scholarly journals Incidental Findings in Neuroimaging: Ethical and Medicolegal Considerations

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Lawrence Leung
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Incidental Findings ◽  
Research Agenda ◽  
Human Subjects ◽  
Legal Liability ◽  
Basic Sciences ◽  
General Duty ◽  
Exponential Increase ◽  
Do No Harm

With the rapid advances in neurosciences in the last three decades, there has been an exponential increase in the use of neuroimaging both in basic sciences and clinical research involving human subjects. During routine neuroimaging, incidental findings that are not part of the protocol or scope of research agenda can occur and they often pose a challenge as to how they should be handled to abide by the medicolegal principles of research ethics. This paper reviews the issue from various ethical (do no harm, general duty to rescue, and mutual benefits and owing) and medicolegal perspectives (legal liability, fiduciary duties, Law of Tort, and Law of Contract) with a suggested protocol of approach.

scholarly journals Issues of research ethics and clinical ethics in developing world, possible solution: a way forward

2012 ◽  
Vol 3 (3) ◽  
pp. 12-15
Author(s):  
Muhammad Waseem Khan ◽  
Imrana Niaz Sultana ◽  
Afrasiab Khan
Keyword(s):  
Developing Countries ◽  
Research Ethics ◽  
Medical Technology ◽  
Research Study ◽  
Developing World ◽  
Human Subjects ◽  
Research Subjects ◽  
Developed Country ◽  
Do No Harm ◽  
Study Participants

Research plays a pivotal role in the progress of inventions in medicines and medical technology. It is noticed that researchers from developing world or multinational companies are interested to conduct their research studies in developing countries, in doing so sometimes it is noticed that rather benefiting the participants it causes significant harm to the research study participants of developing countries. Ethical lapses in research can significantly harm human subjects. In research ethics the basic aim of ethics is distinguishing between right and wrong, to recognize the wrong doings and try to avoid them from harming research subjects in any research study whether that is done in developing country or developed country. It must follow the principle of non malefiecence or do no harm. DOI: http://dx.doi.org/10.3329/bioethics.v3i3.12559 Bangladesh Journal of Bioethics 2012; 3(3):12-15

Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines

2012 ◽  
Vol 40 (4) ◽  
pp. 841-847 ◽  
Author(s):  
Jonathan Kimmelman
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Human Subjects ◽  
Clinical Development ◽  
Nuremberg Code ◽  
Human Research ◽  
Clinical Investigator ◽  
Nazi Doctors ◽  
Personal Interests

Like all policies, contemporary human research policies are the product of their history. The scandals and traumas motivating their creation — the Nazi doctors trials, Tuskegee, the Milgram experiment on obedience — however different in their particulars, all share a common narrative: a scientist, pursuing valued social ends, runs roughshod over the personal interests of disadvantaged human subjects. From the Nuremberg code through the latest revisions of the Declaration of Helsinki, research ethics policies have sought to erect a sphere of protection around the latter.As a consequence of this history, all major policies start with a well-rehearsed model of human investigations. Clinical research is viewed as an encounter between investigators and volunteers. The clinical investigator is given certain duties. The human volunteer has certain moral entitlements. What is ethically at stake in human investigations inheres in the nature and quality of the interactions between investigators and volunteers. These interactions involve an asymmetry because the investigator has privileged knowledge and influence.

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.

A University Wide Model for the Ethical Review of Human Subjects Research

2005 ◽  
Vol 1 (2) ◽  
pp. 39-44 ◽  
Author(s):  
Bryn Williams-Jones ◽  
Søren Holm
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Human Subjects ◽  
Ethics Committees ◽  
Ethical Review ◽  
Research Ethics Committees ◽  
Ethics Review ◽  
Wide System ◽  
Tiered System ◽  
The University

In the United Kingdom (and elsewhere), there are moves to extend formal ethical review of research involving human subjects beyond the traditional oversight by NHS local or multi-centre research ethics committees of medical or clinical research, to also encompass all ‘non-clinical’ research involving human subjects. This paper describes and analyses the development and implementation of a model for ethical review within the university sector. At Cardiff University, a devolved or two-tiered system of ethics review has been created in which a top-level university research ethics committee provides policy advice to and oversight of school-based research ethics committees that engage in formal ethics review of research conducted in their respective schools. We describe the system and reflect on the challenges and benefits of implementing such a coordinated and comprehensive university-wide system of ethics review.

Teaching About Systemic Ethical Misconduct Increases Awareness of Ethical Principles: A Replication and Extension of Grose-Fifer’s (2017) Tuskegee Role-Play Activity

2021 ◽  
pp. 009862832110159
Author(s):  
Maya C. Rose ◽  
Jessica E. Brodsky ◽  
Elizabeth S. Che ◽  
Patricia J. Brooks
Keyword(s):  
Research Ethics ◽  
Human Subjects ◽  
Social Activism ◽  
Role Play ◽  
Public Health Research ◽  
Play Activity ◽  
Ethics Instruction ◽  
Ethical Misconduct ◽  
Unethical Research ◽  
Human Subjects Protections

Background: Introductory Psychology students rarely learn about unethical biomedical research outside the Tuskegee syphilis study, but these practices were widespread in U.S. public health research (e.g., at the Willowbrook State School researchers infected children with disabilities with hepatitis). Objectives: Replicate and extend Grose-Fifer’s research ethics activity by evaluating if an online homework and in-class role-play increased awareness of unethical research and abuses at Tuskegee (replication) and Willowbrook (extension) and subsequent changes in human subjects protections. Method: As homework, students read about the studies and wrote statements from perspectives of individuals involved. In class, students read their statements and discussed how outrage led to research conduct regulations. Online pre/posttests asked students why it was important to learn about both studies. Results: At posttest, students were more aware of unethical research at Willowbrook and that Tuskegee led to changes in human subjects protections. Students who completed the role-play activity were less likely to mention abuses for Tuskegee than students who did not participate. Conclusion: We were partially successful in replicating and extending Grose-Fifer. Teaching Implications: Research ethics instruction should draw attention to historical precedents and how public outrage and social activism led to increased protections for research participants.

The Social Value of Research and Health Research Priority-Setting

2021 ◽  
Author(s):  
D.M. Wenner
Keyword(s):  
Clinical Research ◽  
Priority Setting ◽  
Health Research ◽  
Human Subjects ◽  
Social Value ◽  
Research Priority ◽  
The Social ◽  
Research Questions ◽  
Social Scientific ◽  
Health Research Priority Setting

This chapter discusses the social value requirement in clinical research and its intersection with health research priority-setting. The social value requirement states that clinical research involving human subjects is only ethical if it has the potential to produce socially valuable knowledge. The chapter discusses various ways to specify both the justification for and the content of the social value requirement. It goes on to consider the implications of various accounts of the content and justification for the requirement for the ethics of health research priority-setting, showing that while some accounts of the requirement are largely silent with respect to how research questions should be prioritized, others entail robust obligations to prioritize research that might benefit particular groups. The chapter also briefly examines potential arguments for something like a social value requirement in other kinds of research, specifically social scientific research.

Doubtful use of placebo following placebo in recent controlled trials of lasmiditan and ubrogepant for the treatment of migraine attacks

Cephalalgia ◽  
2021 ◽  
pp. 033310242110299
Author(s):  
Peer Tfelt-Hansen ◽  
Karsten Jørgensen ◽  
Hans-Christoph Diener
Keyword(s):  
Clinical Research ◽  
Migraine Attack ◽  
Human Subjects ◽  
Second Step ◽  
Controlled Trials ◽  
Scientific Rigor ◽  
Protection Of Human Subjects

Purpose In four large controlled trials with lasmiditan and ubrogepant placebo was administered in the first step to demonstrate an effect on migraine attack. In the same trials the investigators also asked the question: is a second dose of the drug effective in non-responders to the first dose? In this phase patients who received placebo in the first phase of the trial again after 2 hours received another dose of placebo. Conclusion To be ethical, clinical research requires balancing rigorous science with the protection of human subjects; and it is, in our view, questionable whether placebo was used with “scientific rigor” in the second step of these trials, and this design is not recommended.

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