Scope of Research Ethics Board oversight
Research Ethics Board (REB) approval is required when conducting research with living people, with information provided by living people or with human biological materials (from living or deceased individuals).
For the purposes of research involving humans, research is defined as an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation. Human participants are defined as individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research questions (TCPS article 2.1).
Research involving humans includes conducting research, including data analysis, with information provided by human participants, regardless of whether or not that information was collected by you (for instance, it could be provided by a data custodian or shared by a research team member).
To be eligible for Dalhousie Research Ethics Board oversight, the research must also fall under the Boards’ auspices or jurisdiction as described in the University’s policy on ethical conduct for research involving humans.
Research exempt from research ethics board review is described in TCPS articles 2.2-2.4. Activities not requiring REB review are described in TCPS articles 2.5 and 2.6.
Program evaluation, quality assurance and quality improvement
Research requires REB review, but program evaluation, quality assurance and quality improvement activity is exempt from REB review (as per TCPS 2.5). The Panel on Research Ethics offers more interpretation of this question on its website (Scope – Questions 2 and 7).
It is often difficult to determine what activities qualify for an exemption from research ethics review. The Dalhousie Research Ethics boards have developed Guidelines for Differentiating Among Research, Program Evaluation and Quality Improvement [PDF 740 kB]. The guidelines intended to guide researchers and evaluators (including students) as they determine whether their proposed activity constitutes research, program evaluation (PE), or quality improvement (QI), and therefore whether it requires research ethics review or is exempt.
Please note that intent to publish does not in itself determine whether the activity is research (therefore requiring REB review).
Indigenous research involving humans
Researchers must seek engagement with the relevant Indigenous community when the research is likely to affect their welfare. The REB application must include a finalized research agreement with each/all communities involved in the research.
Sample forms and templates
Policies, procedures, and guidance
Indigenous research resources
Dalhousie University provides resources to guide the ethical review of research applications involving Indigenous communities.
Other resources
Research involving children and youth
Best Practices for Health Research Involving Children and Adolescents is a publication designed to assist in the application of the guidance in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans in the context of health research involving children and youth.
International research
The United States Office of Human Research Protections has published the International Compilation of Human Research Standards. Researchers planning to work internationally may find it helpful to consult this compilation to learn more about the laws, regulations and guidelines that govern research involving humans in over 100 other countries.