scholarly journals Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation

2018 ◽  
Vol 19 (1) ◽  
Author(s):  
Cory E. Goldstein ◽  
Charles Weijer ◽  
Jamie C. Brehaut ◽  
Dean A. Fergusson ◽  
Jeremy M. Grimshaw ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Ethical Issues ◽  
Recent Literature ◽  
Controlled Trials ◽  
Randomized Controlled

scholarly journals Some Questions of Ethics in RCTs

2021 ◽  
Author(s):  
Reetika Khera
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Ethical Issues ◽  
Human Subjects ◽  
Belmont Report ◽  
Institutional Review Boards ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Institutional Review ◽  
Areas Of Concern

Questions of ethics in Randomized Controlled Trials (RCTs) in development economics need greater attention and a wider perspective. RCTs are meant to be governed by the three principles laid out in the Belmont Report, but often violated them, e.g. when local laws are flouted. In other cases, the framework of the Belmont Report itself has proved inadequate: for instance, when there are unintended outcomes or adverse events for which no-one is held accountable. Primarily using RCTs conducted in India, this paper highlights eight areas of concern. RCTs also have a disproportionate influence on shaping research agendas and on policy. Though ethical issues have been raised, there has been little engagement from the RCT community – a manifestation of its power in the profession. As current safeguards (such as oversight by Institutional Review Boards) have failed to protect human subjects, the concluding section discusses possible ways to resolve these issues.

scholarly journals Evidence-based policies, nudge theory and Nancy Cartwright: a search for causal principles

2020 ◽  
pp. 1-20
Author(s):  
ALEJANDRO HORTAL
Keyword(s):  
Public Policy ◽  
Randomized Controlled Trials ◽  
Ethical Issues ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Policy Interventions ◽  
Nancy Cartwright ◽  
Instrumental View

Abstract Nancy Cartwright argues that evidence-based policies should not only rely on randomized controlled trials (RCTs) to test their effectiveness – they should also use horizontal and vertical searches to find support factors and causal principles that help define how those policies work. This paper aims at analyzing Cartwright's epistemology regarding evidence-based policies and their use of RCTs while applying her findings to current research involving nudges as behavioral public policy interventions. Holding a narrowly instrumental view of rationality, nudge theory tends to neglect other expressive components. Policymakers, in their quest for causal principles, should consider the expressive rationality of individuals in their research. This inclusion would not only increase the effectiveness of nudges, but also address some ethical issues related to people's autonomy when targeted by these interventions.

scholarly journals Critical and Comprehensive Ethical Analysis on Pragmatic Randomized Controlled Trials

2020 ◽  
Author(s):  
Soaad Hossain
Keyword(s):  
Medical Ethics ◽  
Randomized Controlled Trials ◽  
Ethical Issues ◽  
Conflicts Of Interest ◽  
Ethical Analysis ◽  
Ethical Framework ◽  
Controlled Trials ◽  
Research Practice ◽  
Randomized Controlled ◽  
Regulatory Frameworks

The interest of pragmatic randomized controlled trials continues to increase as they are much better suited for studies of how to get medical and health services out into wider practice. However, despite the advantage that such trials have, there are several ethical issues and medical ethics issues that persist with the trial. The ethical and medical ethics issues involve research-practice distinction, consent, disclosure, vulnerable populations, oversight, ethical principles, ethical framework, regulatory frameworks, and conflicts of interest. Through performing an elaborate literature review and analyzing claims and arguments made within the literature, we will provide a critical and comprehensive ethical analysis on pragmatic randomized controlled trials, and we will begin the discussion on conflicts of interest in pragmatic RCTs, arguing that conflicts of interest occur in pragmatic RCTs.

scholarly journals Ethical issues of randomized controlled trials

2014 ◽  
Vol 5 (1) ◽  
pp. 1-4 ◽  
Author(s):  
Jyotirmoy Sarker
Keyword(s):  
Randomized Controlled Trials ◽  
Ethical Issues ◽  
Human Subjects ◽  
Research Result ◽  
Controlled Trials ◽  
Medical Interventions ◽  
Randomized Controlled ◽  
Institutional Review ◽  
Human Participants ◽  
Selection Of

Clinical trials involve the application of different medical interventions on human participants. Randomized controlled trials involve different groups of human subjects undergoing different clinical interventions. This process ensures bias free subject allocation which leads to a way to statistically establish the research result. Strict ethical guidance is necessary from selection of participants to the analysis of trial results. Without proper guidance the trial participants would be subjected to unethical experiments. Before starting the randomized controlled trials the investigators must meet all ethics issues. The institutional review board (IRB) must check whether all ethical demands are met or not before permitting the research. DOI: http://dx.doi.org/10.3329/bioethics.v5i1.18441 Bangladesh Journal of Bioethics 2014 Vol.5(1): 1-4

scholarly journals Critical and Comprehensive Ethical Analysis on Pragmatic Randomized Controlled Trials

2020 ◽  
Author(s):  
Soaad Hossain
Keyword(s):  
Medical Ethics ◽  
Randomized Controlled Trials ◽  
Ethical Issues ◽  
Conflicts Of Interest ◽  
Ethical Analysis ◽  
Ethical Framework ◽  
Controlled Trials ◽  
Research Practice ◽  
Randomized Controlled ◽  
Regulatory Frameworks

The interest of pragmatic randomized controlled trials continues to increase as they are much better suited for studies of how to get medical and health services out into wider practice. However, despite the advantage that such trials have, there are several ethical issues and medical ethics issues that persist with the trial. The ethical and medical ethics issues involve research-practice distinction, consent, disclosure, vulnerable populations, oversight, ethical principles, ethical framework, regulatory frameworks, and conflicts of interest. Through performing an elaborate literature review and analyzing claims and arguments made within the literature, we will provide a critical and comprehensive ethical analysis on pragmatic randomized controlled trials, and we will begin the discussion on conflicts of interest in pragmatic RCTs, arguing that conflicts of interest occur in pragmatic RCTs.

scholarly journals From wealth to health: Evaluating microfinance as a complex intervention

Evaluation ◽  
2017 ◽  
Vol 23 (2) ◽  
pp. 209-225 ◽  
Author(s):  
Neil McHugh ◽  
Olga Biosca ◽  
Cam Donaldson
Keyword(s):  
Public Health ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Impact Evaluation ◽  
Ethical Issues ◽  
Complex Interventions ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Relevant Evidence ◽  
The Social

Innovative interventions that address the social determinants of health are required to help reduce persistent health inequalities. We argue that microcredit can act in this way and develop a conceptual framework from which to examine this. In seeking to evaluate microcredit this way we then examine how randomized controlled trials, currently considered as the ‘gold standard’ in impact evaluations of microcredit, compare with developments in thinking about study design in public health. This leads us to challenge the notion of trials as the apparent gold standard for microcredit evaluations and contend that the pursuit of trial-based evidence alone may be hampering the production of relevant evidence on microcredit’s public health (and other wider) impacts. In doing so, we introduce new insights into the global debate on microfinance impact evaluation, related to ethical issues in staging randomized controlled trials, and propose innovations on complementary methods for use in the evaluation of complex interventions.

The Effect of Partly Missing Covariates on Statistical Power in Randomized Controlled Trials With Discrete-Time Survival Endpoints

Methodology ◽  
2017 ◽  
Vol 13 (2) ◽  
pp. 41-60
Author(s):  
Shahab Jolani ◽  
Maryam Safarkhani
Keyword(s):  
Randomized Controlled Trials ◽  
Discrete Time ◽  
Treatment Effect ◽  
Survival Data ◽  
Controlled Trials ◽  
Missing Covariates ◽  
Indicator Method ◽  
Imputation Methods ◽  
Randomized Controlled ◽  
Baseline Covariates

Abstract. In randomized controlled trials (RCTs), a common strategy to increase power to detect a treatment effect is adjustment for baseline covariates. However, adjustment with partly missing covariates, where complete cases are only used, is inefficient. We consider different alternatives in trials with discrete-time survival data, where subjects are measured in discrete-time intervals while they may experience an event at any point in time. The results of a Monte Carlo simulation study, as well as a case study of randomized trials in smokers with attention deficit hyperactivity disorder (ADHD), indicated that single and multiple imputation methods outperform the other methods and increase precision in estimating the treatment effect. Missing indicator method, which uses a dummy variable in the statistical model to indicate whether the value for that variable is missing and sets the same value to all missing values, is comparable to imputation methods. Nevertheless, the power level to detect the treatment effect based on missing indicator method is marginally lower than the imputation methods, particularly when the missingness depends on the outcome. In conclusion, it appears that imputation of partly missing (baseline) covariates should be preferred in the analysis of discrete-time survival data.

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