The Belmont Principles The Belmont Report: Ethical Principles and Guidelines for the Protection of Human of Research

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1 The Belmont Principles The Belmont Report: Ethical Principles and Guidelines for the Protection of Human of Research National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979 (Provides philosophical underpinnings for current federal laws governing research involving human subjects.) Belmont Principles 1) Beneficence/Non-maleficence 2) Respect for persons/autonomy 3) Justice 1

2 Beneficence in Research Beneficence All research should be designed d to minimize i i risk or possible harms ( Do no harm ) and maximize benefit to the participant and to society. Principles of Beneficence One ought to do or promote good. One ought not to inflict evil or harm One ought to prevent evil or harm One ought to remove evil or harm How would you arrange these subprinciples according to priority? How did you make your decision? 2

3 Beneficence Principle of Beneficence One ought not to inflict evil or harm Most fundamental One ought to prevent evil or harm One ought to remove evil or harm One ought to do or promote good. Possibly not being an obligation Assumed that these acts are required when they can be performed with minimal risk to actor No obligation of beneficence in all circumstances of risk Beneficence in Medicine Better welfare of patients =The foundational value in medical ethics To assist those in need of treatment or in danger of injury Doing of good Active promotion of good, kindness, and charity 3

4 Respect for persons/autonomy 1. Individuals should be treated as autonomous agents Research subjects must sign an informed consent form describing research to be done potential risks and benefits anything else that might influence decision to participate. 2. Persons with diminished autonomy should be protected (vulnerable subjects) Vulnerable subjects can be: Those not capable of deciding for themselves Those subject to coercion or deception special protection to ensure that participation is not subject to undue harm/risk. Classified by the government as vulnerable: children, prisoners, pregnant women Respect for autonomy/persons Based on: principle persons possess intrinsic value independently of other things Kant Treat people as ends not as means. e.g. Not just market worth or science specimen Personhood Self-determining agent Must be given the right to have their own opinions and to be able to act upon them. due regard to their (considered) evaluations and view of the world. 4

5 Enforcement of Belmont Principles 1. Federal Law Code of Federal Regulations (CFR) CFR 45.46: 46: Title 45--Public Welfare Subtitle A--Department Of Health And Human Services Part 46--Protection Of Human Subjects 2. Enforcement: IRB (Institutional Review Board) reviews science research to ensure that participation of subjects is voluntary, and that information provided to participants is adequate and appropriate. Kennesaw IRB Justice Benefits and burdens of medicine/research should be fairly distributed ib t d among all populations Researchers must be careful not to select already burdened or vulnerable groups who might be more easily coerced to participate. 5

6 Justice, cont. Distributive justice fair, equitable and appropriate distribution in society distribution of primary social goods [healthcare or social security]; fair distribution of burdens [e.g. taxes]) By which matrix should we decide to distribute a good/burden? Principles of distributive justice (not necessarily inclusive with one another) To each person an equal share To each person according to individual need To each person according to acquisition in a free market To each person according to individual effort To each person according to societal contribution To each person according to merit Justice, cont. Distributive justice fair, equitable and appropriate distribution in society distribution of primary social goods [healthcare or social security]; includes fair distribution of burdens [e.g. taxes]) By which matrix should we decide to distribute a good/burden? Principles of distributive justice (not necessarily inclusive with one another) To each person an equal share To each person according to individual need To each person according to acquisition in a free market To each person according to individual effort To each person according to societal contribution To each person according to merit 6

7 Different types of theories in distributive justice: Egalitarian theories emphasize equal access to primary goods Libertarian theories emphasize rights to social and economic liberty Utilitarian theories emphasize a mixed use of such criteria for the sake of maximizing public and private utility OATH OF HIPPOCRATES I swear by Apollo the physician, and Aesculapius and Health, and Allheal, and all the gods and goddesses, that, according to my ability and judgment, I will keep this Oath and this stipulation to reckon him who taught me this Art equally dear to me as my parents, to share my substance with him, and relieve his necessities if required; to look upon his offspring in the same footing as my own brothers, and to teach them this Art, if they shall wish to learn it, without fee or stipulation; and that by precept, lecture and every other mode of instruction, I will impart a knowledge of the Art to my own sons, and dthose of my teachers, and dto disciples i bound dby a stipulation and oath according to the law of medicine, but to none other. I will follow that system of regimen which, according to my ability and judgment, I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous. I will give no deadly medicine to anyone if asked, nor suggest any such counsel; and in like manner I will not give to a woman a pessary to produce abortion. With purity and with holiness I will pass my life and practice my Art. I will not cut persons laboring under the stone, but will leave this to be done by men who are practitioners of this work. Into whatever houses I enter, I will go into them for the benefit of the sick, and will abstain from every voluntary act of mischief and corruption; and, further, from the seduction of females, or males, of freemen or slaves. Whatever, in connection with my professional practice, or not in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge, as reckoning that all such should be kept secret. While I continue to beep this Oath unviolated, may it be granted to me to enjoy life and the practice of the Art, respected by all men, in all times. But should I trespass and violate this Oath, may the reverse be my lot. 7

8 Why is it necessary for doctors and health care practitioners to take this oath? Why is it necessary for doctors and health care practitioners to take this oath? They are accorded a measure of respect and trust by society/patients Patients place themselves into a vulnerable position when going to a doctor and doing what the doctor tells them Doctors are given authority to tell people what to do. With authority comes responsibility for the good of those over whom they have authority. The patient is following orders for things over which he [patient] cannot judge for himself (loss of autonomy and self-defense) A malicious doctor is more deadly than a malicious lay person. Doctors are imparted special knowledge of the body and can inflict harm with more efficiency and stealth than the average person. Negligence on the part of the doctor is more deadly than negligence on the part of the non-doctor (another aspect of authority and responsibility over others) 8

9 American Medical Association, Principles of Medical Ethics Preamble The medical profession has long subscribed to a body of ethical statements developed primarily for the benefit of the patient. As a member of this profession, a physician must recognize responsibility to patients first and foremost, as well as to society, to other health professionals, and to self. The following Principles adopted by the American Medical Association are not laws, but standards of conduct which define the essentials of honorable behavior for the physician. Principles of medical ethics A physician shall be dedicated to providing competent medical care, with compassion and respect for human dignity and rights. A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities.* A physician shall respect the law and also recognize a responsibility to seek changes in those requirements which are contrary to the best interests of the patient. A physician shall respect the rights of patients, colleagues, and other health professionals, and shall safeguard patient confidences and privacy within the constraints of the law. A physician shall continue to study, apply, and advance scientific knowledge, maintain a commitment to medical education, make relevant information available to patients, colleagues, and the public, obtain consultation, and use the talents of other health professionals when indicated. A physician shall, in the provision of appropriate patient care, except in emergencies, be free to choose whom to serve, with whom to associate, and the environment in which to provide medical care. A physician shall recognize a responsibility to participate in activities contributing to the improvement of the community and the betterment of public health. A physician shall, while caring for a patient, regard responsibility to the patient as paramount. A physician shall support access to medical care for all people. 9

10 Researchers and scientists are similar but different from doctors. What are the similarities and differences? Accorded a measure of trust and respect in society Keepers of special knowledge Can be placed in positions of decision-making over other people No personal oath is taken by scientists though, since we generally do not work in a special one-on-one relationship with patients This last point is arguable among scientists who work directly with human beings as research subjects. Vulnerability of research subjects is increased due to the opacity/complexity of what the researcher is doing to them (especially if the researcher and doctor are the same person) Biological research can be particularly invasive on subjects, in comparison to other fields. Researchers and scientists are similar but different from doctors. What are the similarities and differences? Accorded a measure of trust and respect in society Keepers of special knowledge Can be placed in positions of decision-making over other people No personal oath is taken by scientists though, since we generally do not work in a special one-on-one relationship with patients This last point is arguable among scientists who work directly with human beings as research subjects. Vulnerability of research subjects is increased due to the opacity/complexity of what the researcher is doing to them (especially if the researcher and doctor are the same person) Biological research can be particularly invasive on subjects, in comparison to other fields. 10