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).

Wondering About Your Own Project?

If you require guidance as to whether your project constitutes requires HREB review, please contact the Ethics Officer (ethicsofficernct@hrea.ca) and submit brief answers to the 7 questions listed below.  Please try to limit yourself, as much as possible, to 1-2 sentences per question.  Once we have your answers to these questions, we’ll review them with the Chair of the relevant HREB subcommittee and get back to you.

• Project team composition –Are any of the project’s principal investigators or co-principal investigators affiliated with Memorial University’s faculty of Medicine, Nursing and/or Pharmacy?
• Overall objective –Do you intend to produce findings that (a) are specifically and exclusively for use within a defined organizational setting, such as a health authority or medical school, OR (b) can be generalized to similar such settings elsewhere?
• Data Collection – What are the principal forms of data you will be collecting and/or requesting?  Examples might include questionnaire data, interviews, validated clinical instruments, etc.
• Participants –Will your project make use of any data collected from residents of Newfoundland and Labrador?
• Randomization – Will your project involve random assignment to separate intervention and control groups?
• Outcomes – What are the principal outcomes you will be measuring?
• Dissemination – If your project is national in scope, will you be disseminating your findings province-by-province or in the aggregate?

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)