5. Discussion
5.3 Guidelinesand frameworks
There is an increasing preference for the use of context applicable guidelines among researchers working with human participants (Fadare & Porteri, 2010). Although there are still researchers who prefer international guidelines, most researchers reported that they find national guidelines helpful.
As more and more HIV/AIDS research takes place in Africa, it is becoming evident that some international ethical guidelines and frameworks are not applicable to African settings. For example, some international guidelines are said to not accommodate and address cultural factors that may influence the conduct of research (Fadare & Porteri, 2010). It is crucial for guidelines to be inclusive of cultural knowledge in order to establish a mutual understanding between the research team and the host community (Tindana, et al., 2007). Failing to do so may lead to some communities becoming resistant to the research because they perceive it to be countering their cultural practices and norms.
Therefore researchers need to be guided by guidelines that are context relevant – such as the MRC’s (2003) guidelines on ethics for medical research: HIV preventive vaccine research and UNAIDS (2007) GPP guidelines.
Researchers from Uganda all reported that they prefer their national guidelines (Grant et al., 2005) on the conduct of trials. The success of Uganda in the fight against AIDS may be contributed to by such initiatives, implementing national guidelines. There is need for other African countries to implement their own national guidelines to the conduct of trials. Only Kenya (“Kenya national guidelines”, 2005), South Africa (MRC, 2003) and Uganda (Grant et al., 2005) appear to have done so to date.
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5.4.1 Theoretical frameworks 5.4.1.1 Ethics
The Emanuel et al. (2004; 2008) framework was used to investigate ethical challenges researchers face on site. The framework was helpful in informing part of the questionnaire that was used to collect data. The framework was also successful in identifying some of the challenges that researchers face when conducting HVTs in African countries. The framework helped identify maintaining ongoing respect for enrolled participants, to working collaboratively with participants, working with communities and determining social value as ethical challenges. However the Emanuel et al. (2004) framework did not address some ethical challenges that researchers face. Below are some of the ethical requirements that the framework does not cover.
The last ethical requirement in the Emanuel et al. (2004) framework is respect for enrolled
participants. This requirement states that trial participants must be ensured of confidentiality of their information and that current and former participants must be allowed access to successful treatment and any new information that is generated from a study they were part of. This ethical requirement can be enhanced by adding the need for continuous regular feedback to current and former trial participants. By only stating that participants are allowed access to information, the framework does not highlight giving continuous regular feedback to current and former trial participants as one of the responsibilities of researchers. Often researchers mention that one of the benefits of participating in trials and research is gaining information. However, comprehensive feedback is seldom given to research participants. It is for this reason that providing feedback to participants must be highlighted as an essential part of any research process by frameworks on ethical requirements.
Some of the researchers who took part in this study mentioned that they experienced co-enrolments at their site. As a result of co-enrolments at these sites, some participants, those who were enrolled in
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more than one study, were terminated from the trials. Co-enrolment at these sites was an
unanticipated problem. As reported by one of the study coordinators who took part in this study, systems such as sharing participants’ identities with other research sites were introduced after the events of co-enrolment. The Emanuel et al. (2004) framework does not cover handling unanticipated problems as one of the ethical requirements when conducting HVTs. As a result it cannot be used by researchers in solving unanticipated problems in HVTs. A framework that covers handling of
unanticipated problems in HVTs as an ethical requirement is needed in that HVT environment is often unpredictable.
Researchers are faced with a variety of unanticipated challenges continuously. For example due to the events of co-enrolments in some HVTs in African countries, co-enrolled participants were terminated from the study. These participants were already using the study product but once terminated they were not followed up. As a result the future impact of the study product on these individuals will never be known because they were not followed up. Ethical frameworks must cover ethical issues such as this to ensure continuity of care of trial participants even after the end of their participation in the trials.
Moreover the Emanuel et al. (2004) framework elaborates on working collaboratively with
communities as an ethical requirement in clinical trials. The word community is usually used to refer to a rural oriented society. Therefore the Emanuel et al. (2004) framework does not elaborate on ethical requirements of clinical trials taking place in a variety of settings, for example urban settings.
As a result this framework might be seen to not be applicable in all settings.
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5.4.1.2 Law
Laws of African countries that took part in this study were used as a framework to investigate laws challenges that researchers face when conducting HVTs. Using the different legal frameworks was useful in identifying how far African countries that took part in the study are in establishing policies and laws that guide the conduct of HVTs. The establishment of laws concerning the conduct of HVT help improve legal issues concerning the conduct of HVTs. By referring to these laws, researchers are able to identify legal issues that are not addressed by current laws concerning the conduct of HVT. For example, some laws relating to the conduct of HVTs in Africa do not cover issues around consent age. In such cases it may be useful to use other relevant laws or guidelines such as UNAIDS (2007) paper on enrolment of adolescents in clinical trials and dealing with issues surrounding consent age. Although countries have consent ages, some African societies still do not follow this when it comes to decision making on whether to join HVTs or not. Researchers from both Southern and Eastern Africa reported that there are participant of consent age who are refused to take part in HVTs by either their parents or male partners. Therefore using a variety of available national and international laws as guidelines to inform the investigation of legal issues that researchers face when conducting trials in Africa was helpful in identifying gaps in law concerning the conduct of HVTs.
On the contrary, using different laws that direct the conduct of HVTs in Africa countries was difficult. It was not possible to compare legal issues regarding the conduct of HVTs in African countries that took part in this study using a single framework. Therefore it is not easy to assess the progress of countries in relation to other countries in this regard (Grant et. al., 2005).
5.4.1.3 Human rights
The Universal Declaration of Human Rights (UN, 1948) was used as a Human Rights framework.
Through this framework it was established that African countries that took part in this study
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experience similar human rights dilemmas and have similar human rights concerns when conducting HVTs. Using the declaration of Human Rights was useful in confirming that human rights are universal hence researchers from different parts of Africa had almost similar Human Rights concerns.