Research ethics

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Short description: Ethical practice in scientific research

Template:Research sidebar 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 social responsibilities of scientists and researchers are not traditionally included and are 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 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 led 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. One major goal being to reduce questionable research practices.

Research in other fields such as social sciences, information technology, biotechnology, or engineering may generate ethical concerns.[2][3][5][6][7][8]

History

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.[2][3][4] 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.[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: 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 typical codes 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, and code used to perform statistical analyses on the data[clarification needed]) as ways to limit questionable research practices and to enhance reproducibility. Having both the data and the actual code enables others to reproduce the results for themselves (or to uncover problems in the analyses when trying to do so). The European Code of Conduct for Research Integrity 2023 states, for example, the principles that, "Researchers, research institutions, and organisations ensure that access to data is as open as possible, as closed as necessary, and where appropriate in line with the FAIR Principles (Findable, Accessible, Interoperable and Reusable) for data management" and that "Researchers, research institutions, and organisations are transparent about how to access and gain permission to use data,

metadata, protocols, code, software, and other research materials".[11] 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

Discipline specific ethics

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.

Medical ethics

Bioethics

Clinical research ethics

Study participant rights

Participants in a clinical trial in clinical research have rights which they expect to be honored, including:[12]

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 research.[13] 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.

Society

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

Governance

An ethics committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international law.
  • 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)[14] as well as two others that split their committee duties between conduct (PRCR) and ethics committee (PRE).[15]
  • 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.[16][17] 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.[18]

See also

References

  1. Douglas, Heather (2014). "The Moral Terrain of Science" (in en). Erkenntnis 79 (S5): 961–979. doi:10.1007/s10670-013-9538-0. ISSN 0165-0106. http://link.springer.com/10.1007/s10670-013-9538-0. 
  2. 2.0 2.1 2.2 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. https://research-repository.uwa.edu.au/en/publications/the-rise-and-much-sought-demise-of-the-adversarial-culture-in-aus. 
  3. 3.0 3.1 3.2 Israel, Mark (2015) (in en). Research Ethics and Integrity for Social Scientists: Beyond Regulatory Compliance. SAGE Publications Ltd. ISBN 978-1-4739-1009-6. https://methods.sagepub.com/book/research-ethics-and-integrity-for-social-scientists-2e. 
  4. 4.0 4.1 Eaton, Sarah Elaine (2020). "Ethical considerations for research conducted with human participants in languages other than English" (in en). British Educational Research Journal 46 (4): 848–858. doi:10.1002/berj.3623. ISSN 0141-1926. https://onlinelibrary.wiley.com/doi/abs/10.1002/berj.3623. 
  5. Stahl, Bernd Carsten; Timmermans, Job; Flick, Catherine (2016-09-19). "Ethics of Emerging Information and Communication Technologies". Science and Public Policy. doi:10.1093/scipol/scw069. ISSN 0302-3427. 
  6. Iphofen, Ron (2011) (in en). Ethical Decision-Making in Social Research. doi:10.1057/9780230233768. ISBN 978-0-230-29634-3. https://link.springer.com/book/10.1057/9780230233768. 
  7. 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. ISSN 2364-6853. 
  8. Whitbeck, Caroline (2011-08-15). Ethics in Engineering Practice and Research. Cambridge University Press. doi:10.1017/cbo9780511976339. ISBN 978-0-521-89797-6. 
  9. Walter, Klein eds. The Story of Bioethics: From seminal works to contemporary explorations.
  10. Laine 2018, p. 52.
  11. "European Code of Conduct for Research Integrity". ALLEA All European Academies. https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/european-code-of-conduct-for-research-integrity_horizon_en.pdf. 
  12. Beecher, Henry K. (June 16, 1966). "Ethics and Clinical Research". N Engl J Med 274 (24): 1354–1360. doi:10.1056/NEJM196606162742405. PMID 5327352. 
  13. 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. PMID 26587202. 
  14. "Research Ethics Board: Overview of the Health Canada and Public Health Agency of Canada REB". Government of Canada. 28 September 2004. https://www.canada.ca/en/health-canada/services/science-research/science-advice-decision-making/research-ethics-board.html. 
  15. Secretariat on Responsible Conduct of Research (5 February 2016). "Panel on Responsible Conduct of Research". Canadian Government. https://rcr.ethics.gc.ca/eng/about_us-propos_de_nous.html. 
  16. 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 
  17. Khaliq, Yasmin (November 2002), Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Informa Healthcare, pp. 876–882, doi:10.3109/9780824706081.150, ISBN 0-8247-0608-0 
  18. 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