On-Site Monitoring of Clinical Trials by an Ethics Committee in India: A Road Less Travelled

Autor/inn/en	Shafiq, Nusrat; Kumari, Savita; Kumar, Vivek; Suri, Vinita; Jayashree, Muralidharan; Duseja, Ajay; Bansal, Arun; Malhotra, Samir
Titel	On-Site Monitoring of Clinical Trials by an Ethics Committee in India: A Road Less Travelled
Quelle	In: Research Ethics, 17 (2021) 1, S.45-54 (10 Seiten)Infoseite zur Zeitschrift PDF als Volltext Verfügbarkeit
Zusatzinformation	ORCID (Malhotra, Samir)
Sprache	englisch
Dokumenttyp	gedruckt; online; Zeitschriftenaufsatz
ISSN	1747-0161
DOI	10.1177/1747016120933923
Schlagwörter	Ethics; Medical Research; Outcomes of Treatment; Foreign Countries; Advisory Committees; Compliance (Legal); Informed Consent; Research Problems; Health Insurance; Supervision; Patients; Guidelines; Recordkeeping; Storage; Drug Therapy; Laws; Compensation (Remuneration); India + Suchen Sie Ihr Suchwort? Ethik; Ausland; Beratungsstelle; Forschungskritik; Krankenversicherung; Patient; Richtlinien; Leistungsnachweis; Speicherung; Law; Recht; Abfindung; Kompensation; Lohnausgleich; Indien
Abstract	Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics Committees to keep an oversight of ongoing clinical trials including on-site monitoring. In this article, we share the experience of on-site monitoring of clinical trials by the Ethics Committee of a tertiary care, academic and research centre in India. We found a large number of shortcomings in the areas of informed consent, adverse events, insurance and reimbursement, which would not have been detected by off-site document review. Interestingly, many shortcomings were also not detected by on-site monitoring arranged by clinical trial sponsors. We therefore conclude that on-site monitoring of ongoing clinical trials is a highly important activity for Indian Ethics Committees. (As Provided).
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Erfasst von	ERIC (Education Resources Information Center), Washington, DC
Update	2024/1/01