How to get R&D approval? LINDA POINTON RESEARCH PROJECT - PDF document

23/10/2019 How to get R&D approval? LINDA POINTON RESEARCH PROJECT MANAGER WELLCOME TRUST CONSORTIUM FOR NEUROIMMUNOLOGY OF MOOD DISORDERS AND ALZHEIMER’S DISEASE (NIMA) 1 Write Get Get R&D your ethics approval protocol approval 2 1

23/10/2019 The BIODEP study Primary Clinical Cohort Adult MDD, 25-50 yrs, sampled from NHS services, N~200 Stratified by monoaminergic (MA) anti-depressant exposure and response MDD MDD MDD not Healthy adults unresponsive to responsive to treated by MA N≥50 MA drugs MA drugs drugs N≈100 N≈50 N≈50 All primary participants will complete the following assessments: • Clinical interview including anti-depressant treatment history • Clinical symptom questionnaires • Venous blood sample for peripheral immunophenotyping and DNA • Routine safety labs Secondary Clinical Cohort Adult MDD, sub-sampled from primary cohort plus new recruits, N~90 Stratified by peripheral blood level of C-reactive protein (CRP) Healthy adults Low CRP ≤ High CRP > N≥45 3mg/L 3mg/L N≈45 N≈45 All secondary participants will complete MRI plus 0, 1 or 2 below: • [ 11 C]-PK11195 positron emission tomography (PET) • Lumbar puncture for cerebrospinal fluid (CSF) sampling 3 Study design  Adults with depression  Standardised clinical questionnaires  Routine safety bloods  Immunophenotyping  MRI scans  PET scans (PK11195)  Lumbar punctures 4 2

23/10/2019 Where do you start? • What is the first thing to do? • How do you write a protocol? • Who do you need to contact in UoC, CUH, CPFT? • What approvals do you need? • What forms do you need to complete? • What training do you/your team need • Other considerations? 5 R&D Roadmap LINDA POINTON RESEARCH PROJECT MANAGER WELLCOME TRUST CONSORTIUM FOR NEUROIMMUNOLOGY OF MOOD DISORDERS AND ALZHEIMER’S DISEASE (NIMA) 6 3

23/10/2019 What is the first thing to do? 7 How do you write a protocol? PROTOCOL PIS ICF 8 4

23/10/2019 Download a good protocol template (CCTU)  Project summary Statistical Analysis  General information  Quality Assurance  Rationale & background  Expected Outcomes of the information Study  References  Dissemination of Results and Publication Policy  Study goals and objectives  Duration of the Project  Study Design  Problems Anticipated  Methodology  Project Management  Safety Considerations  Ethics  Follow-Up  Informed Consent Forms  Data Management and 9 Who do you need to contact? WBIC (MRI/PET) PROTOCOL PIS ICF 10 5

23/10/2019 Wolfson Brain Imaging Centre (WBIC) Contact: Daniel Barnes djb233@cam.ac.uk 11 Who do you need to contact? Neurology WBIC (LPs) (MRI/PET) PROTOCOL PIS ICF 12 6

23/10/2019 Neurology 13 Who do you need to contact? Neurology WBIC (LPs) (MRI/PET) Immunology PROTOCOL PIS ICF 14 7

23/10/2019 Immunology Dr Lori Turner 15 Who do you need to contact? Neurology WBIC (LPs) (MRI/PET) Immunology PROTOCOL PIS ICF PPI (EBE) 16 8

23/10/2019 Patient & public involvement (PPI) Fasting? What time? 17 Who do you need to contact? Neurology WBIC (LPs) (MRI/PET) Statistician Immunology PROTOCOL PIS ICF External PPI (EBE) reviewer 18 9

23/10/2019 else Who do you need to contact? ^ IDE (CenCom) Good draft of PROTOCOL PIS ICF 19 20 10

23/10/2019 else Who do you need to contact? ^ IDE CUH labs (CenCom) Good draft of PROTOCOL PIS ICF 21 22 11

23/10/2019 else Who do you need to contact? ^ IDE CUH labs (CenCom) Good draft of CCRC/HSB PROTOCOL PIS ICF 23 HSB Clinic 24 12

23/10/2019 else Who do you need to contact? ^ IDE CUH labs (CenCom) Insurance Good draft of CCRC/HSB office PROTOCOL PIS ICF 25 26 13

23/10/2019 Complete the IRAS form & submit to REC 27 28 14

23/10/2019 IRAS  Have a good draft protocol first  Look at other examples Beware copy & paste!  Feels repetitive in places  Find out REC meeting dates  Need to factor in getting signatures  ARSAC – for ionising radiation  Don’t be afraid to call the helpdesk  Allow at least a month  Make all documents the same date and “Version 1” 29 After submission  Study manual/SOPs  Training – GCP, EPIC  Get licences, vendor contracts, etc  Set up participant payments with finance  Get taxi coupons if needed  Set up data collection on the IDE 30 15

23/10/2019 Once REC approval comes through  Get final insurance letter  Send all approved documents to WBIC, CCRC 31 And finally... 32 16

23/10/2019 Insurance CUH labs CCRC/HSB IDE office Neurology WBIC (LPs) (MRI/PET) Statistician Immunology PROTOCOL PIS ICF External PPI (EBE) reviewer 33 R&D Roadmap • Study manual/SOPs • Training – GCP, EPIC • Get licences, vendor • Final insurance letter contracts, etc • Send all approved • Set up participant documents to WBIC, payments with finance CCRC • Get taxi coupons if needed • Set up data collection on the IDE Start R&D IRAS/ REC study approval REC approval Research passports 6-12 months 34 17

23/10/2019 Take-aways  There is a lot to do!  Allow at least 6-12 months for set up/approvals  You are not alone – talk to other people  Keep in touch with the R&D Office  Contact the IDE early  Involve service users and carers at all stages 35 Any questions? 36 18

23/10/2019 The Human Tissue Act How to Conduct Clinical Research - Training Event Friday 20 th May 2019 Dr Karen Ersche 37 Biological Safety  What do we mean by human tissue ?  What is the Human Tissue Act ?  What do I need to know for my research ?  Knowledge Quiz 38 19

23/10/2019 Human Tissue  Any sample that consists of or includes human cells: blood  urine  saliva   Human tissue does not include : hair and nails  gametes  embryos  cell lines  DNA  39 The Human Tissue Act (HTA) Provides a legal framework for the removal,  storage and use of human tissue .  Aimed to re-build public trust . 1. Consent 2. License 3. Transparency 40 20

23/10/2019 Relevance for Research Am I allowed to use the samples? Informed consent must be obtained from the  individual concerned to use and store relevant material for research or with the intent to analyse its DNA. Am I allowed to store the samples? An HTA licence must be in place in order to store  relevant material or exceptions apply . 41 I. Consent: Permission to use Samples  Honest information about the risks and the purpose for which the samples are needed .  Voluntary decision to provide a sample .  Promise to deliver expectations . Use samples only for what agreed.  Look after the samples ( preserving integrity ).  Look after the data that adds value to the samples.  Maintain link between data and samples.  Respect the donors’ confidentiality ( anonymity ).  42 21

23/10/2019 Specific versus Generic Consent Specific consent is required for tissue that is to be used  just for a particular piece of research . Leftover material must be disposed of.  “I understand that a blood sample will be taken and that DNA will be extracted to determine variants of gene XYZ involved in brain functions that are being examined by this study.” Generic consent covers more general research including  use of surplus samples for an unspecified use .  “I have been informed that the laboratory may retain any leftover samples to be used in future studies that have been ethically approved. I give consent for my DNA and related material to be stored for use in future studies .” 43 II. Licence : Permission to Store Samples The Department of Psychiatry has no HTA licence .   Samples can only be stored if they relate to a specific study that has been approved by an NHS Research Ethics Committee .  University REC approval is not acceptable! When NHS REC approval expires, samples must be stored  on licensed premises or renewed approval must be sought .  Samples should only be stored in designated freezers after an induction by the Biological Safety Officer. 44 22

23/10/2019 III. Transparency: Building Public Trust Demonstrating that you are working with the samples  in line with the donor's expectations .  purpose, quality, recordings, confidentiality/anonymity Clear processes in place (SOPs).  e.g. sample labelling, storage, tracking, transportation, disposal  Defined responsibilities .  Clear lines of accountability .  45 Standard Operating Procedures Documented standard operating procedures (SOP) are required that describe: the responsibilities of researchers  what to do when samples arrive  how samples should be coded  where samples should be stored  how samples are disposed of  46 23