FORMS AND GUIDES
MANDATORY FORMS - To make an application for Sponsorship from Swansea University, you will need the following key documents:
• IRAS full data set (The Integrated Research Application System (IRAS) is a single system for applying for the permissions and approvals for health and social care / community care research in the UK)
• SU Sponsorship Application (The Research Healthcare Sponsorship Form is accessed through My Apps under the ‘Research Ethics Applicant’ tab. Please use the form entitled ‘Healthcare Sponsorship’).
• SU Quantitative Protocol Template
• SU Qualitative protocol template
• SU PIS template
• SU Consent form template
• SU Consultee Information Sheet
• SU Consultee Declaration form
• Risk assessment template for SU sponsored studies
• Data Management Plan template
• CV template
Contracts - Swansea University Research Contracts team will need to have input into these documents. Only an authorised signatory can sign them off:
• Organisational Information documents (OID)
• Participant Identification Centres (PIC)
• PIC's Leaflet
• Schedule of Events (SoE) / Schedule of Events Cost Attribution Template (SoECAT)
• Material Transfer Agreement (MTA) – A contract governing the transfer of human tissue between two organisations
OTHER DOCUMENTS WHICH MAY BE REQUIRED DEPENDING ON THE STUDY:
• GP letter
• Debriefing template
• Advertisement(s) including posters and texts of email or radio adverts
• Any other media text used to provide information to participants (e.g. reminder texts/emails)
• Study-specific documents (e.g. questionnaires, web-based tools)
• Research Passport – The mechanism for non-NHS staff to obtain permission to carry out research in the NHS
AFTER SPONSORSHIP HAS BEEN AWARDED
This section covers what you will need to consider while conducting your research including progress reports, as well as what to do at the end of your research:
POLICIES AND FRAMEWORKS
UK Policy Framework for Health and Social Care Research - This policy framework sets out principles of good practice in the management and conduct of health and social care research in the UK. It is for organisations and individuals that have responsibilities for health and social care research. This includes funders, sponsors, researchers and their employers, research sites and care providers.
Good Clinical Practice (GCP) - This is the international ethical, scientific and practical standard to which all clinical research is conducted. It is important that everyone involved in research is trained or appropriately experienced to perform the specific tasks they are being asked to undertake.
Human Tissue Act (HTA) - The Human Tissue Act 2004 regulates the removal, storage and use of human tissue. This is defined as material that has come from a human body and consists of, or includes, human cells. It ensures human tissue is used safely and ethically, with proper consent.
Declaration of Helsinki - The World Medical Association (WMA) developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. It is especially important to protect the well-being of human subjects involved in biomedical research, where the welfare of human subjects needs to be safeguarded.
General Data Protection Regulation (GDPR) – This provides a legal framework for keeping everyone's personal data safe by requiring companies to have robust processes in place for handling and storing personal information. Access Swansea University Policy and guidance on this topic and read Health Research Authority guidance.
Mental Capacity Act - This provides a framework for decision making on behalf of adults aged 16 and over who are unable to make decisions for themselves, i.e. they lack capacity. All researchers working with research participants who lack, or may lack, capacity need to be aware of its underlying principles and the provisions relating to research.
Faculty Ethics application forms – If your research doesn’t involve the NHS then submit your study for Swansea University Internal Ethical Review to your specific Faculty.