In general, the ethical codes of biomedical research – such as those prescribed in the Declaration of Helsinki, the Nuremberg Code and as espoused by the Council for International Organizations of Medical Sciences – do not provide adequate insight to guide IR projects. Nevertheless, with a robust research protocol, appropriate study design, a competent and skilful research team and rigorous review by the relevant scientific and ethics committees, ethical interests of the participants and the community can be safeguarded.

Because IR is conducted in real-life situations, researchers face changing sociocultural, economic and political context. Hutton et al²⁸ argue that: “The level at which an intervention is delivered may determine whether patients can opt in or out;” and further state: “For interventions delivered at the level of the health care facility, it is unclear whether one could ever reasonably seek consent for randomization to intervention and control arms from individual patients who may be affected by the trial interventions”.

In 2007, the World Health Organization (WHO) and the Joint United Nations Programme on HIVAIDS (UNAIDS) issued recommendations on medical male circumcision as an HIV prevention strategy, based on strong and consistent scientific evidence. In many settings, however, it has proven difficult to translate this research into policy and practice due to economic, sociocultural and ethical challenges. Thus, specific factors ought to be considered when planning to implement/scale up voluntary male circumcision as a public health intervention.²⁹

Context: For an intervention to be successful, it is important that researchers understand the context in which the intervention will be implemented. Since IR is complex and involves multiple stakeholders, policy-makers, programme implementers, health workers, the community and the prospective beneficiaries should be identified and their respective roles assessed. Furthermore, voluntary male circumcision is a public health intervention impacting cultural dynamics and the health system. For example, in communities where circumcision part of a boy’s right of passage into manhood, introducing neonatal circumcision may be difficult to implement. In addition, power relations in the community should be explored. The level of organization of the health services and capacity of existing human resources to provide safe circumcision will influence decisions to either integrate neonatal male circumcision into postnatal services or as a stand-alone service. At a policy level, the country’s existing policies on male circumcision (such as the age at which a child should not be circumcised or if there are specialized circumcision surgeons, or designated places where circumcision takes place) should be analysed to guide the implementation process.

Ethical challenges: Ethical issues at both individual (neonates and minors under the age of consent) and community level that influence the intervention feasibility:

What should be done in cases where the child refuses to consent but the parents want the circumcision to take place, or where the child wants circumcision but the parents refuse to provide consent?

What if the very notion of obtaining consent for circumcision is culturally absent?

Should only populations at risk of HIV acquisition/transmission such as truck drivers, soldiers, migrant workers be targeted for circumcision? If yes, how can the subsequent stigmatization of this specific population be minimized?

What is the optimal age at which circumcision should be implemented?

Should it be offered only to men who test negative for HIV or be extended to men living with HIV?

To have an ethically sound implementation of voluntary male circumcision as a HIV- prevention strategy, elements of acceptability of different approaches among currently circumcising and non-circumcising groups should be comprehensively assessed.

This intervention comprised a data-driven participatory quality improvement approach implemented in a high HIV prevalence district in South Africa.³⁰ It was designed in three phases: i) a participatory assessment to build capacity of the local programme managers; ii) a feedback and planning phase, during which weaknesses in the system were identified and a corresponding intervention was developed; iii) a 12-month implementation and monitoring phase, during which the intervention to prevent mother-to-child (PMTCT) HIV transmission was implemented, and related output indicators were monitored. Data were collected using structured interviews from the managers and counsellors, observation of the health facilities, review of documents and routine PMTCT data. The data showed large improvements in all key PMTCT output indicators.

Context: The population in the study area, the components of the PMTCT programme, the current PMTCT policy, South Africa’s district health system, the referral system and the core activities of the health care providers were described in the IR proposal. The documents reviewed included country health review reports, protocols on PMTCT care, PMTCT programme implementation policy guidelines, and HIV seroprevalence survey reports. The baseline PMTCT indicators were extracted from routine district PMTCT data. The stakeholders included mid-level managers in the health system (e.g. facility managers, the primary health care supervisors and district programme coordinators) and the community. Their various roles were described accordingly.

Intervention: The conceptual framework used in developing the intervention was based on an expanded health systems approach. The researchers further acknowledged that the weaknesses identified during the assessment were due to the complex interaction between the clients’ lack of information and fear of disclosing their HIV status, and the health system factors of lack of ownership of the PMTCT programme among nurses, unclear roles and responsibilities, lack of knowledge of the protocol, as well as poor recording systems and continuity of care.

Ethical challenges:

• Should being part of the routine health care system qualify the intervention for expedited ethical review?
• How to minimize interference with routine health care?
• How and at what level of interaction do you draw a line between routine care services and/or research?

Background: The persistence of malaria in Viet Nam is related to complexities within the health system, sociocultural, economic and environmental contexts. The establishment of the National Malaria Control Programme with a strategy to distribute bed nets, as well as diagnosing and treating confirmed cases free of charge, dramatically reduced the malaria incidence rate from 1.2 million clinical cases in 1991 to 185 529 in 2002. Despite these efforts, however, the central province of Quang Tri – with poor, low-educated and culturally diverse minority populations – had one of the highest malaria burdens in the country. A study aiming to strengthen to malaria control sought to identify how the health system and community factors are linked to malaria persistence. A multidisciplinary team conducted the study from March 2004 to April 2005. A mixed-methods approach was used in two of the districts with the highest malaria burden. In the formative stage, qualitative approaches were used to inform the later quantitative part of the study. Semi-structured interviews and focus group discussions were conducted with purposively selected health care managers, village heads and villagers to explore beliefs, attitudes, awareness, health care-seeking behaviour and circumstances relevant to malaria exposure and control. A knowledge attitude and practices (KAP) survey was conducted in the assessment stage, face-to-face with the village health workers (VHWs) and community members. Checklists were used to assess the visibility and status of malaria treatment guidelines, quality of microscopy, as well as bed net quality (during KAP survey home visits). To determine actual bed net use, unannounced night visits to homes were also conducted.

Findings: The main deficiencies at a health facility level were understaffing, unqualified staff, lack of in-service training, inaccessible treatment guidelines and lack of equipment and supplies. At a community level, socioeconomic and cultural factors impeded access to and effective use of interventions. Although diagnosis and treatment of malaria were free, patients were unable to afford the associated costs and this led to early self-discharge and failure to attend follow up appointments. Furthermore, although bed nets were supplied free of charge, the target of 80% coverage (i.e. one net per two people) was not met due to cultural sleeping norms, as well as low education and poverty. Overnight socializing among male neighbours is typical and yet the majority of homes did not have spare nets for guests. Risks to exposure was also increased due to the high mobility, which is culturally and economically driven. Whereas the geographical access to health services was addressed by having community health workers (CHWs), many of whom had insufficient training and this greatly affected their capacity to cope with all expected tasks. In addition, due to delays in rolling out the new guidelines for some of the medicines included in VHW kits, some CHWs did not follow prescribed treatment guidelines. Language barriers and mistrust between the ethnic minorities in western Quang Tri and service providers was also reported, and this may have contributed to the community’s lack of responsiveness to medical advice. Geographical inaccessibility due to poor roads, and shortage of telephones, were among the contextual barriers identified.

Conclusion: Deficiencies were established throughout the continuum of care from the health facility all through to the community level. These observations were used as a basis of the proposed intervention.

Lessons: A comprehensive analysis of context is critical for the effectiveness and ultimate success of any proposed intervention.