Informed consent for genetic research in adult patients in a research entity in South Africa: an ethico-legal inquiry

• Main Author: Lundgren, Aina Christina
• Format: Others
• Language: en
• Published: 2016
• Online Access: http://hdl.handle.net/10539/20082

A research report submitted to the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, in partial fulfilment of the requirements of the degree of MSc Med (Bioethics and Health Law) Johannesburg 2015 === Research on human subjects in South Africa is guided by the Research Ethics Guidelines produced by the National Department of Health, as well as many other documents such as the Bill of Rights, the National Health Act and ethical guidelines published by the Health Professions Council of South Africa. The fundamental issue when considering the ethics of human research is to ensure that vulnerable people are protected from exploitation. The ethics of research is based on principle-based ethics, which is made up of the principles of autonomy, beneficence, non-maleficence and justice. Supporting principles include respect for autonomy and the issue of informed consent, scientific integrity, privacy and confidentiality. Many clinical trials initiated by researchers and/or pharmaceutical companies include a genetic component in addition to the main clinical study. The genetic component entails the taking and storing of patients’ blood or other tissues for up to twenty years, often in a foreign country in a biobank or similar repository. Acquiring informed consent for this genetic component of these studies is often problematic, in that the exact nature of the research is not always known at the time that the samples are taken. In addition the patient may not understand the consequences of giving up these samples to various organisations for future experimentation and international data exchange and sharing. The empirical limb of this study investigated the type of consent given by patients for genetic research in studies submitted to the Wits Health Consortium during 2013. Additional factors such as length of time and site of storage of the genetic samples, as well as data storage and sharing were explored, as well as the complexity of the language used for the informed consent. Less than a third of the protocols with a genetic component that were studied, complied with South African regulations and guidelines governing the obtaining of informed consent for genetic research. Recommendations made in order to improve this included a standardized informed consent process, attention to the language used when obtaining informed consent, the type of informed consent obtained, and improved communication with the research participants on the ethical issue of data sharing.