Vulnerable participants - is a broad category. It describes people who have restricted capability to make independent decisions about their “Vulnerability 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 Kaupapa research Research Level of Māori (1) no expected (2) possible involvement (3) probable involvement (4) definite involvement (5) significant involvement: involvement involvement, possibly as participants exclusive • on research No expected involvement Possible involvement as Probable involvement as Definite involvement as Significant involvement, • team junior researcher researchers and/or researchers, senior possibly exclusively Māori positions advisors researchers and advisors researchers and advisors Type of DHB review DHB Māori review DHB Māori review and Full and on-going Full and on-going consultation possible engagement with engagement and engagement and recommended DHB Māori reviewers (face collaboration with collaboration with to face meeting) appropriate Māori appropriate Māori community group(s) community group(s), Māori are kaitiaki of project
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
AHREC%20Frequently%20Asked%20Questions%20v1.docx