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RESEARCH ETHICS Orientation for IRB Members Session 1: The Regulations and the Role of The IRB

RESEARCH ETHICS Orientation for IRB Members Session 1: The Regulations and the Role of The IRB

RESEARCH ETHICS Orientation for IRB Members Session 1: The Regulations and the Role of The IRB. Presented by the Office of Sponsored Programs & Research Administration. Historical Timeline. 1947: Nazi War Crimes Tribunal issued Nuremburg Code 1940s: PHS Tuskegee syphilis study

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877 views • 77 slides
Operationalizing Compliance Requirements in Clinical Trials

Operationalizing Compliance Requirements in Clinical Trials

Operationalizing Compliance Requirements in Clinical Trials. University of Colorado Denver | Anschutz Medical Campus. Presented at NCURA Wednesday April 6 , 2011. Hot Topics. Regulatory (IRB) Role Clinical Trial Agreement (legal and business issues/terms) Budget Negotiation

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286 views • 14 slides
Chapter 5

Chapter 5

Chapter 5. Ethical Concerns in Research. Basics in Ethics. Examples of unethical conduct in research Regulation of research and protection of research participants Scientific misconduct in reporting. Examples of unethical conduct. Nazi Germany experimentation during World War II

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241 views • 13 slides
Reporting Adverse Events to the IRB

Reporting Adverse Events to the IRB

Reporting Adverse Events to the IRB. IRB Responsibilities. Ensure that local management of unanticipated problems in research Assure maximal protection for research participants Comply fully with all laws, regulations, and standards. Purpose of IRB Review of AEs.

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258 views • 11 slides

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