Research ethics

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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]

Contents

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.

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

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

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 Piltdown man.jpg
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 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 audience [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, 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

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

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

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

Study participant rights

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

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. [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

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

Governance

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 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

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

See also

Related Research Articles

The Nuremberg Code is a set of ethical research principles for human experimentation created by the court in U.S. v Brandt, one of the Subsequent Nuremberg trials that were held after the Second World War.

<span class="mw-page-title-main">Informed consent</span> Ethical precondition for obtaining voluntary assumption of risk

Informed consent is a principle in medical ethics, medical law, media studies, and other fields, that a person must have sufficient information and understanding before making decisions about accepting risk, such as their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research, to disclose a person's medical information, or to participate in high risk sporting and recreational activities.

In developmental psychology and moral, political, and bioethical philosophy, autonomy is the capacity to make an informed, uncoerced decision. Autonomous organizations or institutions are independent or self-governing. Autonomy can also be defined from a human resources perspective, where it denotes a level of discretion granted to an employee in his or her work. In such cases, autonomy is known to generally increase job satisfaction. Self-actualized individuals are thought to operate autonomously of external expectations. In a medical context, respect for a patient's personal autonomy is considered one of many fundamental ethical principles in medicine.

Bioethics is both a field of study and professional practice, interested in ethical issues related to health, including those emerging from advances in biology, medicine, and technologies. It proposes the discussion about moral discernment in society 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, ethical education in science, animal, and environmental ethics, and public health.

Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. 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. Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal. These four values are not ranked in order of importance or relevance and they all encompass values pertaining to medical ethics. 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. Medical ethics is particularly relevant in decisions regarding involuntary treatment and involuntary commitment.

<span class="mw-page-title-main">Human subject research</span> Systematic, scientific investigation that involves human beings as research subjects

Human subject research is systematic, scientific investigation that can be either interventional or observational and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question. Medical human subject research often involves analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. On the other hand, human subject research in the social sciences often involves surveys which consist of questions to a particular group of people. Survey methodology includes questionnaires, interviews, and focus groups.

The regulation of science refers to use of law, or other ruling, by academic or governmental bodies to allow or restrict science from performing certain practices, or researching certain scientific areas.

The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics.

<span class="mw-page-title-main">Council for International Organizations of Medical Sciences</span> International non-governmental medical science organization

The Council for International Organizations of Medical Sciences (CIOMS) is an international non-governmental organization of 40 international, national, and associate member groups representing the biomedical science community. It was jointly established by the World Health Organization (WHO) and United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949 as a successor to the International Medical Congress that organized 17 conferences from 1867 until the 1913 outbreak of World War I.

Albert R. Jonsen was one of the founders of the field of Bioethics. He was Emeritus Professor of Ethics in Medicine at the University of Washington, School of Medicine, where he was Chairman of the Department of Medical History and Ethics from 1987 to 1999. After retiring from UW, he returned to San Francisco, where he co-founded the Program in Medicine and Human Values at Sutter Health's California Pacific Medical Center in 2003.

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.

The following outline is provided as an overview of and topical guide to ethics.

<span class="mw-page-title-main">Philosophy of healthcare</span>

The philosophy of healthcare is the study of the ethics, processes, and people which constitute the maintenance of health for human beings. For the most part, however, the philosophy of healthcare is best approached as an indelible component of human social structures. That is, the societal institution of healthcare can be seen as a necessary phenomenon of human civilization whereby an individual continually seeks to improve, mend, and alter the overall nature and quality of their life. This perennial concern is especially prominent in modern political liberalism, wherein health has been understood as the foundational good necessary for public life.

Islamic bioethics, or Islamic medical ethics, refers to Islamic guidance on ethical or moral issues relating to medical and scientific fields, in particular, those dealing with human life.

Human subject research legislation in the United States can be traced to the early 20th century. Human subject research in the United States was mostly unregulated until the 20th century, as it was throughout the world, until the establishment of various governmental and professional regulations and codes of ethics. Notable – and in some cases, notorious – human subject experiments performed in the US include the Tuskegee syphilis experiment, human radiation experiments, the Milgram obedience experiment and Stanford prison experiments and Project MKULTRA. With growing public awareness of such experimentation, and the evolution of professional ethical standards, such research became regulated by various legislation, most notably, those that introduced and then empowered the institutional review boards.

Michael Alan Grodin is Professor of Health Law, Bioethics, and Human Rights at the Boston University School of Public Health, where he has received the distinguished Faculty Career Award for Research and Scholarship, and 20 teaching awards, including the "Norman A. Scotch Award for Excellence in Teaching." He is also Professor of Family Medicine and Psychiatry at the Boston University School of Medicine. In addition, Dr. Grodin is the Director of the Project on Medicine and the Holocaust at the Elie Wiesel Center for Judaic Studies, and a member of the faculty of the Division of Religious and Theological Studies. He has been on the faculty at Boston University for 35 years. He completed his B.S. degree at the Massachusetts Institute of Technology, his M.D. degree from the Albert Einstein College of Medicine, and his postdoctoral and fellowship training at UCLA and Harvard University.

Carlo Maria Petrini is an Italian scientist and bio-ethicist. He is Director of the Bioethics Unit and President of the Ethics Committee at the Italian National Institute of Health ,as well as the President of the National Coordination Center of Ethics Committees. His work focuses on advancing bioethical standards in scientific research, with particular attention to the ethical implications of medical advancements, clinical trials, and data handling.

Various organizations have created guidelines for human subject research for various kinds of research involving human subjects and for various situations.

Research integrity or scientific integrity is an aspect of research ethics that deals with best practice or rules of professional practice of scientists.

<span class="mw-page-title-main">Christine Mitchell</span> American filmmaker and bioethicist

Christine I. Mitchell is an American filmmaker and bioethicist and until her retirement in September 2022, the executive director of the Center for Bioethics at Harvard Medical School (HMS).

References

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