7.1 New knowledge
This study hopefully contributed to new knowledge through several new findings. The study
identified ethical issues that researchers face when conducting HVT that have not been documented before. An example of such knowledge is the events of co-enrolment. Some HVT sites are
experiencing an increasing number of participants who enrol in more than one HVT at the same time. Need for money due to high poverty rates in most host communities was said to be the
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motivation for co-enrolment. Co-enrolled participants gain from this action by collecting
reimbursement money at different sites and use the money for their livelihoods. This finding has highlighted the need to investigate poverty as a barrier to the exercise of human rights as co- enrolment is becoming a serious problem in African countries because of financial desperation among trial participants (Kwagala et al., 2010).
This study also indicates that there is need to educate and update the research staff about relevant and available ethical and legal frameworks that inform the conduct of HVTs in their respective countries.
Researchers expressed the need for locally relevant ethical guidelines. Researchers reported that the main disadvantage of most ethical guidelines used in HVTs is that they are not applicable to some setting especially African settings. Researchers who expressed this concern were from countries that did have national guidelines thus they were unaware of these ethics guidelines.
7.2 Conclusions
Researchers in HVTs in African countries reported that they experience ethics, law and human rights challenges when conducting HVTs at their sites. The main ethical challenge that researchers face when conducting HVTs arises from the high number of enrolled participants who become HIV positive during the trial. No specific percentage was given to demonstrate the extent of sero- conversion at these sites. Other ethical challenges that researchers faced include determining social value of the research, paying participants, working collaboratively with participants and communities and explaining trial closure to participants. When asked about legal challenges that they face at their sites, researchers reported that prevention of individuals who want to participate in HVTs by their parents and/or male partners was a dilemma they face. Researchers reported that at times they terminate participants who meet study inclusion criteria due to demands to do so from their parents and/or male partners. Researchers also reported the lack of support from health care service
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providers when it comes to caring form trial participants. Other legal challenges reported by
researchers include issues around privacy and confidentiality of participants’ information, and future impact of the study drug on the health of the participant after the end of the trial.
The main human rights concern was the understanding of consent age in African countries by communities. It was established that despite the respective consent age of countries, most
communities are still driven by cultural or societal norms and beliefs when it comes to deciding who takes part in HVTs. Parents and male partners often decide for their children and female partners to take part or not to take part in HVTs. The results of this study show that most African HVT sites have most of the infrastructure needed for the conduct of HVTs. Most researchers however reported that they do not have a library at their sites.
7.3 Recommendations
To improve the conduct of HVTs in African countries the following are recommended:
a. Creation of a network between HVT sites in Africa where researchers can interact and share their challenges, problem solving skills and new strategies to improve the conduct of clinical trials in Africa. This would prevent incidents such as co-enrolments because sites would be aware of which participants are enrolled where. This should be validated by the AAVP.
b. It would also be useful for researchers to have regular workshops where they come together and share information on the conduct of trials.
c. Encourage refresher training of research staff on different guidelines that inform the conduct of HVTs such as UNAIDS (2007) guidelines on community involvement of host
communities at the all levels of trials, form planning, to implementation, to follow ups. Most researchers who took part in this study were often unaware of some relevant available guidelines that inform the conduct of HVTs.
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d. It is crucial that HVT websites have the correct contact details to allow easy access to these sites. In addition, websites must be updated regularly. This would not only be useful to other researchers but would also useful to all who need to access the site and information from the site.
e. There is need for libraries and site journals within HVT sites. This would improve the culture of reading amongst those who visit the site and trial participants, and this would also
encourage researchers to remain abreast of new developments in the field.
f. There is need to educate host communities about human rights. This study reflected that a lot of individuals are not aware of their human rights. An example of this is individuals who are not permitted to participate in HVTs, regardless of being of consent age, by the significant others in their lives.
g. There is need for health care providers, department of health and HVT research staff to work collaboratively to provide care and treatment to participants who place themselves at risk by participating in HVTs.
7.3.1 Recommendations for further research
a. Research the HIV incidence rates in HVTs in Africa and how this informs provision of ongoing care and respect for trial participants.
b. Investigate the extent of co-enrolment in African HVT sites. Explore motivation for and implications on participants’ health (Gajic et al., 2004).
c. Evaluate the extent to which money influences recruitment or their willingness to participate in HVTs.
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