3215: ethics

  1. 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
  2. code of ethics include
    • Nuremberg code
    • declaration of Helsinki
    • Belmont report and subsequent governmen
    • imposed codes
    • codes for professional disciplines
  3. Nuremberg Code
    an international set of ethical standards - developed in 1949 in response to the Nazi atrocities
  4. deceleration of Helsinki
    was adopted in 1964 by the world medical association - recently revised in 08
  5. what is the American Nurses Association
    ANA - set ethical guidelines developed by nurses
  6. 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
  7. ethical dilemma
    in research: a situation in which the rights of study participants are in direct conflict with requirements for a rigorous study
  8. 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
  9. beneficence
    - an ethical principle: the duty to minimize harm and maximize benefits
  10. 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
  11. 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
  12. Ethical Principle: Principle of respect for human dignity - name the sub categories
    includes the right to self-determination and the right to full disclosure
  13. right to self-determination
    absence of coercion - have the right to participate or not participant[ate in a study without any consequences
  14. 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
  15. the ethical principle JUSTICE includes?
    • right to fair treatment
    • right to privacy
  16. right to fair treatment
    - should be based on research requirements and not on people's vulnerabilities
  17. 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
  18. 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
  19. informed consent
    means that participants have adequate information about the study comprehend the information, and have the power of free choice
  20. confidentiality procedures
    study participants have the right to expect any data they provide will be in strict confidence
  21. anonymity
    is the most secure means of protecting confidentiality - no identifying information of the participant
  22. 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
    • 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
  24. 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
  25. 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)
  26. implied consent
    self-administered questionnaires
  27. process consent
    renegotiated over time, qualitative studies
  28. vulnerable subjects
    participants who require special protections
  29. external review
    ethical aspects of a study are increasingly likely to be reviewed before permission is granted to conduct a study
  30. research misconduct includes?
    • plagiarism
    • fabrication of results
    • falsification of data
  31. 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
Card Set
3215: ethics