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which of these are real?
1 Thousands of prisoners were forced to participate in painful medical experiments, most of whom were killed or seriously injured.
2 Black men with syphilis were left untreated, even when a treatment was available. Hundreds of men died or were left with permanent disability.
3 Mentally disabled children were coerced into being in a study and infected with Hepatitis.
all three
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code of ethics include
- Nuremberg code
- declaration of Helsinki
- Belmont report and subsequent governmen
- imposed codes
- codes for professional disciplines
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Nuremberg Code
an international set of ethical standards - developed in 1949 in response to the Nazi atrocities
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deceleration of Helsinki
was adopted in 1964 by the world medical association - recently revised in 08
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what is the American Nurses Association
ANA - set ethical guidelines developed by nurses
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belmont report
provided a model for many guidelines adopted by disciplinary organizations in the United States. also served as a basis for regulations affecting research sponsered by the U.S. government including the NINR
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ethical dilemma
in research: a situation in which the rights of study participants are in direct conflict with requirements for a rigorous study
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ethical principles include?
- beneficence
- the right to freedom from harm and discomfort the right to protection from exploitation
- respect for human dignity
- right to self-determination
- right to full disclosure
- justice
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beneficence
- an ethical principle: the duty to minimize harm and maximize benefits
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Ethical principle: Right to protection from harm and discomfort
- researchers have an obligation to prevent or minimize harm in studies with humans
- - participants must not b subjected to unnecessary risks of harm or discomfort
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Ethical Principle: Right to protection from exploitation
should not place participants at a disadvantage. should be assured that their participation or any information gathered will not be used against them in any way
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Ethical Principle: Principle of respect for human dignity - name the sub categories
includes the right to self-determination and the right to full disclosure
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right to self-determination
absence of coercion - have the right to participate or not participant[ate in a study without any consequences
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right to full disclosure
absence of deception or concealment - the researcher has fully described the study, , the person's right to refuse participation, and possible risks and benefits
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the ethical principle JUSTICE includes?
- right to fair treatment
- right to privacy
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right to fair treatment
- should be based on research requirements and not on people's vulnerabilities
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right to privacy
- researchers should ensure tha their research is not more intrusive than it needs to be and that privacy is maintained
- - data should be kept in strict confidence
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risk benefit assessment
is designed to evaluate whether the benefits of participating in a study are in line with the costs, be they financial, physical, emotional, or social
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informed consent
means that participants have adequate information about the study comprehend the information, and have the power of free choice
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confidentiality procedures
study participants have the right to expect any data they provide will be in strict confidence
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anonymity
is the most secure means of protecting confidentiality - no identifying information of the participant
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confidentiality in the absence of anonymity
a promise of confidentiality is a pledge that any information participants provide will not be publicly reported in manners that identifies them and will not be made accessible to others
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what is a CERTIFICATE OF CONFIDENTIALITY
- somethinf reaserchers in the U.S. can apply for from the NIH
- - it allows researchers to refuse to disclose information on study participants in any civil, criminal, administrative, or legislative proceeding
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potential benefits for study participants
- Access to a potentially helpful intervention that might otherwise be unavailable
- Comfort in ability to discuss situation with a friendly, objective person
- Increased self-knowledge (via introspection or direct interaction with researchers)
- Escape from normal routine- Satisfaction that information could help others with similar problems or conditions
- Direct monetary or material gains through stipends or other incentives
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Potential Risks for Study Participants
- Physical harm, discomfort, fatigue, or boredom
- Psychological distress resulting from self-disclosure, introspection, fear of the unknown, discomfort with strangers, anger or embarrassment at the type of questions being asked
- Social risks, such as the risk of stigma, adverse effects on personal relationships, loss of status- Loss of privacy- Loss of time- Monetary costs (e.g., for transportation, time lost from work)
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implied consent
self-administered questionnaires
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process consent
renegotiated over time, qualitative studies
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vulnerable subjects
participants who require special protections
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external review
ethical aspects of a study are increasingly likely to be reviewed before permission is granted to conduct a study
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research misconduct includes?
- plagiarism
- fabrication of results
- falsification of data
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procedure for protecting study participants
- risk-benefit assessments
- informed consent
- confidentially procedures- debriefing and referrals
- special treatment of vulnerable groups
- institutional review boards and external reviews
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