The CIHR Guidelines for Health Research Involving Aboriginal People were adopted by CIHR's Governing Council and are now in effect. These guidelines offer the kind of safeguards that have long been missing for Aboriginal people participating in research. The health research ethics guidelines respond to the pressing needs of the Aboriginal community and the Network Environments for Aboriginal Health Research (formerly Aboriginal Capacity and Developmental Research Environment - ACADREs), and help CIHR and its Institute of Aboriginal Peoples Health meet its fundamental obligation of accountability to Canadians. The ethics guidelines for health research are a contribution to the work of the Tri-Council National Consortium to revise section 6 of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, which addresses research involving Aboriginal people.

Background

In 2004, CIHR initiated a project to develop Aboriginal specific health research guidelines to ensure adequate protections for Aboriginal research participants. CIHR's Aboriginal Ethics Working Group (AEWG) was established in March 2004 as part of this broad national endeavour. The AEWG is representative of Aboriginal interests and disciplines necessary to provide advice and support for the development of ethics guidelines for health research. The AEWG met over the course of 2004 for in-depth analysis and deliberation of Aboriginal and research issues. A series of background papers were commissioned to inform the deliberations of the AEWG. The drafting of research ethics guidelines occurred over the winter of 2004 and early spring of 2005.

Consultation

A comprehensive nation-wide strategy for consultation with Aboriginal communities, researchers and institutions was built on the CIHR-IAPH National ACADRE Network. These broad consultations and vetting within the Aboriginal and research communities were initiated in April 2005 and occurred over the spring and the summer. Consultations took place, at various stages, and Aboriginal communities were involved from the beginning and had opportunities to comment on several drafts. The ACADRE centres played an essential role in ensuring consultation with the Aboriginal communities from the start. They also enabled wider consultation with the research communities. The National Council on Ethics in Human Research (NCEHR) collected comments from such communities. Input was sought from the Federal Government throughout the whole process. Feedback from the consultations formed the basis for revisions to the guidelines. Both Health Canada and Justice Canada endorsed the Guidelines in their final form.

Policy Implications

The Guidelines are designed to be a collaborative tool for researchers, Aboriginal communities and Aboriginal individuals. The Guidelines provide the type of guidance that is needed for researchers who are eager to work with Aboriginal communities. The Guidelines are now policy for CIHR-funded researchers and will be evaluated at least once every four years. These guidelines will promote health through research that is in keeping with Aboriginal values and traditions, as well as assist in developing research partnerships that will facilitate and encourage mutually beneficial and culturally competent research.

CIHR Implementation of the Guidelines

December 2008 marks the first round of competitions that applies the Guidelines to research proposals for which:

1. Being Aboriginal is relevant to the research question (i.e. people are recruited because they are Aboriginal).
2. The analysis of data/biological sample will use Aboriginal identification as a variable.
3. The findings of the research will have an impact on Aboriginal people or communities or will provide interpretation of Aboriginal history or culture.

Applicants whose proposed research involves Aboriginal people must indicate this in the space now provided on the application form. Applicants are also asked to show evidence of community approval by attaching a formal research agreement. In cases where obtaining a formal agreement is not possible or not desirable from the community's perspective, applicants should include a letter of support from the community, along with a short statement of justification to explain why a formal research agreement is either unnecessary or unobtainable at the time of application. It is recognized that for some types of Aboriginal health research, identifying a specific signing authority will not be possible, in which case the statement of justification will suffice. In all cases, applicants should show familiarity with the spirit of the Guidelines.

CIHR has opted to phase-in these requirements of the Guidelines. Thus, if a proposal is deemed fundable, but is not accompanied by the documentation, applicants will be notified of the requirements and given a 1-year grace period in which to submit evidence of approval in order to trigger release of funds (as per section 3-B6 of the Grants and Awards Guide).

To support the uptake of the Guidelines, the CIHR Ethics Office is currently supporting two training opportunities aimed at researchers, Research Ethics Board (REB) members and Aboriginal communities. First, the National Council on Ethics in Human Research (NCEHR) is offering a series of regional training workshops. These case-study based workshops are offered at participating universities across Canada. In addition, the case studies for the workshops are being adapted as an online tutorial, which is expected to be available on the CIHR Ethics webpage by fall 2009. CIHR encourages the use of this tutorial for training members of REBs or community health committees, as well as for Continuing Medical Education or partial course credit within universities, for instance. In addition to these training opportunities, proposal review criteria and training is being provided to peer reviewers to ensure research proposals adhere to the new research policy.

Watch this space for further information on these training opportunities. Information will also be disseminated through CIHR E-Alerts and University Research Administration Offices in the coming months. Enquiries can be emailed to the Aboriginal Ethics Guidelines inbox at aeg-lda@cihr-irsc.gc.ca.