Ethics of Human Subjects Research – Flashcards

Unlock all answers in this set

Unlock answers
question
when were Nazi medical experiments?
answer
1942-1945: 32 known "experiments"
question
examples of Nazi medical experiments
answer
experimental surgery (Ravenbrook) osteology (Auschwitz) sterilization research (Auschwitz) typhus experiments (Buchenwald) poison experiments (Buchenwald) freezing experiments (Dachau)
question
use of human subjects prior to nuremberg
answer
use of prisoners for research is a universally accepted practice -malaria studies at Stateville Penitentiary
question
what was result of nuremberg trial?
answer
Nuremberg Code -also 7 defendants sentenced to death -9 received prison terms
question
Essence of Nuremberg Code
answer
"The voluntary consent of the human subject is absolutely essential..."
question
Why no consent prior to Nuremberg?
answer
Consent is a process ??Respect, Beneficience, Justice???
question
Why was Nuremberg Code conceived?
answer
...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.
question
opinion of Code in US
answer
"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
question
Declaration of Helsinki (1964)
answer
2 categories: -Non-therapeutic clinical research -clinical research combined with professional care
question
non-therapeutic clinical research
answer
"clinical research on a human being cannot be undertaken without his free consent, after he has been fully informed."
question
clinical research combined with professional care
answer
physicians required to obtain consent from patient-subjects only when "consistent with patient psychology"
question
What is a more "dependable safeguard" than consent?
answer
"a truly responsible investigator"
question
What was PHS Syphilis Study?
answer
(1932) research to study natural history of syphilis -400 black men with syphilis from rural south -"this was turning event"
question
PHS syphilis study (1969)
answer
CDC reviewed data & concluded that study should continue -"would be of immense benefit to future patients"
question
Why was PHS syphilis study so unethical?
answer
syphilis patients died untreated
question
Ad Hoc Panel conclusion: PHS syphilis study
answer
-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
question
National Research Act (1974)
answer
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
question
National Commission decided...
answer
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
question
belmont report (1979)
answer
3 basic ethical principles: -respect for persons -beneficence -justice
question
"respect for persons"
answer
informed consent additional protections for vulnerable subjects
question
"beneficence"
answer
maximize benefits for subject & society while minimizing risks
question
What makes research ethical? (7)
answer
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
question
social value
answer
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
question
scientific validity
answer
*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"
question
ipso facto unethical
answer
scientifically unsound research on human subjects
question
fair subject selection (FSS)
answer
-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
question
rules of exclusion (FSS)
answer
-groups or individuals shouldn't be excluded from participation with good scientific or clinical reason -exclusion disenfranchises them from benefits of knowledge gained
question
who should enjoy benefits? (FSS)
answer
groups & individuals who bear the risks & burdens of research should be in a position to enjoy its benefits
question
nonmaleficence
answer
risks to individuals subjects must be minimized
question
beneficence
answer
potential benefits to individual subjects must be enhanced
question
risk/benefit balance
answer
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"
question
example of risk/benefit balance
answer
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
question
is there equipoise?
answer
a state of general uncertainty on the part of the investigator regarding the therapeutic merits of each arm in a trial
question
is there (at least) clinical equipoise?
answer
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
question
independent review
answer
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
question
informed consent
answer
-ensure respect for individuals' values & preferences -what constitutes respect varies from culture to culture so be aware -consent makes research ethical
question
things needed for informed consent
answer
-information -full disclosure -reasonable person v reasonable volunteer -comprehension -voluntary choice ??what reasonable person would want to know??
question
respect for subjects
answer
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
question
what is an IRB?
answer
IRB is a body constituted to assure compliance with 45 CFR 46 (Federal Policy for the Protection of Human Subjects) [Federal regulation]
question
UNMC IRB
answer
responsible for reviewing all research involving human subjects -at UNMC/UNO, TNMC, Children's hospital -conducted anywhere by UNMC/UNO, TNMC, Children's
question
45 CFR 46 Subpart A
answer
Basic Policy for Protection of Human Research Subjects -final regulations issued in 1981
question
21 CFR 50
answer
Informed Consent
question
21 CFR 56
answer
IRBs
question
Federalwide Assurance
answer
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
question
IRB Responsibilities (45 CFR 46.111)
answer
-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
question
What does IRB do?
answer
protects: -human subjects -institution -investigator
Get an explanation on any task
Get unstuck with the help of our AI assistant in seconds
New