Question

Which subpart(s) of the 45 cfr 46 is/are sometimes referred to as the common rule?

Answer 1

Subpart a is the subpart of the 45 CFR 46 which describes the required protections for all human subjects.

 

The application of the federal policy regarding Human Subjects Protection to 17 Federal agencies and offices is called the Common Rule. Federal agencies that did not sign the agreement (e.g., Department of Labor, etc.) are exempted from the policy. The Common Rule’s main elements include the following:

 

1.     research institutions’ requirements for assuring compliance

2.     obtaining and documenting informed consent requirements for researchers'

3.     Institutional Review Board (IRB) membership, operations, function, record keeping, and review of research requirements

 

 

The specific vulnerable research subjects’ additional protections are included in the Common Rule.

 

 

Additional protections for pregnant women, in vitro fertilization, and fetuses is provided in subpart B.

Additional protections for prisoners is contained in subpart C.

The same for children is contained in subpart D.