The Research Ethics Process RPT Conference 28 th April 2006

Presentation Aims To explain how to use the process in order to apply for ethical approval To explain how to use the process in order to apply for ethical approval Clarify use of the online form Clarify use of the online form Clarify FAQs Clarify FAQs

What do you mean I have to complete the COREC form….. This is only: A little piece of research!! A little piece of research!! A simple study!! A simple study!! A questionnaire study!! A questionnaire study!! A staff study!! A staff study!! An observational study!! An observational study!!

What is a Research Ethics Committee (REC)? Lay, expert clinical and non-clinical members (Max 18 members, Hull currently have 16 inc. 5 lay members) Lay, expert clinical and non-clinical members (Max 18 members, Hull currently have 16 inc. 5 lay members) Provide independent advice to participants, researchers, funding bodies, sponsors, employers, care organisations and professionals on the extent to which proposals for research studies comply with recognised ethical standards Provide independent advice to participants, researchers, funding bodies, sponsors, employers, care organisations and professionals on the extent to which proposals for research studies comply with recognised ethical standards The purpose of a REC in reviewing the proposed study is to protect the dignity, rights, safety and well-being of all actual or potential research participants The purpose of a REC in reviewing the proposed study is to protect the dignity, rights, safety and well-being of all actual or potential research participants

EU Directive 2001/20/EC Requirements the directive sets for ethical review are: Requirements the directive sets for ethical review are: deliver a decision on a valid application within 60days deliver a decision on a valid application within 60days (valid application received the clock starts) one decision to be valid for the whole of the UK one decision to be valid for the whole of the UK one written request for clarification or further information to applicants (clock stops whilst waiting for response) one written request for clarification or further information to applicants (clock stops whilst waiting for response)

The Ethical Review process All RECs meet on a monthly basis to ensure that decisions can be made within the 60 day time frame. All RECs meet on a monthly basis to ensure that decisions can be made within the 60 day time frame. Applicants will be invited to attend the meeting in support of their applications (attendance is not compulsory) Applicants will be invited to attend the meeting in support of their applications (attendance is not compulsory)

The Ethics Review Process Contact appropriate R&D dept Contact appropriate R&D dept Write Research Protocol / Proposal Write Research Protocol / Proposal Complete COREC On-line form & R&D On-line form Complete COREC On-line form & R&D On-line form Submit to REC with Supporting Documents Submit to REC with Supporting Documents Ethical Review Carried out by Committee -- after Favourable Opinion Ethical Review Carried out by Committee -- after Favourable Opinion Trust Approval gained Trust Approval gained

The COREC On-Line Form Print off Guidance for Applicants document as reference tool Print off Guidance for Applicants document as reference tool Use link to create a tailor made application form Use link to create a tailor made application form Input user name and a pass word to create your own secure account Input user name and a pass word to create your own secure account

The Filter Page 6 Questions 6 Questions IMPORTANT! Answer carefully as these questions determine the pages of the form IMPORTANT! Answer carefully as these questions determine the pages of the form -- The information icon allows applicant to clarify each question -- The information icon allows applicant to clarify each question

The COREC On-Line Form REC Reference number & Submission date – complete form and enter this information later REC Reference number & Submission date – complete form and enter this information later Answer all Questions in Full Answer all Questions in Full Section A59 – Sponsor details Application not valid without this information Section A59 – Sponsor details Application not valid without this information

The COREC On-Line Form Section A35 – 36 Indemnity Application not valid without this information Section A35 – 36 Indemnity Application not valid without this information Signatures in Ink – Application not valid without the signatures Signatures in Ink – Application not valid without the signatures Separate Research Protocol / Proposal document Separate Research Protocol / Proposal document

Supporting Documents REC must review all documents to be used in the study REC must review all documents to be used in the study Version number and date on supporting documents– document not valid without this information Version number and date on supporting documents– document not valid without this information CV for Chief Investigator (& Ed. Supervisor if student application) CV for Chief Investigator (& Ed. Supervisor if student application)

Ready for Submission? When documents are complete a REC Reference number can be allocated When documents are complete a REC Reference number can be allocated If CTIMP study application must be booked through Central Allocations System ( ) If CTIMP study application must be booked through Central Allocations System ( ) If other study book direct with LREC (Hull ) If other study book direct with LREC (Hull )

Deadline Date LREC Must receive application documents before the deadline date (submission date) in order to process the documents and prepare them for review by committee members LREC Must receive application documents before the deadline date (submission date) in order to process the documents and prepare them for review by committee members Deadline date is the VERY LAST date documents can be submitted Deadline date is the VERY LAST date documents can be submitted

Validation Process LREC Coordinator carries out validation process LREC Coordinator carries out validation process If application not valid then documents will be returned to investigator with letter If application not valid then documents will be returned to investigator with letter If application valid – put forward to the next meeting and information sent out to all members for reading If application valid – put forward to the next meeting and information sent out to all members for reading

THE LREC Meeting All members review all studies All members review all studies Lead 1 and Lead 2 reviewers allocated to look at each study in detail Lead 1 and Lead 2 reviewers allocated to look at each study in detail Investigator in attendance – answer questions – saves time Investigator in attendance – answer questions – saves time No decision given at meeting No decision given at meeting

Decisions Favourable Opinion Favourable Opinion Provisional Opinion Provisional Opinion Unfavourable Opinion Unfavourable Opinion No decision – Expert Referee Opinion Sought No decision – Expert Referee Opinion Sought

Conditions of Approval Adverse Events Reports Adverse Events Reports Protocol Amendments Protocol Amendments Annual Progress Report Annual Progress Report Declaration of End of Study Declaration of End of Study Final Report Final Report

Dont Panic!! LREC Office is open 9am – 4.30pm LREC Office is open 9am – 4.30pm Room SC39 Coniston House Willerby (HMHT NHS Trust HQ) Room SC39 Coniston House Willerby (HMHT NHS Trust HQ) Happy to help Happy to help