Translating Research into Highest Quality Patient Care

When Is Ethics Approval Required


 

1. When is Ethics-DSRB Approval Required?

 

Any study which involves systematic investigation, including research development, testing, and evaluation, and are designed to develop or contribute to generalisable knowledge is considered research and will require NHG DSRB review and approval if it involves patients, staff, premises or facilities of NHG institutions and all other institutions under the oversight of NHG DSRB.

 

Click here to learn more about using the ROAM System for submissions to the DSRB.

 

Click here to find out what documents are required for the submission of an application via ROAM.

 


2. Why is Ethics-DSRB Approval Required?

All research proposals that intend to enrol human subjects must meet certain criteria before study procedures can be initiated. The criteria are based on the principles of respect for persons, beneficence and justice as discussed in the Belmont Report.

 

The Principal Investigator is strongly encouraged to submit their application well before the deadline for submission to allow some time for the DSRB to check for any missing documents for information. The DSRB relies solely on the documentation submitted by the Principal Investigator for review.


3. How do I determine if my research requires Ethics-DSRB Approval?

Types of studies that may require DSRB Approval:

  • Case series (3 or more subjects)
  • Database studies
  • Tissue Repositories

 

Types of studies that may not require DSRB Approval:

  • Case reports
  • Outbreak investigations
  • Disease Management
  • Infection Control

  • Quality Assessment & Improvement (QA/QI)*.

* This Checklist may be used to determine if a QA / QI study requires DSRB review. Where the response to  all  questions  in  the  QA  /  QI checklist is “No”, and where there is no intention to share the information with others (i.e. contributing to generalisable knowledge) at the onset of the study, the QA / QI study will not be subject to DSRB review.

 

When in doubt whether an activity requires DSRB review and approval, the Principal Investigator may contact the DSRB and provide a summary of the proposal for a preliminary assessment. The Principal Investigator may submit an application for the DSRB to review. The DSRB will issue a notification to the Principal Investigator if the DSRB determines that the proposal does not require review/approval.

 

 

4. What are the criteria for approval?

The DSRB will consider the following elements of review which are also the minimum criteria for DSRB approval for new applications, study amendments and continuing review:

  • Risks to subjects are minimised by using procedures which are consistent with sound research design, do not unnecessarily expose subjects to risks, and when appropriate already being performed for diagnostic or treatment purpose.

  • Risks to subjects are reasonable in relation to anticipated benefits, if any, to subject and the importance of the knowledge that may reasonably be expected to result.

  • Selection of subjects is equitable. In making this assessment, the DSRB will take into action account the following:
  • The purpose of the research
  • The setting in which the research will be conducted.
  • Special problems of research involving vulnerable populations (i.e. children, prisoners, pregnant women, mentally disabled persons or economically or educationally disadvantaged persons.)

  • Informed consent will be sought from each prospective subject or the subject’s legally acceptable representative, in accordance, and to the extent requirements for Research Involving Children.

  • Informed consent will be appropriately documented.

  • When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

  • When some or all of the subjects are likely to be vulnerable (i.e. children, prisoners, pregnant women, mentally disabled persons or economically or educationally disadvantaged persons), to coercion or undue influence additional safeguards have been included in the study to protect the rights and welfare of these subjects.


To understand which category of review your study falls under, please see the page "Understand the Ethics Review Process - Review Process".