SSU NURS 300 - HISTORY OF INFORMED CONSENT (54 pages)

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HISTORY OF INFORMED CONSENT



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HISTORY OF INFORMED CONSENT

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Pages:
54
School:
Sonoma State University
Course:
Nurs 300 - Intro To Evidence-based Pract

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HISTORY OF INFORMED CONSENT Human subjects research has a checkered past Nazi experiments 1935 1945 Extensive willfully harmful experimentation Nuremberg war trials for participants USA government testing in World War II to develop vaccines malaria drugs long acting penicillin on non consenting orphaned children retarded and mentally ill persons prisoners and conscientious objectors EXPOSE IN NEW ENGLAND JOURNAL OF MEDICINE 1966 Jewish Home for the Aged residents injected with live cancer cells Willowbrook children s home residents given hepatitis virus Tuskagee syphilis study 1972 African American men with untreated syphilis Tea room trade 1967 Observation of sexual activity CODES IN RESPONSE TO ETHICAL VIOLATIONS Nuremberg code 1949 Geneva convention Belmont report 1979 NIH Title 45 1981 1991 International ethical guidelines from the Council for International Organizations of Medical Sciences in Collaboration with the World Health Organization 1993 Helsinki code 1964 1997 2001 INFORMED CONSENT Ranges from nod of head Spoken to written From general to specific To ultra specific Treatment treated more lightly than research but equally important REQUIREMENTS Patient must receive explanation of risks consequences benefits and alternatives Must be written and spoken in a language that the patient understands Patient must give consent without coercion or persuasion Be competent have legal right to competence Should not have received narcotics x amount time prior Advance directive or will may not be witnessed by anyone having financial interests Witnesses need to be 18 years of age For treatment issues it is also appropriate to discuss when the decision will be revisited BASIC ELEMENTS OF RESEARCH CONSENT Study involves research purpose Procedure risks and benefits to subject and others Appropriate alternatives Confidentiality of records discs tapes papers Compensation and medical treatment Whom to contact Voluntary Refusal no loss of benefits Expected duration Withdraw



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