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Globalization of Clinical Trials- A Review of Underlying Ethical and Scientific Considerations Involving Human Subjects in India


 
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1. Title Title of document Globalization of Clinical Trials- A Review of Underlying Ethical and Scientific Considerations Involving Human Subjects in India
 
2. Creator Author's name, affiliation, country Puneeta Ajmera; Amity University Gurgaon Haryana; India
 
2. Creator Author's name, affiliation, country Anita Gupta; Faculty of Management Studies, Manav Rachna International University, Faridabad, Haryana; India
 
3. Subject Discipline(s)
 
3. Subject Keyword(s) Ethical Committee, Pharmaceutical Industries
 
4. Description Abstract

The conduct of clinical research involving the participation of human beings embroils a variety of ethical issues like dignity, liberty, autonomy, privacy and bodily integrity. The ethical conduct of a clinical trial just not only includes a signature on the informed consent form by the concerned participant but protecting the dignity, rights, interests, and safety of research subjects must continue throughout the duration of the study. Pharmaceutical industries are legally and ethically bound to protect human participants involved in clinical research. This article reviews and describes the scientific and ethical aspects of clinical trials and necessary regulatory mechanism to protect the rights, dignity, and privacy of human subjects: the institutional review board, the Ethical committee, the sponsor, the informed consent process and the investigator in developing countries like India. This article also reviews some of the important issues like informed consent, payment for participation in a clinical trial, and defining standard of care in critically ill patients.

 
5. Publisher Organizing agency, location
 
6. Contributor Sponsor(s)
 
7. Date (YYYY-MM-DD) 2013-05-22
 
8. Type Status & genre Peer-reviewed Article
 
8. Type Type
 
9. Format File format PDF
 
10. Identifier Uniform Resource Identifier http://medical.cloud-journals.com/index.php/IJANHS/article/view/Med-75
11. Source Journal/conference title; vol., no. (year) International Journal of Advanced Nutritional and Health Science; Vol 1, No 1 (2013)
 
12. Language English=en en
 
14. Coverage Geo-spatial location, chronological period, research sample (gender, age, etc.)
 
15. Rights Copyright and permissions

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