15. Research Governance (Responsible Conduct of Research)
15.1 It is the responsibility of the Host Institution to ensure that any research carried out in the course of the Grant Funded Activities is organised and undertaken within a framework of best practice and in accordance with the highest standards of scientific integrity and research methodology including but not limited to ensuring that all necessary permissions are obtained before the research begins and that there is clarity of role and responsibility among the Research Team with any collaborators. The following shall be considered as minimum requirements in achieving the aforementioned high standards:-
15.1.1 The Host Institution shall have in place procedures for governing good research practice and reliable systems for the prevention of Misconduct and clearly defined procedures for the investigation of allegations of Misconduct.
15.1.2 Where possible, research shall avoid the use of animals. Where this is not possible all necessary animal licences must be obtained before the commencement of any research involving animals.
15.1.3.1 The Host Institution shall be responsible for ensuring that issues of an ethical nature relating to research are identified at the earliest opportunity and where necessary approval obtained from an ethics committee(s) recognised by the Host Institution. An ethical approval declaration must be submitted with the completed Acceptance Documentation to the HRB. In the event that research requiring ethical approval begins at a point later than the Commencement Date the declaration must be signed by the Principal Investigator stating that the research will not begin until a copy of the research ethics approval letter has been submitted to the HRB and its receipt confirmed and no payment or further payment of the Grant shall be made until receipt by the HRB of a copy of such approval.
15.1.3.2 Ethical issues shall include, but not limited to, relevant codes of practice, the involvement of human participants, tissue or data in research, the use of animals, research that may result in damage to the environment and the use of sensitive economic, social or personal data.
15.1.4 Where the Host Institution has more than one site, all clinical procedures involving the handling of samples must be carried out using standard operating procedures on all its sites with minimum common data-sets and striving towards best practice as detailed in the International Society for Biological and Environmental Repositories (ISBER) Best Practices for Biorepositories; Collection, Storage, Retrieval and Distribution of Biological Materials for Research (www.isber.org) and Molecular Medicine Ireland Guidelines for Standarised Biobanking (www.molecularmedicineireland.ie))
15.1.5 The Host Institution must have in place effective and verifiable systems for managing research quality, progress and the safety and well-being of patients and other research participants. These systems must promote and maintain the relevant codes of practice and all relevant statutory review, authorisation and reporting requirements.
15.2 The Host Institution shall as soon as possible furnish to the HRB in writing full details of any Misconduct directly or indirectly relating to the Grant Funded Activities.