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Ethics in Practice: Guidelines and Regulations

Explore the evolution of ethical standards in medical research from Nuremberg Code to APA guidelines, featuring key principles and regulations. Learn about informed consent, beneficence, justice, and more.

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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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