计划生育研究实践支助学会:研究人员和机构审查委员会对未成年青少年的性健康和生殖健康研究的考虑。

Maureen K Baldwin, April J Bell, Andrea J Hoopes, Subasri Narasimhan, Mary A Ott
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引用次数: 0

摘要

本指导文件为性健康和生殖健康(SRH)研究人员、机构审查委员会(irb)、研究伦理委员会和资助者提供了将未成年青少年适当纳入性健康和生殖健康研究所需的知识和工具。我们概述了明确将未成年青少年纳入性健康和生殖健康研究的重要性。我们为研究人员和内部审查委员会解释伦理准则。我们敦促研究人员避免使用18岁作为研究纳入的截止年龄,因为在许多司法管辖区,18岁以下的青少年可能会为性健康和生殖健康护理和研究提供自我同意。当需要保护隐私或机密性时,我们描述了放弃父母同意、放弃签署同意和保密证书的选项。我们定义了青少年未成年人的常规临床护理,以帮助确定最小风险研究。最后,我们提倡一个研究同意环境,考虑理解研究参与的发展能力。将未成年青少年纳入研究对促进健康公平和生殖正义至关重要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Society of Family Planning Research Practice Support: Researcher and institutional review board considerations for sexual and reproductive health research with minor adolescents.

This guidance document provides sexual and reproductive health (SRH) researchers, Institutional Review Boards (IRBs), research ethics committees, and funders with the knowledge and tools necessary for the appropriate inclusion of minor adolescents in SRH research. We provide an overview of the importance of explicit inclusion of adolescent minors in sexual and reproductive health research. We interpret ethical guidelines for researchers and IRBs. We urge researchers to avoid using age 18 as a cutoff for research inclusion since, in many jurisdictions, youth less than age 18 may provide self-consent for SRH care and research. We describe options for waiver of parental consent, waiver of signed consent, and Certificate of Confidentiality, when needed for protection of privacy or confidentiality. We define routine clinical care for adolescent minors to aid determinations about minimal risk research. Finally, we promote a research consent environment that considers developmental capacity for understanding research participation. Inclusion of adolescent minors in research is crucial to promote health equity and reproductive justice.

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