TCPS 2 - Chapter 10
The TCPS 2 (2018) has replaced TCPS 2 (2014) as the official human research ethics policy of the Agencies.
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Researchers in social sciences and humanities – such as anthropology, sociology, philosophy, 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 established disciplines in the social sciences and humanities, as well as many areas in the health sciences (e.g., nursing, occupational therapy). The use of qualitative approaches is increasing, whether in health research or in social sciences and humanities disciplines. Within specific disciplines, ethics guidelines have been created to address the issues inherent in the use of, for example, particular methods, technologies and settings. Qualitative research approaches are inherently dynamic and may be grounded in different assumptions than those that shape quantitative research approaches. Many of the research practices and methodological requirements that characterize qualitative research approaches parallel those that characterize quantitative approaches such as concerns regarding research quality. However, as is the case with all research involving humans, the criteria are adapted to the specific subject matter, context and epistemological assumptions about the nature of knowledge in the specific area of research of the specific project.
This chapter seeks to provide specific guidance on some issues that are particularly germane to qualitative research, although such guidance may also be applicable to research using quantitative or mixed methods. In particular, it addresses issues of consent, privacy and confidentiality that may have unique manifestations in 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. Note that subject to applicable laws, the articles in this Policy relating to consent, privacy and confidentiality equally apply in the context of qualitative research.
Researchers and research ethics boards (REBs) should also consult other relevant chapters of the Policy for additional guidance on principles, norms, and practices applicable to qualitative research.
A. Nature of Qualitative Research
Qualitative research aims to understand how people think about the world and how they act and behave in it. This approach requires researchers to understand phenomena based on discourse, actions and documents, and how and why 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 a 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 perspective of the researcher as an observer and analyst. As a result, qualitative researchers devote a great deal of attention to demonstrating the trustworthiness of their findings using a range of methodological strategies.
The section below provides a summary description of the general approach, as well as methodological requirements and practices, of qualitative research, some of which may also apply to quantitative or other types of research involving humans.
General Approach and Methodological Requirements and Practices
- Inductive Understanding: Many forms of qualitative research entail gaining an inductive understanding of the world of participants to acquire an analytic 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 participants attach to their thoughts and behaviours.
- Diversity of Approaches: There is no single approach in qualitative research. Different fields or disciplines, 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 theoretical approaches, questions that guide the research, methodologies, epistemological approaches, and techniques that allow researchers to enter the 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.
- Dynamic, Reflective and Continuous Research Process: The emergence during the course of the research itself of questions, concepts, strategies, theories and ways to gather and engage with the data (e.g., emergent design research, see Article 10.5) requires a constant reflective approach and questioning by the researcher. Such flexibility, reflexivity and responsiveness contribute to the overall strength and rigour of data collection and analysis.
- Diverse, Multiple and Often Evolving Contexts: Qualitative research takes place in a variety of contexts, each of which presents 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. The researcher’s priority is to answer the research question stemming from the study of those individuals in a specific social setting at a specific time.
Researchers sometimes engage in research that questions social structures and activities that create, or result in, inequality and injustice. Studies may involve participants who are in highly vulnerable circumstances 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 institutional authorities. Regardless of the methodological approach, researchers who question social structures, or deal with the disempowered, may face pressures from authority figures. Research may also involve participants, such as business executives or government officials, who may be more powerful than the researchers.
- 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 particularly useful or rich sources of information for furthering one’s understanding of phenomena of interest, and not because the results may prove statistically significant. Participants are selected for their potential to inform theory development, and often selection of participants is guided by emerging patterns over the course of the data collection.
A researcher may rely on multiple sources of information and data gathering strategies to enhance data quality. Researchers use a variety of methods for data gathering, including interviews, participant observation, focus groups and other techniques. In some cases, gathering of trustworthy data is best achieved by closeness and extended contact with participants. In other cases, researchers and participants may continue research exchanges through electronic or other means, after collection of data in the field. Qualitative studies of textual and image-based materials, such as published books, websites, interview transcripts, photographic images or video, use a variety of content analysis techniques.
Appropriate treatments of data after they are gathered may vary greatly (see Article 10.5 and also Article 5.3). At the time of the initial consent discussion, researchers inform prospective participants about the confidentiality of the data and discuss the expectations of participants (see Articles 3.2 and 5.2).
- 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.
- Dynamic, Negotiated and Ongoing Consent Process: Entry into a particular setting for research purposes sometimes requires negotiation with the population of interest; sometimes the researcher cannot ascertain the process in advance of the research, in part because the relevant contexts within which the research occurs evolve over time.
In some cases, participants hold equal or greater power in the researcher-participant relationship, such as 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 (e.g., 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).
- Research Partnerships: Access to particular settings and populations is sometimes 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, advance 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 to the collection of dependable data. Research often becomes a collaborative process negotiated between the participant(s) and the researcher, requiring considerable time spent initially simply figuring out the focus of the research.
In certain 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.
- Research Results: Generalizability of the results to other contexts and the representativeness of the sample may or may not be a concern in qualitative research. Transferability of results from one setting to another is often viewed as more of a theoretical issue than a procedural or a sampling issue.
B. Research Ethics Review of Qualitative Research
This section provides guidance on issues particularly germane to REB review of research employing qualitative methods. Qualitative research is also subject to the general guidelines that are applicable to research involving humans. The requirement for consent and the protection of privacy and confidentiality do not change with the nature of the research.
Qualitative research may pose special 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. Others will arise during the research itself, which will require the exercise of discretion, sound judgment and flexibility commensurate with the level of risk and potential benefit arising from the research, and considering the welfare of the participants, individually or collectively.
Timing of the REB Review
Researchers shall submit their research proposals, including proposals for pilot studies, for REB review and approval of its ethical acceptability prior to the start of recruitment of participants, or access to data. Subject to the exceptions in Article 10.5, REB review is not required for the initial exploratory phase (often involving contact with individuals or communities) intended to discuss the feasibility of the research, establish research partnerships, or the design of a research proposal (see Article 6.11).
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, diary writing and observation long before the researcher formalizes a research project. These types of preliminary activities are not subject to REB review (see Article 6.11). However, if researchers later wish to use material from this phase, they shall say so in their research proposal, and include any plan to seek consent from those interviewed in the exploratory phase to use their remarks.
Researchers need to have the opportunity to engage in preliminary visits and dialogue to explore possible research relationships, and to define research collaborations with particular settings or communities. Activities may include, but are not limited to, determining research questions, methods, targeted sample and sample size, and addressing community-based concerns in the project design and data collection. 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 the REB informally 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) usually follow a process of prior dialogue, exchanges and negotiation of the research, which precedes the formal data collection involving participants. In community-based collaborative research, it may be desirable to engage the community before seeking REB review. For instance, in research in Aboriginal communities, it may be desirable to obtain permission to proceed from community leaders, Elders or representatives (see Chapter 9). Similarly, when designing community-based research involving individuals whose legal status is compromised, it may be desirable to consult with social service providers serving that population.
Modalities of Expression of Consent
Researchers shall explain in their research design the proposed procedures for seeking consent and the strategies they plan to use for documenting consent.
As part of its research ethics review, REBs should consider the range of strategies for documenting the consent process that may be used by researchers using qualitative research approaches (see Article 3.12). Under a variety of circumstances, signed written consent is not appropriate in qualitative research. However, where there are valid reasons for not recording consent through a signed written consent form, the procedures used to seek and confirm consent must be documented.
The consent process should be based on mutual understanding of the project goals and objectives between the participants and the researcher. The participant may perceive attempts to legalize or formalize the process as a violation of that trust. Qualitative researchers use a range of procedures to seek and document consent, including oral consent documented in field notes, and other forms of recording (a consent log, audio or video recordings, or other electronic means) Evidence of consent may also be documented via completed 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 participants, and whether a waiver of the requirement for signed written consent may affect the welfare of the participants. In cases where the participant holds a position of power, or routinely engages in communicative interactions similar to those involved in the research by virtue of their position or profession (e.g., a communications officer or spokesperson for an organization), consent can be inferred by the participant’s agreeing to interact with the researcher for the purpose of the research. For example, some political science research focuses on power structures and individuals in positions of power (e.g., a senior partner in a law firm, a cabinet minister or a senior corporate officer). In this type of research, where a prospective participant agrees to be interviewed on the basis of sufficient information provided by the researcher, it may be sufficient for the participant to signify consent to participate in the research. The researcher should record this in an appropriate way. Researchers shall demonstrate to the REB that the participant will be informed about the research including the option not to participate, or to withdraw from the study at any time. Nothing in this article should be interpreted to mean that prospective participants need not be informed about the study prior to their participation.
Researchers and REBs should consult Chapter 3, and Articles 3.1, 3.2, 3.3 and 3.12 in particular, for additional details and considerations on consent, and how to document consent.
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. Observational studies may be undertaken in publicly accessible spaces (e.g., a stadium, library, museum, planetarium, beach, park), in virtual settings (e.g., Internet chat rooms), or in private or controlled spaces (e.g., private clubs or organizations).
Observational research is of two kinds: “non-participant” where the researcher observes, but is not a participant in, the action (also known as “naturalistic observation”); and “participant” where the researcher engages in, and observes, the action.
Participant observation is often 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 consent from individuals in that setting; in others, researchers will engage in covert non-participant or participant observation and not seek consent.
A matter that is publicly accessible may, nevertheless, be considered private in a prospective participant’s culture. There may be a reasonable expectation of privacy by some groups, or for some activities. For example, individuals involved in religious services or practices, or chat rooms on the Internet, may assume that participants and observers will accord the proceedings some degree of privacy. Observing sacred ceremonies without approval from the appropriate individuals or groups (e.g., Elders or traditional knowledge holders in Aboriginal research) and without engaging them about the subsequent use or interpretation of the data may have unintended negative implications (see Articles 9.5, 9.6 and 9.8). Considerations of the nature of the research, its aims and its potential to invade sensitive interests may help researchers improve the design and conduct of such research.
Observational studies in public places where there is no expectation of privacy are exempt from REB review (see Article 2.3).
In research involving observation in natural environments or virtual settings where people have a reasonable or limited expectation of privacy, the researcher shall explain the need for an exception to the general requirement for consent. The REB may approve research without requiring that the researcher obtain consent from individuals being observed on the basis of the justification provided by the researcher and appropriate privacy protection.
Observational studies raise concerns for the privacy of those being observed. In observational research, breaches of privacy may arise from identification of individuals, groups or communities in the publication or dissemination of research results.
Observational research that does not allow for the identification of the participants in the dissemination of results, that is not staged by the researcher, and is non-intrusive should normally be regarded as being of minimal risk.
REBs and researchers need to consider the methodological requirements of the proposed research project and the ethical implications associated with observational approaches, such as the possible infringement of privacy. 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 prospective 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. REBs shall ensure that the proposal contains measures to protect the privacy of the individual in accordance with the law.
Researchers and REBs should consult Chapters 3 and 5 for additional details and considerations regarding consent, and privacy and confidentiality.
For observational research in which consent is not sought, researchers shall demonstrate to the REB that necessary precautions and measures have been taken to address privacy and confidentiality issues.
Because the 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 for research purposes. Typically the researcher has no direct interaction with the individuals being observed and therefore their consent is not sought. Covert observation of queuing behaviours in shopping malls is one example of a study where the research could not be completed if shoppers knew that they were being observed. Some forms of qualitative research seek to observe and study criminal behaviours, violent groups, or groups with restricted membership or access using covert participant observation. 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. Other observational studies may be anonymous but involve intervention by the researcher (e.g., studying the propensity of bystanders to help in an emergency normally requires a staged emergency). These methodological approaches may require the researcher seeking an exception to the requirement to seek prior consent.
Where no personal information is collected, consent is not required. Where personal information will be collected, researchers must explain whether the need for such covert research justifies an exception to the requirement to seek prior consent, and REBs should exercise their judgment taking into consideration the methodological requirements (see Article 3.7A). Researchers and REBs shall take the necessary steps to ensure that the privacy of the individual is protected in accordance with the law in the absence of consent. Where no consent is sought, researchers and REBs may also consider whether debriefing is possible, practicable and appropriate (see Article 3.7B). Chapter 5 on privacy and confidentiality provides additional information.
Researchers and REBs shall take the necessary steps to ensure that the privacy of the individual is protected in accordance with the law in the absence of consent. Where no consent is sought, researchers and REBs may also consider whether debriefing is possible or necessary. Chapter 5 on privacy and confidentiality provides additional information.
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.
Privacy and Confidentiality in the Dissemination of Research Results
In some research contexts, the researcher may plan to disclose the identity of participants. In such projects, researchers shall discuss with prospective participants or participants whether they wish to have their identity disclosed in publications or other means of dissemination. Where participants consent to have their identity disclosed, researchers shall record each participant’s consent.
In some types of qualitative research (e.g., oral history, a biographical study or a study involving specific personalities) 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.For instance, in an interview study with visual artists concerning some aspect of the way they work, it might be appropriate and respectful to identify the respondents. If failing to identify participants would be unethical because of any disrespect it would represent, or if informed participants assert their desire to be named, then researchers should do so, according to the practices of their discipline. For example, social historians seek to document and archive the lives of individuals, or highlight the contributions that ordinary people make in social and political life. In oral history, anonymity is the exception. Researchers make the option for anonymity known to participants as part of the discussion around the nature and conditions of their consent.
In some types of critical inquiry, anonymity would result in individuals in positions of power not being held accountable for their actions, and for how their exercise of power has implications for others. The safeguards for those in the public arena are through public debate and discourse, and through action in the courts for libel.
In much other social science and some humanities research, it is primarily the harm that can result from violations of confidentiality that REBs and researchers need to address.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 maintain confidentiality of the research data. In some instances, participants may waive anonymity (e.g., if they wish to be identified for their contributions to the research). The researcher may accept the waiver of anonymity by the participant as long as such a waiver does not compromise the welfare of other participants (see Article 3.2(f) and the Application of Article 5.1). In some cases, the researcher may decide to maintain the anonymity of the participant in publications or dissemination of research results to ensure confidentiality of the data and anonymity of other participants.
REBs need to be sensitive to whether anonymity, confidentiality or identification is relevant in any given research context, and acknowledge that individuals may want to be credited for their contribution by being named.
Researchers and REBs should consult Chapter 3 and 5 for additional details and considerations (see also Chapter 9).
Qualitative Research Involving Emergent Design
In qualitative research, emergent design involves data collection and analysis that can evolve over the course of a research project in response to what is learned in earlier parts of the study. Specific questions or other elements of data collection may be difficult to anticipate, identify and articulate fully in the research proposal in advance of the project’s implementation.
In studies using emergent design in data collection, researchers shall provide the REB with all the available information to assist in the review and approval of the general procedure for data collection.
Researchers shall consult with the REB when, during the conduct of the research, changes to the data collection procedures may present ethical implications and associated risks to the participants.
Although initial research questions may be outlined in the formalized research proposal, REBs should be aware that it is quite common for specific questions (as well as shifts in data sources or discovery 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.
Researchers using emergent design shall provide the REB with all the available information to allow for a proportionate approach to research ethics review of the research project. In cases where final versions of a questionnaire or interview schedule have not been developed at the time of the ethics review of the research project, researchers should submit a draft set of sample questions, thematic categories or other outlines of the procedures to be followed in data collection. Final versions should be submitted as soon as they become available. 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 methodological requirements, and acknowledge that questionnaires or interview guides may change to adapt to emerging data or circumstances in the field.
In emergent design, 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. Consistent with Article 6.15, where changes of data collection procedures would represent a change in the level of the risk that may affect the welfare of the participants, researchers shall seek approval from the REB prior to implementing such changes. Additional REB review and approval may be required (see Chapter 2 and Articles 6.14 and 6.15).
- Canadian Institutes for Health Research. CIHR Best Practices for Protecting Privacy in Health Research. September 2005.
- Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada, Access to Research Results: Guiding Principles.
- 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.
- National Health and Medical Research Council (Australia), Australian Research Council and Australian Vice-Chancellors’ Committee. National Statement on Ethical Conduct in Human Research. 2007.
- Social Sciences and Humanities Research Council of Canada. SSHRC Research Data Archiving Policy.
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