2 Feb, 2016
By HAYA Research Unit
More than 30 specialists from key stakeholder groups, many working in Africa, met in late November 2015 at a workshop in Durban. The primary aim of hosting such a workshop was to discuss the South African ethical-legal framework in terms of how to plan and implement ethically appropriate and scientifically rigorous research with adolescents in South Africa. It was an opportunity for all involved to reflect on the current legal versus ethical standards in South Africa, in recognition of the complex questions of consent to research involving minors under the age of 18 years. Deborah Farmer, reports on some of the main messages from the meeting…
From researchers to members of research ethics committees, legal and ethics scholars, the local and national Departments of Health, representation from a child rights non-governmental organisation, a young HIV activist- the workshop brought together a wide range of people, each participant adding a different perspective to the mix.
The group shared case studies and explored the current legal constraints and ethical considerations that make it a challenge to enroll minors in research while ensuring that this vulnerable, at-risk population is both adequately represented and protected.
The context for enrolment of minors is complex due, in part, to specific behavioural and structural factors which affect adolescents. These can create widely recognised barriers to the conduct of research with adolescents. The group sought to delve into these issues and debate the merit of different solutions.
Harmonising the legal and ethical requirements
The National Health Act, 2003 (Act No. 61 of 2003) in South Africa is the first effort made by the South African government to protect health-related research participants under law. Implemented on March 1, 2012, the law mandates active consent from a parent or legal guardian for all research conducted with research participants under the age of 18 years. The National Health Research Ethics Council was established in terms of the Act. The role of the Council is to promote and monitor compliance of South African ethics committees within relevant legislation and regulations, ethical guidelines and standards.
Section 71 (3)(a) of the same Act requires Ministerial consent for non-therapeutic research with minors – minors are defined as anyone under the age of 21 years; children are under the age of 18. While the Act defines circumstances under which the Minister of Health may not give consent, there is no provision for waiver of consent. Instead, the Minister has delegated authority to registered research ethics committees (RECs). In South Africa, RECs are thus mandated to consent to the participation of adolescents in non-therapeutic research on behalf of the Minister, and concurrently authorise such research.
Furthermore, informed consent for minors is explicitly governed by statutory law and minors have to consent to their participation in research. Informed consent documentation should therefore spell out to parents that their permission is sought to approach the child to request participation. It is the child’s decision whether to participate.
The most striking contradiction in the South African legal framework is the issue of consent. According to the law, enrolment in research is not discretionary; it is only with parent or legal guardian consent. However, South African legal regulations and ethical guidelines state there is discretion for a broader range of consent strategies, while at the same time providing for ‘exceptional circumstances’ where consent from a parent/legal guardian can be waived and where a child aged 12 years or older, has the right to self-consent and confidentiality for various components in a research study. The National Health Act, 2003 Regulation (R719; commencement date: 19 September 2014) provides a positive child rights perspective, recognising inclusion for ‘children’ in health research given valid and ethical scientific reason. In fact, excluding children from research when it is unjustifiable is seen as a form of unfair discrimination.
“The challenge is a protectionist legal framework rather than an access to research framework”- Catherine Slack, The HIV AIDS Vaccines Ethics Group (HAVEG) based at the School of Applied Human Sciences, University of KwaZulu-Natal, one of the workshop participants.
The debate concerning exemption for parent permission in research with adolescents is ongoing. While waiving parent permission can be an option for RECs, any decision to do so involves careful consideration of risk of harm and the autonomy (and increasing capacity) of adolescents to make independent decisions concerning their own health. Exemptions are often not uniformly considered, or applied, even in different regions of the country.
Understanding the complicated, sometimes contradictory, ethical and legal framework continues to be a challenge. So as not to deter research studies that address important health problems relevant to adolescents, striking a balance between the two will require further undertakings from all those involved.
From left to right: Neetha Morar, South African Medical Research Council and Lebo Madisha – National Department of Health, SA. Photo courtesy of Lisa Butler.
It became clear during the workshop that many additional issues exist, beyond those outlined here. South Africa imposes explicit disclosure obligations in relation to research involving persons under 18. Researchers must think very carefully about their methodology, goals and consequences regarding the reporting obligations set out in various Acts. The research protocol must explain fully how the researcher plans to deal with the obligation to report, so that the REC is able to deliberate effectively.
Other barriers to research enrolment range from confidentiality assurances of privacy that can be afforded adolescents according to the law, to whether appropriate safeguards are in place for adolescents identified at-risk or in-harm. Reporting alone does not absolve from ethical responsibilities, arrangements must be made to assist affected minors. Researchers and their research staff (field workers, social workers, nurses etc.) should also feel adequately supported when faced with these concerns.
A number of different solutions to the various challenges were discussed, with some of the key messages including:
The need for uniform definition of age of adolescents- currently described as 12-17 years in the Dept. of Health, South Africa (2015) Ethics in Health Research. Principles, Processes and Structures guidance, to bring it in line with the United Nations definition – between 10 and 19 years of age. This is important for both study design (inclusion/exclusion criteria) and RECs when reviewing research governance in relation to informed consent. At this time the The National Health Act, 2003 does not distinguish between minors who are children and minors who are adolescents.
Researchers need to provide assurance to RECs that due consideration has been given in protocol development, consent materials have been carefully designed, and mechanisms are in place to mitigate against any potential adverse research outcomes. Effective strategies to engage stakeholders, including Community Advisory Boards, in identifying unrecognised risks are important, and these examples should be shared between researchers.
The need to encourage networking between RECs that promotes systematic compliance with relevant legislations and regulations, ethical guidelines and standards for adolescent health research. RECs might also consider appointing a key member with appropriate adolescent health expertise to support the decision-making process.
Generation of a repository of materials to support all stakeholders concerned. Included in the repository would be a range of documentation to include precedents for the management of reportable events, examples of studies where waiver of parental/guardian consent has been granted and informed consent materials that take age, cultural and linguistic considerations in to account.
Further regulatory and policy reform is necessary to facilitate research on adolescents – the lack of clear guidance continues to pose a problem for RECs when faced with making decisions that necessarily require taking several factors in to account; the research topic, where it is implemented, participants age and the extent to which these factors affect their vulnerability.
At the end of the two days one message was clear: whilst improvements to existing mechanisms could be made, overcoming the challenges to research on adolescents needs to be considered as part of a much broader conversation for which partnerships will be essential.
As a result of the meeting we are now preparing a brief commentary highlighting the main issues and recommendations from the workshop – to be published in early 2016. We are also collating a consensus document of recommendations from the workshop where we could make a difference. We will endeavour to share our plans moving forward and as these are developed.