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Revised Draft 2nd Edition of the TCPS (December 2009)

Chapter 10


Researchers in social sciences and humanities – such as anthropology, 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 quantitative research approaches. Many of the research practices and methodological requirements that characterize qualitative research approaches parallel those that characterize quantitative approaches – concerns regarding research quality, for example – but, as is the case with all research involving human participants, the criteria are adapted to the particular 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.

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.    The Nature of Qualitative Research

Qualitative research reflects an 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 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 of the general approach as well as methodological requirements and practices of qualitative research.

General Approach 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 theoretical approaches, questions that guide the research, methodologies, epistemological approaches 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 during the course of the research itself of questions, concepts, strategies, theories and ways to gather and engage with the data(e.g. in emergent design research, see Article 10.6) requires a constant reflective approach and questioning from the researcher. Such flexibility, reflexivity and responsiveness contribute to the overall strength and rigour of data collection and analysis.

(d)  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 – 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 particularly useful or rich sources of information for furthering one’s understanding of phenomena of interest, not because the results may prove statistically significant.

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 comes best from closeness and extended contact with research 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 potential research participants about the confidentiality of the data and discuss the expectations of research participants (See Chapters 2, 5 and 9).

(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 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, research 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).

(h)  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 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 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.

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

B.    Research Ethics Review of Qualitative Research

This section provides guidance on implications particularly germane to 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 potential benefit arising from the research, and the welfare of the participants individually or collectively.

Timing of the REB Review

Article 10.1 Researchers shall submit their research project for REB review and approval of its ethical acceptability prior to the start of recruitment of research participants or access to data. Subject to the exception in Article 10.6, REB review is not required for the initial exploratory phases involving contact with individuals or communities intended to establish research partnerships or the design of a research study. (See Article 6.11).

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, diary writing, and observation made long before the researcher formalizes a research project. These types of preliminary activities are not subject to REB review. (See Article 6.11).

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 involving Aboriginal populations (see Chapter 9) 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.

Modalities of Expression of Consent

Article 10.2 Researchers shall explain in their research design the consent procedures and strategies they plan to use for documenting consent.

Application  REBs should consider the range of strategies for documenting the consent process that may be used by researchers using qualitative research approaches. Under a variety of circumstances, written consent is not required in qualitative research. However, where there are valid reasons for not recording consent in writing, the procedures used to seek consent must be documented.

The consent process should reflect trust between the research participants and the researcher. Often this is based on mutual understanding of the project’s goals and objectives. The research participant may sense attempts to legalize or formalize the process as a violation of that trust. 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 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 research participants and whether a waiver of the requirement for signed written consent may affect the welfare of the 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 (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 persons 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 potential participant agrees to be interviewed on the basis of sufficient information provided by the researcher, it may be sufficient to signify consent to participate in the research. Researchers should demonstrate to the REB that the participant will be informed about the option not to participate or to withdraw from the study at any time. Nothing in this article should be interpreted to mean that potential participants need not to be informed about the study prior to their participation in the study.

Researchers and REBs should consult Chapter 3 and Article 3.12 in particular for additional details and considerations on consent.

Proportionate Approach to Review of Observational Studies

Article 10.3  Research ethics review is required for research involving observation in places where personal information is being collected. When considering research involving observation in such environments or settings where the researcher collects personal information and where individuals or groups have a reasonable presumption of privacy, REBs 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 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 should focus on projects above the threshold of minimal risk, or they should modulate requirements for protection proportionate to the magnitude and probability of harms, including the likelihood that published reports may identify individuals or groups.

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 participant observation. Researchers should demonstrate to the REB how they will address ethics issues derived from the specific methodological approaches in these types of research.

Observational studies raise concerns for the privacy of those being observed. In this regard, the nature of the research, its aims and its potential to invade sensitive interests may help researchers better design and conduct research. A matter that is public in the researcher’s culture may be private in a prospective participant’s culture. For example, 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 9.6 and 9.8). REBs and researchers need to consider methodological requirements of the proposed research project and the ethical implications associated with observational approaches, such as the possible infringement of consent or 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 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.

Waiver of Consent

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 conse Covert observation of queuing behaviours in shopping malls, which does not involve any audio or video recording that may allow identification of particular individuals 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). Researchers should justify whether the need for such covert research justifies an exception to the general requirement for consent, and REBs should exercise their judgment taking into consideration the methodological requirements (See Article 3.7). Researchers and REBs may also consider whether debriefing is possible or necessary.

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.

Researchers and REBs should consult Chapter 3 and Chapter 5 for additional details and considerations.

Observational Studies Exempt from REB Review

Article 10.4 REB review is not required for research involving the observation of people in public places where:

(a) it does not involve any intervention staged by the researcher or direct interaction with the individuals or groups;

(b) it does not involve collecting personal information that will be disseminated through photographic, film or video footage in the research results; and

(c) where individuals or groups targeted for observation have no reasonable expectation of privacy.

Application For the purpose of this Policy, data collection through observation of acts or behaviours occurring in public places intended to attract public attention are exempt from review by the REB. Research involving observation of people in public spaces where there is no presumption of privacy and where no personal 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) – does not require REB review, since it can be expected that participants are aware of the public nature of the event or gathering. Similarly, where individuals should reasonably expect that their identities will be evident – for instance, as a result of their celebrity or public persona – research that refers to their presence does not require REB review. To determine whether Article 10.4 applies, when designing their research researchers shall pay attention to whether dissemination of research results will allow the identification of individuals in published reports. When in doubt, researchers should consult the REB prior to the conduct of the research involving observation in public places.

Some activities carried on in public places may be intended to involve a particular community of interest and may be based on a limited presumption of privacy. 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 respect. Data collection for research purposes through observation of such acts or behaviours occurring in public places are subject to research ethics review and Article 10.3 of this Policy.

Where no personal information is collected, consent is not required. (See also Articles 2.2, 2.3 and Chapter 5).

Privacy and Confidentiality in the Dissemination of Research Results

Article 10.5 Researchers shall discuss with prospective participants whether their identity will be disclosed in publications or other means of disseminating research results, as appropriate to the research context. Researchers shall record the waiver of confidentiality by the participant.

Application In some types of qualitative research – oral history, a biographical study or a study involving specific personalities, for example – 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 the disrespect it would involve, 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 position of power not being held accountable for their actions and for how the exercise of power of some has implications for others. The safeguard for those in the public arena is through public debate and discourse, and in extremis, 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 research confidentiality that pose risks which the REB 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. Where confidentiality is preferred or where there is no compelling reason to the contrary, confidentiality would be maintained in a manner commensurate with the expectations of the research participants and the project. In some cases, the researcher may decide to maintain anonymity of the research participant in publications or dissemination of research results to ensure confidentiality of data of other research participants.

REBs need to be sensitive to whether anonymity, confidentiality or identification is operative in any given research context, and acknowledge that individuals may want to be credited for their contribution.

Researchers and REBs should consult Chapter 5 for additional details and considerations. (See also Chapter 9).

Emergent Design

In qualitative research involving emergent design that 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 articulate fully in the research plan in advance of the project’s implementation.

Article 10.6 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 inform the REB in cases, where changes to the data collection procedures during the conduct of the research may present ethical implications and risks to the participants associated with the new proposed change.

Application 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 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 should provide the REB with all the available information to allow for a proportionate review of the study using emergent design. 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 methodological requirements and acknowledge that questionnaires or interview guide may change to adapt to emerging data or circumstances in the field.

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. Where changes of data collection procedures would represent a change in the level of the risk that may affect the welfare of the research participants, researchers should reflect on these changes and notify the REB. Additional REB review may be required. (See Chapter 2 and Articles 6.14 and 6.15).