Netherlands - RECs and Medical Research

History

The Netherlands was one of the first European countries to have developed and implemented ethics committees. Hospital ethics committees started appearing at the beginning of the 1980s and grew until nowadays many public hospitals and nursing homes have one. There are very rarely private hospitals in the Netherlands, so these do not need to be considered. A reason put forward for the ease in which ethics committees were incorporated and accepted is that the Netherlands has a 'natural affinity to deliberative structures and consultative bodies' due to its political structure (Gordjin 2000, 205).

Hospital ethics committees (HECs), which review clinical ethics, are separate to Medical Ethics Review Committees (METCs), which review medical research protocols. Research involving human subjects has been legally regulated since 1999 via the Medical Research Involving Human Subjects Act (WMO), which stipulates two types of committee involved in the assessment of research protocols involving humans - the METCs and the Central Committee on Research Involving Human Subjects (CCMO). All research involving human subjects must be assessed in advance by a committee. This can be undertaken by a METC or the CCMO, depending on the type of research.

The Parliament is currently in the process of making a further amendment to the WMO. (Click here for latest updates)

Summary of Netherlands RECs

Type of REC	Medical Ethics Review Committees (METCs)	Central Committee on Research Involving Human Subjects (CCMO)
Where situated?	Normally in an Institution such as a hospital	The Hague
Who applies to them?	Researchers - depends on type of research: Subjects capable of giving informed consent Therapeutic, subjects not capable of informed consent Non-therapeutic, subjects not capable of informed consent and is not interventional (observational)	Researchers - depends on type of research: Gene therapy Xenotransplantation (and other areas specified by Council) Involving embryos or gametocytes (advisory) Non-therapeutic, subjects not capable of informed consent and is interventional Non-therapeutic observational research the CCMO has ruled itself competent to review.
Formal/Informal	Formal - regulated by law	Formal - regulated by law
National/Regional	Regional	National
Laws Involved (see below)	1999 Medical Research Involving Human Subjects Act (WMO) Multicentre Directive Decree on Compulsory Insurance General administrative regulation on gene therapy and xenotransplantation	1999 Medical Research Involving Human Subjects Act (WMO) Multicentre Directive Decree on Compulsory Insurance General administrative regulation on gene therapy and xenotransplantation
Guidance Involved	CCMO Manual for the Review of Medical Research Involving Human Subjects 2002 Declaration of Helsinki ICH -GCP	CCMO Manual for the Review of Medical Research Involving Human Subjects 2002 Declaration of Helsinki ICH-GCP
Membership requirements	At least 5 members: At least one physician A lawyer An expert in medical research methodology An ethicist Person who can assess the medical research from the patient's viewpoint And If the committee is to review medicinal product trials, it should (preferably) include an expert or experts in clinical pharmacology and clinical pharmacy. Preferably an expert in nursing or nursing science If attached to an institution, at least one member must be independent of that institution.	See webpage below. At most 13 members, including At least 1 doctor Persons with expertise in: Pharmacology Nursing Behavioural science Law Research methodology Ethics Assessor of research from patient's viewpoint Advisors are listed for: - Gene therapy - Xenotransplantaion - In-vitro fertilization - Embryonal stem cell - Legal affairs - Immunology
Responsible/accountable to whom?	Independent administrative agency. However, all decisions are forwarded to the CCMO, who is also responsible for accreditation of METCs. The METC can still be part of a hospital or other body.	Answerable to the Minister of Health, Education and Sport and to Parliament.
Approval or Advisory powers	Approval	Approval and advisory

Not submitting research or failing to follow review

As this area is regulated by law, there are penalties in place for any person 'who performs research for which no protocol has been approved, or contrary to the protocol approved for it' (WMO section 33(5)) - they shall receive imprisonment of up to six months, or a fine in the 4th category (Euro: 12 500).

Which body, if not the REC itself takes this action, and how do they proceed?

Compliance with the WMO (relevant law) is monitored by Public Health Inspectors appointed by the Minister of Health, Welfare and Sport. They are empowered to require the provision of information and the production of documents (WMO S.28, 29).

Impact of Directive 2001/20/EC

Many of the principles present in the Guideline for Good Clinical Practice (first version 1993) published by the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), have already been incorporated into the law or practice. The Guideline for GCP has been incorporated into Article 55 of the Decree on Manufacturing and Delivering Medicinal Products (BBA), issued pursuant to the Medicines Act (WOG). Essentially, Article 55 of the BBA states that a medicinal product trial involving human subjects must be organized in accordance with the GCP Guidelines.
The Parliament is currently considering a further amendment to the WMO. (Click here for latest updates)

Legal action that can be taken against RECs

All decisions of a METC must be submitted to the CCMO, and they can reverse these decisions on administrative appeal. Appeal against a CCMO decision can be made to the administartive law division of the Appellant's High Court.

Links section

1999 Medical Research Involving Human Subjects Act (WMO)
Medical Research (Human Subjects) Compulsory Insurance Decree
General administrative regulation on gene therapy and xenotransplantation
Central Committee on Research Involving Human Subjects (CCMO)
CCMO External Review Directive
Manual for the review of medical research involving human subjects in the Netherlands, by the CCMO

Papers

Gordjin, B 'Ethics Committees in the Netherlands' In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

See the REC bibliography section for more links and papers