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- Pilot: a draft guide to providing effective IG assurances in IRAS submissions
- Preface
- Introduction
- Core IG topics and legal provisions
- 1. What good IG looks like and how to evidence it in IRAS guidance
- 2. Additional advice for sponsors
- 3. Additional advice for NHS/HSC participating organisations
- Appendix 1 – summary of key national standards supporting digital and data assurance in health and care research
- Appendix 2 – Glossary of Abbreviations
- Ionising radiationUnder the Ionising Radiation (Medical Exposure) Regulations 2000 (“IRMER”) and subsequent amendments, ethical approval is required by a Research Ethics Committee (REC) where any of the procedures in the research protocol involves exposure to ionising radiation and the participants are involved in medical or biomedical, diagnostic or therapeutic, research programmes.
- Prison researchFor this purpose, a prisoner or young offender is defined as any inmate of the prison systems of England and Wales, Scotland or Northern Ireland. It does not include patients detained under the Mental Health Act at special hospitals or other psychiatric secure units, or juvenile offenders detained in local authority secure accommodation or secure training centres.
- Research involving childrenThere are many ethical and legal issues to consider when involving children and young people in research.
- Phase 1 clinical trialsAll investigational medicinal products (IMPs) go through a series of trials before they can be licensed for use.
- Long description for Phase 1 application process
- Generic screening of potential Phase 1 trial participants: guidance for using the HRA generic screening information sheet and consent form template
- Research tissue banks and research databasesIf you are planning to create a research database or a research tissue bank (‘biobank’) then the following information may be helpful.
- Research Tissue Banks FAQs
- Social care researchWhen the HRA became a Non Departmental Public Body on 1 January 2015, we took formal responsibility for research in adult social care.
- Research in emergency settingsEmergency research poses its own set of challenges in terms of providing information about the research and obtaining consent.
- Public health emergency research