ETHICS,  IRAS  &  DATA  PROTECTION  

 Clinical  Research  Methods  Course  

 14th  March  2017  

Priyanthi  Dias  Senior  Trials  Coordinator  

Adult  CriDcal  Care  Research  Unit  Queen  Mary  University  of  London  

p.dias@qmul.ac.uk    

DefiniDons  

CI:  Chief  InvesDgator    CTIMP:  Clinical  Trial  of  an  InvesDgaDonal  Medicinal  Product    IRAS:  Integrated  Research  ApplicaDons  system    MHRA:  Medicines  and  Healthcare  products  Regulatory  Agency    HRA:  Health  Research  Authority      REC:  Research  Ethics  CommiSee    CRN:  Clinical  Research  Network  

Who  are  the  main  organisaDons?

PaDents  

CI  

Sponsor  

HRA/  REC  

Sites  

CRN  

MHRA  

Clinical  trial  pathway

h"p://www.ct-­‐toolkit.ac.uk/routemap/  

Clinical  trial  pathway

h"p://www.ct-­‐toolkit.ac.uk/routemap/  

Where  do  I  start?  

CI  Trial  Manager/  Coordinator    Collaborators  

StaDsDcian    

QA  Manager  

Trial  Documents  Protocol  IRAS  PaDent  InformaDon  Sheet  Informed  Consent  GP  leSer  Funding  Contracts  

   

Sponsor  

Database  Manager  

Study  protocol  

Consent  Form(s)  

PaDent  InformaDon  Sheet  

Is  Your  Study  Ethical?

Ethics  applicaDon  –  Part  1

Sponsor  

Local  Peer  Review  

Peer  reports/  Risk  assessments  

Trial  team  

Trial  documents  

Integrated  Research  ApplicaDon  System  (IRAS)  

Standardised  pla_orm  for  Permissions  &  Approvals  for  UK  Health  Research        

• Register  for  an  IRAS  account  (hSps://www.myresearchproject.org.uk)    

• Create  a  new  project  •  Transcribe  study  protocol  into  Project  document  

•  Provide  further  clarificaHon  around  study  procedures  &  ethical  consideraHons  

• Single  system  for  approvals  for  research  in  the  UK  

• Depending  on  the  type  of  study,  uses  filters  to  ensure  the  appropriate  informaHon  is  collected  

• Add  parHcipaHng  sites  and  the  principal  invesHgators    

IRAS  -­‐  RegistraDon  

hSps://www.myresearchproject.org.uk  

IRAS  –  Create  New  Project  

hSps://www.myresearchproject.org.uk  

IRAS  –  Core  Study  QuesDons  

IRAS  –  Project  filter  quesDons  non-­‐CTIMP  

IRAS  –  Project  filter  quesDons  CTIMP  

C  

IRAS  –  Project  filter  quesDons  CTIMP  

C  

   

• CTIMPS  need  to  be  registered  on  EudraCT  (ISRCTN  for  non-­‐CTIMPS)  

• Clinical  Trial  ApplicaHon  Form  needs  to  be  completed  

Provide  further  informaHon  on  the  -­‐  InvesHgaHonal  Medicinal  Products  (IMPs)  

                                             -­‐  Placebos  if  required  

 (h"ps://eudract.ema.europa.eu/eudract-­‐web/index.faces)  

IRAS  –  Project  filter  quesDons  CTIMP  

IRAS  –  Check  List  

CTIMPS  only  

Document  check  list  

Provisional  Sponsorship  

h"p://bartshealth.nhs.uk/research/strategy-­‐and-­‐policy/standard-­‐operaHng-­‐procedures/  

Provisional  Sponsorship  and  Indemnity  

IRAS  –  Electronic  AuthorisaDons    

•  Book  meeDng  with  the  REC    

•  Submission  can  be  made  only  ader  electronic  authorisaDons  

•  If  you  change  any  informaDon  ader  authorisaDons,  signatures  will  need  to  be  

requested  again  

 

IRAS  –  NIHR  Por_olio  AdopDon  

• Studies  funded  as  a  result  of  open  compeDDon  in  England  with  high  

quality  peer  review    

• Research  that  is  of  clear  value  to  the  NHS  

• Studies  that  take  appropriate  account  of  the  prioriDes,  needs  and  

realiDes  of  the  NHS  hSp://www.nihr.ac.uk/research-­‐and-­‐impact/nihr-­‐clinical-­‐research-­‐network-­‐por_olio/  

REC/HRA  Approvals  Pathway

Capacity  and  Capability

Approvals  Checklist

 REC  Favourable  opinion    

LeSer  of  HRA  approval    

NIHR  Por_olio  adopDon    

ConfirmaDon  of  Capacity  and  Capability    

Full  Sponsorship  

IRAS  -­‐  Amendments

Data  ProtecDon  Act  1998

Importance  of  Consent  in  Data  CollecDon

Sharing  of  Study  Materials

Centralised  Repositories  Study    

PaDent  

Data  

Tissue  

Local    Stores  

Study  Protocol  

CRF  

Consent  logs  

PIS  &  Consent  Forms  

Summary  

YOU  NEED  CONSENT  AND  ETHICAL  APPROVAL  FOR  YOUR  MATERIALS        

•  Partner  the  Sponsor  when  seeking  ethical  approvals  for  your  studies  

• Use  DEIDEINTIFIED  MATERIALS  wherever  possible  

•  Create  applicaDon  PDFs  using  IRAS:  

•  New  projects  

•  One  system  to  apply  for  all  the  required  approvals  

•  Changing  the  study  (SubstanDal  Amendments)      

•  Implement  robust  documents  to  protect  your  study  materials:  

•  Standardised  SOPs  (Study  protocol,  Database,  Biobank)  

•  Data  Usage  Agreements  (DUA)  /  Materials  Transfer  Agreements  (MTA)    

 

QUESTIONS?