Monash Bioethics Review Vol. 22 No. 4 31 October 2003

Comparative Canadian Aboriginal perspectives on Draft Values and Ethics in Aboriginal and Torres Strait Islander Health Research JOSEPH M KAUFERT Centre for Aboriginal Health Research Department of Community Health Sciences Faculty of Medicine, University of Manitoba JOSÉE G LAVOIE LSHTM Research Associate Centre for Aboriginal Health Research Introduction

The paper by Gillam and Pyett is of direct relevance to researchers, ethicists, policy makers and community members working in the area of Aboriginal1 health in Canada. It describes and critically evaluates the ethical frameworks guiding research within Aboriginal and Torres Strait Islander communities in Australia.2

In our response to Gillam and Pyett’s commentary we emphasize a comparative perspective describing divergent and parallel developments in ethics review of research in Aboriginal communities in Canada. A comparative perspective on the development of indigenous research ethics reflects parallels in the influence on both indigenous and research communities in Canada and Australia of (1) inequities in population health and service access within colonial and post-colonial environments, (2) growing demands for indigenous governance of health care and control/ownership of health research, (3) increased awareness of common interests and strategies between indigenous health professionals and researchers, particularly in Canada, Australia and New Zealand.

Gillam and Pyett’s commentary3 is particularly relevant to Canadians because it documents the historical development of research policies within the context of indigenous values and also explores pragmatic approaches to representing and protecting the interests of participants, communities and organizations through an indigenous ethical review process. The Commentary proposes a framework for more effective implementation of the ‘Draft’ for Human Research Ethics Committees within Aboriginal and Torres Strait Islander communities and external health research ethics committees through the development of three targeted documents. These documents would expedite value clarification, promote mutual respect and fair sharing of research benefits, and facilitate the development of

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full representation of indigenous communities. They advance concrete, if incomplete, proposals for ensuring indigenous representation and monitoring and enforcement of principles of ethical conduct for under-resourced and over-worked ATSI committees, and propose alternative mechanisms for representing indigenous perspectives on external committees. Independent guidelines versus inclusion of research protection for Aboriginal communities within generalized research ethics policy frameworks

The 2002 Australian NHMRC Draft Values and Ethics Statement contrasts directly with Canadian initiatives. The Canadian process has opted to define research ethics protections for Aboriginal communities within a generalized policy governing all research ethics. In contrast, Gillam and Pyett describe the development of the NHMRC’s initial (1991) document Interim Guidelines on Ethical Matters in Aboriginal and Torres Strait Islander Health Research, and the (2002) Draft Values and Ethics in Aboriginal and Torres Strait Islander Health Research, as initiatives to define distinct research ethics guidelines and indigenous structures for research ethics review within ATSI communities.

In some ways the development of the Australian NHMRC’s expanded National Statement on Ethical Conduct in Research Involving Humans,4 released in 1999 paralleled the development of the Canadian Tri-Council Policy Statement.5 The more general National Statement, like the Canadian Tri-Council Policy Statement, provided guidelines not just for health research, but also for guiding non-medical multidisciplinary research supported by the Australian Research Council and the Academies of Humanities and Social Sciences. As Gillam and Pyett emphasize, the broad multidisciplinary orientation of the comprehensive review ‘meant that Aboriginal and Torres Strait Islander research could not be omitted, since this was one of the types of research specifically covered by existing NHMRC documents’. The approach adopted in Australia to update and clarify the ambiguous and contested sections of the Draft Guidelines involved a Working Party composed of stakeholders from the Aboriginal community-controlled health sector, representatives from research ethics committees, researchers and policy makers to develop a framework for revising the Interim guidelines. The development of separate ‘Guidelines on Ethical Matters in Aboriginal and Torres Strait Islander Health’6 and ‘Draft Values and Ethics in Aboriginal and Torres Strait Islander Health Research’7 reflected both broad, inclusive and critical use of models from national and international literature in indigenous ethics, and the continuing efforts of the Working Party Group in consultation and negotiation with Aboriginal Torres Strait Islander communities and members of the research community. The ongoing process of consultation continued after the release of the Draft Values document with further solicitation of comments, generating 53 submissions.

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In contrast to the Australian decision to develop differentiated ethics policy guidelines to guide research in ATSI communities, the final version of the Canadian Tri-Council Policy Statement included a brief section describing issues and ‘best practice’ approaches to research ethics review involving Aboriginal individuals and communities. The Statement did refer to the concept of respecting human dignity, but linked demonstration of respect to the core principles. Section 6 stated:

A general principle is that the obligation to respect human dignity in research involving aboriginal groups gives rise to both special considerations and to basic ethical duties regarding ethics review, informed consent, confidentiality, conflict of interest and inclusion (see sections 1–5). This principle is not intended to preclude critical inquiry and research, or research that may come to negative conclusions; it seeks to advance accurate, informed and ethical research.8

In contrast to the ‘principalist approach’ of the Canadian Tri-

Council Policy Statement, the six core values outlined in the 2002 Draft Values and Ethics (including reciprocity, respect, equality, survival, protection and responsibility) are identified as reflecting the perspectives of ATSI culture in health research ethics. Although the six values are, as Gillam and Pyett suggest, compatible with accepted Western principles of research ethics, they provide a more workable framework for developing an ATSI process of equitable and co-participatory research ethics. Gillam and Pyett’s most significant contribution is in their analysis of how the framework based on ATSI values and less legalistic relationships could be applied in the actual deliberations of working Health Research Ethics Committees (HREC). For example, achievement of the core value of reciprocity could be evaluated by an HREC in terms of the researcher/community agreement on explicit provisions for resource exchange, capacity-building data protection, and ownership. Indigenous participation

In Canada the 1998 Tri-Council Policy Statement recognized that formal development of research ethics frameworks for Aboriginal communities would have to wait until appropriate consultations took place with ‘representatives of the affected peoples or groups, or with the various organizations or researchers involved.’9 The lack of meaningful co-participation in the development and revision of the Canadian Tri-Council Policy statement contrasted with broad critical review and extended consultation process involved in developing and revising the Australian Interim Guidelines and ongoing consultation centring on the 2002 Draft Values document. The Canadian Tri-Council Policy did reference, but did not incorporate, knowledge and models from Australian and other international literature on indigenous research ethics. Section 6 noted that ATSI peoples in Australia had already ‘set

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out their own guidelines for conduct of research in aboriginal communities’.10 The Policy Statement also asserted that there was a very high degree of agreement between Canadian, American, and Australian guidelines and attributed similarities to common historical experience of indigenous communities internationally. The references to similarities in the frameworks advocated by international aboriginal groups for research ethics review did not recognize the impact of the growing international network of indigenous organizations and researchers who share experience and models continuously. Gillam and Pyett provide an alternative model for development and implementation of guidelines by clearly defining the advantages of developing both independent Aboriginal and Torres Strait Islander Research Ethics Committees, and by also proposing a system of Indigenous Ethics Advisers where no Indigenous ethics committees exist.

While the Australian guidelines and Gillam and Pyett’s proposal go beyond the provisions of Canadian guidelines, they nevertheless fall short of specifying a pragmatic process for engaging ATSI communities, at three separate levels. First, Australian ATSI Ethics Committees function in only a handful of sites. These Committees aim at representing an Aboriginal and Torres Strait Islander perspective in proposal review. But they are yet to be appropriately resourced to ensure equitable participation. Appropriate ATSI representation on ATSI committees should not be limited to academic representation. Ethics committees continue to be based in universities, and it may very well be that appropriate ATSI representation requires the participation of community elders and leaders who may not be compensated for their participation to the same extent as university-based academics and professionals. Thus there is a need for appropriate resourcing to ensure appropriate ATSI representation.

Second, the value statement and Gillam and Pyett’s proposal continue to blur the separation between ATSI community and ethics committee. The approval of a research proposal by an institution-based ethics committee by no means implies that ATSI communities are in agreement with the research being undertaken in their community. In the ATSI environment, consent is required at the individual and community levels, once ethical approval has been received. The guidelines and Gillam and Pyett’s comments on them, make no provision for the distinction between ATSI participation on ethics committee and community consent, and provide no template to define the relationship between them. Also, independent ATSI boards or university-based committees with indigenous participation may still have to struggle with the fundamental problem of defining what constitutes a community, and determining what individuals or stakeholder groups most legitimately represent its interests. This point is particularly relevant to Canadian Aboriginal people, where First Nations may claim the exclusive role of representing the interests of communities. Community-based models of Aboriginal oversight have already developed in Canada through ‘bottom up’ initiatives involving

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development of separate research ethics guidelines and research ethics boards by Aboriginal communities and regional organizations.

Indigenous research frameworks developed in Canada include the Kahnawake Schools Diabetes Prevention Project Code of Research Ethics,11 the Inuit Tapirisat Background Paper on Negotiating Research Relationships in the North,12 and Dene Tracking: a Participatory Research Process for Dene/Métis Communities.13

Research ethics guidelines, like the Kahnawake Code of Research Ethics, were developed at community or regional level to deal with specific relationships. Like most other indigenous codes or documents, the development of the Kahnawake Code was informed by surveying indigenous ethics documents. The code defines a relationship between the communities of Kahnawake; community- based researchers and academic researchers in universities. The key mechanism for representing the voice of the community is the Community Advisory Board with membership including local health workers volunteers, organizational representatives, and community elders. The process of developing the community-based research ethics framework code has been as important as the formal document. Researchers met with the Advisory Board and successive drafts of the agreement were developed and circulated between researchers and the board over an eight-month period.14 In contrast to the ‘top down’ initiative of the Canadian Tri-Council Policy Statement, the Kahnawake code makes explicit the wishes, perspectives and values of a specific Mohawk community.

Although the influence and local relevance of Aboriginal codes and preliminary development of research and information committees in Manitoba and Quebec was recognized, there has to date been no policy statement defining the relationship of local Aboriginal guidelines to the existing Tri-Council Statement or to future national guidelines. Rather, the guidelines developed by Aboriginal communities are treated as a set of additional requirements whose purpose was to ensure that the rights and interests of the community as a whole are respected.15 Interestingly, there was no comment on whether or not such research can be initiated without the permission of the community, although this is a critical issue in many of the ethical guidelines developed by Canadian Aboriginal organizations. Although there are community-initiated research ethics frameworks and initiatives by regional Aboriginal organizations in Manitoba and Quebec to develop ‘research and research ethics committees’, the national Tri-Council guidelines16 (1998) do not define the rights of communities or role of Aboriginal ethical review boards to block research that a community may deem irrelevant, harmful or as involving unacceptable risk.

Third, current developments in pan-indigenous research not only require that indigenous ethical guidelines and processes be in place locally, regionally and nationally, but will eventually call for the definition of an international process to ensure that comparative international research understood as important by indigenous people does not get stalled because of a lack of ‘ethics committee

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infrastructure.’ In that regard, both the Canadian and Australian processes discussed in this submission have a long way to go.

To our knowledge, the New Zealand model, with its thirteen regional committees with Māori representation, standardized form and coordinated process of review for multi-site research project, is a pragmatic model which may be applicable at a national level.17 An international model has yet to emerge. Future directions for the development of Aboriginal research ethics in Canada: Learning from the Australian experience

The ultimate contribution of Gillam and Pyett’s commentary documenting the development and proposals for ATSI implementation of the NHMRC Draft Values and Ethics in Aboriginal and Torres Strait Islander Health Research, for both researchers and Aboriginal stakeholders in Canada, may be in providing models for development and implementation of new ethical frameworks and processes. Initiatives to disseminate the Canadian (1998) Tri-Council Policy Guidelines,18 to educate the research community and to monitor compliance by researchers funded by national councils have met with broad-based criticism and strong resistance from individual researchers’ professional organizations and stakeholder communities. Members of the research community identified significant gaps in the capacity of the Policy Statement to guide ethical review of research involving diverse methodological and disciplinary bases, different research cultures and different frameworks for research ethics review in the medical, natural, social sciences, and the humanities. Since 1998, the Tri-Council Policy Statement has been heavily criticized by both Aboriginal and non-Aboriginal researchers, and by Aboriginal organizations who have emphasized that the guidelines were developed and revised without an inclusive process of consultation and negotiation with the communities and First Nations governments most directly impacted. At the present time a major independent body, the Panel on Research Ethics, is developing the framework and consulting widely with the objective of redeveloping the overall ethics policy framework guiding research within all science councils. However, specific provisions in an integrated ethics policy framework and process addressing Aboriginal values, or a separate Aboriginal research ethics framework, are now being developed by major Aboriginal stakeholder organizations, including the Institute for Aboriginal Peoples’ in the Canadian Institutes of Health Research, and the National Aboriginal Health Organization. The contributions of the 2002 Draft Values and Ethics and Gillam and Pyett’s framework, for Canadians, include the importance of differentiated guidelines for Aboriginal health research, and specification of the real processes through which Aboriginal control will be maintained. At the implementation level, both countries would benefit from exploring the applicability of the New Zealand model.

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ENDNOTES

1 For the sake of clarity, the term ‘Aboriginal’ is used to refer to the First Nations,

Inuit, and Métis population of Canada. The abbreviation ATSI is used throughout to refer to Aboriginal and Torres Strait Islanders of Australia.

2 National Health and Medical Research Council, Draft values and ethics in Aboriginal and Torres Strait Islander health research, Canberra: National Health and Medical Research Council, 2002.

3 Gillam L, Pyett P, ‘A commentary on the NHMRC Draft values and ethics in Aboriginal and Torres Strait Islander health research’, Monash Bioethics Review, vol. 22, no. 4, October 2003.

4 Commmonwealth of Australia, National statement on ethical conduct in research involving humans, Commonwealth of Australia, 1999.

5 Medical Research Council of Canada, National Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada, Canadian Tri-Council policy statement, Ottawa: Government of Canada, 1998.

6 National Health and Medical Research Council, Guidelines on ethical matters in Aboriginal and Torres Strait Islander health, Canberra: National Health and Medical Research Council, 1991.

7 NHMRC, Draft Values and ethics in Aboriginal and Torres Strait Islander health research, op. cit.

8 Medical Research Council of Canada et al, op. cit., Section 6, 1998. 9 Ibid., Section 6.1 to 6.4, 1998. 10 Ibid., Section 6.1, 1998. 11 Kateri Memorial Hospital Centre, Kahnawake schools diabetes prevention project

code of research ethics, Kateri Memorial Hospital Centre, Kahnawake Territory, Mohawk Nation, via Quebec, 1997.

12 Inuit Tapirisat Kanatami, Inuit Tapirisat background paper on negotiating research relationships in the north, Inuit Tapirisat Kanatami, Ottawa, 1994.

13 Mazumi and Quirk S, Dene tracking: A participatory research process for Dene/Métis communities: Exploring community-based research concerns for aboriginal northerners, Dene Cultural Institute (So' bak?ç, Denedeh), Hay River, 1993.

14 Macaulay A, Cross E, Delormier L, Paradis G and McComber A, ‘Developing a code of research ethics for research with a native community in Canada: A report from Kahnawake schools diabetes project’, International Journal of Circumpolar Health, vol. 157, supp. 1, 1998, pp. 38–40.

15 Medical Research Council of Canada et al, op. cit., Section 6.1, 1998. 16 Ibid.,1998. 17 See information at http://www.hrc.govt.nz and Health Research Council of New

Zealand, Guidelines for researchers on health research involving Maori, Wellington: Health Research Council of New Zealand, 2000.

18 Government of Canada, op. cit., Ottawa, 1998.