Ireland

Country Analysis

1.
Are there specific legal requirements in Ireland for a patient living in Ireland who wants to participate in a clinical trial in another country?

No. There are currently no regulatory/legal processes in place for Ireland regarding cross-border access to clinical trials.  The HPRA does not have an approval or notification process for IE patients participating in CTs conducted in another jurisdiction, or for patients from another jurisdiction participating in clinical trials authorised in Ireland.  The HPRA is supportive of cross border access to CTs for EU patients, with the caveats that clinical trials should be conducted in accordance with relevant legal provisions and GCP, and the patient&rsquos principal medical care team should be aware of their participation in a clinical trial in another jurisdiction.  For Irish patients participating in CTs conducted in another jurisdiction, in general, trial-related activities should not be performed in Ireland without formal authorisation of the trial in Ireland.

2.
Are there specific legal requirements in Ireland if an investigator wants to enroll a foreign patient in a clinical trial?

No. There are currently no regulatory/legal processes in place for Ireland regarding cross-border access to clinical trials.  The HPRA does not have an approval or notification process for IE patients participating in CTs conducted in another jurisdiction, or for patients from another jurisdiction participating in clinical trials authorised in Ireland.  The HPRA is supportive of cross border access to CTs for EU patients, with the caveats that clinical trials should be conducted in accordance with relevant legal provisions and GCP, and the patient&rsquos principal medical care team should be aware of their participation in a clinical trial in another jurisdiction.  For Irish patients participating in CTs conducted in another jurisdiction, in general, trial-related activities should not be performed in Ireland without formal authorisation of the trial in Ireland.

3.
Are there national health authority requirements in Ireland for a patient living in Ireland who wants to participate in a clinical trial in another country?

No. There are currently no regulatory/legal processes in place for Ireland regarding cross-border access to clinical trials.  The HPRA does not have an approval or notification process for IE patients participating in CTs conducted in another jurisdiction, or for patients from another jurisdiction participating in clinical trials authorised in Ireland.  The HPRA is supportive of cross border access to CTs for EU patients, with the caveats that clinical trials should be conducted in accordance with relevant legal provisions and GCP, and the patient&rsquos principal medical care team should be aware of their participation in a clinical trial in another jurisdiction.  For Irish patients participating in CTs conducted in another jurisdiction, in general, trial-related activities should not be performed in Ireland without formal authorisation of the trial in Ireland.

4.
Are there specific national health authority requirements in Ireland if an investigator in Ireland wants to enroll a patient living in another country in a clinical trial?

No. There are currently no regulatory/legal processes in place for Ireland regarding cross-border access to clinical trials.  The HPRA does not have an approval or notification process for IE patients participating in CTs conducted in another jurisdiction, or for patients from another jurisdiction participating in clinical trials authorised in Ireland.  The HPRA is supportive of cross border access to CTs for EU patients, with the caveats that clinical trials should be conducted in accordance with relevant legal provisions and GCP, and the patient&rsquos principal medical care team should be aware of their participation in a clinical trial in another jurisdiction.  For Irish patients participating in CTs conducted in another jurisdiction, in general, trial-related activities should not be performed in Ireland without formal authorisation of the trial in Ireland.

5.
Are there specific ethics committee requirements in Ireland for a patient living in Ireland who wants to participate in a clinical trial in another country?

No. There is currently no framework for this. The National Office for Research Ethics Committees is not notified if a participant from Ireland travels to another jurisdiction to access a trial.

6.
Are there specific ethics committee requirements in Ireland if an investigator in Ireland wants to enroll a patient living in another country in a clinical trial?

No. There is currently no framework for this. The National Office for Research Ethics Committees is not notified if a participant from Ireland travels to another jurisdiction to access a trial.

7.
Are there national health insurance rules or experiences in Ireland concerning coverage of any additional costs for a patient living in Ireland when participating in a trial in another country?

No information provided.

8.
Are there national health insurance rules or experiences in Ireland concerning coverage of follow-on healthcare costs occurring after a patient has returned from participating in a clinical trial in another country?

No information provided.

9.
Are there national rules or experiences in Ireland concerning additional costs (not covered by the trial sponsor) if an investigator wants to enroll a patient living in another country?

No information provided.

10.
Are there requirements for clinical trial liability insurance in Ireland to cover the costs of trial associated damages occurring in the participating patient's home country?

No information provided.

11.
Are there any additional liability insurance requirements to join an ongoing trial in Ireland from another country?

No information provided.

12.
From where do patients in Ireland get information on clinical trials taking place in another country?


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13.
Did patients living in Ireland get enrolled in a clinical trial in another country?


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14.
Did patients living in Ireland experience challenges with getting their trial medication when they returned to their country of residence?


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15.
Did patients living in Ireland experience challenges with continuation of their medical care after returning to their country of residence?


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16.
Did patients living in Ireland experience challenges with coverage of their basic healthcare costs like hospital stay, baseline diagnostics or treatments, etc. when joining a clinical trial in another country?


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17.
Are there clinical investigators in Ireland that accept trial participation of patients from another country?


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18.
Is there experience with transfer of medical information when a patient living in Ireland wants to join a clinical trial in another country?


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19.
Are there clinical investigators in Ireland who have experience with enrolling patients from another country?


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20.
Do treating physicians in Ireland inform patients about the option to participate in a clinical trial in another country?


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