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Lecture Conducting and reading research in health and human performance (4/e): Chapter 5 - Ted A. Baumgartner, Larry D. Hensley

Chapter 5 - Ethical concerns in research. This chapter includes contents: Historical perspective on ethics, ethical standards for the protection of research participants, basic principles of belmont report, informed consent, protecting vulnerable subjects,. | Chapter 5 Ethical Concerns in Research Historical Perspective on Ethics Nazi Experimentation in WWII “medical experiments” Nuremberg War Crime Trials Nuremberg Code – basic principles to govern research involving human subjects Tuskegee Syphilis Study PHS project related to untreated syphilis Highlights deception and informed consent Human radiation experiments Ethical Standards for the Protection of Research Participants Nuremberg Code (1947) – first set of guidelines Helsinki Declaration (1964) – medical research Belmont Report (1979) – fundamental document for current federal regulations in US Common Rule (1991) – 45 C.F.R. 46 Federal rules that govern research involving human participants in the US Institutional Review Boards (IRB) Basic Principles of Belmont Report Respect for persons Proclaims individuals capable of self-determination; thus voluntary consent is essential Beneficence Obligates researchers to maximize potential benefits and minimize possible harm Justice Requires the benefits and burdens of research be fairly distributed Informed Consent Arguably the most important ethical standard Refers to telling research participants about all aspects of the research that might reasonably influence their decision to participate Four important elements Subjects are fully aware of nature and purpose of research project Consent is voluntarily given Person has legal capacity to give consent Responsibility for obtaining consent rests with researcher Protecting Vulnerable Subjects Particular precautions must be taken to protect the welfare of subjects that might be considered especially vulnerable or at risk for some reason The following types of subjects might be considered to be vulnerable: children, handicapped, cardiac rehab patients, welfare recipients, prisoners, pregnant women, patients in a mental hospital, etc. Privacy & Confidentiality Privacy – refers to the capacity of individuals to control when and under what conditions others have access to their . | Chapter 5 Ethical Concerns in Research Historical Perspective on Ethics Nazi Experimentation in WWII “medical experiments” Nuremberg War Crime Trials Nuremberg Code – basic principles to govern research involving human subjects Tuskegee Syphilis Study PHS project related to untreated syphilis Highlights deception and informed consent Human radiation experiments Ethical Standards for the Protection of Research Participants Nuremberg Code (1947) – first set of guidelines Helsinki Declaration (1964) – medical research Belmont Report (1979) – fundamental document for current federal regulations in US Common Rule (1991) – 45 C.F.R. 46 Federal rules that govern research involving human participants in the US Institutional Review Boards (IRB) Basic Principles of Belmont Report Respect for persons Proclaims individuals capable of self-determination; thus voluntary consent is essential Beneficence Obligates researchers to maximize potential benefits and minimize possible harm Justice Requires