Ethics committees and the changed clinical research environment in India in 2016: A perspective!
Introduction: Institutional and Independent Ethics Committees (ECs) have as their primary mission the protection of human research subjects. The Central Drugs Standard Control Organization has in the period 2013–2016 introduced several new regulations and amendments to existing regulations overseein...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2017-01-01
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| Series: | Perspectives in Clinical Research |
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| Online Access: | http://www.picronline.org/article.asp?issn=2229-3485;year=2017;volume=8;issue=1;spage=17;epage=21;aulast=Davis |
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| author | Sanish Davis Poonam Sule Murtuza Bughediwala Vrunda Pandya Shilpi Sinha |
| author_facet | Sanish Davis Poonam Sule Murtuza Bughediwala Vrunda Pandya Shilpi Sinha |
| author_sort | Sanish Davis |
| collection | DOAJ |
| description | Introduction: Institutional and Independent Ethics Committees (ECs) have as their primary mission the protection of human research subjects. The Central Drugs Standard Control Organization has in the period 2013–2016 introduced several new regulations and amendments to existing regulations overseeing the conduct of Research in India. Several of these have direct effect on the functioning of the EC from a review, approval, and oversight mechanism.
Methodology: The Ethics Council of Indian Society for Clinical Research conducted a questionnaire survey among EC members to understand the impact of these changes in their functioning. The domains surveyed included awareness about recent changes/amendments and impacts, serious adverse events (SAEs) and compensation, informed consent and audio-video recording, monitoring and auditing of research, and future working of ECs.
Results: Seventy-nine percent of ECs are of the opinion that the new regulations/guidelines will add to their existing burden in the process of review and approval, providing subject protection and research oversight. Even though 68% of ECs stated that they are comfortable with SAE assessment and compensation determination, they state that there is variability in calculation of compensation amount using the formulae. An overwhelming majority (80%) of ECs stated that they were not in favor of centralized EC for providing review, approval, and oversight of clinical studies.
Discussion: Ethics Committees act as local regulator for clinical trials at sites providing Human Subject protection. The survey captures the contemporary issues faced by the ECs and also raises important questions on the ease of doing research, oversight of approved research, and administrative burden on the EC.
Conclusion: Recent changes in regulations have on the one hand empowered Ethics committees but brought in challenges in the way that they provide oversight and monitor research carried out at the site. |
| first_indexed | 2024-12-13T19:58:06Z |
| format | Article |
| id | doaj.art-3609531225c648a59e252d5137ee376c |
| institution | Directory Open Access Journal |
| issn | 2229-3485 |
| language | English |
| last_indexed | 2024-12-13T19:58:06Z |
| publishDate | 2017-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Perspectives in Clinical Research |
| spelling | doaj.art-3609531225c648a59e252d5137ee376c2022-12-21T23:33:15ZengWolters Kluwer Medknow PublicationsPerspectives in Clinical Research2229-34852017-01-0181172110.4103/2229-3485.198555Ethics committees and the changed clinical research environment in India in 2016: A perspective!Sanish DavisPoonam SuleMurtuza BughediwalaVrunda PandyaShilpi SinhaIntroduction: Institutional and Independent Ethics Committees (ECs) have as their primary mission the protection of human research subjects. The Central Drugs Standard Control Organization has in the period 2013–2016 introduced several new regulations and amendments to existing regulations overseeing the conduct of Research in India. Several of these have direct effect on the functioning of the EC from a review, approval, and oversight mechanism. Methodology: The Ethics Council of Indian Society for Clinical Research conducted a questionnaire survey among EC members to understand the impact of these changes in their functioning. The domains surveyed included awareness about recent changes/amendments and impacts, serious adverse events (SAEs) and compensation, informed consent and audio-video recording, monitoring and auditing of research, and future working of ECs. Results: Seventy-nine percent of ECs are of the opinion that the new regulations/guidelines will add to their existing burden in the process of review and approval, providing subject protection and research oversight. Even though 68% of ECs stated that they are comfortable with SAE assessment and compensation determination, they state that there is variability in calculation of compensation amount using the formulae. An overwhelming majority (80%) of ECs stated that they were not in favor of centralized EC for providing review, approval, and oversight of clinical studies. Discussion: Ethics Committees act as local regulator for clinical trials at sites providing Human Subject protection. The survey captures the contemporary issues faced by the ECs and also raises important questions on the ease of doing research, oversight of approved research, and administrative burden on the EC. Conclusion: Recent changes in regulations have on the one hand empowered Ethics committees but brought in challenges in the way that they provide oversight and monitor research carried out at the site.http://www.picronline.org/article.asp?issn=2229-3485;year=2017;volume=8;issue=1;spage=17;epage=21;aulast=DavisAmendmentsCentral Drugs Standard Control Organizationethics committeesregulations |
| spellingShingle | Sanish Davis Poonam Sule Murtuza Bughediwala Vrunda Pandya Shilpi Sinha Ethics committees and the changed clinical research environment in India in 2016: A perspective! Perspectives in Clinical Research Amendments Central Drugs Standard Control Organization ethics committees regulations |
| title | Ethics committees and the changed clinical research environment in India in 2016: A perspective! |
| title_full | Ethics committees and the changed clinical research environment in India in 2016: A perspective! |
| title_fullStr | Ethics committees and the changed clinical research environment in India in 2016: A perspective! |
| title_full_unstemmed | Ethics committees and the changed clinical research environment in India in 2016: A perspective! |
| title_short | Ethics committees and the changed clinical research environment in India in 2016: A perspective! |
| title_sort | ethics committees and the changed clinical research environment in india in 2016 a perspective |
| topic | Amendments Central Drugs Standard Control Organization ethics committees regulations |
| url | http://www.picronline.org/article.asp?issn=2229-3485;year=2017;volume=8;issue=1;spage=17;epage=21;aulast=Davis |
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