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Pre-review Requirements

Guidelines for Research Involving First Nations, Métis, and Inuit Peoples

Research involving First Nations, Métis, and Inuit and their communities and knowledge requires review, collaboration, engagement, and support from these groups. This type of review and collaboration helps ensure that research is conducted in a way that is respectful, responsible, and sensitive to the unique cultural, historical, and social context of Indigenous peoples. These reviews may vary in nature and should be conducted by the most appropriate group(s) related to or involved in the research. This group may include, but is not limited to:

  • Band Council resolutions or letters of support
  • Health Information and Research and Governance Committee (HIRGC) letters of support or approval
  • Manitoba Metis Federation (MMF) letters of support or approval
  • Manitoba Inuit Association letters of support
  • Letters of support from community members or community organizations

As a researcher, it is important to engage in a thorough and thoughtful process to ensure that your research involving First Nations, Métis, and Inuit communities is conducted in an ethical, relational, and respectful manner. This engagement may involve collaborating with Indigenous partners and communities, consulting with Indigenous scholars and experts, and following established guidelines and protocols for Indigenous research.

Key Considerations:

1. Engage early in meaningful consultation and collaboration with First Nations, Métis, and Inuit partners and communities. This engagement may involve seeking the input and guidance of Indigenous elders, community leaders, and scholars. It is important to approach this process with humility and openness, as well as recognition of your own positionality in relation to Indigenous partners and communities, and to be prepared to listen and develop your research plans based on the feedback you receive. Indigenous partners and communities should also be meaningfully involved in all steps of the research cycle from planning to dissemination. Ideally, you should be building authentic relationships with Indigenous peoples before engaging in research with them.

2. Respect First Nations, Métis, and Inuit cultural protocols and protocols of research. Each community and organization will have distinct protocols that you should learn about and follow. Protocols may involve seeking permission and obtaining consent from Indigenous communities and individuals before conducting research, engaging in specific ceremonies or other cultural activities, and following established guidelines (check with your home institution) for conducting research in Indigenous communities.

3. Align your research objectives with the needs of the people or community involved to ensure your work is relevant to them and make a plan that privileges Indigenous ownership, control, access, and possession or stewardship of any data generated through the research. Depending on the needs of the organization or community, this data management plan may involve resource investment in data infrastructure within the community or partner organization and/or development of data repatriation agreements that ensure the ownership/stewardship of Indigenous data is returned to the relevant organization or community once it has the necessary resources to store the data securely.

4. Educate yourself about the unique cultural, historical, and social contexts of Indigenous peoples. This learning involves becoming familiar with the history and current situation of the Indigenous community or communities with whom you are working and being self-reflexive about addressing the potential impacts of your research on the community.

5. Be transparent and accountable in your research process. This accountability involves being open about your research plans and methods and actively listening and responding to feedback from Indigenous partners and communities. Consider setting up and following Indigenous-led governance processes for your research.

6. Consider the potential impacts of your research on Indigenous knowledge and cultural heritage. This consideration involves being careful not to appropriate Indigenous knowledge or cultural heritage without permission (and where possible, co-authorship and co-presentations with Indigenous community/partner members) and mitigating any negative impacts that your research may have on Indigenous knowledge and cultural heritage.

By engaging in meaningful consultation and collaboration with First Nations, Métis, and Inuit partners and communities and being responsive to the unique cultural, historical, and social context of Indigenous peoples, you can help to ensure that your research is conducted in a way that is ethical and respectful.

The RITHIM Harmony Health Research Application form requires that information is provided regarding community engagement when research involves First Nations, Métis, and Inuit.  Researchers are strongly encouraged to consult early with First Nations, Métis, and Inuit communities and organizations to clarify expectations, to learn local protocols for developing meaningful partnerships, and to obtain evidence of approval or support (as appropriate) prior to submitting an application in Harmony.

Please see our Resources page for links to additional information.

Scientific Review

Scientific Review, often also called scholarly or peer review is generally understood to be a review of the importance of the research question (value) and the validity of the methodology.

While it is within the scope of research ethics boards to review the scientific validity of research proposals, the primary focus of CHIPER (Committee for Harmonized Health Impact, Privacy and Ethics Review) in evaluating a research project should be ethical acceptability.

The primary goal of the scholarly review requirement is to ensure that health research projects that are submitted for ethics review satisfy the relevant disciplinary standards in terms of both value and scientific validity such that the participant’s time and effort regardless of level of risk of the project, is not being expended with no corresponding benefit to either society or to the participants.

The scholarly review requirement will facilitate submission quality and the ethics review process for CHIPER, reduce the number of project modifications required by researchers, and improve the research’s overall success. 

Minimal Risk Research

As defined in TCPS2, “minimal risk” research is defined as research in which the probability and magnitude of possible harms implied by participation in the research are no greater than those encountered by participants in those aspects of their everyday life that relate to the research.

Documentation of scholarly review is not required in the Harmony application for health research projects that pose no more than minimal risk. However, CHIPER must be satisfied with both the value and scientific validity of the project and may, at its discretion, require a scholarly review for some minimal risk projects.

Examples of minimal risk projects that may be submitted to RITHIM include, but are not limited to:

  • Retrospective chart reviews
  • Individual Case Reports
  • Projects undertaken for the sole purpose of establishing a biobank or registry.

Above Minimal Risk Research

Converse to the TCPS2 definition of minimal risk, above minimal risk research has a probability and magnitude of possible harms implied by participation in the research greater than those encountered by participants in those aspects of their everyday life. Documentation of scholarly review may be required for health research projects that pose a greater than minimal risk.

Researchers have a role to play in demonstrating to CHIPER whether, when, and how appropriate scientific review has been or will be undertaken for their research and CHIPER may request that the researcher provide full documentation of completed scientific reviews.

When no formal scholarly review has been undertaken and the research involves more than minimal risk, CHIPER may require that a researcher assist with obtaining a review by a qualified expert.

Waiver of Scientific Review Documentation

The following types of projects are generally considered to have undergone scholarly review and are exempt from providing evidence of scholarly review in the Harmony Health Research Application. However, CHIPER, at its discretion, may require documentation of scholarly review for some projects.

  •  Projects that have received Health Canada approval
  • Projects developed and funded by a for-profit company
  • Projects sponsored by regionally, nationally, or internationally recognized cooperative research groups (e.g., Canadian Cancer Trials Group, Canadian Critical Care Trials Group, etc.)
  • Projects funded by regionally, nationally, or internationally recognized funding agencies (e.g., Research Manitoba, CIHR (Canadian Institutes for Health Research), NIH (National Institutes of Health), etc.)
  • Projects approved by another Canadian REB (Research Ethics Boards) where a scientific review has been undertaken.

Special Note Regarding Student-Led Projects

Specific to projects with Student PIs (Principal Investigators), the Academic Supervisor is responsible for scientific review of the project. The Academic Supervisor will be required to attest when signing the Harmony Health Research Application that appropriate scientific review was completed, and that all reviewer feedback has been adequately addressed.  

CIHR Stem Cell Oversight Committee (SCOC)

In accordance with TCPS 2, Article 12.10 – “Research involving human pluripotent or human totipotent stem cells that have been derived from an embryonic source, and/or that will be grafted or transferred in any other form into humans or non-human animals requires review and approval by SCOC and an REB. The researcher shall provide evidence of SCOC approval to the REB.”

In recognition of the complex ethical issues associated with research involving pluripotent stem cells, the Stem Cell Oversight Committee (SCOC) was created by CIHR in 2003. Review by the SCOC is required for all research being conducted at universities or other institutions that receive agency funds that involve human pluripotent and human totipotent stem cells that have been derived from an embryonic source and/or will be transferred into humans or non-human animals, among other responsibilities.

In addition to following the guidance provided in TCPS 2 and the CIHR Policy, researchers are responsible for compliance with all applicable legal and regulatory requirements (e.g., the Assisted Human Reproduction Act and its Regulations and the Food and Drugs Act and its Regulations).

For additional information, please go to https://cihr-irsc.gc.ca/e/19306.html

As part of their Harmony Health Research Application, researchers must attach a copy of the Stem  Cell Oversight Committee Approval Letter.

Manitoba Centre for Health Policy (MCHP) Feasibility

The Manitoba Centre for Health Policy (MCHP) is a centre of research excellence based at the University of Manitoba that conducts world-class population-based research on health and the social determinants of health. MCHP maintains The Manitoba Population Research Data Repository on behalf of the government of Manitoba for use by the local, national and international research community.

The Manitoba Population Research Data Repository is a comprehensive collection of administrative, registry, survey, and other data primarily relating to residents of Manitoba. It was developed to describe and explain patterns of health care and profiles of health and illness, facilitating interdisciplinary research in areas such as health care, education, social services and justice.

For additional information, please visit their site.

MCHP strongly recommends that any projects utilizing The Manitoba Population Research Data Repository) are submitted to MCHP for feasibility review prior to completing the Harmony Health Research Application.

Other Pre-Review Requirements

There may be additional health system (e.g. institutional feasibility review) or post-secondary (e.g. University of Manitoba Survey Review Committee) pre-review requirements outside the scope of RITHIM. Please contact the research department of the applicable organization(s) for guidance.