Research ethics

Ethical practice in scientific research

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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 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

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This section needs expansion. You can help by adding to it. (March 2024)

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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 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

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### Scientific integrity

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This section is an excerpt from Scientific integrity.[edit]

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

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This section is an excerpt from Scientific misconduct.[edit]

A reconstruction of the skull purportedly belonging to the Piltdown Man, a long-lasting case of 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 the 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,[12] reproduced in The COPE report 1999:[13]

* 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 audiences[14][15] and for any individual who exposes it.[16] In addition there are public health implications attached to the promotion of medical or other interventions based on false or fabricated research findings. Scientific misconduct can result in loss of public trust in the integrity of science.[17]

Three percent of the 3,475 research institutions that report to the US Department of Health and Human Services' Office of Research Integrity (ORI) indicate some form of scientific misconduct.[18] 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.[19]

## Discipline specific ethics

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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.

### Medical ethics

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This section is an excerpt from Medical ethics.[edit]

Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research.[20] Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice.[21] Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal.[22] These four values are not ranked in order of importance or relevance and they all encompass values pertaining to medical ethics.[23] 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.[24] 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.[24] This document dates back to the fifth century BCE.[25] 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.[26] 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.[27][28]

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.[29][30] 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.[31][32][33] In addition, medical ethics and culture are interconnected as different cultures implement ethical values differently, sometimes placing more emphasis on family values and downplaying the importance of autonomy. This leads to an increasing need for culturally sensitive physicians and ethical committees in hospitals and other healthcare settings.[29][30][34]

### Bioethics

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This section is an excerpt from Bioethics.[edit]

Bioethics is both a field of study and professional practice, interested in ethical issues related to health (primarily focused on the human, but also increasingly includes animal ethics), including those emerging from advances in biology, medicine, and technologies. It proposes the discussion about moral discernment in society (what decisions are "good" or "bad" and why) and it is often related to medical policy and practice, but also to broader questions as environment, well-being and public health. Bioethics is concerned with the ethical questions that arise in the relationships among 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

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#### Study participant rights

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Participants in a clinical trial in clinical research have rights which they expect to be honored, including:[35]

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

#### Vulnerable populations

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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.[36] 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

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This section needs expansion. You can help by adding to it. (March 2024)

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

## Governance

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This section is an excerpt from Ethics committee.[edit]

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)[37] as well as two others that split their committee duties between conduct (PRCR) and ethics committee (PRE).[38]
* 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.[39][40] The US first legislated institutional review boards procedures in the 1974 National Research Act.

## Criticism

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Published in Social Sciences & Medicine (2009) several authors suggested that research ethics in a medical context is dominated by principlism.[41]

## See also

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* 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
* Research Integrity Risk Index
* Philosophy of engineering
* Philosophy of science

## References

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1. ^ 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.
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. ^ a b c Israel, Mark (2015). Research Ethics and Integrity for Social Scientists: Beyond Regulatory Compliance. SAGE Publications Ltd. ISBN 978-1-4739-1009-6.
4. ^ a b 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.
5. ^ 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.
6. ^ Iphofen, Ron (2011). "Ethical Decision-Making in Social Research". SpringerLink. doi:10.1057/9780230233768. ISBN 978-0-230-29634-3.
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. hdl:10871/33650. ISSN 2364-6853. S2CID 256465844.
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" (PDF). ALLEA All European Academies. Retrieved 9 August 2024.
12. ^ Nylenna, M.; Andersen, D.; Dahlquist, G.; Sarvas, M.; Aakvaag, A. (1999). "Handling of scientific dishonesty in the Nordic countries. National Committees on Scientific Dishonesty in the Nordic Countries". Lancet. 354 (9172): 57–61\. doi:10.1016/S0140-6736(98)07133-5. PMID 10406378. S2CID 36326829.
13. ^ "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."
14. ^ Xie, Yun (2008-08-12). "What are the consequences of scientific misconduct?". Ars Technica. Retrieved 2013-03-01.
15. ^ Redman, B. K.; Merz, J. F. (2008). "SOCIOLOGY: Scientific Misconduct: Do the Punishments Fit the Crime?" (PDF). Science. 321 (5890): 775. doi:10.1126/science.1158052. PMID 18687942. S2CID 206512870.
16. ^ "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.
17. ^ Morreim, E H; Winer, Jeffrey C (2023). "Guest authorship as research misconduct: definitions and possible solutions". BMJ Evidence-Based Medicine. 28 (1): 1–4\. doi:10.1136/bmjebm-2021-111826. ISSN 2515-446X. PMID 34933927.
18. ^ Singh, Dr. Yatendra Kumar; Kumar Dubey, Bipin (2021). Introduction of Research Methods and Publication Ethics. New Delhi: Friends Publications (India). p. 90\. ISBN 978-93-90649-38-9.
19. ^ "Part III. Department of Health and Human Services" (PDF). Archived from the original (PDF) on October 22, 2021.
20. ^ Young, Michael; Wagner, Angela (2023), "Medical Ethics", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 30570982, retrieved 2023-11-24
21. ^ Beauchamp, J. (2013). "Principles of Biomedical Ethics". Principles of Biomedical Ethics. 7.
22. ^ Weise, Mary (2016). "Medical Ethics Made Easy". Professional Case Management. 21 (2): 88–94\. doi:10.1097/ncm.0000000000000151. PMID 26844716. S2CID 20134799.
23. ^ "Bioethic Tools: Principles of Bioethics". depts.washington.edu. Archived from the original on 2017-05-10. Retrieved 2017-03-21.
24. ^ a b Berdine, Gilbert (2015-01-10). "The Hippocratic Oath and Principles of Medical Ethics". The Southwest Respiratory and Critical Care Chronicles. 3 (9): 28–32–32. doi:10.12746/swrccc.v3i9.185. ISSN 2325-9205.
25. ^ Riddick, Frank (Spring 2003). "The Code of Medical Ethics of the American Medical Association". The Ochsner Journal. 5 (2): 6–10\. PMC 3399321. PMID 22826677.
26. ^ Butler, Catherine R.; Mehrotra, Rajnish; Tonelli, Mark R.; Lam, Daniel Y. (2016-04-07). "The Evolving Ethics of Dialysis in the United States: A Principlist Bioethics Approach". Clinical Journal of the American Society of Nephrology. 11 (4): 704–709\. doi:10.2215/CJN.04780515. ISSN 1555-9041. PMC 4822659. PMID 26912540.
27. ^ "Safeguarding the future of human gene editing". login.proxylib.csueastbay.edu. Retrieved 2019-03-19.
28. ^ Veit, Walter (2018). "Procreative Beneficence and Genetic Enhancement". KRITERION – Journal of Philosophy. 32 (11): 1–8\. doi:10.13140/RG.2.2.11026.89289.
29. ^ a b Coward, Harold G. (1999). A Cross-Cultural Dialogue on Health Care Ethics. Canada: Waterloo, Ont : Wilfrid Laurier university Press. pp. 119–126\. ISBN 9780889208551.
30. ^ a b Brow, Julie A. (June 2002). "When culture and medicine collide". The Dental Assistant. 71 (3): 26, 28, 36. PMID 12078071.
31. ^ Appel, JM. Must My Doctor Tell My Partner? Rethinking Confidentiality In the HIV Era, Medicine and Health Rhode Island, Jun 2006
32. ^ Prah Ruger, Jennifer (October 2014). "Good medical ethics, justice and provincial globalism". J Med Ethics. 41 (1): 103–106\. doi:10.1136/medethics-2014-102356. JSTOR 43283237. PMID 25516948.
33. ^ Güldal D, Semin S (2000). "The influences of drug companies' advertising programs on physicians". Int J Health Serv. 30 (3): 585–95\. doi:10.2190/GYW9-XUMQ-M3K2-T31C. PMID 11109183. S2CID 36442226.
34. ^ Ahmed, Furqaan (August 2013). "Are medical ethics universal or culture specific". World Journal of Gastrointestinal Pharmacology and Therapeutics. 4 (3): 47–48\. doi:10.4292/wjgpt.v4.i3.47. PMC 3729866. PMID 23919215.
35. ^ 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.
36. ^ 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.
37. ^ "Research Ethics Board: Overview of the Health Canada and Public Health Agency of Canada REB". canada.ca. Government of Canada. 28 September 2004.
38. ^ Secretariat on Responsible Conduct of Research (5 February 2016). "Panel on Responsible Conduct of Research". Canadian Government.
39. ^ 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
40. ^ 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
41. ^ 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

[edit]

* 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

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* 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

[edit]

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

* v
* t
* e

Research participant rights

Rights|

* Beneficence
* Justice
* Respect for persons
* Privacy for research participants
* Right to withdraw
* Return of results
* Informed consent

Human subject research|

* Clinical research
* Biobank
* Social research

Ethical systems|

* Research ethics
* Medical ethics
* Bioethics
* Clinical research ethics
* Biobank ethics

Guidelines for human subject research|

* List of medical ethics cases
* Nuremberg Code
* Declaration of Helsinki
* Belmont Report
* Common Rule

Monitoring in clinical trials|

* Ethics committee
* Institutional review board
* Data monitoring committee
* Community advisory board

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