ABSTRACT
Background: Adolescents are a unique population with significant unmet health needs. They are often excluded from research that may benefit them as they are perceived as vulnerable and needing protection from research participation. For Research Ethics Committees, conflicting positions in statutes, regulations and ethical guidelines about who provides informed consent for adolescent involvement in health research can be a significant barrier to approving adolescent research. For researchers, the requirement for parental/guardian proxy consent or prolonged approval processes may potentially result in the exclusion of those adolescents most vulnerable and at risk, particularly if issues such as gender-based violence, gender identity, sexuality and sexual practices are in question. Objectives: To describe the challenges to adolescent research and suggest strategies to address these. Method: We consider the legal and ethical framework in South Africa regarding the consenting age for adolescents in research, outline the challenges and, using examples of best practices, suggest strategies to address the current conundrum. Results: We suggest three principles to guide Research Ethics Committees on their approach to reviewing health research involving adolescents. Strategies to develop ethically acceptable approaches to adolescent research and consent processes are described, which include community involvement. We elaborate on examples of nuanced approaches to adolescent research. Conclusion: The inclusion of adolescents in research is critical in informing appropriate and effective health services for this vulnerable population, whilst providing an opportunity to link them into care and services where relevant.
ABSTRACT
Benchmarks of ethical research in developing countries stipulate collaborative partnership, which necessitates the involvement of research participants and taking cognizance of their opinions in decisions regarding research activities. Little data regarding participants' perceptions about research activities exists in the developing world. This study assessed the knowledge and perceptions of research participants in Nigeria about clinical trials. A validated semi-structured questionnaire was used in a cross-sectional survey. Data were analysed using SPSS version 17. Seventy-five respondents (70.7% females, 29.3% males) with a mean age of 36.5±10.3 years, enrolled in an efficacy and safety study of Artequin in Ikorodu LGA, Nigeria, participated in the survey. Most of them (64%) had secondary education while 6.7% were illiterate. Only 5 (6.7%) had previously participated in a clinical trial. The majority of respondents (70.7%) did not know how medicines are determined to be safe and none knew how new drugs are tested. While only 10(13.3%) respondents felt that people were well treated during clinical trials, only two knew of someone who had been harmed because of participation and only one respondent could report on the type of harm experienced by the participant. The majority (86.7%) did not know if people were well treated or abused or whether people's rights were protected during clinical trials (84%). Despite being enrolled in a clinical trial, participants have limited knowledge about such trials. This lack of knowledge might impact the quality of informed consent provided. If true collaboration is to be achieved in developing world settings, the community in general, and trial participants in particular, should be educated about the basic principles of research.
