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Ethics & Regulation of Human Subjects Research

Ethics & Regulation of Human Subjects Research. Jeffrey M. Cohen, Ph.D., CIP President, HRP Associates, Inc. The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research

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Ethics & Regulation of Human Subjects Research

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  1. Ethics & Regulation of Human Subjects Research Jeffrey M. Cohen, Ph.D., CIP President, HRP Associates, Inc.

  2. The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research April 18, 1979

  3. The Belmont Report Three Basic Ethical Principles: • Respect for Persons • Individual autonomy • Protection of individuals with reduced autonomy • Beneficence • Maximize benefits and minimize harms • Justice • Equitable distribution of research costs and benefits

  4. Public Trust • The conduct of research is a privilege granted by society, not an inalienable right • The granting of the privilege is based on the public’s trust that research will be conducted responsibly • Erosion of that trust can result in the public’s withdrawal of the privilege • Public trust is maintained through accountability • Documentation

  5. Federal Regulations and Policy • 45 CFR 46 - Basic DHHS Policy for Protection of Human Research Subjects Originally adopted May, 1974, Revised January 13, 1981, Revised June 18, 1991 • Additional protections for vulnerable populations in Subparts B-D

  6. Federal Regulations and Policy • Federal Policy for the Protection of Human Subjects - “The Common Rule” June 18, 1991 • Departments of Agriculture, Energy, Commerce, HUD, Justice, Defense, Education, Veterans Affairs, Transportation, and HHS. NSF, NASA, EPA, AID, Social Security Administration, CIA, and the Consumer Product Safety Commission.

  7. Federal Regulations and Policy Additional Protections Included in 45 CFR 46: • Subpart B - Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research (revised December 13, 2001) • Subpart C - Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects • Subpart D - Additional DHHS Protections for Children Involved as Subjects in Research

  8. Definitions 46.102(d) & (f) • Research - a systematic investigation designed to develop or contribute to generalizable knowledge.

  9. Definitions 46.102(d) & (f) • Human Subject - a living individual about whom an investigator conducting research obtains • data through intervention or interaction with the individual, or • identifiable private information

  10. Ethical Challenges in Cross-Cultural Research • Conflicting values and beliefs regarding appropriate conduct • Potential for coercion of vulnerable populations • Political/scientific agendas to achieve results

  11. Challenges for IRBs • Inexperience of IRB members with cross-cultural studies • Unavailability of experienced reviewers for cross-cultural studies • Difficulties meeting U. S. criteria for ethical approval of studies

  12. Informed Consent in Cross-Cultural Context • Requirements for informed consent • Communication of study goals • Comprehension of information • Voluntary participation • Risks and benefits • Culturally appropriate

  13. Authority to Provide Consent • Western Assumptions • Centered on individual person and rights • Emphasis on personal control, individual agency • Non-Western Assumptions • Emphasis on person as a member of family and community • Emphasis on social agency

  14. Language Differences • Problems with translation of research instruments • Language • Concepts • The Use of Interpreters in Obtaining Consent • Communication of information • Relationship of translator to research participant

  15. Socioeconomic Influences on Informed Consent • Status differences between researcher and participant • age, gender, education, income, religion, ethnicity • Implications for Expressions of Power • vulnerability of subjects • potential for coercion • importance of trust and integrity

  16. Ethical Challenges in Cross-Cultural Research • Privacy/Confidentiality • Reimbursement • Individual vs. Group • Community Involvement • Lack of Infrastructure & Experience

  17. General Principles • Respect cultural context • Identify points of value conflict • Educate researchers on need to respect persons, respect human rights • Act with integrity

  18. Summary • There are ethical principles underlying research involving human participants • The Federal regulations are designed to: • assure that research is conducted according to the ethical principle • preserve the public trust • There are special concerns with cross-cultural research

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