In response to the experiences of York University researchers working in Aboriginal/Indigenous Peoples’ contexts and in light of the Tri-Council Policy Statement, 2nd Edition (hereafter “the policy”), the Office of Research Ethics took on the task of articulating research guidelines for implementation of Chapter 9 of the policy. A group of Aboriginal/Indigenous Peoples and non-Aboriginal/Indigenous Peoples researchers, including graduate students, met over a period of two years to discuss the issues in depth and to draft this set of guidelines related to research involving the First Nations, Métis and Inuit peoples of Canada. These guidelines are intended to inform researchers and the Human Participants Review Committee as they prepare for and review research to be conducted in an Aboriginal/Indigenous Peoples context and/or with Aboriginal peoples.
We particularly recognize the unique considerations necessary for conducting research in each, distinct Aboriginal/Indigenous Peoples context. In addition, we are aware of the concerns of many Aboriginal/Indigenous Peoples about the ways research has taken and is taking place in their communities. As renowned decolonizing scholar, Linda Tuhiwai Smith has clearly stated in her 1999 text Decolonizing Methodologies, “The term “research” is inextricably linked to European imperialism and colonialism. The word itself, “research”, is probably one of the dirtiest words in the indigenous world’s vocabulary.” Cognizant of this historical context, the guidelines are at least partly an attempt to redress this situation.
Aboriginal/Indigenous Peoples, as host peoples of this nation, remain distinct within Canada and, for this reason, deserve separate attention when it comes to research. In light of their histories and contemporary circumstances, intensive preparation and culturally appropriate protocol are required of each researcher who chooses to do their work in Aboriginal contexts.
- Community engagement is required.
One of the key principles of research involving Aboriginal/Indigenous Peoples is the engagement of the community or communities within which the research will be conducted. Specifically, researchers conducting research where the research is likely to affect the welfare of an Aboriginal/Indigenous Peoples community, or communities, to which prospective participants belong, researchers shall seek engagement with the relevant community. The nature and extent of community engagement in a project shall be determined jointly by the researcher and the relevant community, and shall be appropriate to community characteristics and the nature of the research. 
Wherever possible and appropriate to the nature of the research, researchers should consider a collaborative and/or participatory action approach to their research. Similarly, where the form of community engagement and the nature of the research make it possible, research should be relevant to community needs and priorities. The research should benefit the participating community (e.g., training, local hiring, recognition of contributors, return of results), as well as extend the boundaries of knowledge.  The project should seek to strengthen capacity building within the community through the enhancement of the skills of community personnel in research methods, project management, and ethical review and oversight.
- Researchers must recognize and engage Aboriginal/Indigenous Peoples organizations, service organizations and communities of interest as communities.
For the purposes of community engagement and collaboration in research undertakings, researchers and REBs shall recognize Aboriginal/Indigenous Peoples organizations, including First Nations, Métis and Inuit representative bodies, and service organizations and communities of interest, as communities. They shall also recognize these groups through representation of their members on ethical review and oversight of projects, where appropriate.
In engaging territorial or organizational communities, researchers should ensure, to the extent possible, that they take into consideration the views of all relevant sectors – including individuals and subgroups who may not have a voice in the formal leadership. Groups or individuals whose circumstances make them vulnerable may need or desire special measures to ensure their safety in the context of a specific research project. Those who have been excluded from participation in the past may need special measures to ensure their inclusion in research. 
- A community engagement plan must be developed and provided to the REB for review.
When proposing research expected to involve First Nations, Métis and Inuit participants, researchers shall advise their REB how they have engaged, or intend to engage, the relevant community. Generally, it is advised that the REB be notified via a community engagement plan whereby the proposed methods of engagement are clearly articulated. 
In those communities which have a recognized governing authority and/or have community organizations with recognized authority, researchers may formalize their engagement with the community through a research agreement. Where a community has formally engaged with a researcher or research team through a designated representative, the terms and undertakings of both the researcher and the community should be set out in a research agreement before participants are recruited.
- First Nations, Metis and Inuit governing authorities must be respected.
Where a proposed research project is to be conducted on lands under the jurisdiction of a First Nations, Inuit or Métis authority, researchers shall seek the engagement of formal leaders of the community. In such instances, both review by the institutional REB and the responsible community body recognized by the First Nations, Métis or Inuit authority is required. Where alternatives to securing the agreement of formal leadership are proposed for research on First Nations, Métis and/or Inuit lands or in organizational communities, researchers should engage community processes and document measures taken, to enable the REB to review the proposal with due consideration of complex community authority structures. 
Further, researchers should engage the community in identifying Elders or other recognized knowledge holders to participate in the design and execution of research, and the interpretation of findings in the context of cultural norms and traditional knowledge. Community advice should also be sought to determine appropriate recognition for the unique advisory role fulfilled by these persons.
It is important that researchers understand the community context within which they are conducting their research. Researchers have an obligation to become informed about, and to respect, the relevant customs and codes of research practice that apply in the particular community or communities affected by their research. Inconsistencies between community custom and this Policy should be identified and addressed in advance of initiating the research, or as they arise. 
Note however that institutional REB review and approval will be required regardless of approval by Aboriginal/Indigenous Peoples governing authorities’ and/or organizations approval. Specifically, Research ethics review by community REBs or other responsible bodies at the research site will not be a substitute for research ethics review by institutional REBs, and will not exempt researchers affiliated with an institution from seeking REB approval at their institution, subject to Article 8.1.
- Researchers who wish to be exempt from the requirement of community engagement must provide a written rationale to the REB for review.
There are circumstances when community engagement may not be possible or appropriate. Researchers who wish to proceed without a community engagement plan must provide a detailed rationale to the REB for review and consideration.
Note, however, that a rational need not be required for specific circumstances and/or research methods. For example, “…where research relies only on publicly available information or on legally accessible information as defined in Article 2.2 (TCPS), community engagement is not required. Where the information can be identified as originating from a specific community or a segment of the Aboriginal/Indigenous Peoples community at large, seeking culturally informed advice may assist in identifying risks and potential benefits for the source community.”
- Research involving critical inquiry within or about Aboriginal/Indigenous Peoples communities, may not require community engagement and/or community consent.
Research involving Aboriginal/Indigenous Peoples that critically examines the conduct of public institutions, First Nations, Métis and Inuit governments, institutions or organizations or persons exercising authority over First Nations, Métis or Inuit individuals may be conducted ethically, notwithstanding the usual requirement of engaging community leaders. However, irrespective of the fact that community engagement may not be required, researchers must remain respectful of the community as they conduct their research.
- Research involving secondary data analysis – and in particular the use of biological materials – is subject to research ethics review.
Prospective research and secondary use of data and human biological materials for research purposes is subject to research ethics review. Regardless of the source, if researchers wish to conduct secondary data analysis on data that is “…identifiable as originating from a specific Aboriginal/Indigenous Peoples community or segment of the Aboriginal/Indigenous Peoples community at large, researchers shall, through community engagement as appropriate, address any potential inadvertent identification of communities, or misuse of traditional knowledge.” Thus, unless specifically authorized through an appropriate consent process, researchers cannot use data for secondary purposes without further community engagement, consent and ethics review and approval.
Specifically, if the data and/or biological materials are “identifiable as originating from an Aboriginal/Indigenous Peoples’ community or peoples is subject to REB review” and/or there is no formal research agreement for additional use and/or the data is not publicly available researchers must engage the community and provide documentation of such engagement to the REB prior to use of said data. Further, Individual consent for the secondary use of identifiable information is required unless the REB agrees that one of Articles 5.5 or 5.6 or Articles 12.3 or 12.4 may apply.
Given the historical context, the collection of biological samples requires careful consideration by researchers and extensive engagement and consultation with the community from which the data and samples will be collected. Where collection of biological materials forms part of the research project, researchers shall engage the community to “…address and specify in the research agreement the rights and proprietary interests of individuals and communities, to the extent such exist, in human biological materials and associated data to be collected, stored and used in the course of the research.”
Special care and consideration shall be given by researchers as it pertains to the privacy and confidentiality of the participants’ and their data. “The extent to which limited or full disclosure of personal information related to the research is to be disclosed to community partners shall be addressed in research agreements where these exist. Researchers shall not disclose personal information to community partners without the participant’s consent, as set out in Article 3.2(i).”
Finally, REB review is required where the researcher seeks data linkage of two or more anonymous datasets or data associated with human biological materials and there is a reasonable prospect that this could generate information identifiable as originating from a specific Aboriginal/Indigenous Peoples community or a segment of the Aboriginal/Indigenous Peoples community at large.
- Researchers must address the issues of intellectual property, data interpretation and dissemination of results prior to commencement of research.
The issue of intellectual property should be addressed during the process of community engagement. Ideally the issue should be addressed formally in either a research agreement or community engagement plan. “In collaborative research, intellectual property rights should be discussed by researchers, communities and institutions. The assignment of rights, or the grant of licenses and interests in material that may flow from the research, should be specified in a research agreement (as appropriate) before the research is conducted.” 
Further, prior to the publication and dissemination of research, community members should be provided with the opportunity to review the research results. Specifically, “researchers should afford community representatives engaged in collaborative research an opportunity to participate in the interpretation of the data and the review of research findings before the completion of the final report, and before finalizing all relevant publications resulting from the research.”
 We use the term Aboriginal as in the 1982 Constitution of Canada. While we recognize its limitations, our intention is that it includes all those individuals and community members who claim ancestry based in the lands we now call Canada. We also look to the etymology of the word from the Latin a/ab meaning “out of” or “from”, and “origin” as it relates to the original peoples.
 TCPS Article 9.1
 TCPS article 9.2
 TCPS article 9.12
 TCPS article 9.13
 TCPS article 9.14
 TCPS article 9.4
 TCPS article 9.6
 Generally TCPS article 9.10
 TCPS article 9.11
 TCPS article 9.3
 TCPS article 9.5
 TCPS article 9.15
 TCPS article 9.8
 TCPS article 9.10
 TCPS article 9.21
 TCPS article 9.7
 TCPS article 9.20
 TCPS article 9.19
 TCPS article 9.16
 TCPS article 9.22
 With respect to the matter of intellectual property, for a more comprehensive statement on what intellectual property is or may be considered within the Aboriginal/Indigenous peoples’ context, please consult the AFN guidelines on research ethics at: http://www.afn.ca/uploads/files/rp-research_ethics_final.pdf
 TCPS article 9.18
 TCPS article 9.17