Does your study require ethics review?

1. Research requiring ethics review

1. Research involving living human participants (human participants are those individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question).
2. Research involving human biological materials (including remains, cadavers, tissues, biological fluids, embryos, fetuses, fetal tissue, reproductive materials and stem cells).
3. Research about individuals in the public arena if s/he is to be interviewed and/or private papers (personal letters or journals) accessed.
4. Research involving secondary use of data (use of data initially collected for another purpose) if any form of identifier is involved and/or if data linkage or results could generate identifiable information – including, but not limited to, health records, employee records, student records, computer listings, banked tissue, data collected for a different research project.
5. The collection of data or biological materials for the storage for future research purposes (in or outside the province); even if it is a biobank/repository located outside the province and one sample is being sent for storage.

2. Activities not requiring ethics review

The following are examples of activities that do not require review by a research ethics board (REB). These may, nevertheless, raise ethical issues that would benefit from careful consideration outside of the REB.

1. Quality assurance and quality improvement studies, program evaluation activities, performance reviews, and testing within normal educational requirements if there is no research question involved (see below for further information);
2. 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;
3. 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);
4. Research based on review of published/publicly reported literature;
5. 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;
6. Case reports which may be based on the clinical notes of an individual patient/client collected with informed consent; and
7. Creative practice activities (where an artist makes or interprets a work or works of art).

Quality assurance and program evaluation

Studies conducted for internal use for assessment, management or improvement purposes are considered program evaluations and do not require review. Studies that look to create generalizable knowledge (e.g., examining your processes as a case for the purpose of extending knowledge to other similar programs) are considered research and do require review.

The following may be present in program evaluation as well as in research:
• Intent to publish. Both research and program evaluation can be published.  Intent to publish does not mean that your project requires REB review.
• Use of rigorous methods of data collection and data analysis. Program evaluation may share some methods and techniques with those employed in research.

Please note, the HREB cannot provide approval once a study is complete. If a project is conducted for the purposes of program evaluation, and then it is later decided to use the information for research, then this would be secondary use of data and the REB process for secondary use of data should be followed.

Program evaluations involving MUN programs may require a privacy impact assessment through the university’s privacy office.

3. Resources

• TCPS2 ,  Article 2.1 (definition of research)
• TCPS 2 , Article  2.5 (exemptions from research)
• TCPS 2 interpretations posted by the Panel on Research Ethics (REB Review and Scope)
• Good Clinical Practice: Consolidated Guideline; ICH Topic E6 Article 4.4 Communication with IRB/IEC/REB (Research Ethics Board, REB)

If you are still in doubt or have questions please email the Research Ethics Office (info@hrea.ca) and inquire. Your email should include a summary of the project objectives, method, and purpose.