Questions & Answers
Who can volunteer?
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.
Why should I volunteer?
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.
Are clinical trials safe?
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 you are invited to participate. The Institutional Review Board (IRB) is the regulatory 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.
|Examples of clinical research
||Possible measures to minimise risks
Epidemiological studies e.g. Analysis of questionnaires or medical records
|Loss of confidentiality or privacy of personal data
Access to records is restricted to designated personnel. As much as possible, information is coded and de-identified in analyses to ensure confidentiality of individuals
Bruising where blood is drawn
|Only a reasonable amount of blood is allowed to be drawn and blood is drawn by trained nurses or doctors
Potential new treatment (drug / device / therapy protocol)
Drug allergy; side effects or complications
New drugs are administered at low doses, so that unfavourable effects are minimised and only increased slowly
Volunteers are monitored closely so that any adverse effects can be addressed quickly
The potential risks and benefits will be explained before you're asked to give your written consent.
What is the goal of a clinical trial?
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
Can I find out more without any commitment?
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.
Can I change my mind after I give consent?
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. Your participation in a clinical trial is entirely voluntary.
What is informed consent?
Before 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:
(i) The 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.
Will I get paid?
Most clinical trials compensate you for your time and travel expenses. In addition, they generally cover the cost of required medical tests and treatment.
What’s involved in participating in a clinical trial at SingHealth IMU?
|Sign up to our database
Call +65 6323 7532 or sign up here
|Pre-Screen (over the phone)
Match you to clinical trial based on your medical history and schedule
Scheduling of a screening appointment
|Get screened & enroll
The investigator will review of your medical history and give you a detailed information about the study
|Take part in the trial
- Answer questionnaires
- Blood tests
- Try new devices
- Try new drugs
|Complete the trial
Length of clinical trial vary from one day to several years
How do I volunteer?
Sign up here
. Or if you would just like to talk to us first, please call us at +65 6323 7532 or email us at firstname.lastname@example.org
Can I volunteer in multiple studies?
Participating in multiple clinical trials at the same time is not
encouraged and 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 the observed change.
You should tell researchers if you’re 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.
It is important to remember that you should volunteer for the reason of helping to advance medical science, and you may not receive personal benefits from your participation.
I have a medical condition, can I still volunteer?
People with existing medical conditions should talk to their doctors about taking part in a clinical trial.
Who protects my interests?
Before any clinical trial can start, the Institutional Review Board (IRB), has to review and approve it. The IRB is a regulatory 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 to participate is appropriate and there is 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, a Clinical Trial Certificate (CTC) from the Health Sciences Authority (HSA) 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 Medicines Act, Medicines (Clinical Trials) Regulations 2000 and Singapore Good Clinical Practice Guidelines.
What should I consider before giving consent to join a clinical trial?
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 before?
- What are the medical credentials and experience of the researchers and other study personnel?
Responsibilities of the participant:
- 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?
What happens when a clinical trial is over?
After a clinical trial has finished, researchers analyse the results to determine what they mean. After a phase I or II trial, they need to decide whether to advance to the next phase or discontinue testing.
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 standard practice in medical centres locally and internationally.
My question is not covered here
If you have any further questions or would like to talk to us about volunteering, please call us on +65 6323 7532.