Translating Research into Highest Quality Patient Care

Understand the Ethics Review Process


Application Process

 

All research applications must be submitted to the DSRB via the Research Online Administration and Management system (ROAM). The ROAM portal may be accessed HERE.

Once the Principal Investigator submits an application via ROAM, it will be automatically routed to the Department Representative (DR) and subsequently the Institution Representative (IR) for endorsement. The DSRB will receive the application only after both the DR and IR have endorsed it.

The Principal Investigator should select the most appropriate DSRB domain to review their study. The DSRB may re-assign your application to another Domain upon preliminary review of your application.

 

For more details of the specialties under each DSRB domain, please click HERE.

 

 

Review Process

 

Based on the level of risk in which research participants will be exposed to, all research studies submitted will be classified under one of the following review categories,:

a.    Exempt review - Research studies that involve anonymous surveys and questionnaires, collection or study of anonymous existing data or tissue specimens, where data/tissue are either publicly available or subjects cannot be identified, or public benefit programmes.

b.    Expedited review - Research studies that involve collection of data or biological samples via non-invasive procedures, medical case-notes review, surveys or interviews with identifiers.

c.    Full Board review - Research studies that do not qualify for exempt or expedited review will be reviewed under full board review. Such studies may include research studies that involve the study of the safety and efficacy of a medicinal product, medical device, or research study that involve invasive procedures.
 

For more information on the types of research studies that fall under each review category, please click HERE (Page 43).

 

Studies that fall into the exempt and expedited review categories will be reviewed by the Domain Chairperson at the weekly chair meeting.  

Studies that require full board review will be reviewed at the monthly convened meeting at which a quorum is present.

All new applications accepted by the DSRB will be reviewed within thirty calendar days. However, the time frame from submission to approval will vary depending on factors such as the completeness of the application, complexity of the study, the response of the Investigator to DSRB's queries and availability of a meeting quorum.

 

 

Review Criteria

 

All research studies that intend to involve human subjects, use their biological samples and/or data, must meet certain criteria before study procedures can be initiated. The criteria are based on the principles of autonomy, beneficence and justice as discussed in the Belmont Report.

In general, a research study must fulfill the following criteria:

a.    Risks are minimized, and are reasonable in relation to anticipated benefits.
b.     Selection of subjects is equitable.
c.    Informed consent will be sought, and appropriately documented.
d.    Adequate provision for monitoring of data to ensure safety, protection of privacy of research participants and confidentiality of data collected.
e.    Additional protection for vulnerable populations.