Week 3 – Flashcard
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identify the most influential event that led to the HHS Policy for Protection of Human Research Subjects A. Nuremberg trials B. syphilis study at tuskegee c. jewish chronic disease hospital study d. willowbrook study
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b
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drafted as a set of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp prisoners. This code became the prototype of many later codes (1) intended to assure that research involving human subjects would be carried out in an ethical manner.
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nuremburg code
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23 Nazi Doctors and Scientists on Trial after World War II
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nuremberg trials
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mentally retarded children in Staten Island, New York were intentionally given Hepatitis in an attempt to trck the development of the viral infection. began in 1956 and lasted 14 years
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willowbrook study
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what are the 3 ethical principles that constitute the basis for the HHS Human Subjects Regulations (45 CFR 46) a. honesty, trust, respect b. informed consent, IRB review, research integrity c. respect for persons, beneficence, justice d. protections for pregnant women, children, children
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c
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which entity has regulatory authority for the protection of human subjects for PHS-funded research? a. OHRP b. NIH c. institutes that receive federal funds d. HHS
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a
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office for human research protections
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OHRP
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us public health service
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PHS
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national institute of health
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NIH
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US department of health and human services
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HHS
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T/F all research that involves interaction or intervention with humans or human samples/data, whether they are alive or dead, is human subjects research
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f
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T/F an institutionally designated authority, other than the investigator, should determine that proposed studies are exempt from regulatory requirements
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t
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which of the following should be eliminated or minimized in the research design? a. coercion b. research risks c. repeated recruitment of research participants for new protocols d. all of the above
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d
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when might human subjects research require investigators to obtain informed consent a. investigators must obtain informed consent if the study involves interaction with research participants b. investigators must obtain informed consent if the study involves interventions with research participants c. investigators must obtain informed consent if the study involves collection of private information from or about research participants d. all of the above
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d
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T/F after informed consent for a research study is given, a research participant must complete the study
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f
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T/F in general, informed consent should be a process rather than a one-time event
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t
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in order to participate in research, children must a. provide written informed consent b. provide written permission c. prove assent, unless the IRB determines they are too young d. sign, or put an X on the assent document
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c
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expression of approval or agreement, typically officially
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assent
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for research involving pregnant women, participation requires... a. that women have completed the first trimester b. that the study be conducted first in men c. permission of the father d. consideration of risks and potential benefits for the fetus and the pregnant woman
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d
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why might an individual have diminished autonomy? a. they are neonate b. they are incarcerated or involuntarily confined c. they are unconscious d. all the above
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d
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T/F risks to research participants must be completely eliminated for the study to be considered ethical
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f
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when are researchers specifically required by NIH policy to describe Data and Safety Monitoring? a. for all research involving human subjects b. for all research involving children such as subjects in research c. for all clinical trials d. for all research with prisoners
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c
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T/F there must be equipoise in order to justify conducting a clinical trial
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t
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what is an appropriate method for maintaining confidentiality of private information obtained from human subjects? a. keeping data in password-protected databases b. coding data or specimens and keeping the key to the code in a separate, locked drawer d. all of the above are ways to maintain confidentiality
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d
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T/F if a researcher determines that his/her study poses no more than minimal risks as defined in 45 CFR 46, there is no need for the protocol to have IRB review and approval
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f
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children must be included in all NIH-supported human subjects research unless: a. the researcher is not a pediatrician b. past experience has shown it is time consuming and expensive to recruit children c. there are scientific and ethical reasons to exclude them d. the researcher does not possess the pediatric equipment necessary to involve children in the proposed research
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c
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T/F for HIV antiretroviral treatment trials conducted in developing countries, the NIH expects investigators/contractors to address the provision of antiretroviral treatment to trial participants after their completion of participation in the clinical trial
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t
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which of the following is true regarding applications for NIH-funded research overseas? a. it is illegal to spend NIH funds in research overseas b. research conducted overseas is subject to HHS Human Subjects Regulations (45 CFR 46) and local regulations and policies c. research conducted overseas is only subject to local regulations and policies d. research conducted overseas need not address human subjects protections
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b
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in localities where community consent is the norm a. a family member's consent for another individual may be sufficient, as long as community consent is given b. federal regulations preclude the conduct of PHS-funded research c. community consent to participate in the research study is sufficient and no IRB approval is required d. in addition to the cultural norm, individuals informed consent is required
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d
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in 19th and 20th centuries, medical research participants were often
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poor ward patients
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benefits of improved medical care flowed mainly to ____ in 19th and 20th centuries
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private patients
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T/F in 19th and 20th century medical and social science research often involved risks to participants without their knowledge of the risks
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t
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"it is not cruel to inflict on a few sufferings which may benefit multitudes of innocent people through all centuries"
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1st century physician Celsus
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an experiment focusing on the conflict between obedience to authority and personal conscience
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milgram's obedience study
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experiment to answer the question "Could it be that Eichmann and his million accomplices in the Holocaust were just following orders? Could we call them all accomplices?"
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milgram's obedience study
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participant was paired with another person and they drew lots to find out who would be the learner and who would be the teacher. fixed so participant was always teacher. the learner went into a room and had electrodes attached to his arms and the teacher and researcher went into a room next door where teacher was told to shock if learner gave wrong answer.
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milgram's obedience study
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____ % of participants in milgram's study continued to the highest level. all continued to 300 volts
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65%
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concluded ordinary people are likely to follow orders given by an authority figure, even to the extent of killing an innocent human being. obedience to authority is ingrained in us all from the way we are brought up
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milgram's obedience study
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people direct their own actions, and they take responsibility for the results of those actions
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autonomous state
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people allow others to direct their actions, and then pass off the responsibility for the consequences to the person giving the orders. act as agents for another person's will
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agentic state
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millgram's two states of behavior when they are in a social situation
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autonomous and agentic state
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set of ethical principles underlying acceptable research involving human subjects prepared by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research submitted September 30, 1978
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Belmont Report
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3 ethical and moral principles of belmont report
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respect for persons beneficence justice
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recognition of the personal dignity and autonomy of individuals special protection of anyone with diminished autonomy
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respect for persons
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a/an ________ person can deliberate about personal goals and act under the direction of such deliberation
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autonomous
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obligation to protect persons from harm and to secure their well being maximizing anticipated benefits from participation in the research minimizing possible risks of harm
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beneficence
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benefits and burdens of research should be distributed fairly
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justice
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research participants shouldn't be systematically selected because of their easy availability, compromised position, or manipulability
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justice
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therapeutic research should not unduly involve persons from groups unlikely to be the beneficiaries of applying the research
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justice
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research participants, to the degree that they are capable, choose what shall or shall not happen to them
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informed consent
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components of informed consent
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information comprehension voluntariness
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to apply respect for persons one uses
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informed consent
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to apply beneficence
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a risks/benefits assessment of possible harms and anticipated benefits
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to apply justice
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fair procedures and outcomes don't select research subjects because they are favored/held in disdain avoid selection bias that arises from social, racial, sexual, and cultural biases institutionalized in society" don't select subjects because they are readily available or manipulable
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study of untreated syphilis in black males from 1932-1972 in which U.S. Public Health Service purposefully withheld known effective treatments from black men suffering from syphilis from 1930s to 1960s
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tuskegee syphilis study
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longest nontherapeutic study on human beings in medical history contributed to distrust and suspicion about public health programs and medical research
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tuskegee syphilis study
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highly contagious -- acquired, usually from sex, or congential, three stages -- primary, secondary, tertiary (or late)
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syphilis
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transmitted to the fetus from the infected mother
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congential
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___ syphilis inflicts the greatest damage (e.g. damage to cardiovascular and central nervous systems)
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late
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___, a former veneral disease interviewer and investigator for PHS told the story of tuskegee syphilis study to a reporter for the AP and on July 25th, 1972 The Washington Star ran a fron-page story about the experiment
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Peter Buxton
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contributed to AIDS conspiracy theories hampered HIV/AIDS education in black communities became a metaphor for racism, ethical mistakes, and the danger of state-run medical research
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tuskegee syphilis study
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proposed study for pregnant women infected with HIV in Africa to be given a drug to stop mother-to-infant transmission of HIV or a placebo
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AZT study
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___ % of adults receiving care for HIV participated in medical trial or study
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14
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T/F minority groups were underrepresented in medical trials of treatment of HIV infection
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t
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T/F there are differences among racial/ethnic groups in major cancer and heart disease trials
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f
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T/F drug companies could in past suppress data showing their drugs to be useless after first obtaining approval to market the drug
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t
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___ concealed negative info about Paxil, a drug used to treat depression in adolescents and children
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GSK
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T/F two studies found Paxil was no more effective than a placebo in treating adolescent depression and might even provoke suicidal thoughts
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t
