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CTSA Institution

University of Pennsylvania, School of Medicine

Disclaimer Please cite the appropriate authors/contacts when using or adapting these materials.
Acknowledgment Emma A. Meagher, M.D.
Associate Professor of Medicine and Pharmacology
Coordinator, POR & MTR Programs
University of Pennsylvania

Contacts Marti Dandridge, Coordinator, Masters of Science in Translational Research, (MTR) Program
Format PowerPoint?
URL Download
Materials Provided PPT (30 Slides)
Title Ethical Principles in Human Subject Research (Parts II & III)
Topics Description This power point presentation covers The Belmont Report by explaining prescriptive judgments, ethical issues inherent in human subject research. It covers the Common Rule, which is a regulatory framework that governs human subject research by the US federal government or facilities that receive federal funds. In addition, the Common Rule mandates the role of the IRB, defines requirements for informed consent, and codifies special requirements for vulnerable populations.
Keywords 21 CFR 56; 45 CRF 46; Assent; Audits; Beneficence; Benefit; Conflict of Interest; Consent; Disclose; Exclusion; Experimental Design; Federal Agencies; Federalwide Assurance (FWA); Financial Disclosure; Food and Drug Administration (FDA); Funding; Generalizable Knowledge; HIPAA; Hypothesis; Inclusion; Institutional Review Board (IRB); Investigational Device Exemptions (IDE); Investigational New Drug (IND); Investigator; Justice; Modifications; Monitors; New Drug Application; Observes; Office for Human Research Protections (OHRP); Peer Review; Practice; Protocol; Research; Research Costs and Benefits; Research Integrity; Respect for Persons Autonomy; Risk; Selection of Subjects; Sponsor; Surrogate; Suspends; Terminates; The Belmont Report; The Common Rule
See Also

Topic Conflicts of Interest and Commitment, Human Subjects, Collaborative Science, Other
Topic revision: r4 - 30 Mar 2010 - 19:38:39 - MaryBanach
ResearchEthics.Ethical_Principles_In_Human_Subject_Research_Parts_II_and_III moved from ResearchEthics.EthicalPrinciplesInHumanSubjectResearchPartsIIandIII on 12 Jun 2009 - 19:24 by CTSpediaAdmin - put it back
 
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