Research in Humans: Chapter 2

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What is the main difference between research in humans and other research?

The human subject has decision-making power

What was the purpose of establishing elaborate rules and procedures to protect human participants in research?

To prevent exploitation of human subjects

According to the Nuremberg Code 1947, what is the principle related to voluntary informed consent?

Autonomy

Which principle from the Nuremberg Code 1947 emphasizes good science and favorable benefit to risk ratio?

Beneficence

What was the responsibility of the investigator according to the Nuremberg Code 1947?

Ensuring ethical requirements were met

Why did the Nuremberg Code 1947 emphasize equal opportunity to participate and to not participate?

To ensure fairness and respect for individual choices

What is the primary responsibility of physicians according to the Declaration of Helsinki?

The best care, with research being secondary

What is the main provision of the Belmont Report regarding 'Research'?

A systematic investigation to develop or contribute to generalizable knowledge

What does 'Human Subject' refer to according to the Belmont Report?

An individual about whom an investigator obtains data through intervention or interaction

What is the requirement for consent in research involving human subjects according to the Declaration of Helsinki?

It must be voluntary and informed, with documented consent and ability to withdraw

What is the primary focus when scrutinizing a research protocol according to the Declaration of Helsinki?

Risks and benefits, with minimization of risks and maximization of benefits

What is required for the population studied in research involving humans according to the Declaration of Helsinki?

A reasonable chance of benefiting from the results

What is the limitation placed on jointly providing clinical care and research by the Declaration of Helsinki?

A limitation was placed on jointly providing clinical care and research

'Placebo use' in research involving human subjects is strictly limited according to which document?

Declaration of Helsinki

'Intervention' in research refers to which of the following according to the Belmont Report?

Physical procedures and manipulations for research purposes

'Private Information' in research refers to which of the following according to the Belmont Report?

'Private Information' refers to behavior that occurs in a context where no observation or recording is taking place

Explore the historical context and ethical considerations surrounding research in humans, including the Nuremberg Code of 1947. Understand the importance of respecting human participants in research and the establishment of rules to protect their rights.

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