Ethics of Human Subjects Research – Flashcards
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when were Nazi medical experiments?
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1942-1945: 32 known "experiments"
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examples of Nazi medical experiments
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experimental surgery (Ravenbrook) osteology (Auschwitz) sterilization research (Auschwitz) typhus experiments (Buchenwald) poison experiments (Buchenwald) freezing experiments (Dachau)
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use of human subjects prior to nuremberg
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use of prisoners for research is a universally accepted practice -malaria studies at Stateville Penitentiary
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what was result of nuremberg trial?
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Nuremberg Code -also 7 defendants sentenced to death -9 received prison terms
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Essence of Nuremberg Code
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"The voluntary consent of the human subject is absolutely essential..."
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Why no consent prior to Nuremberg?
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Consent is a process ??Respect, Beneficience, Justice???
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Why was Nuremberg Code conceived?
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...in reference to Nazi atrocities and was written for specific purpose of preventing brutal excesses from being committed or excused in the name of science.
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opinion of Code in US
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"The code...is in our opinion not necessarily pertinent to or adequate for the conduct of medical research in the US." Dean, Harvard Medical School
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Declaration of Helsinki (1964)
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2 categories: -Non-therapeutic clinical research -clinical research combined with professional care
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non-therapeutic clinical research
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"clinical research on a human being cannot be undertaken without his free consent, after he has been fully informed."
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clinical research combined with professional care
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physicians required to obtain consent from patient-subjects only when "consistent with patient psychology"
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What is a more "dependable safeguard" than consent?
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"a truly responsible investigator"
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What was PHS Syphilis Study?
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(1932) research to study natural history of syphilis -400 black men with syphilis from rural south -"this was turning event"
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PHS syphilis study (1969)
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CDC reviewed data & concluded that study should continue -"would be of immense benefit to future patients"
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Why was PHS syphilis study so unethical?
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syphilis patients died untreated
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Ad Hoc Panel conclusion: PHS syphilis study
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-PHS study was "ethically unjustified" and should be stopped immediately & remaining subjects be given necessary medical care -neither DHEW nor any other agency in the govt had adequate policies for oversight of human subjects research
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National Research Act (1974)
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established National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research -recommend regulations to protect the rights & welfare of human subjects of research -develop principles to govern the ethical conduct of research
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National Commission decided...
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investigators should NOT have the sole responsibility for determining whether research involving human subjects fulfills ethical standards. others who are independent of the research must share in this responsibility
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belmont report (1979)
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3 basic ethical principles: -respect for persons -beneficence -justice
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"respect for persons"
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informed consent additional protections for vulnerable subjects
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"beneficence"
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maximize benefits for subject & society while minimizing risks
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What makes research ethical? (7)
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1. social value 2. scientific validity 3. fair subject selection 4. reasonable balance of risks & benefits 5. independent review 6. informed consent 7. respect for enrolled subjects
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social value
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study must ask an important question -valuable for improving health and/or for basic scientific knowledge -may be difficult to justify research if the question is trivial, or has already be answered ("me-too" studies) -ex. what's social value of new drug if old drug with a different name
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scientific validity
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*the research must be able to answer the scientific question that has been posed -"for clinical research to be ethical the methods must be valid & feasible; the research must have a clear scientific objective; be designed using accepted principles, methods & practices; have sufficient power & offer a plausible data analysis plan"
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ipso facto unethical
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scientifically unsound research on human subjects
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fair subject selection (FSS)
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-in past, risk or non-beneficial research has enrolled mostly vulnerable populations (ex. minorities, mentally incapacitated) -scientific goals of the study should main basis for deciding groups & individuals enrolled
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rules of exclusion (FSS)
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-groups or individuals shouldn't be excluded from participation with good scientific or clinical reason -exclusion disenfranchises them from benefits of knowledge gained
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who should enjoy benefits? (FSS)
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groups & individuals who bear the risks & burdens of research should be in a position to enjoy its benefits
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nonmaleficence
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risks to individuals subjects must be minimized
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beneficence
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potential benefits to individual subjects must be enhanced
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risk/benefit balance
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potential benefits to individual subjects & society outweigh the risks -"risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, & the importance of the knowledge that may reasonably be expected to result"
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example of risk/benefit balance
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phase III placebo-controlled trial of an investigational drug in patients with progressive GI tumor -drug is expected to produce significant improvement in a proportion of subjects -subjects on placebo arm can't receive "standard therapy" for the duration of the trial
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is there equipoise?
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a state of general uncertainty on the part of the investigator regarding the therapeutic merits of each arm in a trial
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is there (at least) clinical equipoise?
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there exists an honest, professional disagreement among expert clinicians about the preferred treatment a clinical trial is instituted with the aim of resolving this dispute
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independent review
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independent review minimize the potential impact of such conflicts of interests since investigators inherently have multiple interests these diverse interests can generate conflicts that may put research at risk
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informed consent
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-ensure respect for individuals' values & preferences -what constitutes respect varies from culture to culture so be aware -consent makes research ethical
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things needed for informed consent
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-information -full disclosure -reasonable person v reasonable volunteer -comprehension -voluntary choice ??what reasonable person would want to know??
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respect for subjects
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maintain confidentiality, respect privacy share new information during the trial -changes in risk/benefit profile -incidental findings monitor subjects, provide necessary care for adverse events and/or injuries inform subjects of results of the research after the trial is completed
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what is an IRB?
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IRB is a body constituted to assure compliance with 45 CFR 46 (Federal Policy for the Protection of Human Subjects) [Federal regulation]
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UNMC IRB
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responsible for reviewing all research involving human subjects -at UNMC/UNO, TNMC, Children's hospital -conducted anywhere by UNMC/UNO, TNMC, Children's
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45 CFR 46 Subpart A
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Basic Policy for Protection of Human Research Subjects -final regulations issued in 1981
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21 CFR 50
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Informed Consent
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21 CFR 56
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IRBs
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Federalwide Assurance
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agreement btwn federal govt & the institution that: -all research activities will be guided by ethical principles (ex. Belmont Report) -research will comply with Common Rule -All research will require written informed consent* -All research will be reviewed by an IRB* **any research done under organization not covered is governed by Federalwide Assurance
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IRB Responsibilities (45 CFR 46.111)
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-risks to subjects are minimized -> beneficence -risks to subjects are reasonable in relation to anticipated benefits to subjects, & the importance of the knowledge that may be expect -> beneficence -selection of subjects is equitable -> justice -informed consent obtained & documented -> respect -adequate provision for monitoring data & to protect privacy of subjects -> beneficence
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What does IRB do?
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protects: -human subjects -institution -investigator
