Research ethics committees: Need for harmonization at the national level, the global and Indian perspective

Walanj, Aparna Sanjiv

doi:10.4103/2229-3485.128022

Cited by 11 publications

(7 citation statements)

References 12 publications

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“…Since different ECs in India are at different stages of evolution and maturity (with some having good processes, expertise, and experience while others have no experience), can also can bring in additional level of variability. [ 10 ]…”

Section: Discussionmentioning

confidence: 99%

Ethics committees and the changed clinical research environment in India in 2016: A perspective!

Davis¹,

Sule²,

Bughediwala³

et al. 2017

Perspect Clin Res

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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.

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Section: Discussionmentioning

confidence: 99%

Ethics committees and the changed clinical research environment in India in 2016: A perspective!

Davis¹,

Sule²,

Bughediwala³

et al. 2017

Perspect Clin Res

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show abstract

“…The Act on the Secondary Use of Health and Social Data 76 was finalized on April 26, 2019. The main purpose of this Act is to simplify processing and access to personal social and health data for steering, supervision, research, statistics and development in the health and social sector.…”

Section: Finlandmentioning

confidence: 99%

Record linkage of population-based cohort data from minors with national register data: a scoping review and comparative legal analysis of four European countries

Doetsch¹,

Dias

Indredavik

et al. 2021

Open Res Europe

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Background: The General Data Protection Regulation (GDPR) was implemented to build an overarching framework for personal data protection across the European Union/Economic Area (EU/EEA). Linkage of data directly collected from cohort participants based on individual consent must respect data protection rules and privacy rights of data subjects. Our objective was to investigate possibilities of linking cohort data of minors with routinely collected education and health data comparing EU/EEA member states. Methods: A legal comparative analysis and scoping review was conducted of openly online accessible published laws and regulations in EUR-Lex and national law databases on GDPR’s implementation in Portugal, Finland, Norway, and the Netherlands and its connected national regulations purposing record linkage for health research that have been implemented up until April 30, 2021. Results: EU/EEA has limited legislative authority over member states. The GDPR offers flexibility for national legislation. Exceptions to process personal data, e.g., public interest and scientific research, must be laid down in EU/EEA or national law. Differences in national interpretation caused obstacles in cross-national research and record linkage: Portugal requires written consent and ethical approval; Finland allows linkage mostly without consent through the national Data Protection Supervisory Authority; Norway when based on regional ethics committee’s approval and adequate information technology safeguarding confidentiality; the Netherlands mainly bases linkage on the opt-out system and Data Protection Impact Assessment. Conclusions: Though the GDPR is the most important legal framework, national legislation execution matters most when linking cohort data with routinely collected health and education data. As national interpretation varies, legal intervention balancing individual right to informational self-determination and public good is gravely needed for scientific research. More harmonization across EU/EEA could be helpful but should not be detrimental in those member states which already opened a leeway for registries and research for the public good without explicit consent.

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“…However, local sociocultural issues including review of consent forms in regional languages will have to be deliberated by local ECs at the site. [ 65 ] And finally, what is paramount is to see whether ECs function to achieve their primary objective – that of protecting the research participant. It has been said before that while we have tools to assess whether ECs adhere to policies and SOPs, there are not adequate tools to assess whether ECs actually protect participants.…”

Section: Way Forwardmentioning

confidence: 99%

Ethics Committees in India: Past, present and future

Thatte

Marathe

2017

Perspect Clin Res

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Following watershed amendments in Schedule Y India's star rose rather rapidly on the clinical research (especially clinical trials) horizon. Just as dramatic was the fall of this empire. At the centre of these events has been the participant and indirectly, the Ethics Committee (EC) that is established primarily to protect this individual. This paper traces the evolution of the concept of ECs in India, examines the current state of these committees in the country and suggests the way forward.The Past:The requirement for an EC to oversee clinical research was first made in the ICMR Policy Statement for Ethics published in 1980 and then again in the Schedule Y (1988). Later, both the Amended Schedule Y (2005) assigned regulatory responsibility on the EC and the ICMR Guidelines (2006) described the functioning of ECs. Several challenges including inadequate formal training, contribution from non-technical members, administrative support as well no SOPs and a heavy workload were identified. In the absence of regulatory oversight of ECs, the introduction of the Clinical Trial Registry - India (CTRI) and self-regulation through voluntary accreditation programs brought a measure of accountability and transparency.The Present:A slew of regulatory reforms led to more than 1000 ECs to be registered with CDSCO although the actual impact on participants' protection and safety of these new regulations still remains to be seen.Way Forward:A method to oversee all ECs, improved functioning of ECs including on site monitoring, central ECs for multicentric studies, the development of metrics to assess the ability of ECs to protect the participant are other ideas for the future.Conclusions:Although ECs in India have evolved from being mere rubber stamps for approval of protocols to efficiently functioning accredited ECs, yet there is much to be done for and by Ethics Committees.

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Research ethics committees: Need for harmonization at the national level, the global and Indian perspective

Cited by 11 publications

References 12 publications

Ethics committees and the changed clinical research environment in India in 2016: A perspective!

Ethics committees and the changed clinical research environment in India in 2016: A perspective!

Record linkage of population-based cohort data from minors with national register data: a scoping review and comparative legal analysis of four European countries

Ethics Committees in India: Past, present and future

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