ETHICS, IRAS & DATA PROTECTION Clinical Research Methods Course 14 th March 2017 Priyanthi Dias Senior Trials Coordinator Adult CriDcal Care Research Unit Queen Mary University of London p.dias@qmul.ac.uk
DefiniDons CI: Chief InvesDgator CTIMP: Clinical Trial of an InvesDgaDonal Medicinal Product IRAS: Integrated Research ApplicaDons system MHRA: Medicines and Healthcare products Regulatory Agency HRA: Health Research Authority REC: Research Ethics CommiSee CRN: Clinical Research Network
Who are the main organisadons? HRA/ REC PaDents MHRA Sponsor Sites CRN CI
Clinical trial pathway h"p://www.ct- toolkit.ac.uk/routemap/
Clinical trial pathway h"p://www.ct- toolkit.ac.uk/routemap/
Where do I start? StaDsDcian Trial Documents Protocol IRAS PaDent InformaDon Sheet Informed Consent GP leser Funding Contracts Collaborators CI Trial Manager/ Coordinator QA Manager Database Manager Sponsor
Is Your Study Ethical? Consent Form(s) PaDent InformaDon Sheet Study protocol
Ethics applicadon Part 1 Peer reports/ Risk assessments Local Peer Review Trial documents Sponsor Trial team
Integrated Research ApplicaDon System (IRAS) Standardised pla_orm for Permissions & Approvals for UK Health Research Register for an IRAS account (hsps://www.myresearchproject.org.uk) Create a new project Transcribe study protocol into Project document Provide further clarificahon around study procedures & ethical considerahons Single system for approvals for research in the UK Depending on the type of study, uses filters to ensure the appropriate informahon is collected Add parhcipahng sites and the principal inveshgators
IRAS - RegistraDon hsps://www.myresearchproject.org.uk
IRAS Create New Project hsps://www.myresearchproject.org.uk
IRAS Core Study QuesDons
IRAS Project filter quesdons non- CTIMP
IRAS Project filter quesdons CTIMP C
IRAS Project filter quesdons CTIMP C CTIMPS need to be registered on EudraCT (ISRCTN for non- CTIMPS) Clinical Trial ApplicaHon Form needs to be completed Provide further informahon on the - InvesHgaHonal Medicinal Products (IMPs) - Placebos if required (h"ps://eudract.ema.europa.eu/eudract- web/index.faces)
IRAS Project filter quesdons CTIMP
IRAS Check List CTIMPS only
Provisional Sponsorship Document check list Provisional Sponsorship and Indemnity h"p://bartshealth.nhs.uk/research/strategy- and- policy/standard- operahng- procedures/
IRAS Electronic AuthorisaDons Book meedng with the REC Submission can be made only ader electronic authorisadons If you change any informadon ader authorisadons, signatures will need to be requested again
IRAS NIHR Por_olio AdopDon Studies funded as a result of open compeddon in England with high quality peer review Research that is of clear value to the NHS Studies that take appropriate account of the priorides, needs and realides of the NHS hsp://www.nihr.ac.uk/research- and- impact/nihr- clinical- research- network- por_olio/
REC/HRA Approvals Pathway
Capacity and Capability
Approvals Checklist REC Favourable opinion LeSer of HRA approval NIHR Por_olio adopdon ConfirmaDon of Capacity and Capability Full Sponsorship
IRAS - Amendments
Data ProtecDon Act 1998
Importance of Consent in Data CollecDon
Sharing of Study Materials Study Protocol PIS & Consent Forms Consent logs CRF Study PaDent Data Tissue Local Stores Centralised Repositories
Summary YOU NEED CONSENT AND ETHICAL APPROVAL FOR YOUR MATERIALS Partner the Sponsor when seeking ethical approvals for your studies Use DEIDEINTIFIED MATERIALS wherever possible Create applicadon PDFs using IRAS: New projects One system to apply for all the required approvals Changing the study (SubstanDal Amendments) Implement robust documents to protect your study materials: Standardised SOPs (Study protocol, Database, Biobank) Data Usage Agreements (DUA) / Materials Transfer Agreements (MTA)
QUESTIONS?