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Dagmar M Haller,* Lena A Sanci,† George C Patton,‡ Susan M Sawyer§
* General Practitioner and PhD Candidate, ‡VicHealth Professor and Director of Adolescent Health Research, §Professor of Adolescent Health, and Director, Centre for Adolescent Health, Murdoch Children's Research Institute and The University of Melbourne, 2 Gatehouse Street, Parkville, VIC 3052. †Senior Lecturer, Department of General Practice, The University of Melbourne, Melbourne, VIC. dagmar.hallerATmcri.edu.au
To the Editor: We recently advocated the inclusion of a mature-minor clause in the National Health and Medical Research Council ethics guidelines on teenagers’ participation in research.1 This would allow minors (teenagers younger than 18 years) who show sufficient maturity and understanding to consent to participation in minimal risk research (eg, observational studies and quality assurance studies) without requiring parental consent. This is important in primary care research, as teenagers presenting to general practitioners without an accompanying parent or carer frequently wish their visit to remain confidential. To exclude this group from research would deny them the benefit of potential improvements to their health care as a result of research.
As no such data were available in Australia, we sought to document, as part of a larger primary care study of young people’s perspectives on their health problems and their expectations from a GP consultation, the proportion of teenagers aged 16 to 18 years who potentially would not be able to participate because they presented without a parent. We also documented whether, when present, parents would express concern about not being asked to provide consent for their teenaged child to participate.
We recruited up to 20 consecutive patients aged 16 to 24 years in each of 26 randomly selected practices throughout Victoria and invited them to participate in an interview on their perspectives on the health problem for which they had come to see the doctor and their expectations from the consultation. Our institutional ethics committee approved inclusion of minors aged 16 to 18 years without parental consent. One of the authors, a GP (D H), obtained consent from participants and conducted the interviews.
Results are reported with 95% confidence intervals adjusted for clustering within practices. Of the 501 young people approached, 101 were minors. Five minors (5%; 95% CI, 0.6%–9%) were excluded (too unwell, intellectually disabled or non-English speaking), and another five (5%; 95% CI, 1%–8%) declined participation. Of the 91 minors who consented to participation, 40 (44%; 95% CI, 35%–53%) had come without a parent. Although 37 of the parents of the 51 minors who were accompanied (73%; 95% CI, 59%–86%) went into the GP consulting room with their children, only one was concerned about her child consenting and participating in an interview on his own.
Had parental consent been mandatory, nearly half the patients aged 16 to 18 years could not have been included in this primary care study. When present, the overwhelming majority of parents did not disapprove of their children consenting and participating on their own.
These findings support the idea that, for low-risk studies in primary care, mature minors should be given the opportunity to consent to participation on their own.
Acknowledgements: Lena Sanci’s postdoctoral fellowship is funded by the National Health and Medical Research Council. Dagmar Haller receives an International Postgraduate Research Scholarship at the University of Melbourne and a fellowship grant from Geneva University, Switzerland.
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©The Medical Journal of Australia 2005 www.mja.com.au PRINT ISSN: 0025-729X ONLINE ISSN: 1326-5377