Understanding minimal risk and delegated review
The following notes and guidelines have been adapted with permission from UBC's clinical research:
The concept of 'minimal risk' provides a foundation for proportionate review. Minimal Risk is defined in TCPS 2 as follows: "research in which the probability and magnitude of possible harms implied by participation in the research are no greater than those encountered by participants in those aspects of their everyday life that relate to the research."
Applications that meet minimal risk criteria are eligible for delegated review and it is expected that the majority of research submitted to the HREB will fall into the minimal risk category. The HREB retains the right to decide to put any application submitted for delegated review forward for full board review. In such cases, the applicant will be notified of the change in status of the application.
Some examples of activities NOT requiring ethics approval
If you are collecting data from human participants for research purposes, UFV ethics approval is usually required. HREB does not grant retroactive ethics approval so it important you are certain from the onset. Always consult with the HREB if you are still unsure if you require approval or if you think you can proceed without an ethics review (i.e. professional education and skill development or program evaluation, etc.).
Professional and/or skill development:
- Nursing students gathering patient information or practicing interview skills with no research intentions or dissemination of the data gathered.
Program evaluation/ quality assurance studies:
Creative practice activities:
- With the exception if the research employs creative practice to obtain responses from participants that will be analyzed to answer a research question ethics approval is required.
Observations in public places, as long as:
- It does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups.
- Individuals or groups targeted for observation have no reasonable expectation of privacy.
- Any dissemination of research results does not allow identification of specific individuals.
- NOTE: A classroom is not a public place.
Anonymous secondary data:
- Only if the process of data linkage or recording or dissemination of results does not generate identifiable information.
Publicly available data:
- Only if the data is obtained through a mechanism set out by legislation or regulation and that is protected by law.
- Or when in the public domain and the individuals to whom the information refers have no reasonable expectation of privacy.
Types of studies that would require a full board review
A full board review may be needed when your research involves BOTH vulnerable populations AND highly personal, sensitive or incriminating topics or questions. Some examples include:
- studying people engaged in illegal activities (e.g. heroin use or euthanasia) and asking them about these activities;
- discussing experiences of bullying amongst school-aged children who have been bullied;
- talking to people who are currently suicidal about their experiences of depression.
This does not mean that studies about these topics must always be reviewed at the full board. The overall risk level would be dependent on the population being studied and the methods of research being used.
Research that does not qualify for minimal risk review:
- Research that uses deception
- Research involving Indigenous communities (there are some exceptions to this - please contact the HREB to discuss)
What if I survey teachers or have children in school as participants?
Before the HREB can approve a protocol that involves anyone in any school district, we need written consent from the school district and/or the principals at the schools (this depends on the school). Consent letters need to be given to the parents with enough time for them to make an informed decision. It is recommended that you have a completed criminal record check on file if you are going to be working with children. Although the HREB cannot require the criminal record check (in terms of jurisdictional responsibility), the school district will likely require it.
Conducting Research in K-12 Schools
