Outline of the Belmont Report_Parts B & C
Contributor: M. Bourgeois, Biomedical Engineering, m-bourgeois@northwestern.edu
Posted: 2010
Outline: parts B & C of The Belmont Report
PART B: Basic Ethical Principles
Respect for Persons
• Individuals should be treated as autonomous agents
• Persons with diminished autonomy are entitled to protection
Beneficence
• Do not harm
• Maximize possible benefits and minimize possible harms
Justice: Who ought to receive the benefits of research and bear its burdens?
• Ensure that some classes are not systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied (7).
• Whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands
o That these not provide advantages only to those who can afford them
o That such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.
PART C: Applications
Informed Consent
Information
• Complete disclosure
Or
• Incomplete disclosure only provided that
o Incomplete disclosure is truly necessary to accomplish the goals of the research
o There are no undisclosed risks to subjects that are more than minimal
o There is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them
Comprehension: Presentation of information must be adapted to the subject’s capabilities.
Voluntariness
Assessment of risks and benefits
Selection of subjects (and care for vulnerable subjects)
