Anyone can volunteer so long as you are over the age of 21. Both healthy volunteers and patients with specific medical conditions are essential to clinical research. Some research specifically looks at medical conditions in children. In those cases the parent or guardian makes the decision on behalf of the child.
The most basic reason why people volunteer is to help advance medical science. Without the help of volunteers like you, medical research cannot progress, and medical care cannot improve. You may not gain anything personally from participation, but you will play an important role in advancing scientific knowledge and helping future patients.
Research seeks to find answers. Therefore an element of the unpredictable is inevitable. However, researchers will have completed many studies in laboratories and in animal models to understand the new drug and minimise potential risks. All risks that are reasonably foreseeable will be highlighted to you when the investigator or his /her designated staff explains the study to you. In addition, before a clinical trial is approved, the potential risks and benefits are weighed up. Any clinical trial has to prove that its potential benefits are greater than its potential risks before volunteers are invited to participate. An approved clinical trial will need to obtain both ethics and regulatory approvals. The Health Sciences Authority (HSA) will regulate the conduct of clinical trials under the Health Products Act and Medicines Act, whereas the Institutional Review Board (IRB) is the ethical board that ensures that the interests and safety of volunteers are protected. Throughout the clinical trial, volunteers are closely monitored, and doctors are able to respond promptly to manage any adverse effects. Clinical trials are only one form of medical research, which is a very diverse field. This means that the extent of potential benefits and acceptable risks varies between research studies. Here are a few examples of the types of possible risks and corresponding measures to minimise these risks.
The potential risks and benefits will be explained before you're asked to give your written consent.
Researchers conduct clinical trials to accomplish a variety of goals. The different types of clinical trials are:Potential treatment trials, which test the efficacy and safety of new drugs, medical devices, medical procedures, or combinations of treatments
Prevention trials, which look for better ways to prevent diseases through medicines, vaccines, vitamins, minerals, or lifestyle changes
Screening trials, which look for new ways to test for the presence of a disease or health condition
Quality of life trials, which explore ways to improve comfort and quality of life for chronically ill individuals
Yes, we would be happy to talk to you about volunteering for one of our trials. You have the right to refuse to participate at any stage with no impact to your medical care. Your participation in clinical trials is entirely voluntary.
Yes, you can change your mind. You have the right to withdraw at any time after you give your consent. You will not be treated any differently if you decide to withdraw.
you can take part in a clinical trial, the researchers have to explain the
trial to you and seek your agreement. This is known as informed consent. The
researcher will explain the trial in detail to you, including:
aim of the trial
(ii) The potential risks and benefits
(iii) What is required of you
You then have as much time as you need to decide whether to give your consent or not. Without your informed consent, researchers cannot include you in the trial.
Most clinical trials compensate you for your time and travel expenses. In addition, they generally cover the cost of required medical tests and treatment.
You may sign up here to join our database. Or if you have any queries, feel free to talk to us at 6323 7532 / 6323 7544 or email us.
This will be dependent on the types of trials that you are participating in. But participating in multiple clinical trials at the same time is not encouraged as it can be dangerous. It also makes all the information gathered from you invalid as the doctors cannot be sure that their intervention has led to any observed change. You should tell researchers if you are involved in another trial and always discuss the possible implications of participating in multiple trials with the researchers of your current and potential study, before agreeing to participate.
People with existing medical conditions should talk to their doctors about taking part in a clinical trial.
Before any clinical trial can start, the Institutional Review Board (IRB), has to review and approve it. The IRB is an ethics board, usually made up of professionals well-versed in medicine, science and law.
The IRB checks that: • The potential benefits are likely to outweigh the potential risks • The information provided to potential participants is clear and satisfactory • The way in which people are asked has no undue inducement to participate• The interests of the participants are protected (measures to safeguard confidentiality and privacy, measures to reduce risks, etc.)
In addition, for clinical trials involving drugs, approval from HSA to conduct a trial is required. This is part of the regulation in place to govern the safe conduct of clinical trials. For more information, you can read the Health Products Act and ICH Guidelines for Good Clinical Practice (ICH-GCP).
Objective of the trial:
•What is the purpose of the trial?
•Why do the researchers think the approach being tested may be effective? Has it been tested
•What are the medical credentials and experience of the researchers and other study personnel?
Responsibilities of the volunteers to be considered before agreeing to participate in a clinical trial:
•How long will the trial last? How many visits are involved?
•Do I need to stay overnight?
•What tests and procedures are involved?
•What happens at the end of the study? Are follow-up visits required?
Potential risks and benefits:
•What are the short-term and long-term risks and benefits?
•What will happen if I withdraw from the trial?
•Do I have to pay for the tests and procedures?
•Will I be reimbursed for other expenses?
•Will I be compensated for any injury or side effects caused by the trial?
At the end of a clinical trial, researchers analyse the data that they have collected. They then determine if the trial should advance to the next phase or be discontinued, which is usually at phase I or II of the trial. After phase III trials are completed, researchers assess the medical importance of the data. If the results show that the new treatment or drug is safe and effective, it may become the standard practice in medical centres locally and internationally.
If you have any further questions or would like to talk to us about volunteering, please call us on 6323 7532 / 6323 7544.