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Human Subjects Regulations
 

Human Subjects Regulations

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Slides from the lecture on codes of ethics governing human subjects research, in my "Ethics in Science" course at San Jose State University.

Slides from the lecture on codes of ethics governing human subjects research, in my "Ethics in Science" course at San Jose State University.

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    Human Subjects Regulations Human Subjects Regulations Presentation Transcript

    • Human subjects research: regulations and the shifting interpretation of “justice”. Phil 133 – Ethics in Science San José State University
    • Medicine and science.
      • Science is aimed at knowledge-building (often to build knowledge to help people)
      • Medicine is focused on caring for patients (and involves explicit duties to patients)
      • How have physicians and patients understood these obligations historically?
    • The Hippocratic Oath
      • The Hippocratics, in Ancient Greece, aimed to make medicine more “scientific” (sought understanding , not just ways to heal)
      • Established standards to professionalize medicine (and to “create a climate of opinion favorable to learned medicine”)
    • The Hippocratic Oath
      • I swear by Apollo the healer, by Aesculapius, by Health and all the powers of healing, and call to witness all the gods and goddesses that I may keep this Oath and Promise to the best of my ability and judgment.
    • The Hippocratic Oath
      • I swear by Apollo the healer, by Aesculapius, by Health and all the powers of healing, and call to witness all the gods and goddesses that I may keep this Oath and Promise to the best of my ability and judgment.
      • It’s a serious oath.
    • The Hippocratic Oath
      • I will pay the same respect to my master in the Science as to my parents and share my life with him and pay all my debts to him. I will regard his sons as my brothers and teach them the Science, if they desire to learn it, without fee or contract.
    • The Hippocratic Oath
      • I will pay the same respect to my master in the Science as to my parents and share my life with him and pay all my debts to him. I will regard his sons as my brothers and teach them the Science, if they desire to learn it, without fee or contract.
      • Debt to professional community, those who taught you.
      • Duty to educate next generation of profession.
    • The Hippocratic Oath
      • I will hand on precepts, lectures and all other learning to my sons, to those of my master and to those pupils duly apprenticed and sworn, and to none other.
    • The Hippocratic Oath
      • I will hand on precepts, lectures and all other learning to my sons, to those of my master and to those pupils duly apprenticed and sworn, and to none other.
      • Keeping trade secrets secret.
    • The Hippocratic Oath
      • I will use my power to help the sick to the best of my ability and judgment; I will abstain from harming or wronging any man by it.
      • Duty to patients.
      • (Do no harm.)
    • The Hippocratic Oath
      • I will not give a fatal draught to anyone if I am asked, nor will I suggest any such thing. Neither will I give a woman means to procure an abortion.
    • The Hippocratic Oath
      • I will not give a fatal draught to anyone if I am asked, nor will I suggest any such thing. Neither will I give a woman means to procure an abortion.
      • No euthanasia or abortion.
      • (Note that other writings in the Hippocratic corpus indicate that physicians in this tradition did participate in such procedures)
    • The Hippocratic Oath
      • I will be chaste and religious in my life and in my practice.
    • The Hippocratic Oath
      • I will be chaste and religious in my life and in my practice.
      • Conduct yourself as a good person.
      • (Reputation of whole profession connected to reputation of individual practitioners.)
    • The Hippocratic Oath
      • I will not cut, even for the stone, but I will leave such procedures to the practitioners of that craft.
    • The Hippocratic Oath
      • I will not cut, even for the stone, but I will leave such procedures to the practitioners of that craft.
      • No surgery.
      • (Note that other writings in the Hippocratic corpus indicate that physicians in this tradition did participate in such procedures)
    • The Hippocratic Oath
      • Whenever I go into a house, I will go to help the sick and never with the intention of doing harm or injury.
    • The Hippocratic Oath
      • Whenever I go into a house, I will go to help the sick and never with the intention of doing harm or injury.
      • Awareness of power and responsibilities that come with it.
    • The Hippocratic Oath
      • I will not abuse my position to indulge in sexual contacts with the bodies of women or men, whether they be freemen or slaves.
    • The Hippocratic Oath
      • I will not abuse my position to indulge in sexual contacts with the bodies of women or men, whether they be freemen or slaves.
      • Power, responsibility, reputation of the profession again.
    • The Hippocratic Oath
      • Whatever I see or hear, professionally or privately, which ought not to be divulged, I will keep secret and tell no one.
    • The Hippocratic Oath
      • Whatever I see or hear, professionally or privately, which ought not to be divulged, I will keep secret and tell no one.
      • Patient privacy?
      • More likely trade secrets, again.
    • The Hippocratic Oath
      • If, therefore, I observe this Oath and do not violate it, may I prosper both in my life and in my profession, earning good repute among all men for all time. If I transgress and forswear this Oath, may my lot be otherwise.
    • The Hippocratic Oath
      • If, therefore, I observe this Oath and do not violate it, may I prosper both in my life and in my profession, earning good repute among all men for all time. If I transgress and forswear this Oath, may my lot be otherwise.
      • It’s a serious oath.
    • The Nuremberg Code
      • Direct response to Nazi medical experiments
      • Focus on the most appalling features of those experiments (harms to human subjects and lack of consent from subjects)
    • The Nuremberg Code
      • 1. The voluntary consent of the human subject is absolutely essential.
    • The Nuremberg Code
      • 1. The voluntary consent of the human subject is absolutely essential.
      • Description of legal requirements for voluntary consent.
      • Consent must be informed.
    • The Nuremberg Code
      • 1. (cont’d) The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
    • The Nuremberg Code
      • 1. (cont’d) The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
      • Free informed consent non-negotiable.
    • The Nuremberg Code
      • 2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
    • The Nuremberg Code
      • 2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
      • Benefit to society
      • No other way to get that benefit
    • The Nuremberg Code
      • 3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
    • The Nuremberg Code
      • 3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
      • Probability of benefit must be maximized (since you’re risking harms to subjects)
    • The Nuremberg Code
      • 4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
    • The Nuremberg Code
      • 4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
      • Harms are serious, and must be minimized
    • The Nuremberg Code
      • 5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
    • The Nuremberg Code
      • 5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
      • The line you cannot cross with human subjects
    • The Nuremberg Code
      • 6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
    • The Nuremberg Code
      • 6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
      • Even if you don’t cross the line, benefit must outweigh harms.
    • The Nuremberg Code
      • 7. Proper preparation should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
    • The Nuremberg Code
      • 7. Proper preparation should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
      • Taking care not to cross the line accidentally
    • The Nuremberg Code
      • 8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
    • The Nuremberg Code
      • 8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
      • Skill further increases chance of benefit, decreases likely harms
    • The Nuremberg Code
      • 9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where the continuation of the experiment seemed to him to be impossible.
    • The Nuremberg Code
      • 9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where the continuation of the experiment seemed to him to be impossible.
      • Subject autonomy – gets to stop at any point.
    • The Nuremberg Code
      • 10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
    • The Nuremberg Code
      • 10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
      • Scientist’s duty to avoid harms
    • Declaration of Helsinki
      • Recognition that experiments with humans are necessary to medical progress
      • Concept of research in a clinical setting, potentially benefiting the human subject directly.
      • In clinical setting, can’t decouple duties of physician to patient from duties of physician to science.
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 1. Experiment must “conform to generally accepted scientific principles,” be grounded in a literature search and appropriate animal experiments.
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 1. Experiment must “conform to generally accepted scientific principles,” be grounded in a literature search and appropriate animal experiments.
      • Better preparation, knowledge increases chance of benefit, decreases likely harms
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 2. Experimental protocol must be formulated and evaluated by “a specifically appointed committee independent of the investigator and the sponsor.”
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 2. Experimental protocol must be formulated and evaluated by “a specifically appointed committee independent of the investigator and the sponsor.”
      • Requirement for Institutional Review Board (IRB)
      • Investigator can’t trust self to be objective in weighing risks and benefits.
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 3. Experiment must be conducted by qualified scientists and clinicians.
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 3. Experiment must be conducted by qualified scientists and clinicians.
      • Skill increases chance of benefit, decreases likely harms
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 4. Can’t do the experiment unless benefit is in proportion to potential harm to the subject.
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 5. Must assess predictable risks and foreseeable benefits before the experiment.
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 6. Must protect the subject’s integrity, minimizing physical and mental impacts, impacts on personality, impacts on privacy.
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 6. Must protect the subject’s integrity, minimizing physical and mental impacts, impacts on personality, impacts on privacy.
      • Duty to well-being of subjects, to increase chance of benefit, decrease likely harms (and not just physical ones)
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 7. Can’t do experiment if hazards are unpredictable (and must halt experiment in which they turn out to be so).
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 7. Can’t do experiment if hazards are unpredictable (and must halt experiment in which they turn out to be so).
      • Minimum level of knowledge/control required. Below that level, human subject research cannot be ethical.
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 8. Experimental results must be published accurately. Experiments not following these principles shouldn’t be published.
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 8. Experimental results must be published accurately. Experiments not following these principles shouldn’t be published.
      • Avoiding unnecessary duplication (unnecessary additional risk)
      • Punishing researchers for ignoring ethical requirements.
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 9. Informed consent is required. Patient may opt out.
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 9. Informed consent is required. Patient may opt out.
      • Finally, informed consent and patient autonomy.
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 10. Need to ensure that the consent is freely given, not obtained under duress.
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 11. Consent from subject’s legal guardian is possible.
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 11. Consent from subject’s legal guardian is possible.
      • Important for research with children, the mentally disabled, etc.
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 12. Research protocol must address ethical considerations and must explicitly adhere to these principles.
    • Declaration of Helsinki (1989 version) (points paraphrased)
      • 12. Research protocol must address ethical considerations and must explicitly adhere to these principles.
      • Research with human subjects not a right but a privilege.
      • Ethical considerations as part of experimental design.
    • Declaration of Helsinki (1989 version) Clinical Research (points paraphrased)
      • 1. New techniques acceptable if they might save life or health, or alleviate suffering.
    • Declaration of Helsinki (1989 version) Clinical Research (points paraphrased)
      • 2. Must be a cost/benefit analysis of new method vs. existing methods.
    • Declaration of Helsinki (1989 version) Clinical Research (points paraphrased)
      • 2. Must be a cost/benefit analysis of new method vs. existing methods.
      • Unless there’s good reason to think new method will be better for the patient’s outcome than existing methods, must use existing methods.
    • Declaration of Helsinki (1989 version) Clinical Research (points paraphrased)
      • 3. All subjects (including controls) “should be assured of the best proven diagnostic and therapeutic method.”
    • Declaration of Helsinki (1989 version) Clinical Research (points paraphrased)
      • 3. All subjects (including controls) “should be assured of the best proven diagnostic and therapeutic method.”
      • Same duties to subjects as to patients who are not experimental subjects
    • Declaration of Helsinki (1989 version) Clinical Research (points paraphrased)
      • 4. Opt-out by patient shouldn’t interfere with patient – physician relationship.
    • Declaration of Helsinki (1989 version) Clinical Research (points paraphrased)
      • 4. Opt-out by patient shouldn’t interfere with patient – physician relationship.
      • Ceasing to be a subject doesn’t mean researchers can cut you out of continued medical care
    • Declaration of Helsinki (1989 version) Clinical Research (points paraphrased)
      • 5. “If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee.”
    • Declaration of Helsinki (1989 version) Clinical Research (points paraphrased)
      • 5. “If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee.”
      • Deception in research
    • Declaration of Helsinki (1989 version) Clinical Research (points paraphrased)
      • 6. Research in clinical setting needs to be justified by “potential diagnostic or therapeutic value for the patient”.
    • Declaration of Helsinki (1989 version) Clinical Research (points paraphrased)
      • 6. Research in clinical setting needs to be justified by “potential diagnostic or therapeutic value for the patient”.
      • Otherwise, duty to provide standard treatment
    • Declaration of Helsinki (1989 version) Non-therapeutic research (paraphrased)
      • 1. Duty to protect life and health of subject.
    • Declaration of Helsinki (1989 version) Non-therapeutic research (paraphrased)
      • 1. Duty to protect life and health of subject.
      • Even though research not expected to directly benefit subject, you have a duty to well-being of the subject, and there’s a line you cannot cross.
    • Declaration of Helsinki (1989 version) Non-therapeutic research (paraphrased)
      • 2. Subjects must be volunteers and healthy, or at least suited to the experimental design.
    • Declaration of Helsinki (1989 version) Non-therapeutic research (paraphrased)
      • 3. Researchers must stop experiment if continuing it would be harmful to the subject.
    • Declaration of Helsinki (1989 version) Non-therapeutic research (paraphrased)
      • 3. Researchers must stop experiment if continuing it would be harmful to the subject.
      • Even though research not expected to directly benefit subject, you have a duty to well-being of the subject, and there’s a line you cannot cross.
    • Declaration of Helsinki (1989 version) Non-therapeutic research (paraphrased)
      • 4. Well-being of subject outweighs interests of science and society.
    • Belmont Report
      • Direct response to uproar about the Public Health Service’s Tuskegee syphilis experiment
      • Focus on addressing most glaring ethical violations of that experiment
      • Shift from adding more duties to list to focusing on “spirit of the law”
    • Belmont Report Ethical principles summarized
      • 1. Respect for persons . Individuals to be treated as autonomous agents; requirement to protect those with diminished autonomy.
    • Belmont Report Ethical principles summarized
      • 1. Respect for persons . Individuals to be treated as autonomous agents; requirement to protect those with diminished autonomy.
      • Informed consent (or consent by guardian looking out for best interests of subject).
      • Ability to opt out.
    • Belmont Report Ethical principles summarized
      • 2. Beneficence . Make efforts to secure people’s well-being. Maximize possible benefits and minimize possible harms.
    • Belmont Report Ethical principles summarized
      • 2. Beneficence . Make efforts to secure people’s well-being. Maximize possible benefits and minimize possible harms.
      • Weighing of risks and benefits.
    • Belmont Report Ethical principles summarized
      • 3. Justice . Research subjects must not be asked to take on an unfair burden. New knowledge and techniques ought to be distributed fairly. People ought not to be deprived of the opportunity to participate in research.
    • Belmont Report Ethical principles summarized
      • 3. Justice . Research subjects must not be asked to take on an unfair burden. New knowledge and techniques ought to be distributed fairly. People ought not to be deprived of the opportunity to participate in research.
      • Who takes on risks? Who gets benefits? Fairness in wake of Tuskegee Experiment.