Clark Crawford: Ethics and Governance - The Life Cycle of a Clinical Project.

Ethics and GovernanceOr

The Life Cycle of a Clinical Project

Clark Crawford

Clarifications

Grant Funded Project

Clinical Study

Funds

Activity that delivers

Grant Funded Project

Clinical StudyClinical Study

Clinical StudyOne to many Clinical Study

Grant Funded Project

Grant Funded Project

Grant Funded Project

Many to one Clinical StudyGrant Funded

ProjectGrant Funded

ProjectGrant Funded

Project

Many to ManyClinical Study

Clinical Study

Clinical Trial vs. Clinical Study

• Trial:

– Surgery

– Investigatory Drugs

– Radiotherapy

– Investigatory Medical Devices

– MHRA Inspect-able studies

– “High Risk”

• Study:– Tissue/biological

sample/data collection

– Questionnaires

– Qualitative

– Physiological measurements

– Medium-Low risk?

– Consider:• Pregnant Women

• < 5 Years of Age

Actual Difference

• In legislation only?

• Additional bureaucracy?

• All should be conducted to high standard.

– Safeguard the science, patients and data.

– Institutional/Personal Reputation.

– Best practice: Good Clinical Practice (GCP).

• Requirement of Funding Bodies.

NHSR&D•SSI

•R&D Form

• Pre-award• Discussions

• Post Award (3 Months)– IRAS forms +

– Associated documents

– Sponsor Letter

– Insurance Documents

• Initiation – After all Local NHS R&D management approvals

– Notification of amendments

– Yearly report

• Close– Close of study report

NHSEthics•REC Form

NHSR&D•SSI

•R&D Form

Sponsorship•Pink form

Insurance•Insurance

Questionnaire

NHSEthics

NHSR&D(s)

Sponsor

NHSEthics

NHSR&D(s)

Sponsor

IRAS System

Sponsor+

Insurance

NHSR&D(s)

•SSI(s)•One R&D Form

NHSR&D(s)

ClinicalTrial Unit?? ?

NHSR&D•SSI

•R&D Form

• Pre-award• Discussions

• Post Award (3 Months)– IRAS forms +

– Associated documents

– Sponsor Letter

– Insurance Documents

• Initiation – After all Local NHS R&D management approvals

– Notification of amendments

– Yearly report

• Close– Close of study report

NHSEthics•REC Form

NHSR&D•SSI

•R&D Form

Sponsorship•Pink form

Insurance•Insurance

Questionnaire

NHSEthics

NHSR&D(s)

Sponsor

NHSEthics

NHSR&D(s)

Sponsor

IRAS System

Sponsor+

Insurance

NHSR&D(s)

•SSI(s)•One R&D Form

NHSR&D(s)

ClinicalTrial Unit?? ?

Inter-related Approvals

NHSEthics

Sponsor

NHSR&D(s)

Exceptions

SponsorResearch Tissue

Bank

SponsorResearch Database

SponsorUniversity REC

(UREC)

Laboratory study only involving samples

from an NHS REC approved Tissue Bank

Study only involving Data from an NHS

REC approved Data Bank

Study involving healthy participants

without storing tissue for research

SponsorURECNHS

R&D(s)

Study involving NHS Staff without storing

tissue for research

NHSR&D•SSI

•R&D Form

• Pre-award• Discussions

• Post Award (3 Months)– IRAS forms +

– Associated documents

– Sponsor Letter

– Insurance Documents

• Initiation – After all Local NHS R&D management approvals

– Notification of amendments

– Yearly report

• Close– Close of study report

NHSEthics•REC Form

NHSR&D•SSI

•R&D Form

Sponsorship•Pink form

Insurance•Insurance

Questionnaire

NHSEthics

NHSR&D(s)

Sponsor

NHSEthics

NHSR&D(s)

Sponsor

IRAS System

Sponsor+

Insurance

NHSR&D(s)

•SSI(s)•One R&D Form

NHSR&D(s)

ClinicalTrial Unit??

Favourable Ethical Opinion

• NHS Ethics Committee– IRAS NHS REC form

• National Guidance:– http://www.nres.npsa.nhs.uk/

• University Ethics Committee– http://www.rcs.bham.ac.uk/ethics/index.shtml

• For studies involving: Healthy volunteers, relatives of patients only.

• Not suitable for participants involved by virtue of their disease

NHSEthics•REC Form

R&D Management Approval

• Applications to each relevant NHS organisation.

• Submit:– the study-wide R&D form generated from the

integrated dataset in IRAS;

– the Site-Specific Information (SSI) Form providing specific information about the conduct of the research at the research site;

– supporting documentation as specified in the R&D submission checklist in IRAS.

NHSR&D(s)

•SSI(s)•One R&D Form

Multicentre studies

• Projects involving more than one NHS Trust• NHS R&D management approval co-ordinated by

Coordinated System for gaining NHS Permission (NIHR CSP).• Generic review approval

– Conducted on behalf of all Trusts

• Local review approval– Can the local health trust host the study?

• Submit all documents to CSP– CSP distributes to relevant NHS Health Trusts

• For more information.– http://www.crncc.nihr.ac.uk/about_us/processes/csp

NHSR&D(s)

•SSI(s)•One R&D Form

NHSR&D(s)

•SSI(s)•One R&D Form

NHSR&D(s)

•SSI(s)•One R&D Form

Free to start study?

• Final document to allow study start:

– Local NHS Management Approval Letter

– “Green Light Approval”

NHSR&D•SSI

•R&D Form

• Pre-award• Discussions

• Post Award (3 Months)– IRAS forms +

– Associated documents

– Sponsor Letter

– Insurance Documents

• Initiation – After all Local NHS R&D management approvals

– Notification of amendments

– Yearly report

• Close– Close of study report

NHSEthics•REC Form

NHSR&D•SSI

•R&D Form

Sponsorship•Pink form

Insurance•Insurance

Questionnaire

NHSEthics

NHSR&D(s)

Sponsor

NHSEthics

NHSR&D(s)

Sponsor

IRAS System

Sponsor+

Insurance

NHSR&D(s)

•SSI(s)•One R&D Form

NHSR&D(s)•Costs (if

necessary)

ClinicalTrial Unit

NHS Ethics / University EthicsStudy Amendments

• Substantial Amendments– Changes that will affect:

• The safety of the subjects of the trial• The scientific value of the trial• The conduct or design of the trial

• Minor Amendments

• Examples of substantial and non-substantial amendments can be found on NRES website.

• Forms are part of IRAS• Amendments must be notified to

– The Sponsor for approval in principle– The REC– The NHS R&D providing NHS R&D Management Approval

Study Reporting

• Annual Study reports to be sent to:

– The Sponsor

– The REC

– NHS R&D providing NHS R&D Management Approval

• And final report at the end of your study.

• Same document to all

– NRES website for form

• http://www.nres.npsa.nhs.uk/

GCP training

• Key members of the research team have GCP training.

• Mandatory for Trials

• Strongly advised for Studies

– 1 day

– Updates required every 2 years.

• www.crncc.nihr.ac.uk/training

– Taster course – 9th of March

Study Clinics

• Worried about the complex bureaucracy?

• Need some guidance?

• Want a “health check” for your ongoing studies?

• One on one clinics lead by Research Governance Officer + Research Facilitator

• Friendly and supportive!

• Accelerate start-up