• IRB: ETHICS & HUMAN RESEARCH

Ethical Review of Interpretive Research: Problems and Solutions

 Since prior review and approval of human subject research became standard some thirty years ago, social scientists have voiced concern about the ways in which the rules and regulations that structure ethics review may affect their research practices.1 The last few years have seen a proliferation of reports, articles, and books describing and analyzing the situation.2 In particular, investigators using interpretive methodologies (e.g., ethnography, grounded theory) and qualitative methods have documented the difficulties they encounter when submitting proposals to research ethics committees that are unfamiliar with such approaches. They argue that the structure and process of ethics review penalizes interpretive research because it is based on assumptions relevant to biomedical research, and thus that it may have a chilling effect on scholarship.
Much of this discussion has been directed at other interpretive social scientists—a readership likely to be highly sympathetic, but one that may not be in a position to alter the structure and process of ethics review. With this article we hope to engage a new audience—one with a greater ability to effect change. Our focus is on interpretive research using qualitative methods, but many of the tensions we describe also apply to other forms of “emergent” inquiry3 —research in which study design and process are shaped by an iterative interplay among research questions, data collection, and analysis. We begin by locating the genesis of the problem in issues of epistemology and power. We then draw upon the extant literature to provide an overview of how these issues, as well as the structure of ethics review regimes, have been reported to affect the process and impact of review for interpretive research. Finally, we summarize several solutions that have been proposed in the literature and make a proposal of our own.

Because the stakes are so high for academic investigators, published reports of problems with ethics review have, at times, tended to be quite heated. In some cases, frustrations have been so great that scholars have raised questions and made claims about threats to academic freedom,4 and others have decried some ethics review practices as “one more inane bureaucratic requirement in one more bureaucratic set of procedures, ill-suited to accomplish the goals that [they are] intended to serve.”5 While we do not discount the possibility of violations of academic freedom in specific cases, our assumption is that academic freedom does not confer a “right to do research”6 that can be threatened by the very existence of ethics review. We do believe, however, that much of the current structure and process of ethics review is misdirected when it comes to interpretive inquiry and thus fails to offer meaningful protection to participating individuals and groups.

Knowledge and Power in the Research Process

The regulations and guidelines that structure the ethical review of research in North America—theBelmont Report 7 and the Common Rule8 in the United States and theTri-Council Policy Statement (TCPS)9 in Canada—provide direction for researchers and for the entities charged with oversight of research performed in academic institutions. In general, these documents emphasize the vulnerabilities of human subjects and the need to balance the benefits of knowledge generation against the risks of harm. Despite their claims to universal applicability, extant review policies and practices make many assumptions about the process of knowledge generation and the nature of vulnerability. As many authors have argued, these regimes reflect the epistemological tenets of a positivist, often biomedical, paradigm10 and are premised upon a rigid notion of unequal power.11

In the positivist research paradigm, investigators operate from a certain set of ontological, epistemological, and methodological propositions:12 that an independent reality or truth exists and that it may be known; that the researcher and the subject are separate entities whose interaction must be strictly controlled in order to avoid contamination or bias; and that science proceeds through a logicodeductive process of hypothesis testing involving the operationalization, manipulation, and analysis of variables. Rigor is conferred through adherence to standardized procedures designed to ensure reliability and validity. By contrast, in an interpretive research paradigm, reality is understood to be socially situated and the investigator and the participant to be engaged in a mutual process of constituting knowledge.13 Investigations are flexible and iterative, aiming to produce either rich description or theory. Although vigorously contested, criteria for judging the quality of interpretive research include concepts like credibility, relevance, and complexity,14 which locate rigor not in fixed procedure, but in a defensible research strategy and a product that demonstrates depth and resonance.

Power has long been understood to be at the root of ethical peril in research.15 The violations that led contemporary ethics review to its current form—well-known atrocities like the human experiments performed by Nazi doctors or the Tuskegee study—featured powerless and profoundly marginalized individuals and groups in contact with powerful and high status professionals. The power differential meant that research subjects had no real choice about participating and no means of finding out what would be done to them. These conditions led to horrific violations of their bodies and their dignity. Analogous power dynamics may exist in biomedical research, particularly in clinical research involving sick and desperate individuals and healthcare providers who mediate their access to needed resources.

However, while in most interpretive inquiry there may be social distance between investigators and participants, the participants are usually not in a position of dependence relative to the investigators. The interpretive research process is collaborative: researchers immerse themselves in participants’ worlds and seek to understand and “give voice” to their perspectives. Access depends on a relationship of reciprocity—one in which various forms of exchange draw investigators and participants over time toward equality.16 These characteristics give interpretive inquiry its own power dynamics and thus its own ethical conundrums. For example, interpretive researchers must think carefully about the promises they make to their participants, learn to recognize and manage the conflicts and inequities within the communities they study, and be sensitive to issues of interpretation and representation in the products of their work.17 Such issues are often the focus in disciplinary codes of ethics18 and in discussions of research ethics in texts devoted to qualitative methods.19

The Problems and Their Impact: A Review of the Literature

These disjunctions in foundational assumptions lead to problems in the review of interpretive research. Because ethics committees rely on descriptions of research design in order to evaluate proposed studies,20 positivism is privileged over other approaches. Investigators are asked to submit detailed proposals that include specific interview questions and sampling procedures. This level of detail and specificity is not usually known (or knowable) at the outset of an interpretive study. Rather, such choices are made as initial data are collected and analyzed. The requirement that research be fully planned in advance forces interpretive researchers to prejudge the focus, conduct, and results of their studies in ways that violate the principles of emergent inquiry.21 Even the terminology (e.g., “research subject,” “hypothesis”) used by most committees is incompatible with the tenets of interpretive research. Interpretive researchers find such language alienating and argue that imposing it on their project descriptions distorts their work.22
The conceptualization of harm developed for biomedical research is not a good fit with interpretive research.23 While the former focuses on adverse effects that may result from exposure to the procedure or technology being tested by the research, the nature of the research exposure in the latter—either being observed in the course of activities that would be taking place regardless of the study or talking about experiences, perceptions, and opinions—is unlikely to be harmful in and of itself.24 The potential for injury resides less in the research act and more in the issues of expectation, interpretation, and representation that we described earlier.

Ethics review procedures dictate that the likelihood, nature, and level of harm should be considered when evaluating research.25 Determining the likelihood of harm involved in the expectations engendered by research participation, or the humiliations that may follow publication of a controversial interpretation, is not a trivial task, and there has been little empirical work devoted to studying such harms in context.26 Thus, the actual harms linked to participating in interpretive research are often unknown.27 Under conditions of uncertainty, ethics review committees default to assuming the same high levels of risk of harm as in clinical or experimental research.28 Many authors have argued that this assumption is likely to exaggerate the potential for harm29 and discount the potential for benefit30 among participants in interpretive studies.

Unlike positivist research, where a detached investigator is the ideal, interpretive inquiry makes the researcher the research instrument. Thus, interpretive social scientists often use their “sociological imaginations,” drawing upon their own life experiences to describe and theorize their subjects of interest.31 Participatory action research, cooperative inquiry, and other types of community-engaged research are increasingly respected, and there is an extensive literature describing the benefits of clinicians, educators, and others studying their own institutions and reflecting on their own practices. In these studies, investigators hold multiple roles within the settings they wish to examine, allowing them to gain the access and credibility needed to pursue the study. However, this blurring of the researcher role appears unfamiliar and uncomfortable to many ethics committees. Researchers who have proposed studies amongst their peers or within their workplaces have encountered extensive challenges to obtaining ethical clearance. Similarly, researchers who have in the past used informal conversations and their own life experiences as material have been discouraged from continuing these practices by ethics committees who perceive them as forms of unauthorized data collection.32

The mandate for prospective, written consent also imposes procedures designed for positivist clinical or experimental research on interpretive investigations. Written consent might be appropriate in certain cases, but unworkable or inappropriate in others—such as when the investigator cannot inform participants about possible harms because the research is still evolving, or when the ritual of signing an informed consent document is either culturally foreign or politically objectionable to the participants.33 (Both of these problems are common to other types of research, as well—for example, drug trials in developing countries.) Investigators working in interpretive and other emergent inquiry paradigms have argued that consent should be viewed less as a contract and more as a relationship-based covenant. In these new models of “ethics as process,” consent involves a series of interactions between researchers and participants that promote the engagement of all parties in frank discussion of possible harm and benefit as the research unfolds.34

Interpretive researchers are troubled by the default assumption by many ethics committees that they extend promises of confidentiality to all participants. The Common Rule and the TCPS allow confidentiality to be the choice of the participant, but many ethics review committees in North America expect that the identities of all research participants will be held in confidence. In contrast, a number of interpretive research traditions specifically aim to recognize the perspectives of marginalized communities. For example, the Social Sciences and Humanities Research Ethics Special Working Committee has argued that “the rigid requirement that participants not be identified can reflect disrespect for the participant because of the manner in which it features the researcher’s voice instead of the participant’s.”35 In circumstances where individuals and groups have long been rendered voiceless and invisible, treating participants with dignity might include giving them the right to be identified and to have their contributions acknowledged. Also, in research that engages individuals and communities over long periods of time and results in “thick description” of settings or events, blanket promises of confidentiality are difficult or impossible to keep.36

Ethics committees’ decisions about risks of harm and benefit—and thus about which studies may be approved or disapproved—are tightly bound to epistemology. Committee members use positivist conceptions of “good science” to determine the likely contribution of proposed research to knowledge. When the likelihood of contribution is deemed high, committees are disposed to allow a higher level of risk; when studies are perceived to have little potential to contribute to knowledge, no risk is acceptable. Interpretive research is highly disadvantaged in this environment. Because it does not conform to the methodological tenets of “good” (positivist) science, it is often perceived by those operating from a positivist frame of reference to have a low potential for benefit. Therefore, committees are prepared to tolerate little or no risk of harm. Finally, as we have described, because so little is known about the risks of participating in interpretive research, those risks are assumed to be high.

Similarly, assumptions about power are built into ethics committees’ expectations. We see this most clearly in the tensions arising around the researcher’s role, written informed consent, and confidentiality. The model of research used by ethics committees assumes an all-powerful investigator and a vulnerable participant. In order to prevent that inequality from causing harm, committees expect to see safeguards like researcher detachment, written consent, and promises of confidentiality built into study design. In some circumstances, these safeguards may be relevant and useful in interpretive research. Their blanket imposition by ethics committees, however, risks forcing investigators either to compromise their relationships with participants and perhaps the quality of their research, or to put a certain gloss on their descriptions of what they are actually doing in order to gain ethics approval.

In addition to the problems caused by divergent epistemologies and assumptions about power, other difficulties identified in the literature are a consequence of what van den Hoonaard calls “the social organization of ethics review”37 (i.e., weaknesses with the structure and process of research ethics review as currently constituted in North America) and as such apply to all forms of inquiry, not only to interpretive research. For instance, commentators have complained that in many academic environments there is little or no transparency in the ethics review process.38 Researchers submit their proposals and several weeks or months later are notified about the committee’s decision and receive  comments about the committee’s concerns. While some committees invite (or require) researchers to appear before them, in other settings the opportunities for dialogue between researchers and the committee are limited or nonexistent. Many investigators report that their institutions have no official mechanism in place to appeal a research ethics committee’s decision.39 Perhaps in part because of this lack of transparency, commitee responses appear to be inconsistent and unpredictable. At a single institution, different committees and different members within each committee may apply different standards. Even within a single committee, one proposal may be approved with few concerns, while another similar proposal may raise a multitude of objections.40

Institutional ethics regimes have been criticized for lacking an evidence base to ground their decision-making policies and practices. As previously noted, several authors have observed that knowledge about the nature and extent of risk attached to many kinds of research is highly uncertain and that, under conditions of uncertainty, the default position of most ethics review committees is to assume a worst-case scenario and impose the most stringent restrictions.41 McDonald has argued that ethics review committees have few effective structures or procedures in place to let them know when their decisions have been correct and when they have been in error. Without such “virtuous learning loops,” committees continue to substitute cautious best guesses for evidence.42

The problems we have reviewed are seen to threaten researchers, research, and the process of ethical review itself. Investigators report experiencing long delays in getting projects started.43 For students, this might result in being unable to meet targets for graduation. For investigators with grant funding, this might cause deadlines for project completion to be missed. Such delays could affect eligibility for future grants, which in turn affects overall career advancement.

Current procedures, it has been argued, have resulted in ethics committees placing inappropriate constraints on the research questions that can be addressed within academic institutions.44 Supervisors might advise students to consider other research topics or approaches in order to ensure the feasibility of their studies. Faculty might begin avoiding certain methodologies or subjects that are likely to raise caution signs for committees. All researchers might avoid work with populations perceived to be particularly vulnerable or dangerous, thereby furthering their marginalization.

In much of the literature there is a sense that ethics review has been reduced to a formalized set of administrative rules or checklists that pits researchers against committees in an adversarial relationship.45 Some authors have argued that under current conditions research ethics committees are acting more to protect institutions from possible litigation than they are to protect research participants from harm.46 As well as being a violation of their mandate, such practices undercut the potential for ethics committees to serve as honest and open venues for careful consideration of the dilemmas faced by researchers. Researchers talk about ethics as something that they have to “get through,” rather than as a fundamental process of contemplating and addressing the particular harms and benefits associated with their proposed plans of study. Discussions about the ethical quandaries that many researchers encounter while working with participants are not occurring.47 Ethical issues that arise are avoided or even covered up for fear of the possible consequences to the researcher or the research program. Faced with what they perceive as insurmountable obstacles, a few researchers have publicly admitted to avoiding ethical review altogether.48

In summary, the burgeoning literature on the tensions between ethics review and interpretive research argues that epistemological and methodological disjunctions between ethics review and interpretive research—as well as more general problems with the current organization of ethics review regimes—have made it difficult and at times impossible to gain ethics approval for interpretive research. More importantly, despite this apparent stringency, by continuing to apply standards derived from positivist, biomedical models of research, ethics committees are not aiding interpretive researchers in the task of considering the real risks of their inquiries, and thus are losing an opportunity to provide better, more meaningful protection to research participants.49

A major limitation of the current scholarship on this issue—and thus one reflected in this paper—is that, with the notable exception of work by Fitzgerald,50 there has been little systematic research on the topic. Thus, while the published literature reflects the experiences of a wide range of researchers working across North America (and beyond), it is not clear how common the problems are nor what the generalized patterns of causality might be. For example, while some problems are clearly embedded in the inappropriate application of positivist assumptions to interpretive work, others may be the result of policies instituted by individual ethics review committees.

We do not wish to suggest, nor does the literature imply, that ethics committees and their members are intentionally acting to make life difficult for interpretive researchers or to limit the advancement of knowledge. Rather, it is important to acknowledge that committees are being called upon to evaluate increasing numbers of protocols that reflect a wide range of research approaches. They hold a profound responsibility to protect potential research participants, but many committees lack adequate resources and expertise;51 members may be overwhelmed by demands to respond to the diverse and often conflicting needs of researchers, potential research participants, and their own institutions.

Solutions

Proposals to ameliorate the conceptual and practical difficulties identified in the literature seem to be coalescing around three general approaches that are not mutually exclusive: “playing the system,” “changing or adapting the system,” and “replacing the system.”52

Playing the System. This refers to those solutions that seek to ease the passage of research through the ethics process by using education and participation to build more common ground between interpretive researchers and ethics committees.53 Advocates for educational intervention emphasize the need for investigators and committee members to understand each other’s assumptions and practices: interpretive investigators must educate research ethics committees about the implications of their research paradigm, and research ethics committees must make researchers aware of the policies that structure their deliberations and decisions. An example of this strategy might be the chapters devoted to qualitative methods in two recent textbooks for ethics review committees.54 The participation solution aims to increase the direct engagement of interpretive researchers in the ethics process. Researchers are encouraged to serve on their institutions’ ethics committees, and ethics committees are urged to draw upon the expertise of interpretive researchers in their deliberations—for example, by inviting them to be ad hoc reviewers for proposals the committee is unable to assess.55

Changing or Adapting the System. Individual scholars and working groups charged with examining the treatment of social science and emergent inquiry by ethics review regimes have made a number of recommendations for “changing or adapting” the structure and processes of the ethics review system,56 and anecdotal reports suggest that some ethics committees are adopting these innovative practices. Among these have been proposals to allow more frequent granting of exempt status to interpretive research; to revise the standardized forms used by ethics committees to make the language more inclusive of researchers working in alternative paradigms; to allow researchers to be present when their submissions are discussed; to increase the flexibility of requirements for prospective, written informed consent; and to enlist journals and peer reviewers in the task of monitoring the conduct of research after ethics review. A key structural recommendation has been to institute grievance and appeals boards for cases in which committees may be placing unreasonable restrictions upon scholarly work. The movement for “evidence-based” ethics review presents another strategy for change. An evidence-based system would support collection of empirical data directed at ascertaining the nature and likelihood of harm from participating in interpretive research, and then use these data to promote more informed and equitable decisions.57

Replacing the System. Finally, solutions directed at “replacing the system” seek to devise separate structures and processes for the review of emergent inquiry.58 Proponents of this approach, which was first broached as much as thirty years ago,59 call for an examination of the range of existing alternatives—such as the use of separate medical and social science ethics review committees within institutions,60 or the U.K. practice of committees devoted solely to the review of nursing research61 —to gather ideas for the kinds of innovative structures or processes that might work most effectively and efficiently both to review proposals and to protect research participants.

Our suggestion for amelioration builds upon and brings together all three approaches. We propose a two-stage/two-body process of ethics review for interpretive research and other forms of emergent inquiry. In the first stage, a basic narrative description of the proposed project would be submitted to a traditional research ethics committee using the existing procedure for expedited review. This narrative, which might be structured by broad questions like those suggested in an article by Tolich and Fitzgerald,62 would outline the investigator’s general areas of theoretical or practical interest, briefly note the kinds of data collection and analysis methods likely to be used, supply information about the characteristics of the individuals and groups who might participate, and also report the investigator’s previous experience with this population or area of research. The overview would address the fulfillment of ethical requirements that were easily foreseen and accommodated (for example, the need for secure storage of data), but would not require a complete (and at this early stage, often fictional) account of all research procedures. Based on a review of this document, and in the absence of any striking—and evidence-based—concerns, the reviewer(s) would grant approval for the commencement of this research, with a conditional exemption from further oversight by the ethics committee. The conditions of this exemption would include: 1) an agreement on the part of the investigator to return to the committee should the focus or approach of the research change drastically or should a serious problem occur; and 2) the participation of the investigator in a peer group devoted to reflective (and reflexive) discussion and monitoring of ethical research practice.

This group would consist of interpretive researchers and investigators engaged in other forms of emergent inquiry, a representative of an institutional ethics review committee or an ethicist with a specialization in research ethics, and individuals with current or past experience as research participants. Additional participants could be invited on an ad hoc basis. Depending on demand (i.e., the number of active emergent inquiry researchers to be involved), it might be located at the departmental, school, or institutional level. The group would meet at least once a month—often enough for all participants to have a chance to discuss their research. Its ethical explorations would be guided by the codes of ethics applicable to participants’ various disciplines, as well as the relevant federal documents—in Canada, for example, by the TCPS. At each meeting, participants would examine individual investigators’ projects and discuss ethical questions common across projects. A researcher conducting ethnographic research in a clinical setting might report to the group about a developing shift in her research question. The group would question the researcher to examine the implications of this shift, seeking to understand if it would require new conversations about consent with workers in the setting, or if the shift was substantial enough to warrant an updated report to the ethics review committee. (Such decisions would emerge through a process of argument and consensus.) Another investigator might describe a recent experience in which her summary of study results at a community forum met with anger and accusations of betrayal from some community members. The group’s discussion of how this incident might have been averted or ameliorated would lead to a broader consideration of the tensions inherent in many researchers’ dual loyalties to knowledge and to the communities in which they work. Recognizing the importance of this issue, the group might arrange for a community development worker and an expert in the ethical practice of community-based research to facilitate further discussion at a future meeting.

This “two stage/two body” solution would address many—albeit not all—of the concerns that have been raised in the literature. In their interactions with the “first stage/first body” (the expedited submission to the traditional ethics review committee), interpretive researchers would no longer be disadvantaged by the requirement that they submit detailed research protocols in advance, nor would they be obliged to distort their scholarship by using forms designed for biomedical or positivist research to describe it. The transparency and consistency of the process would be improved because most of the substantive discussions related to the ethics of a particular project would take place within the peer group. Similarly, rather than just imposing blanket requirements on all research, the peer group would allow for project-specific considerations of matters like informed consent, confidentiality, researcher role, and the weighing of harm and benefit. As an ongoing entity, the peer group would institutionalize an “ethics as process” mindset—one emphasizing consideration of the ethical quandaries that cannot necessarily be foreseen at the initiation of a project.

The new approach would also address concerns that the real purpose of ethics review—the protection of human participants in research—is being lost. By developing “communities of practice” focused on ethical issues in the design and conduct of interpretive research, the “second stage/second body” would promote investigators’ engagement with relevant and grounded research dilemmas. The creation of a safe, collegial setting for discussing such dilemmas would moderate the increasingly adversarial environment surrounding ethics review, making it more likely that investigators would seek counsel for troubling situations. Such peer groups would serve as natural sites for educating new generations of researchers and could be marshaled as sources for gathering initial data about the nature and frequency of harm in interpretive research projects. Most importantly, by providing a forum for making ethics review—the “complex and context-specific moral reflection”63 envisioned by the TCPS—more meaningful, this new structure and process would provide better protection for research participants.

Acknowledgments

The authors wish to acknowledge the members of the Qualitative Research Group at the Centre for Addiction and Mental Health for their contributions to the discussions that led to the writing of this paper and the two anonymous reviewers whose thorough and thoughtful comments improved it.

Nora Jacobson, PhD, is Scientist, Health Systems Research and Consulting Unit, Centre for Addiction and Mental Health, and Assistant Professor, Department of Psychiatry, University of Toronto, Toronto, ON, Canada;Rebecca Gewurtz, MSc, OT Reg. (Ont.), is a PhD student in the Graduate Department of Rehabilitation Science, University of Toronto, Toronto, ON, Canada, and an Assistant Professor in the School of Rehabilitation Science, McMaster University, Hamilton, ON, Canada; andEmma Haydon, MSc, is a Research Coordinator at the Centre for Research on Inner City Health, St. Michael’s Hospital, Toronto, and a JD student in the Faculty of Law at the University of Toronto, Toronto, ON, Canada.

References

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18. See, for example, American Anthropological Association.Code of Ethics of the American Anthropological Association. June 1998.www.aaanet.org/committees/ethics/ethicscode.pdf; Association of Social Anthropologists of the U.K. and the Commonwealth.Ethical Guidelines for Good Research Practice.http://www.theasa.org/ethics/ethics_guidelines.htm; International Sociological Association.Code of Ethics. 2001.http://www.ucm.es/info/isa/about/isa_code_of_ethics.htm.

19. For example, Patton MQ.Qualitative Research and Evaluation Methods, 3rd ed. Thousand Oaks, CA: Sage Publications, 2002; Denzin NK, Lincoln YS, eds.The Sage Handbook of Qualitative Research, 3rd ed. Thousand Oaks, CA: Sage Publications, 2005.

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21. See ref. 2, Haggerty 2004; See ref. 11, Adler and Adler 2002.

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23. See ref. 2, Lincoln and Tierney 2004; See ref. 1, AAUP 2000; See ref. 2, SSHRESWC 2004; See ref. 2, Haggerty 2004; See ref. 2, Bosk and De Vries 2004.

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25. See ref. 9, TCPS.

26. See ref. 1, AAUP 2000; See ref. 6, Oakes 2002; See ref. 24, Corbin and Morse 2004.

27. See ref. 2, Haggerty 2004; See ref. 11, Milne 2005.

28. See ref. 2, Lincoln and Tierney 2004; See ref. 24, Corbin and Morse 2004.

29. See ref. 2, Haggerty 2004.

30. See ref. 1, AAUP 2000; See ref. 24, Corbin and Morse 2004.

31. See ref. 11, Adler and Adler 2002.

32. See ref. 2, Lincoln and Tierney 2004; See ref. 11, Adler and Adler 2002.

33. See ref. 2, SSHRESWC 2004; See ref. 2, Haggerty 2004; van den Hoonaard WC. Ethical norming and qualitative research. In: van den Hoonaard WC, ed.Walking the Tightrope: Ethical Issues for Qualitative Researchers. Toronto, ON, Canada: University of Toronto Press , 2002, p. 3-16.

34. See ref. 2, SSHRESWC 2004; See ref. 20, Ramcharan and Cutcliffe 2001; Munhall PL. Institutional review of qualitative research proposals: A task of no small consequence. In: Morse JM, ed.Qualitative Nursing Research: A Contemporary Dialogue. Newbury Park, CA: Sage Publications; 1991, p. 258-271.

35. See ref. 2, SSHRESWC 2004, p. 30.

36. See ref. 2, SSHRESWC 2004; Tolich M. Internal confidentiality: When confidentiality assurances fail relational informants.Qualitative Sociology2004;27(1):101-106.

37. See ref. 33, van den Hoonaard 2002, p. 5.

38. See ref. 2, Haggerty 2004.

39. See ref. 1, AAUP 2000; See ref. 2, Haggerty 2004.

40. See ref. 2, Lincoln and Tierney 2004; See ref. 24, Corbin and Morse 2004.

41. See ref. 1, AAUP 2000; See ref. 6, Oakes 2002; See ref. 2, Haggerty 2004; See ref. 11, Milne 2005.

42. MacDonald M. Canadian governance of health research involving human subjects: Is anyone minding the store?Health Law Journal2001;9:1-21.

43. See ref. 2, Lincoln and Tierney 2004; see ref. 2, Bosk and De Vries 2004; see ref. 22, Pearce 2002.

44. See ref. 1, AAUP 2000; see ref. 2, Lincoln and Tierney 2004; see ref. 11, Adler and Adler, 2002; see ref. 2, Haggerty 2004.

45. Greenhalgh T. The new ethics.BMJ2004;13(328):651; See ref. 2, Haggerty 2004; Edwards R, Mauthner M. Ethics and feminist research: Theory and practice. In: Mauthner M, Birch M, Jessop J, Miller T, eds.Ethics in Qualitative Research. London, U.K.: Sage Publications; 2002.

46. See ref. 2, Lincoln and Tierney 2004; see ref. 2, Haggerty 2004; see ref. 24, Corbin and Morse 2004.

47. See ref. 2, Bosk and De Vries 2004.

48. See ref. 4, Shea 2000.

49. See ref. 2, Bosk and De Vries 2004; see ref. 45, Edwards and Mauthner 2002.

50. Fitzgerald’s work can be accessed athttp://www.ethicsproject.com.

51. See ref. 42, MacDonald 2001.

52. See ref. 20, Ramcharan and Cutcliffe 2001, p. 362.

53. See ref. 1, AAUP 2000; see ref. 2, Lincoln and Tierney 2004; see ref. 6, Oakes 2002; see ref. 2, Bosk and De Vries 2004.

54. See ref. 17, Cribb 2003; see ref. 24, Gallant and Bliss 2006; Parrott ES. Ethnographic research . In: Bankert EA, Amdur RJ.Institutional Review Board: Management and Function, 2nd ed. Sudbury, MA: Jones and Bartlett Publishers, 2006. p. 402-409.

55. See ref. 22, Pearce 2002.

56. See ref. 2, Tolich and Fitzgerald 2006; see ref. 1, AAUP 2000; see ref. 2, SSHRESWC 2004; see ref. 6, Oakes 2002; see ref. 2, Bosk and De Vries 2004; see ref. 33, van den Hoonaard 2002.

57. See ref. 42, MacDonald 2001.

58. See ref. 2, Bosk and De Vries 2004; see ref. 33, van den Hoonaard 2002.

59. See ref. 1, Wax 1977.

60. Amdur RJ, Bankert EA. Social science versus biomedical institutional review boards. In: Bankert EA, Amdur RJ.Institutional Review Board: Management and Function, 2nd ed. Sudbury, MA: Jones and Bartlett Publishers, 2006, p.402-409.

61. Mitchell T, Fletcher I. Stating the case for nursing research ethics committees: A discussion paper.Nurse Education Today1998;18:133-137.

62. Tolich and Fitzgerald suggest that ethics review of interpretive research be structured by the following four questions: What is the research project about? What ethical issues does the researcher believe are raised by this project? How does the researcher plan to address these ethical problems? What contingencies are in place if the research project changes its focus after the research has been approved and has begun? See ref. 2, Tolich and Fitzgerald 2006.

63. See ref. 9, TCPS, p. i.9.

Nora Jacobson, Rebecca Gewurtz, and Emma Haydon, “Ethical Review of Interpretive Research: Problems and Solutions,”IRB: Ethics & Human Research29, no. 5 (2007): 1-8.