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:
- Risks are minimized, and are reasonable in relation to anticipated benefits.
- Selection of participants is equitable.
- Informed consent will be sought, and appropriately documented.
- Adequate provision for monitoring of data to ensure safety, protection of privacy of research participants and confidentiality of data collected.
- 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.