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
The consent process is fully discussed in chapter 3 of the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans. This includes a discussion of the information generally required for informed consent. The following are some sample consent forms that you may use to guide the development of the consent forms that are most appropriate to your research study:
- Consent form for participation in prospective data collection such as interviews, focus groups, observation and surveys (including signature page) [PDF - 216 kB]
- Consent form for participation in an online survey (no signature requested) [PDF - 111 kB]
- Consent form for secondary use of personal records [PDF - 153 kB]
- Consent form for secondary use of existing research records [PDF - 156 kB]
- Assent script for children when parents or guardians have provided consent [PDF - 74 kB]
This guide discusses some helpful hints for research recruitment messages and provides an example of a recruitment poster.
It is advisable (and ethically prudent) for researchers to clarify roles and responsibilities with respect to the confidentiality of research participant information by transcriptionists and research staff who work with this information, ensuring commitments made to participants about the confidentiality of their research participation and information are honoured. One way to do this is through the use of a confidentiality agreement. In such agreements, lead researchers should explain:
The expectation that the transcriptionist / research staff will maintain and safeguard the confidentiality of information to which they have access. In some cases, the transcriptionist / research staff will be asked to remove names and other identifying information from transcripts or other records; the researcher should clearly describe their expectations about what is considered identifying information and how to de-identify such information in the transcript or other records. Transcriptionists / research staff may not share or discuss with any third party information to which they are privy by virtue of providing transcription or research support services. This includes the use of artificial intelligence; such use is not permitted without the written permission/instruction of the lead researcher as approved by the research ethics board. Transcriptionists / research staff should only discuss the research with lead researchers or members of the research team (as delegated by the lead researchers).
The expectation for secure transmission, storage and destruction of research material (as described by lead researchers to, and approved by, the research ethics board). Describe how the researchers will send/share information with the transcriptionist / research staff securely, how they expect the transcriptionist / research staff to store and/or access the information securely, and how the transcriptionist / research staff should return materials to the researcher securely (and what to return) and how the transcriptionist / research staff should securely destroy any research records (and when).
This template agreement may be used to clarify expectations between researchers and individuals hired to conduct specific research tasks, e.g., recording or editing image or sound data, transcribing, interpreting, translating, entering data, destroying data and should be amended as appropriate for the specific research tasks and context.
Policies, procedures, and guidance
The responsibilities of supervisors with respect to research ethics is described in the Dalhousie University Policy on the Ethical Conduct of Research Involving Humans and included here [PDF - 758 KB], along with recommendations for supervisors on how to help their students throughout the research ethics review process.
The following guide was created to help researchers manage the information participants provide to researchers. The focus of this reference guide is on personally identifiable participant information but can be applied to any type of participant research data. It identifies tools/methods that researchers can use to collect, transfer, and store identifiable participant data in ways that are ethically sound and comply with key pieces of privacy legislation.
Dalhousie Information Technology Services provides the following online survey services for current employees and students: Opinio and REDCap. Opinio is a Dal hosted and supported tool researchers can use to collect survey information online. The survey data from Opino are stored on Dalhousie servers and therefore helps researchers adhere to various pieces of privacy legislation, and the Dalhousie Policy for the Protection of Personal Information from Access Outside Canada.
REDcap is a secure web application for building and managing online surveys and databases. Like Opinio, the data are stored on Dalhousie servers and similarly upholds the same privacy legislation and Dalhousie Policies mentioned above. Some researchers will find REDCap to be better suited to more complex research designs.
If researchers would like to use a different survey tool, they must be mindful of the requirements to protect personally identifiable information of participants (or information, when combined with other information that could become personally identifiable). Not all surveys collect personally identifiable information, but those that do must demonstrate to the REB that:
Any personally identifiable information is stored on Canadian servers. This is required to comply with the Personal Information International Disclosure Protection Act, and the Dalhousie Policy for the Protection of Personal Information from Access Outside Canada.
If the personally identifiable information is not to be stored on Canadian servers, then the risks to participants of having their data stored outside of Canada (and potentially subject to access by foreign governments), must be clearly presented in the consent documents.
Sometimes as a researcher you may want to record a research session with participants, such as interviews or focus groups. Recording interviews means that personally identifiable information is being collected about a person—as their face and/or voice is personally identifying—and this enhanced risk to participants should be carefully weighed against convenience for you the researcher. If recording a research session is integral to the success of the research, Dalhousie IT recommends the use of Microsoft Teams for this purpose.
If you do not need to record the video for the research and audio will serve the purposes for the research, it is recommended to only record the audio. Always collect as little personally identifying information as needed for the research purposes and images of a face with a voice are more personally identifying than just a voice.
When collecting personally identifying information about a participant, researchers need to be in compliance with Dalhousie’s Protection of Personal Information Policy, and the Nova Scotia Personal Information International Disclosure Protection Act. This means that the personally identifiable information must not be accessible outside of Canada or participants need to give informed consent for their information to be accessible outside of Canada. “Informed” consent means they are informed about the security and privacy risks. It is the researcher’s responsibility to understand those risks and communicate them clearly to the participant. Recordings taken using Microsoft Teams are securely routed and stored in Canada.
If you choose to use another videoconferencing tool to record research sessions (such as Zoom, Skype for Business, Collaborate Ultra, etc.), you will need to learn if any of the participant data is accessible from outside of Canada at any time (e.g., if audio and video content is routed outside of Canada during recording, or when stored afterwards). If personally identifiable information is accessible outside of Canada (either with video or audio), Section 2.7.5 of the Prospective REB application form should be checked “Yes”, and an explanation should be provided about how compliance with the Dalhousie policy is being achieved (usually this means that participants are informed about this via the consent form). Ensure that consent information is clear about potential security and privacy risks of any technology used. If you have questions about the security and privacy risks of other tools, consult with Dal ITS at support@dal.ca.
Another option to recording using the videoconferencing tool is to record on a separate device like a hand-held recorder or smartphone app (use one that does not sync to the cloud). This way the recorded information is more secure as it is not connected to the internet.
Remember, the more sensitive the research, the more diligent you must be in ensuring rigorous privacy protection for your participants.
Note: The information provided here is correct as of November 2023. We will endeavour to keep this FAQ current. However, technology and Dalhousie’s recommended best practices may change without notice to the Research Ethics office.
The REB has developed two tools to help researchers when designing and conducting course-based research:
Guidelines
Dalhousie University Research Ethics Board Guidelines on the Scholarship of Teaching and Learning [PDF - 513 kB] is intended to help guide researchers in the application of research ethics principles to scholarly investigation (research) of the effectiveness of pedagogical innovation and practice related to course-based interventions. It identifies the key ethical challenges of scholarship of teaching and learning (SoTL) research with the overarching aim of articulating the issues, recommending best practices and communicating these clearly to researchers to support the conduct of ethically sound SoTL research.
User Guide
Adopting an interactive approach, the user guide helps researchers navigate ethical issues by addressing key questions they may encounter while designing their course-based research project. This user guide was designed to help researchers apply the guidelines (above), which should be consulted first.
Learn about ethically acceptable strategies for preventing participant misrepresentation in research as well as mitigation strategies for situations in which researchers suspect that participants have misrepresented their eligibility for a research study.
Reporting of unit-level research ethics review
For minimal risk, course-based (non-thesis) research, the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans (TCPS) requires that unit-level (department/school-level or faculty-level) research ethics reviews are documented and reported to the research ethics boards in a timely manner (TCPS 6.12).
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.