Parental waivers to enable adolescent participation in certain forms of health research: lessons from a South African case study | BMC Medical Ethics

This discussion is based on the assumption that parental or guardian consent is generally the gold standard for research involving children. The reasons for this protection approach are articulated in the CIOMS guidelines [16] which state that children are at increased risk of research-related harm compared to adults and may be less able to protect their own interests through the informed consent process due to their lack of full legal capacity. However, the mandatory parental consent limits the type of research that can be conducted with children [2, 7,8,9, 11,12,13, 15] and the ability to enroll and retain children in research [7, 8, 13, 15, 25, 26]. This limits advances in children’s health, including the development or improvement of children’s health services.

In determining whether ethical norms on parental waivers are appropriate, we examine three sub-questions: (1) When are parental consent waivers appropriate? (2) What safeguards are required if parental consent is waived? and (3) what procedural requirements should be met when issuing a parental waiver?

Our underlying approach is to (1) examine how the ethics guidelines and the flexibility they provide could be strengthened by developing additional factors to guide decision-making, and (2) identify the broader issues that may arise other countries that wish to do so will assess their own ethical standards in relation to parental waivers.

  1. (I)

    When is waiving parental consent appropriate?

As noted above, the grounds for parental waivers are included in our national ethics guidelines [6] are largely in line with the principles of international ethical guidelines [16]. The circumstances in which parental waivers in favor of carers are appropriate are clearly articulated in the South African guidelines [6]. The use of a definition of caregiver in the Children’s Act is a strength of the guidelines as it ensures clarity on the qualifiers for surrogate parent consent. CIOMS requires a “legally authorized person”.

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However, renunciations in favor of adolescent self-consent are less clear. The literature has identified some useful factors relevant to determining whether adolescent self-consent is ethical, including an examination of both the study and the potential child cohort. In relation to the study, the following relevant factors should be considered: the nature of the study and whether parental consent is desirable or feasible [27, 28]; whether a parental consent approach compromises scientific validity [29]; the risks, benefits, and benefit-risk balance of the study [27, 28]; and any proposed safeguards put in place to support juvenile decision-making [29]. In the case of risks, a distinction should be made between the level of risk posed by the study and the risks that may arise from the behavior of the participants [22, 29]. Regarding the youthful participants, Relevant factors include: the capacity, maturity and cognitive abilities of the child participants, including whether any of the participants will be legally competent as defined by local law [22, 29] and a review of the best interests of potential child participants [29].

Bauman, Mellins, and Klitzman [29] suggest that parental waivers are ethical when there is an appropriate level of risk, the adolescent is of sound mind, and when obtaining parental consent is not in the best interests of the child or if the parents cannot give permission. We contend that a key factor to consider is the capacity requirements for study consent. Hunter and Pierscionek [30] argue that a child would have discernment if they could demonstrate that they understood (1) the nature of the research, (2) their rights as a participant, and (3) the risks and benefits of participation. We argue that an ability-based waiver approach is consistent with the principles of a child’s developing ability and right to participate in decisions that affect them [17, 31]. Nonetheless, Hunter and Pierscionek caution against making individual assessments of capacity by researchers who they believe may be biased by their own self-interest in the outcome [31]. Therefore, they suggest that the assessment should be made by a person independent of the study [31].

  1. (ii)

    What safeguards are required if parental consent is waived?

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Following the approach in CIOMS [16], we argue that protection should be provided when parental consent is waived. Safeguards must be in place for waivers in favor of caregivers and for youth self-consent. CIOMS Guidelines [16] Give two examples of possible protective measures in the form of decision-making aids for young people. These are the child’s appointment or hiring of another adult (other than a parent). independently psychological or medical practitioner to support the participants [16]. In addition, the standard for assessing whether the protection is adequate is whether it ensures that the best interests of research participants are protected from children [16]. If consent is allowed for representation by adult surrogate parents, the protection needed should be to ensure that the adult has the legal or ethical authority to give consent. In the South African context, this would mean that the child head of a CHH cannot consent to the participation of his younger siblings in the research, even if they are considered carers within the meaning of the Children’s Act. If children are to consent to themselves, decision support should be required. These can take many forms, such as peer support groups [32] or the support of another trusted adult.

  1. (iii)

    What procedural requirements must be met if a parental waiver is granted?

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As mentioned above, the CIOMS guidelines [16] require no additional procedural protection. In the South African context, the procedural requirement of community consent appears to provide very little, if any, additional protection. This is primarily because it is unworkable without further details on who researchers should consult with to obtain this approval, or the justification for obtaining community consent. The guidelines do not specify who would comprise the relevant community and whether community consent would (a) be a substitute for parental consent or (b) give adolescents permission to consent? In the former case, it is unclear which community representatives would be the most appropriate proxy for parental permission (e.g. do representatives have to be parents themselves?). Regarding the identification of specific community representatives for consultation purposes, it is unclear how this would be operationalized for national research or in the case of virtual access to target groups (e.g. young people using online platforms). The vagueness of the Community consultation standard in deliberation has led to inconsistencies in its application. While community engagement is critical to research, it seems arbitrary to require it as a precursor to an approach to adolescent self-consent.

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