Framework overlap

Does 21 CFR Part 211 cover Australia NHMRC National Statement on Ethical Conduct in Human Research?

You hold 21 CFR Part 211 and have been told to do Australia NHMRC National Statement on Ethical Conduct in Human Research. Here is how much overlaps, control by control.

52% of Australia NHMRC National Statement on Ethical Conduct in Human Research you already have

21 CFR Part 211 already covers about 52% of Australia NHMRC National Statement on Ethical Conduct in Human Research, leaving 13 of 27 controls as genuinely new work.

Already covered 0 Likely covered 14 New work 13

No control in 21 CFR Part 211 maps directly to one in Australia NHMRC National Statement on Ethical Conduct in Human Research. Everything counted as covered is covered because both map to the same third standard, which is what a crosswalk is, but it is an inference rather than a lookup.

What is genuinely new work

Nothing in 21 CFR Part 211 reaches these. This is the list to scope.

NHMRC-NS-1.2
Justice
NHMRC-NS-3.2
Human biospecimens in laboratory based research
NHMRC-NS-3.3
Genomic research
NHMRC-NS-3.4
Animal-to-human xenotransplantation
NHMRC-NS-4.1
Women who are pregnant and the human fetus
NHMRC-NS-4.3
People in dependent or unequal relationships
NHMRC-NS-4.4
People highly dependent on medical care who may be unable to give consent
NHMRC-NS-4.6
People who may be involved in illegal activities
NHMRC-NS-4.7
Aboriginal and Torres Strait Islander Peoples
NHMRC-NS-4.8
People in other countries
NHMRC-NS-5.5
Minimising duplication of ethics review
NHMRC-NS-5.6
Disclosure of interests and management of conflicts of interest
NHMRC-NS-5.7
Complaints
Show the 14 you already have
NHMRC-NS-1.1
Research merit and integrity
NHMRC-NS-1.3
Beneficence
NHMRC-NS-1.4
Respect
NHMRC-NS-2.1
Risk and benefit
NHMRC-NS-2.2
General requirements for consent
NHMRC-NS-2.3
Qualifying or waiving conditions for consent
NHMRC-NS-3.1
The elements of research
NHMRC-NS-4.2
Children and young people
NHMRC-NS-4.5
People with cognitive impairment, an intellectual disability, or a mental illness
NHMRC-NS-5.1
Governance responsibilities of institutions
NHMRC-NS-5.2
Responsibilities of HRECs and other ethics review bodies
NHMRC-NS-5.3
Responsibilities of researchers
NHMRC-NS-5.4
Monitoring
NHMRC-NS-5.8
Accountability

How this is calculated

Already covered means a mapping runs from a control in 21 CFR Part 211 to that control. Likely covered means no direct mapping exists but both frameworks map to the same control in a third standard. New work means neither. We keep those separate rather than adding them into one friendlier number, because blending them would present a two-hop inference as a verified fact.

Coverage is not symmetric. Run it the other way and you will get a different number; both are correct.

From 332,959 cross-framework control mappings across 723 frameworks, 531 of them verified against their source documents. It does not tell you that you are compliant: a mapped control means the two standards ask for the same thing, not that you have done it.

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