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Confidentiality and Privacy in Digital Clinical Trials
In today’s digitalized world, new technologies have been modifying not only the forms of patient care but also clinical research, where handling...
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The Inclusion of Racial and Ethnic Minority Groups in Clinical Trials
Clinical trialsClinical trials, also knownMinority groups as clinical studies, are research studies performed on people to evaluate the effectiveness...
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Ethical Evaluations of Clinical Trials in France: Towards European Standardization
In France, any request to carry out research involving human beings is evaluated by two distinct and independent structures: the ANSM (National...
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Ethical challenges of clinical trials with a repurposed drug in outbreaks
Drug repurposing is a strategy of identifying new potential uses for already existing drugs. Many researchers adopted this method to identify...
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Clinical Trials (See Research Ethics; Clinical Research)
Clinical trials are scientific research projects involving human subjects.
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Equality, diversity, and inclusion in oncology clinical trials: an audit of essential documents and data collection against INCLUDE under-served groups in a UK academic trial setting
BackgroundClinical trials should be as inclusive as possible to facilitate equitable access to research and better reflect the population towards...
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Regulation (EU) on Clinical Trials
The European Union regulated clinical trials long before the most recent regulation entered into force (2014)
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Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam
BackgroundThe informed consent process in clinical trials has been extensively studied to inform the development processes which protect research...
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Military Medicine Research: Incorporation of High Risk of Irreversible Harms into a Stratified Risk Framework for Clinical Trials
Clinical trials aim to minimise participant risk and generate new clinical knowledge for the wider population. Many military agencies are now...
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Navigating ethical challenges of conducting randomized clinical trials on COVID-19
BackgroundThe contemporary frameworks for clinical research require informed consent for research participation that includes disclosure of material...
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The role of community advisory boards in community-based HIV clinical trials: a qualitative study from Tanzania
BackgroundCommunity Advisory Boards (CAB) have become essential organs of involving communities in HIV clinical trials especially in develo**...
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Human Challenge Trials in Pandemics: Risks and Benefits
Human challenge trials deliberately expose subjects to diseases upon consent to get more knowledge about the early stages of the disease and its...
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Unapproved clinical trials in Russia: exception or norm?
BackgroundIn modern Russia, any clinical investigation of a pharmaceutical for use in humans is subject to prior evaluation and approval by the...
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Parachutes, randomized controlled trials, and all-cause mortality
In 2003 and 2018 researchers discussed the perils of blind reliance on randomized controlled trials that have been substituted for medical experience...
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The Role of Family Members in Psychiatric Deep Brain Stimulation Trials: More Than Psychosocial Support
Family members can provide crucial support to individuals participating in clinical trials. In research on the “newest frontier” of Deep Brain...
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Checklist to assess Trustworthiness in RAndomised Controlled Trials (TRACT checklist): concept proposal and pilot
ObjectivesTo propose a checklist that can be used to assess trustworthiness of randomized controlled trials (RCTs).
DesignA screening tool was...
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Clinical Diagnosis: Evidence, Ethics, and Justice
The process of clinical diagnosis is the cornerstone of modern medical practice. In this chapter, it will be shown that in order to facilitate...
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Motivation to participate and experiences of the informed consent process for randomized clinical trials in emergency obstetric care in Uganda
BackgroundInformed consent, whose goal is to assure that participants enter research voluntarily after disclosure of potential risks and benefits,...
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Ethical Relativism and Circumstances of Social and Cultural Contingencies on Informed Consent in the Conduct of Research: Clinical Trials in Nigeria
There have been debates across the globe for a social and culturally sensitive ethics to meditate a catalyst of template for informed consent (IC) in...
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When the Trial Ends: The Case for Post-Trial Provisions in Clinical Psychedelic Research
The ethical value—and to some scholars, necessity—of providing trial patients with post-trial access (PTA) to an investigational drug has been...