research meets certain criteria before study procedures are initiated. The criteria are based on the principles of autonomy, beneficence and justice in the Belmont Report.
In general, a clinical study must fulfil the following criteria:
Clinical studies approved by the IRB are reviewed at least once a year, and the frequency of review may be increased if the degree of risk is higher. During this renewal process, the investigator conducting the research must provide a report of the study status and other safety information. The IRB will then review these studies again to ensure the rights, safety and welfare of the research participants are protected.
In addition, no deviation or changes to the approved study is allowed without approval from the IRB.
For more information regarding the review process by DSRB (IRB appointed by NUHS), click here.
