[BIOETH] General Bioethical Principles and Guidelines in Research.pdf

BIOETHICS 2 08/28/2024. MOD 2: GENERAL BIOETHICAL...

BIOETHICS 2 08/28/2024. MOD 2: GENERAL BIOETHICAL PRINCIPLES AND GUIDELINES IN RESEARCH Dr. Melchor Victor G. Frias, MD, MScE, FPPS Trans Group/s: 4B GENERAL BIOETHICAL GUIDELINES AND PRINCIPLES 5 Independent review Health research advances the understanding of science and promotes human health, however it is 6 Informed consent important to remember the individuals who volunteered to participate in research. 7 Respect for potential and enrolled subjects There are precautions researchers can take in the planning, implementation, and follow-up studies to protect these participants in research. A. SOCIAL AND CLINICAL VALUE Bioethical guidelines and principles are established Every research study is designed to answer a for health research to protect patient volunteers and to specific question. preserve the integrity of the science. Answers to every research study/question should: I. GENERAL BIOETHICAL GUIDELINES 1 Have significant value An answer to the Ethics refers to doing what is morally and legally right in for society or for present research question should conducting research. or future patients with be important or valuable Research ethics deals primarily with the interaction particular disease. enough to justify asking between researchers and the people they study. people to be research A researcher should be knowledgeable about what is participants and to accept being done, to use reasoning when making some risk or decisions; to be both intellectual and truthful in inconvenience for others. approach and reporting; and to consider the consequences, in particular, to be sure that the outcome of research outweighs and negatives that might 2 Contribute to scientific ONLY if the society will occur. understanding of health gain useful knowledge, The goal of health research is to develop generalizable or improve our ways of which requires sharing knowledge that improves human health or increases preventing, treating, or results both negative and understanding of human biology. caring for people with a positive, can exposing People who participate in research makes it possible given disease. human research to secure that knowledge. participants to the risk ○ For example, the path to finding out if the new drug and burden of research or treatment is safe or effective, is to test it on be justified. patient volunteers. ○ However, by placing people at risk of harm for B. SCIENTIFIC VALIDITY the good of others, health or clinical research has A study should be designed in a way that will get an the potential to exploit patient volunteers. understandable answer to the valuable research The ethical guidelines in place today were primarily a question being asked. response to past abuses. ○ This includes considering whether the question ○ E.g., In America, an experiment in Tuskegee, researchers are asking is answerable. Alabama, in which treatment was withheld from 400 ○ Whether the study is validly designed with clear African-American men with syphilis so that scientific objectives and using accepted scientists could study the course of the disease. principles, methods, and reliable practices. Thus, various ethical guidelines were developed in ○ And, whether the research methods are rigorous response to such study. and feasible. It is also important that statistical plans be of SEVEN MAIN PRINCIPLES sufficient power to definitively test the objective. Invalid research is unethical because it is a waste of Described to guide the conduct of ethical research: resources and exposes people to risks for no purpose at all. 1 Social and Clinical Value CHARACTERISTICS OF A RESEARCH STUDY 2 Scientific validity 1 Research question that is answerable 3 Fair subject selection 2 Valid study design 4 Favorable risk benefit ratio 3 Rigorous and feasible research methods Bioethics 2 - Mod 2 Ethics in Research 1 of 4 The use of trans, practice questions, and evals ratio must be used discreetly and social media/public exposure of the aforementioned shall be strictly prohibited.  E. INDEPENDENT ETHICS REVIEW 4 Plausible statistical plan A RESEARCH STUDY SHOULD UNDERGO ETHICS C. FAIR RESEARCH PARTICIPANT SELECTION REVIEW AND APPROVAL TO In recruiting or selecting individuals to join a study, researchers should ask “Who does the study need to 1 Ensure researchers are competent and free of bias include to answer the question it is asking?” The primary basis for recruiting and enrolling groups and individuals should be the scientific goals of the study. 2 Protect welfare of the research participants ○ Not vulnerability, privilege, or other factors unrelated to the purposes of the study 3 Confirm ethical and scientific soundness Consistent with a scientific purpose, people should be chosen in a way that minimizes risks and enhances 4 Guarantee favorable risk-benefit ratio benefits to individuals and society. Groups and individuals who accept the risk and For the purpose of minimizing potential conflicts of burdens of research should be in a position to enjoy its interest and making sure a study is ethically benefits acceptable before it even starts ○ Those who may benefit should share some of the An independent review panel with no vested interest risks and burdens. in the particular study should review the proposal and ask important questions including: A RESEARCH STUDY SHOULD RECRUIT AND ○ Are those conducting the study sufficiently ENROLL RESEARCH PARTICIPANTS IN A WAY THAT competent and free of bias? ○ Is the study doing all it can to protect research 1 Minimizes risks and enhances benefits to volunteers? individuals and society ○ Has the research been ethically and scientifically designed? ○ Is the risk-benefit ratio favorable? 2 Avoids arbitrary exclusion of specific groups or Independent evaluation of research projects is done individuals through regulatory or branding agencies, local institutional review boards, and data or safety monitoring D. FAVORABLE RISK-BENEFIT RATIO boards. Uncertainty about the degree of risks and benefits ○ These groups also monitor a study while it is associated with a drug, device, or procedure being ongoing. tested is inherent in clinical research, otherwise there would be little point to doing the research. F. INFORMED CONSENT There is more uncertainty about risks and benefits in early-phase research than in later-phase research. THE INFORMED CONSENT PROCESS SHOULD Depending on the particulars of the research, research ENSURE THAT RESEARCH PARTICIPANTS risk might be trivial or serious, might cause transient discomfort or long term changes. 1 Receive accurate and relevant information A RESEARCH SHOULD MAXIMIZE BENEFITS AND 2 Understand and deliberate on the disclosed MINIMIZE RISKS information Physical Risk Death, Disability, Infection 3 Make a voluntary and informed decision Psychological Risk Depression, Anxiety. For research to be ethical, most agree that individuals should make their own decision about whether they Economic Risk Job Loss want to participate or continue participating in a research. Social Risk Discrimination or stigma from ○ This is done through a process of informed participating in a certain study or consent in which individuals are accurately trial informed of the purpose, methods, risk and benefits, and alternatives to the research. 1. ASSESSMENT OF RISK-BENEFIT RATIO ○ They should understand this information and how it relates to their own clinical situation or interest ○ Make a voluntary decision about whether to 1 Has everything been done to minimize the risk and participate/. inconvenience to research participants and to There are exceptions to the need for informed consent maximize the potential benefits? from the individual. For example: ○ Children 2 Is the potential benefits to individuals and society ○ An adult with severe Alzheimer’s disease proportionate to or outweigh the risk? ○ An adult unconscious by head trauma ○ Someone with limited mental capacity In such cases, ensuring that the individual’s research Research volunteers often receive some health services participation is consistent with his/her values and and benefits in the course of participating (e.g., free interest usually entails empowering a proxy decision comprehensive physical laboratory examinations), yet maker to decide about participation, usually based on the purpose of health or clinical research is not to what research decision the subject would have made, if provide health services. doing so were possible. Bioethics 2 - Mod 2 🏠 Ethics in Research 2 of 4 The use of trans, practice questions, and evals ratio must be used discreetly and social media/public exposure of the aforementioned shall be strictly prohibited.  1 Autonomy G. RESPECT FOR RESEARCH PARTICIPANTS Individuals should be treated with respect from the 2 Protection of persons with impaired or diminished time they are approached for possible participation, autonomy even if they refuse enrollment in a study. This is continued throughout their participation and even 1. AUTONOMY after it ends. Research participants should be respected by: Requires that those who are capable of deliberation of their personal goals should be treated with respect for their independence and their capacity for 1 Maintaining Respecting their privacy and self-determination. privacy and keeping their private information This principle is amply applied when we obtain the confidentiality confidential. informed consent of the research participants. Concerned with the concept of informed consent. 2 Upholding Respecting their right to ○ People who agreed to take part in a study, know freedom to change their mind, to decide what they are agreeing to and authorize the refuse and that the research does not researcher to collect information without any form of withdraw match their interest. coercion or influence. Allowing them to withdraw without penalty. 2. PROTECTION OF PERSONS WITH IMPAIRED OR Informing them of new DIMINISHED AUTONOMY information that might emerge in the course of the Requires that those who are dependent or vulnerable research which might change be afforded against harm or abuse. their assessment of the risk May include but not limited to minor patients (i.e. infants and benefits of participating. and children), pregnant women, the elderly, those who are mentally challenged, and other institutionalized 3 Protecting Monitoring their welfare (e.g. individuals. patients’ best adverse reactions, untoward interest and events, changes in clinical B. BENEFICENCE welfare status) “Doing good” Ensure the appropriate Ethical obligation to maximize possible benefits and to treatment and determine minimize possible harms and wrongs. when removal is necessary. Gives rise to norms requiring that: ○ The risk of research be reasonable in the light of 4 Disclosing Informing them about what was expected benefits research data learned from the research. ○ The research design be sound and; and study ○ The researchers be competent both to conduct results the research and to assure the well-being of the participants Most researchers do a good job of monitoring Research should only be carried out if some sort of volunteers’ welfare and making sure they are well. benefit or good can be derived from it, for example: They are not, however, always so good about disclosing ○ Contribution to knowledge the results of the study. So if they don’t tell you the ○ Improve service or treatment results, ask. The question whether or not a research is worth undertaking should always be uppermost in the mind of II. GENERAL BIOETHICAL PRINCIPLES the researcher. ○ If no benefit can be derived, then it is unethical. All research involving human participants should be conducted in accordance with four basic ethical principles: C. NONMALEFICENCE “Do no harm” Holds a central position in the tradition of medical 1 Respect for persons ethics. Ethical obligation not to harm others and that guards 2 Beneficence against avoidable harm to research subjects. 3 Non-maleficence Places an obligation to researchers NOT to harm research participants or expose them to 4 Justice unnecessary risk. Harm can come in many forms: ○ Blows to self esteem It is usually assumed that these principles guide the ○ Looking bad to others conscientious preparation of proposals for scientific ○ Loss of funding or earnings studies. ○ Boredom, frustration, or time-wasting In varying circumstances they may be expressed It is good practice to assume that every research differently and given different weight. project will involve some form of harm and to Moreover, their application in research may have consider in advance how to best deal with it. different effects and may lead to different decisions or courses of action. D. JUSTICE Implies that everyone should be treated fairly and A. RESPECT FOR PERSONS equally. The principle of Respect For Persons incorporates two Ethical obligation that requires that cases considered fundamental ethical principles: to be alike be treated alike, and that cases Bioethics 2 - Mod 2 🏠 Ethics in Research 3 of 4 The use of trans, practice questions, and evals ratio must be used discreetly and social media/public exposure of the aforementioned shall be strictly prohibited.  considered to be different be treated in ways that acknowledge the difference. Studies should be designed to obtain knowledge that benefits the class of persons of which the participants are representative. ○ This means that the class of persons bearing the burden should receive an appropriate benefit and the class primarily intended to benefit should bear a fair proportion of the risks and burden of the study When the principle of justice is applied to dependent or vulnerable research participants, its main concern is with the rules of restrictive justice. The rules of distributive justice are applicable within or among communities. ○ Weaker members of communities should not bear disproportionate burdens of studies from which all members of the community are intended to benefit. ○ And more dependent communities and countries should not bear disproportionate burdens of studies from which all communities and countries are intended to benefit. III. SUMMARY General bioethical guidelines: ○ Social and clinical value ○ Scientific validity ○ Fair subject selection ○ Favorable risk benefit ratio ○ Independent review ○ Informed consent ○ Respect for potential ○ Enrolled subjects General bioethical principles: ○ Respect for persons ○ Beneficence ○ Non-maleficence ○ Justice These are essential in the development, conduct, writing and publication of the students’ health research project. It is expected that students should use these guidelines and principles in executing the research process. Bioethics 2 - Mod 2 🏠 Ethics in Research 4 of 4 The use of trans, practice questions, and evals ratio must be used discreetly and social media/public exposure of the aforementioned shall be strictly prohibited.