Compensation for trial-related injury: does simplicity compromise fairness?

A Journal of Healthcare Ethics & Humanities. Published since 1993 by Forum for Medical Ethics Society.
Peer-reviewed. Indexed in Medline, PubMed, The Philosopher’s Index, Scopus.

ISSN: 0975-5691 (Online); 0974-8466 (Print) RNI Reg No. MAHENG/2016/67188


Dublin Core		PKP Metadata Items	Metadata for this Document

1.	Title	Title of document	Compensation for trial-related injury: does simplicity compromise fairness?

2.	Creator	Author's name, affiliation, country	Mala Ramanathan; AMCHSS, SCTIMST, Medical College PO, Thiruvananthapuram 695 011; IN

3.	Subject	Discipline(s)

3.	Subject	Keyword(s)

4.	Description	Abstract	India’s regulatory framework for research ethics is two pronged. Schedule Y of the Drugs and Cosmetics Act, 1940, of the Government of India, lays down the requirements for undertaking clinical trials for drugs and medical devices in India; it also requires compliance with the ICMR’s Ethical guidelines for biomedical research on human participants for such trials. Other health research may use the ICMR’s guidelines but this is not mandatory. The regulatory framework is operationalised through the offices of the Central Drugs Standard Control Organisation. However, the mechanisms of monitoring drug trials using this framework have proved to be rather weak.

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/compensation-for-trial-related-injury-does-simplicity-compromise-fairness/

11.	Source	Title; vol., no. (year)	Indian Journal of Medical Ethics;: Strengthening the core

12.	Language	English=en	en

13.	Relation	Supp. Files

14.	Coverage	Geo-spatial location, chronological period, research sample (gender, age, etc.)

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