Display: A A A Contact  | Links
Enabling Clinical and Translational Research

General Information on Clinical Research in Ireland


This section contains information on Competent Authority and Ethical requirements for Clinical Research in Ireland. It also includes general information on Medical Devices, other interventional therapeutic trials not using Medicinal products or devices, and Diagnostic and Epidemiology studies.

 

Quicklinks

. 3

. 9

 

. 1821. 2

1 Introduction 5.6 Animal derived products
1.1

Human research protections in Ireland. 3

5.7 Other interventional therapeutic trials not using medicinal products nor medical devices
2 Submission to Competent Authority and Ethics Committee in Ireland 5.7.1 Radiotherapy trials
2.1 Initial submission to Competent Authority and Ethics Committees 5.7.2 Surgery trials
2.1.1 Table of documents required in addition to the general procedure in Ireland 5.7.3 Transplantation
2.1.2 Documents to translate in national language for the submission 5.7.4 Transfusion
2.1.3 Completing a CTA form 5.7.5 Physical therapy
2.2 Submission of Amendment to Competent Authority and Ethics Committees 5.7.6 Psychotherapy without medicinal product
2.2.1 Definition of substantial amendment 5.8 Diagnostic studies
2.3 Declaration of the End of the trial to Competent Authority and Ethics Committees 5.9 Clinical research on nutrition
2.3.1 Flowchart for the submission of the end of the trial in Ireland 5.10 Other interventional clinical research not using medicinal products nor medical devices
3 General information about ethics committee 5.10.1 Complementary and alternative medicines
3.1 Local ethics committee 5.10.2 Physiology, physiopathology and psychological trials
3.2 Member of ethics committee 5.11 Epidemiology
3.3 Contact details 5.11.1 Interventional pharmaco epidemiology
3.4 Table with fees and timeline 5.11.2 Non interventional pharmaco epidemiology
4 General information about competent authority 5.11.3 Interventional epidemiology not using medicinal products nor medicinal devices
4.1 Name of the competent authority 5.11.4 Non interventional epidemiology not using medicinal products nor medicinal devices
4.2 Contact details 5.11.5 Registries of patients
4.3 Specific competent authority 5.12 Miscellaneous
4.4 Table with fees and timeline 5.12.1 Usual care
5 Specificity by types of studies 5.12.2 Genetic or genotype/ phenotype studies
5.1 Summary of ethical and regulatory requirement 5.12.3 Compassionate use, requirements for sponsor
5.2 Investigational product 6 Other information about clinical trial
5.2.1 Definition 6.1 Specific population
5.3 Medical devices 6.1.1 Healthy participants
5.3.1 Medical devices alone authorised 6.1.2 Vulnerable population
5.3.2 Medical devices alone non authorised 6.2 Information and Informed Consent Form
5.3.3 . 18Medical devices combined with medicinal products authorised or not authorised 6.2.1 Responsibilities
5.3.4 Ethics committee 6.2.2 Content of Informed Consent Form
5.3.5 Competent authority 6.3 Personal data protection
5.4 Genetically modified organisms 6.3.1 Responsibility
5.4.1 Competent authority 6.3.2 General Principles
5.4.2 Ethics committee 6.4 Transparency: register and information to the participants
5.4.3 Manufacturing 6.5 Archiving
5.4.4 Importation 6.6 Non commercial trials / non commercial sponsors
5.5

Stem cells

6.7

Co sponsorship

 

 

. 36

1. Introduction

1.1 Human Research Protections in Ireland


Key Organisations
Legislation/ Regulations
Guidelines
General

1. Irish Council for Bioethics (ICB)

2. Irish Medicines Board (IMB)

3. Department of Health and Children


1. ICB: Operational Procedures for Research Ethics Committees: Guidance 2004

2. Guidance on the Application for Recognised Ethics Committee Opinion ad the Ethical review of Clinical Trials on Medicinal Products for Human Use (2007)

 

Drugs
Irish Medicines Board (IMB)

1.European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004

2. European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (S.I. No. 878 of 2004

3.European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment No.2) Regulations 2006 (S.I. 374 of 2006)

4.European Communities (Clinical Trials on Medicinal Products for Human Use)Regulations 2004 to 2006 (Informal Codification Text)


Devices

Irish Medicines Board (IMB)

National Standards Authority of Ireland (NSAI)


ISO 14155 (2011)
Data Protection
Data  Protection Commissioner
Data Protection Act (1988), as amended (2008)

Human Biological Samples
1. Irish Council for Bioethics (ICB)

Genetics Research
Irish Medicines Board (IMB)
Guidelines for Pharmacogenetic Research (2006)
Embryos, Stem Cells and Cloning
Irish Medicines Board (IMB) Convention on Human Rights and Biomedicine (Convention of Oviedo), Additional Protocol on Prohibition of Human Cloning  

 

back_to_top 

 

 

2. Submission to Competent Authority and Ethics Committee


 

 

2.1. Initial Submission to Competent Authority and Ethics Committee


 

 back_to_top

 

2.1.1. Table of documents required in addition to the general procedure in Ireland

Documents

 

CA
EC
CV of the principal investigators in each MS concerned Yes Yes
Summary of the protocol in the national language Yes Yes
Outline of all active trials with the same IMP Yes Yes
If IMP not manufactured in E.U. and if no marketing authorisation in EU: Certification of the QP that the manufacturing site works in compliance with GMP at least equivalent to EU GMP or that each production batch has undergone all relevant analyses, tests or checks necessary to confirm its quality Yes Yes
If IMP not manufactured in E.U. and if no marketing authorization in EU: Certification of GMP status of active biological substance Yes Yes
If IMP not manufactured in E.U. and if no marketing authorization in EU: Copy of the importer's manufacturing authorisation as referred to in Art.13 of the Directive
Yes Yes
Examples of the label in the national language Yes Yes
Copy of authorisation to cover trials or products with special characteristics e.g. GMOs, radiopharmaceuticals Yes Yes

CA= Competent Authority   EC=Ethics Committee

back_to_top

 

2.1.2 Documents to translate into national language for the submission

N/A unless not in English

2. 1.3. Completing a CTA form

IMB: Guide to Documents for new Clinical Trial Applications

2.2. Submission of Amendments to the Competent Authority and Ethics Committee



 

 back_to_top

 


 

 back_to_top

2.2.1. Definition of Substantial and non-substantial amendments

Detailed guidance for the request for authorisation of a clinical trial for a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial. October (2005) Section 4.3.2.1.

2.3 Declaration of the End of the Trial to Competent Authority and Ethics Committee

2.3.1. Flow chart for the submission of the end of the trial in Ireland.

 

 back_to_top 

3. General Information about Ethics Committees

The principal investigator (PI) is responsible for the submission to a recognised ethics committee (in practice this is usually carried out by the sponsor on behalf of the PI). The application and choice of a single recognised ethics committee is the decision of the sponsor. Each local ethics committee must sign the Site Specific Assessment Form (SSA form) in order to confirm that a) local staff are suitably qualified and b) there are sufficient resources to carry out the trial locally. In practice, however, two local ethics committees also carry out an additional ethical review of the study in relation to the hospital ethos and culture.

back_to_top

3.1. Local Ethics Committee

Local ethics committees assess the suitability of the investigator, the site staff and resources

3.2. Members of Ethics Committee

 A maximum of 21 members, of which at least one third shall be lay members and at least one half of those lay members shall have never been health-care professionals. All members may have designated deputies.

7 is the minimum quorum for a valid ethics committee, of which one is the chairperson, one is a lay person who has never been a health-care professional or served on or been employed by a health service body, and one is an expert member.

back_to_top

3.3. Contact Details

There are 13 recognised Ethics Committees in Ireland that have been certified by the Department of Health and Children as the only ethics committees that can give a single opinion in the case of IMP trials only.

Name of Ethics Committee
Address for correspondence Date of Recognition Area for which committee may act Description or class of clinical trials for which committee may act
SJH/AMNCH Research Ethics Committee
Tallaght Hospital Dublin 24- (01) 4142860 13 July 2004 The whole State Clinical Trials of all descriptions and classes
St. Vincent's Healthcare Group Ethics and Medical Research Committee Administrator, St. Vincent's Healthcare Group Ethics and Medical Research Committee, Education and Research Centre, Elm park, Dublin 4. - (01) 277 4117
13 September 2004  The whole State Clinical Trials of all descriptions and classes
Clinical Research Ethics Committee of the Cork Teaching Hospitals Secretariat, Clinical Research Ethics Committee of the Cork Teaching Hospitals, 1st floor, lancaster Hall, 6 Little Hanover St., Cork- (021) 490 1901 27 September 2004 The whole State Clinical Trials of all descriptions and classes
HSE North East Area Research Ethics Committee Secretary, HSE North East Area Research Ethics Committee, Dublin Rd, Kells, Co. Meath- (046) 9280521/564 26 January 2005 The whole State Clinical Trials of all descriptions and classes
Research Ethics Committee, Mater Misericordiae University Hospital and Mater Private Hospital  Administrator, Research Ethics Committee, Mater Misericordiae University Hospital, Eccles St., Dublin 7. (01) 8032971 22 February 2005 The whole State Clinical Trials of all descriptions and classes
Beaumont Hospital Ethics Committee Gillian Vale, Administrator, Ethics Committee, Beaumont Hospital, Beaumont Rd, Dublin 9. (01) 8092680 9 March 2005 The whole State Clinical Trials of all descriptions and classes
Galway Regional Hospitals Research Ethics Committee Secretary, Research Ethics Committee, Unit 4, Merlin park Hospital, Galway- (091) 775022  21 April 2005 The whole State Clinical Trials of all descriptions and classes
Research Ethics Commitee, Our Lady's Children's Hospital, Crumlin Secretary Research Ethics Committee, Our Lady's Children's Hospital Crumlin, Dublin 12. (01) 409 6243/6307 17 May 2005 The whole State Clinical Trials of all descriptions and classes
Irish College of General Practitioners Research Ethics Committee Admin, ICGP Research Ethics Committee, 4/5 Lincoln Place, Dublin 2. (01) 6763705
17 May 2005 The whole State Clinical Trials of all descriptions and classes
Ethics Research Committee, National Maternity Hospital Secretary Research Ethics Committee, CEO Office, National Maternity Hospital, Holles St., Dublin 2. (01) 63 73 100 20 July 2005 The whole State Clinical Trials of all descriptions and classes
HSE South-Eastern Area Research Ethics Committee Secretary Research Ethics Committee, Old School of Nursing, Waterford Regional Hospital, Dunmore Road, Waterford. (051) 842 391 30 August 2005 The whole State Clinical Trials of all descriptions and classes
Research Ethics Committee Sligo General Hospital Administrator, Research Ethics Committee, Sligo General Hospital, The Mall, Sligo- (071) 917 11 11 20 September 2005 The whole State The Committee shall act in relation to clinical trials and classes other than those to which Regulation 13 (4) refers (i.e. gene therapy, somatic cell therapy etc.)
HSE Mid-Western Area Research Ethics Committee

Secretary, Ethics Committee, Mid-Western Regional Hospital, Dooradoyle, Limerick- (061) 482 482

22 March 2006 The whole State Clinical Trials of all descriptions and classes

 

 back_to_top

3.4. Table with Fees and Timeline

  Fee
Timeline
Initial Submission €1000 Within 60 days of receipt of valid application. This includes the necessary site specific assessments.
Amendment €250 35 days

 back_to_top 

4. General Information about Competent Authority

The only Competent Authority (CA) is the Irish Medicines Board (IMB). The IMB will consult its clinical trials subcommittee for trials involving products for gene therapy, somatic cell therapy or products containing GMOs. The sponsor is responsible for the Clinical Trial Application (CTA) but it can also be a legal representative (if the sponsor is not established in EEA countries) or an applicant authorised by the sponsor. The CA will issue written notice of acceptance of a clinical trial application. In addition, a letter of authorisation is issued for all trials recommended for approval. For blood-derived products, monoclonal antibodies, recombinant proteins, peptides and oligonucleotides, a written authorisation from the IMB can be requested. In this case the IMB will send a notice to the applicant within seven days of the receipt of the valid application informing that a written authorisation is required.

back_to_top

4.1. Name of the Competent Authority

 The Irish Medicines Board (IMB)

4.2.  Contact Details

 Irish Medicines Board website: www.imb.ie

4.3. Specific Competent Authorities

Medical Devices: NSAI (National Standards Authority, Ireland)

 

4.4 Table with Fees and Timelines

  Timelines Fees
Initial Submission
  • 30 days
  • for gene therapy, somatic cell therapy and products containing GMOs: 90 days
  • If accepted with conditions or rejected, the sponsor has 14 days (30 days for gene therapy, somatic cell therapy and products containing GMOs) to answer.
  • The final decision is made within 60 days (180 days for gene therapy, somatic cell therapy or products containing GMOs) of the general request.
  • Only one cycle of correspondence on any queries, which arise from the assessment, is allowed. if no answer is received from the sponsor or if the answer is not acceptable, the applicant is refused. opportunities exist for dialogue with the IMB to ensure questions are adequately addressed prior to submission of the final response
  • From €256 to €2754 depending on agent (e.g. novel agent costs more than trial on drug used within its license)

 

  • In addition, academic trials may be free of charge, if there is no financial support for the trial
Amendment Coming soon From €80 to €162

 

 back_to_top 

5. Specificity by Types of Studies

 

5.1. Summary of Ethical and Regulatory Requirement

 

 


  back_to_top

 

 

5.2. Investigational Medicinal Product (IMP)

5.2.1. Definition

Is it a Clinical Trial of  a Medicinal Product?

The following algorithm will help you to answer that question. Please start on Column A and follow the instructions. If you have any doubts, please contact the clinical trials unit of your competent authority.

A B C D E
A Clinical Trial of a Medicinal Product? A Non-Interventional Clinical Trial?
Is it a medicinal product? (MP) Is it not a medicinal product? What effects of the medicine are you looking for? Why are you looking for those effects? How are you looking for those effects?

If you answer NO to all the questions in Column A, the activity is not a clinical trial on an IMP.

If you answer YES to any of questions A1-A3 below go to Column B

If you answer yes to question B1 the activity is not a clinical trial on an IMP

If you answer NO to question B1 below, go to column C

If you answer NO to all the questions in Column C, the activity is not a clinical trial under the scope of Directive 2001/20/EC.

If you answer YES to any of questions C1-C4 below, go to Column D

If you answer NO to all the questions in Column D, the activity is not a clinical trial under the scope of Directive 2001/20/EC.

If you answer Y|ES to either question D1 or D2 below, go to Column E

If you answer YES to all the questions below the activity is a non-interventional trial which is outside the scope of Directive 2001/20/EC.

If your answer in columns A,B,C & D brought you to Column E and you answer NO to any of questions E1-E6, the activity is a clinical trial within the scope of Directive 2001/20/EC

A1. Is it a substance or combination of substances presented as having properties for treating or preventing disease in human beings?

A2. Does the substance function as a medicine, i.e., can it be administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action or to make a medical diagnosis or is otherwise administered for a medicinal purpose?

A3 Is it an active substance in a pharmaceutical form?

B1. Are you only administering any of the following substances?

  • Human Whole  Blood
  • Human Blood Cells
  • Human Plasma
  • Tissues except somatic cell therapy medicinal products
  • A food product (including dietary supplements) not presented as a medicine
  • A cosmetic product
  • A medical device

 

C1. To discover or verify/compare its clinical effects?

C2. To discover or verify/compare its pharmacological effects e.g. pharmacodynamics?

C3. To identify or verify/compare its adverse reactions?

C4. To study or verify/compare its absorption distribution, metabolism or excretion (ADME)?

D1. To ascertain or verify/compare the efficacy of the medicine?

D2. To ascertain or verify/compare the safety of the medicine?

E1. Is this a study of one or more medicinal products, which have a marketing authorisation in the Member State concerned?

E2. Are the products prescribed in the usual manner in accordance with the terms of that authorisation?

E3. Does the assignment of any patient involved in the study to a particular therapeutic strategy fall within current practice and is not decided in advance by a clinical trial protocol?

E4.Is the decision to prescribe a particular medicinal product clearly separated from the decision to include the patient in the study?

E5. Will no diagnostic or monitoring procedures be applied to the patients included in the study, other than those which are applied in the current course of practice?

E6. Will epidemiological methods be used for the analysis of the data arising from the study?

 back_to_top 

5.2.2. Labeling of Medicinal product and Waivering of Costs for Non-commercial Trial

 

5.3. Medical Devices

5.3.1. Medical devices alone authorised

When the device is used alone and it is European Conformity (CE) labelled and used within its indication, the only requirement is an authorisation of the clinical trial from the ethics committee and the national data protection agency. Studies with a medical device are not governed by a central ethics committee, so permission must be sought form the governing ethics committee for each hospital where the research is conducted.

back_to_top

5.3.2. Medical devices alone non-authorised

Clinical Trials with a non-authorised device alone require review and approval by the Irish Medicines Board prior to commencement, except in some cases when the trial is initiated and sponsored by clinicians and is not for commercial purposes. The ethical review is not reviewed by a central ethics committee, so permission must be sought from the governing ethics committee for each hospital where the research is conducted. The competent authority is the Irish Medicines Board, that will provide written acknowledgment of the valid application. The time frame for review at the IMB is 60 calendar calendar days. Prior to the 60 days, the IMB will issue a letter to the sponsor indicating whether the IMB has an objection to the investigation proceeding.

There must be a responsible applicant for the submission and there is a need for insurance. Claims arising from patients whose treatment was part of a clinical trial or approved research project are covered under the Clinical Indemnity Scheme (ICS). In trials sponsored by external organisations such as pharmaceutical companies, the coverage under this scheme extends to treatment only and does not cover product liability or claims arising form trial design or protocol. Cover against such claims remains the responsibility of the body conducting the trial or  research project and an appropriate indemnity must be secured from external sponsors and external cover will be sought from manufacturer applicant.

Serious adverse events, anticipated and unanticipated, must be reported by the sponsor to the medical device section of the competent authority and the relevant ethics committee in line with definitions of harmonised standards. Time-lines for reporting are aligned with those of the medical device vigilance system (MEDDEV 2.12-1 rev5). Specific adverse event reporting requirements may be required and summary safety reporting is also required.

back_to_top

5.3.3. Medical devices combined with medicinal products authorised or non-authorised

Legislation applied to clinical trials of drug device combinations is dependent on the primary action of the combination. When the device has the primary action in the combination and the medicinal substance acts in a manner ancillary to that of the device, the relevant medical device directive is applied (93/42/EEC or 90/385/EEC). When the medicinal substance has the primary effect in the combination, Directive 2001/20/EC is applicable.

There must be a responsible applicant for the submission and there is a need for insurance. Claims arising from patients whose treatment was part of a clinical trial or approved research project are covered under the Clinical Indemnity Sheme (ICS). In trials sponsored by external organisations such as pharmaceutical companies, the coverage under this scheme extends to treatment only and does not cover product liability or claims arising form trial design or protocol. Cover against such claims remains the responsibility of the body conducting the trial or  research project and an appropriate indemnity must be secured from external sponsors and external cover will be sought from manufacturer applicant.

Adverse incidents must be reported, by the sponsor or the investigator (if no sponsor) to the medical device section of the competent authority and the relevant ethics committee, as soon as possible or within 10 days. A safety report is also requested.

back_to_top

5.3.4. Ethics Committee

No central ethics committee exists for medical devices. Local ethics committee approval for each site where research is conducted is required.

5.3.5. Competent Authority

Irish Medicines Board (IMB)

National Standards Agency Ireland (NSAI)

back_to_top

5.4. Genetically Modified Organisms

5.4.1. Competent Authority

Irish Medicines Board (IMB)

5.4.2. Ethics Committee

Central Ethics Committee

5.4.3. Manufacturing

GMP and manufacturing authorisation in EEA country. If the product is manufactured outside of the EEA, the importing company must hold a manufacturing authorisation for this "third country" importation. The Qualified Person (QP) in the importing manufacturing compnay must satisfy him/herself of the GMP status of the manufacturing site outside the EU/EEA. The CA reserves the right to perform GMP inspections at such sites, under SI 190 (2004).

5.4.4. Importation

See 5.4.3.

5.5. Stem Cells

 

5.6. Animal-derived Products

 

5.7. Other Interventional Therapeutic Trials Not Using Medicinal Products or Medical Devices

Review by research ethics committee may not be required for:

  • (a) Reseearch utilising existing publicly available documents or data
  • (b) Observationall studies in public places in which the identities of the participants remain anonymous.
  • (c) Case Study of one patient with the proviso that written informed consent has been obtained from the relevant participant.
  • (d) Quality assurance studies
  • (e) Audits.

The opinion of the research ethics committe should be sought whenever there is any doubt about the applicability of this guidance to a particular research project. The ethical review of other therapeutic trials detailed above is not overseen by a central ethics committee, so permission must be sought from the governing ethics committee of each hospital where the research is conducted.

Competent authority (IMB) approval is requirede only if a medicinal product or a medical device is used, but it may be necessary to solicit an IMB response on a case-by-case basis. Claims arising from patients whose treatment was part of a clinical trial or approved research project are covered under the Clinical Indemnity Sheme (ICS). In trials sponsored by external organisations such as pharmaceutical companies, the coverage under this scheme extends to treatment only and does not cover product liability or claims arising form trial design or protocol. Cover against such claims remains the responsibility of the body conducting the trial or  research project and an appropriate indemnity must be secured from external sponsors.

Regarding adverse events reporting, there is no statutory obligation to report events but it is considered best practice for investigators to report SAEs to the relevant ethics committee. In addition, for transplantation and transfusion trials, serious adverse events require reporting to the competent authority.

back_to_top

5.7.1. Radiotherapy trials

Local Ethics Committee approval only.

5.7.2. Surgery trials

Local Ethics Committee approval only.

5.7.3. Transplantation

Local Ethics Committee approval only.

5.7.4. Transfusion

Local Ethics Committee approval only.

5.7.5. Physical Therapy

Local Ethics Committee approval only.

5.7.6. Psychotherapy without medicinal product

Local Ethics Committee approval only.

 back_to_top 

5.8. Diagnostic Studies

In general there is no specific legislation unless the study involves an in-vitro diagnostic device in which case the requierments of the In-Vitro Diagnostic Directive (98/79/EC) apply and the device may need to be registered for 'performance evaluation' with the competent authority. A submission of the study to the governing ethics committee, where the trial is being conducted by the sponsor or person resonsible, is required.

Claims arising from patients whose treatment was part of a clinical trial or approved research project are covered under the Clinical Indemnity Sheme (ICS). In trials sponsored by external organisations such as pharmaceutical companies, the coverage under this scheme extends to treatment only and does not cover product liability or claims arising form trial design or protocol. Cover against such claims remains the responsibility of the body conducting the trial or  research project and an appropriate indemnity must be secured from external sponsors. For studies involving General Practitioners, their medical malpractice insurance will also be pertinent. There is no statutory obligation to report adverse events but it is considered best practice for the investigator to report serious adverse events to the relevant ethics committee.

back_to_top

5.9. Clinical Research on Nutrition

Depending on whether nutrition and nutritional supplements are considered as food, cosmetic or medicinal products, a competent authority authorisation must be obtained. It may be necessary to solicit an IMB response on a case-by-case basis. If the nutritional supplement is licensed a medicinal product, the adverse event reporting is the same for clinical trials with medicinal products. In the other cases, there is no statutory obligation to report adverse events but it is considered best practice for the investigator to report serious adverse events to the relevant ethics committee.

 back_to_top

5.10. Other Interventional Clinical Research Not Using Medicinal Products or Medical Devices

Herbal medicines trials have to follow the requirements of medicinal products (submission to EC, CA, need for sponsor and insurance) if they fall under the definition of a clinical trial in SI 190 of 2004. The collection of blood, other fluids or tissue samples requires an ethical approval (to be done by the principal investigator). There is no statutory obligation to report adverse events but it is considered best practice for the investigator to report serious adverse events to the relevant ethics committee.

5.10.1. Complementary and alternative medicines

Local Ethics Committee approval only.

5.10.2. Physiology, physiopathology and psychological trials

 

5.11.Epidemiology

5.11.1. Interventional pharmaco-epidemiology

The interventional pharmaco-epidemiological studies follow the same requirements as for clinical trials on medicinal products, i.e. IMB authorisation, ethics committee approval, need for a sponsor (no opinion on co-sponsorship).

Claims arising from patients whose treatment was part of a clinical trial or approved research project are covered under the Clinical Indemnity Sheme (ICS). In trials sponsored by external organisations such as pharmaceutical companies, the coverage under this scheme extends to treatment only and does not cover product liability or claims arising form trial design or protocol. Cover against such claims remains the responsibility of the body conducting the trial or  research project and an appropriate indemnity must be secured from external sponsors. For studies involving General Practitioners, their medical malpractice insurance will also be pertinent. The serious adverse events must be reported on an expedited basis (within 15 days) to the competent authority of the Member State on whose territory the incident occured. All adverse events, including those which are considered non-serious, should be summarised in the final study report to be submitted to the competent authority.

back_to_top

5.11.2. Non-interventional pharmaco-epidemiology

For non-interventional pharmaco-epidemiological studies, there is  a notification to the competent authority (Clinical Trial Application is not requested), an ethical review (it is necessary to obtain separate ethics committee approvals for each site/ region that is conducting the study).

Claims arising from patients whose treatment was part of a clinical trial or approved research project are covered under the Clinical Indemnity Sheme (ICS). In trials sponsored by external organisations such as pharmaceutical companies, the coverage under this scheme extends to treatment only and does not cover product liability or claims arising form trial design or protocol. Cover against such claims remains the responsibility of the body conducting the trial or  research project and an appropriate indemnity must be secured from external sponsors. For studies involving General Practitioners, their medical malpractice insurance will also be pertinent.

back_to_top

5.11.3. Interventional epidemiology not using medicinal products or medical devices

For interventional epidemiology not using medicinal products or medical devices, a sponsor and an ethical review is required.

Claims arising from patients whose treatment was part of a clinical trial or approved research project are covered under the Clinical Indemnity Sheme (ICS). In trials sponsored by external organisations such as pharmaceutical companies, the coverage under this scheme extends to treatment only and does not cover product liability or claims arising form trial design or protocol. Cover against such claims remains the responsibility of the body conducting the trial or  research project and an appropriate indemnity must be secured from external sponsors. For studies involving General Practitioners, their medical malpractice insurance will also be pertinent. The serious adverse events are reported to the ethics committee by the sponsor.

back_to_top

5.11.4. Non-interventional epidemiology not using medicinal products or medical devices

For non-interventional epidemiology studies, there is a need for a sponsor, an ethical review and a requirement for notification to the competent authority.The serious adverse events are reported to the ethics committee by the sponsor.

5.11.5. Registries of patients

Submission to the local ethics committee depends on data collection. If classified as audit with completely anonymised data, no ethical review is needed. If identifiers are collected there is a need to obtain an ethical approval (separate ethics committee approval for each site/ region that is conducting the study) and consent from the participant. There is no statutory obligation to report adverse events but it is considered best practice for the investigator to report serious adverse events to the relevant ethics committee.

back_to_top

5.12. Miscellaneous

5.12.1. Usual Care

Usual care studies are treated as non-interventional studies. However, depending on whether the data collected in these trials are truly anonymised and not pseudo-anonymised, there is room for collection of data such as prescription monitoring, retrospective studies where consent cannot be obtained. This must be collected in line with the Data Protection Act.

5.12.2. Genetic or genotype/ phenotype studies

The Irish Council for Bioethics details recommendations for use. The Irish Medicines Board also has detailed guidance in pharmacogenetic research.

5.12.3. Compassionate use, requirements for sponsor

Currently, compassionate use studies can fall under either SI 190 of 2004 or 'named patient'. SI 540 of 2007, Schedule I, exempts a product without a marketing authorisation in Ireland to be imported, but the prescription and responsibility of the oversight of the product is that of the prescriber (consultant). Products provided on a compassionate use basis between completion of Phase III and the expected regulatory approval time frame is treated as a clinical trial under SI 190. The Irish Competent Authority has recently established a statutory notification system for use of unauthorised medicines.

back_to_top

6. Other Information About Clinical Trials

6.1. Specific Population

6.1.1. Healthy participants

There are no compensation fees for participants in clinical research. However, small expenses incurred by participants for involvement in the study may be reimbursed.

6.1.2. Vulnerable population

Vulnerable populations can be interpreted as children and adults unable to give consent by physical or mental incapacity.

There is no waiver of consent in case of emergency research. In case of incapacity to consent (unconscious, dementia, etc), there is no specific legislation in this regard, but a report form the Irish Council for Bioethics recommends that next of kin or legal guardian consent must be sought and must represent the patient's presumed will. In addition, research ethics committees will have special regards to consent in the vulnerable populations.

Vulnerable population: Legal Representative

Incapacitated adults: Legal Representative

Legal Representative: As defined by S.I. 190: (a) a person, other than a person connected with the conduct of a trial, who (i) by virtue of his or her family relationship with that adult, is suitable to act as the legal representative for the purposes of that trial (ii) is available and willing to act for those purposes, or, (b) if there is no such person, a person other than a person connected with the conduct of a trial, who is a solicitor nominated by the relevant health care provider

Person with parental responsibility: A natural or adoptive parent, a guardian, a person who has acted in loco parentis to a child or a person having charge or control over a child, where such a person is actively involved in making decisions affecting the child's welfare.

 back_to_top

6.2. Information and Informed Consent Form

In Ireland, two witnesses must attest that the participant was given the written information orally, and consented to their participation.

6.2.1. Responsibilities

 

6.2.2. Content of Informed Consent Form

 

 back_to_top

 

ICH

Item

Y / N

Comments

4.8.10 (a)

That the trial involves research

 

 

4.8.10 (b)

The purpose of the trial

 

 

4.8.10 (c)

The trial treatment(s) and probability for random assignment to each treatment (if applicable)

 

 

4.8.10 (d)

The trial procedures to be followed including all invasive procedures

 

 

4.8.10 (e)

The subject’s responsibilities

 

 

4.8.10 (f)

The aspects of the trial that are experimental

 

 

4.8.10 (g)

The reasonably foreseeable risks/inconveniences to subject/embryo/foetus/nursing infant

 

 

4.8.10 (h)

The reasonably expected benefits. If none expected, subject must be informed

 

 

4.8.10 (i)

The alternative procedure(s) or course(s) of treatment available and their important potential benefits and risks

 

 

4.8.10 (j)

The compensation/treatment available in case of trial-related injury

 

 

4.8.10 (k)

The anticipated prorated payment if any, to the subject for participating in the study

 

 

4.8.10 (l)

The anticipated expenses, if any, to the subject for participating in the study

 

 

4.8.10 (m)

That subject’s participation is voluntary and that the subject may refuse to participate or withdraw at any time without penalty or loss of benefits to which the subject is otherwise entitled

 

 

 

 

ICH

Item

Y / N

Comments

4.8.10 (n)

That monitors, auditors, the IECs/IRBs, and regulatory authorities will be granted direct access to the subject’s medical records without violating the subject’s confidentiality, to the extent permitted by applicable laws & regulations and that by signing the consent the subject or the subject’s legally acceptable representative is authorising direct access to his/her medical records

 

 

4.8.10 (o)

That identifying records will be kept confidential and will not be made publicly available.  If the results are published the subject’s identity will remain confidential

 

 

4.8.10 (p)

That the subject or the legally acceptable representative will be informed in a timely manner if information becomes available that might influence the subject’s willingness to stay in the trial

 

 

4.8.10 (q)

The person(s) to contact for further information regarding the trial and the rights of trial subjects, and whom to contact in the event of trial-related injury

 

 

4.8.10 (r)

The foreseeable circumstances/reasons under which the subject’s participation might be terminated

 

 

4.8.10 (s)

The expected duration of the subject’s participation in the trial

 

 

4.8.10 (t)

The approximate number of subjects involved in the trial

 

 

Additional Considerations

 

The text should not contain any language that causes the subject to waive or appear to waive any legal rights (ICH 4.8.4)

 

 

 

The text should be written in understandable, non-technical language (ICH 4.8.6)

 

 

 

ICH recommends that the subject’s primary care physician be informed of his/her participation in the trial, if the subject agrees (ICH 4.3.3).

 

 

 back_to_top

 

CFR

Item

Y / N

Comments

50.20

The information that is given to the subject or the representative shall be in a language understandable to the subject or the representative.

 

 

50.20

No informed consent may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

 

 

50.25 (a) Basic elements of informed consent :

50.25 (a) (1)

A statement that the study involves research

 

 

50.25 (a) (1)

An explanation of the purposes of the research

 

 

50.25 (a) (1)

The expected duration of the subject’s participation

 

 

50.25 (a) (1)

A description of the procedures to be followed

 

 

50.25 (a) (1)

Identification of any procedures which are experimental

 

 

50.25 (a) (2)

A description of any reasonably foreseeable risk or discomfort to the subjects

 

 

50.25 (a) (3)

A description of any benefits to the subject or to others which may reasonably be expected from the research

 

 

50.25 (a) (4)

A disclosure of appropriate alternative procedures or course of treatment, if any, that might be advantageous to the subject

 

 

50.25 (a) (5)

A statement describing the extent, if any, to which confidentiality of records identifying the subjects will be maintained and that notes the possibility that relevant competent authorities may inspect the records

 

 

50.25 (a) (6)

For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained

 

 

CFR

Item

Y / N

Comments

50.25 (a) (7)

An explanation of whom to contact for answers to pertinent questions about the research and research subject’s rights, and whom to contact in the event of a research-related injury to the subject

 

 

50.25 (a) (8)

A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled

 

 

50.25 (a) (8)

A statement that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

 

 

50.25 (b) Additional elements of informed consent (when appropriate) :

50.25 (b) (1)

A statement that the particular treatment or procedure may involve risk to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable

 

 

50.25 (b) (2)

Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent

 

 

50.25 (b) (3)

Any additional costs to the subject that may result from participation in the research

 

 

50.25 (b) (4)

The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject

 

 

50.25 (b) (5)

A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject

 

 

50.25 (b) (6)

The approximate number of subjects involved in the study

 

 

 back_to_top


Item

Y / N

Comments

Ensure that the name of the Sponsor is clearly identified.

 

 

Ensure that IC has been suitably adapted and additional considerations made for trials involving special patient populations (i.e. minors, elderly subjects or other vulnerable subjects as per ICH E6 1.61).

 

 

If a patients primary physician is to be contacted the patient needs to explicitly consent to this 

 

 

The SI/ICF should contain a statement that confidentiality of data processed and transferred within or outside of Europe will be assured.

 

 

back_to_top

6.3. Personal Data Protection

The research must adhere to the Data Protection Act of 1988 and 2003 with respect to data handling and transfer. The transfer of personal data to a country or territory outside the European Economic Area may not tkae place unless that country or territory ensures an adequate level of protection for the privacy and the fundamental rights and freedom of data participants, in relation to the processing of personal data having regard to all the circumstances surrounding the transfer. Guidelines have been issued by the Data Protection Commisioner on research in the health sector, which has clarified use of anonymised and pseudo-anonymised data.

back_to_top

6.3.1. Responsibility

  • Sponsor
  • Public authority
  • Ethics Committee

6.3.2. General Principles

  • Data collection
  • Data processing
  • Data storage
  • Data transfer

Not specifically addressed in the law.

6.4. Transparency: Register and Information to the Participants

Industry trials are generally registered via the IFPMA Clinical Trials Portal . There is no agreement upon national register for clinical trials conducted in academia. There is no national plan to register anonymised data from the trial once it has been analysed, or publications deriving from clinical trials. Patients are usually informed of any laboratory, physical exam or imaging results resulting from the trial. It is encouraged in those trials falling under the clinical trials legislation that participants are informed of the outcome by the investigator. often it is not possible to inform the participants. Usuallys, data access etc. are outlined in the informed consent form and patient information leaflet.

 back_to_top

6.5. Archiving

There are no national requirements in addition to those mandated by the European Directive 2005/28/EC.

 

6.6. Non Commercial Trials/ Non Commercial Sponsors

There is not a strict definition for non-commercial trials or sponsor, but the regulations "...non-commercial trial conducted by an investigator-sponsor, without the participation of the pharmaceutical industry, in circumstances where the investigator-sponsor has no commercial or financial interest in the outcome of the trial".

 

6.7. Co-sponsorship

There is no formal opinion on co-sponsorship of trials but the IMB do allow for shared sponsorship, where the responsibilities of each party are clearly outlined.

 back_to_top