Research Ethics in Life Sciences PDF

RESEARCH ETHICS SIS/CELS Dr. George Odhiambo  Research The primary purpose for applied research is: discovering, interpreting, and the development of methods and systems for the advancement of human knowledge on a wide variety of scientific matters of concern....

RESEARCH ETHICS SIS/CELS Dr. George Odhiambo  Research The primary purpose for applied research is: discovering, interpreting, and the development of methods and systems for the advancement of human knowledge on a wide variety of scientific matters of concern.  Ethics Norms for conduct that distinguish between acceptable and unacceptable behavior The discipline of dealing with what is good and bad, with moral duty and obligation A set of moral principles or values The principle of conduct governing an individual or group  Research Ethics Research ethics provides guidelines for the responsible conduct of research. Scientists conducting research should ensure high ethical standards  Research Ethics Research ethics specifically concerns the analysis of ethical issues that are raised when people are involved as participants in research. There are three objectives in research ethics: to protect human participants (dignity, confidential information, health…) to ensure that research is conducted in a way that serves interests of individuals, groups and/or society as a whole. to examine specific research activities and projects for their ethical soundness, looking at issues such as the management of risk, protection of confidentiality and the process of informed consent.  Science tends to be self-correcting Science is built upon a foundation of trust and honesty. Incorrect data or incorrect interpretation of data are usually (often? sometimes?) corrected by the continuing process of scientific investigations. This is true whether the errors are caused by mistake or misconduct. Three sets of obligations of a researcher to adhere to professional standards An obligation to honor the trust that their colleagues place in them. An obligation to themselves. Irresponsible conduct in research can make it impossible to achieve a goal. An obligation to act in ways that serve the public.  Data Manipulation Researchers who manipulate their data in ways that deceive others are violating both the basic values and widely accepted professional standards of science. They mislead their colleagues and potentially impede progress in their field or research. They undermine their own authority and trustworthiness as researchers. Misleading data can also arise from poor experimental design or careless measurements as well as from improper manipulation… https://www.nature.com/articles/s41586-019-1585-5 See, “Nature” Papers Retractions in 2023  Research Misconduct Some research behaviors are so at odds with the core principles of science that they are treated very harshly by the scientific community and by institutions that oversee research. Collectively these actions have come to be known as scientific misconduct To be considered research misconduct, actions must represent a “significant departure from accepted practices,” must have been “committed intentionally, or knowingly, or recklessly,” and must be “proven by a preponderance of  What is not acceptable Research reports that are routine extensions of previous reports and that do not appreciably advance fundamental understanding or knowledge in the area Incremental / fragmentary reports of research results Verbose, poorly organized, papers cluttered with unnecessary or poor quality illustrations Violations of ethical guidelines, including plagiarism of any type or degree (of others or of oneself) and questionable research practices (QRP)  Research Misconduct Research misconduct means Fabrication, Falsification, or Plagiarism (FFP) in proposing, performing, or reviewing research, or in reporting research results – The three elements of research misconduct (a) Fabrication is making up data or results and recording or reporting them…“making up data or results.” (b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. (c) Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or differences of opinion.  Distinction Between FFP and Error or Negligence A crucial distinction between falsification, fabrication, and plagiarism (sometimes called FFP) and error or negligence is the intent to deceive. When researchers intentionally deceive their colleagues by falsifying information, fabricating research results, or using others’ words and ideas without giving credit, they are violating fundamental research standards and basic societal values  Bioethics - Human Participants and Animal Subjects in Research Any scientist who conducts research with human participants needs to protect the interest of research subjects by complying with national and local regulations as well as with relevant codes established by professional groups. These provisions are designed to ensure that risks to human participants are minimized; that risks are reasonable given the expected benefits; that the participants or their authorized representatives provide informed consent; that the investigator has informed participants of key elements of the study protocol; and that the privacy of participants and the confidentiality of data are maintained. Basic Principles of Research on Human Subjects Respect for persons Beneficence Justice  Basic Principles of Research on Human Subjects Respect for persons Choices of autonomous individuals should be respected People incapable of making their own choices should be protected Voluntary subjects need adequate information for decision-making  Informed Consent Inherent to this principle are 4 elements: 1. Subjects are made fully aware of the nature and purpose of the research project 2. Consent is voluntarily given 3. The person involved has the legal capacity to give consent 4. The responsibility for obtaining consent rests with the researcher  Privacy and Confidentiality Privacy refers to capacity of individuals to control when and what conditions others have access to their behaviors, beliefs, and values. Confidentiality refers to linking information to a person’s identity Informed consent should indicate how researcher will protect confidentiality of participants Some procedures that can ensure confidentiality: Obtaining anonymous information Code data so that identifying info is eliminated Substitute other names Limit access that could reveal individual identity Report data only in group form Used computerized methods for encrypting data  Basic Principles of Research on Human Subjects Beneficence Participation in research is associated with a favorable balance of potential benefits and harms Maximize possible benefits, minimize potential harm  Basic Principles of Research on Human Subjects Justice May not exploit or exclude vulnerable individuals who may benefit without good reason. Participation in research is associated with a favorable balance of potential benefits and harms  Summary - Principles and Foundations of Research Ethics All codes and regulations advocate three fundamental principles: Respect for persons Beneficence Justice Research is a privilege, not a right The well-being of the participant is paramount Assessment of Benefits and Risks  Assure That Benefits Outweigh Risks Research must be justified on the basis of a favorable benefit/risk assessment for the research participant. Benefits must outweigh risks. This is similar to the principal of beneficence or “do no harm.” Researchers must protect participants from harm and maximize their well- being.  Risk and Benefit A “risk” refers to a harm or likelihood of a harm. The degree of severity of a possible harm may be unclear. A “benefit” refers to a positive value that accrues to the participant and/or to the society. The precise degree of gain that might accrue to the participant and/or to the society may be uncertain.  Types of Risks and Benefits Risks or harms and benefits may be physical (pain or injury), psychological, social, economic Risks or benefits of research may apply to individual participants, families, groups or organizations, communities, or nations. Risks and benefits to the research participant usually carry the most weight.  General Principles There is absolutely no justification for inhumane treatment of participants. Risks to participants should always be reduced to the minimum extent possible. If a significant risk is involved, justification of the research must be examined with particular care. Whenever vulnerable persons are participants, the need to involve them must be carefully demonstrated.  Informed consent Informed consent requires that research staff and participants should be given appropriate (a) information about the research (b) in a comprehensible manner (c) without duress or inappropriate inducement. The information should include: the research procedure, the purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the participant the opportunity to ask questions and to withdraw at any time from the research. The extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge. Even when some direct benefit to them is anticipated, the participants should understand clearly the range of risk and the voluntary nature of participation.  Informed consent Comprehension entails that the manner and context in which information is conveyed is as important as the information itself. For example, presenting information too quickly or in a format that is confusing may adversely affect a participant's ability to make an informed choice. Because a participant's ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the participant’s capacities. Investigators are responsible for ascertaining that the participant has comprehended the information. Special provision may need to be made when comprehension is severely limited – for example, by conditions of immaturity or mental disability (e.g., infants and young children or those with mentally disabilities). Voluntariness requires that a participant make their decision without duress or other undue influence. Also, inducements that would ordinarily be acceptable may become undue influences if the participant is especially vulnerable. Unjustifiable pressures usually occur when persons in positions of authority or commanding influence – especially where possible sanctions are involved – urge a course of action for a participant.  Ethical Principles Honesty: Honestly report data, results, methods and procedures, and publication status. Do not fabricate, falsify, or misrepresent data. Objectivity: Strive to avoid bias in experimental design, data analysis, data interpretation, peer review, personnel decisions, grant writing, expert testimony, and other aspects of research. Integrity: Keep your promises and agreements; act with sincerity; strive for consistency of thought and action. Carefulness: Avoid careless errors and negligence; carefully and critically examine your own work and the work of your peers. Keep good records of research activities. Openness: Share data, results, ideas, tools, resources. Be open to criticism and new ideas. Respect for Intellectual Property: Honor patents, copyrights, and other forms of intellectual property. Do not use unpublished data, methods, or results without permission. Give credit where credit is due. Never plagiarize. Confidentiality: Protect confidential communications, such as papers or grants submitted for publication, personnel records, trade or military secrets, and patient records.  Ethical Principles Social Responsibility: Strive to promote social good and prevent or mitigate social harms through research, public education, and advocacy. Competence: Maintain and improve your own professional competence and expertise through lifelong education and learning; take steps to promote competence in science as a whole. Legality: Know and obey relevant laws and institutional and governmental policies. Animal Care: Show proper respect and care for animals when using them in research. Do not conduct unnecessary or poorly designed animal experiments. Human Subjects Protection: When conducting research on human subjects, minimize harms and risks and maximize benefits; respect human dignity, privacy, and autonomy.  Some references F. Macrina. Scientific Integrity, 2nd edition, ASM Press and Lucinda Peach. 1995. An Introduction to Ethical Theory. In: Research Ethics: Case and Materials, Robin Levin Penslar, ed. Bloomington, Indiana University Press Universal Declaration on Bioethics and Human Rights https://unesdoc.unesco.org/ark:/48223/pf0000146180 Principles of research ethics. https:// www.city.ac.uk/research/support/integrity-and-ethics/ethics/principles Guiding Principles for Ethical Research. https:// www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-princi ples-ethical-research