Research ethics is a discipline within the study of applied ethics. It is concerned with the moral issues that arise or as part of scientific research, as well as the conduct of individual researchers. It has implications for research communities.[1]
Ethical issues may arise in the design and implementation of research involving human or animal experimentation. Consequences for the environment, for society and for future generations must be considered.
Governance
Historically, scandals such as Nazi human experimentation and the Tuskegee syphilis experiment led to the realisation that clear measures are needed for the ethical governance of research to avoid undue harm from scientific inquiry. No approach has been universally accepted.[2][3][4] Declarations, treaties, and best practices have been proposed. Research ethics committees (institutional review boards in the US) are one governance mechanism.
Fields of study that involve human and animal experimentation are the subject of research ethics. The discipline is most developed in medical research. Typically cited codes are the 1947 Nuremberg Code, the 1964 Declaration of Helsinki, and the 1978 Belmont Report. Informed consent is a key concept in biomedical research.
Research in other fields such as social sciences, information technology, biotechnology, or engineering may generate ethical concerns.[2][3][5][6][7][8]
Research ethics may be included as part of the broader field of responsible conduct of research (RCR in North America) or Responsible Research and Innovation in Europe. Government agencies such as the United States Office of Research Integrity or the Canadian Interagency Advisory Panel on Responsible Conduct of Research promote/require relevant training for researchers. Research integrity part of RCR, but is distinct from research ethics. The former includes issues such as scientific misconduct (e.g. fraud, fabrication of data or plagiarism).
Legislation
In Canada, mandatory research ethics training is required for students, professors and others who work in research.[9][10] The US first legislated institutional review boards procedures in the 1974 National Research Act.
Bioethics
Medical ethics
Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research.[11] 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.[12] Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal.[13] It is important to note that these four values are not ranked in order of importance or relevance and that they all encompass values pertaining to medical ethics.[14] 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.[15] 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.[15] This document dates back to the fifth century BCE.[16] 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 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.[17] 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,[18][19] yet remain controversial due to their association with eugenics.[20]
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.[21][22] 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.[23][24][25] 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.[21][22][26]Ethics committees
Guidelines for human subject research
The main points of the 1931 Guidelines for Human Experimentation are:[27]
JUnambiguous and informed consent from test subjects is required, except in extreme extenuating circumstances. Risks must be balanced by potential benefits. Caution must be taken for juvenile subjects. Extreme caution should be taken if microorganisms are involved. Poor or socially disadvantaged subjects must not be exploited. Animal testing must be conducted first, and human experiments are to be avoided if other means of collecting data are still available.
References
- ↑ 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.
- 1 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.
- 1 2 Israel, Mark (2015). Research Ethics and Integrity for Social Scientists: Beyond Regulatory Compliance. SAGE Publications Ltd. ISBN 978-1-4739-1009-6.
- ↑ 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.
- ↑ 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.
- ↑ Iphofen, Ron (2011). "Ethical Decision-Making in Social Research". SpringerLink. doi:10.1057/9780230233768.
- ↑ 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.
- ↑ Whitbeck, Caroline (2011-08-15). Ethics in Engineering Practice and Research. Cambridge University Press. ISBN 978-0-521-89797-6.
- ↑ 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, ISBN 978-3-031-11809-8, retrieved 2024-01-07
- ↑ Khaliq, Yasmin (November 2002), "Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans", Encyclopedia of Clinical Pharmacy, Informa Healthcare, pp. 876–882, ISBN 0-8247-0608-0, retrieved 2024-01-07
- ↑ Young, Michael; Wagner, Angela (2023), "Medical Ethics", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 30570982, retrieved 2023-11-24
- ↑ Beauchamp, J. (2013). "Principles of Biomedical Ethics". Principles of Biomedical Ethics. 7.
- ↑ Weise, Mary (2016). "Medical Ethics Made Easy". Professional Case Management. 21 (2): 88–94. doi:10.1097/ncm.0000000000000151. PMID 26844716. S2CID 20134799.
- ↑ "Bioethic Tools: Principles of Bioethics". depts.washington.edu. Archived from the original on 2017-05-10. Retrieved 2017-03-21.
- 1 2 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.
- ↑ 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.
- ↑ 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 : CJASN. 11 (4): 704–709. doi:10.2215/CJN.04780515. ISSN 1555-9041. PMC 4822659. PMID 26912540.
- ↑ "Safeguarding the future of human gene editing". login.proxylib.csueastbay.edu. Retrieved 2019-03-19.
- ↑ Veit, Walter (2018). "Procreative Beneficence and Genetic Enhancement". KRITERION – Journal of Philosophy. 32 (11): 1–8. doi:10.13140/RG.2.2.11026.89289.
- ↑ Veit, Walter; Anomaly, Jonathan; Agar, Nicholas; Singer, Peter; Fleischman, Diana; Minerva, Francesca (2021). "Can 'eugenics' be defended?". Monash Bioethics Review. 39 (1): 60–67. doi:10.1007/s40592-021-00129-1. PMC 8321981. PMID 34033008.
- 1 2 Coward, Harold G. (1999). A Cross-Cultural Dialogue on Health Care Ethics. Canada: Waterloo, Ont : Wilfrid Laurier university Press. pp. 119–126. ISBN 9780889208551.
- 1 2 Brow, Julie A. (June 2002). "When culture and medicine collide". The Dental Assistant. 71 (3): 26, 28, 36. PMID 12078071.
- ↑ Appel, JM. Must My Doctor Tell My Partner? Rethinking Confidentiality In the HIV Era, Medicine and Health Rhode Island, Jun 2006
- ↑ 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.
- ↑ 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.
- ↑ 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.
- ↑ Sass, HM. "Reichsrundschreiben 1931: Pre-Nuremberg German Regulations Concerning New Therapy and Human Experimentation," Journal of Medicine and Philosophy 8 (1983): 99-111
- ↑ WMA Press Release: WMA revises the Declaration of Helsinki. 9 October 2000 Archived 27 September 2006 at the Wayback Machine
- ↑ Snežana, Bošnjak (2001). "The declaration of Helsinki: The cornerstone of research ethics". Archive of Oncology. 9 (3): 179–84.
- ↑ Tyebkhan, G (2003). "Declaration of Helsinki: the ethical cornerstone of human clinical research". Indian Journal of Dermatology, Venereology and Leprology. 69 (3): 245–7. PMID 17642902.