Research Ethics Lecture PDF

Research ethics Lecture (6) Research Codes of Ethics ⚫​ The general moral principles of action discussed earlier become formalized when they are developed into codes of ethics to guide the practice of various professionals. There are five codes of...

Research ethics Lecture (6) Research Codes of Ethics ⚫​ The general moral principles of action discussed earlier become formalized when they are developed into codes of ethics to guide the practice of various professionals. There are five codes of ethics that can provide physical Therapy researchers with guidance on ethical issues: (1)​ The first of these is the Nuremberg Code, developed in 1947 as a reaction to Nazi atrocities in the name of research. (2)​ The second is the World Medical Association's Declaration of Helsinki, developed in 1964 and modified in 1975. (3)​ The third is the US Department of Health and Human Services (DHHS). (4)​ The fourth is Belmont report (1976). (5)​ The fifth is the Integrity I Physical Therapy Research document adapted by the APTA in 1987. ⚫​ Ethics of Clinical Research “Historical Overview” 1- Nuremberg Code of ethics (1947) ⚫​ During the 2nd world war, Nazi doctors had done several crimes during human experiments on concentration camp prisoners. As a response of that Nuremberg Trials, the Nuremberg code of ethics was introduced in 1947 as a landmark document in The history of medical research ethics. 2- Belmont report (1976) ⚫​ The Belmont report was written by the national commission for the protection of human subjects of biomedical & behavioral research. It outlines three key ethical Principles for conducting research with human subjects: respect for persons , beneficence and justice. 1 3- Declaration of Helsinki ⚫​ The declaration of Helsinki was adopted by the 18th general assembly of the world medical association in Helsinki, Finland, June 1964. It was amended several times in 1975, 83, 89, 96, 2000, 2002, 2004, 2008, and 2013. The declaration of Helsinki is currently the cornerstone of human research ethics in the world. 2 3 Patient rights in clinical Research ⚫​ Autonomy ⚫​ Informed consent ⚫​ Beneficence 4  ⚫​ Non-maleficence ⚫​ Justice ⚫​ Confidentiality Ethical issues ⚫​ Various organizations have created guidelines for human subject research for the various kinds of research and situations. A set of guidelines was published to guide researchers who work with human subjects. Good Clinical Practice (GCP) enforces guidelines on ethical aspects of clinical research. GCP aims to protect and preserve human rights through making sure that studies are conducted with high scientific standards with proper documentation. It provides principles on how clinical research should be conducted, define the roles and responsibilities of sponsors, clinical researchers, and investigators. ⚫​ The following are a few points essential for ethical considerations in clinical research: a. Informed consent ⚫​ An informed consent is a voluntary agreement to participate in a clinical research study. It is not merely a form that is signed but is a process, in which the subject has an understanding of the research and its risks. It must be obtained for all types of human subjects research including; diagnostic, therapeutic, interventional, social and behavioral studies. ⚫​ The goal of the informed consent process is to provide sufficient information so that a participant can make an informed decision about whether or not to enroll in a study or to continue participation. It is a document that should be written in a lay language, which makes it easily understood by the participant. ⚫​ It should include information about the objectives and procedures of the study, and potential risks and benefits of participation. It should indicate information about the right of the patient to withdraw from the study at any time without affecting the healthcare they are receiving. 5  ⚫​ Informed consent should be obtained before enrolling a participant and its regulations should be maintained throughout the whole research process. b. Vulnerable groups ⚫​ Vulnerable groups should be given extra attention and precautions in terms of ethical considerations when to be included in clinical research. Researchers refer to populations which have low autonomy as "vulnerable populations". These are groups which may not be able to fairly decide for themselves whether to participate in clinical research or those who are relatively (or absolutely) incapable of protecting their own interests. Examples of groups which are considered as vulnerable populations include: prisoners, children, pregnant women, human fetuses, neonates, racial minorities, as well as people who are very sick, physically handicapped, mentally disabled, economically or educationally disadvantaged, or institutionalized. c. Institutional Research Board (IRB) ⚫​ An IRB, also known as an independent ethics committee or ethical review board, is a committee that has been formally designated to approve, monitor, and review the ethicality of biomedical and behavioral research, in protecting the rights of participants in a research projects. a. Principles 6 The three main principles that guide the IRB in making its decision are derived from the Basic Ethical Principles enumerated in the Belmont Report document dated April 18, 1979. They are as follows: ⚫​ Respect for Persons: The principle of respect requires that subjects participating in the research should be fully aware of the nature of such research and assured that such participation is voluntary, with no pressure or duress. They should also be aware of the physical, psychological, and socio-economic risks that such participation might bring to the subject immediately or in the future. ⚫​ Beneficence: Beneficence requires researchers to maximize the potential benefits to the subjects and minimize the potential risks. ⚫​ Justice: The principle of justice requires an equitable and fair selection of subjects and a fair and equitable distribution of risks and benefits of research. b. IRB structure ⚫​ IRBs are formed by academic, research, and other institutions, and they include at least five members of different professions, having enough expertise to make an informed decision on whether the research is ethical, informed consent is sufficient, and appropriate safeguards have been put in place. c. Tasks of IRB The IRB is empowered to: ⚫​ Review research proposals submitted to the committee for approval ⚫​ Identify the risks entailed due to participation in the research study ⚫​ Assess steps proposed by the investigators to minimize the risks on participants ⚫​ Assess safeguards to be used for maintaining confidentiality, anonymity, and well-being of participants ⚫​ Conduct risk-benefit analysis in an attempt to determine whether or not research should be done ⚫​ Give a final decision on the proposal submitted, which might be approving, requiring modifications, or disapproving the proposal 7 8