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CHAPTER 6

CHAPTER 6. International Research Ethics By: Jonathan B. Van Geest and Deborah S. Cummins. Ethics is the study of right behavior Ethics also seeks to delineate basic standards of conduct that are independent of: Personal opinion and feelings Social customs

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CHAPTER 6

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  1. CHAPTER 6 International Research Ethics By: Jonathan B. Van Geest and Deborah S. Cummins

  2. Ethics is the study of right behavior • Ethics also seeks to delineate basic standards of conduct that are independent of: • Personal opinion and feelings • Social customs • Political and religious ideologies

  3. Theoretical ethics • Applied ethics

  4. Research Ethics • Fair distribution of authorship credit among members of a research team • Issues of plagiarism • Ensuring the confidentiality and integrity of data collection, analyses, and report • Responsible treatment of research subjects • Balancing the needs of subjects with a researcher’s responsibility to society

  5. The Use of Human Subjects in Research • Defined as “any manipulation, test, or procedure of an experimental nature performed on a human being as part of a scientific or social science investigation

  6. Ethical considerations when human subjects are used in research are: • Justifications for the use of placebo controls • The adequacy of informed consent • Subject risk versus benefits in areas of potential harm • Selection of subjects into control and intervention groups

  7. Experiments conducted on humans during the war years in the name of science include: • High levels of electricity and radiation • Hypothermia • Decompression • Vaccination and infection • -Typhus -Tetanus • -Tuberculosis -Smallpox • -Malaria -Scarlet fever

  8. Research Ethics in Today’s Global Context • National Research Council, 2002

  9. A Closer Look: Clinical Trials in the Prevention of MTCT of HIV • Mother-to-child transmission (MTCT) • Immunodeficiency virus (HIV) • In 2005 an estimated 700,000 children under age 15 became infected with HIV • Almost 90% of these were MTCT infections in Africa

  10. Reasonable Standard of Care Debate • Normal standard of care is not well defined or is subject to interpretation • Research must ask the following questions: • What are the ethical justifications • When treatments are available what are the most appropriate comparison groups for studies • Under what circumstances is it ethical to use placebos • What are the responsibilities and/or obligations of researchers

  11. BASIC PRINCIPLES • Universal Requirements for Ethical Research • Respect for Persons • Value • Beneficence • Scientific Validity • Justice • Relevance to Local Situation • Host Community Benefit • Host Community Nonmaleficence

  12. Applications: Another Look at Clinical Trials in the Prevention of MTCT of HIV • Protecting Human Subjects Globally: A Need for Oversight and Monitoring • Professional judgment and expertise remain essential elements • There should be community involvement in all phases of the research design

  13. IRB group as the authority to do: • Approve, disapprove or terminate research activities • Require modifications • Require information be given to participants • Require documentation of voluntary informed consent

  14. IRB has the authority to do the following: • Approve, disapprove, or terminate research activities within its jurisdiction • Require modifications to the study procotols • Require that information about the study be given to participants • Require documentation of voluntary informed consent

  15. Refer to TABLE 6-2 VULNERABLE SUBJECTS

  16. Refer to TABLE 6-2 VULNERABLE SUBJECTS

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