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© HRP Associates, Inc. Ethics & Regulation of Human Subjects Research Jeffrey M. Cohen, Ph.D., CIP President, HRP Associates, Inc.
© HRP Associates, Inc. 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
© HRP Associates, Inc. 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
© HRP Associates, Inc. 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
© HRP Associates, Inc. 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
© HRP Associates, Inc. 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.
© HRP Associates, Inc. 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
© HRP Associates, Inc. Definitions Research - a systematic investigation designed to develop or contribute to generalizable knowledge. 46.102(d) & (f)
© HRP Associates, Inc. Definitions Human Subject - a living individual about whom an investigator conducting research obtains –data through intervention or interaction with the individual, or –identifiable private information 46.102(d) & (f)
© HRP Associates, Inc. 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
© HRP Associates, Inc. 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
© HRP Associates, Inc. Informed Consent in Cross-Cultural Context Requirements for informed consent – Communication of study goals – Comprehension of information – Voluntary participation – Risks and benefits – Culturally appropriate
© HRP Associates, Inc. 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
© HRP Associates, Inc. LanguageDifferences Problems with translation of research instruments –Language –Concepts The Use of Interpreters in Obtaining Consent –Communication of information –Relationship of translator to research participant
© HRP Associates, Inc. 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
© HRP Associates, Inc. Ethical Challenges in Cross-Cultural Research Privacy/Confidentiality Reimbursement Individual vs. Group Community Involvement Lack of Infrastructure & Experience
© HRP Associates, Inc. General Principles Respect cultural context Identify points of value conflict Educate researchers on need to respect persons, respect human rights Act with integrity
© HRP Associates, Inc. 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
Office for Protection from Research Risks (OPRR) Department of Health and Human Services National Institutes of Health OPRR Dissolved June, 2000.
Office for Human Research Protections (OHRP) Department of Health and Human Services Office of Public Health and Science Director: Greg Koski, Ph.D. M.D.
Criteria For Approval 45 CFR CFR Minimized risks Reasonable risk/benefit ratio Equitable subject selection Informed consent process Informed.
Top Ten Investigator Responsibilities When Conducting Human Subjects Research Thanks to Ada Sue Selwitz, Univ. of Kentucky and PRIM&R (Public Responsibility.
Regulation of Clinical Trials Robert Silbergleit, MD Department of Emergency Medicine NETT Clinical Coordinating Center.
Research Involving Humans! OHRP- Office For Human Subject Protections
Ethical Considerations when Developing Human Research Protocols A discipline “born in scandal and reared in protectionism” Carol Levine, 1988.
FERPA and IRB: Implications for Testing Centers Judith W. Grant, Ph.D.,CIP NCTA Conference San Antonio, Texas August 6, 2009.
DO NO HARM IRRB Presentation Purposes Responsibilities Processes NLU IRRB Home page.
University of Central Florida Office of Research & Commercialization
Daylene Meuschke, Ed.D Barry Gribbons, Ph.D RP Conference: April 2, 2013.
IRB 101: Introduction to Human Subject Research
IRB-Investigator/ Research Coordinator Mtg. “What You Can Do to Facilitate an Efficient IRB Review” January 13, 2004 George Gasparis.
8 Criteria for IRB Approval of Research 45 CFR (a)
Scientific Data Management for the Protection of Human Subjects Robert R. Downs NASA Socioeconomic Data and Applications Center (SEDAC) Center for International.
History and Ethical Principles
Ethical Principles of Human Subjects Protection
Human Subject Research Ethics
IRB Discussion Consent and Assent Issues in Vulnerable Populations December
1 Wheaton College INSTITUTIONAL REVIEW BOARD (IRB)
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