Guidance for Applicants on Ethical and Scientific Issues
This guidance document provides essential information for all applicants preparing SFI grant applications. While applicants are advised to be cognisant of all the information provided in this document, it is recognised that certain applications may not need to directly address all of the issues outlined:
Science Foundation Ireland’s policy concerning use of animals in research is informed by European legislation outlined in Directive 2010/63/EU. This legislation was transposed into Irish law in December 2012 by SI No 543 of 2012 and is implemented by the Health Products Regulatory Authority (HPRA), the competent authority in Ireland responsible for the protection of animals used for scientific purposes.
Science Foundation Ireland aims to improve the welfare of animals used for scientific purposes and to promote the principles of the 3Rs - Replacement, Reduction and Refinement (See Figure 1). Applicants are expected to adhere to the general principles and best practice outlined in the guidance provided by the HPRA and are advised to consult the ARRIVE guidelines (Animal Research: Reporting In Vivo Experiments) produced by the UK National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs).
Where research funded by SFI involves the use of animals, the following requirements must be met.
- The Research Body and Principal Investigator must ensure that, before the research commences and for the full award duration, all the necessary ethical, legal and regulatory requirements in order to conduct the research are met, and all the necessary licences and approvals have been obtained.
- The Research Body and Principal Investigator must ensure that research involving the use of animals is conducted with such ethical guidelines and codes of practice as may be published or adopted by SFI, any relevant industry or any competent regulatory body from time to time, including those described in this policy.
- SFI will support research using animals providing that it is fully compliant with the requirements of the HPRA, it has been independently peer reviewed and consideration has been given to the use of alternative approaches not involving the use of live animals and addressing the principles of the 3R’s (replacement, reduction, refinement).
- Applicants to SFI, whose research proposals include the use of animals, must fully justify the experimental design and its suitability to address the research questions posed in the appropriate section of their application. Applicants must provide detailed justification for their choice of design, intervention and numbers of animals to be used. Sufficient information concerning methodological issues must be provided.
- If any research is to be carried out in a third country, the Research Body must ensure that research involving the use of animals is carried out in the spirit of Irish legislation and complies at all times with the relevant laws and regulations in the host country.
These requirements apply whether or not the animals are to be purchased with funds requested within the proposal itself.
Figure 1. The 3Rs - Replacement, Reduction and Refinement
- Using alternative methods that do not require the use of live vertebrate animals
- Examples include: in vitro tests such as cell lines, computer simulation and modelling, video material, or the use of invertebrates such as fruit flies or worms
- Using the most appropriate number of animals for each project required to obtain statistically robust data without using more animals than neccessary
- Examples include - Improved experimental design and statistical analysis; data and resource sharing; and use of techniques such as imaging
- Where there is no alternative to the use of live animals, investigators must ensure that suffering is minimalised and the highest standard of animal welfare and care are applied
- Examples include - careful handling by trained individuals, provision of high standards of housing and husbandry to include enrichment materials and the appropriate use of anaesthesia and pain relief during procedures.
SFI also supports the Joint European Funding Principles for Research involving Animals
Information required for animal studies
SFI will require evidence that relevant ethical and regulatory approval has been granted for studies involving animals prior to an award commencing. In exceptional cases where such research may not commence until a late stage of an award, SFI may permit submission of ethical and regulatory approvals following the award start date but prior to commencement of the research involving animal and/or human subjects.
In order to allow for the appropriate evaluation of the scientific merit of applications for funding involving animal use, applicants submitting proposals must provide the information requested in this Table within the description of their proposed research and methodology.
Last Updated June 2016
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.
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. 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.