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Ethics in Practice: Guidelines and Regulations

Ethics in Practice: Guidelines and Regulations. Nuremberg Code. One of the first guidelines for the ethical conduction of medical research involving human subjects 1947 – A direct response to the experiments conducted by the Nazi doctors Identified key components of ethical research design:

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Ethics in Practice: Guidelines and Regulations

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  1. Ethics in Practice:Guidelines and Regulations

  2. Nuremberg Code • One of the first guidelines for the ethical conduction of medical research involving human subjects • 1947 – A direct response to the experiments conducted by the Nazi doctors • Identified key components of ethical research design: • Informed consent, benefice, absence of deceit, qualification of researchers, participant autonomy

  3. Declaration of Helsinki • World Medical Association • Originally published 1964, Last rev. 2008 • Expands on many of the ideas presented in the Nuremburg Code. • Explains: • Informed consent, risk/benefit, IRB, putting the subject/patient first, publication of results, confidentiality, etc.

  4. Belmont Report • Department of Health, Education, and Welfare - 1979 • Partially in response to the Tuskegee Syphilis Experiment • “Ethical Principles and Guidelines for the Protection of Human Subjects of Research” • Defines: • Practice vs. Research • Respect for Persons • Beneficence and Justice • How to apply the guidelines

  5. Title 45 – Section 46 • Protection of Human Subjects • Defines the construct and purpose of an IRB • Gives detailed regulations for research involving special populations: • Pregnant women and fetuses • Prisoners • Children

  6. Title 45 – Section 46 • IRB: • 5 members, diverse in characteristics and credentials • One member from scientific community • One member from non-scientific community • One member not affiliated with the institution (or related to a member of the institution) • Members may not be involved if there is a conflict of interest • Experts in a particular area of study, may consult without voting ability • Let’s look at UB’s IRB.... http://www.ubalt.edu/template.cfm?page=3048

  7. IRB Process • All researchers must follow their institution’s IRB process (which should incorporate Title 45- section 46 procedures) • Application with explanation of research to be conducted, usually includes: • Researcher information • Informed consent document • Instruments/Scales to be used • Research procedures • Evaluation of risk/benefit • Debriefing documentation/methods • Funding sources (if applicable) • The application process must be completed at every institution involved in the research.

  8. Special Populations • Pregnant women • Fetuses • Prisoners • Children • Individuals with mental health issues

  9. Ethical Principles of Psychologists and Code of Conduct • APA Members a supposed to uphold the code, acceptance of membership means one accepts the code • Psychologists are responsible for understanding the code • Not all inclusive

  10. APA Code of Conduct • General Principles • Beneficence and Nonmaleficence • Fidelity and Responsibility • Integrity • Justice • Respect for Rights and Dignity

  11. APA Code of Conduct • Section 1: Resolving Ethical Issues • Section 2: Competence • Section 3: Human Relations • Section 4: Privacy and Confidentiality • Section 5: Advertising and Public Statements • Section 6: Record Keeping and Fees • Section 7: Education and Training • Section 8: Research and Publication • Section 9: Assessment • Section 10: Therapy

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