Research ethics

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Research ethics is a discipline within the study of applied ethics. Its scope ranges from general scientific integrity and misconduct to the treatment of human and animal subjects. The societal responsibilities science and reseach has are not traditionally included and less well defined.[1]

The discipline is most developed in medical research. Beyond the issues of falsification, fabrication and plagiarism that arise in every scientific field, research design in human subject research and animal testing are the areas that raise ethical questions themselves most often.

The

Tuskegee syphilis experiment which lead to international codes of research ethics. No approach has been universally accepted,[2][3][4] but typically cited codes are the 1947 Nuremberg Code, the 1964 Declaration of Helsinki, and the 1978 Belmont Report
.

Today,

research ethics committees, such as those of the US, UK and EU
, govern and oversee the responsible conduct of research.

Research in other fields such as

History

The

Tuskegee syphilis experiment which lead to international codes of research ethics.[2][3][4] Out of centuries of science motivated by results only and general malpractice the medical ethics developed, which in turn lead to today's more broad understanding in bioethics.[9]

Scientific conduct

Scientific integrity

Research integrity or scientific integrity is an aspect of research ethics that deals with best practice or rules of professional practice of scientists.

First introduced in the 19th century by Charles Babbage, the concept of research integrity came to the fore in the late 1970s. A series of publicized scandals in the United States led to heightened debate on the ethical norms of sciences and the limitations of the self-regulation processes implemented by scientific communities and institutions. Formalized definitions of scientific misconduct, and codes of conduct, became the main policy response after 1990. In the 21st century, codes of conduct or ethics codes for research integrity are widespread. Along with codes of conduct at institutional and national levels, major international texts include the European Charter for Researchers (2005), the Singapore statement on research integrity (2010), the European Code of Conduct for Research Integrity (2011 & 2017) and the Hong Kong principles for assessing researchers (2020).

Scientific literature on research integrity falls mostly into two categories:[unclear what the two categories are.] First, mapping of the definitions and categories, especially in regard to scientific misconduct and second, empirical surveys of the attitudes and practices of scientists.[10] Following the development of codes of conduct, taxonomies of non-ethical uses have been significantly expanded, beyond the long-established forms of scientific fraud (plagiarism, falsification and fabrication of results). Definitions of "questionable research practices" and the debate over reproducibility also target a grey area of dubious scientific results, which may not be the outcome of voluntary manipulations.

The concrete impact of codes of conduct and other measures put in place to ensure research integrity remain uncertain. Several case studies have highlighted that while the principles of the code of conduct adhere to common scientific ideals, they are seen as remote from actual work practices and their efficiency is criticized.

After 2010, debates on research integrity have been increasingly linked to open science. International codes of conduct and national legislation on research integrity have officially endorsed open sharing of scientific output (publications, data or code[clarification needed]) as ways to limit questionable research practices and to enhance reproducibility. References to open science have incidentally opened up the debate over scientific integrity beyond academic communities, as it increasingly concerns a wider audience of scientific readers.

Scientific misconduct

Scientific misconduct is the violation of the standard codes of scholarly conduct and ethical behavior in the publication of professional scientific research. It is violation of scientific integrity: violation of the scientific method and of research ethics in science, including in the design, conduct, and reporting of research.

A Lancet review on Handling of Scientific Misconduct in Scandinavian countries provides the following sample definitions,[11] reproduced in The COPE report 1999:[12]

  • Danish definition: "Intention or gross negligence leading to fabrication of the scientific message or a false credit or emphasis given to a scientist"
  • Swedish definition: "Intention[al] distortion of the research process by fabrication of data, text, hypothesis, or methods from another researcher's manuscript form or publication; or distortion of the research process in other ways."

The consequences of scientific misconduct can be damaging for perpetrators and journal audience[13][14] and for any individual who exposes it.[15] In addition there are public health implications attached to the promotion of medical or other interventions based on false or fabricated research findings.

Three percent of the 3,475 research institutions that report to the
Office of Research Integrity, indicate some form of scientific misconduct.[16] However the ORI will only investigate allegations of impropriety where research was funded by federal grants. They routinely monitor such research publications for red flags and their investigation is subject to a statute of limitations. Other private organizations like the Committee of Medical Journal Editors (COJE) can only police their own members.[17]

Discipline specific ethics

Research ethics for Human subject research and Animal testing derives, historically, from the Medical ethics and, in modern times, from the much more broad field of Bioethics.

Medical ethics

non-maleficence, beneficence, and justice.[19] Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal.[20] These four values are not ranked in order of importance or relevance and they all encompass values pertaining to medical ethics.[21] However, a conflict may arise leading to the need for hierarchy in an ethical system, such that some moral elements overrule others with the purpose of applying the best moral judgement to a difficult medical situation.[22] Medical ethics is particularly relevant in decisions regarding involuntary treatment and involuntary commitment
.

There are several codes of conduct. The Hippocratic Oath discusses basic principles for medical professionals.[22] This document dates back to the fifth century BCE.[23] Both The Declaration of Helsinki (1964) and The Nuremberg Code (1947) are two well-known and well respected documents contributing to medical ethics. Other important markings in the history of medical ethics include Roe v. Wade[why?] in 1973 and the development of hemodialysis in the 1960s. With hemodialysis now available, but a limited number of dialysis machines to treat patients, an ethical question arose on which patients to treat and which ones not to treat, and which factors to use in making such a decision.[24] More recently, new techniques for gene editing aiming at treating, preventing and curing diseases utilizing gene editing, are raising important moral questions about their applications in medicine and treatments as well as societal impacts on future generations,[25][26] yet remain controversial due to their association with eugenics.[27]

As this field continues to develop and change throughout history, the focus remains on fair, balanced, and moral thinking across all cultural and religious backgrounds around the world.[28][29] The field of medical ethics encompasses both practical application in clinical settings and scholarly work in philosophy, history, and sociology.

Medical ethics encompasses beneficence, autonomy, and justice as they relate to conflicts such as euthanasia, patient confidentiality, informed consent, and conflicts of interest in healthcare.
culturally sensitive physicians and ethical committees in hospitals and other healthcare settings.[28][29][33]

Bioethics

life sciences, biotechnology, medicine, politics, law, theology and philosophy. It includes the study of values relating to primary care, other branches of medicine ("the ethics of the ordinary"), ethical education in science, animal, and environmental ethics
, and public health.

Clinical research ethics

Study participant rights

Participants of a clinical trial in clinical research have rights which they expect to be honored, including:[34]

Vulnerable populations

Study participants are entitled to some degree of autonomy in deciding their participation. One measure for safeguarding this right is the use of

Ethical problems particularly encumber using children in clinical trials
.

Society

Consequences for the environment, for society and for future generations must be considered.

Governance

In Canada, mandatory research ethics training is required for students, professors and others who work in research.[38][39] The US first legislated institutional review boards procedures in the 1974 National Research Act.

Criticism

Published in Social Sciences & Medicine (2009) several authors suggested that research ethics in a medical context is dominated by principlism.[40]

See also

References

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    .
  2. ^ a b c Israel, Mark; Allen, G.; Thomson, C. (2013). "The Rise and Much-Sought Demise of the Adversarial Culture in Australian Research Ethics: Australasian Ethics Network Conference 2013". Proceedings of the 2013 Australasian Ethics Network Conference. N/A: 12–27.
  3. ^ .
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  9. ^ Walter, Klein eds. The Story of Bioethics: From seminal works to contemporary explorations.
  10. ^ Laine 2018, p. 52.
  11. S2CID 36326829
    .
  12. ^ "Coping with fraud" (PDF). The COPE Report 1999: 11–18. Archived from the original (PDF) on 2007-09-28. Retrieved 2006-09-02. It is 10 years, to the month, since Stephen Lock ... Reproduced with kind permission of the Editor, The Lancet.
  13. ^ Xie, Yun (2008-08-12). "What are the consequences of scientific misconduct?". Ars Technica. Retrieved 2013-03-01.
  14. S2CID 206512870
    .
  15. ^ "Consequences of Whistleblowing for the Whistleblower in Misconduct in Science Cases". Research Triangle Institute. 1995. Archived from the original (PDF) on 2017-08-24. Retrieved 2012-05-24.
  16. .
  17. ^ Part III. Department of Health and Human Services Archived 2021-10-22 at the Wayback Machine
  18. PMID 30570982
    , retrieved 2023-11-24
  19. ^ Beauchamp, J. (2013). "Principles of Biomedical Ethics". Principles of Biomedical Ethics. 7.
  20. S2CID 20134799
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  21. ^ "Bioethic Tools: Principles of Bioethics". depts.washington.edu. Archived from the original on 2017-05-10. Retrieved 2017-03-21.
  22. ^
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  24. .
  25. ^ "Safeguarding the future of human gene editing". login.proxylib.csueastbay.edu. Retrieved 2019-03-19.
  26. .
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  30. ^ Appel, JM. Must My Doctor Tell My Partner? Rethinking Confidentiality In the HIV Era, Medicine and Health Rhode Island, Jun 2006
  31. PMID 25516948
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  32. .
  33. .
  34. .
  35. .
  36. ^ "Research Ethics Board: Overview of the Health Canada and Public Health Agency of Canada REB". canada.ca. Government of Canada. 28 September 2004.
  37. ^ Secretariat on Responsible Conduct of Research (5 February 2016). "Panel on Responsible Conduct of Research". Canadian Government.
  38. , retrieved 2024-01-07
  39. , retrieved 2024-01-07
  40. ^ Shaw SE, Petchey RP, Chapman J, Abbott S (2009). "A double-edged sword? Health research and research governance in UK primary care." Social Science & Medicine, 68: 912-918

Sources

Further reading

External links