The Belmont Report - C Flashcards
(37 cards)
What is the purpose of the Belmont Report (April 18, 1979)?
It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects
Who wrote the Belmont Report?
The National Commision for the Protection of Human Subjects of Biomedical and Behavioral Research
What did the Commission consider for the principles?
- boundaries between biomedical and behavioral research and the accepted and routine practice in medicine
- role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects
- appropriate guidelines for the selection of human subjects for participation in such research
- nature and definition of informed consent in various research settings
What does “practice” mean?
Refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success
The purpose is to provide diagnosis, preventive treatment or therapy to particular individuals.
What are the main parts of the Belmont Report?
A. Boundaries between practices and research
B. Basic ethical principles
C. Applications
What does “research” mean?
“research” designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge
- is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective
What are the basic ethical principles?
- Respect for Persons
- Beneficence
- Justice
Respect for Persons meaning
- individuals should be treated as autonomous agents - respect autonomy = give weight to autonomous persons’ considered opinions and choices while refraining from obstructing their actions unless detrimental to others
- persons with diminished autonomy are entitled to protection
Who is an autonomous person?
an individual capable of deliberation about personal goals and of acting under the direction of such deliberation
What does Respect for Persons demand in most cases?
Subjects enter into the research voluntarily and with adequate information
Protection under Respect for Persons
The extent of protection afforded should depend upon the risk of harm and the likelihood of benefit.
The judgement that any individual lacks autonomy should be periodically reevaluated and will vary in different situations.
What example is provide for application of Respect for Persons?
Prisoners: they should not be deprived of the opportunity to volunteer for research BUT they may be coerced to participate in the given situation and so not volunteer - they need protection
Principle of Beneficence meaning
Two general rules:
1. Do not harm
2. Maximize possible benefits and minimize possible harms
The obligation of beneficence extent
The obligations of beneficence affect both
- individual investigators (obligation to give forethought to the maximization of benefits and reduction of risk of the research investigation) and
- society in large (members of the larger society are obligated to recognize the longer-term benefits and risks).
What example is provided for application of principle of beneficence?
Research involving children
- effective ways of treating childhood diseases and fostering healthy development are benefits that serve to justify research involving children
- difficult ethical problem remains about research that presents more than minimal risk without immediate prospect of direct benefit to the children involved
Principle of Justice meaning
Equals ought to be treated equally
Widely accepted formulations of just ways to distribute burdens and benefits
- to each person an equal share
- to each person according to individual need
- to each person according to individual effort
- to each person according to societal contribution
- to each person according to merit
What example of Principle of Justice is provided?
The selection of research subjects needs to be scrutinized in order to determine whether some classes are being systematically selected simply because of their easy availability, their compromised position, or their manipulation, rather than reasons directly related to the problem being studied.
Research supported by public funds - justice demand
Whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands that those not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.
Application - Informed consent. Which principle is applied?
Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. Adequate standards for informed consent must be satisfied.
Application - Informed consent. What are the general items providing sufficient information
- research procedure
- purpose(s) of the procedures
- risks (range of risks)
- anticipated benefits
- alternative procedures
- statement offering the opportunity to ask questions
- statement offering the opportunity to withdraw at any time (voluntary nature)
Application - Informed consent.
When can be information incomplete?
Incomplete disclosure is justified if:
1. incomplete disclosure is truly necessary to accomplish the goals of the research
2. there are no undisclosed risks to subjects that are more than minimal, and
3. there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them
Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from cases in which disclosure would simply inconvenience the investigator.
Application - Informed consent.
Responsibility for comprehension
It is necessary to adapt the presentation of the information to the subject’s capabilities (intelligence, rationality, maturity, language).
Investigators are responsible for ascertaining that the subject has comprehended the information.
Application - Informed consent.
Severely limited comprehension
E.g. conditions of immaturity or mental disability (infant, young children, mentally disabled patients, terminally ill…) - each class should be considered on its own terms.
Respect for Persons requires
- giving them opportunity to choose to the extent they are able
- seeking the permission of other parties
