Lecture 4 Flashcards
Informed consent for research participants - nuremberg code
Nuremberg code 1947 - judicial summary of the war trials of 23 Nazi physicians. The first internationally recognized code of research ethics. Requirements for consent as a protection first appeared. Prototype for subsequent codes of ethics - participant should enter into research knowingly, intelligently, and willingly.
Tuskegee syphilis study
1932-1972: 35% syphilis rate in this population during the study. Studied natural history of untreated syphilis without informed consent. 400 poor, AA males, uninformed of diagnosis and not given treatment that had been discovered in 1947. CDC decided to continue the study in 1969. Abuses not revealed until 1972 - 100 plus died. They supposedly got free health care and food.
Guatemala syphilis study
1940s. US government funded, 700 male and female prisoners exposed to or injected with syphilis. Prostitutes and injections, then received penicillin. Guatemala got lots of medical supplies in exchange.
Radioactive research
1940s. New Mexico deception research. Involved injecting plutonium in human subjects who were indigent as well as in mentally retarded children. Only revealed in 1993. Some will say it was revolutionary in cancer treatment and job safety considerations.
Later acts
National research act (1974). National Commission for the protections of human subjects of biomedical and behavioral research (1974). Belmont report in 1978 - prompted the establishment of IRBs at the local level. Required IRB review and approval of all federally funded research involving human participants. IRBs have to meet certain standards in order to remain credible as IRBs.
Informed consent
Voluntarily - coercion (8.04, 8.06), right to withdraw. Knowingly - comprehension capacity - depends on the research, there are assessments that can help you determine if someone can’t consent - have to see if they can comprehend. Intelligently - understanding - evaluation of the information including risks and benefits (as the research relates to their particular situation, including risk and benefit).
Dispensing with informed consent
8.05. Federal regulations 45, 46.116 (c-d): government approved research on public programs. Minimal risk research.
Deception
Deceptive techniques intentionally withhold information or misinform participants about the purpose of the study, the experimental procedures or equipment, or the roles of research team members. Herein, informed consent creates a moral paradox because it compromises a person’s ability to make a fully informed decision. Nuremberg Code codified the international community’s distrust in scientists’ motivation to make decisions that would best serve interests of subjects. Participants in deception have no decisional control over potential discomforts that may occur during or at the end when debriefed.
Deception standard
8.07 - only conduct study with deception if use of deceptive techniques is justified by study’s significant prospective, scientific, educational, or applied value and effective non-deceptive procedures are not available. b) do not deceive prospective participants about research that is reasonably expected to cause physical pain or severe emotional distress (doing no harm). c) explain any deception that is an integral feature of the design as early as feasible, preferably at the conclusion of their participation, but no later than at the conclusion of the data collection and permit participants to withdraw their data (dignity/respect/autonomy). This is a conflict between advancement of research and integrity in research. Utilitarianism principle is the fall back, knowledge we gain must outweigh risk.
Cost/benefit analysis with deception
Validity and scientific value, efficacy of alternative procedures, possibility of experimentally induced harm, ability to remove the harm done, compatibility of the deception with participants’ moral values.
NIH human participant protections education for research teams
Again it just exists
Who is considered vulnerable or limited
No specific standard in code that addresses this, but common rule does, and common rule in FDA is what instructs IRB. Common rule and FDA regulations - children, individuals with serious mental/emotional/physical disorders. Prisoners. Pregnant women. Economically or educationally disadvantaged.
Stanford Prison Experiment
Milgram 1963 study and then Stanford Prison 1971. Funded by US gov. Undergrads had realistic arrest staging, went on for 6 days in prison, Zimbardo told no physical attacks, make them feel imprisoned though. Prisoners rebelled, guards got verbally abusive, conditions deteriorated. Zimbardo’s girlfriend told him to stop (a grad student). Conclusions that situational factors go into abuse more than character traits do.
Lawd Humphrey
Tearoom sex study, mid 1960s. Sociologist at Wash U. 1950 - interstate system started. Police trying to catch people having sex at rest stops. Was assigned to watch for police, Humphreys did that for men in restroom. Asked them questions after, those who refused, he wrote down license tag then went to their doors and asked Qs “for a healthy survey.” Most of the men were happily married, only 20% identified as gay. Broke down stereotypes in the restrooms, no one reported they were coerced. So police stopped arresting people. Wash U was outraged though.
Children
3.10 b (informed consent with legally incapable people). Federal regulation 45 CFR and 46.408 b. Require guardian permission, require assent, and passive consent procedures are not adequate.
