Research ethics

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.<ref>Douglas, Heather (2014). "The Moral Terrain of Science". Erkenntnis. 79 (S5): 961–979. doi:10.1007/s10670-013-9538-0. ISSN 0165-0106. S2CID 144445475.</ref>

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 list of historic cases includes many large scale violations and crimes against humanity such as Nazi human experimentation and the Tuskegee syphilis experiment which lead to international codes of research ethics. No approach has been universally accepted,<ref name=":0"></ref><ref name=":1"></ref><ref name=EatonS></ref> 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 social sciences, information technology, biotechnology, or engineering may generate ethical concerns.<ref name=":0" /><ref name=":1" /><ref>Stahl, Bernd Carsten; Timmermans, Job; Flick, Catherine (2016-09-19). "Ethics of Emerging Information and Communication Technologies". Science and Public Policy: scw069. doi:10.1093/scipol/scw069. hdl:2086/12331. ISSN 0302-3427.</ref><ref>Iphofen, Ron (2011). "Ethical Decision-Making in Social Research". SpringerLink. doi:10.1057/9780230233768. ISBN 978-0-230-29634-3.</ref><ref>Wickson, Fern; Preston, Christopher; Binimelis, Rosa; Herrero, Amaranta; Hartley, Sarah; Wynberg, Rachel; Wynne, Brian (2017-06-09). "Addressing Socio-Economic and Ethical Considerations in Biotechnology Governance: The Potential of a New Politics of Care". Food Ethics. 1 (2): 193–199. doi:10.1007/s41055-017-0014-4. hdl:10871/33650. ISSN 2364-6853. S2CID 256465844.</ref><ref>Whitbeck, Caroline (2011-08-15). Ethics in Engineering Practice and Research. Cambridge University Press. doi:10.1017/cbo9780511976339. ISBN 978-0-521-89797-6.</ref>

History

See also: Unethical human experimentation, Ethics committee § History, and List of medical ethics cases

The list of historic cases includes many large scale violations and crimes against humanity such as Nazi human experimentation and the Tuskegee syphilis experiment which lead to international codes of research ethics.<ref name=":0">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.</ref><ref name=":1">Israel, Mark (2015). Research Ethics and Integrity for Social Scientists: Beyond Regulatory Compliance. SAGE Publications Ltd. ISBN 978-1-4739-1009-6.</ref><ref name=EatonS>Eaton, Sarah Elaine (2020). "Ethical considerations for research conducted with human participants in languages other than English". British Educational Research Journal. 46 (4): 848–858. doi:10.1002/berj.3623. ISSN 0141-1926. S2CID 216445727.</ref> 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.<ref>Walter, Klein eds. The Story of Bioethics: From seminal works to contemporary explorations.</ref>

Discipline specific ethics

See also: Guidelines for human subject research

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.

Clinical research ethics

Study participant rights

Participants of a clinical trial in clinical research have rights which they expect to be honored, including:<ref>Beecher, Henry K. (June 16, 1966). "Ethics and Clinical Research". N Engl J Med. 274 (24): 1354–1360. doi:10.1056/NEJM196606162742405. PMC 2566401. PMID 5327352.</ref>

• informed consent
• shared decision-making
• privacy for research participants
• return of results
• to withdraw

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 informed consent for clinical researches.<ref>Mohamadi, Amin; Asghari, Fariba; Rashidian, Arash (2014). "Continuing review of ethics in clinical trials: a surveillance study in Iran". Journal of Medical Ethics and History of Medicine. 7: 22. PMC 4648212. PMID 26587202.</ref> Researchers refer to populations with limited autonomy as "vulnerable populations"; these are subjects who may not be able to fairly decide for themselves whether to participate. Examples of vulnerable populations include incarcerated persons, children, prisoners, soldiers, people under detention, migrants, persons exhibiting insanity or any other condition which precludes their autonomy, and to a lesser extent, any population for which there is reason to believe that the research study could seem particularly or unfairly persuasive or misleading. 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 the United Kingdom, the National Research Ethics Service is the responsible quango that forms Research Ethic Committees.
• In the United States, the Institutional review board is the relevant ethics committee.
• In Canada, there are different committees for different agencies. The committees are the Research Ethics Board (REB)<ref>"Research Ethics Board: Overview of the Health Canada and Public Health Agency of Canada REB". canada.ca. Government of Canada.</ref> as well as two others that split their committee duties between conduct (PRCR) and ethics committee (PRE).<ref>Secretariat on Responsible Conduct of Research. "Panel on Responsible Conduct of Research". Canadian Government.</ref>
• The European Union only sets the guidelines for its member's ethics committees.
• Large international organizations like the WHO have their own ethics committees.

In Canada, mandatory research ethics training is required for students, professors and others who work in research.<ref>Stockley, Denise; Wright, Madison (2022), "The Course on Research Ethics (CORE): Implications for SoTL", Ethics and the Scholarship of Teaching and Learning, Cham: Springer International Publishing, pp. 1–11, doi:10.1007/978-3-031-11810-4_1, ISBN 978-3-031-11809-8, retrieved 2024-01-07</ref><ref>Khaliq, Yasmin (November 2002), "Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans", Encyclopedia of Clinical Pharmacy, Informa Healthcare, pp. 876–882, doi:10.3109/9780824706081.150, ISBN 0-8247-0608-0, retrieved 2024-01-07</ref> 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.<ref>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</ref>

See also

• List of medical ethics cases
• Children in clinical research
• Unethical human experimentation
• Self-experimentation in medicine
• Clinical trial
• Academic freedom
• Scientific literature § Ethics
• Psychology § Ethics
• Information ethics
• Regulation of genetic engineering
• Engineering ethics
• Ethics of technology
• Philosophy of engineering
• Philosophy of science

References

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Sources

• Laine, Heidi (31 December 2018). "Open science and codes of conduct on research integrity". Informaatiotutkimus. 37 (4). doi:10.23978/inf.77414. ISSN 1797-9129. Retrieved 2021-11-11.

Further reading

• Speid, Lorna (2010). Clinical trials : what patients and healthy volunteers need to know. Oxford: Oxford University Press. ISBN 978-0-19-973416-0.
• The Oxford Textbook of Clinical Research Ethics, Ezekiel Emanuel, Christine Grady, Robert Crouch, Reidar Lie, Franklin Miller, David Wendler, Oxford University Press, 2008

External links

• list of research participant rights from Harvard School of Public Health