Multisite Research Ethics Review: Problems and Potential Solutions

Ferguson, Aidan; Master, Zubin

doi:10.7202/1044265ar

Cited by 6 publications

(8 citation statements)

References 55 publications

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“…Not surprisingly, given its common presence in the empirical literature (e.g. Angell et al, 2006; Caulfield et al, 2011; Ferguson and Master, 2016), participants frequently expressed concern about the amount of variability and inconsistency in decisions or opinions rendered by RECs across sites within the same jurisdiction or across several jurisdictions. Participants also criticised the duplication of ethics reviews, leading to bureaucracy and significant time delays in research projects.…”

Section: Resultsmentioning

confidence: 99%

“…In our discussions, we encountered a general sense of concern about the present ethics review system, which has also been expressed in the literature (e.g. Ferguson and Master, 2016). This said, all participants were of the opinion that ethics review is a critical component of research involving humans (even if such research only involves humans indirectly) and should not be seen by researchers as merely a hurdle to get past.…”

Section: Discussionmentioning

confidence: 99%

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Expert perspectives on ethics review of international data-intensive research: Working towards mutual recognition

Garattini

2017

Research Ethics

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Life sciences research is increasingly international and data-intensive. Researchers work in multi-jurisdictional teams or formally established research consortia to exchange data and conduct research using computation of multiple sources and volumes of data at multiple sites and through multiple pathways. Despite the internationalization and data intensification of research, the same ethics review process as applies to single-site studies in one country tends to apply to multi-site studies in multiple countries. Because of the standard requirement for multi-jurisdictional or multi-site ethics review, international research projects are subjected to multiple ethics reviews of the same research protocol. Consequently, the reviews may be redundant and resource-consuming, whilst the opinions delivered by ethics committees may be inconsistent both within and across jurisdictions. In this article, we present findings based on interviews conducted with international experts in research ethics on the topic of ethics review mutual recognition. We explore the issues associated with ethics committee review of multi-jurisdictional data-intensive research projects, identifying current problems, real-life experiences, and potential solutions that are both bottom-up (via researchers, participants and publics) and top-down (via statutory regulation), as well as challenges in achieving both. Research EthicsOn the whole, participants recommended multiple changes to the current ethics review regime for data-intensive international research with the aim of reducing inefficiency and inconsistency. But, the changes recommended differ in terms of degree and scope. In general, participants stressed that key drivers of success in a reformed system should be strong leadership (on the ground and in government) and demonstration of value.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Expert perspectives on ethics review of international data-intensive research: Working towards mutual recognition

Garattini

2017

Research Ethics

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“…Notably, IRBs also differ in how they handle risk and protect research participants. The literature shows variation between how boards interpret what is considered research and what type of ethics review is necessary [ 141 , 142 ]. Even if IRBs were to consider some of the broader consequences of using secondary data for one study, this consideration might differ from IRB to IRB.…”

Section: Discussionmentioning

confidence: 99%

If you build it, they will come: unintended future uses of organised health data collections

et al. 2016

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BackgroundHealth research increasingly relies on organized collections of health data and biological samples. There are many types of sample and data collections that are used for health research, though these are collected for many purposes, not all of which are health-related. These collections exist under different jurisdictional and regulatory arrangements and include:Population biobanks, cohort studies, and genome databasesClinical and public health dataDirect-to-consumer genetic testingSocial mediaFitness trackers, health apps, and biometric data sensorsEthical, legal, and social challenges of such collections are well recognized, but there has been limited attention to the broader societal implications of the existence of these collections.DiscussionAlthough health research conducted using these collections is broadly recognized as beneficent, secondary uses of these data and samples may be controversial. We examine both documented and hypothetical scenarios of secondary uses of health data and samples. In particular, we focus on the use of health data for purposes of:Forensic investigationsCivil lawsuitsIdentification of victims of mass casualty eventsDenial of entry for border security and immigrationMaking health resource rationing decisionsFacilitating human rights abuses in autocratic regimesConclusionsCurrent safeguards relating to the use of health data and samples include research ethics oversight and privacy laws. These safeguards have a strong focus on informed consent and anonymization, which are aimed at the protection of the individual research subject. They are not intended to address broader societal implications of health data and sample collections. As such, existing arrangements are insufficient to protect against subversion of health databases for non-sanctioned secondary uses, or to provide guidance for reasonable but controversial secondary uses. We are concerned that existing debate in the scholarly literature and beyond has not sufficiently recognized the secondary data uses we outline in this paper. Our main purpose, therefore, is to raise awareness of the potential for unforeseen and unintended consequences, in particular negative consequences, of the increased availability and development of health data collections for research, by providing a comprehensive review of documented and hypothetical non-health research uses of such data.

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“…It is likely to be a costly endeavour due to the initial time and resource investment, which might deter boards from initiating these agreements. [7] In addition, an appellate mechanism does not exist in the proposed models which means that the ’IEC of record’ would have to make decisions taking into consideration the magnitude of impact it will have on human subject protection across the country. A rejection from the ’IEC of record’ would mean the trial will not see light of day.…”

Section: Bridging the Gapmentioning

confidence: 99%

“…Alternate IEC models have been adopted in countries including USA, Australia, UK and Canada and have been successful at reviewing multicentre research more efficiently, cost-effectively and with reduced turnaround time of projects. [7] A similar system could be replicated albeit with minor customization to suit our requirements. For a start, a common application form for all IECs across India can be an important step to achieve uniformity in functioning of IECs.…”

Section: Bridging the Gapmentioning

confidence: 99%

Central Institutional Ethics Committee needed to facilitate timely review of multicenter clinical trials

Desai

Dixit

Gota

2019

Journal of Postgraduate Medicine

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A multicenter trial in India undergoes review by Institutional Ethics Committees (IECs) of all participating institutions. The failure to obtain approval even from a single institution's IEC creates a situation of inequitable access to clinical trials. The dichotomy in decisions of different IECs is attributed to lack of standardization and accountability in their functioning. The registration of IECs with Central Drugs Standard Control Organization notwithstanding, the current model of IEC review has failed to ensure uniformity in IEC decisions in multicenter trials. Alternative models that allow central review of multicenter clinical trials should be explored.

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Multisite Research Ethics Review: Problems and Potential Solutions

Cited by 6 publications

References 55 publications

Expert perspectives on ethics review of international data-intensive research: Working towards mutual recognition

Expert perspectives on ethics review of international data-intensive research: Working towards mutual recognition

If you build it, they will come: unintended future uses of organised health data collections

Central Institutional Ethics Committee needed to facilitate timely review of multicenter clinical trials

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