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      Observational research with adolescents: a framework for the management of the parental permission

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          Abstract

          Background

          Waiving parent permission can be an option in some epidemiological and social research with adolescents. However, exemptions have not been uniformly considered or applied. Our aim is to critically assess the different factors that could be taken into account when making decisions about waiving active parental permission in observational research with adolescents.

          Discussion

          In some cases alternatives to parental permission could be applied to protect the rights of both adolescents and parents and also to assure the benefits to adolescents as a group that can come from appropriately conducted studies. However, the criteria of ensuring minimal risk can be difficult to define and apply and a distinction between harm and discomfort is reviewed. Waiving active parental permission could be acceptable when the risk of harm is minimal; when the research questions are related to an activity for which adolescents are not legally considered to be children; when the risk of harm or discomfort may increase if parental permission is required; and when risk of discomfort is low because the questionnaire is not potentially offensive for some adolescents and/or for some parents.

          Summary

          Stringent rules concerning parental permission in some studies could be detrimental to adolescents. A framework and a decision tree guide are proposed to help researchers and Research Ethics Committees in their decisions on whether active parental permission must be obtained.

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          Most cited references41

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          Written informed consent and selection bias in observational studies using medical records: systematic review

          Objectives To determine whether informed consent introduces selection bias in prospective observational studies using data from medical records, and consent rates for such studies. Design Systematic review. Data sources Embase, Medline, and the Cochrane Library up to March 2008, reference lists from pertinent articles, and searches of electronic citations. Study selection Prospective observational studies reporting characteristics of participants and non-participants approached for informed consent to use their medical records. Studies were selected independently in duplicate; a third reviewer resolved disagreements. Data extraction Age, sex, race, education, income, or health status of participants and non-participants, the participation rate in each study, and susceptibility of these calculations to threats of selection and reporting bias. Results Of 1650 citations 17 unique studies met inclusion criteria and had analysable data. Across all outcomes there were differences between participants and non-participants; however, there was a lack of consistency in the direction and the magnitude of effect. Of 161?604 eligible patients, 66.9% consented to use of data from their medical records. Conclusions Significant differences between participants and non-participants may threaten the validity of results from observational studies that require consent for use of data from medical records. To ensure that legislation on privacy does not unduly bias observational studies using medical records, thoughtful decision making by research ethics boards on the need for mandatory consent is necessary.
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            The competency of children and adolescents to make informed treatment decisions.

            This study was a test for developmental differences in competency to make informed treatment decisions. 96 subjects, 24 (12 males and 12 females) at each of 4 age levels (9, 14, 18, and 21), were administered a measure developed to assess competency according to 4 legal standards. The measure included 4 hypothetical treatment dilemmas and a structured interview protocol. Overall, 14-year-olds did not differ from adults. 9-year-olds appeared less competent than adults with respect to their ability to reason about and understand the treatment information provided in the dilemmas. However, they did not differ from older subjects in their expression of reasonable preferences regarding treatment. It is concluded that the findings do not support the denial of the right of self-determination to adolescents in health-care situations on the basis of a presumption of incapacity. Further, children as young as 9 appear able to participate meaningfully in personal health-care decision making.
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              Ethical approaches to adolescent participation in sexual health research.

              In this paper we make the case for the importance of adolescent sexual health research, and argue that requiring parental consent for adolescent participation may (a) be unwarranted, (b) be inconsistent with the principles of justice and inclusiveness, (c) be confusing, and (d) serve to silence young people who most need to have a voice in sexual health research. Through a case study of the Toronto Teen Survey, we offer concrete suggestions and alternatives for protecting adolescent health research participants in community-based settings and promoting ethical research approaches. Strategies suggested include: (1) adopting a community-based participatory research approach, (2) careful attention to youth-friendly protocols and consent procedures, (3) proper training of all research staff and peer researchers, (4) partnering with experienced community based youth-serving agencies, (5) paying maximum attention to issues of confidentiality and anonymity, and (6) valuing participation appropriately. Institutional review boards and researchers should be encouraged to adopt localized context-dependent strategies that attend to the unique vulnerabilities of their particular study populations. Attention to flexibility, vulnerability, and community-specific needs is necessary to ensure appropriate ethical research practices that attend to the health and well-being of young people.

                Author and article information

                Contributors
                Journal
                BMC Med Ethics
                BMC Med Ethics
                BMC Medical Ethics
                BioMed Central
                1472-6939
                2013
                3 January 2013
                : 14
                : 2
                Affiliations
                [1 ]Institute for Culture and Society, University of Navarra, Pamplona, Spain
                [2 ]Department of Biomedical Humanities, University of Navarra, Pamplona, Spain
                [3 ]Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain
                [4 ]Department of Education, University of Navarra, Pamplona, Spain
                Article
                1472-6939-14-2
                10.1186/1472-6939-14-2
                3585740
                23286743
                0102460c-4805-4d1a-8fe3-c7c3ee93a39f
                Copyright ©2013 Ruiz-Canela et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 14 September 2012
                : 31 December 2012
                Categories
                Debate

                Medicine
                adolescents,parental consent,research ethics,observational research,health surveys,research subjects

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