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CIP Study guide

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Exam of 4 pages for the course Chapter 5: Ethics and Bioethical Issues at Chapter 5: Ethics and Bioethical Issues (CIP Study guide)

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CIP Study guide
1st barrier that make it difficult for IRBs to evaluate the ethics of research
proposals - CORRECT ANSWER-Federal research regulations do not
emphasize the role of ethics in IRB decision making and the Belmont Report
doesn't explain how to apply ethical principles to the application of research

2nd barrier of research - CORRECT ANSWER-Many people don't understand
that ethical analysis requires us to make judgments based on thoughtful
deliberation rather than simply asserting that something is right or wrong

6 main deficiencies that threaten the effectiveness of the IRB system -
CORRECT ANSWER-Excessive Workload

Minimal continuing review of research

Little devotion to the evaluation of IRB performance

COIs that threaten independence

3 main suggestions for protecting & improving the effectiveness of the IRB
system - CORRECT ANSWER-1. Sustain a capability for independent review
2. Strengthen continuing review
3. Serve as an ambassador for human protection

Public Responsibility in Medicine and Research (PRIM&R) was founded in 1977
with a mission to - CORRECT ANSWER-Promote ethical conduct of human
research through education of the scientific community and the public

A well-integrated Human Research Protection Program should consist of -
CORRECT ANSWER-IRB Members
IRB administrative staff
Investigators
Community and subject input
Institutional oversight
Policies & Procedures

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