Actors involved in the regulation of clinical research: comparison of Finland to England, Canada, and the USA

Table 2 Actors in the regulation of clinical research in Finland, compared to England, Canada (Ontario), and USA, around 2010

	Finland	England	Canada	USA
Responsible ministry	Two (health and education)	Health	Health	Health
National leadership	None	NHS ^a, MHRA	CIHR	OHRP and FDA
Government research funders	0	+	+++	+++
Health care	+	++	++	+++?
Permission giver	“Head physician”/Health care unit ^b	NHS Trust	“Head physician”/Health care unit ^b	“Head physician”/Health care unit ^b
Procedures for permission	Light	Bureaucratic	Effective/professional	Effective/professional
Conflict of interest bodies	No	Integrated to RECs	Yes +	Yes +++
Researchers’ impact	+	+++	+	+++
Regulation business	0	NK	++	+++
Drug research particularly
Drug control agency ^c	++	++	+	+++
Drug agency costs	Mainly fees	Mainly fees	Taxation and fees (~50%)	Taxation and fees (~50%)
Products covered	Drugs	Drugs (devices)	New ^c drugs + devices	New ^c drugs + devices + food

0/+ gives a subjective estimate of the importance of the actor, in relative terms within the four countries; 0, no or little activity. CIHR, Canadian Institutes of Health Research (a research funder); FDA, Food and Drugs Administration; NHS, National Health Service; MHRA, Medicines and Healthcare Products Regulatory Agency; NK, Not known to me; OHRP, Office of Human Research Protection.
^a Since 2012, the Health Research Authority has played a central role.
^b This task was delegated to someone among the health care providers, e.g., a clinic head.
^c For new drug trials.

ISSN: 1478-4505