Vulnerable participants - “Vulnerability is a broad category. It describes people who have restricted capability to make independent decisions about their participation in the study (ie, who might traditionally be regarded as lacking the capacity to consent to participate). It also encompasses people who may lack the ability to consent freely or may be particularly susceptible to harm either because of their health status, physical or mental capacity or employment status, or as a result of imprisonment. Non-exhaustive examples of potentially vulnerable people include: • children and young people • people with mental illness • people with serious intellectual disability • people with English as a second language and/or a different cultural background to the investigators (for studies whose details are primarily, or only, stated in English) • people whose freedom to make independent choices is restricted (eg, prisoners, employees of a sponsoring company) • people with serious illness for which the study treatment offers potential benefits that substantially exceed those of any other available treatment.” Table1: Criteria to help researchers determine the level of consultation with Māori appropriate to their project Non-Māori initiated research Māori-centred research Kaupapa Research Level of Māori involvement: • as participants (1) no expected involvement (2) possible involvement (3) probable involvement (4) definite involvement (5) significant involvement, possibly exclusive • on research team No expected involvement Possible involvement as junior researcher positions Probable involvement as researchers and/or advisors Definite involvement as researchers, senior researchers and advisors Significant involvement, possibly exclusively Māori researchers and advisors Type of consultation recommended DHB review DHB Māori review DHB Māori review and possible engagement with DHB Māori reviewers (face to face meeting) Full and on-going engagement and collaboration with appropriate Māori community group(s) Full and on-going engagement and collaboration with appropriate Māori community group(s), Māori are kaitiaki of project
Description of research • Māori have not been included in the design of the project • There are still possibilities to contribute to Māori development • The research topic is not designed to be analysed by ethnicity • Not a topic of particular relevance for • There are still possibilities to contribute to Māori development • the contribution of the research to Māori health and equity is detailed • an area of health that Māori have high representation • a topic of particular relevance for Māori (nationally or locally) • aims for the contribution of the research to Health and equity • Māori knowledge produced, but Māori methods may be used • Clear aims for the contribution of the research to health and equity • Māori analysis is undertaken and Māori knowledge produced Control Non-Māori Non-Māori and/or Māori Māori Analysis Non-Māori Non-Māori • and/or Māori • Ethnicity analysis • Equity analysis • Non-Māori and/or Māori • Ethnicity analysis Kaupapa Māori Tools Non-Māori Non-Māori Possibly some Kaupapa Māori Research methods Non-Māori or Kaupapa Māori Research methods and Kaupapa Māori Epidemiology Kaupapa Research methods and Kaupapa Māori Epidemiology