Table 1.

Application of South African and RTI ethical guidelines to assess the appropriateness for the In Loco Parentis consent procedure.

Requirement of Ethical Guidelines	Application of In loco Parentis
Circumstances for Waiver of Guardian Consent
In particular circumstances, e.g. for reasons of sensitivity, like discussions about sexual activities, substance abuse, etc., it may be desirable and ethically justifiable for minors (especially older minors, i.e., 16 years or older) to choose independently i.e. without parental assistance, whether to participate in research.	The study involved assessing (i.e., interviewing) and addressing (i.e., group-based intervention) sexual risk behaviors and substance use among young women 16–21 years old. The study also involved pregnancy testing, substance use screening, HIV testing, and linkage to HIV and/or substance use treatment if needed.
Generally, only minimal risk research is suitable for independent consent by minors.	This study was considered minimal risk. There were no physical or substantial psychological, social, or legal risks noted. However, minimal psychological, social, or legal risks included the possible disclosure of confidential information; possible mental discomfort associated with issues raised during interviews and intervention sessions; and potential psychological/social/legal consequences of gaining knowledge of HIV test results and/or potential interactions with alcohol and other drug use and their antiretroviral medications. However, all risks were adequately addressed with the proper protections.
Reasons supporting the desirability of independent consent may include recruiting sufficient numbers of minors who otherwise would not be willing to participate if they must tell their parents about the nature of the research to obtain parental permission.	Young women who use substances and engage in sexual intercourse are highly vulnerable to stigma and are unlikely to request permission from their parents and guardians for participation in an HIV and substance use-focused study for fear of negative repercussions. The research teams’ prior research in the same region demonstrated that one of the major barriers to seeking treatment for substance use disorders among young people was fear of negative repercussions from their parents.(Morojele, 2013) Therefore, it would be challenging to recruit a representative sample of young women if they had to obtain guardian consent.
Components of Justification for Waiver of Guardian Consent
Prior engagement with participating community role players, the principal investigator (PI) can request (and justify explicitly) research ethics committee approval of a waiver of the parent (or substitute) permission requirement. Engagement could include outreach to relevant role players such as canvassing the opinion of a representative body of parents via schools.	The research team also consulted with a long-standing Community Advisory Board (CAB, which includes community members, substance use treatment providers, and local government officials, to discuss the appropriateness of waiving guardian consent as well as the implementation of the in loco parentis procedure. This discussion included the identification of respected women living in the communities where the study was taking place who could serve as consenters.
Factual evidence of such engagement must form part of the PI’s justification in the protocol. Factual evidence may be in the form of a letter from a relevant role player (like a community leader, school principal, or a CAB) that confirms the view that independent consent is acceptable to the parents.	The CAB provided feedback on the development of the in loco parentis procedure and provided their support. Specifically, they helped to identify trusted women in the community to serve as in loco parentis representatives. However, the research team did not submit a letter to the ethic boards because we were not requesting independent consent of a minor.
If the research ethics committee accepts the ethical justification and the factual evidence of parental support for independent choice by their minor children, then the research ethics committee may grant a waiver of the requirement of written parental permission and must document the process carefully.	The decision of each ethics review board to allow in loco parentis consenting was recorded in writing via the approval of the research protocol application by both SAMRC and RTI International.