Belmont Report

According to the Belmont Report, when is it okay to NOT honor an 'Incompetent Person's' objection of participation in research?

When the research provides them a therapy unavailable elsewhere and 3rd parties act on the Incompetent Person's best interest

How is 'volunteeriness' defined in the Belmont Report?

Free of coercion and undue influence

How is 'risk' defined in the Belmont Report?

Probability and magnitudes of harm

In terms of selection of subjects, what are the requirements for individual justice?

Researchers exhibit fairness *should not offer potentially beneficial research only to some patients who are in favor or 'undesirable' persons for risky research

How is 'coercion' defined in the Belmont Report?

When an overt threat of harm is intentionally presented by one person to another in order to obtain compliance

How is 'benefits' defined in the Belmont Report?

Compared to harm (rather than risk of harm)

What was one of the National Commission's responsibility that led to the Belmont Report?

Identify the basic ethical principles that should underlie the conduct of the biomedical and behavioral research involving human subjects AND Develop guidelines which should be followed to assure that such research is conducted in accordance to those principles

What are the principles behind 'Respect for Persons'?

Individuals should be treated as autonomous agents * Demands that subjects enter into research voluntarily and with adequate information Persons with diminished autonomy are entitled to protection

How does the Belmont Report's 'Principle of Respect for Persons' apply to research?

Informed Consent

What is 'Practice'?What is its purpose?

Interventions that are designed solely to enhance the well-being of individual patients AND have reasonable expectation of success Purpose: to provide diagnosis, preventative treatment or therapy

What is the Belmont Report? What are the 3 basic principles?

Ethical principles and guidelines for research involving human subjects Basic Principles: 1) Respect for persons 2) Beneficence 3) Justice

How does the Belmont Report's define 'injustice'?

Involvement of vulnerable subjects to be in research solely for administration of convenience (i.e.: socioeconomic condition, institutionalization, etc.)

What 5 assessments of justifiability of conducting human research should be conducted, according the the Belmont Report's Principles of Beneficence?

1) Brutal or inhumane treatment of participants is never morally justified 2) Should determine whether use of human subjects is necessary at all - reduce risk 3) Significant risk of serious risk of impairment - review committees should be insistent on justification of risks 4) Appropriateness of involving vulnerable populations should be demonstrated 5) Risks and benefits must be presented in ICF

Who developed the Belmont report?

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research The National Commission came to be since 'National Research Act' was signed into law

How is 'undue influence' defined in the Belmont Report?

Offer an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance Inducements that would ordinarily be acceptable may become undue influence if the subject is especially vulnerable

How does the Belmont Report's 'Principles of Beneficence' apply to research?

Risks vs. Benefits Assessments

How does the Belmont Report's 'Principles of Justice' apply to research?

Selection of subjects

What are the principles behind 'Beneficence'?

*Do not harm *Maximize possible benefits and minimize possible harm

What are the principles behind 'Justice'? (3)

*Who should bear the burden of participating vs. who should receive the benefits *Research should not unduly involve persons from groups unlikely to be among the beneficiary of subsequent applications of the research

What did the National Commission consider when creating the Belmont Report? (4)

1) Boundaries between Practice and Research 2) Role of assessment of risk-benefit to determine appropriateness of research involving human subjects 3) Appropriate guidelines for selecting human subjects 4) Nature and definition of informed consent in various research settings

According to the Belmont's Report, what 3 things do the Informed Consent form ensure?

1) Information 2) Comprehension 3) Volunteeriness

What are the 4 conditions under which 'Incomplete Disclosure' is allowed?

1) It is truly necessary to accomplish the goals of research 2) There are not undisclosed risks to subjects that are more than minimal 3) There is an adequate plan for debriefing subjects and for dissemination of research results to them 4) Information of risks should never be withheld

What does the 'Principles of Beneficence' dictate we protect? and what should we be concerned about?

1) We protect against harm of risk to subjects AND 2) We be concerned about the loss of substantial benefits that might be gained from research

In terms of selection of subjects, what are the requirements for social justice?

Distinction be drawn between classes of subjects that should or should not participate due to the ability of them to bear burdens *there is an order of preference in selection of classes of subjects (i.e.: adults before children OR healthy before sick - unless research is directly related to the sick)

Per the Belmont Report, what bodies requires that risks to subjects be outweighed by the sum of (anticipated benefit to the subject) + (anticipated benefit to society in the form of knowledge gained) from research?

Federal codes and regulations

According to the Belmont Report, who is responsible for ascertaining that the subject has comprehended the research information?

Investigators

What prompted the development of the Belmont report?

Syphilis study at Tskegee The study used disadvantaged, rural black men to study the untreated course of a disease that is not confined to that population. These subjects were deprived of effective treatment in order to not interrupt the project, long after treatment became generally available

Whenever research is being supported by public funds leads to development of therapeutic devices and procedures, what does the principles of justice dictate?

The therapeutic devices and procedures must not provide advantages only to those who can afford them

According to the Belmont Report, what opportunity should a 3rd party have when acting on an 'Incompetent Person's' best interest?

To observe the research as it proceeds in order to withdraw the subject from the research

What is 'Research"?

To test a hypothesis, permits conclusions to be drawn and thereby contribute to generalized knowledge