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:
<span>1.
</span>research institutions’
requirements for assuring compliance
<span>2.
</span>obtaining and
documenting informed consent requirements for researchers'
<span>3.
</span>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.
<span>Additional protections for pregnant women, in
vitro fertilization, and fetuses is provided in subpart B.
Additional protections for prisoners is contained in subpart C.</span>
<span>
The same for children is contained in subpart D.</span>
