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Table 1 Examples and types of health and medical research exempted from ethics reviews

From: Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands

Exemption

Australia

United Kingdom

United States of America

Netherlands

Existing data/specimen

Existing collection of data or records that contain only non-identifiable data

Previously collected, non-identifiable tissue samples

Secondary research use of identifiable biospecimens (subject to criteria)

Exempt

Questionnaire or survey

Filling in a form, participating in a street survey (where those are no more than inconvenience)

Ā 

Educational tests, survey procedures (subject to criteria)

Exempt, unless it imposes rules of behaviour (e.g. required to be done repeatedly) or topic is sensitive (e.g. suicide, abortion)

Interviews

Ā Ā 

Interview procedures (subject to criteria)

Exempt, unless it imposes rules of behaviour (e.g. required to be done repeatedly) or topic is sensitive (e.g. suicide, abortion)

Post-marketing studies

Ā 

Healthcare market research conducted by professional market researchers

Ā 

e.g. collecting data on adverse effects of medicines already available on the market

Evaluation of public benefit or service programme

Ā Ā 

e.g. procedures for obtaining benefits, alternatives, changes in payment levels

Ā 

Randomised controlled trials

Ā Ā Ā 

May be exempt if meets the exemption rule below (see ā€˜otherā€™ category)

Research with staff in their professional role

Ā 

Research involving NHS staff acting in their professional roles

Ā Ā 

Audit and service evaluation

a

Audit and service evaluation

Ā Ā 

Other exemptions

ā€œGiving up time to participate in researchā€ (example of an inconvenience)

Ā Ā 

Medical/scientific research that does not expose persons to treatment, or require persons to follow certain behavioural rules

  1. a Dealt with outside of the National Statement (see below)