Question

T/F: For Federal regulations, the informed consent process and document does not contain specific statements related to the risks, benefits, and alternatives.

T/F: The “Common Rule” regulations represent a set of equivalent regulations, policies, and executive orders that apply to research that is conducted, supported, or otherwise subject to regulation by federal departments and agencies.

Answer 1

Ans -

1. For Federal regulations , the informed consent process and documents does not contains specific statement related to the risks ,benefits , and alternative.

Ans - False .

Explanation :

Obtaining informed consent process includes:

1. Describing purpose of interventions.

2. Emphazising the patient role in decision making.

3. Discussion about alternative of interventions.

4. Discussion of the risk of the proposed interventions

5. Explanation of benefits big procedure.

2. The ' common rules ' regulations represent a set of equivalent regulations, policies, and executive orders that apply to research that is conducted supported ,or otherwise subject to regulations by federal department and agencies.

Ans - True.