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Overview. Requirements for applications to ethics committees in the Regulations and Commission guidance SSA
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1. Using IRAS to apply for ethical review; procedures for SSA
David Neal
Head of Policy and Deputy Director, NRES
3. Philosophy Clarify roles and responsibilities
Avoid duplication; also avoid issues falling between the cracks
Ensure consistent guidance from relevant bodies
Simplify procedures, reduce bureaucracy consistent with need to comply with regulation and protect subject safety
4. Applications to ethics committees Schedule 3 to the Clinical Trials Regulations lists information to be included in the application document
European Commission guideline on applications to ethics committee (ENTR/CT2)
5. Regulation 15 - matters the ethics committee must consider Relevance of trial and its design
Risk/benefit analysis
Protocol
Investigator brochure or SPC
Investigator(s) and supporting staff
Quality of the facilities
Consent process / PIS
Recruitment arrangements
Justification for including minors or adults lacking capacity
Insurance, indemnity and compensation
Rewards / payments
Any sponsor/site agreements relevant to rewards
6. Site-specific assessment The Regulations imply a requirement for the “main ethics committee” to approve each site and investigator in a trial
SSA is a check that the site, investigator, supporting staff and facilities are suitable to conduct a particular trial
7. NRES SOPs Revised SOPs to be issued on 25 March 2009 (version 4.0)
Section 4 of the SOPs set out procedures for SSA
Issued on a consultation-in-use basis, leading to further revision later in 2009 in light of feedback from RECs and other stakeholders
NRES SOPs will be formally adopted by AAPEC and apply to Phase 1 RECs outside the NHS
8. Responsibility for SSA – NHS sites From 1 April 2009, responsibility is transferred to NHS R&D offices
SSA integrated within standard NHS research governance review
Ethics committee gives a favourable opinion subject to permission from the NHS organisation
9. Responsibility for SSA – non-NHS sites Responsibility continues to lie with the ethics committee
SSA is undertaken either by “main REC” (as part of main review) or by the local REC for the site, as appropriate
If undertaken by another REC, this REC (“the SSA REC”) notifies the outcome to the main REC, which then formally approves the site
10. Phase 1 SSA Network (April 2008) NRES/AAPEC has appointed designated SSA RECs to undertake SSAs at each commercial Phase 1 trial site
Where the SSA REC is also the main committee for the ethical review, SSA will be an integral part of the main review
Where it is a different committee, the SSA REC provides advice on the site to the main committee within 14 days and in parallel with the main review
11. Applying for SSA – where the SSA REC is also the main REC Sponsor / Chief Investigator includes SSI Form and supporting documentation with the main application package
12. Applying for SSA – where the SSA REC is not the main REC CRO / Local Principal Investigator submits SSI Form and supporting documentation to the SSA REC as soon as the main application has been validated for review
SSA application may be made in parallel with main review or at any time subsequently (e.g. to add new site)
13. Current content of SSI Form Site/CRO name
MHRA accreditation?
Management/monitoring arrangements
Investigator (plus CV) and supporting staff
Identifying subjects
Consent procedure (plus local PIS)
Advice for subjects
Complaints
Notifying GPs
Any special facilities or emergency measures
Any local variations to protocol procedures
Insurance / indemnity
Over-volunteering
14. Supporting documentation for SSA CV for Principal Investigator
Local version of Participant Information Sheet (including contact details and other site-specific information)
Accreditation certificate (where applicable)
Copy of protocol and main application form for information only where SSA REC is not the main REC for the trial
Other documentation may be requested by SSA REC
15. Review of SSI Form and documentation requirements Remove question about CRO insurance
Consider removing any unnecessary questions, e.g. if unit is accredited by MHRA can we disable questions on issues addressed in accreditation?
Consider any other suggestions from RECs and CROs
Populate background information about purpose and design of trial from Part A of IRAS – for information not for review, avoids need to provide copy of main application form and protocol to SSA REC
16. Undertaking SSA Documentary check
Minimum of two members, can be in correspondence
Local investigator may be asked to provide any further information within 14 day timeline
17. Outcome of SSA Where SSA undertaken by main REC, site will be approved as part of its favourable opinion (FO) letter
Where SSA undertaken by a different REC:
SSA REC notifies the main REC of its advice electronically via the Research Ethics Database (RED) or via email if not using RED
If no objection, main REC confirms approval for site in FO letter
If objections, SSA REC should give reasons and the issues should be discussed between the RECs; final decision is the responsibility of the main REC
18. Site visits by SSA committees Not routinely required for SSA
Occasional visits (e.g. annual) may be helpful for familiarisation
Site visit recommended for a new site not yet inspected by the MHRA
Any concerns identified in visits can be reported to the GCP Inspectors
19. General advertising and screening Advice on non-trial specific advertising and screening procedures is outside the scope of ethical review under the Regulations
NRES encourages SSA RECs to provide advice on a voluntary basis
21. Objectives Background to IRAS
Using IRAS
Recent developments
Forthcoming priorities
Potential
22. Aims Web-based system
Capture all the information required to apply for relevant permissions and approvals for health research in the UK
Researchers enter information about their project once
Use filters to ensure data collected appropriate to the type of study, approvals and permissions required
Build on familiar features of NRES on-line form
23. Builds on… Creation of standard R&D application form alongside COREC online form (2005)
Inclusion of study-wide R&D issues into REC form to minimise duplication, and modification of some questions to allow dual use of REC form (2006)
Creation of Site-Specific Information Form (SSI Form) for both Site-Specific Assessment and R&D review (2007)
24. Who was involved?
25. Which applications are included? Administration of Radioactive Substances Advisory Committee (ARSAC)
Gene Therapy Advisory Committee (GTAC)
Medicines and Healthcare products Regulatory Agency (MHRA) – Medicines and Devices
Ministry of Justice – England and Wales
NHS / HSC research offices
NRES / NHS / HSC Research Ethics Committees
National Information Governance Board (NIGB, formerly PIAG) – England and Wales
26. Development & Consultation Launched January 2008
Consultation-in-use to July 2008
Version upgrades – import/ export EudraCT and IRAS; entry point for NIHR CSP; electronic authorisations and improvements in response to feedback
Existing (parallel) application systems will be withdrawn in due course
Feedback continues to be encouraged from users on the content, design and practical operation of IRAS to iras@nres.npsa.nhs.uk
27. IRAS usage Use of IRAS will be the preferred application route from April 09
Take-up is encouraging with half of REC applications now made using IRAS
The NRES application form system will be closed for new applications at the end of March 09
Transitional arrangements will be made for existing applications in progress, applications are not transferable
28. Using IRAS Setting up a user account
Create a project
Enter information about a project
Navigating the system and key functionality
29. How to set up an account First enter web address to your browser: www.myresearchproject.org.uk
If you already have existing NRES (COREC) account you can use your current log-in and password.
If you do not have an existing NRES account you can easily create a new account by following instructions on help page
30. Log in page
Same log in as for NRES form system can be used
Can create a log in and dummy applications to “play around” with the systemLog in page
Same log in as for NRES form system can be used
Can create a log in and dummy applications to “play around” with the system
31. Creating a new project
32. IRAS – project filter Short list of questions about the project
Dynamic – subsequent filter questions may alter depending on responses
Generates project dataset questions and application forms required for study type
Answer all the questions carefully and refer to question specific guidance as necessary
33. This open the Project Filter which determines what questions will apply for the type of study, and what applications are requiredThis open the Project Filter which determines what questions will apply for the type of study, and what applications are required
34. How does IRAS work? It consists of a single integrated dataset
This is the set of questions and answers for all the questions in all the application forms
The set of questions that need to be answered by a researcher will depend on the type of study and the types of applications required
The application forms for each reviewing body are generated from the single dataset
The single dataset and application forms cross-populate
i.e. information about the project in response to a question is entered only once Information about the project can be completed in application forms or dataset
Information about the project can be completed in application forms or dataset
38. IRAS Functionality Filter, integrated project dataset and application forms on the left
Select each form to show tabs relevant to that form on the right hand side of page:
Navigation tab – questions to complete
Other tabs – functions available for that form
Move around system using:
Underlined links (e.g. dataset, forms or question / sections)
Tabs
Buttons (e.g. print, save, navigation)
Following slides illustrate layout and functionalityFollowing slides illustrate layout and functionality
39. Printing and submitting application forms Each review body has different submission requirements
Select the appropriate form on the navigation page and then select the submission tab for specific guidance
To print hard copy for submitting follow instructions on submission tab and create submission code
NOTE: Remember application forms are submitted NOT the integrated project dataset!NOTE: Remember application forms are submitted NOT the integrated project dataset!
40. “Locking” forms and submission codes Application forms in IRAS cannot be locked
Instead of a “lock code” IRAS allocates a “submission code” once the applicant proceeds to final submission
This code will appear on the foot of the application form on print-out
An audit trail is created of the dataset at the time at which a submission code is generated.
It is the responsibility of applicants to keep their IRAS project dataset up to date
When applicants make changes to the dataset following a submission, they will be prompted to consider whether other review bodies need to be notified of the change NRES forms were “locked” – this does not take place in IRAS because IRAS collates information for multiple review bodies. That is information may continue to be added once one form is submitted to allow for other applications to madeNRES forms were “locked” – this does not take place in IRAS because IRAS collates information for multiple review bodies. That is information may continue to be added once one form is submitted to allow for other applications to made
41. IRAS features Contacts – keep details of collaborators
Standard CV
Electronic authorisation
42. Contacts Enables you share contact details across all your projects
Access from menu bar
Or whenever you see the icon
Build up an address book:
Yourself
You collaborators
43. Within the dataset, this icon allows you to enter contact data that you have already savedWithin the dataset, this icon allows you to enter contact data that you have already saved
44. These are all available in My Contacts and you simply select and click to copy into the datasetThese are all available in My Contacts and you simply select and click to copy into the dataset
45. Electronic authorisations New functionality from December 2008 to allow electronic authorisation in IRAS as alternative to ink signature
Authorisation operates by secure email transfer, with audit trail confirming what has been authorised, when and by whom
Can be used for e.g. R&D/SSI Forms, sponsor declaration, academic supervisor, radiation experts
Some ink signatures still required, in particular CI declaration on REC application for CTIMPs
46. Help and support Throughout system green “i” button leads to Question Specific Guidance
Contacts
Review bodies
Technical support
Help section:
QSG for each section
Standard blank forms to print off
47.
Technical queries on IRAS to: helpdesk@infonetica.net
Feedback on IRAS to:iras@nres.npsa.nhs.uk
48. IRAS Developments Complete
CSP link (November 08)
Changes in response to initial consultation (December 08)
Electronic authorisations (December 08)
Full EudraCT dataset (March 09)
In progress
Social Care REC (April 09)
Skeleton dataset for “old NRES form study” in IRAS (May 09)
Agreed
Review dataset
EudraCT Notice of Amendment
Medical Research Information Service (NHS Information Centre)
National Offender Management Service (prisons/probation)
49. IRAS potential Considerable potential for further development:
Facilitate trial registration
Direct electronic submission and decision notification
Safety and end of trial reporting