1. Research and Development 07/05/2015 Bala Thirugnanabalan & Dale Batham

2. Who We Are: Facts & Figures Guy’s Hospital, St Thomas’ Hospital, Evelina London Children’s Hospital and Community Services for Lambeth & Southwark Foundation Trust status Employ 13,200 staff 2 million patient contacts per year 1161 beds £1.2billion annual turnover Specialist services include: cancer, cardiothoracic, women’s, children, renal One of the largest critical care units in UK Busiest A&E department in London Strong track record in clinical excellence, teaching and research with sound financial management

3. Outstanding R&D Environment & Infrastructure Facilities: Location Centre for Stem Cell 28th Floor Regenerative Medicine NIHR BRC Faculty of Translational Medicine, School of Translational & Experimental Medicine, 16th Floor GSTT R&D, KHP CTO, NIHR CRN: South London, NIHR RDS (London), Bioinformatics Core, Scientific Cafe, Seminar rooms NIHR Clinical Research Facility, GMP Cell Therapy Suite,15th Floor Immune Monitoring and Flow Cytometry Core Quintiles Phase 1 Clinical Trials Unit 14th Floor GMP Pharmacy 13th Floor Cell Therapy Catapult 12th Floor Assisted Conception Unit 11th Floor (with GMP ES Suite) Genomics Core 5th-8th Floor GMP Flow Sorting Suite 4th Floor NIHR BRC Imaging Core 2nd Floor Intensive Care Unit (ICU) 1st Floor Hosts for: NIHR CRN South London – delivering research across 30 specialties TSB’s Cell Therapy Catapult

4. Why do we need ethics and governance reviews? Human Tissue Act (2004) The Human Tissue Act was implemented as a result of these cases. Ethics: facilitates ethical research beneficial to participants, science and society. Protects participants. Governance: Ensures research is feasible and is compliant with Research Governance standards set by the Department of Health.

5. Is Your Project Research? Do You need Ethics Approval? Service Evaluation, Audit or Research??? Online decision tool- http://www.hra-decisiontools.org.uk/research/index.html Do I need approval from an NHS Research Ethics Committee? Online decision tool - http://www.hra-decisiontools.org.uk/Ethics/ Research involving staff Research involving previously collected, non-identifiable information × ×

6. Service Evaluation, Audit or Research??? Key factors are: 1. Intent Research is to find out what you should be doing; audit is to find out if you are doing planned activity and assesses whether it is working. 2. Treatment/service Neither audit nor service evaluation uses an intervention without a firm basis of support in the clinical or health community. 3. Allocation Neither audit nor service evaluation allocate treatment or service by protocol. It is a joint decision by the clinician and patient. 4. Randomisation If randomisation is used, it is research.

7. Roles and Responsibilities…  Submit proposals for ethical review  Conduct research according to agreed protocol & in accordance with legal requirements  Ensure participant welfare  Record keeping and report recruitment  Adverse Event reporting  Dissemination of results  Assure of scientific quality of proposed research  Ensure ethics approval obtained  Ensure arrangements in place for management & monitoring of research  Promote quality research culture  Ensure researchers understand & discharge their responsibilities  Ensure independent scientific review  Ensure research is properly managed & monitored  Authorises all research involving their patients, staff or facilities  Ensure research meets standards of RGF  Ensure ethics committee approval obtained  Duty of Care to participants PI & other Researchers Sponsor Employing Organisation Care Organisation

8. Discuss Roles & identify ‘Sponsor’ Partner Consultation Secure Funding Develop Protocol Develop trial docs Confirm Sponsor Ethics Host Organisation Site File Begin Approvals Development Consultation Set up Research Idea The Research Governance Process- summary Finalise Trial docs Finalise roles and contracts GLOBAL LOCAL

9. Set up…. Writing a protocol… Write Patient Information sheets and Consent forms- ensure all procedures are detailed. Identify a Sponsor- Institution that takes responsibility for the initiation, management of the study. Identify Chief Investigator (CI) and Principal Investigator (PI) KCL policy dictates that students cannot be CI. Students as PI is reviewed case by case. Think about recruitment target- realistic Set up an IRAS account: https://www.myresearchproject.org.uk/

10. Approvals…Ethics submission guidance GLOBAL All ethics submissions (not amendments) are made electronically via IRAS Upload all supporting documents to the checklist Obtain electronic authorisations via IRAS (sponsor representative, C.I if student project both supervisors) Ring the Central Booking Service (0161 625 7836) to obtain your REC booking details Add these details to Page 1 of REC form (this will not invalidate your authorisations) E-submit. Booking and submission MUST be the same day

11. Approvals summary – LOCAL Once you have been approached by the lead site, you will need to liaise with your local R&D department to complete a local feasibility to gain NHS permission (R&D approval). The R&D review includes collecting: REC approval letter and copies of every document listed on the letter (documents must be localised with Trust logo and have the contact details of the local research team) CVs, HTA, GCP certificates (if a drug study) Departmental approval as listed in the SSI form Fully executed agreements (as applicable) Once all checks completed- we will issue R&D approval letter First patient must be recruited within 30 days

12. Page 12 Research Passport Flowchart

13. Amendments – Post approval Two types of amendment 1.Substantial 2.Minor Definitions and further guidance is available on the Health Research Authority website http://www.hra.nhs.uk/resources/after-you-apply/amendments/ Review and authorisation differ depending on type of amendment and type of study. REC doesn’t approve minor amendments only acknowledges. Once REC approve the amendment, R&D need to approve before implementation. We will do review and confirm compliance.

14. R&D Department does….. Provide advice, guidance and training (documents and in person) to help you through the system Provide template documents for most aspects of research projects (protocol, PIS and consent forms) Negotiate contracts, issue research passports and site file Take the study through national governance requirements in order to get the research started Try to get studies through the process as quickly as we are able Report all research activity to multiple research bodies and the DoH

15. R&D Department does not…. Manage or Coordinate research trials or recruit patients Set up/manage other sites research approvals Make it up as we go along

16. Summary Develop idea- consult supervisors, colleagues, external help- e.g. RDS London, KHP statistics service Secure funding, write grant applications, Protocol, PIS, Consent forms Confirm sponsorship Apply to Ethics Apply to R&D Recruit!!

17. Contact details Balathas.Thirugnanabalan@gstt.nhs.uk R&D Facilitator Ext.51389 Dale.Batham@gstt.nhs.uk R&D Facilitator Ext. 51954 Drop in clinic every Wednesday 2-5pm, no need to book just turn up and tell reception you are here for the drop-in. 16 th Floor Tower Wing, Guy’s Hospital

18. Page 18 Questions?