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Draft 2nd Edition of the TCPS (December 2008)

Chapter 10


Researchers in social sciences and humanities, such as sociology, psychology, criminology, business administration, political science, communications, education and history, have a common belief in the desirability of trying to understand human action through systematic study and analysis. Some researchers use quantitative research approaches, others opt for qualitative research methods, and some use a combination of both.

Qualitative research has a long history in many well-established disciplines in the social sciences and humanities, as well as many areas in the health sciences (e.g., nursing). Research developments point to an increasing prevalence of qualitative approaches, whether in health research or in social sciences and humanities disciplines. Within specific disciplines, ethics guidelines have also been created to address the issues inherent in the use of particular methods, technologies, settings, etc. Qualitative research approaches are inherently dynamic and are grounded in different assumptions than those that shape the biomedical model of research. Many of the research practices and methodological requirements that characterize qualitative research approaches parallel those that characterize quantitative approaches - concerns regarding research quality (e.g., dependability and trustworthiness of data), for example - but, as is the case with ethics principles, the criteria are adapted to the particular subject matter, context and epistemological assumptions (i.e., related to the nature and production of knowledge in a specific area of research) of the specific project.

This chapter seeks to provide some guidance on qualitative research and its implications for the ethics review process. In particular, it addresses issues of consent, privacy and confidentiality that are particular to qualitative research. Some procedural issues related to the dynamics and characteristics of qualitative research that affect the timing and scope of the research ethics review process are detailed below. Researchers and research ethics boards (REBs) should also consult other relevant chapters of the Policy for additional details on principles, norms and practices applicable to qualitative research.

A. The Nature of Qualitative Research

Qualitative approaches reflect a human-centred approach that highlights the importance of understanding how people think about the world and how they act and behave in it. This approach requires researchers to understand how individuals interpret and ascribe meaning to what they say and do, and to other aspects of the world (including other people) they encounter.

Some qualitative studies extend beyond individuals’ personal experiences to explore interactions and processes within organizations or other environments. Knowledge at both an individual and cultural level is treated as socially constructed. This implies that all knowledge is at least to some degree interpretive and hence dependent on social context. It is also shaped by the personal standpoint (and possibly also the values) of the researcher as an observer.

The section below provides a summary of general principles and methodological requirements and practices of qualitative research.

General Principles and Methodological Requirements and Practices

(a) Inductive Understanding: Many forms of qualitative research entail gaining an inductive understanding of the world of research participants to acquire an analytical understanding of how they view their actions and the world around them. In some projects, this approach also applies to the study of particular social settings, processes and experiences.

To the extent that the methods involve direct interaction with participants, there is often an emphasis on gaining insights into participants’ perceptions of themselves and others, and of the meanings that research participants attach to their thoughts and behaviours.

(b) Diversity of Approaches: There is no single approach in qualitative research. Each field or discipline, and even individual scholars within a discipline, have different perspectives on and approaches to the use of qualitative methods. Qualitative research uses a variety of epistemological approaches, methodologies and techniques that allow researchers to enter the research participants’ world or to engage with particular social environments. Methodological approaches include, but are not limited to, ethnography, participatory action research, oral history, phenomenology, narrative inquiry, grounded theory and discourse analysis. The term “qualitative research” covers a wide range of overlapping paradigms or perspectives.

(c) Dynamic, Reflective and Continuous Research Process: The emergence in the course of the research itself of questions, concepts, strategies, theories and ways to gather and engage with the data requires a constant reflective approach and questioning from the researcher. Such flexibility, reflexivity and responsiveness contribute to the overall strength and rigour of data analysis.

(d) Diverse, Multiple and Often Evolving Contexts: Qualitative research takes places in a variety of contexts, each of which present unique ethical issues. As knowledge is considered to be context-contingent in qualitative research, these studies tend to focus on particular individuals, sites or concepts that are empirically derived from other social settings - and the researcher’s priority is to understand that social setting involving those people at this time.

Researchers sometimes engage in research that questions social structures and activities that create or result in inequality and injustice. They may involve research participants who are highly vulnerable because of the social and/or legal stigmatization that is associated with their activity or identity and who may have little trust in the law, social agencies, or university authorities, or they may involve research participants, such as business executives or government officials, who may be more powerful than the researchers.

(e) Data Collection and Sample Size: There is generally a greater emphasis placed on depth of research than on breadth. Most qualitative researchers would emphasize gathering diverse but overlapping data on a limited number of cases or situations to the point of data saturation or thematic redundancy. Samples and research sites in these studies are chosen because they are viewed as strategically useful or rich sources of information for furthering one’s understanding of phenomena of interest, not because they are necessarily statistically significant.

A researcher may rely on multiple sources of information and data-gathering strategies (e.g., triangulation) as one mechanism for enhancing data quality. Researchers use a variety of methods for data gathering, including interviews, participant observation, focus groups and other human-focused techniques. Gathering of trustworthy data comes best from closeness and extended contact with research participants. Textual qualitative studies also use a variety of content analysis techniques, whether with published books, websites, interview transcripts, images or other textual forms.

Appropriate treatments of data after they are gathered may vary greatly. For some research, protection of research participants requires confidentiality, anonymity, and the destruction of data after they are used. In other cases, the data may provide a valuable historical record that must be preserved or they may make a valuable contribution by publicly attesting to the role played by particular individuals. (See Chapter 2 [“Scope and Approach”] and Chapter 5 [“Privacy and Confidentiality”].)

(f) Research Goals and Objectives: The aims of qualitative research are very diverse, both within and across disciplines. The intended goals of qualitative projects may include “giving voice” to a particular population, engaging in research that is critical of settings and systems or the power of those being studied, affecting change in a particular social environment, or exploring previously understudied phenomena to develop new theoretical approaches to research.

(g) Dynamic, Negotiated and Often Ongoing Free and Informed Consent Process: Entry into a particular setting for research purposes sometimes requires negotiation with the population of interest; the process sometimes cannot be ascertained in advance of the research, in part because the relevant contexts within which the research occurs evolve over time.

In some cases, research participants hold equal or greater power in the researcher-participant relationship - for example, in community-based and/or organizational research when a collaborative process is used to define and design the research project and questions, or where participants are public figures or hold other positions of power (for example, research involving economic, social, political or cultural elites). In other cases, researchers themselves may hold greater power when access to prospective participant populations is gained through gatekeepers with whom the researcher has established a relationship (e.g., when a researcher engages with the police to do research in relation to a problem population, or when researchers engage with prison authorities to do research with offenders).

(h) Research Partnerships: Access to particular settings and populations is often developed over time, and the relationships that are formed may well exist outside the research setting per se, which sometimes makes it difficult to determine exactly where the “research” relationship begins and ends. In many cases, despite in-depth, advanced preparation, a researcher may not know until the actual data collecting starts just where the search will lead. Indeed, the emergent nature of many qualitative studies makes the achievement of rapport with participants and feelings of interpersonal trust crucial to the generation of questions considered important or interesting by both parties and of dependable data. Research often becomes a collaborative process negotiated between the research participant(s) and the researcher, requiring considerable time spent initially simply figuring out the focus of the research.

In many cases, contacts between researchers and participants can extend over a lifetime, and these individuals may engage in a variety of relationships over and above their specific “research” relationship.

(i) Research Results: Transferability of results from one setting to another is considered, but is often viewed as more of a theoretical issue than a procedural or sampling issue.

B. Research Ethics Review in the Context of Issues Distinctive to Qualitative Research

This section seeks to provide guidance on particular implications of the use of qualitative approaches for the ethics review process. This section should also be read in conjunction with other chapters of this Policy.

Qualitative research can pose unique ethical issues around gaining access, building rapport, using data and publishing results. Researchers and REBs should consider issues of consent, confidentiality and privacy, and relationships between researchers and participants in the design, review and conduct of the research. Some of these may be identified in the design phase, but others will arise during the research itself, which will require the exercise of discretion, sound judgment and flexibility in the context of a proportionate approach to the level of risk and benefit arising from the research, the well-being of the individual, and welfare defined in a broad sense.

Modalities of Expression of Free and Informed Consent

Article 10.1 Research ethics boards should consider the range of strategies for documenting the consent process that may be used by researchers using qualitative research approaches. Researchers should explain in their research design the consent procedures and strategies they plan to use.

Application The consent process should usually reflect trust between the research participants and the researcher. Often this is based on mutual understanding of the project’s intentions. The research participant may sense attempts to legalize or formalize the process as a violation of that trust. Under a variety of circumstances, written consent is not required in qualitative research. Qualitative researchers use a range of consent procedures, including oral consent, field notes, and other strategies such as recording (audio or video, or other electronic means) for documenting the consent process. Evidence of consent may also be via completed survey questionnaires (in person, by mail or by email or other electronic means).

REBs may need to consider the power relationship that might exist between researchers and research participants. In cases where the research participant holds a position of power or routinely engages in communicative interactions similar to those involved in the research by virtue of his or her position or profession, informed consent can be inferred by the participant’s agreeing to interact with the researcher for the purpose of the research. No further verification of consent is needed. For example, “elite” research focuses on power structures and persons in positions of power (for example, a senior partner in a law firm, a cabinet minister, or a senior corporate officer). In this type of research, the fact that a potential participant agrees to be interviewed by a researcher may be sufficient to signify consent to participate in the research.

Researchers and REBs should consult Chapter 3 (“Free and Informed Consent”) for additional details and considerations.

Observational Studies

Exemption from REB Review

Article 10.2 Research ethics board review is not required for observation of people in public places that does not involve collecting personal identifiable information through direct interaction with the individuals, and that does not involve any intervention staged by the researcher. Such research does not involve human participants as defined by this Policy.

Application Research involving observation of people in public spaces where there is no presumption of privacy and where no personal identifiable information is being collected directly from the individuals - for example, political rallies, demonstrations, or other public events or settings (e.g., a free concert in a public park, a shopping mall) - does not require REB review, since it can be expected that participants are aware of the public nature of the event or gathering. Where individuals should reasonably expect that their identities will be evident - for instance, as a result of their celebrity - research that refers to their presence does not require REB review. (See also Article 2.5 in Chapter 2 [“Scope and Approach”] and Chapter 5 [“Privacy and Confidentiality”].)

Article 10.3 Web-based research that uses exclusively publicly available information for which there is no presumption of privacy does not require REB review. Such research does not involve human participants as defined by this Policy.

Application Research that is non-intrusive, does not require direct interaction between the researcher and individuals through the Internet medium, and that draws its data primarily from postings on websites is not required to obtain REB review. Cyber-material such as documents, records, performances, on-line archival materials or published third-parties interviews to which the public is given access on the Internet or that clearly seeks public visibility might be considered as publicly available information (see Chapter 2 [“Scope and Approach”]). Researchers may need to consider other factors when using this information, such as copyright, dissemination restrictions, privacy and intellectual rights. These, however, fall outside of the scope of the REB review.

Proportionate Approach to Review of Observational Studies

Article 10.4 When considering research involving observation, including web-based research where personal identifiable information is being collected or where individuals have a presumption of privacy, research ethics boards should apply a proportionate approach to ethics review.

Application In qualitative research, observation is used to study behaviour in a natural environment. It often takes place in living, natural and complex communities or settings; in physical environments; or in virtual settings such as the Internet. Observational studies may be undertaken in public spaces or in virtual settings where individuals might have some limited expectation of privacy or in private or controlled spaces where individuals have an expectation of privacy. The spectrum of settings where observational research typically requiring review may occur include, for example, classrooms, hospital emergency wards, private Internet chat rooms, or within members-only communities or organizations.

Observational research is of two kinds: “non-participant” (i.e., where the researcher observes, but is not a participant in, the action) and “participant” (i.e., where the researcher engages in, and observes, the action).

Participant observation often is identified with ethnographic research, in which the researcher’s role is to gain a “holistic” overview of the studied context through engagement in and observation of the setting to describe its social environments, processes and relationships. Participant observation may or may not require permission to observe and participate in activities of the setting studied. In some situations, researchers will identify themselves and seek free and informed consent from individuals in that setting; in others, researchers will engage in covert participant observation. Where specific disciplines and methodological approaches provide guidelines relating to the ethics issues involved in these types of research, researchers and REBs should consider the similarity, divergence or overlap of such codes or guidelines with this Policy and seek mutual understanding and clarification to address the ethical issues that may arise in a particular project.

Observational studies raise concerns of the privacy of those being observed. REBs and researchers need to consider the ethical implications associated with observational approaches, such as the possible infringement of free and informed consent or privacy, as well as the disciplinary and methodological norms of the proposed research project. They should pay close attention to the ethical implications of such factors as the nature of the activities to be observed, the environment in which the activities are to be observed, whether the activities are staged for the purpose of the research, the expectations of privacy that potential participants might have, the means of recording the observations, whether the research records or published reports involve identification of the participants, and any means by which those participants may give permission to be identified.

Because knowledge that one is being observed can be expected to influence behaviour, research involving non-participant or covert observation generally requires that the participants not know that they are being observed (typically there is not direct interaction with the individuals being observed), and therefore they cannot give their free and informed consent. Some forms of qualitative research seek to observe and study criminal behaviours, violent groups, or groups with restricted membership or access. For example, some social science research that critically probes the inner workings of criminal organizations might never be conducted if the participants know in advance that they are being observed. Similarly, observing queuing behaviours in shopping malls is one example of a study that may be deemed minimal risk, where the research could not be completed if shoppers knew that they were being observed. Researchers should justify whether the needs for such covert research justify an exception to the general principle of free and informed consent, and REBs should exercise their judgment in this type of situation. Such research should also be carried out according to professional and disciplinary standards.

Researchers should demonstrate to the REB that necessary precautions and measures have been taken to address privacy and confidentiality issues in the case of observational studies, commensurate with the level of risk and the research context. Researchers and REBs should also be aware that, in some jurisdictions, publication of identifying information - for example, a photograph taken in a public place, but focused on a private individual who was not expecting this action - may be interpreted in a civil suit as an invasion of privacy.

REBs should focus on projects above the threshold of minimal risk, or they should modulate requirements and protection proportionate to the magnitude and probability of harms, including the likelihood that published reports may identify individuals or groups. Observational research that does not allow for the identification of the participants and that is not staged and is non-intrusive should normally be regarded as of minimal risk.

Researchers should be aware that web-based research may pose concerns outside the scope of the research ethics review process. Such concerns may arise, for example, when the web-based setting involves minors or other populations that may become vulnerable because of the lack of surveillance in this electronic setting. Such issues, which are not related to the ethics of the research proposal itself, are not covered by this Policy.

Researchers and REBs should consult Chapter 3 (“Free and Informed Consent”) and Chapter 5 (“Privacy and Confidentiality”) for additional details and considerations.

Privacy and Confidentiality in the Dissemination of Research Results

Article 10.5 Subject to the research context and the scholarly traditions used in the research proposal, research ethics board review should acknowledge that individuals may want to be identified for their contribution.

Application In much social science and some humanities research, the biggest possible risk for researchers and REBs to manage is the harm that can result from violations of research confidentiality. This can pose a particular challenge in qualitative research because of the depth, detail, sensitivity and uniqueness of information obtained. The default approach is to guarantee confidentiality of the research data. In some cases, anonymity of the research participant may be used in publications or dissemination of research results to ensure confidentiality of data.

In some types of qualitative research, respect for the participant’s contribution is shown by identifying the individual in research publications or other means of dissemination of the results from the research. If failing to identify participants would be unethical because of the disrespect it would involve, or if informed participants assert their desire to be named, then researchers should do so, according to the normal principles and practices of their discipline. Where confidentiality is preferred or where there is no compelling reason to the contrary, confidentiality would be maintained in a manner commensurate with the needs of the research participants and the project.

Reviewers need to be sensitive to which principle is operative in any given research context, and which disciplinary traditions are being invoked.

Researchers and REBs should consult Chapter 5 (“Privacy and Confidentiality”) for additional details and considerations.

Timing of the REB Review

Article 10.6 Research ethics board (REB) review is not required for the initial exploratory phase when the researcher is developing the research design. Research ethics review is required once the terms of the research are established. The researcher must receive REB approval prior to the start of the formal data collection in the field.

Application It is sometimes difficult to ascertain the beginning and end of a qualitative research project. Access to particular settings and populations often develops over time, and it is not unusual for researchers to be passive observers or simply passively interested in a setting for some time before any formal effort is made to establish a “research” relationship. Preliminary activities may include note taking, scribbling, diary writing, and observation made long before the researcher has any inkling that these would turn into formal research projects. These types of preliminary activities are not subject to REB review.

Researchers need to have the opportunity to engage in preliminary visits and dialogue to explore possible research relationships and define research collaborations with particular settings or communities, including the determination of research questions, methods, targeted sample and sample size, and inclusion of community-based concerns into the project design and data collections. REBs should be aware that dialogue between researchers and communities at the outset and prior to formal REB review is an integral component of the research design. Researchers may need to consult informally the REB when ethics issues arise prior to the data collection or inform the REB of such issues over the course of the research.

Qualitative research approaches involving a community, group or population of interest (e.g., marginalized or privileged groups) follows a process of prior dialogue, exchanges and negotiation of the research, which precedes the formal data collection involving human participants. For instance, in research in Aboriginal communities or with Aboriginal populations (see Chapter 9 [“Research Involving Aboriginal Peoples”]) or other types of community-based collaborative research, it may be desirable to obtain permission to proceed from community leaders, elders or representatives before seeking individual consent. A researcher might use a community gathering to inform the group about the research and gain agreement from the group to proceed with the actual research before seeking to obtain individual consent as a second step of the research implementation.

Although initial research questions may be outlined in the formalized research plan, REBs should be aware that it is quite common for specific questions (as well as shifts or discovering of data sources) to emerge only during the research project. Due to the inductive nature of qualitative research and the emergent design approach of the research, some of these elements may evolve as the project progresses. Some resulting changes to the research design will not merit requiring additional REB review, as they are not necessarily significant changes to the approved research. Research ethics issues may also arise over the course of the research, and it might be sufficient for the researcher to inform the REB about such issues. (See Chapter 2 [“Scope and Approach”] and Article 6.16 in Chapter 6 [“Governance of Research Ethics Review”].)

Article 10.7 When researchers are using emergent designs in data collection, research ethics boards should review and approve the general procedure in accordance with appropriate professional and disciplinary standards.

Application In qualitative research involving data collection with emergent designs (e.g., unstructured interviews or focus groups), specific questions or other elements of data collection cannot be known or articulated fully in advance of the project’s implementation. In these cases, REBs may ask to review a draft set of sample questions or other outlines of the procedures to be followed in data collection. REBs should not require researchers to provide them with a full questionnaire schedule in advance of data collection. Rather, REBs should ensure that the data collection is conducted according to disciplinary and professional standards.


  • Australian Research Council, National Statement on Ethical Conduct in Human Research, National Health and Medical Research Council, Australian Vice-Chancellors Committee. 2007.
  • Canadian Institutes for Health Research, CIHR Best Practices for Protection Privacy in Health Research. 2005.
  • Canadian Institutes for Health Research, Natural Sciences and Engineering Research Council of Canada and Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Integrity in Research and Scholarship.
  • Canadian Institutes for Health Research, and Social Sciences and Humanities Research Council of Canada, The Social Sciences and Humanities in Health Research: A Canadian Snapshot of Fields of Study and Innovative Approaches to Understanding and Addressing Health Issues. 2000.
  • Social Sciences and Humanities Research Council of Canada. SSHRC Research Data Archiving Policy.