Question

A basic element of informed consent requires a statement that the study involves research. State the items that should be described about the research: (21CFR50.25)

Answer 1

Informed consent in research involving human participants requires a clear description of the research. This should include potential risks, implications, and confidentiality, and inform participants of the voluntary nature of their involvement. If participants are under 18, informed consent should be obtained from their parents or legal guardians.

Step-by-step explanation:

Informed consent is an important component of research involving human participants. When describing the research, several items should be included:

1. A clear statement that the study involves research
2. Description of what participants can expect during the experiment
3. Potential risks and implications of the research
4. Voluntary nature of participation, allowing participants to withdraw at any time without penalty
5. Confidentiality of data collected
6. Requirements for informed consent of parents or legal guardians for participants under 18 years of age

These are some of the key elements that should be described in a research study to ensure informed consent.