CHAPTER TWO LITERATURE REVIEW
2.4 RECOMMENDATIONS IN ETHICAL GUIDELINES
2.4.1 GUIDANCE NOT SPECIFIC TO SOUTH AFRICAN HIV VACCINE TRIALS
The Declaration of Helsinki (WMA, 2008; 2013) asserts that physicians have a duty to protect the life and health of patients including research participants. This has led to two interpretations. Specifically a strong interpretation where it is held to mean that researchers must provide care for diseases that threaten the health of their participants (Tarantola et al., 2007) which has been criticized as placing unreasonably expansive obligations on researchers (Participants, 2008). It has also had a weaker interpretation that researchers must merely minimize research-related risks, take steps to prevent research-related harms, and provide treatment for adverse events (Tarantola et al., 2007).
CIOMS (2002) asserts that ancillary care responsibilities are non-obligatory but are rather morally praiseworthy or supererogatory (CIOMS, 2002; Pratt et al., 2013; Stobie & Slack, 2010). More specifically, CIOMS (2002) asserts that sponsors only have an obligation to provide health-care services if the services are essential to scientific or safe conduct of research, or constitute treatment for injury, or are explicitly agreed to, or are part of post-trial availability commitments - all other instances of service-provision would be morally praiseworthy.
The Nuffield Council on Bioethics (NCOB, 2002) asserts that participants in prevention trials who develop the disease that is the target of the preventive intervention should be offered a universal standard of care but where this is ‘not appropriate’ they should be offered the best available intervention as part of the national public health system for that disease (p. 96). For participants in prevention trials who develop diseases unrelated to the target condition, they should be offered the best intervention available as part of the national public health system.
Local guidelines for health research in South Africa do not deal in much detail with the explicit issue of ancillary care. One guideline that provides general guidance for researchers funded by the Medical Research Council (SA MRC, 2002) asserts that participants in international collaborative research should be provided with care and treatment that they would not normally get – implying at first glance that researchers reject the local de facto standard of medical services for participants and take steps to help participants secure improved care. However, this short statement is somewhat ambiguous because it is conceivable that participants could be provided with care and treatment they would not normally obtain merely through their involvement in procedures intended to promote the science or safety of trials (for example, better monitoring for adverse events).
National guidelines for all health research conducted in South Africa (SA DOH, 2004) assert that in multinational collaborative research, developed-country participants should not be offered better standards of care than South African study participants, even while criticizing a narrow focus on equivalent drug regimens in standard of care debates and acknowledging that it may not be possible to have equivalency between settings in all components (care facilities, technology). These guidelines suggest that ‘researchers from highly resourced countries bear some responsibility to promote better health care and research conditions by garnering additional support from partners in their own countries’ and ‘to improve the often deplorable conditions’ in host countries (p. 8). Guidelines for good clinical practice (SA GCP, 2006) merely assert that the principal investigator should inform participants when they become aware that medical care is needed for inter-current illnesses.
Many recommendations on the explicit issue of ancillary care exist in international ethical guidelines specifically for HIV prevention trials (UNAIDS/WHO, 2007) which were updated with an additional guidance point on intravenous drug users in 2012 (UNAIDS/WHO, 2012); as well as international guidelines for stakeholder engagement in HIV prevention trials (UNAIDS/AVAC, 2011). Guidance also exists in ethical guidelines for HIV vaccine trials in specific countries such as South Africa (SA MRC, 2003). There are also recommendations in ethical guidelines for specific prevention trial networks (HPTN, 2009) which are reviewed briefly before a fuller review of guidance impacting directly on South African HIV vaccine trials.
The guidelines governing researchers affiliated with the HIV Prevention Trials Network (HPTN, 2009) recommend that trial participants have access to care for HIV and sexual and reproductive health needs. Sponsor-investigators should take various steps for care such as reviewing relevant health needs and available services and partnering with local institutions.
These guidelines appear to recommend the partial entrustment model of ancillary care, and set out familiar factors from that model for researchers making decisions about ancillary-care responses. More specifically they recommend that researchers consider the factors of vulnerability, engagement, gratitude for risks and burdens, as well as the costs of various responses. They also assert that researchers must provide at the very least equally adequate care services to those in the local community, and seek to enhance standards of care in the local community where they are low by capacity-building. They recommend that stakeholders should strive to provide ART for participants acquiring HIV during the course of trials, but where there is a plan to improve local services, a lack of ART to sero-convertors is permissible. The guidance recommends that participants should understand different kinds of care they will get (care related to the study versus purely to benefit them) and information about care should be reviewed by review bodies. Communities should be consulted to help anticipate the ancillary-care needs of participants and to decide on care, and stakeholders should reach consensus on care.