Research ethics#Vulnerable populations

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{{See also|Unethical human experimentation|Ethics committee#History|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 led to international codes of research ethics.{{Cite journal |last1=Israel |first1=Mark |last2=Allen |first2=G. |last3=Thomson |first3=C. |date=2013 |title=The Rise and Much-Sought Demise of the Adversarial Culture in Australian Research Ethics: Australasian Ethics Network Conference 2013 |url=https://research-repository.uwa.edu.au/en/publications/the-rise-and-much-sought-demise-of-the-adversarial-culture-in-aus |journal=Proceedings of the 2013 Australasian Ethics Network Conference |volume=N/A |pages=12–27}}{{Cite book |last=Israel |first=Mark |url=https://methods.sagepub.com/book/research-ethics-and-integrity-for-social-scientists-2e |title=Research Ethics and Integrity for Social Scientists: Beyond Regulatory Compliance |date=2015 |publisher=SAGE Publications Ltd |isbn=978-1-4739-1009-6 |language=en}}{{Cite journal |last=Eaton |first=Sarah Elaine |date=2020 |title=Ethical considerations for research conducted with human participants in languages other than English |url=https://onlinelibrary.wiley.com/doi/abs/10.1002/berj.3623 |journal=British Educational Research Journal |language=en |volume=46 |issue=4 |pages=848–858 |doi=10.1002/berj.3623 |issn=0141-1926 |s2cid=216445727}} Medical ethics developed out of centuries of general malpractice and science motivated only by results. Medical ethics in turn led to today's more broad understanding in bioethics.Walter, Klein eds. The Story of Bioethics: From seminal works to contemporary explorations.

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{{Excerpt|Scientific misconduct}}

{{See also|Guidelines for human subject research}}

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

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Participants in a clinical trial in clinical research have rights which they expect to be honored, including:{{cite journal|last=Beecher|first=Henry K.|title=Ethics and Clinical Research|journal=N Engl J Med|date=June 16, 1966|issue=24|pages=1354–1360|doi=10.1056/NEJM196606162742405|pmid=5327352|volume=274|pmc=2566401}}

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

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 research.{{Cite journal|last1=Mohamadi|first1=Amin|last2=Asghari|first2=Fariba|last3=Rashidian|first3=Arash|date=2014|title=Continuing review of ethics in clinical trials: a surveillance study in Iran|journal=Journal of Medical Ethics and History of Medicine|volume=7|pages=22|pmc=4648212|pmid=26587202}} 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 that 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.

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

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• 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){{cite web|url=https://www.canada.ca/en/health-canada/services/science-research/science-advice-decision-making/research-ethics-board.html|title=Research Ethics Board: Overview of the Health Canada and Public Health Agency of Canada REB|website=canada.ca|date=28 September 2004 |publisher=Government of Canada}} as well as two others that split their committee duties between conduct (PRCR) and ethics committee (PRE).{{cite web|url=https://rcr.ethics.gc.ca/eng/about_us-propos_de_nous.html|title=Panel on Responsible Conduct of Research|author=Secretariat on Responsible Conduct of Research|date=5 February 2016 |publisher=Canadian Government}}
• 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.{{Citation |last1=Stockley |first1=Denise |title=The Course on Research Ethics (CORE): Implications for SoTL |date=2022 |url=http://dx.doi.org/10.1007/978-3-031-11810-4_1 |work=Ethics and the Scholarship of Teaching and Learning |pages=1–11 |access-date=2024-01-07 |place=Cham |publisher=Springer International Publishing |isbn=978-3-031-11809-8 |last2=Wright |first2=Madison|doi=10.1007/978-3-031-11810-4_1 }}{{Citation |last=Khaliq |first=Yasmin |title=Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans |date=November 2002 |url=http://dx.doi.org/10.3109/9780824706081.150 |encyclopedia=Encyclopedia of Clinical Pharmacy |pages=876–882 |access-date=2024-01-07 |publisher=Informa Healthcare |doi=10.3109/9780824706081.150 |isbn=0-8247-0608-0}} The US first legislated institutional review boards procedures in the 1974 National Research Act.

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

• 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

• {{Cite journal |last=Laine |first=Heidi |title=Open science and codes of conduct on research integrity |journal=Informaatiotutkimus |volume=37 |issue=4 |date=31 December 2018 |issn=1797-9129 |doi=10.23978/inf.77414 |url=https://journal.fi/inf/article/view/77414 |access-date=2021-11-11|doi-access=free }}

• {{cite book|last=Speid|first=Lorna|title=Clinical trials : what patients and healthy volunteers need to know|year=2010|publisher=Oxford University Press|location=Oxford |isbn=978-0-19-973416-0|url-access=registration|url=https://archive.org/details/clinicaltrialswh00lorn}}
• The Oxford Textbook of Clinical Research Ethics, Ezekiel Emanuel, Christine Grady, Robert Crouch, Reidar Lie, Franklin Miller, David Wendler, Oxford University Press, 2008

• [http://www.hsph.harvard.edu/research/human-research-administration/for-research-participants/participant-rights/index.html list of research participant rights] from Harvard School of Public Health

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Research ethics

Category:Methodology

Category:Ethics

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