Informed Consent Document and Process in India: Ethical and Quality Issues

The paper identifies ethical issues and challenges in clinical research in India. In the first part, the paper provides the results of a survey of Indian clinical research professionals about the administration of clinical trials in India. A key finding of the survey is that many Indian clinical research professionals are concerned about prevailing procedures of obtaining research subjects’ consent. The second part of the paper discusses this result. It offers some reasons as to why Indian clinical research professionals are particularly concerned about consent. The paper then offers some suggestions for improving methods of obtaining consent. Implementing these methods may potentially alleviate researchers’ concerns.