Ethics Application Screening Tool

Please find below an infographic of the ‘Ethics Application Screening Tool’ – a tool to help guide researchers to the appropriate application for ethics review for the various REBs in the province.  There are additional supplementary interpretations/definitions below to help researchers answer some of the critical questions in the tool.  It is highly recommended that all researchers complete the ‘Ethics Application Screening Tool’ prior to accessing an application form in the Researcher Portal, as applications cannot be transferred between the different REBs if the incorrect application is selected.  In addition, through the creation of the Researcher Portal, the various REBs have updated their processes and forms and these changes may impact which application to complete.

This ‘Ethics Application Screening Tool’ was developed by Sandra Veenstra on behalf of the Health Research Ethics Authority (HREA).  This tool is not to be replicated without permission.  If you have any questions about the tool you can contact Sandra Veenstra, Ethics Director to the HREA at ethicsdirector@hrea.ca or (709) 777-8905.

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Is your project exempt from review?

Research that does not require review:

  • Research that relies exclusively on publicly available information when the information is legally accessible to the public and appropriately protected by law; or the information is publicly accessible and there is no reasonable expectation of privacy.
  • Research involving naturalistic observation in public places (where it does not involve any intervention staged by the researcher, or direct interaction with the individual or groups; individuals or groups targeted for observation have no reasonable expectation of privacy; and any dissemination of research results does not allow identification of specific individuals).
  • Quality assurance and quality improvement studies, program evaluation activities, performance reviews, and testing within normal educational requirements if there is no research question involved (used exclusively for assessment, management or improvement purposes).
  • Research based on review of published/publicly reported literature.
  • Research exclusively involving secondary use of anonymous information or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information.
  • Research based solely on the researcher’s personal reflections and self-observation (e.g. auto-ethnography).
  • Case reports.
  • Creative practice activities (where an artist makes or interprets a work or works of art).

 

Is your research health research?

HREA Act, section 2(d) “health research involving human subjects” means activities whose primary goal is to generate knowledge in relation to human health, health care and health care systems, and involving human beings as research subjects, health care information respecting human beings or human biological material.

This includes all research related to health education (e.g. curriculum development in nursing or medicine).  Health research does not include tests on non-healthcare equipment or tools to be used by humans, even where the research methods may put humans at risk (e.g. automobile or helicopter safety studies, research to study early childhood learning patterns, human kinetic research to establish parameters of safety for sports equipment).

To note: health research being conducted where the researcher is not affiliated with MUN and participants or data are not about Newfoundland and Labrador or its population does not require local ethics review.

In addition, national health surveys being conducted where the researcher is not affiliated with MUN that include Newfoundlanders and Labradoreans as participants, but do not identify Newfoundland and Labrador as an aggregate and do not report findings specific to Newfoundland and Labrador or to aggregates within Newfoundland and Labrador, does not require local ethics review.

 

Is your health research a clinical trial?

A clinical trial is ‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.’

Interventions include but are not restricted to drugs, radiopharmaceuticals, cells and other biological products, surgical procedures, radiological procedures, devices, genetic therapies, natural health products, behavioural treatments, process-of-care changes, preventive care, manual therapies and psychotherapies.

 

Is your health research exclusively involving secondary use of data or human biological materials?

Secondary use of data/biological samples refers to both:

  • Accessing data/samples that was collected for a different purpose to answer a research question (e.g. research using medical charts); and
  • Re-analyzing an existing research data set with a different research question.

 

Coming soon – an interactive version of the screening tool!   By responding to ‘Yes/No’ questions, researchers will determine whether or not their research requires REB review and will be navigated to the relevant application form for their study. 

The Privacy Compliance Review Form can be found here.

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