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23 Cards in this Set
- Front
- Back
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What does to treat equitably mean
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to treat fairly
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What does to treat equally mean
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to treat in exactly the same way
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Do all groups have to be treated equally?
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All groups may not be equally represented, but are represented fairly and justly based on the risks and potential benefits associated with the research.
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What are the three ethical principles that constitute the basis for the HHS Human Subjects Regulations
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1. Respect for persons
2. Beneficence 3. Justice |
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Define informed consent
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Define informed consent
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Nuremberg trials
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Nazi Medical War Crimes (1939–1945) The Nuremberg Military Tribunals found that the defendants had:
* Corrupted the ethics of the medical and scientific professions * Repeatedly and deliberately violated the rights of the subjects |
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Syphilis Study at Tuskegee
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The Syphilis Study at Tuskegee involved approximately 600 African-American men: about 400 with syphilis (cases) and about 200 without syphilis (controls). These men were recruited without informed consent and, in fact, were led to believe that some of the procedures done in the interest of research (e.g., spinal taps) were actually “special free treatment.”
A legally-effective, voluntary agreement that is given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study. By 1936, it was apparent that many more infected men than controls had developed complications, and 10 years later, reports indicated that the death rate among those with syphilis was about twice as high as it was among the controls. In the 1940s, penicillin was found to be effective in the treatment of syphilis. The Syphilis Study at Tuskegee continued, however, and the men were neither informed about nor treated with the antibiotic. |
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The principle of respect for persons can be broken down into
two basic ideas: |
Individuals should be treated as autonomous agents “An individual capable of deliberation about personal goals and of acting under the direction of such deliberation.”
Persons with diminished autonomy are entitled to additional protections |
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What are the 3 fundamental aspects of Informed Consent?
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Voluntariness
Comprehension Disclosure |
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Belmont principle of beneficence
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Two general rules have been articulated as complementary expressions of beneficent actions:
1. Do no harm 2. Maximize possible benefits and minimize possible harms |
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Belmont principle of respect for persons
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The principle of respect for persons can be broken down into two basic ideas:
1. Individuals should be treated as autonomous agents Red colored male shape and black colored female shape standing. An autonomous person is able to: “An individual capable of deliberation about personal goals and of acting under the direction of such deliberation.” * Consider the potential harms and benefits of a situation * Analyze how those risks and potential benefits relate to his or her personal goals and values * Take action based on that analysis Prospective research participants must be given the information they need to determine whether or not they want to participate in research. There should be no pressure to participate and ample time to decide. Respect for persons demands that participants enter into the research voluntarily and with adequate information. This is called informed consent, and will be covered in detail in other sections of this training. A legally-effective, voluntary agreement that is given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study. 2. Persons with diminished autonomy are entitled to additional protections According to the Belmont Report, “Special provisions may need to be made when an individual’s comprehension is severely limited or when a class of research participants is considered incapable of informed decision making (e.g. children, people with severe developmental disorders, or individuals suffering from dementias). Even for these persons, however, respect for persons requires giving them the opportunity to choose, to the extent they are able, whether or not they wish to participate in research activities. In some cases, respect for persons may require seeking the permission of other parties, such as a parent or legal guardian.” “Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” “The agreement of parent(s) or guardian to the participation of their child or ward in research.” |
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An autonomous person is
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The principle of respect for persons can be broken down into two basic ideas:
1. Individuals should be treated as autonomous agents Red colored male shape and black colored female shape standing. An autonomous person is able to: “An individual capable of deliberation about personal goals and of acting under the direction of such deliberation.” * Consider the potential harms and benefits of a situation * Analyze how those risks and potential benefits relate to his or her personal goals and values * Take action based on that analysis Prospective research participants must be given the information they need to determine whether or not they want to participate in research. There should be no pressure to participate and ample time to decide. Respect for persons demands that participants enter into the research voluntarily and with adequate information. This is called informed consent, and will be covered in detail in other sections of this training. A legally-effective, voluntary agreement that is given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study. 2. Persons with diminished autonomy are entitled to additional protections According to the Belmont Report, “Special provisions may need to be made when an individual’s comprehension is severely limited or when a class of research participants is considered incapable of informed decision making (e.g. children, people with severe developmental disorders, or individuals suffering from dementias). Even for these persons, however, respect for persons requires giving them the opportunity to choose, to the extent they are able, whether or not they wish to participate in research activities. In some cases, respect for persons may require seeking the permission of other parties, such as a parent or legal guardian.” “Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” “The agreement of parent(s) or guardian to the participation of their child or ward in research.” |
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Persons with diminished autonomy are entitled to additional protections
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According to the Belmont Report, “Special provisions may need to be made when an individual’s comprehension is severely limited or when a class of research participants is considered incapable of informed decision making (e.g. children, people with severe developmental disorders, or individuals suffering from dementias). Even for these persons, however, respect for persons requires giving them the opportunity to choose, to the extent they are able, whether or not they wish to participate in research activities. In some cases, respect for persons may require seeking the permission of other parties, such as a parent or legal guardian.”
“Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” “The agreement of parent(s) or guardian to the participation of their child or ward in research.” |
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Debriefing of research participants after the study involves
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an explanation of the deception or
incomplete disclosure of research goals to participants as well as a complete disclosure of the true goals of the research. |
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Justice requires
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Justice requires that individuals and groups be treated fairly and equitably in terms of bearing the burdens and receiving the benefits of research.
The principle of justice may arise in decisions about inclusion and exclusion criteria for participation in research and requires investigators to question whether groups are considered for inclusion simply because of their availability, their compromised position, or their vulnerability — rather than for reasons directly related to the problem being studied. “OHRP considers the term investigator to include anyone involved in conducting the research. OHRP does not consider the act of solely providing coded private information or specimens (for example, by a tissue repository) to constitute involvement in the conduct of the research. Note that if the individuals who provide coded information or specimens collaborate on other activities related to the conduct of this research with the investigators who receive such information or specimens, then OHRP would consider such additional activities to constitute involvement in the conduct of the research. Examples of such additional activities include, but are not limited to: (1) the study, interpretation, or analysis of the data resulting from the coded information or specimens; and (2) authorship of presentations or manuscripts related to the research.” The challenge of applying the Belmont principle of justice is how to decide which criteria should be used to ensure that harms and benefits of research are equitably distributed to individuals and populations. |
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Coercion
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Influencing an individual’s decision about whether or not to do something by using explicit or implied threats (loss of good standing in a job, poor grades, etc.)
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Diminished autonomy
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An individual with restricted capability of deliberation about personal goals and of limited ability to act under the direction of their deliberations.
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Incomplete disclosure
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Withholding some information in order to conduct an unbiased study, with the understanding that the information could be material to a decision by prospective participants about whether or not to participate in the study.
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Correlational
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Two variables, two different scores are measured for each child
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Nonexperimental
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Two different groups are compared, but the researcher does not manipulate a variable to create the groups
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Experimental
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: The researcher manipulates the amount of television violence and controls the assignment of children to groups.
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Descriptive
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The researcher is simply observing and describing aggressive behavior in two different conditions.
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When to use a within-subjects design
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Number of participants is limited
Individual Differences are large By reducing variance in Individual Differences a within-subjects design increases likelihood of finding statistical significance and prevents Individual Differences from becoming a confound |
