Ethical Issues in HIV Vaccine Trials
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There is increasing evidence of the effectiveness of male condoms in preventing HIV infection. Education and risk-reduction counselling is a key component of HVTs. It is not clear when a prevention method is considered 'proven' or 'established effective'. While RCTs are considered the gold standard for establishing the efficacy of interventions, most of the currently accepted effective HIV prevention tools e.
Additionally, there are omissions from, and contradictions in, key ethical guidelines. Examples include that male circumcision receives no discussion as a recommended risk-reduction method under the guidance point on standard of prevention in the UNAIDS-WHO 2 guidelines. These same guidelines recommend that risk-reduction counselling possibly be provided by an independent agency owing to concerns around conflict of interest; 2 however, other prevention services apparently do not raise such concerns.
Ethical issues in HIV vaccine trials in South Africa.
Also, the UNAIDS-AVAC 14 guidelines set a very high procedural standard, including that researchers should consult with stakeholders, document the consultations, map service providers that will support sites, build capacity to do so, and monitor uptake of prevention services. Trials should also not be conducted in circumstances when 'agreements have not been reached among all research stakeholders on [the] standard of prevention' 2 p. Furthermore, there has been little empirical investigation of the prevention services provided to participants in HVTs. More attention has been paid to microbicide and diaphragm studies where three South African sites have been researched.
Recommendations for addressing complexities with providing currently available tools. Guidelines must be formally evaluated to highlight where guidance is least clear, to bring the most relevant guidance to the foreground, and to clarify researchers' responsibilities. Prevention services offered to HVT participants, as well as decision-making practices, should be assessed. It should be assessed whether practices correspond with ethical guidelines, and whether ethical guidelines provide direction on researchers' actual dilemmas.
Current international ethical guidance asserts that researchers, research staff and sponsors provide new methods to trial participants when they are 'scientifically validated or approved by the relevant authorities'. South African guidance states that new methods are added as they are 'discovered and validated'. What new methods could become part of the prevention package? Pre-exposure prophylaxis PrEP. Results are expected in and , respectively. Results are expected in Two trials of tenofovir were stopped in Cambodia and Cameroon because of ethical controversies. Microbicides are female-initiated products applied to the vagina to prevent HIV infection.
No microbicide products tested in efficacy trials e. Carraguard, cellulose sulphate have proven effective in reducing the risk of HIV infection. Behavioural interventions.
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Complexities of adding new tools to the package of prevention. The level of evidence needed for new methods seems to surpass what is accepted for current tools. Also, several regulatory complexities may exist. Some new prevention technologies must be approved by national regulatory authorities to be used in a country e. Furthermore, for some products licensure requirements may be unclear, e.
However, from another perspective it was argued that acyclovir has an anti-HIV effect 19 that may have explained any decreases in HIV transmission, therefore requiring researchers to apply for a change of indication. Some regulatory authorities have not outlined their requirements for licensure of products such as microbicides or vaccines.
However, regulators often require that to be licensed, new products must be tested in at least two RCTs or a single pivotal trial phase III trial that provides as much evidence of effectiveness as two trials would have. Furthermore, once regulatory obstacles are overcome, manufacturing, distribution and surveillance capacity may become important considerations.
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Furthermore, ethical guideline requirements that trials should not be conducted without consensus among all research stakeholders on the standard of prevention 2 may not adequately take into account how difficult consensus-building can be, that canvassing the opinion of affected parties may be morally relevant but not morally definitive, 21 and that in some instances this procedural requirement may serve to lower the substantive standard that such a package be 'state of the art'.
Lastly, when new tools are added to the standard of prevention, the incidence of HIV in large-scale late-phase trials is likely to decrease. When incidence is reduced, the statistical power of the study to detect significant differences decreases, making it increasingly difficult to demonstrate the efficacy of the candidate product. When the addition of new tools will invalidate trial results or otherwise make trials impossible to run, then arguably the obligation to provide all such tools to participants is weakened.
This is because invalid trial results mean that participants will have been exposed to risks for no purpose in that important societal knowledge for future beneficiaries will not be gained. In our view this is the ethical crux of the matter.
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Efforts 12 to thoroughly explore this concern need to be strengthened. Recommendations for addressing complexities with adding new tools to the prevention package. There should be an expert consultation by HVT researchers, sponsors, regulatory authorities, community representatives and ethics committees to define the acceptable level of effectiveness to add new tools to the prevention package. Also, the threshold at which adding new tools will invalidate trial results should be explored.
Efforts should be made to understand how decisions are and will be made to add new tools to the prevention package offered to HVT participants. Developing country regulators should outline their requirements for the licensure of new products. Sponsors and international donors should consider how trial budgets will be expanded to take into account new prevention technologies. There has been little empirical exploration of what prevention services researchers currently provide to participants in HVTs, how they make decisions about what to provide, and their challenges and successes.
Data are also limited on the degree to which service-delivery and decision-making practices correspond with standards in ethical guidelines. Empirical research is needed to fill this gap. Furthermore, new and promising results of products such as PRO gel plus the imminent possibility of positive results for PrEP or behavioural interventions indicate that HVT researchers must deliberate now about the implications for the prevention package offered to trial participants.
We gratefully acknowledge helpful comments from Helen Rees, Sinead Delany-Moretlwe and Earl Burrell on issues related to regulatory challenges for new prevention tools. Stover J, Fahnestock M.
The Science and Ethics of HIV Vaccine Research
Methodological challenges in biomedical HIV prevention trials. Px wire: A quarterly update on HIV prevention research. Our work in a rural part of South Africa has revealed that adolescents, some as young as 12 years old, routinely seek antenatal care, treatment for sexually transmitted infections, or family planning at district clinics. They do so autonomously, despite the legal age for consent to treatment being 14 years of age, and, perhaps, they do so because they do not have parents or legal guardians or because they perceive that confidentiality is assured.
These factors no doubt motivate adolescents to present at clinics for treatment in other settings, too. Following the guidance of the General Principles for adolescent research attached to such clinics will make such research impossible.
Ethical issues in HIV vaccine trials in South Africa.
Although the General Principles are, strictly speaking, only binding on MRC-sponsored studies, they are generally considered influential among members of South Africa's research ethics community. Adolescents' best interests will be served by their autonomous participation. The NHA mandates the solicitation of parental consent for adolescent enrolment in therapeutic and nontherapeutic studies, as well as ministerial consent in the case of nontherapeutic studies. In May , South Africa issued its first national health research ethics guidelines intended to govern all health-related research in the country.
However, some of its provisions are incompatible with the NHA. Paragraph 5. However, unlike the NHA, which does not recognise the rights of children to autonomously participate in research in any circumstance, the EHR adopts a flexible approach that seemingly puts it at odds with the NHA. The EHR also seems to have heeded the concerns of investigators participating in sensitive research involving adolescents, who voiced their concerns about the inflexibility of the NHA on this issue.
The opinion of the REC must be informed by information gathered from the community concerned and by contributions from the lay members of the committee. The EHR stipulates that in all cases, the protocol must provide sufficient information to justify clearly why adolescents should be included as participants and must justify clearly why the adolescent participants should consent unassisted. Conventional wisdom dictates that provisions of law take precedent over provisions in policy or guidance documents. However, there are at least five important reasons why a REC should embrace the stance of the EHR, in regards to research on minors, over that of the NHA, notwithstanding the latter's legal nature.
First, adhering to the flexible stance of the EHR will make it possible to investigate valuable and necessary sexuality-related research on adolescents, of the type outlined above. Second, a REC's primary mandate should be to make decisions based on ethical considerations versus exclusively legal considerations.
Blindly following ill-considered law could evidence unethical and unconstitutional outcomes. Third, the EHR was launched by the minister of health in the aftermath of the promulgation of the NHA and the numerous concerns that were raised about its provisions pertaining to research on minors.
It should be assumed that the minister applied her mind to the issue, realised the inconsistency between the NHA and the EHR, but gave her unreserved endorsement to the latter because doing so was in the best interests of adolescent minors. To assume otherwise would imply that the minister did not apply her mind to the implications of the EHR before approving it. Fourth, as in other countries, South African law holds that the best interests of the child must dictate what approach to follow in matters pertaining to a child. Given the invaluable biological, sociological, behavioural, and clinical data that the inclusion of an adolescent cohort will generate in HIV studies, the enrolment of this cohort is crucial for future prevention and treatment interventions in this group.
Accordingly, the best interests of adolescents will be served by their autonomous participation in such studies. The NHA is intended to protect the interests of children.
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RECs should respect the spirit of the law rather than merely the letter of the law. The interests of children will be protected and promoted by their participation in minimal risk HIV observational studies. Fifth, in growing recognition of the autonomous decision-making abilities of young individuals, South Africa's draft Children's Bill [ 19 ] promises to bring sweeping changes to the law in regards to children.