the research ethics process rpt conference 28 th april 2006

The Research Ethics The Research Ethics ProcessProcess

RPT Conference 28RPT Conference 28thth April 2006 April 2006

Presentation AimsPresentation Aims

To explain how to use the To explain how to use the process in order to apply for process in order to apply for ethical approval ethical approval

Clarify use of the online formClarify use of the online form Clarify FAQsClarify FAQs

What do you mean I have to What do you mean I have to complete the COREC form…..complete the COREC form…..This is only:This is only:

A ‘little’ piece of A ‘little’ piece of research!!research!!

A simple study!!A simple study!! A questionnaire A questionnaire

study!!study!! A staff study!!A staff study!! An observational An observational

study!!study!!

What is a Research Ethics What is a Research Ethics Committee (REC)?Committee (REC)? Lay, expert clinical and non-clinical members (Max Lay, expert clinical and non-clinical members (Max

18 members, Hull currently have 16 inc. 5 lay 18 members, Hull currently have 16 inc. 5 lay members) members)

Provide independent advice to participants, Provide independent advice to participants, researchers, funding bodies, sponsors, employers, researchers, funding bodies, sponsors, employers, care organisations and professionals on the extent care organisations and professionals on the extent to which proposals for research studies comply with to which proposals for research studies comply with recognised ethical standardsrecognised ethical standards

The purpose of a REC in reviewing the proposed The purpose of a REC in reviewing the proposed study is to protect the dignity, rights, safety and study is to protect the dignity, rights, safety and well-being of all actual or potential research well-being of all actual or potential research participantsparticipants

EU DirectiveEU Directive 2001/20/EC2001/20/EC

Requirements the directive sets for Requirements the directive sets for ethical review are: ethical review are: deliver a decision on a valid deliver a decision on a valid

application within 60daysapplication within 60days (valid application received the clock (valid application received the clock

starts)starts)

one decision to be valid for the whole one decision to be valid for the whole of the UKof the UK

one written request for clarification one written request for clarification or further information to applicantsor further information to applicants (clock stops whilst waiting for response)(clock stops whilst waiting for response)

The Ethical Review processThe Ethical Review process

All RECs meet on a monthly basis to All RECs meet on a monthly basis to ensure that decisions can be made within ensure that decisions can be made within the 60 day time frame. the 60 day time frame.

Applicants will be invited to attend the Applicants will be invited to attend the meeting in support of their applications meeting in support of their applications (attendance is not compulsory)(attendance is not compulsory)

The Ethics Review ProcessThe Ethics Review Process

Contact appropriate R&D dept Contact appropriate R&D dept Write Research Protocol / ProposalWrite Research Protocol / Proposal Complete COREC On-line form & Complete COREC On-line form &

R&D On-line formR&D On-line form Submit to REC with Supporting Submit to REC with Supporting

DocumentsDocuments Ethical Review Carried out by Ethical Review Carried out by

Committee -- after Favourable Committee -- after Favourable OpinionOpinion

Trust Approval gainedTrust Approval gained

The COREC On-Line FormThe COREC On-Line Form

www.corec.org.ukwww.corec.org.uk Print off Guidance for Applicants Print off Guidance for Applicants

document as reference tooldocument as reference tool Use link to create a tailor made Use link to create a tailor made

application formapplication form Input user name and a pass Input user name and a pass

word to create your own secure word to create your own secure accountaccount

The Filter PageThe Filter Page

6 Questions6 Questions IMPORTANT! Answer carefully IMPORTANT! Answer carefully

as these questions determine as these questions determine the pages of the formthe pages of the form

-- The information icon allows -- The information icon allows applicant to clarify each applicant to clarify each question question


REC Reference number & REC Reference number & Submission date – complete Submission date – complete form and enter this information form and enter this information laterlater

Answer all Questions in FullAnswer all Questions in Full Section A59 – Sponsor details Section A59 – Sponsor details

Application not valid without this Application not valid without this informationinformation


Section A35 – 36 Indemnity Section A35 – 36 Indemnity Application not valid without this Application not valid without this informationinformation

Signatures in Ink – Application Signatures in Ink – Application not valid without the signaturesnot valid without the signatures

Separate Research Protocol / Separate Research Protocol / Proposal documentProposal document

Supporting DocumentsSupporting Documents

REC must review all documents REC must review all documents to be used in the studyto be used in the study

Version number and date on Version number and date on supporting documents– supporting documents– document not valid without this document not valid without this informationinformation

CV for Chief Investigator (& Ed. CV for Chief Investigator (& Ed. Supervisor if student Supervisor if student application)application)

Ready for Submission?Ready for Submission?

When documents are complete When documents are complete a REC Reference number can a REC Reference number can be allocatedbe allocated

If CTIMP study application must If CTIMP study application must be booked through Central be booked through Central Allocations System (0845 270 Allocations System (0845 270 4400)4400)

If “other” study book direct with If “other” study book direct with LREC (Hull 01482 389246)LREC (Hull 01482 389246)

Deadline DateDeadline Date

LREC Must receive application LREC Must receive application documents before the deadline documents before the deadline date (submission date) in order date (submission date) in order to process the documents and to process the documents and prepare them for review by prepare them for review by committee memberscommittee members

Deadline date is the VERY Deadline date is the VERY LAST date documents can be LAST date documents can be submittedsubmitted

Validation ProcessValidation Process

LREC Coordinator carries out LREC Coordinator carries out validation processvalidation process

If application not valid then If application not valid then documents will be returned to documents will be returned to investigator with letter investigator with letter

If application valid – put forward If application valid – put forward to the next meeting and to the next meeting and information sent out to all information sent out to all members for readingmembers for reading

THE LREC MeetingTHE LREC Meeting

All members review all studiesAll members review all studies Lead 1 and Lead 2 reviewers Lead 1 and Lead 2 reviewers

allocated to look at each study allocated to look at each study in detailin detail

Investigator in attendance – Investigator in attendance – answer questions – saves timeanswer questions – saves time

No decision given at meeting No decision given at meeting

Decisions Decisions

Favourable OpinionFavourable Opinion Provisional OpinionProvisional Opinion Unfavourable OpinionUnfavourable Opinion No decision – Expert Referee No decision – Expert Referee

Opinion SoughtOpinion Sought

Conditions of ApprovalConditions of Approval

Adverse Events ReportsAdverse Events Reports Protocol AmendmentsProtocol Amendments Annual Progress Report Annual Progress Report Declaration of End of StudyDeclaration of End of Study Final ReportFinal Report

Don’t Panic!!Don’t Panic!!

LREC Office is LREC Office is open 9am – open 9am – 4.30pm4.30pm

Room SC39 Room SC39 Coniston House Coniston House Willerby (HMHT Willerby (HMHT NHS Trust HQ)NHS Trust HQ)

Happy to helpHappy to help