Ethical review: Standardizing procedures and local shaping of ethical review practices

Jaspers, Patricia; Houtepen, Rob; Horstman, Klasien

doi:10.1016/j.socscimed.2013.03.043

Cited by 7 publications

(5 citation statements)

References 17 publications

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“…To explore these latter questions further investigations taking into account social factors and group dynamics need to be developed. This is consistent with previous work in group decision making that has suggested factors such as committee culture, local thinking [ 23 , 24 ], leadership styles/ability [ 25 ], levels of member experience [ 26 ] and social interactions [ 27 ] play roles in committee decision making. Inconsistency is probably inevitable in research ethics committee review, but to determine how inevitable, studies must now move beyond ShED.…”

Section: Discussionsupporting

confidence: 91%

Measuring inconsistency in research ethics committee review

Trace

Kolstoe

2017

BMC Med Ethics

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BackgroundThe review of human participant research by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority (HRA) coordinates 67 committees, and has adopted a consistency improvement plan including a process called “Shared Ethical Debate” (ShED) where multiple committees review the same project. Committee reviews are compared for consistency by analysing the resulting minutes.MethodsWe present a description of the ShED process. We report an analysis of minutes created by research ethics committees participating in two ShED exercises, and compare them to minutes produced in a published “mystery shopper” exercise. We propose a consistency score by defining top themes for each exercise, and calculating the ratio between top themes and total themes identified by each committee for each ShED exercise.ResultsOur analysis highlights qualitative differences between the ShED 19, ShED 20 and “mystery shopper” exercises. The quantitative measure of consistency showed only one committee across the three exercises with more than half its total themes as top themes (ratio of 0.6). The average consistency scores for the three exercises were 0.23 (ShED19), 0.35 (ShED20) and 0.32 (mystery shopper). There is a statistically significant difference between the ShED 19 exercise, and the ShED 20 and mystery shopper exercises.ConclusionsShED exercises are effective in identifying inconsistency between ethics committees and we describe a scoring method that could be used to quantify this. However, whilst a level of inconsistency is probably inevitable in research ethics committee reviews, studies must move beyond the ShED methodology to understand why inconsistency occurs, and what an acceptable level of inconsistency might be.Electronic supplementary materialThe online version of this article (10.1186/s12910-017-0224-7) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 91%

Measuring inconsistency in research ethics committee review

Trace

Kolstoe

2017

BMC Med Ethics

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“…24 Studies involving REC members in Europe and North America similarly endorse local review of a multisite study when it includes international partners and where sociocultural differences warrant local input. 25 According to another study of REC members in The Netherlands, RECs manage bureaucratic tensions in the review process based on resource availability and institutional context. These differences help RECs develop what the authors call "situational authority" over when, how, and which studies proceed 26 and was a common theme identified in discussions with REC members represented in the COVID-19 Coalition when deciding the merits of centralizing multisite review of vaccine-related trials in the early stages of the pandemic.…”

Section: Protecting Local Rec Review and Decision-making Authoritymentioning

confidence: 99%

Enhancing Reciprocity, Equity and Quality of Ethics Review for Multisite Research During Public Health Crises: The Experience of the COVID-19 Clinical Research Coalition Ethics Working Group

Rahimzadeh,

Ambe,

de Vries

2023

J. Law. Med. Ethics

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In this paper we report findings from a commissioned report to the COVID-19 Clinical Research Coalition on approaches to streamline multinational REC review/approval during public health emergencies. As currently envisioned in the literature, a system of REC mutual recognition is theoretically possible based on shared procedural REC standards, but raises numerous concerns about perceived inequities and mistrust.

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“…For linguistic ethnographers (and others), the concern for ethics goes beyond compliance with university ethical procedures, which generally involve the completion of forms and their review by a central ethics board. These institutional "macroethics" (Kubanyiova 2008) have been criticised for imposing standardised regulations across diverse research contexts, challenging academic freedom, and removing ethics from the research process (Jaspers et al 2013;Kubanyiova 2008). One problem with macroethics is that researchers are encouraged to assume they have addressed ethical concerns by gaining approval at the start of the research, therefore distracting researchers from the need to respond ethically to local dilemmas and decisions that arise during research; what Kubanyiova (2008) calls "microethics" or "ethics of care".…”

Section: Ethics In Linguistic Ethnographymentioning

confidence: 99%

The ethics of digital ethnography in a team project

Tagg

Lyons

et al. 2016

Applied Linguistics Review

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This article draws on researcher vignettes to explore ethical decisions made in the process of collecting and analysing mobile messaging data as part of a team ethnographic project exploring multilingualism in superdiverse UK cities. The research involves observing key participants at work as well as recording them at home and collecting their digital interactions. The nature of ethnographic research raises ethical issues which highlight the impossibility of divorcing ethics from project decision-making. We therefore take on board a reconceptualisation of research ethics not as an external set of guidelines but as being at the core of research, driving decision-making at all steps of the process. The researcher vignettes on which we draw in exploring this process facilitate a reflexive approach and enable us to identify and address ethical issues in our research. In this article, we focus on the potential impact that digital communication technologies can have on the kinds of relationships that are possible between researchers and research participants, and on the roles that both carry out within the project. In doing so, we explore the part that digital communications play in the co-construction of social distance and closeness in research relationships. Our discussions around these issues highlight the need for an awareness not only of how our participants' media ideologies shape their use and perceptions of digital technologies, but also how our own assumptions inform our handling of the digital data.

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Ethical review: Standardizing procedures and local shaping of ethical review practices

Cited by 7 publications

References 17 publications

Measuring inconsistency in research ethics committee review

Measuring inconsistency in research ethics committee review

Enhancing Reciprocity, Equity and Quality of Ethics Review for Multisite Research During Public Health Crises: The Experience of the COVID-19 Clinical Research Coalition Ethics Working Group

The ethics of digital ethnography in a team project

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