Does ICH E6(R3) cover Australia NHMRC National Statement on Ethical Conduct in Human Research?

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

ICH E6(R3) 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 14 Likely covered 0 New work 13

What is genuinely new work

Nothing in ICH E6(R3) 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 ICH E6(R3) 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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