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The Declaration of Helsinki: 50 th Anniversary

The Declaration of Helsinki: 50 th Anniversary. An IRB Infoshort December 2013. Purpose. A statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. History . Developed by the World Medical Association 1964

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The Declaration of Helsinki: 50 th Anniversary

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  1. The Declaration of Helsinki: 50th Anniversary An IRB Infoshort December 2013

  2. Purpose • A statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data

  3. History • Developed by the World Medical Association 1964 • Revised 1975, 1983, 1989, 1996, 2000, 2002, 2004, 2008, 2013

  4. Differences from The Belmont Report (By Category) • #15: General principle: “Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.” • # 22 Scientific Requirements and Research Protocols: “The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed.”

  5. Differences Cont’d Informed Consent • #26 “All medical research subjects should be given the option of being informed about the general outcomes and results of the study.” • #27 “When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.”

  6. Differences, Cont’d • # 34 Post trial provisions: “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention.” • # 36 Dissemination of Results: “Negative and inconclusive as well as positive results must be published or otherwise made publically available.”

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