How to Apply for Ethics (Non-CTIMPs) including Sponsorship

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1 How to Apply for Ethics (Non-CTIMPs) including Sponsorship Joint Research & Enterprise Office (JREO) St George s University of London Lucy H H Parker Clinical Research Governance Manager Joint Research & Enterprise Office Training 17 th November 2015

2 Outline Background to Ethics Introduction to Ethics in UK Research Ethics Review Process Sponsorship including indemnity After REC HRA UPDATE Joint Research & Enterprise Office Training 17 th November 2015

3 Background : WWII atrocities Nazi Holocaust Unit : Tuskegee Syphilis Study 1947 Nuremburg Code World Medical Association s Declaration of Helsinki

4 : Placebo controlled study of zidovudine to prevent vertical transmission of HIV in Cote d Ivoire, Uganda, Tanzania, South Africa, Malawi onwards: Pfizer in court in Nigeria for Trovan studies during Meningitis epidemic in International Conference of Harmonisation Good Clinical Practice (ICH GCP) EU, Japan and US - Ethical and scientific quality standard Joint Research & Enterprise Office Training th November

5 Introduction Ethical approval: Protects human rights Gives balanced independent view of research Required by regulatory bodies and NHS Prevents scandals in biomedical research Who are the ethics committee? Laymen, clinicians, nurses, pharmacists and other interested parties ICH GCP: An IRB/IEC should safeguard the rights, safety and well being of all trial subjects

6 Research? The attempt to derive generalisable new knowledge If the study involves randomisation it is research MUST come through the JREO for review May require REC review Please see the NRES: Defining Research leaflet: Joint Research & Enterprise Office Training 13 th November 2014

7 Service Evaluation or Clinical Audit? Service Evaluation Designed and conducted solely to define or judge current care Requires Department Lead permission Clinical Audit Designed and conducted to produce information to inform delivery of best care Requires Clinical Audit Manager s review - kate.hutt@stgeorges.nhs.uk

8 UK Ethics National Research Ethics Service (NRES) - core function and directorate of the HRA Dec HRA (Health Research Authority) Special Government Authority Plan for Growth Patients and public Streamline regulation Fundamental remit: Participant safety Facilitate and promote ethical research Joint Research & Enterprise Office Training 13 th November 2014

9 Current REC system National application form Standard operating procedures Single, Independent review Central allocation system Quorate Meetings Simultaneous processing Tight timelines (60 day max) Rejections justified Written clarification once only Approval for amendments Proportionate review Joint Research & Enterprise Office Training 13 th November 2014

10 Is REC review required? Legal requirement: Clinical Trial of an Investigational Medicinal Product (CTIMP) Medical Device if not CE marked or CE marked and used outside clinical indication Involves exposure to ionising radiation additional to routine care Involves intrusive procedures with adults who lack capacity to consent for themselves Joint Research & Enterprise Office Training 13 th November 2014

11 Is REC review required continued Patients and users of the NHS Relatives or carers of patients/users of NHS Access to data/organs/tissue of NHS patients Foetal material and IVF involving NHS patients Recently dead in NHS premises Use of NHS premises/facilities Joint Research & Enterprise Office Training 13 th November 2014

12 Is REC review required continued All relevant material under the Human Tissue Act 2004 Involves storage of relevant material from the living or the deceased on premises without a storage licence from the Human Tissue Authority (HTA) Involves storage or use of relevant material from the living, collected on or after 1 September 2006, and the research is not within the terms of consent for research from the donors Involves analysis of DNA in material from the living, collected on or after 1 September 2006, and the analysis is not within the terms of consent for research from the person whose body manufactured the DNA Joint Research & Enterprise Office Training 13 th November 2014

13 Research Not Requiring REC Review Involving previously collected, non-identifiable information Involving previously collected, non-identifiable tissue samples Involving acellular material Involving NHS staff Please read the guidance carefully and consult the JREO Even if your study does not require REC review, it is likely it will still need R&D approval Does my project require REC review? Joint Research & Enterprise Office Training th November

14 Where to book Proportionate Review Allocation System (PRAS) Studies eligible for proportionate review Central Allocation System (CAS) CTIMP (single or multi site) Non-CTIMP Student Research (non-ctimp) Medical Devices Establishing a Research Tissue Bank Establishing a Research Database CAS to a flagged REC Other Research Phase 1 CTIMPs in healthy volunteers only Directly to an NHS REC with type 1 recognition. Gene therapy or stem cell clinical trials Book to a flagged REC ying-to-recs/nhs-rec-where-to-book/ Adults Lacking capacity Involves Prisoners/Young Offenders Funded by US Department of Health and Human Sciences Joint Research & Enterprise Office Training 13th 17 November

15 CI books in application and given reference number Application PART A&B received DAY 1 Non-valid application returned with feedback and may re-enter system Valid application acknowledged DAY 5 SITE SPECIFIC ASSESSMENT(S) PI at each site applies for SSA via SSIF DAY 1 REC considers application seeking clarification as appropriate Ethical Decision advised Final Decision per site Clock stops DAY 60 (max) Site specific assessment completed DAY 15 (max) Site specific assessments may continue beyond main REC recommendation

16 Proportionate Review No material ethical issues and low burden on participants: Research using data or tissue fully anonymized to the researcher Research using existing tissue samples already taken with consent for research Research using extra tissue (e.g. further blood taken at time of routine sampling or tissue taken at clinically directed operation) Questionnaire research/research interview/focus group (NOT for highly sensitive areas or areas where accidental disclosure would = serious consequences) Research surveying safety/efficacy of established non-drug treatments, involving limited intervention and no change to the patients treatment Minimally invasive basic science studies involving healthy volunteers Turn around time 14 days initial opinion (Favourable or Provisional)

17 IRAS (Integrated Research Application System) Single system for applying for approval for health care research in the UK Enables you to enter the information about your project once instead of duplicating information in separate application forms Filters to ensure that the data collected and collated is appropriate to the type of study Helps you to meet regulatory and governance requirements Joint Research & Enterprise Office Training 13 th November 2014

18 IRAS continued 1. Start a New Project

19 IRAS continued IRAS captures the information needed for the relevant approvals from: Medicines and Healthcare products Regulatory Agency (MHRA) Confidentiality Advisory Group (CAG) ( formerly NIGB or PIAG) Ministry of Justice (National Offender Management Service) Administration of Radioactive Substances Advisory Committee (ARSAC) National Institute for Heath Research (NIHR) Trust approvals (SSAs) **Will also be used to for the HRA process**

20 Sponsorship The sponsor is the individual, or organization (or group of individuals or organizations) that takes on responsibility for confirming there are proper arrangements to initiate, manage and monitor, and finance a study. Research Governance Framework, 2 nd Edition, Department of Health 2005 Non-Commercial studies: Funder Investigator led - Chief Investigator s substantive employer University or the Trust Student Institution where student is studying

21 St George s Sponsorship Submission of Essential Documents to the JREO: Valid Submission: IRAS NHS REC Form (draft, PDF) Supporting Documentation: - Protocol - Participant Information Sheet(s) & Consent Form(s) Additional: - Data Collection Tools - CV s for all key personnel Sponsorship (when Sponsor signs Part D2 of REC form) Evidence of Funding (if applicable) Evidence of Peer Review (if applicable) The JREO will aim to review your valid Sponsorship application within 5 working days

22 REC Essential Documents IRAS REC Form Final Research Protocol Summary CV for CI/PI Patient Information Sheet(s) (PIS) Consent form(s) Signed declaration from CI (D1) Signed declaration from Sponsor (D2) Evidence of insurance or indemnity Remember to version control and date your documents!

23 Good Practice Documents Covering Letter Peer Review - (JREO provides guidance about peer review) GP letter Letter from funder Statistical Analysis Sample diary / patient cards Sample advertisements

24 Ethics: Tricky Questions 1 Project Filter Questions - Q2: Study type consult with JREO if not sure - Q2e (a) If ANY ionising radiation Yes (b/c) If ANY tissue taken Yes - Q9 If any part of study educational - Yes Part A Scientific justification A12 and Scientific Methodology A13 Lay terms Recruitment (A through to A30) how participants will be identified, approached and recruited Advertisements (A28) Submit every advertisement format that you plan to use e.g. posters, plasma screen adverts as well as s

25 Ethics: Tricky Questions 2 Advocacy (A33-1) Provide evidence that arrangements are in place to ensure inclusion in your research of those who are not fluent in English Monitoring arrangements Please consult the JREO (proportionate to risk of study) Main ethical considerations (A6-1 & A6-2) Sponsor Representative (A4) - - use your assigned Research Governance Officer details

26 Ethics: Tricky Questions 3 Part B Ionising Radiation, Radioactive Materials and Human Tissue - Please contact: Radiation Protection Officer Designated Individuals Local Pathology (if above routine) Part C Research Sites - Site (NHS or non-nhs) where any research procedure being conducted - Require Host Site Approval (or NHS Permission) - Applications submitted to R&D departments (SSA) - Local authorisations required

27 Sponsorship and Indemnity Employing organisation should act as sponsor (A64-1) - Chief Investigator s substantive employer Research Governance Officer s details (A68) Indemnity/Insurance assessment required Approval is project specific and must be sought from the Sponsor The NHS site applies its own indemnity for clinically negligent acts University indemnity provides both negligent and non-negligent harm

28 Indemnity For SGUL sponsored studies: Management of the research (A76-1) Tick other and state that SGUL indemnity applies Design of the research (A76-2) Tick other and state that SGUL indemnity applies Conduct of the research (A76-3) Tick all participants from NHS

29 Ethics: Common Reasons for Provisional Approvals (1) IRAS REC form Spelling mistakes and typos Anonymized tissue samples and data sets should be used whenever possible Unless, Confidentiality Advisory Group (CAG, formerly NIGB) Discrepancies between application form and protocol and patient/participant information sheets (PIS) Patient information sheet Too much technical information Insensitive or inappropriate language Clear procedures i.e. what is part of routine clinical care, what is additional for research Diagram of what will happen to participant Follow-ups should be clearly described Use visual terms, e.g. 10ml blood = 2 teaspoons State in PIS that the participant is free to withdraw at any time Separate information sheets for control groups/healthy volunteers/minors

30 Ethics: Common Reasons for Provisional Approvals (2) Consent forms Specific consent for genetic research Consent to use samples for any future research that may take place, emphasizing that full ethical approval will be sought for each future project Clarify what the patient must consent to in order to take part in the study, and what is optional Ask permission to inform the GP of their taking part in the study State that responsible individuals from regulatory authorities may look at sections of their medical notes

31 Amendments Substantial An amendment to the protocol or any other supporting documentation that is likely to affect to a significant degree the: 1. Safety or physical or mental integrity of the trial subjects 2. Scientific value of the trial 3. Conduct or management of the trial Non-substantial Requires notification only (e.g. typos, amending members of research teams except CI & PIs) Amendment forms generated in IRAS Inform Sponsor and Trust R&D REC has 35 days to respond Trust R&D must also approve

32 Progress Reports, Declaration of End of Study and Final Report Annual progress reports to REC Anniversary of REC approval Until end of study Declaration of End of Study to REC Appropriate form within 90 days of the end of the study Or within 15 days if the study is terminated early Final report on the research to REC Within 12 months of the end of the study No standard format required (but JREO can provide template) Copy all reports to the Sponsor and all R&D departments involved in the study

33 Other Approvals Confidentiality Advisory Group ( CAG formerly NIGB) - identifiable patient data Human Fertilisation & Embryology Authority (HFEA) - Creation of embryos in vitro and/or storing embryos Administration of Radioactive Substances Advisory Committee (ARSAC) Confirmation of compliance with Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) Medicines and Healthcare products Regulatory Agency (MHRA) Medical Device R&D approvals - No study should commence without NHS Trust R&D approval

34 HRA Update

35 Useful Information o HRA o SGUL SOPs - governance/training/1an-overview-of-st-georges-sops-2013.pdf/view OR ohttps:// o Declaration of Helsinki - o European Convention of Human Rights and Biomedicine o World Health Organisation - o R&D Forum o IRAS researchgovernance@sgul.ac.uk

36 JREO Workshops * Talk will last approximately 1 hour* How to apply for ethics (CTIMPS) including Sponsorship 25 November 2015 Board Room H2.6 Hunter Wing 12:30 Research Contracts and Agreements 15 December 2015 G :30 How to apply for NHS R&D/Host site Approval 27 January 2016 Board Room H2.7 Hunter Wing 12:30 **For full list, please visit the portal or Trust website**

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