Division of Clinical Research and Training

INFORMED CONSENT IN A LOCAL SETTING–Stakeholders understanding, attitudes and values towards the concept of informed consent in Bangalore, India: a Qualitative study-VAN ALPHEN, INGE A.S as part of a masters thesis from the Univ of Maastricht, Netherlands

Health Humanities
Project Lead
Dr. Mario Vaz
Source of Funding

This study highlights some of the complexities and context-specific factors that are relevant to obtaining individual informed consent during clinical trials, in a private hospital and research center in Bangalore, South India. The motivation for this study is the realization that informed consent procedures can be specific to local settings and that local stakeholders’ views on this are under-represented. Health and socioeconomic status, income, culture, language, and level of education are some of the factors that determine the level of understanding of trial terminology, the amount of disclosure and information needed for proper conceptualization of, and informed, consent. In light of international and global efforts to ameliorate practices of consent-seeking, the current hindrances to obtaining informed consent present a  concern that can have tremendous and at times life-threatening consequences for the poor, which are often more vulnerable to inducement, because they do not have adequate access (financial or physical) to the medicines they need. The current barriers to obtaining individual informed consent calls for the possibility of indigenizing bioethics, and this study aims to increase insights into the understanding, attitudes, and values of local stakeholders. The study analyses interviews with physicians that are both trialists and non-trialists, and other stakeholders such as members of Contract Research Organizations (CROs), Ethical Committees and professors in ethical departments. The study highlight innovative ways in which informed consent can be obtained, seeks to understand the dynamics behind consent to participate, and challenges the universality of the current informed consent process as an extrapolation of standards from developed countries to developing countries. The larger implications of the findings relate to the protection of patient rights and research integrity with regard to experimental medication and procedures, codes of conduct of the pharmaceutical industry, principal investigators, contract research organizations (CROs) and trial physicians, and finally the question of how international agreements and ethical guidelines and standards apply in a local context.