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Clinical Trail

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Sara McDermand

on 7 December 2010

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Transcript of Clinical Trail

The Effects of Early
Clinical Trails on Today's
Ethical Regulations Sara McDermand
AN 380
4-26-10 Decision to be in the study
Choice to leave/disclose information
Obtain Copy of Records
Ask Questions
Legal Rights QUESTIONS When did a patient’s ethical rights become recognized?
How have studies around the globe effected how ethics are regulated today?
What is being said about the cultural philosophy in research involving human subjects and their rights? HISTORY 1906-Pure Food and Drug Act
1948-Nuremberg Code
1962-Kefauver Amendments in the Food, Drug and Cosmetic Act
1964-Decleration of Helsinki
1974-National Research Act
1979-Belmont Report
1981-Regulations issued
1991-Core Department of Health and Human Services Regulations Registration and Qualifications
Consent Form Procedure and Study Details
Rights in the Study EXPERIENCE Nazi Germany "Euthanasia" Program
conducted pseudoscientific medical experiments on prisoners Trials 23 leading German physicians and administrators German doctors had argued that their experiments
differed little from previous American or German ones No international law or informal statement differentiated
between legal and illegal human experimentation The Nuremberg Code This worried Dr. Andrew Ivy and Leo Alexander 10 parts to it Research risk must be minimal an relative to benefits
Research must benefit society
Research must be based on pre-clinical studies
Subjects have the right to end participation Thalidomide Approved by FDA in 1950s in Europe but not in the US
The drug was prescribed to control sleep and nausea throughout pregnancy
Taking this drug during pregnancy caused severe deformities in the fetus
Patients were not told it was not approved by FDA or given informed consent "Kefauver Amendments" Food, Drug and Cosmetic Act were passed into law to ensure drug efficacy and greater drug safety
Drug manufacturers were required to prove to FDA the effectiveness of their products before marketing them. Declaration of Helsinki tries to take into account the evolving nature of scientific research
governs international research ethics and defines rules for "research combined with clinical care" and "non-therapeutic research." Research with humans should be based on the results from laboratory and animal experimentation
Research protocols should be reviewed by an independent committee prior to initiation
Informed consent from research participants is necessary
Research should be conducted by medically/scientifically qualified individuals
Risks should not exceed benefits Tuskegee Syphilis Study 600 African-American males were monitored for 40 years
Free medical examinations were given, but they were not told about their disease
Penicillin became available in the 1950s
Stopped in 1972 by the U.S. Department of Health, Education, and Welfare National Research Act of 1974 Created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Identify the basic ethical principles
Develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. The Belmont Report 1979-National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Summarize the basic ethical principles identified by the National Commission in the course of its deliberations
Statement of basic ethical principles and guidelines that assist in resolving the ethical problems that surround the conduct of research with human subjects Respect for People Beneficence Justice Informed consent Assessment of risks
and benefits Selection of Subjects CURRENT REGULATIONS 1981-Department of Health and Human Services and the Food and Drug Administration issued regulations FDA DHHS Code of Federal Regulations
Title 45-public welfare
Part 46-protection of human subjects CFR Title 21-food and drugs
Part 50-protection of human subjects
Part 56-Institutional Review Boards Federal Policy for the Protection of Human Subjects Requirements for assuring compliance by research institutions;
Requirements for researchers obtaining and documenting informed consent
Requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping
Additional protections for certain vulnerable research subjects-- pregnant women, prisoners, and children Common Rule
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