Fresh thinking about the Declaration of Helsinki

  title={Fresh thinking about the Declaration of Helsinki},
  author={Michael D E Goodyear and Lisa Eckenwiler and Carolyn Ells},
  journal={BMJ : British Medical Journal},
A comprehensive approach to ethical research 
Does the FDA have the authority to trump the Declaration of Helsinki?
A new rule seems to be more about imperialism than harmonisation, according to a report by the International Institute for Strategic Studies (IISS). Expand
Evaluation of adherence to the glucose control protocol in a cardiothoracic ICU
A research report submitted to the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, in partial fulfilment of the requirements for the degree of Master of Medicine in theExpand
Rethinking the Therapeutic Obligation in Clinical Research
A highly debated question in the field of human medical research is the ethically fundamental distinction between clinical research and clinical care. In this regard, the “therapeutic obligation”Expand
Reconsidering "vulnerability" in research ethics: a critical analysis and proposal for the refinement of this concept
In the context of human subjects research, it is widely accepted that some persons are more vulnerable than others and that there exists a moral obligation to pay special attention to and provideExpand
[Analysis of the main ethical conflicts in the 2008 declaration of Helsinki and the proposed changes in the new version].
An ethical analysis is presented of the main changes contained in the DoH, including the proposed changes in the new version, referring, when appropriate, to relevant Chilean laws governing research on human subjects. Expand
Análisis de los principales conflictos éticos entre la Declaración de Helsinki 2008 y su propuesta de cambio
The Declaration of Helsinki (DoH) of the World Medical Association is the basis of the rules governing research on human beings. The latest version (enacted in Korea, 2008) has been a source ofExpand
Drug toxicity in children: paediatric randomised controlled drug trials and global child health
High quality, ethical paediatric RCTs should add to the evidence base for paediatric medicines, however they should correspond with the health needs of children on a global basis. Expand
Clinical presentation and long-term follow-up of perimyocarditis
This study underlines the benign mid- to long-term outcome of PMY regardless of clinical laboratory characteristics at presentation, different aetiology and possibility of relapses; minimizing the role of endomyocardial biopsy in these specific patients. Expand
Helicobacter pylori Infection in Clinical Practice: Probiotics and a Combination of Probiotics + Lactoferrin Improve Compliance, But Not Eradication, in Sequential Therapy
Background:  Sequential therapy (ST) seems to offer higher success rates than triple therapy (TT) in the eradication of Helicobacter pylori (H. pylori) infection. However, from the standpoint ofExpand
Frequency and Predictors of Extra-articular Manifestations in Patients with Rheumatoid Arthritis
Extra-articular manifestations are common among rheumatoid arthritis patients and disease duration and disease activity were independent predictors of extra-artsicular manifestations occurrence in rheumatic arthritis. Expand


Autonomy, paternalism, and justice: ethical priorities in public health.
  • D. Buchanan
  • Sociology, Medicine
  • American journal of public health
  • 2008
To promote autonomy, the field should redirect current efforts toward clarifying principles of justice, and recommendations for initiating this process are presented. Expand
Whither Bioethics?: How Feminism Can Help Reorient Bioethics
This paper argues that the various approaches to ethics that bioethicists rely on are not adequate to provide effective moral guidance in how to avoid a series of looming human catastrophesExpand
Ethical oversight of public health research: can rules and IRBs make a difference in developing countries?
  • L. London
  • Sociology, Medicine
  • American journal of public health
  • 2002
Concurrent with developments shaping the new public health that seek to operationalize empowerment of communities by placing them as initiators and organizers of their own health, ethical review of public health research must find ways to recognize the agency of vulnerable individuals, groups, and communities in the review process. Expand
Assuring Adequate Protections in International Health Research: A Principled Justification and Practical Recommendations for the Role of Community Oversight
The analysis presented here lays out the ethical warrants for requiring community oversight of health research conducted in international settings. It reviews the inadequacies with the currentExpand
Rethinking Research Ethics
  • R. Rhodes
  • Medicine
  • The American journal of bioethics : AJOB
  • 2010
This paper clarifies different senses of autonomy that have been confounded and present more intelligible justifications for informed consent and takes issue with several of the now accepted dogmas that govern research ethics. Expand
Hopes for Helsinki: reconsidering “vulnerability”
Ideas on how to re-conceive the concept of “vulnerability” and its links with the principle of justice and, in turn, redirect the attention of researchers towards those who might be so designated are offered. Expand
The Limitations of “Vulnerability” as a Protection for Human Research Participants
Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policyExpand
Partnership as an ethical model for medical research in developing countries: the example of the “implementation trial”
  • D. Dowdy
  • Economics, Medicine
  • Journal of Medical Ethics
  • 2006
Alternative models— for example, partnership—and means to balance power—for example, implementation trials—must be explored to ensure that medical research provides knowledge of value to societies in the developing world. Expand
Declaration of Helsinki. Dead.
Servicing the overarching interests of the drug and medical device industry, the United States has apparently successfully intervened in the past (and still tries) with provisions that weaken theExpand
What to do about CAM?
Doug Kamerow seems excessively tolerant of people who make lots of money out of unproved and disproved treatments.1 I prefer the straight talking of his compatriot, Gerald Weissmann, “If the trendExpand