Where does R&D fit? Dr Clara Kalu Senior Portfolio Co-ordinator UCL Students’ Research.

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Presentation transcript:

Where does R&D fit? Dr Clara Kalu Senior Portfolio Co-ordinator UCL Students’ Research

R&D is at the

Why approve studies? Assess safety and risk Promote quality Create a climate of transparency Quantify resources Protect study, participants, investigator and the host’s/sponsor’s finances and reputation

Research management and governance Research Governance Framework for Health and Social Care (2005) 2 nd Edition Peer review/Science Information Ethics Health & Safety Finance & Intellectual Property.

Pilot

Prepare for approval Governance reviews IRAS form Participant Information sheet Consent forms Protocol Questionnaire, CV, GP letter, recruitment material etc., Corrections

Occasionally…

plea Come to R&D early 30 days Respond to us Follow our instructions!

Who’s my sponsor? Your university/educational institute Sponsor responsibilities Initiate Manage Funding

Where does R&D fit? Sponsorship - the process register Contact JRO Unique ID number IDR Insurance Data Protection Registration Risk assessment sponsor review Study documents preferred formats, supporting material IRAS full data set (& SSI) or UCL Ethics form

Where does R&D fit? Authorisation & apply to REC authorisation IRAS REC sponsor IRAS R&D sponsor IRAS Site Specific Info. (Principal Investigator or Local Collaborator) Div. Clinical Lead Apply to REC REC Checklist IRAS authorised REC form and study documents, supporting material

Where does R&D fit? R&D approval process prepare Authorised R&D form Authorised SSI form Research passport REC favourable opinion letter REC-approved documents NHS SSI, (IRAS A68 and Part C) local approval Research passport R&D approval letter(s) Amendments Archiving Declaration of end.

Non-NHS R&D Healthy volunteers, Community groups/centres members of the Public Schools Students/University staff … Etc.

How we help Information Suite of Guides Short Guides IRAS training-groups and individuals Available end October

Joint Research Office (UCL/UCLH/Royal Free London) Start to end of study R&D at the heart of your research R&D connects all elements of your research Joint Research Office is the point of contact for all new research applications.

Where can you find support? 1st Floor, Maple House 149 Tottenham Court Road London W1P 9LL