Vaz Manjulika, Vaz Mario, Srinivasan K
Health and Humanities, St John's Research Institute, Bangalore 560 034, India.
Health and Humanities.
Indian J Med Ethics. 2015 Apr-Jun;12(2):68-77. doi: 10.20529/IJME.2015.024.
Medical research, from clinical trials to novel research on stored samples, is growing rapidly in India. Ethical regulations largely reflect standard international guidelines and the norms of "good clinical practice". Through in-depth interviews, this study aimed to explore the perceptions, motivations and concerns of the public with respect to participation in clinical trials and biobanking-related research. It was found that the expectation of therapeutic benefit reflects "therapeutic misconception" and this, along with a poor understanding of research, leads to favourable participation in clinical trials. A relatively low level of awareness and knowledge of health matters and research (health literacy), along with the differences in the power of the doctor and the participant, lead to an unquestioning trust in the physician or the institution conducting the research. "Informed consent" is thought to protect the interests of the researcher and the institution rather than the participants' rights. Biobanking research was very new to the participants and relatively unknown. Thus, it has not yet filtered into the public consciousness. As a result, the perceptions of the general public do not appear to be sufficiently evolved.
从临床试验到对储存样本的创新性研究，印度的医学研究正在迅速发展。伦理规范在很大程度上反映了国际标准指南和“良好临床实践”的规范。通过深入访谈，本研究旨在探讨公众对参与临床试验和生物样本库相关研究的看法、动机和担忧。研究发现，对治疗益处的期望反映了“治疗误解”，而这一点，连同对研究的理解不足，导致公众对参与临床试验持积极态度。公众对健康问题和研究的认识及知识水平相对较低（健康素养较低），再加上医生与参与者权力的差异，导致公众对进行研究的医生或机构不加质疑地信任。“知情同意”被认为是在保护研究者和机构的利益，而非参与者的权利。生物样本库研究对参与者来说非常新颖，相对不为人知。因此，它尚未渗透到公众意识中。结果，普通公众的观念似乎尚未充分发展。
