Ethics In Medical Research Dr.TG 2022 PDF

Ethics in Medical Research Dr.Theingi Associate Professor Community Medicine Learning outcomes § Identify the historical and contemporary examples of abuses in medical research § Discuss the ethical principles of beneficence and justice in biomedical research § Enumerate the requirements for infor...

Ethics in Medical Research Dr.Theingi Associate Professor Community Medicine Learning outcomes § Identify the historical and contemporary examples of abuses in medical research § Discuss the ethical principles of beneficence and justice in biomedical research § Enumerate the requirements for informed consent, assessment of risks and benefits, and selection of subjects in the conduct of biomedical research § Describe the legal and professional regulation of medical research Ethics and Morals Ethics is the systematic study of values, so as to decide what is right and what is wrong. (A subject that deals with values , principles, beliefs, and opinions) Morality (or morals) is the beliefs and standards of good and bad, right and wrong. Ethics  Morality (Theory) (Practice) • Ethics refer to rules provided by an external source, e.g., codes of conduct in workplaces or principles in religions. • Morals refer to an individual's own principles regarding right and wrong. Bioethics • Bioethics is a way of understanding and examining the moral aspects of biomedical research and practice BALANCING TWO GOALS in Research HUMAN SUBJECT RESEARCH Ethical requirements in clinical research – minimize the possibility of exploitation; – ensure that the rights and welfare of subjects are respected History 1. 2. 3. 4. The Nuremberg Code (1947) The Declaration of Helsinki (1964) U.S. Code of Federal Regulations (1974) The National Research Act and The IRB System (1974) 5. The Belmont Report (1979) 6. ICMR Guidelines (2000,2006) Nazi ExpErimENts Nuremberg Trials of Nazi Germany • Physicians • Projects carried out . . . 1. Improving survival and rescue of German troops 2. Testing of medical procedures and pharmaceuticals 3. Experiments to confirm Nazi racial ideology Children in concentration camps who had been used for medical experiments Thalidomide - phocomelia 1945-1947- The Nuremberg Trial -Photograph of an injury caused by a phosporous experiment conducted at Ravensbruek in 1941 -to test the effectiveness of pharmaceutical remedies on phosphorus burns . Subjects were purposely burned with phosphorus matter from those bombs, which was severely painful. 1945-1947- The Nuremberg Trial Dachau concentration camp, Germany, 1944 This is an image of a gypsy forcibly given a sea water injection. Bodies and parts of bodies of people subjected to medical experiments § High altitude experiments were performed to test how long pilots would survive after being ejected from their planes. § Prisoners were put into low-pressure tanks with little oxygen. § Many of those who did not die immediately were put under water until they died. Autopsies followed. § A prisoner is submerged in a tank filled with cold water. § The goal of this type of experiments was to determine how long German pilots would survive after parachuting into the cold north sea. • 15 of 23 guilty, 7 hanged, 5 life sentences Nuremberg Trials • Nazi Experiments – experimental starvation - induced gangrene – low barometric pressure – induced hypothermia – induced burns and wounds Nuremberg Trials Characteristics of Nazi experiments – conducted without consent of participants – caused unnecessary pain, suffering and death – absence of benefits for the participants – lack of adequate scientific rationale Nuremberg Code (1949) The Nuremberg Code is a set of research ethics principles for human experimentation set as a of the Subsequent Nuremberg Trials at the end of the Second World War. • Voluntary consent is essential • Subject can terminate participation at any time • Conducted as to avoid all unnecessary physical and mental suffering and injury The Declaration of Helsinki • Developed by the World Medical Association in Finland in 1964. • Provide guidance for physicians and participants in medical research. • Many updates were introduced in 1975, 1983, 1989, 1996, 2000 and in 2008. The Declaration of Helsinki It indicates: • The well-being of the subject should take precedence over the interests of science and society. • Physician should obtain the subject’s freely given informed consent in writing. • Ethical review committee approval is a must. • Belmont Report Tuskegee Syphilis Study • cited as "arguably the most infamous biomedical research study in U.S. history” Tuskegee Syphilis Study § The study recruited about 600 poor AfricanAmerican men at Tuskegee: about 400 with syphilis and about 200 without syphilis, without informed consent. § They were recruited by spreading the word among Black people in the county that volunteers would be given free tests for "bad blood" Tuskegee Syphilis Study § They were led to believe that some procedures done in the interest of research (e.g.,spinal taps) were actually “special free treatment". § In the1943, penicillin was found to be effective in the treatment of syphilis. § But the study continued and the men were neither informed about nor treated with the antibiotic. § The study was not withheld from the nation's medical community. Most venereal disease experts supported the project. Ethical Issues § Inadequate disclosure of information § Subjects believed they were getting free treatment § Told that spinal taps was therapy § US Gov’t actively prevented men from receiving penicillin § 1963 -- Brooklyn - Jewish Chronic Diseases Hospital: Cancer cells were injected into debilitated elderly patients to see if they would immunologically reject the cells. § 1972 - Willowbrook State Hospital in New York: Retarded children were deliberately infected with viral hepatitis to study its natural history. § In 1974 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established in USA in response to Tuskegee study. § In 1978 the commission submitted its report called “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.” Belmont Report Core Principles of Clinical Trial Ethics • National Research Act/Belmont Report 1979 • The report established three basic principles of ethical research, ürespect for persons (Autonomy) übeneficence and and non-malaficence - maximize benefits - minimize harms and wrongs - do no harm üjustice Vulnerable persons § Those who are relatively (or absolutely) incapable of protecting their own interests. § They have limited capacity or freedom either to consent or to decline to consent VULNERABLE POPULATIONS • Pregnant women / fetuses • Children • Elderly • Mentally disabled • Sick persons • Unconscious persons • Prisoners • Persons with little/ no education • Poor persons Research involving children § The research might not equally well be carried out with adults § The purpose of the research is to obtain knowledge relevant to the health needs of children § A parent or legal representative of each child has given permission § The agreement (assent) of each child has been obtained to the extent of the child‘s capabilities § A child‘s refusal to participate or continue in the research will be respected. Consent given by a competent individual who: – has received the necessary information – has adequately understood the information – after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation (threats).” (The type, extent and method of information provided requires the review and approval of an appropriate ethical committee) § Explanation of Confidentiality of Records § Who to contact regarding patient rights ü For research with more than minimal risks, comment on compensation and care for injury § Right to withdraw without prejudice § Statement regarding unforeseen risks, especially to unborn child § Maximize benefits § Minimize harms (Nonmaleficence) § Favorable risk-benefit ratio § Use best possible research design to minimize harms § Use qualified investigators Types of risk Physical Drug side effects Adverse surgical outcomes Injury Psychological Emotional distress Anxiety Relapse Precipitation of depression Legal Arrest, prosecution Civil or criminal liability Social Embarrassment Ostracism Stigma Loss of status Economic Loss of job or income Loss of insurance/insurability Reduced employability Financial loss Fairness in § Benefits and risks of research distributed fairly among all groups distribution of risks in society and benefits § Fairness in selection Avoid choosing groups based on easy availability or compromised of human subjects position. § Do not involve groups unlikely to benefit from the subsequent applications of the research. § International Ethical Guidelines for Biomedical Research Involving Human Subjects § First code to consider developing countries Ø Ø Ø Ø 1st version in 1982 2nd version in 1993 3rd version in 2000 4th version in 2002 § 21 guidelines § Pay special attention to circumstances and needs of resourcepoor countries and multinational research § Due to their global applicability, the guidelines have been widely disseminated and adopted in many national guidelines. • CASE STUDIES • Please check it on LMS