scholarly journals How Community Pharmacists Perceive Ethics in Clinical Research: A Qualitative Study

Healthcare ◽  
2021 ◽  
Vol 9 (11) ◽  
pp. 1496
Author(s):  
Miku Ogura ◽  
Rieko Takehira ◽  
Tatsuya Watanabe ◽  
Etsuko Arita
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Educational Program ◽  
Ethical Issues ◽  
Community Pharmacists ◽  
Opportunities To Learn ◽  
Research Subjects ◽  
Ethical Decisions ◽  
Poor Understanding ◽  
Regular Work

In recent years, the importance of building evidence in clinical practice that is increasingly acknowledged globally has been recognized in Japan as well, and it is expected that clinical research by community pharmacists will grow. In Japan, however, community pharmacists have few opportunities to learn about research ethics and may lack the training to make ethical decisions. We conducted a questionnaire survey of community pharmacists (n = 200) using a free descriptive format to understand how they perceived research ethics. Our qualitative analysis of 170 respondents revealed various perspectives (<A pharmacist’s grounding>, <How pharmacists perceive research>, and <Ethical issues entailed by research>) of Japanese pharmacists on ethics in the context of clinical research. With respect to how to understand research, the following perspectives were found: “research that prioritizes researchers,” “research that prioritizes research subjects (patients),” and “research that enters into regular work.” The perspectives on “research that prioritizes research subjects (patients)” and “research that enters into regular work” may inadvertently lead to ethically inappropriate research due to mismatch in professional values or poor understanding of research. These findings can contribute to the development of an educational program for community pharmacists on research ethics.

Pediatric Assent: Subject Protection Issues among Adolescent Females Enrolled in Research

2006 ◽  
Vol 34 (2) ◽  
pp. 451-459 ◽  
Author(s):  
Theresa O'Lonergan ◽  
John J. Zodrow
Keyword(s):  
Clinical Research ◽  
Randomized Clinical Trials ◽  
Ethical Issues ◽  
Pediatric Population ◽  
Medical Community ◽  
Research Subjects ◽  
Regulatory Requirements ◽  
Number Of Factors ◽  
Clinical Investigations ◽  
Scientific Attention

Randomized Clinical Trials (RCTs) in the medical community are generally lasting longer due to a number of factors, including an increase in the total volume of biomedical research, expanded federal regulatory requirements, and a rise in patient interest in participating as research subjects. Leading national and international initiatives promote clinical research in children. The primary impetus for these initiatives is the need for adequate data for clinical application of new products and treatment approaches in the pediatric population. Clinical investigations must maintain ethical conduct as an essential component of pediatric research.Ethical issues associated with clinical research in general have received prominent public and scientific attention. Of particular interest is informed consent, or assent, as applied to pediatrics. There is little practical guidance concerning pediatric assent from legal and ethical disciplines; the law has played only a small role in few cases.

scholarly journals Care-full research ethics in multispecies relations on dairy farms

2021 ◽  
pp. 147447402098724
Author(s):  
Annika Lonkila
Keyword(s):  
Research Ethics ◽  
Empirical Work ◽  
Dairy Farms ◽  
Research Subjects ◽  
Human Research ◽  
Ethical Decisions ◽  
Human Research Ethics ◽  
Starting Point ◽  
Social Scientific ◽  
Human Research Subjects

Although ethical questions are at the core of more-than-human geographies, more attention needs to be paid on researchers’ ethical responsibilities to more-than-human research subjects in social scientific research. In this paper I critically analyze my empirical work on Finnish dairy farms from the perspective of multispecies research ethics. I suggest that the concept of care is useful in understanding more-than-human research ethics. Attending to the needs of others can work as a starting point for making difficult ethical decisions in the field. However, in contested moments, different needs are often in conflict. Here, situated ethical responses might be needed in relation to the practices of fieldwork, for example to avoid causing harm to research subjects. Importantly, researchers have to care for their research subjects also through their analysis; addressing the questions related to research ethics also in terms of knowledge politics. When the ethics of care is complemented with the notion of ethics of exclusion, it has potential to tease out broader responsibilities both in interactions and knowledge about other animals and more-than-human research settings.

scholarly journals Methodological aspects of regulation of neuroresearch and neurotechnologies in neuroethics

2020 ◽  
pp. 29-45
Author(s):  
Tatyana Sidorova
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Technological Development ◽  
Research Subjects ◽  
Ethical Assessment ◽  
Regulatory Systems ◽  
Two Factors ◽  
Brain And Behavior ◽  
And Behavior ◽  
Methodological Aspects

This article is dedicated to methodological questions in ethical regulation of neuroresearch. Neuroethics has emerged recently within the framework of the neuro-trend in modern technoscience; its regulatory capabilities are yet to be discovered. Sciences that study human brain and behavior orient towards existing institutions of ethical regulation, which do not consider the complexity and specificity of the emerging threats and risks. The author examines the circumstances for formation of the research ethics and points of intersection with neuroethics. Research ethics is viewed as a part of bioethics, which not only assessed the potential harm for the examinees, but also the social and anthropological consequences of scientific and technological development. The author provides a &ldquo;narrow&rdquo; understanding of research ethics as a system of rules within the framework of particular disciplines, and as a clinical research practice. Based on the historically established ethical regulation of clinical research and the forming beneath our eyes rules of modification of human genome and artificial intelligence, the author demonstrates contradictions and trends of the separate regulatory systems, which should be taken into account to prevent risks in neuroresearch and prediction of social implications of the spread of neurotechnologies. Ethical examination became a part of a complex system of international control of clinical research, which leads to fading of the value component aimed at protection of research subjects. The author underlines two factors that form the types of harm peculiar to neuroresearch: orientation towards technological realization and vulnerability of mental sphere as a subject of research. The conclusion is made on inefficiency of application of the calculation of harm/advantage in ethical assessment of neuroresearch. Leaning on the experience of bioethics, neuroethics requires development of the own systems of rules that would become the institutions of neuroethical regulation. For preventing formalization of ethical control, it is essential to advance extensive socio-humanistic assessment of new achievements in neuroscience, as well as neuroethical education for the scientists.

Medical Research Ethics: What We Need to Comply When Obtaining Informed Consent from Human Subjects?

2009 ◽  
Vol 16 (4) ◽  
pp. 271-276
Author(s):  
CSK Tay
Keyword(s):  
Patient Safety ◽  
Informed Consent ◽  
Medical Ethics ◽  
Clinical Research ◽  
Medical Research ◽  
Research Ethics ◽  
Human Subjects ◽  
Well Being ◽  
Research Subjects ◽  
Medical Research Ethics

Patient safety and well-being are very important to safeguard in medical research. A subject's life cannot be sacrificed for the benefits of future mankind, as medical ethics of autonomy dictate the respect of an individual. By reference to the Declaration of Helsinki, this article discusses the ethical principles and processes in obtaining a valid and proper informed consent from the research subjects who should freely consent and voluntarily participate in the clinical research, including the ‘contents’ of the informed consent and the ‘skills’ of obtaining informed consent.

scholarly journals Ethical Dilemmas Associated With Profit-Driven Research in Developing Countries

2019 ◽  
Vol 5 (1) ◽  
pp. 22-35
Author(s):  
EVangel Sarwar
Keyword(s):  
Developing Countries ◽  
Low Income ◽  
Ethical Issues ◽  
The United States ◽  
Low Income Countries ◽  
Healthcare Personnel ◽  
Research Subjects ◽  
Double Standards ◽  
Ethical Decisions ◽  
Set Up

The phenomenal growth of the global pharmaceutical sales, which exceeded $US one trillion in revenues in 2014 alone, has resulted in the growing ethical concerns associated with the need for the unprecedented search for human test subjects to participate in clinical drug trials - particularly in middle and low-income countries – and concerns about possible exploitation. While this expansion has provided access to vital medical resources that would have otherwise been unattainable for this population - this outsourcing also created problems which may be termed as exploitation – such as faulty trials at times, and manipulation of data about the benefits and risks of the drugs being tested on the populations in developing countries. Although the United States and European countries have sponsored much biomedical research in developing countries, they considered their work done once the trials concluded, and this has been criticized and termed as “safari research,” – which is a form of exploitation of developing countries and their populations from which research subjects are recruited. These trials do not address the needs of the developing countries and contribute to the exploitation of some of the most “vulnerable” populations. It is unethical to enter a country, set up facilities for research then leave with the healthcare personnel and equipment after giving hope to its people of some form of benefit. Several historical events have led to the awareness of the need for protecting research subjects. There is a need for a better understanding of what constitutes as exploitations, to ensure researchers make ethical decisions with planning and implementation of research involving research participants. The paper looks at the ethical issues and their importance in international research, and the double standards that are of growing concern in profit-driven research in low-income countries by developed sponsor countries, while also making recommendations for preventing exploitations.

scholarly journals Teaching Research Ethics to Pharmacists: The Practice of Participatory Learning

Pharmacy ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 179
Author(s):  
Miku Ogura ◽  
Rieko Takehira ◽  
Etsuko Arita
Keyword(s):  
Research Ethics ◽  
Educational Program ◽  
Ethics Education ◽  
Community Pharmacists ◽  
Learning Motivation ◽  
Motivation To Learn ◽  
Participatory Learning ◽  
History Of ◽  
Research Ethics Education ◽  
Applied Skills

The research history of community pharmacists in Japan is short, and ethical responses may not be mature. Therefore, the Japan Pharmaceutical Association and universities are working on research ethics education to help pharmacists make appropriate ethical responses. In this study, we evaluated whether an educational program using participatory learning was effective in research ethics education for pharmacists. Regarding the educational effects of our workshop, the score for motivation to learn about research ethics was high, and that for judgment and applied skills related to research ethics was low. Overall, participants’ assessment of the program contents was extremely favorable, indicating their satisfaction. Participatory learning was widely accepted and suggested to be effective in improving learning motivation. Additionally, to be able to apply the knowledge of research ethics to own research, it was considered necessary to continue learning through participatory learning. This will help pharmacists gain judgment and applied skills related to research ethics.

scholarly journals Regulatory, scientific, and ethical issues arising from institutional activity in one of the 90 Italian Research Ethics Committees

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
G. Benfatto ◽  
◽  
F. Drago ◽  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Final Approval ◽  
The Subject ◽  
Multidisciplinary Staff ◽  
Time Required

Abstract Background This paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review process and ensuring review quality. Publications on the subject from Italy and the rest of Europe are limited; encouraging constructive debate can improve RECs’ service to the subject of the clinical trial. Methods We retrospectively reviewed a cohort of 822 clinical trial protocols, initially reviewed by REC, from June 2014 to December 2018. Data collected for each protocol were type of trial, sample size, use of placebo, number and kind of revisions requested by the REC before approval, and time taken for approval. Data for each protocol were collected by a trained clinical research assistant using the REC’s files and electronic archives. Results Almost 45% of the reviewed studies (374/822) required clarifications, significant changes to the documentation, or minor changes before final approval. Conclusions Preventive measures are needed to reduce the number of requested corrections and thus also the time required for approval, while maintaining review quality. All critical points and proposals presented in this paper require harmonization through updates to European regulations, as regulatory harmonization produces better compliance with rules and reduces the number of changes required before the trials’ final approval. Such updates include the development of standardized formats for informed consent, the verification of any evidence in favor of using off-label treatments over placebo as comparators, using multidisciplinary staff in clinical trials with children and adolescents, improving the legal definition of RECs to assign responsibilities and ensure independence, and providing guidance for RECs to engage clinical research assistants in internal audits.

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