Ireland - RECs and Medical Research
History
There are approximately 50 RECs in hospitals, universities and research institutions which consider applications from researchers or pharmaceutical companies. The majority of RECs are attached to hospitals and/or health boards. A fewer number are attached to higher education institutions with the remainder representing a variety of Organisations such as GPs, nurses, the Irish Prison Service and the Irish Travellers Ethics committee. Applications to the RECs then have to be ratified by the Irish Medicines Board.
EU directive 2001/20/EC has been integrated into Irish law through the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 which came into effect in May, 2004. The regulations supersede the Control of Clinical Trials Acts 1987 – 1990 for clinical trials using medicinal products. However because of the Act’s definition of the conduct of a clinical trial in Article 6 (as amended), the Act still applies to clinical trials involving non-medicinal substances.
The regulation set up a new supervisory body, the Ethics Committees Supervisory Body to establish and monitor RECs. This committee is based at the Ministry of Health. The Irish Medicines Board is the competent authority required by the Directive for authorisation of clinical trials .
The Irish Council for Bioethics was established in 2002 as an independent, autonomous body to consider the ethical issues raised by recent developments in science and medicine. In 2004, they produced Operational Procedures for Research Ethics Committees: Guidance. Additionally they provide public education on bioethics, issue reports and suggest guidelines.
Summary of Irish RECs
| Type of REC | Irish Council for Bioethics | Local RECs |
| Where situated? | Centrally | Hospitals, universities or research institutions |
| Who applies to them? | They set their own agenda | Researchers |
| Formal/Informal | Formal | Formal |
| National/Regional | National | Regional |
| Laws Involved |
|
|
| Guidance Involved | ||
| Membership requirements |
21
members including: |
Maximum
of 21 members consisting of expert and lay members. One third must be lay members. The operational procedures advise that each REC should consist of- |
| Responsible/accountable to whom? | Irish Medicines board - in future the Ethics Committees Supervisory Body | |
| Approval or Advisory powers | Advisory | Approval |
Not submitting research or failing to follow review
Approval by a recognized ethics committee is an essential part of the statutory scheme. IMB approval is a statutory requirement. Where IMB approval is granted for a clinical trial, it may not proceed until the ethics committee for the trial has given approval under the 2004 Regulations.
Part 8 of the 2004 Regulations provides that any alleged offence may be prosecuted by the IMB. Section 44(7) of the Regulations provides that a person guilty of an offence under these regulations shall be liable on summary conviction to a fine not exceeding 3 000 Euros or to imprisonment for a term not exceeding six months, or both. Defences of due diligence and reasonable precautions are available.
Contravention of the 1987 Act may lead to a fine or imprisonment.
Which body, if not the REC itself takes this action, and how do they proceed?
The Ethics Committees Supervisory Body takes appropriate action.
Impact of Directive 2001/20 EC
This has been implemented into Irish law through the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004. This came into force in May, 2004.
Legal action that can be taken against RECs
An appeal can be made to
the Ethics
Committees Supervisory Body for
a second REC opinion or against the original REC decision.
The 1987 &1990 Acts stipulate that no legal action can be taken against
an REC. There is provision for clinical
indemnity for all members of ethics committees in the Department of Health
guidance.
Links section
Laws
Organisations and Ethics Committees
See the REC bibliography section for more links and papers