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UK-based Company Applicants
Clinical Trials of Medicines / Medicinal Products
UK-based companies making their first submission in the Republic of Ireland should note that there is no central allocation system in place in Ireland.
There is no equivalent to NRES in Ireland, and your contact will be directly with the ethics committee you are applying to.
The European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 were enacted into Irish law on the 1st May 2004
via a statutory instrument called Statutory Instrument 190 of 2004. This legislation is identical to the UK legislation covering clinical trials of medicinal products.
There are 13 Ethics Committees in Ireland recognised to give a single opinion for the state of Ireland for a clinical trial of a medicinal product only.
Beaumont Hospital Ethics (Medical Research) Committee is one of these recognised committees.
All recognised committees are ICHGCP compliant and compliant with S.I. 190 of 2004. The Department of Health and Children has provided guidelines for recognised
ethics committees in relation to review of clinical trials of medicines only.
In the UK there are no fees applicable for ethical review of clinical trials of medicines.
In Ireland, standard fees have been laid down by Irish legislation.
All recognised committees charge the same standard fees for review of clinical trials of medicines only
You will be familiar with making an application to a 'Competent Authority' as well as making an application for ethical review in the UK.
The equivalent of the MHRA in the Republic of Ireland is the Irish Medicines Board (IMB).
In Ireland, you must make an application to the Irish Medicines Board
and to one recognised ethics committee, in respect of any clinical trial of a medicinal product.
Once a favourable ethics committee opinion is in place,
you will then be approaching the site CEOs to sign the relevant forms of indemnity and clinical trial agreements.
Each hospital and site has developed different procedures prior to signing these agreements.
There is a Standard Form of Indemnity which is compulsory for use in in all public hospitals and healthcare institutions in the Republic of Ireland. Your clinical trial cannot begin at a site until the agreements have been signed by the site CEO on behalf of that site.
Generally, typical sites will be hospitals. Public hospitals and all employees of public hospitals (similar to the NHS) are
insured by an insurance scheme called the Clinical Indemnity Scheme. This scheme is run by the State Claims Agency. Private hospitals and Private Clinics will have alternative private insurance in place.
You will be familiar with submitting individual SUSAR reports within specific timelines in the UK.
In Ireland, it is only necessary to submit SUSAR Reports which relate to SUSARS which have occurred in Ireland only.
There is no requirement to submit international SUSARs to the recognised Ethics Committee.
The Recognised Committee will review international SUSARs via Six-Monthly and Annual Safety Reports.
There are also fees in the Republic of Ireland for review of substantial amendments to clinical trials of medicines only.
Again, these are standard fees and have been set by legislation.
With reference to legislation in the Republic of Ireland,
the Data Protection Legislation in the Republic of Ireland is similar to the Data Protection Legislation in the United Kingdom.
There is however no equivalent to the UK Human Tissue Act in Ireland as yet.
An Irish Human Tissue Act is still at consultation stage.
Applications Other Clinical Trials of Medicines / Medicinal Products
If your application is not a clinical trial of a medicine,
e.g. a non-interventional, epidemiological or observational study,
then applying for ethical review in the Republic of Ireland will involve ethics applications to each relevant ethics committee.
The reason for this is that there is no legislation in the Republic of Ireland to allow an ethics committee to give a single ethical opinion
for these types of studies. A Health Information Bill is currently at consultation stage.
and is expected to be enacted in 2012. However in the interim, you must apply to multiple research ethics committees to conduct this type of research.
Each committee will have an individual application form and individual submission requirements.
(This is subject to ongoing and daily change. Many committees have started to move towards acceptance and use of a Research Ethics Committee Standard Application Form for these types of studies.
This form is subject to regular consultation and updated on a six monthly basis.
Fees and processes will also vary from committee to committee.
Some Irish committees will wish to review the application in full.
Other committees may have a method of expediting your application if the application has already received a favourable opinion from one or more Irish Ethics Committees.
There are many research ethics committees (incomplete listing)
in the Republic of Ireland. Once you have decided which sites you intend to run your study in, the investigator at that site should be in a position to
inform you which Research Ethics Committee provides ethical approval in respect of a particular site.
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