A clinical study:

• involves the participation of human volunteers, their data and/or biological samples; and
• is conducted to obtain generalisable information by reviewing past data, interacting with the human volunteer or an intervention, to evaluate how a new medicine, device or treatment works.

Through these clinical studies, clinicians find new and alternative ways to prevent, detect, diagnose, control and treat illnesses.

Types of clinical studies

• Observational Study - A type of study in which participants are observed or certain outcomes are measured. The  researcher does not make any attempt to change or affect the outcome.
• Questionnaire/Survey/Interviews - These studies collect information from the participant’s written or verbal responses to a set of questions.
• Medical Records Review - This involves use of information collected previously in the medical records. By studying the medical records of large groups of people over long periods of time, researchers can evaluate the progress of diseases and long term outcomes of treatments and other clinical interventions.
• Clinical Research - These studies may require collection of blood samples or biological specimens, or collection of data through procedures such as X-rays or ultrasound scans.
• Clinical Trial - Clinical trials are designed to test the safety and/or effectiveness of drugs, devices, and other medical interventions.
  
  

• to contribute or play a part in the understanding of diseases to improve healthcare.
• to seek new or alternative treatments that are otherwise not available to them, for patients who have exhausted conventional treatment options .

How do you decide whether to participate in a clinical study?

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:

• What will I have to do in the clinical study?
• How long will it last?
• How many times will I have to come for study appointments?
• How long will the study appointments last?
• Who will be watching out for my health?
• What are the potential benefits and risks in the clinical study?
• Will I incur any costs if I participate in the clinical study?

It is important to fully understand and have all your queries answered before agreeing to take part in the clinical study.

If you do decide to participate in a clinical study, the PI and/or his staff 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 to you an Informed Consent Form, which should include all the relevant information (such as the details about the purpose, duration, required procedures, potential risks and potential benefits of the clinical study) for  your consideration.

Please take your time to read and understand it. 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 have 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.

• You can choose not to enrol in the clinical study.
• You are not obligated to follow through to the end of the clinical study. You may withdraw from the clinical study at any time even after you have signed the Informed Consent Form.
• You have the right to ask questions pertaining to the clinical study or the procedures involved.
• You have the right to receive as much information regarding the nature and purpose of the clinical study you are involved in. This includes information such as the procedure(s), the drug(s) and device(s) involved, potential risks and benefits of the clinical study.

If you want 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 a Joint Commission Institution (JCI) accredited Academic Medical Centre, NUHS has a robust Human Research Protection Program to protect the safety and well-being of research participants. All clinical studies, involving human participants and conducted in NUHS, are reviewed by an independent ethics review board called the Domain Specific Review Boards (DSRB). The DSRB 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 DSRB 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:

1. Risks are minimized, and are reasonable in relation to anticipated benefits.
2. Selection of participants is equitable.
3. Informed consent will be sought, and appropriately documented.
4. Adequate provision for monitoring of data to ensure safety, protection of privacy of research participants and confidentiality of data collected.
5. Additional protection for vulnerable populations.

For more information, please click HERE to refer to Investigator’s Manual 2nd Edition, Chapter 4.1.

Clinical studies approved by DSRB are also required to apply for renewal at least once per year, and the frequency of review may be increased if the degree of risk is higher. During the renewal process, the doctor conducting the research must provide a report of the study status and other safety information. DSRB 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 DSRB.

For more information regarding the review process by DSRB, please click HERE.

There are several avenues for you to find a study to participate in:

• Your doctor may know of studies that are suited for your condition. You may ask your doctor to refer you to the research team involved.
• Some clinical studies may use posters or brochures to announce the recruitment of participants. You may look out for the posters in the hospital lifts or the brochures in the clinics.
• The NUHS Investigational Medicine Unit is always conducting clinical studies that recruit healthy participants.