Table 1 Original Research Evaluating the Consent Process with Indigenous Populations

Russell et al. 2005 (Alice Springs, NT, Australia) [33]

A pilot study of informed consent materials for Aboriginal participants in clinical trials

Information about an unlicensed vaccine trial for children was provided to 20 mothers who identified as Aboriginal and 20 non-Aboriginal mothers using verbal, written and visual materials. Preference and understanding was evaluated through a questionnaire.

▪ A single presentation to all participants was unlikely to enable informed consent;

▪ Participants identifying as Aboriginal preferred a flip chart with visual content presented by a doctor with an Aboriginal researcher present

Bull 2010 (Labrador, Canada) [34]

Research with Aboriginal Peoples: Authentic relationships as a precursor to ethical research

A researcher who identifies as Aboriginal and local to the community of Labrador interviewed 15 community leaders (11 leaders who identified as Inuit, Innu, or Inuit-Metis and 4 non-Aboriginal leaders nominated by the community) to investigate why authentic research relationships are important and how they are achieved with people who identify as Aboriginal.

To seek consent, the researcher must:

▪ Establish a reciprocal relationship with the community, involving them in the research process and interpretation of results

▪ Ensure the community understands the risks as well as the benefits of participating

▪ Respect cultural protocol

▪ Ensure the research is relevant to the community

For this research project:

▪ Seek “collective consent” from communities

▪ Provide the option of oral or written consent for individual participants

▪ The individual consent process was not evaluated

McCabe et al. 2005 (Navajo Nation: Arizona, New Mexico & Utah, USA) [35]

The informed consent process in a cross-cultural setting: Is the process achieving the intended result?

The consent process for a diabetes education project with people of the Navajo Nation was analysed. Standardised consent forms in English were transcribed into a phonetic version of Navajo using the English alphabet. This was back translated to English and compared to the original English by a Navajo language expert. A second version was then tested with the Navajo Nation Medical Terminology Standardisation Committee. 333 Navajo people who do not use the written word were then asked to sign these forms by 4 Medical Interpreters who reflect on this process.

▪ Concerns were raised about this process by both participants and interpreters

▪ The consent process was contradictory; repetitive; untrustworthy; lengthy and discouraged participation

Researchers conclude that consent forms should:

▪ Avoid legal and scientific jargon;

▪ Avoid repetition and wording that creates mistrust

▪ Have a logical flow of information when translated into complex languages

Researchers should also:

▪ Ensure those seeking consent are culturally competent

▪ Avoid reliance on telephone communication

▪ Have community input into the consent forms

▪ Use graphics to illustrate concepts and assist understanding

Fong, M. 2004 (Hawai’i, USA) [36]

Native Hawaiian preferences for informed consent and disclosure of results from research

A survey was conducted with 429 Hawaiian participants (327 of whom were Native). The survey enquired whether participants would want to be asked for consent for the reuse of stored biological samples.

▪ Of native Hawaiian participants 77.9 % said they would want to be asked for consent for the reuse of biological samples if samples were identifiable compared to only 35–37 % if samples were anonymised

Fong postulates that findings may be due to:

▪ Mistrust of research due to past discrimination

▪ Cultural beliefs, one which includes forbidding desecration of the placenta of the deceased

Baydala et al. 2013 (Alexis Nakota Sioux Nation, Alberta, Canada) [37]

“Making a Place of Respect”: Lessons learned in carrying out consent protocol with first nations elders

Research team members from the Alexis Nakota Sioux Nation and from the University of Alberta held 2 focus groups of 6 participants to reflect on a substance abuse prevention program for the youth of the Alexis Nakota Sioux Nation.

▪ Asking community Elders to sign a standard research consent form was considered insulting if they had already accepted a ceremonious offering of tobacco

▪ In response, researchers developed a new protocol to keep track of oral consent. This was approved by the ethics board, ensuring trust and respect of the community and integrity in research