Bioethics in Research PDF

Bioethics is the study of ethical, social, and legal issues that arise in biomedicine and biomedical research. Bioethics includes the following: A- Medical ethics, which focuses on issues in health care. B- Research ethics, which focuses issues in the conduct of research. C- Environmental ethics,...

Bioethics is the study of ethical, social, and legal issues that arise in biomedicine and biomedical research. Bioethics includes the following: A- Medical ethics, which focuses on issues in health care. B- Research ethics, which focuses issues in the conduct of research. C- Environmental ethics, which focuses on issues pertaining to the relationship between human activities and the environment. D- Public health ethics, which addresses ethical issues in public health. Bioethicists: Conduct research on ethical, social, and legal issues arising in biomedicine and biomedical research; teach courses and give seminars; help draft institutional policies; serve on ethics committees, and provide consultation and advice on ethical issues. Bioethicists work for academic institutions, hospitals and medical centers, government agencies, private corporations and foundations. Bioethicists usually have a graduate degree in bioethics or a related discipline, such as philosophy, law, medicine, nursing, public health, psychology, political science, biology, or theology. (https://www.niehs.nih.gov/research/resources/bioethics/index.cfm) Research ethics provides guidelines for the responsible conduct of research. In addition, it educates and monitors scientists conducting research to ensure a high ethical standard. The following is a general summary of some 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 and patient records. Responsible Publication: Publish in order to advance research and scholarship, not to advance just your own career. Avoid wasteful and duplicative publication. Responsible Mentoring: Help to educate, mentor, and advise students. Promote their welfare and allow them to make their own decisions. Respect for Colleagues: Respect your colleagues and treat them fairly. Social Responsibility: Strive to promote social good and prevent or mitigate social harms through research, public education, and advocacy. Non-Discrimination: Avoid discrimination against colleagues or students on the basis of sex, race, ethnicity, or other factors that are not related to their scientific competence and integrity. 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. (https://libguides.library.cityu.edu.hk/researchmethods/ethics) Research misconduct: What are research misconducts? Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. \(a) Fabrication - making up data or results and recording or reporting them. \(b) Falsification - manipulating research materials, or changing or omitting data or results such that the research is not accurately represented in the research record. \(c) Plagiarism - the appropriation of another person\'s ideas, processes, results, or words without giving appropriate credit. \(d) Research misconduct does not include honest error or differences of opinion. () The protection of human subjects: The use of human subjects in research benefits society in many ways, from contributing to the development of new drugs and medical procedures to understanding how we think and act. It also can and has imposed unacceptable risks on research subjects. To help ensure that the risks do not outweigh the benefits, human subjects research is carefully regulated by society. Investigators who conduct research involving humans that is subject to regulation must comply with all relevant Federal regulations as well as any applicable state and local laws, regulations, and policies related to the protection of human subjects. They are also expected to follow other relevant codes that have been formulated by professional groups. To meet these responsibilities requires, among other things: knowing what research is subject to regulation, understanding and following the rules for project approval, getting appropriate training, and accepting continuing responsibility for compliance through all stages of a project. If you expect to use or study living humans in your research, no matter how harmless that use may seem, and receive Federal funding, familiarize yourself with your responsibilities and check with someone in a position of authority before making any contacts or undertaking any work. IRB: Funded research that uses human subjects must be reviewed and approved by an independent committee called an Institutional Review Board or IRB. The IRB provides an opportunity and place for individuals with different backgrounds to discuss and make judgments about the acceptability of projects, based on criteria set out in the Common Rule. IRBs must have at least five members and include at least one scientist, one non-scientist, and "one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. IRBs have authority to approve, require modification and disapprove all research activities covered by the Common Rule. They also are responsible for conducting continuing review of research at least once per year and for ensuring that proposed changes in approved research are not initiated without IRB review and approval, except when necessary to eliminate apparent immediate hazards to the subject. IRBs weigh many factors before approving proposals. Their main concern is to determine whether: \- risks to subjects are minimized; -risks to subjects are reasonable in relation to anticipated benefits. -selection of subjects is equitable. -informed consent will be sought from each prospective subject or the subject's legally authorized representative; -informed consent will be appropriately documented; Informed consent: Informed consent. It is widely agreed that research subjects should be fully informed about experiments in which they may participate and give their consent before they enroll. However, some subjects, such as children, some adults with impaired decision-making capacity, and some critically ill patients, cannot give informed consent, either because they are not old enough to understand the information being conveyed or because they have lost their ability to understand. These and other problems could be eliminated by forbidding researchers to do studies that raise difficult questions about respect for persons, beneficence, and justice, but this would make it difficult or even impossible to get some crucial information needed to make informed decisions about medicine and public health. Since children do not respond to medicines in the same way as adults, it is important to include children in some clinical trials. However, it is not easy to decide when they should be included and how consent can/should be obtained. Right to withdraw. It is widely agreed that research subjects should have the right to withdraw from experiments at any time. The welfare of laboratory animals: Animal research is as carefully regulated as human research, for different reasons. With humans, regulation stems from the need to assure that the benefits all humans gain from human research do not impose unacceptable burdens on some research participants. Animals may benefit from the information gained through animal experimentation and some research with animals is conducted specifically for the purpose of improving animal health (veterinary medicine and animal husbandry research). But most animal research is conducted primarily for the benefit of humans, not animals. Moreover, unlike humans, animals cannot consent to participate in experiments or comment on their treatment, creating special needs that should be taken into consideration in their care and use. To help researchers and Institutional Animal Care and Use Committee (IACUC) make decisions about the responsible and appropriate use of animals in research, the Federal government has adopted nine Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training. These principles specify requirements for planning and conducting research and are useful to investigators and IACUCs. () 1- The transportation, care, and use of animals should be in accordance with the Animal Welfare Act and other applicable Federal laws, guidelines, and policies. 2- Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society. 3- The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered. 4- Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals. 5- Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents. 6- Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure. 7- The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally, the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied. In any case, veterinary care shall be provided as indicated. 8- Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals. 9- Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned but should be made, with due regard to Principle II, by an appropriate review group such as an institutional animal care and use committee. Such exceptions should not be made solely for the purposes of teaching or demonstration. () Conflict of interest: A conflict of interest in research exists when the individual has interests in the outcome of the research that may lead to a personal advantage and that might therefore, in actuality or appearance compromise the integrity of the research. () Conflict of interest in medical research or clinical trial refers to situations where a patient\'s health is compromised by either financial or non-financial gains. It is defined as a dispute between a physician\'s decision in patient\'s best interest, and any potential personal gain. Types of conflict of interest: Financial conflict of interest: The commercialization of research to attain any monetary benefits by compromising the quality or integrity of research leads to financial conflict of interest. It affects an investigator's main responsibility to perform unbiased research making them pass skewed judgments. Investigator based conflict of interest: Financial conflict of interest arising at the level of investigators is referred as investigator/physician led conflict of interest. A clinical trial investigator trial may develop financial links with the sponsors and may compromise the quality of research leading to biased and altered results. Institutional based conflict of interest: Institutional conflict of interest occurs when the financial interest of institutions or its officials may affect the processes such as conduct, oversight, and review of research involving human participants. These generally result into large donations from the industry to sponsor research projects. Institutional Review Board (IRB) based conflict of interest: Institutional Review Board (IRB) is the primary body that protects the potential research participants and ensures that the patients are properly informed about the risks and benefits associated with the clinical research study in the US. However, there has been growing concern pertaining to the involvement of IRB in making monetary profits at the cost of patient's health. (Anu Rastogi (Author), 2015, Conflict of Interest in Medical Research and Clinical Trials, Munich, GRIN Verlag, ) Conflict of interest in publication Plagiarism: Plagiarism is presenting someone else's work or ideas as your own, with or without their consent, by incorporating it into your work without full acknowledgement. All published and unpublished material, whether in manuscript, printed or electronic form, is covered under this definition. Plagiarism may be intentional or reckless, or unintentional. Under the regulations for examinations, intentional or reckless plagiarism is a disciplinary offence. Ref.