Ethical Concerns in Clinical Research

2019 ◽  
pp. 425-451
Author(s):  
Jonathan C. Young ◽  
Lori Nesbitt
Keyword(s):  
Clinical Research ◽  
Ethical Concerns

scholarly journals Therapeutic appropriation: a new concept in the ethics of clinical research

2016 ◽  
Vol 42 (12) ◽  
pp. 805-808 ◽  
Author(s):  
Rosalind McDougall ◽  
Dominique Martin ◽  
Lynn Gillam ◽  
Nina Hallowell ◽  
Alison Brookes ◽  
...  
Keyword(s):  
Primary Care ◽  
Clinical Research ◽  
Clinical Care ◽  
Research Participation ◽  
Therapeutic Benefit ◽  
Therapeutic Misconception ◽  
Ethical Problems ◽  
Ethical Concerns ◽  
Research Participants ◽  
Therapeutic Needs

Ethical concerns about therapeutic misconception have been raised since the early 1980s. This concept was originally described as research participants' assumptions that decisions relating to research interventions are made on the basis of their individual therapeutic needs. The term has since been used to refer to a range of ‘misunderstandings’ that research participants may have. In this paper, we describe a new concept—therapeutic appropriation. Therapeutic appropriation occurs when patients, or clinicians, actively reframe research participation as an opportunity to enhance patients' clinical care, while simultaneously acknowledging the generalised research aims. To illustrate the concept of therapeutic appropriation, we draw on data from an interview study which we conducted to investigate the experiences of patients and general practitioners involved in clinical trials in primary care. We argue that therapeutic appropriation has two key elements: comprehension that the research project is not necessarily aiming to benefit participants and the deliberate use of incidental features of the research for personal therapeutic benefit of various kinds. We conclude that therapeutic appropriation is a useful concept that refines understanding of potential ethical problems in clinical research, and points to strategies to address them.

Ending Concerns about Undue Inducement

2004 ◽  
Vol 32 (1) ◽  
pp. 100-105 ◽  
Author(s):  
Ezekiel J. Emanuel
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Human Subjects ◽  
Human Subjects Research ◽  
Ethical Concerns ◽  
Substantial Risk ◽  
Heavy Burden ◽  
The Common ◽  
Undue Inducement ◽  
Radical Claim

For decades, worries about undue inducement have Pervaded clinical research, and are especially common when research is accompanied by payment or conducted in developing countries. Few ethical judgments carry as much moral opprobrium or are thought to undermine the ethical soundness of a clinical trial as thoroughly as undue inducement. Indeed, the admonition to prevent undue inducement is one of the few explicit instructions in the Common Rules requirements for informed consent.Despite their long history and pervasiveness, charges of undue inducement in clinical research are almost always mistaken. Indeed, I will advance an even more radical claim: Aresearch trial that otherwise fulfills the fundamental ethical requirements for human subjects research inherently cannot create the possibility of undue inducement because substantial risk of serious harm isprecluded. Charges of undue inducement tend to express displaced and mislabeled ethical concerns about other aspects of human subjects research. Consequently, claims of undue inducement should rarely be made, and when they are advanced should be treated with skepticism, placing a heavy burden of proofon those advancing such charges.

scholarly journals Towards a fair and transparent research participant compensation and reimbursement framework in Vietnam

2020 ◽  
Vol 12 (6) ◽  
pp. 533-540 ◽  
Author(s):  
Lucy J Sansom ◽  
Trang Pham Nguyen Minh ◽  
Iona E Hill ◽  
Quyen Nguyen Than Ha ◽  
Thuan Dang Trong ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Research ◽  
Financial Incentives ◽  
Research Participant ◽  
Research Unit ◽  
Decision Making Process ◽  
Ethical Concerns ◽  
Advisory Boards ◽  
Fair Compensation ◽  
Context Specific

Abstract Background Providing compensation for participants in clinical research is well established and while international guidelines exist, defining a context-specific and fair compensation for participants in low-resource settings is challenging due to ethical concerns and the lack of practical, national compensation and reimbursement frameworks. Methods We reviewed Oxford University Clinical Research Unit (OUCRU) internal reimbursement documentation over a 10-y period and conducted a scoping literature review to expand our knowledge of compensation and reimbursement practices including ethical concerns. We developed a preliminary reimbursement framework that was presented to community advisory boards (CAB) and clinical investigators to assess its applicability, fairness and transparency. Results The main topics discussed at the workshops centered on fairness and whether the reimbursements could be perceived as financial incentives. Other decisive factors in the decision-making process were altruism and the loss of caregivers’ earnings. Investigators raised the issue of additional burdens, whereas the CAB members were focused on non-monetary elements such as the healthcare quality the patients would receive. All elements discussed were reviewed and, where possible, incorporated into the final framework. Conclusion Our new reimbursement framework provides a consistent, fair and transparent decision-making process and will be implemented across all future OUCRU clinical research in Vietnam.

scholarly journals A Social Work Perspective on Paediatric and Adolescent Research Vulnerability

2016 ◽  
Vol 18 (2) ◽  
pp. 67-78
Author(s):  
Kyle A McGregor ◽  
James A Hall ◽  
David A Wilkerson ◽  
Larry W Bennett ◽  
Mary A Ott
Keyword(s):  
Social Work ◽  
Informed Consent ◽  
Clinical Research ◽  
Vulnerable Populations ◽  
Biomedical Research ◽  
Pediatric Research ◽  
Complex Interplay ◽  
Screening Techniques ◽  
Ethical Concerns ◽  
The Impact

Children’s and adolescents’ capacity to provide valid informed consent is one of the key ethical concerns in pediatric research. This review of adolescent vulnerability is presented to highlight the complex interplay between capacity and other forms of vulnerability. This review is offered as an interdisciplinary analysis to better understand why the study of vulnerable populations is critical to the ethical advancement of clinical research. Results from this analysis suggest the need for enhanced screening techniques as well as the utilization of specialized staff to identify and reduce the impact of different forms of vulnerability. These findings also provide insights into ways to ethically involve youth in complex biomedical research.

The Global Conduct of Cancer Clinical Trials: Challenges and Opportunities

2015 ◽  
pp. e132-e139 ◽  
Author(s):  
Carlos H. Barrios ◽  
Gustavo Werutsky ◽  
Jeovany Martinez-Mesa
Keyword(s):  
Clinical Research ◽  
Academic Research ◽  
Essential Element ◽  
Developed Countries ◽  
Pharmaceutical Companies ◽  
Cooperative Groups ◽  
Ethical Concerns ◽  
Ethical Implications ◽  
Challenges And Opportunities ◽  
Research Demands

The nature of clinical research has changed substantially over the last 2 decades, evolving from being centered almost exclusively in developed countries to a more global scenario that is increasingly involving less developed regions of the world. Pharmaceutical companies and some academic cooperative groups have been conducting challenging, large pivotal registration studies with multinational participation. The much more needed globalization of academic research demands particular attention and represents a worthwhile subject for a more profound discussion. The requirement of large sample sizes and the potential for fast recruitment leading to a speedy completion of clinical studies are probably the most important factors that have fueled globalization of studies. Reduced operational costs and the ability to expedite the regulatory approval of drugs in various countries or regions are also important drivers. Globalization of research should be seen as having a much wider effect in the societies involved, in particular, when we consider public health, economic, social, and ethical implications. Most importantly, the process of expanding the network of clinical research sites also fosters the integration and the development of closer relationships among investigators at a global level. We consider this an essential element that should remain a prominent element in the discussion. In this article, we address the underlying reasons for globalization and we highlight some of the scientific and ethical concerns arising as a consequence. Finally, some strategies to address and mitigate the challenges of conducting multinational clinical research are proposed.

scholarly journals Social Media, Research, and Ethics: Does Participant Willingness Matter?

2020 ◽  
Vol 29 (01) ◽  
pp. 176-183
Author(s):  
Annie Y. S. Lau ◽  
Pascal Staccini ◽  
Keyword(s):  
Social Media ◽  
Clinical Research ◽  
Social Networking Sites ◽  
Health Informatics ◽  
Ethical Issues ◽  
Online Data ◽  
Ethical Concerns ◽  
Participant Engagement ◽  
Social Media Platforms ◽  
The Impact

Objective: To summarise the state of the art published in 2019 in consumer health informatics and education, with a special emphasis on “Ethics and Health Informatics”. Methods: We conducted a systematic search of articles published in PubMed using a predefined set of queries, which identified 368 potential articles for review. These articles were screened according to topic relevance and 15 were selected for consideration of best paper candidates, which were then presented to a panel of international experts for full paper review and scoring. The top five papers according to the external reviewers’ ranking were discussed in a consensus meeting. Finally, the paper that received the highest score from four of the five experts was selected as the best paper on social media and ethics for patients and consumers of the year 2019. Results: Despite using the terms “ethics” and “ethical” in the search query, we retrieved very few articles. The bibliometric analysis identified three major clusters centred on “social”, “health”, and “study”. Among the top five papers, one was a review where the authors identified ethical issues across four areas at the intersection of social media and health: 1) the impact of social networking sites on the doctor-patient relationship; 2) the development of e-health platforms to deliver care; 3) the use of online data and algorithms to inform health research; and 4) the broader public health consequences of widespread social media use. The other papers highlighted ethical concerns in using social media to interact with patients at different phases of a clinical research protocol, such as recruitment phase, participant engagement, data linkage, and detection and monitoring of adverse events. Conclusions: Findings suggest that most users do not think that using social media for patient monitoring in clinical research, for example using Twitter for clinical trial recruitment, constitutes inappropriate surveillance or a violation of privacy. However, further research is needed to identify whether and how views on ethical concerns differed between social media platforms and across populations.

scholarly journals Ethical considerations in research with children

2014 ◽  
Vol 5 (1) ◽  
pp. 36-42
Author(s):  
Shahanaz Chowdhury
Keyword(s):  
Clinical Research ◽  
Children And Adolescents ◽  
Research Process ◽  
Ethical Standards ◽  
Ethical Considerations ◽  
Research Activity ◽  
Ethical Thought ◽  
Ethical Concerns ◽  
Research With Children ◽  
Medical Advances

Ethical concerns and medical advances unique to children and adolescents make pediatric research an evolving endeavor. The current regulations for clinical research are based on a combination of ethical thought and history, some of it being very tragic. This article presents the ethical and historical underpinnings of these regulations, including elaborative discussion on ethical standards in research. In addition, the article highlights that every effort should be made to actively involve children as participants in the research process and care must be taken to protect the rights of all children, as well as specific groups of children, in research activity. DOI: http://dx.doi.org/10.3329/bioethics.v5i1.18445 Bangladesh Journal of Bioethics 2014 Vol.5(1): 36-42

Sign in / Sign up

Export Citation Format

Share Document