CLINICAL RESEARCH AND THE NHS

CLINICAL RESEARCH AND THE NHS

• Research and clinical governance

• Translational research using samples and data

• Qualitative research• Multidisciplinary nature

of successful clinical research

Considerations and regulatory approvals largely the same

Who do you need on board?

Clinician/surgeon

Statistician

Pathologist

Clinical Trialist

Research Nurse

What approvals are required before you start?

Ethical approval

R&D approval (NHS permission and site-specific)

Clinical trials: MHRA, GTAC

Sponsorship

Ethical approval: Where do you apply?

Non-NHS participantsUniversity Ethics Review CommitteeWith or without sample collection/storage?

NHS staff, premises, facilitiesUniversity Ethics Review Committee

NHS patientsNational Research Ethics Service (NRES)All types of research with or without sample collection

Ethical review: What will be considered? Identification and recruitment Consent Scientific validity of the study Collection of samples; existing/prospective Access to personal/clinical data; anonymisation Storage and retention of personal data Funding Sponsorship Incidental findings and feedback What will happen to samples/data when study finished Vulnerable groups

R&D approval: What will be considered? Principal Investigator

Identification and recruitment

Consent

Location

Whether procedures are additional to clinical pathway

Access to personal/clinical data; anonymisation

Storage and retention of personal data

Sponsorship

MONEY!

Clinical trials

Clinical trial authorisation from the MHRA

GTAC

Good Clinical Practice

Contractual agreements

Quality Management System

Adverse event reporting

Sponsor

Under the Research Governance Framework …… Requirement for all research using NHS patients, staff and facilities

The Sponsor is legally responsible for the management of the researchInvestigators appropriateFundingRegulatory approvalsInsuranceCurrent legislation e.g. Human Tissue Act, DPA

Integrated Research Application Service (IRAS)

Streamlining the research application process

https://www.myresearchproject.org.uk/

Ethical approval NHS permission/R & D approval MHRA GTAC NOMS, MOJ