The 2008 Declaration of Helsinki — First among Equals in Research Ethics?

@article{Rid2010The2D,
  title={The 2008 Declaration of Helsinki — First among Equals in Research Ethics?},
  author={Annette Rid and H Schmidt},
  journal={The Journal of Law, Medicine \& Ethics},
  year={2010},
  volume={38},
  pages={143 - 148}
}
  • A. Rid, H. Schmidt
  • Published 2010
  • Medicine, Political Science
  • The Journal of Law, Medicine & Ethics
The World Medical Association's (WMA) Declaration of Helsinki is one of the most important and influential international research ethics documents. Launched in 1964, when ethical guidance for research was scarce, the Declaration comprised eleven basic principles and provisions on clinical research. The document has since evolved to a complex set of principles, norms, and directions for action of varying degrees of specificity, ranging from specific rules to broad aspirational statements. It has… Expand
Declaration of Helsinki
TLDR
The Declaration of Helsinki was at that time the most extensive document offering ethical guidelines in conducting research with human subjects and extended of its application to include identifiable human material or data in research. Expand
A Review and Critique of International Ethical Principles
Recognizing the perpetual tension between the advancement of scientific knowledge and the protection of clinical research participants, this chapter analyzes the different ethical codes that haveExpand
Impossible, impractical, and non-identifiable? New criteria regarding consent for human tissue research in the Declaration of Helsinki.
TLDR
The implications of paragraph 25 of the Declaration of Helsinki, dealing specifically with the standards of informed consent required for research involving identifiable human tissue samples and/or data, are examined, and the use of the term "identifiable" weakens the paragraph. Expand
International Guidelines and Ethical Context
Clinical practice and clinical research are subject to numerous ethical principles and guidelines, both formal and informal. Protect and promote patients’ and subjects’ clinical interests. RespectExpand
In defence of Helsinki and human rights
The Declaration of Helsinki (DoH) is widely recognised as the leading authoritative source on ethical standards of medical research worldwide. Yet, in the past decade, different sources haveExpand
Procedure versus process: ethical paradigms and the conduct of qualitative research
TLDR
The implications of contrasting ethical paradigms for the conduct of qualitative research and the value of ‘empirical ethics’ as a means of liberating qualitative research from an outmoded and unduly restrictive research governance framework based on abstract prinicipalism are considered. Expand
Closing the translation gap for justice requirements in international research
TLDR
It is argued that research ethics guidelines need to be more informed by international research practice and empirical work is necessary to inform the articulation of obligations of justice in international research and to develop guidance on how to fulfil them in order to facilitate better adherence to guidelines' requirements. Expand
Human Rights and the Regulation of Transnational Clinical Trials
One of the more worrying trends in globalization today is the growing practice of Western companies relocating clinical trials to impoverished countries. This article begins by providing aExpand
Misleading by Omission: Rethinking the Obligation to Inform Research Subjects about Funding Sources.
  • N. Manson
  • Political Science, Medicine
  • The Journal of medicine and philosophy
  • 2017
TLDR
An alternative approach-grounded in a general obligation to refrain from misleading, an obligation that is independent of informed consent-provides a basis for a norm that protects subjects' interests, without the informational fallacy. Expand
The barriers to sample and data sharing between biobanks in Switzerland
Background The potential benefits of biobanks for biomedical research have received much attention in the last decade. Research using stored biosamples enables material from numerous individuals toExpand
...
1
2
3
...

References

SHOWING 1-10 OF 24 REFERENCES
The 2000 revision of the Declaration of Helsinki: a step forward or more confusion?
TLDR
The process of revision and the major changes made to the Declaration of Helsinki are analyzed, which resulted in a controversial version of the declaration. Expand
The revision of the Declaration of Helsinki: past, present and future.
TLDR
A review of the past and present versions of the Declaration of Helsinki and some of the possible future trajectories for the Declaration in the light of its history and standing in the world of the ethics of medical research are given. Expand
The standard of care debate: against the myth of an “international consensus opinion”
TLDR
It will be demonstrated in this paper that there is not such a thing as an international consensus opinion, and that the authorities used by Lie et al as evidence in support of their claim should not be relied upon as authorities or final arbiters in this debate. Expand
The standard of care debate: the Declaration of Helsinki versus the international consensus opinion
TLDR
The authors show that there is also consensus regarding the broad conditions under which this is acceptable, and it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Expand
After Helsinki: Unresolved Issues in International Research
  • R. Macklin
  • Political Science, Medicine
  • Kennedy Institute of Ethics journal
  • 2001
TLDR
An analysis of current controversies regarding research sponsored by industrialized countries and conducted in developing countries reveals reasons why they are not likely to be readily resolved, despite apparent agreement by opponents on overarching ethical principles. Expand
International ethical guidelines for biomedical research involving human subjects
TLDR
This is a very seriously written book which is, incidentally, beautifully edited and well produced and it is essentially for educationists and community physicians who will follow the discussions with interest and benefit. Expand
The standard of care debate: can research in developing countries be both ethical and responsive to those countries' health needs?
TLDR
A framework for the conditions under which it is acceptable to provide subjects with less than the best methods is proposed, and institutional review boards should be willing to grant exceptions to this default. Expand
The ethics of research related to healthcare in developing countries
In April 2002 the Nuffield Council on Bioethics published the Report The Ethics of Research Related to . It provides an ethical framework for those designing or conducting healthcarerelatedExpand
Double Standards in Medical Research in Developing Countries
This book examines the ethical controversies that have surrounded the design and conduct of international medical research sponsored by industrialized countries or industry, and carried out inExpand
Human subject protection; foreign clinical studies not conducted under an investigational new drug application. Final rule.
  • Medicine
  • Federal register
  • 2008
TLDR
The final rule updates the standards for the acceptance of foreign clinical studies not conducted under an IND and helps ensure the protection of human subjects and the quality and integrity of data obtained from these studies. Expand
...
1
2
3
...