Introduction

South Africa has one of the highest incidences of HIV among adolescent girls and young women (AGW), ages 15–24, and recent research has focused on developing interventions for HIV prevention. However, the South African National Health Act requires those under 18 years of age to obtain a guardian's permission to participate in research. Limiting research enrolment to AGYW who can obtain guardian consent may lead to non-representative findings. Therefore, innovative, inclusive consent approaches that protect AGYW from the risks of research are needed.

Methods

This report details the development and implementation of an approach called the in loco parentis (in place of parent) consent procedure. In loco parentis consent provides a vehicle for adolescent participation that protects adolescents from potential social harms. The in loco parentis consent procedure does not seek to obtain independent minor consent but seeks to obtain permission for the minor to participate in research from a trusted adult who is not a minor's parent or legal guardian. This report also qualitatively explores the experiences of 31 AGYW who were recruited into a behavioral HIV prevention study using this method.

Results

Findings suggest that the in loco parentis consent procedure is a feasible and acceptable method to inclusively AGYW in HIV research.

Conclusions

The in loco parentis procedure may provide a more inclusive strategy to recruit AGYW for HIV research to increase the generalizability of findings.

中文翻译：

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“因为所有母亲都是不一样的”：制定和实施替代父母知情同意程序，以招募少女和年轻妇女参与艾滋病毒研究

 介绍

南非是 15 至 24 岁少女和年轻女性 (AGW) 艾滋病毒发病率最高的国家之一，最近的研究重点是制定艾滋病毒预防干预措施。然而，南非《国民健康法》要求18岁以下的人参与研究必须获得监护人的许可。将研究纳入仅限于能够获得监护人同意的 AGYW 可能会导致不具有代表性的研究结果。因此，需要创新、包容的同意方法来保护 AGYW 免受研究风险的影响。

 方法

本报告详细介绍了一种称为“代替父母”同意程序的方法的开发和实施。代替父母的同意为青少年参与提供了一种手段，保护青少年免受潜在的社会伤害。代替父母同意程序并不寻求获得独立的未成年人同意，而是寻求从非未成年人父母或法定监护人的可信赖成年人那里获得未成年人参与研究的许可。本报告还定性探讨了 31 名 AGYW 的经历，他们被招募到使用这种方法进行艾滋病毒行为预防研究。

 结果

研究结果表明，替代父母同意程序是将 AGYW 纳入艾滋病毒研究的可行且可接受的方法。

 结论

代替父母程序可能会提供更具包容性的策略来招募 AGYW 进行艾滋病毒研究，以提高研究结果的普遍性。