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| Dublin Core | PKP Metadata Items | Metadata for this Document | |
| 1. | Title | Title of document | Putting patients first: draft guidelines for compensation for research-related injury in clinical trials in India |
| 2. | Creator | Author's name, affiliation, country | Gagandeep Kang; The Wellcome Trust Research Laboratory, Christian Medical College, Vellore, Tamil Nadu 632 004; IN |
| 3. | Subject | Discipline(s) | |
| 3. | Subject | Keyword(s) | |
| 4. | Description | Abstract | With the recent highlighting of ethical issues in several clinical trials, and the increase in awareness among parliamentarians, there has been some concern about the conduct of trials in India. The areas of concern include ensuring that consent is truly informed, and monitoring participant safety, the occurrence of deaths, and the payment of compensation. On November 18, 2011, the draft of the Drugs and Cosmetics (3rd Amendment) rule, 2011, was published in the Gazette of India, with a plan for implementation 45 days after publication. In addition, the draft guidelines for compensation were posted for comment by the Indian Council of Medical Research (ICMR), where bioethicists have been responsible for developing and updating the Ethical guidelines for biomedical research on human participants, last revised in 2006. These guidelines state that research participants who suffer an injury as a result of participation in research are entitled to compensation for impairment or disability. |
| 5. | Publisher | Organizing agency, location | Forum for Medical Ethics Society |
| 6. | Contributor | Sponsor(s) | |
| 7. | Date | (YYYY-MM-DD) | 2016-11-30 |
| 8. | Type | Status & genre | |
| 8. | Type | Type | |
| 9. | Format | File format | HTML , PDF |
| 10. | Identifier | Uniform Resource Identifier | https://ijme.in/articles/putting-patients-first-draft-guidelines-for-compensation-for-research-related-injury-in-clinical-trials-in-india/ |
| 11. | Source | Title; vol., no. (year) | Indian Journal of Medical Ethics;: Some lives are cheaper than others |
| 12. | Language | English=en | en |
| 13. | Relation | Supp. Files | |
| 14. | Coverage | Geo-spatial location, chronological period, research sample (gender, age, etc.) | |
| 15. | Rights | Copyright and permissions | All articles published in IJME are available on its website free of charge. The copyright for published material belongs to IJME/FMES. IJME freely permits the reprint (or reproduction on a website) of articles from the journal, as long as this is for non-commercial use and appropriate credit is given to the author and the journal and publication details are mentioned. The commercial use of our content can be made only after obtaining permission from and on payment to IJME. This is intended to support production of the journal. |