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Table 1 Rules regulating research ethics committees (RECs) and their work in clinical research, Finland compared to England, Canada (Ontario), and the USA, around 2010

From: Research ethics committees in the regulation of clinical research: comparison of Finland to England, Canada, and the United States

 

Finland

England

Canada

USA

Type of research handled

Medical

Within NHS; specific typesa

Human and health care

Human and health care

Specific research law

Yes, medical research

No

No

Yes, general

Main basis

Law

Health Ministry rules

Requirements from national grant agency

Government rules

Special law for drug trials

EU clinical trials directive, national laws

EU clinical trials directive, national laws

Drug and devices law

Drug, devices and food law

Leading document

No single

No single

Tri-Council statementb

Common rule

Helsinki declaration

Separate document

Separate document

Some parts integrated in leading document

Some parts integrated in leading document

International Committee on Harmonization (drug trials) Good Clinical Practice guidelines

Separate document for drug trials

Integrated to rules

Integrated in leading document

Integrated in leading document

  1. aRegardless of place, a certain type of research, such as investigational drugs and devices, adults lacking capacity to consent, exposure to ionizing radiation.
  2. bTri-Council statements, tri-council policy statement: ethical conduct for research involving humans.