Study notes for the CITI

Informed consent

Adequated standards for informed consent:

• Information: should be sufficient so that “reasonable volunteer” can decide whether to participate
• Comprehension: Investigators are responsible for ascertaining that the subjcet has comprehended the information
• Voluntariness

Privacy

Beneficence

“do no harm”

Systematic Assessment of Risks and Benefits

risks are reasonable in relation to the anticipated benefits

Minimization of Risk

Justice

The principle of justice requires that the selection of subjects is equitable.

• requires a fair sharing of the burdens and benefits of research and that groups are not exploited because of their circumstances.

Selection of Subjects\

determined whether some classes are beging systematically selected simply because of their easy availability, their compromised position etc.

why do i have to know this kind of regulatory history……