I represent the sponsor and am submitting a clinical trial of a medicinal product for review by Beaumont Hospital Ethics (Medical Research) Committee. Can I submit the ethics application at the same time as the IMB application?

Of course. You may submit the applications simultaneously, or submit in any order. The legislation requires that you obtain ethical approval and Irish Medicines Board approval, but there is no requirement as to which should be obtained first. The trial cannot proceed until both are in place.

Can you clarify what application form applies?

Yes, for clinical trials of medicinal products, please ensure to use the Department of Health and Children Application Form. For all other studies, the Research Ethics Committee Standard Application Form (RECSAF) applies. Both application forms are available here

Does the committee wish to review the Draft Clinical Trial Agreement and the Draft Form of Indemnity?

Yes, the committee reviews these documents with a view to ensuring that adequate insurance and/or indemnity is in place in case of harm occurring to research participants.

The committee's emphasis during review of the Form of Indemnity is to ensure that no changes have been made to the text of the Form of Indemnity and to ensure that the correct appointing authority has been listed e.g. the appointing authority for Beaumont Hospital is 'Beaumont Hospital Board.' (Of note, as of the 1st of July 2007, there is a standard Form of Indemnity which it is compulsory to use at many sites in the Republic of Ireland.)

With respect to the Clinical Trial Agreement, the committee will be keen to ensure that this document allows participants to seek compensation in the Republic of Ireland as opposed to outside the jurisdiction.

A common problem with Clinical Trial Agreements, Investigator Agreements or Financial Agreements is that they refer to institutions etc. which do not exist in the Republic of Ireland e.g. the NHS, Hospital Trusts etc.

Please submit the draft agreements and forms for review by the committee.

The Committee will also require a copy of the Certificate of Insurance for the sponsor company.

Please further note that the requirement to submit copy Forms of Indemnity, Clinical Trial Agreements and Certificates of Insurances applies to all studies submitted by external agencies and not just to studies which are 'clinical trials of medicinal products.'

I represent a sponsor and am submitting a clinical trial of a medicinal product for review by Beaumont Hospital Ethics (Medical Research) Committee. Can you tell me more about 'Site Specific Assessment Forms.'

''Site Specific Assessment' Forms are forms which are signed by the Principal Investigator at a site and the Chief Executive Officer at a site. By signing these forms, both parties confirm to the Research Ethics Committee that they agree that the site has the facilities and personnel to conduct a particular interventional trial of a medicinal product.

The Committee recognises however that while it is often feasible for sponsors to arrange for signatures of these documents by the Site 'Principal Investigator' that there can be delays in arranging for signatures of hospital CEOs (or site equivalents). Hence, the committee will review unsigned versions of this document on condition that the signed versions are received as soon as possible following signature.

The Committee is aware that a number of CEOs (or site equivalents) may not be willing to sign Site Specific Assessment Forms without evidence of ethical approval or indeed Irish Medicines Board approval.

I note that the agenda (for your meetings) books out quickly, and we are required to book an agenda slot at a meeting.

Yes. Priority placement is given to clinical trials of medicinal products, and the committee aims to review a maximum of 4 such trials per meeting. Part of the reason pharmaceutical companies are requested to book an agenda slot is to give the committee time to co-opt the relevant expert reviewers on board to review your trial.

The committee also needs time to arrange for external and specialist review, for example, in the case of gene therapy trials, trials involving minors or trials involving incompetent adults.

I represent the sponsor and the application I am submitting is a non-interventional trial of a medicinal product.

If your application is a non-interventional trial of a medicinal product, the committee's opinion is limited to Beaumont Hospital, St. Joseph's Hospital Raheny and St. Ita's Hospital, Portrane. If your study includes sites other than these, please contact the ethics committee relevant to those sites for ethical approval to proceed at those other sites.

Although the study is not a clinical trial of a medicine, it does have approval to proceed from a recognised ethics committee. Is this approval valid for Beaumont Hospital?

No. Recognised ethics committees can give approval for the state of Ireland for clinical trials of medicinal products only. An application should be made to Beaumont Hospital Ethics (Medical Research) Committee in respect of all other types of research. The opinion of any other ethics committee is not valid for Beaumont Hospital.

Please note that this position is subject to change and legislation is expected in 2012. (This site is regularly updated and any changes in legislation will be reflected in the content on this site.)