Belmont Report Flashcards
According to the Belmont Report, respect for persons usually demands that subjects
Enter in research voluntarily & with adequate information
According to the Belmont Report, the moral requirements that there be fair outcomes in the selection of research subjects, express the principle of
Justice
What are the 3 ethical principles discussed in the Belmont Report?
Respect for persons, justice and beneficence
An example of how the Principle of Beneficence can be applied to a study employing human subjects?
Determining that that study has a maximization of benefits and a minimization of risks
What is an example of how the principle of beneficence is applied to a study involving human subjects?
Ensuring that risks are reasonable in relationship to anticipated benefits
Which study is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection?
The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male
The Belmont Principle of beneficence requires that…
Potential benefits justify the risks of harm
The Belmont Principles
Respect for persons, beneficence, and justice
Five Basic Categories of Harm as noted in The Belmont Report
- Social harm
- Economic harm
- Legal harm
- Psychological harm
- Physical harm
The National Commission/The National Research Act
1974 Congress authorized the formation of the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. The Commission was charged with the task of identifying the basic ethical principles that underlie the conduct of human subject research. In 1979, the Commission published the Belmont Report.
1st barrier that makes it difficult for IRBs to evaluate the ethics of research proposals
Federal research regulations don’t emphasize the role of ethics in IRB decision making and the Belmont Report doesn’t explain how to apply ethical principals to the application of research
Belmont Circle of trust
a. Investigator
b. Subject
c. Federal government
d. Sponsoring institution
e. IRB
A poorly designed protocol is considered unethical because….
Research subjects may be put at risk or inconvenienced for insufficient reason
Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:
Respect for Persons
The researcher’s failure to protect research subjects from deductive disclosure is the primary ethical violation of which study?
Harvard “Tastes, Ties and Time (T3) study (2006-2009)
