New ethics form and procedures: New ethics form and procedures Alison Clark, Randamp;D Co-ordinator Patricia Murray, Randamp;D Information Officer Randamp;D Office, NHS Lothian – University Hospitals Division December 2004


What’s changed?: What’s changed? Ethics form Ethics process Definitions Responsibilities


Topics to be covered: Topics to be covered Changes to ethics process Guidance on some specific questions Technical aspects of using the new form


Changes to ethics process: Changes to ethics process


Definitions: Definitions Chief Investigator (CI) – responsible for whole study Principal Investigator (PI) – responsible for study at local site Domain – Health Board (in Scotland) Research site – Operational unit within a Health Board (e.g. UHD) Site Specific Assessment (SSA) – locality assessment Multi-centre study – more than one site Sponsor – more later


For Example:: For Example:


New names for committees: New names for committees Recognised RECs – recognised by COREC to deal with: drug trials (all) studies in more than one domain and studies involving adults with incapacity Most of these are the old MRECs Authorised RECs – authorised by COREC to give ethical opinion on studies except for those listed above. Most of these are the old LRECs. Main REC – REC giving ethical opinion


EU Directive requires that:: EU Directive requires that: Each study has one ethical opinion Ethical opinion is given within 60 days of receipt of a valid application Ethics committee can return to researchers with one set of questions only Decision: approved, rejected, provisional opinion and no decision


How to submit an application 1: How to submit an application 1 Complete forms (include signing off): If more than one site – CI completes parts A andamp; B, PIs in all sites complete part C. CIs and PIs complete Randamp;D forms to apply for Management Approval at each site If only one site – CI completes parts A, B andamp; C and completes Randamp;D form


How to submit an application 2: How to submit an application 2 Clinical trials, studies in more than one domain or studies involving adults with incapacity – phone Central Allocation System (0845 270 4400) Studies in one site only or in one domain only – phone Lothian REC (536 9126)


How to submit an application 3: How to submit an application 3 Given a reference number and main REC to which you should submit you application You can ask for a specific committee (NB Adults with Incapacity) You now have 4 calendar days to submit your application – see checklist for what is needed Submit copies of all ethics paperwork (a list of all centres submitting part Cs) plus a completed Randamp;D form to the Randamp;D office


Approvals: Approvals In parallel: One ethical opinion – locality assessment (SSA) fed back to main RECs Randamp;D approval before research can start Drug trials – Clinical Trial Authorisation (CTA)


Amendment – Adding Sites: Amendment – Adding Sites To an existing MREC or COREC application Complete Section C Submit to local Ethics Committee If approved by old ethics process, specific questions in part A must be completed – see page 47


Slide14:


Amendments - Substantial: Amendments - Substantial Defined as an amendment to the terms of the REC application, or to the protocol or any other supporting documentation, that is likely to affect to a significant degree: the safety or physical or mental integrity of the subjects of the trial the scientific value of the trial the conduct or management of the trial the quality or safety of any investigational medicinal product used in the trial Fill out form available from: http://www.corec.org.uk/wordDocs/Amendment%20notice%20form.doc Submit to main REC


Guidance on some specific questions: Guidance on some specific questions


Guidance available from COREC: Guidance available from COREC Question specific guidance – available from COREC Patient information sheet guidance – available from COREC Supplied today – general guidance from COREC and applicant’s checklist


A6. Do you consider that this research falls within the category where there is no local investigator?: A6. Do you consider that this research falls within the category where there is no local investigator? Appointment of PI and a SSA not normally required (from current COREC SOPs): Routine investigations Simple questionnaires and surveys Collection of data or human tissue Facilitating the recruitment of participants Studies must have a ‘local collaborator’ Randamp;D Management approval must be sought


A31. Does this study have, or require approval of Patient Information Advisory Group (PIAG) or other bodies with a similar remit?: A31. Does this study have, or require approval of Patient Information Advisory Group (PIAG) or other bodies with a similar remit? PIAG oversees how patient identifiable data is handled in England and Wales (section 60 of Health and Social Care Act 2001) No corresponding group in Scotland Remember, a REC in England/Wales may be looking at your application


A35. What arrangements have been made ….. for negligent harm?: A35. What arrangements have been made ….. for negligent harm? Your employer/honorary employer is usually vicariously liable for your negligent acts NHSScotland is insured through CNORIS against clinical negligence and other risks NHS employees/honorary employees are insured for approved activities, conducted on behalf of the NHS body, which involve patients CNORIS does not cover healthy volunteer studies Suggested wording: 'Cover for negligence is in place by virtue of the code of employment for approved patient research.'


A36. What arrangements have been made …. for non-negligent harm?: A36. What arrangements have been made …. for non-negligent harm? NHS cannot hold insurance to cover non-negligence (ex gratia payment possible) Commercial companies may offer ABPI indemnity for studies If no special arrangements have been made to provide indemnity for non-negligence, then say so Ensure that your Patient Information Sheet informs participants of this situation In reality, non-negligence is not recognised by Scottish courts Suggested wording: 'No special arrangements will be made to cover non-negligent actions but normal channels for dealing with complaints are in place'


Negligence/Non-Negligence: Negligence/Non-Negligence Ensure that your patient information sheet details arrangements. Suggested wording: If you are harmed by taking part in this research project there are no special compensation arrangements. If you are harmed due to somebody’s negligence then you may have grounds for a legal action but you may have to pay for it. Regardless of this, if you wish to complain or have any concerns about any aspect of the way you have been approached or treated during the course of this study, the normal National Health Service complaints mechanism should be available to you.'


A57. What arrangements are in place for monitoring and auditing the conduct of the research?: A57. What arrangements are in place for monitoring and auditing the conduct of the research? Responsibility to monitor and audit studies falls to: Sponsor MHRA (regulatory authority, drug trials) RECs (annual reports) PIs responsibility to make data available to monitors/auditors at each site (RGF) Participants confidentiality and welfare to be protected


A59. Sponsorship: A59. Sponsorship Sponsor to have overall responsibility for management and governance of study Charities not keen on Sponsorship (as it costs money!) Universities and NHS Bodies can be sponsors LUHD working closely with local HEIs If funder not willing to sponsor – Tick ‘not yet known’ box


Technical aspects of using the new ethics form: Technical aspects of using the new ethics form


Where to find the form: Where to find the form Online form Available at http://www.corecform.org.uk Register to use it Available on all systems (including Mac) NB: the downloadable form is being phased out


Advice Regarding the Online Form: Advice Regarding the Online Form Must be online to use it – ie have a connection to the internet Dial up connection not recommended Must have an email address Must have adobe acrobat installed on computer


Slide28: If it’s the first time you are using the on-line form, you will need to create an account


Slide29: Can be any email address One user account per email address Need to have access to email when registering as there is an activation number


Slide30: This screen appears when logged in. It presents a summary of all the forms in the account. Name of research project Click to create new form


Slide31: The Short Title will become the name that the form is referred to in the main forms menu


Slide32:


Slide33: Click on forms to get back to the main form page Click on these to navigate through the pages. Previous and next work in the same way as turning the pages in a book. Navigate takes you to……


Slide34: …the form index. Click on the page you want to access. Pages will become enabled dependent on the tick boxes selected in the questions. When you print, only the enabled pages will print.


Intelligent Form?: Intelligent Form? Some check boxes will automatically make section appear/disappear (eg A5 if involves a medicinal product is checked, part B section 1 will appear) Repeated questions will automatically be filled in – eg the Project Reference, the Chief Investigator Don’t assume all checklists are active As a result, only relevant pages will be printed


Slide36: This question populates box C4


Slide37: It is specified that the information is taken from a previous question by the term 'Populated from….'


Who should complete what…: Who should complete what… The Chief Investigator (CI) should fill in parts A andamp; B The Principal Investigator (PI) (the local lead) should fill in Part C At a single centred site, the CI should fill in parts A, B andamp; C


Transferring the form to another user: Transferring the form to another user Transfer to another user (only one user at a time) User must have created an account Other user can make changes Changes not tracked Must re-claim form Whilst form is transferred out, form is inaccessible For every transfer an automatic email is sent to the recipient


Slide40: To transfer the form to another user click 'Manage/Lock Application'


Slide41: Type in the email address of the recipient. Recipient must also have an account. Click 'Transfer to User'


Slide42: Don’t click on 'Retrieve Application' (unless you want to). To navigate to the main forms page, click forms at the top of the sheet.


Slide43: Unable now to click on form until the form is retrieved The pending will disappear when the user accepts the form


Slide44: Click retrieve application to re-claim the form into your account. This can be done at any time.


On completion of Parts A and B: On completion of Parts A and B Lock and submit Must get reference number before submitting – see 'How To Submit An Application – 2' Once locked no changes can be made and the form cannot be deleted Can be unlocked by phoning COREC with reference code Or form can be duplicated Removes the lock Changes can be made If you lock the form accidentally, don’t panic – duplicate!


Slide46: Click 'Submit Application' to lock and submit the application. This will submit it to the central database. It is essential that you have the correct reference number entered (see next page and 'How To Submit an Application – 2') before you submit this so it is picked up by the REC that will review your application.


Slide47: Enter in this box, the Project Reference you have been given Enter in this box, the REC committee (either local or allocated through the Central Allocation System)


Slide48: To unlock the application: Duplicate the application (easier). This will replicate the form and add it to your list of forms. OR you can unlock by following the instructions on this webpage. A code will be needed – this is at the top of the page. For this form it would be 'AB/24216/1'.


Section C: Section C A Section C is needed for each site of the project The CI adds Section Cs to the main form under Manage/Lock application Section C is transferred to the PIs at each site including the site of the CI The CI must inform all the PIs when the ethics application is deemed valid (ie ethics confirm all paperwork has been received, not approved) The PIs can then complete and submit their form to their local ethics committee for Site Specific Assessment


Slide50: To add more Section C’s – click ' + Add Section C'. You can add as many as you need.


Slide51: C To access a Section C, click on these Section Cs.


Slide52: Enter at least these details so that each Section C has a PI named before they are distributed.


Slide53: The PI surname is displayed To transfer this to the local PI, click on the relevant Manage/Lock Section C


Slide54: Type in the email address of the recipient. Recipient must also have an account. Click 'Transfer to User'. This can be retrieved later by the CI.


Slide55: The recipient must click Manage/Lock Section C


Slide56: The recipient must click Accept


Slide57: This page will appear. Do not click 'Lock'. Click on 'Forms' to navigate to the main forms page to edit the form


Slide58: Click on the form to edit


On Completion of Part C: On Completion of Part C Phone local REC to get reference number Fill in REC details (see next slide) Lock form (this also submits to the REC) Print the form and send to local REC CI can re-claim part C if multi-centred project Part C can be unlocked by the PI but not the CI unless the CI phones COREC


Slide60: Complete Enter these details after phoning your local REC office


Slide61: From the main forms page, click on Manage/Lock beside the relevant part C. Click Lock and this will submit the project to the relevant REC.


Slide62: From the main forms page, click on Manage/Lock beside the relevant part C. Click unlock and this will allow changes.


Printing the form: Printing the form To print the form, adobe acrobat reader must be installed The form is downloaded and can be saved onto your computer


Slide64: Click print


Slide65: Choose an option Choose the Section C you would like printed. If you have a Section C transferred out you will be unable to print it


Slide66: Click Proceed Click Open if you just want to view it. If you would like to save it to you directory, click Save.


Slide67: You cannot edit this form, although can re-create from the COREC website. CIs should email this to their colleagues for their information and to send to the Randamp;D Office. NB: There will only be the number of pages that are enabled.


Signatures: Signatures Electronic signatures are not legally binding in the UK Therefore cannot submitted just electronically 1 signed paper copy has to be submitted (in addition to the information required on the applicant’s checklist)


Aide Memoire: Aide Memoire Submission of forms: Complete – phone – submit Completion includes signing Printed form will have pages ‘missing’ More than one Health Board, adults with incapacity (in Scotland) or drug trial – CAS – recognised REC Remainder of projects go to authorised RECs Pass all paperwork (eg ethics, protocols, patients information sheets etc) to Randamp;D Office with Randamp;D form


More information: More information Central Office for Research Ethics Committees http://www.corec.org.uk Randamp;D office http://www.show.scot.nhs.uk/luht/RandD Tel: 23330 or Randamp;DOffice@luht.scot.nhs.uk