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1
Intro
2
Clinical Research
3
The First Clinical Trial?
4
Virtues
5
Concerns
6
Conflicts of Interest
7
National Commission
8
Challenges
9
Benefits and Risks
10
Primary Ethical Concern
11
Regulations and Guidelines
12
Comparison
13
8 Ethical Requirements
14
Collaborative Partnership
15
Social Value
16
#2: Evaluation
17
Scientific Validity
18
Clinical Equipoise
19
Assessment
20
Exceptions
21
Fair Subject Selection
22
Protection to Access
23
Favorable Risk-Benefit Ratio.
24
Independent Review
25
Informed Consent
26
Waiver
27
Incompetent Participants?
28
Therapeutic Misconception
29
Respect for Subjects
30
Resolving Conflicts
31
Problems
32
Rebirth of the Integrated Model?
33
Application to LHC
34
SUPPORT Trial
35
Research and/or Care?
36
Summary
Description:
Explore ethical considerations in human subjects research through this 56-minute lecture by Dave Wendler from the NIH Clinical Center. Delve into the history of clinical trials, virtues and concerns in research, conflicts of interest, and key ethical principles. Examine the National Commission's work, challenges in balancing benefits and risks, and the primary ethical concerns in human research. Learn about regulations, guidelines, and the eight ethical requirements for conducting research, including collaborative partnership, social value, scientific validity, and fair subject selection. Discuss the importance of informed consent, respect for subjects, and resolving conflicts in research ethics. Analyze the application of these principles to learning healthcare systems and the SUPPORT trial. Gain valuable insights into the complex ethical landscape of clinical and translational research as part of the NIH Clinical and Translational Research Summer Course.

Ethical Considerations in Human Subjects Research - Lecture 1

NIH Clinical Center
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