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SFI Clinical Trial and Clinical Investigation Policy

SFI permits early stage regulated clinical trials (Phase I or combined Phase I/II) and investigations to be undertaken under the scope of the following SFI programmes:  SFI Research Centres, Spokes, and Strategic Partnerships in addition to SFI Research Professorship where the successful candidate will become a Co-Principal Investigator within an SFI Research Centre. Clinical trials and investigations requiring approval by the Health Products Regulatory Authority (i.e., HPRA) will not be permitted through other SFI funding programmes.

This policy shows our requirements under the EU Clinical Trials Directive and EU Medical Device Directives for SFI-funded researchers from eligible Research Bodies who are undertaking trials or investigations within Clinical Research Facilities/Centres (CRF/Cs) and hospitals. The requirements cover all clinical trials and investigations of investigational medicinal products and medical devices that fall under the remit of the Health Products Regulatory Authority and which we support, including those that we co-fund with other organisations.

Relevant Legislation:

The EU Clinical Trials and EU Medical Device Directives are intended to protect the rights, safety and well-being of research participants and to simplify and harmonise regulatory processes. These regulations and guidelines apply to trials and investigations designed to generate information on the efficacy or safety of medicines and/or medical devices. If you are planning a clinical trial or investigation but are uncertain whether it falls within the scope of the regulations, please contact the HPRA directly.  Both the Medicinal Products and Medical Device regulations are continually undergoing revision and are subject to change over time. For reference to current legislation please visit the HPRA website.

Summary of SFI Requirements

Investigator(s) proposing to undertake clinical trials or investigations should avail of the input, advice, services and/or support of a Clinical Research Facility/Centre (CRF/CRC), a Clinical Trials Unit (CTU) or other specialist facilities at the study design stage and the clinical trial must be under the governance and oversight of an established CRF/CRC, evidence of which must be provided to SFI in the form of a letter from the Director of the facility at the time of application for funding.

It is the responsibility of the Principal Investigator of the grant application to assure SFI that the clinical trial or investigation is conducted in a manner that is compliant with all applicable legislation, regulations, guidelines and international best practice, including but not limited to, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines and EMA guidelines for first in human trials[1]. SFI cannot take on the role of sponsor; therefore appropriate sponsorship arrangements, satisfactory to SFI, must be made in compliance with relevant  EU Clinical Trials Directives and related regulations, or, where relevant, the EU Medical Device Directives.  Details of intended Sponsors must be provided to SFI at the time of application for funding.  The Sponsor should submit a signed statement to SFI, confirming that the study will be conducted in compliance with Irish and European legislation and guidance and in accordance with the ethical and scientific principles of the Declaration of Helsinki and ICH guidelines in addition to international best practice3, prior to initiation of the clinical trial.

Furthermore, evidence that the requisite approvals such as ethical, competent authority (e.g., HPRA) and Hospital approval has been secured, and that the appropriate insurance cover (including no-fault compensation and legal liability insurance placed with an insurer authorized by the Central Bank to operate in Ireland, for a minimum liability of €6.5 million) is in place to cover the liability of all parties including the Principal Investigator, Research Body and Sponsor, must be provided to SFI prior to initiation of the clinical trial.  Responsibilities of the Principal Investigator of the grant application shall also include providing assurance to SFI that the clinical trial or investigation will be well managed and monitored in respect of any inherent risks and subject safety, that the principles of good clinical practice are applied effectively, and that robust safety reporting and monitoring systems are put in place.

In the event that the competent authority or a research ethics committee requires amendments that substantially affect the research question, methodology, trial duration or costs to the extent that the project is no longer the same as that approved for funding by SFI, the PI of the grant application must notify SFI.

 The details of all SFI funded clinical trials (at any Phase) and investigations are to be registered in a publicly available, free to access, searchable clinical trial or investigation registry where available, prior to initiation of the study.  The listing within the registry must be updated as necessary, including the main findings from the study.

Payment on awards involving clinical trials and investigations will not be issued until evidence of ethical and competent authority approval and the requisite insurance cover has been submitted to SFI. Additionally, the Host Research Body and/or Sponsor (as stipulated by SFI) must fully indemnify SFI from all claims and proceedings arising from the trial.

The award shall be subject to such terms and conditions for clinical trials and investigations at the discretion of SFI and notified to the Research Body.  In the case of any clinical trials that may be multi-site, SFI may apply additional terms and conditions. Multi-jurisdictional trials will be treated on a case-by-case basis and require pre-approval from SFI prior to submitting an application for funding.

[1] European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). July 2007. Guideline on strategies to identify and mitigate risks for first in human trials with Investigational Medicinal Products. [EMEA/CHMP/SWP/28367/07] (