Engaging the humanities? Research ethics in Canada. (Applied Research).

Introduction

In 1997, after four years of consultation with the Canadian academic community, Canada's three national research funding agencies--the Social Sciences and Humanities Research Council (SSHRC), the Medical Research Council, and the Natural Sciences and Engineering Research Council (NSERC)--issued the Tri-Council Policy Statement on Ethics in Human Research (TCPS). The councils required that Canadian universities and health research institutions implement the policy framework by autumn 1999 and apply it to all research funded by these three groups. In 2002, the three councils established the Inter-Agency Panel on Research Ethics (PRE) to continue monitoring this process.

This paper reports the results of a survey on the impact of the TCPS on humanities scholars in Canada and raises questions about research practices in the humanities and the role of Research Ethics Board (REBs) also known as Institutional Research Boards (IRBs). The importance of this study is its findings about the lack of awareness of the TCPS or resistance to the application of what is perceived as a biomedical, clinical model to research in the humanities, fine arts, and social sciences. This resistance to the ethical review of their research activities amongst humanists is not unique to Canada and serves as an alert to IRBs and sponsors with regard to compliance issues.

Standards for Ethical Conduct of Research In The Humanities

To 1997

In 1977, the Canada Council, the precursor to SSHRC, issued a report entitled Ethics: Report of the Consultative Group on Ethics. The Consultative Group was to advise "on the application of general ethics principles that should be observed by researchers in the humanities and social sciences," (p. iv) including the creation of "a common ethical code which institutions will be asked to apply." It also was to address the composition of institutional committees and procedures to be used by these committees. The Consultative Group (1977, p. 1) struggled to strike "a proper balance" between "respect for the rights and sensibilities of the individual or collectivity" and "society's need for advancement of knowledge." The Consultative Group was prescient in its recognition that

the economist, linguist, demographer, political scientist, and criminologist--even the historian, biographer, and archaeologist ... gather data through direct and indirect contact with people and can have an impact on their lives. It is not therefore the discipline that determines the presence or absence of ethical considerations, but whether or not the methodology employed results in the research having a direct impact on human beings. (p. 5)

The Consultative Group reinforced the principle that humanists must be alerted to the possibilities of ethical conflict in their work. This report became the basis for SSHRC's policy on ethics for research involving human participants until 1997.

1999 Tri-Council Policy Statement

The TCPS on Ethics for Research Involving Human Subjects had a lengthy gestation period. The Medical Research Council, reflecting on the internationalization of standards of biomedical and clinical research, recognized a need to revise its research ethics policies and, since underlying ethical principles are common to all disciplines, convinced SSHRC and NSERC of the reasonableness of a common policy. After a lengthy consultation (Canadian Psychological Association, 1996), the TCPS was approved by the councils' governing boards, administratively promulgated as a requirement for individuals and teams who received research funding from the councils, and implemented by institutions that managed the grants. Recipient institutions were required to have their policies compliant with the TCPS by the autumn of 1999. The TCPS secretariat reviewed these policies and advised the institutions whether they were in compliance or if modifications were required. By the autumn of 2000, most universities had complied.

SSHRC's Standing Committee on Ethics and Integrity (CEI) and REBs became aware of the uneven implementation of the TCPS. Two communities--humanities and fine arts faculty--were conspicuous by their absence in the submission of research protocols to institutional REBs. Members of these scholarly communities objected to the imposition of alien regulations on the conduct of their research. In the autumn of 2000, the CEI contracted the Humanities and Social Sciences Federation of Canada (HSSFC) to assess the impact of the TCPS on research in the humanities and fine arts. The HSSFC and SSHRC were concerned that these scholars might be unfamiliar with or not understand thoroughly the TCPS or use of the ethics review processes. There was apprehension that REBs were less familiar with the traditional research practices of humanists and might apply the TCPS guidelines to humanities research without fathoming which research activities from these disciplines should undergo expedited reviews or be exempt from ethics revi ew. The HSSFC consulted with the research community and REBs to define the boundaries and issues in humanities and fine arts disciplines: (a) as experienced by REBs, (b) as experienced by the researchers, and (c) as articulated by faculty, REBs, or others.

Methodology

The HSSFC established an expert panel to inform its consultation and to analyze the results of the survey. REB approval for the study protocol and instruments was obtained. Two questionnaires, each containing six items, were distributed either to chairs and members of REBs and other research administration staff, or to deans of humanities and fine arts, department chairs, faculty members, and presidents of the 35 scholarly associations representing disciplines in the humanities.

An introduction letter accompanying the questionnaire outlined the purpose of the study and stressed procedures in place for ensuring confidentiality of the data and anonymity of the respondents. The questionnaires were distributed by surface mail and via three electronic listservs (Canadian Association of University Research Administrators, National Council on Ethics in Human Research, and HSSFC). Over 300 unduplicated questionnaires were distributed. There was only one mailing without follow-tip and a two-week timeframe for response. Eighty-six (86) responses were received. Thirty universities (43% response) responded to the REB chairs' and research administrators' questionnaire while the questionnaire to deans, chairs, faculty members, and presidents of scholarly associations received responses from nearly 40 different institutions but a response rate of less than 20%. Although these response rates are low and there was under-representation from francophone universities in Quebec, they are representative of the opinions of the research community at the time of the survey.

Findings

Question 1: Institutional Guidelines or Policies for Humanities Research

This question asked whether REBs apply the TCPS uniformly to all research involving humans within an institution or whether the REBs had created guidelines and procedures that were specific to disciplinary groups.

The overwhelming impression of responses from REBs and research administrators was that the TCPS is the universal standard and that REBs apply the TCPS guidelines to all disciplines. At the time of the study, few institutions placed any qualifications on the application of the TCPS to humanities and fine arts disciplines or had specific guidelines that addressed issues related to research in these areas.

REB chairs and administrators reported that institutional policies and procedures were developed in consultation with faculties and departments. Yet nearly one-fifth of faculty respondents contradicted this claim. One individual noted that humanities scholars were involved in the development of institutional guidelines "more in protest." One administrator commented that while scholars in the humanities were solicited to participate in the research ethics committee, "there has been very little interest ... by the humanities ... in the work of the REB."

Some respondents identified difficulties with the administration of the TCPS, while others reported on efforts to ensure flexibility and to ensure that the administration of the policy acknowledged that much of the research performed in universities is not biomedical. The creation of departmental REBs, with central oversight, made the implementation flexible in "ways relevant to specific disciplines."

Question 2: Included and Excluded Research

The TCPS, Article 1.1 (c)(d) and Article 1.6 allow for REBs to exclude or provide expedited review of research protocols. The explanatory note on this article excludes research that "involves no interaction with the person who is the subject of public records." Article 1.1(c) states:

research about a living individual involved in the public arena, or about an artist, based exclusively on publicly available information, documents, records, works, performances, archival materials or third-party interviews, is not required to undergo ethics review. Such research only requires ethics review if the subject is approached directly for interviews or for access to private papers, and then only to ensure that such approaches are conducted according to professional protocols and to Article 2.3 of this policy. (p. 1.1)

REB chairs and administrators emphasized that the TCPS applied to all research involving human participants, without exception, but that researchers could communicate with the REB chair or research ethics administrator to determine whether a particular study required REB review. The experience of deans, chairs, and faculty members were more mixed. Most respondents reported that REB review was required for all research involving humans and were not aware of any exceptions.

Responses demonstrated that researchers normally submit applications to a REB before they learn whether a research study was exempt from review or if it qualified for expedited review Some institutions published guidelines that described what types of studies were eligible for an expedited review. The practice across the university system demonstrates flexibility and sensitivity to institutional culture. However, faculty members' responses revealed a lack of awareness of processes and a perception that the system was inflexible. Most faculty respondents were unaware of the process for expedited review while others indicated that they were able to consult with the REB chair or research administrators prior to submission of a protocol for approval. Some respondents adamantly maintained that their research did not require any form of ethics review.

REB responses demonstrated that expedited review of research is common and that the process facilitated the research of faculty and graduate students. At most universities, expedited review consisted of ethics review by the chair and/or up to two members of the REB. While chairs emphasized informal communications strategies, communication between faculty members and REBs is highly formal, with written responses from the REB, including identifying whether a protocol was deemed exempt or was given expedited review. The formality of communications reflects a concern for correct procedural practices, ensuring that both the REB and the research ethics administration, on the one hand, and the researcher, on the other, are fully cognizant of the issues involved and what modifications are required before a study is approved and may proceed.

Question 3: Problems of Application of the TCPS to Humanities and Fine Arts Research

Both REB chairs and faculty responses suggest that the TCPS has not had a significant impact on research in the humanities and fine arts. This implies a lack of interaction between the REBs and these researchers. Forty percent of REB chairs and administrators reported no or very little experience dealing with research protocols involving scholars in the humanities or fine arts. Alternatively, the responses may suggest that researchers in this area are blissfully unaware of the TCPS and its application to their research modalities, or are simply ignoring the TCPS and institutional policies.

Most deans, chairs, and faculty members responded "no", "not so far", or "did not know" to the question, "the application of the TCPS is troublesome or lacks clarity with respect to the kinds of humanities or fine arts research that require REB review and approval." One theme emerged from these responses--the problems are not limited to the humanities but are also found in social science research. One associate dean argued that the TCPS "should be revised to include a more refined and up-to-date discussion of the methods commonly used by humanists, fine arts scholars, as well as those used by social scientists."

Nearly one-third of REB chairs and administrators specified ways in which the TCPS could be made less ambiguous and more adaptable to humanities research. Respondents focused, however, on the lack of awareness of the TCPS among scholars in the humanities and fine arts and their resistance to the application of the TCPS. One respondent bluntly asserted that the TCPS is "completely inappropriate for research in the humanities and the arts." Another claimed that the origin of the TCPS was fundamental to its rejection by humanists. The point is, biomedical (clinical) research is viewed as the norm and practices in the humanities, fine arts, and social sciences are viewed as exceptions and as such must be justified.

Humanities and fine arts scholars expressed the fear that research ethics reviews "prevent or circumscribe perfectly legitimate scholarly criticism or inquiry." This fear underscored resistance to written informed consent as the gold standard and the need for detailed interview questions, which, in the view of some scholars, affected the relational dynamics between the researcher and interviewee or community. One scholar stated that in her research she interviewed scholars and artists without a set of preplanned questions because "we are having a conversation [that does] ... not follow a set pattern, nor should it, since each person we interview has a different perspective and history."

Many scholars focused on the qualitative and participatory nature of their research but rarely noted that these methodologies and the ethical issues arising therein have been addressed by other disciplinary traditions (AFS, 1988; OHA, 1992; IOH, 1997). Other problems identified included (a) no rationale for excluding public policy research; (b) biography projects involving third-party issues; (c) cultural issues related to research with seniors, First Nations Elders, and non-western cultures "where the use of a consent form to be signed would be culturally inappropriate"; (d) definition of naturalistic observation; and (e) the interpretation of undergraduate, course-based research and when it needs review.

Certain principles that are central to the TCPS need to be given greater thought in light of the different meaning and implications that they have in humanities and fine arts research. The principles identified are informed consent, minimal risk, vulnerable populations, confidentiality, and destruction of data, relationship between research and subject, and broader definition and conception of research.

Problems arise because of the ambiguous and sometimes contradictory wording of TCPS. Issues were related to methodological approaches representing areas of overlap between the humanities, fine arts, and social sciences. Research methodologies are not mentioned in the policy and their ethical implications are not discussed. The absence of articulated professional and ethical standards within many humanities disciplines was noted. The development and fostering of an ethical research culture within the discipline was recommended as a responsibility of academic or scholarly associations.

Question #4: Experience With the New Ethics Policy and Review Process

This question attempted to determine if there was any similarity between the experiences of humanities faculty members with the ethics review processes and the REB's assessment of the impact of the process on humanists.

Of the faculty members who responded to the component of this question designed to solicit a measure of impact, nearly 62% identified the impact of the TOPS on their research as minimal, yet were more likely to assess negatively the impact of the TCPS on their colleagues. However, the low number of faculty respondents to this question (<40%) does not allow for a conclusive statement. REB chairs and administrators were more likely to assess the impact of the TOPS on colleagues in the humanities and fine arts as minimal or moderate. The ambiguity of responses may reflect the REB experience that few protocols emerge from these fields so the impact was minimal.

The researchers also sought information on "special issues or problems faculty encountered with respect to the REB process ... and, from the perspective of the REB, what problems occurred most frequently when dealing with human research applications from the humanities or fine arts." Research faculty, deans, and chairs most frequently reported no problems whereas some faculty members claimed that the ethics review process slowed down or interfered with their research. REB chairs reported a limited understanding of ethics review principles among humanists. One argued that more experienced researchers were less likely to have difficulty with the research ethics review process. Several commented that, in practice, humanities and fine arts disciplines traditionally have not required nor recognized that the SSHRC standards prior to 1997 required ethics review, and the implementation of the TOPS created problems. One termed this culture clash: "faculty in these disciplines aren't accustomed to writing ethics propos als, to allowing time for review before a project start date, and to explaining their plans to other people on demand." For example, one questioned whether the TOPS now required choreographers "to have their dancers sign informed consent forms" prior to conducting research on new forms of dance. To overcome this cultural divide, one administrator encouraged researchers to identify aspects of their research "that may present ethical problems and discuss how they intended to deal with them."

Reflecting an underlying antagonism to the TOPS, some deans and faculty members responded with strongly worded views on the imposition of an alien research ethics regime on their scholarship and questioned the need for the TCPS. Arguing that the TOPS emerged from a biomedical model, these humanists were irritated that "harmful intentions were being imputed into innocuous projects." Others viewed the research ethics process as a bureaucratic hurdle that interfered with their research. One suggestion that humanists viewed the REB as "yet another policing institution" is particularly troublesome as it implies a high degree of cynicism and distrust.

A number of respondents argued cogently that the focus should not be on the disciplines but on the nature of the research. It is "the perception that discipline is the sole determinant of whether a proposal needs review, what is ethical, and how any review ought to proceed; rather it is the nature of the work that determines these things." One REB chair vigorously asserted that that "we should aim to ensure that ethical principles are observed in ways appropriate to the research concerned." Yet from the perspective of humanists, disciplinary concerns lie at the very heart of much of the debate over the TOPS.

Question 5: Improvements to the REB Review of Humanities and Fine Arts Research and Question 6: Ethics Education

Only 25% of REB chairs argued that there were issues inherent in the humanities and fine arts that required special consideration by REBs. Less than one-third of the deans, chairs, or faculty responded to this question, so we know more exploration is needed in this area. Of those who did respond, new research methodologies, or research with participants from cultures other than one's own, were identified as problematic issues. The responses demonstrate that humanists have a limited knowledge of the TOPS and are wary about its application to their research programs. While some REB chairs suggested that there were issues and practices about which humanities or fine arts faculty could benefit from some guidance, others reported confusion and resistance by faculty to the TCPS requirements for ethics review. This also suggests a need for better understanding of humanists' research methodologies and practices by REBs, the need for education, and the need to clarify the application of the TGPS to these disciplines.

Moreover, issues discussed earlier were reiterated including the problem of applying the TOPS to specific research methods and practices, such as oral history, public archival material written by persons still alive, cultural inappropriateness of written informed consent, confidentiality issues, and open-ended interviews. What of disciplinary practices where participatory, feminist, or action research methodologies were the norm-methodologies that are akin to and ever-more incorporated into research of humanists and creative artists? Respondents questioned how the TOPS applied to disciplines and methodologies that had both scholarly and professional components. Did professional standards of conduct apply or did the TOPS apply (TOPS, 1 .A, p. 1.2.)? For others, concerns that needed to be addressed focussed on the research and creative methodologies in the arts.

For those who suggested areas of guidance for humanist or fine arts colleagues, several identified issues previously cited (ambiguity of informed consent, individuals in the public arena, oral history, cultural issues/analyses). Additional issues identified were (a) "permission of subjects to release information obtained by interview or archival research," (b) copyright ownership of interview material, and (c) definitions of human subject and risk "must go beyond the physical."

The increased demands of ethical review and opposition to these demands were highlighted. Faculty resisted "increased paperwork when [they did] ... not see why their research now presents this additional demand"; the "theatrical tradition is in complete opposition to the philosophy behind the TOPS ...," and "due to such widespread resistance, it will continue to be a tricky matter to provide guidance and to heighten sensitivity in an effective manner." While some commented upon a lack of awareness of the TOPS and a "general confusion and ignorance about ethics issues," others openly urged the rewriting of the TCPS, and greater guidance for REBs and researchers from NCEHR on humanities and fine arts research issues. The creation of departmental- or faculty-based REBs helped to overcome the initial resistance to the implementation of the TCPS and ensured that it was a living document, adapted to the disciplinary needs of the researchers.

An underlying theme throughout this analysis is the necessity of educating REB members on the traditions and practices of humanists and conversely, educating humanists on the definition of research and the principles of research ethics reviews and the processes for protocol development and review. Nearly one half of the REB chairs and research administrators did not report any form of education or training activities at their institutions. None reported any information activity specific to the humanities and fine arts. Most researchers did not respond or were unaware of any educational or outreach activities. Of those who reported educational activities, most referenced programs offered through the offices of research administration or research ethics. Others noted that issues of research ethics were integrated into graduate courses such as workshops, seminars, and education on research ethics. Planned activities included interdisciplinary workshops to discuss methodological techniques and to share experience s, departmental workshops open to graduate students and faculty researchers, and greater consideration of other dimensions of ethics such as gender equity (that are not factored into the biomedical model), participatory and ethnographical concerns, other models of informed consent, and problems inherent in oral history, especially with native people and other non-Western cultures.

Summary and Conclusions

Canadian REBs are conscientiously executing their responsibilities to research participants, researchers, their institutions, and society to ensure that their procedures are both rigorous and efficient. REBs work hard to guarantee that review procedures are commensurate with risks inherent in specific research methodologies. Yet they have had little interaction with humanists and fine arts scholars. At those institutions where humanists and creative artists are engaged in the ethics review process, the institutional response has been to adapt policies and practices to become more inclusive as well as establishing faculty-based or departmental REBs. REBs noted the absence of protocols from the humanities and fine arts and the absence of humanists, other than philosophers and historians, on the REBs. Hence, the divide between the REBs and their understanding of humanists' research methodologies, practices, and concerns with the implementation of the TCPS, and humanists and their understanding of the policies, p ractices, and issues that confront REBs continues to grow.

There is much REBs could do to overcome the resistance of humanists to the ethical review of their research. REBs must engage in a program of basic information sharing and education with all disciplinary traditions, and among researchers employing the breadth of research methodologies. Scholarly associations too must take an active role in the educational process and assist in overcoming resistance to research reviews among humanists. Associations have the ability to represent the interests of scholars and the principles embedded in the TCPS to disciplinary colleagues. Multiple outreach strategies are essential to reduce resistance in many disciplines. These and other recommendations were made to the Social Sciences and Humanities Research Council of Canada. A follow-up study, focusing on the experience of REBs, was initiated in the autumn of 2002.

Although these initial findings are based on a small group of responders in Canada, this issue is of global importance. With the increasing demand for compliance, driven primarily by public scrutiny of biomedical research, humanities, and social science scholars will be affected and will be required to abide by ever-more stringent regulations. Recent consultations on behavioural research (National Bioethics Advisory Commission, 2001; Sieber, 2001) and the response from the American Association of University Professors (2000), I would argue, demonstrate that the issues identified in this Canadian study are common to those in American universities. As humanists adopt and adapt research methodologies that are common in the social sciences and as their research involves human subjects--e.g., interviews with living authors and dramatists, ethnographic histories of holocaust survivors and immigration since the 1960s, and the use of new technologies for conducting humanist research--garner the attention of instituti onal review boards and federal oversight agencies, the encounters with human ethics review processes will lead to conflict and resistance. It is important to understand the scholarly culture of the humanists and their perceptions that IRB demands might be alien and an infringement of academic freedom.

Hence the responsibility of IRBs to engage the entire academic community has become critical. Without such engagement, advances already made will be in jeopardy as these influential, articulate, and numerous faculty confront and challenge not only the codes of research ethics but efforts to implement new compliance and accountability systems.

References

American Association of University Professors. (2000). Protecting human beings: Institutional review boards and social science research. Retrieve at http://www.aaup.org/ statements/Redbook/repirb.htm

American Folklore Society. (1988). A statement of ethics for the American Folklore Society. AFS News, vol. 17, no 1. Retrieve at http://afsent.org/ethics.htm

Canada Council. (1977). Ethics: Report of the consultative group on ethics. Ottawa: The Canadian Council.

Canadian Psychological Association. (1996). Review and commentary on the draft code of conduct for research involving humans. Ottowa: Canadian Psychological Association.

Institute for Oral History, Baylor University Ottowa: Canadian Psychological Association (1997). Ethical and legal considerations. Retrieve at http://www3.bavlor.edu/Oral History/Erhicalrev.htm

Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada. (1998). Tri-council policy statement on ethics in human research. Ottawa: Medical Research Council of Canada.

National Bioethics Advisory Commission. (2001). Ethical and policy issues in research involving human subjects. Bethesda: Maryland.

Oral History Association. (1992). Oral history evaluation guidelines. Retrieve from http://omega.dickinson.edu/organizations/oha/ EvaluationGuidelines.html.

Joan E. Sieber. (2001). "Privacy and confidentiality as related to human research in social and behavioral science," in National Bioethics Advisory Commission, Ethical and policy issues in research involving humans. Vol. II, Commission Papers. Bethesda: Maryland. pp. N-i to N-50.

Author's Note: Dr. Owen acknowledges the support and consultation of his colleagues Susan Sykes, University of Waterloo; Noreen Golfman, Memorial University of Newfoundland; Joanne Burgess, Universite du Quebec Montreal; and Louise Robert, past Executive Director of the Humanities and Social Sciences Federation of Canada.

The content of the article, its interpretation, and any errors or omissions are the author's alone and do not represent the position of the HSSFC, the SSHRC, or his colleagues. Contact Dr. Owen, Director, Office of Research Services. Brock University, 500 Glenridge Avenue, St. Catharines, ON L2S 3AI or by Email: [e-mail]

Michael Owen, PhD, is Director, Office of Research Services and Associate Faculty of Education at Brock University, St. Catharines, ON, Canada. He has 17 years experience in research administration and related work. Prior to joining Brock University, Dr. Owen was Director of Research Services at Ryerson Polytechnic University and the University of Saskatchewan and was Assistant to the Vice President Academic at Athabasca University. Dr. Owen received his doctorate in educational theory from OISE/University of Toronto. His other publications are in technology transfer and research administration. He is SPA President Elect, past president of the Canadian Section, and a member of the SPA Board of Directors since 1998.