Belmont Report

Application of beneficence

Assessment of Risks and Benefits

Issued in 1974, 45 CFR 46 raised to regulatory status: a. The 1974 National Research Act b. Kefauver-Harris Drug Amendments to the Federal Food, Drug & Cosmetics Act c. The Nuremberg Code d. US Public Health Service Policy

d. US Public Health Service Policy

Application of Justice

Selection of Subjects

Application for respect of persons

Informed Consent

Which law created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research?

The National Research Act

Two requirements for respect for persons

1. Individual autonomy; and 2. Protection for those with diminished autonomy

Belmont Report 3 elements of consent

1. Information 2. Comprehension 3. Voluntariness

What did the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research consider when developing the conduct for human subjects research?

1. boundaries between biomedical and behavioral research and the accepted and routine practice of medicine; 2. the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects; 3. appropriate guidelines for the selection of human subjects for participation in such research; and 4. the nature and definition of informed consent in various research settings.

Two requirements for beneficence

1. do not harm; and 2. maximize possible benefits and minimize possible harms.

What year was the National Research Act signed into law?

1974

The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: a. Persons involved in research cannot financially benefit. b. Persons with diminished autonomy are entitled to protection. c. Persons with diminished autonomy should be excluded from research. d. Persons with diminished autonomy should only participate in no more than minimal risk research.

b. Persons with diminished autonomy are entitled to protection

The National Research Act of 1974 a. Identified the basic ethical principles of human subjects research. b. Required that all federal agencies have the same regulations governing human subjects research. c. Established the National Commission. d. Identified guidelines to ensure the ethical conduct of research.

c. Established the National Commission

Which of the following are the three principles discussed in the Belmont Report? a. IRB Review, Federal Regulations, Declaration of Helsinki b. Privacy, Confidentiality, Equitable Selection of Subjects c. Informed Consent, Institutional Assurance, Researcher Responsibility d. Respect for Persons, Beneficence, Justice

d. Respect for Persons, Beneficence, Justice

Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? a. Ensuring that the selection of subjects includes people from all segments of the population. b. Providing detailed information about the study and obtaining the subject's consent to participate. c. Ensuring that persons with diminished autonomy are protected. d. Determining that the study has a maximization of benefits and a minimization of risks.

d. Determining that the study has a maximization of benefits and a minimization of risks.

The use of prisoners in research is a concern under the Belmont principle of Justice because: a. Prisoners are less educated that the general population and have difficulty understanding research b. Prisoners are not a representative sample of the general population c. Prisoners are not free to say no d. Prisoners may not be used to conduct research that only benefits the larger society

d. Prisoners may not be used to conduct research that only benefits the larger society

Informed consent is considered an application of which Belmont principle? a. Justice b. Beneficence c. Non-maleficence d. Respect for Persons

d. Respect for Persons