Risk Level of a Study

Researchers may request an ethics waiver when a formal ethics review is not considered necessary, but evidence of ethics review is still required. For instance, when submitting to a journal or applying for funding.

The process of requesting an ethics waiver is outlined on the Ethics Waiver page on the REC-H website. 

High risk research poses a real and foreseeable risk of harm or serious adverse consequences to participants and researchers if not managed in a responsible manner.

Medium risk research – research involving vulnerable groups, sensitive or potentially sensitive topics, access to private information, and in which there is a potential risk of harm or discomfort, but where appropriate steps can be taken to mitigate or reduce overall risk.

Low risk research – where the only foreseeable risk is one of inconvenience or discomfort, or where the probability and magnitude of possible harms implied by participation are no greater than those posed by everyday life in a stable society

FORMAL ETHICS REVIEW IS NOT REQUIRED WHEN:

• the study does not involve humans or use data or biological materials belonging to humans.
• the research relies exclusively on information that is publicly available (i.e., involves the analysis of information in the public domain) or that is accessible in terms of legislation or regulation, and:
  • does NOT require gatekeeper, site, or platform permission,
  • does NOT involve sensitive or potentially sensitive information,
  • AND uncontroversial topics are being investigated,
  • AND participants are not from vulnerable populations,
  • AND data collection and dissemination of research findings will not identify individuals or groups and does not create the possibility of re-identification.
• the research involves the observation of people in public spaces (including virtual public spaces) and natural environments, provided that:
  • the researcher does not interact directly with individuals or groups,
  • the researcher does not stage any intervention, the individuals or groups do not have a reasonable expectation of privacy,
  • and dissemination of research findings does not identify individuals or groups and does not create the possibility of re-identification.
• research that is exclusively for quality assurance, quality improvement (audits), programme evaluation activities, performance reviews, and consumer surveys.