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Central Committee on Research Involving Human Subjects
CCMO, PO Box 16302, 2500 BH The Hague, The Netherlands www.ccmo.nl
The Dutch System of Research EthicalAssessment and Weportal
ReviewOnline
EFGCP workshop: Streamlining application to the regulatory & ethical review processes
Kingston-Upon-Thames, 2 March 2011
Marcel Kenter, executive directorCentral Committee on Research Involving Human Subjects
Central Committee on Research Involving Human Subjects
CCMO, PO Box 16302, 2500 BH The Hague, The Netherlands www.ccmo.nl
Presentation
• Dutch review system
• Implementation EU clinical trial directive
• Webportal ToetsingOnline
• Summary
Central Committee on Research Involving Human Subjects
CCMO, PO Box 16302, 2500 BH The Hague, The Netherlands www.ccmo.nl
Presentation
• Dutch review system
• Implementation EU clinical trial directive
• Webportal ToetsingOnline
• Summary
Central Committee on Research Involving Human Subjects
CCMO, PO Box 16302, 2500 BH The Hague, The Netherlands www.ccmo.nl
Legislation on review of medical research
• April 1999: installation of the Central Committee on Research Involving Human Subjects (CCMO)
• December 1999: Medical Research Involving Human Subjects Act (WMO) into force
• September 2001: Embryos Act
• March 2006: EU Clinical Trial Directive into force (implementation in WMO)
Central Committee on Research Involving Human Subjects
CCMO, PO Box 16302, 2500 BH The Hague, The Netherlands www.ccmo.nl
Tasks of the CCMO (1/2)
• Competent authority of drug trials in NL• review specific categories of medical
research• appeals body• collect data of all research in national
registry
Central Committee on Research Involving Human Subjects
CCMO, PO Box 16302, 2500 BH The Hague, The Netherlands www.ccmo.nl
Tasks of the CCMO (2/2)
• accreditation of local MRECs ⇒governmental bodies
• supervision of accredited MRECs• improving the quality and harmonisation of
the MREC’s review • make legally binding directives for
aMRECs
CommitteeOffice
CCMO
New Developments
AnnualReport
ECOversight
Appealbody
CompetentAuthority
EthicsCommittee
CommitteeOffice
CCMO
New Developments
AnnualReport
ECOversight
Appealbody
CompetentAuthority
EthicsCommittee
Researchwith
gametocytes
Researchwith
GMOs
Non-therap.research with
incap. subjects
Celltherapy
Embryo research
Genetherapy
Xeno-transplantation
Nucleotideresearch
Vaccintrials
Herointrials
CommitteeOffice
CCMO
New Developments
AnnualReport
ECOversight
Appealbody
CompetentAuthority
EthicsCommittee
Marginal reviewof
drug trials
CommitteeOffice
CCMO
New Developments
AnnualReport
ECOversight
Appealbody
CompetentAuthority
EthicsCommittee
Drug trials Non-drug trials
CommitteeOffice
CCMO
New Developments
AnnualReport
ECOversight
Appealbody
CompetentAuthority
EthicsCommittee
EC members
ECSOPs
Samplesurvey
Trial registration
EC accreditation
EC regulation
EC annualreport
EC directive
Observationalresearch
Sitevisits
CommitteeOffice
CCMO
New Developments
AnnualReport
ECOversight
Appealbody
CompetentAuthority
EthicsCommittee
CCMOwebsite
Houses of parliament
CommitteeOffice
CCMO
New Developments
AnnualReport
ECOversight
Appealbody
CompetentAuthority
EthicsCommittee
Researchwith
embryos
Research with
gametocytes
Central Committee on Research Involving Human Subjects
CCMO, PO Box 16302, 2500 BH The Hague, The Netherlands www.ccmo.nl
Accreditation is given to MREC when:• minimal requirements for the MREC-composition are fulfilled
– one physician– one ethical expert– one lawyer– one research methodologist– one research subject member – one clinical pharmacologist– one pharmacist
• MREC has proper regulations • a minimum number of research dossiers is reviewed• MREC has a quality assurance system (e.g. SOPs)
• For all disciplines criteria have been established
• All members have to be approvedby the CCMO
Accredited MRECs January 2002
Average number of decisions/ MREC/ year; over the years: 2001 - 2002 - 2003
01020304050
60708090
100110120130140
150160170180190200
MRECs
Num
ber o
f dec
isio
ns
010
2030
4050
6070
8090
Q3
1999
Q1
2000
Q1
2001
Q1
2002
Q1
2003
Q1
2004
Q1
2006
num
ber a
ccre
dite
d M
REC
s
0
5
10
15
20
num
ber w
ithdr
awal
s
accredited MRECswithdrawals
Accredited MRECs in 1999 - 2006
non-official transition period professionalisation MREC’s
Central Committee on Research Involving Human Subjects
CCMO, PO Box 16302, 2500 BH The Hague, The Netherlands www.ccmo.nl
Accredited MRECs September 2004
University medical centres
Hospitals
Others
CCMO
Central Committee on Research Involving Human Subjects
CCMO, PO Box 16302, 2500 BH The Hague, The Netherlands www.ccmo.nl
Presentation
• Dutch review system
• Implementation EU clinical trial directive
• Webportal ToetsingOnline
• Summary
Central Committee on Research Involving Human Subjects
CCMO, PO Box 16302, 2500 BH The Hague, The Netherlands www.ccmo.nl
Ethical review
MREC Compet. AuthorityMHRA
Protocol, IB & IMPD
protocol & pat. info
Medical & scientific review
Research file
Review
system in U
nited Kingdom
60 days 30 days
EudraVigdb
Central Committee on Research Involving Human Subjects
CCMO, PO Box 16302, 2500 BH The Hague, The Netherlands www.ccmo.nl
Medical scientifical and ethical review Marginal review
Accredited EC Compet. AuthorityCCMO
IB & IMPD
protocol & pat. info
Research file
+
Review
system in the N
etherlands
60 days 14 days
EudraVigdb
Central Committee on Research Involving Human Subjects
CCMO, PO Box 16302, 2500 BH The Hague, The Netherlands www.ccmo.nl
Central versus decentral assessmentCentral review• hudge workload• review by civil servants• review limited to part of the
research file• responsibility CA & EC unclear• no interdisciplinary discussion• harmonisation easy• scientific/safety review
independent of ECs• no support for ECs required
Decentral review• modest workload• review by peers in institute• review of the complete research
file• responsibility CA & EC clear• interdisciplinary discussion in
committee meeting• harmonisation difficult• scientific/safety review by ECs• support ECs is essential
BMJ 8 nov 2008
Letter to The Times, January 14, 2009
Central Committee on Research Involving Human Subjects
CCMO, PO Box 16302, 2500 BH The Hague, The Netherlands www.ccmo.nl
Presentation
• Dutch review system
• Implementation EU clinical trial directive
• Webportal ToetsingOnline
• Summary
Webportal ToetsingOnline
ABR-form(research file)
Amendment
Annual rep.
SUSAR/SAE
End of trial report
ReviewOnline
Correspond.
Decision
Webportal ToetsingOnline(ReviewOnline)
CCMO website: www.ccmo.nl
CCMO website: www.ccmo.nl
CCMO public trial register with core data on different types of research
( February 2006 - April 2010)
obervational research
medicinal productsmedical devices
vaccin trials
other
Central Committee on Research Involving Human Subjects
CCMO, PO Box 16302, 2500 BH The Hague, The Netherlands www.ccmo.nl
Presentation
• Dutch review system
• Implementation EU clinical trial directive
• Webportal ToetsingOnline
• Summary
Central Committee on Research Involving Human Subjects
CCMO, PO Box 16302, 2500 BH The Hague, The Netherlands www.ccmo.nl
Decentral controlled & integrated peer review system
• Decentral:review by 27 accredited MRECs
• Controlled:oversight by the CCMO
• Integrated:all documents in one review
• Peer review:review by experts in accredited MRECs
• Limited central review:by CCMO (i.e., gene therapy, embryo research, xenotransplantation)
CCMO
Central Committee on Research Involving Human Subjects
CCMO, PO Box 16302, 2500 BH The Hague, The Netherlands www.ccmo.nl
Contact: [email protected]
More information: www.ccmo.nl
Central Committee on Research Involving Human Subjects
CCMO, PO Box 16302, 2500 BH The Hague, The Netherlands www.ccmo.nl
DisclaimerAan deze presentatie kunnen geen rechten worden ontleend.
Hoewel de CCMO grote zorg heeft besteed aan de in deze presentatie opgenomen informatie, kan zij niet instaan voor de juistheid daarvan.
In deze presentatie opgenomen opvattingen of meningen zijn uitsluitend die van de auteur en zijn daarmee niet per definitie een weergave van die van de CCMO.
De CCMO aanvaardt geen aansprakelijkheid voor de gevolgen van het gebruik van deze presentatie of de daarin opgenomen informatie.
Hergebruik van informatie opgenomen in de presentatie is toegestaan onder voorwaarde van bronvermelding.