GU Research Module 2

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GU Research Module 2
2015-09-22 17:25:40
GU Research
GU Research
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  1. _______ provided a model for many disciplinary guidelines.
    Belmont Report
  2. Three major ethical principles from the Belmont Report.
    • Beneficence
    • Respect for Human Dignity
    • Justice
  3. ______ involves the performance of some good and the protection of participants from physical and psychological harm and exploitation (nonmalificence).
  4. _____________ involves participants' right to self-determination, which means they have the freedome to control their own actions, including voluntary participation.
    Respect for Human Dignity
  5. _________ means that researchers have fully divulged participants' rights and the risks and benefits of the study.
    Full disclosure
  6. When participants' rights and study demands are in direct conflict, this is called?
    ethical dilemma
  7. ________ imposes a duty on researchers to minimize harm and maximize benefits.
  8. This means that prospective participants can voluntarily decide whether to take part in a study, without risk of prejudicial treatment.
  9. A person's right to self-determination includes freedom from _______.
  10. ______ involves threats of penalty from failing to participate in a study or excessive rewards from agreeing to participate.
  11. What is a stipend?
    a monetary incentive offered to encourage participation among an economically disadvantaged group
  12. The collection of data without participants' knowledge and consent.
    covert data collection
  13. Deliberately withholding information about the study or providing participants with false information.
  14. What is a risk-benefit assessment?
    examines whether the benefits of participating in a study are in line with the costs
  15. Minimal risk is no greater than those ordinarily encountered in ____ _____  or during routine ____ or ______.
    • daily life
    • tests
    • procedures
  16. Informed consent means that participants have adequate information about _____, __________, and have ability to consent or decline ________?
    • the research
    • comprehend the information
    • voluntarily
  17. What must be done if a short form is used?
    the oral presentation must be witnessed by a third party, and witness's signature must appear on the short consent form
  18. The U.S. formal committee for reviewing proposed research plans.
    Institutional Review Board
  19. The Canadian formal committee for reviewing proposed research plans.
    Research Ethics Board
  20. Who carries out the expedited review?
    a single IRB member (usually the chairperson)
  21. For researchers evaluating interentions in clinical trials, NIH also requires review by?
    a data and safety monitoring board (DSMB)
  22. Which of the three major ethical principles from the Belmont Report means that researchers have fully dibuled participants' rights and the risks and benefits of the study?
    Full disclosure
  23. Which of the three major ethical principles from the Belmont Report involves the right to self-determination?
    Respect for human dignity
  24. _______ means the participants have the freedome to control their own actions.
  25. What do researchers sometimes use when full discosure could yield biased results?
    covert data collection or concealment or deception
  26. This includes either withholdig info from participants or providing false info.
  27. Of the three major ethical principles from the Belmont Report, JUSTICE includes what two things?
    • the right to fair treatment
    • the right to privacy
  28. What protects researchers against the forced disclosure of confidential information through a court order or other legal or admin process?
    Certificate of Confidentiality
  29. What three groups of people may be considered vulnerable?
    • children
    • prisoners
    • pregnant women
  30. When can an expedited review be done?
    When risks to participants are minimal
  31. Forms of research misconduct
    • plagiarism
    • fabrication of results
    • falsification of data
  32. What type of consent is used in qualitative studies to continually negotiate?
    process consent
  33. What three things must be included in an authorization for a hospital to disclose individually identifiable health info?
    • what type of info will be disclosed
    • who will receive the info
    • what further disclosures the researcher anticipates
  34. Privacy Boards are used to review researchrs' compliance with what?
    HIPAA, including review of authorization forms & requests for waivers
  35. For researchers evaluating interventions in clinical trials, NIH also requires review by who?
    Data and Safety Monitoring Board
  36. The US agency responsible for overseeing efforts to improve research integrity and for handling allegations of research misconduct.
    Office of Research Integrity w/in DHHS
  37. Making up data or study results
  38. Manipulating research materials, equipment, or processes.
  39. Changing or omitting data.
  40. Distorting results such that the research is not accurately represented in reports.
  41. To be construed as misconduct, there must be a _______ from _______.
    • significant departure
    • accepted practices
  42. To be construed as misconduct, it must have been committed _______.
    intentionally, knowingly, or recklessly