Ethical Issues in HIV Vaccine Trials

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Every day that we do not have a vaccine, every day that we delay testing of candidate vaccines, is another quantum increase of approximately 10, in new individual infections and new personal tragedies. The economic impact, particularly in developing communities, is already serious and is growing daily more severe.

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These costs are already devastating in some communities, as we will see, and are expected to become even more dramatic. When measured in years of potential life lost YPLL , the impact of the pandemic is particularly severe because the age group that is most susceptible to infection is so young. It is also the age group, of course, that does much of the productive work in a society, and that does most of the child care in families as well.

The mutual interactions between HIV disease and tuberculosis have contributed to an increasingly severe recrudescence of TB which is the one opportunistic infection that can be readily transmitted to non-HIV-infected persons , and to increasingly numerous strains of multi-drug-resistant TB MDRTB. These developing TB epidemics around the world also take their own tolls on persons, on families, and on regional economies. Nor can we ignore the possibility of HIV's developing interactions with other microbes in a manner that could potentiate either or both of them.

Although there is as yet no evidence for this in present strains of HIV, the longer we wait before gaining control of the AIDS pandemic, the greater potential there is for unanticipated interactions to develop between HIV and other microbes. Finally, must we not acknowledge that when the well-being of the larger community is at risk, it may be best that certain forms of individual freedom be temporarily modified.

The concepts of legal military conscription, of laws of taxation, of regional zoning ordinances, and so on, are all based on the principle that sometimes individual freedoms must be temporarily modified for the well-being of the larger community. If it is even partially true that "AIDS is the single greatest threat to well-being facing the world's population today," then, in order to develop a successful preventive measure such as a vaccine, some codes and guidelines that have usually governed medical research in the developed world may need to temporarily take a back seat to the needs of the larger community, until we find some ways to get this pandemic under adequate control.

Enrolling Adolescents in Research on HIV and Other Sensitive Issues: Lessons from South Africa

All these reasons provide strong support for the claim that, for the common good of society and of the human species , efficacy trials for HIV candidate vaccines should be undertaken as soon as possible. Some researchers argue that this is especially true given the fact that we do already have available candidate vaccines that have proven to be both safe and immunogenic as we will see later. Some viral subunit candidate vaccines have even been proven partially efficacious in some animal models.

Given these considerations, say some researchers, it would seem grossly unethical to continue postponing these trials, especially in developing nations which are themselves anxious to have the trials take place among their own populations. In other words, say Thesis proponents, we must consider the ethics of waiting. To wait, after all, is an act, an act that has consequences, and in this case it has severe consequences.

If we choose to not support the Thesis position, and to instead recommend delay of the trials, then we should be aware that that choice will be attended by costs, and they are costs that deserve our serious attention. These reasons lead us to the conclusion that we must not delay initiation of HIV vaccine trials any longer; rather, we must boldly go forward with them. The longer we wait, the greater the tragic cost will be. If the Thesis position primarily urges boldness and moving ahead toward finding a safe and effective vaccine, out of a deep concern for the protection of those not yet infected, the Antithesis position primarily urges caution, reflection, wariness of haste; it urges a profound concern for the well-being of those tens of thousands of volunteers who will probably be participating in the trials.

In order to get a brief glimpse of some of the ethical issues raised by those who hold the Antithesis position, consider this one question among numerous others that could equally well be posed : Why would any sensible, even moderately self-interested person ever consent to participate in experiments which entail the potential for so much risk to their personal health and their social well-being, and which have so little potential for any personal benefit?

Might the reasons be that perhaps they simply have not been made fully aware of the degree of risk involved? Perhaps they were not fully informed by researchers? Or if they did participate in an "informing session," perhaps the information they were given did not register with them; perhaps they did not fully understand what they were told? Or perhaps they were, in some subtle way, deluded into thinking there would be some potential benefit to them in the form of possible protection against HIV infection?

Perhaps they were offered some inducement, by research sponsors, to participate? Perhaps they were in some way persuaded, or pressured, or possibly even coerced into participation by someone at the institution where the research is being conducted.

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Perhaps they were pressured or coerced by government or community leaders, or perhaps even by someone else close to them, such as a spouse or boss. When there is so much to potentially lose, and almost no likelihood of any personal benefit, why would anyone choose to volunteer for such trials? These questions, and numerous others like them, are raised by those who hold the Antithesis position. They insist that it would probably be illegal, that it would certainly be immoral, and that it would likely have disastrous consequences for future research protocols if trials were to be initiated without fully adequate compliance with all requisite ethical guidelines.

In the largest sections of this book I will be primarily exploring and defending the point of view expressed by the Antithesis position, though it will be the task of this book to lay out the reasoning, the concepts, and the information that lie behind both of these positions. It is hoped that when the full force of the Thesis and Antithesis positions are more clearly understood, then the chances for a viable Synthesis position to emerge will become more promising. Ethicists and researchers at the World Health Organization in Geneva and at the National Institutes of Health in the US have already been discussing these issues, of course, but as of the summer of many of the issues are still undecided and remain quite controversial.

Abstract no. Godbole S, Mehendale S. Press Information Bureau. Press Release, Vaccine ; Sahay S, Mehendale S.


Engaging community to support HIV prevention research. Eastern J Med ; Evaluation of the ability of clinical research participants to comprehend informed consent form. Contemp Clin Trials ; This article has been cited by. Satyanarayana Ramanaik,Leigh M. Lorway,Peter A Newman. Experiences in recruiting volunteers through community based initiatives in Phase- 1 vaccine trials in India.

Various mechanisms for ensuring access to STI treatment at screening were adopted across sites and for both trials, including on-site provision where funds permitted , or referral to a co-located or public healthcare facility. A few respondents reported that participants were informed about where their partners could access treatment. For the phase IIB study, a circumcision assessment was conducted at screening and volunteers were informed of the benefits of circumcision.

PEP was reportedly only ensured for enrolled participants. Respondents at some sites described that the provision of prevention services to non-enrolled persons is difficult in the context of constrained trial budgets. Sites have generally exceeded guideline requirements by ensuring access to certain prevention services for non-trial participants. Previous research has found that trial sites endeavour to provide a variety of services to partners and screen-outs but noted that this may make conducting research prohibitively expensive Ngongo et al.

Similarly in this study, resource and budget constraints were reported as impeding the provision of prevention interventions to non-trial participants. Guidance is unclear on the standards of prevention for those not enrolled in trials Tarantola et al.

Ethical and Legal Issues in AIDS Vaccine Trials

Therefore, it has been recommended that researchers and sponsors should make such determinations in consultation with relevant stakeholders Tarantola et al. The phase I protocol only specified that risk-reduction counselling would be provided to participants. Informed consent forms for both studies specified that counselling would be provided to participants but provided no information about other prevention options.

However, respondents reported that HIV prevention components are described to participants in the informed consent process. This research aimed to explore the extent to which actual practices in HVTs corresponded with related recommendations in ethics guidelines, to identify complexities with implementation of services and to make possible recommendations for guideline revisions and strengthened practices. In some instances, practices at sites exceeded guideline recommendations, for example, by paying for VMMC at private facilities. Site services also sometimes exceeded preventive options available in the local community, for example, by ensuring access to PEP for all sexual exposures, and to VMMC at a time of limited public access. This study found that practices deviated from guidelines in terms of the content of consent forms and protocols—sites provided substantially more to participants than was specified in the consent documents for both trials and in the phase I trial protocol.

More specifically, for STI treatment, sites had to engage service providers to dispense STI treatment on-site, or themselves raise funds; alternatively they made referrals to the public sector. Further, the network raised funds to pay for VMMC in one trial, and the sites ensured access in the other trial. Restrictions on sponsor funds for care provision not necessary for scientific validity or participant safety Philpott et al.

In line with UNAIDS guidelines, these data indicate that the burden of providing prevention interventions is shared among sponsors, researchers, government service-providers and, in some instances, private donors. This study found that access to VMMC was ensured for both trials and at all sites on-site or via referrals to private facilities , and identified the reported concern that other concurrent or overlapping trials may adopt different approaches to delivering VMMC e.

This study found that access to PEP was ensured for all risky sexual exposures for the two trials at all sites, and identified the reported concern that for some trials and some sites, this approach may not be possible for example, where sites do not have the resources to self-fund PEP. This raises the concern that where trials and sites use different approaches for PEP, this may create differences between participants in different protocols at the same site or between participants enrolled at different sites.

This suggests that guidelines allow for some flexibility in approaches to the implementation of standards of prevention. Findings from this study indicate that referral is not a common strategy for the delivery of prevention services, with most prevention services provided on-site. However, the DoH emerged as a key partner in ensuring access to many prevention services.

Engaging this partner was associated with some tensions, for example, late delivery of condoms from government, or constraints bearing on STI treatment at public sector facilities, as predicted by literature Chatterjee et al.