Proportionate Review (PR) IRAS Application & Documents. Authorisations & Signatures. Contact CBS Team

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1 Proportionate Review (PR) What is Proportionate Review? Is my study suitable for Proportionate Review? IRAS Application & Documents What is an IRAS application form? What documents do I need? Completing the IRAS Application form & supporting documentation Authorisations & Signatures Getting your NHS REC form authorised with electronic signatures (e-signatures) Contact CBS Screening & Booking Submission Submission Guidance Validation Process and Criteria Post Validation The Review The Review The Decision

2 What is Proportionate Review (PR)? The Proportionate Review Service (PRS) provides an expedited, proportionate review of research studies which raise no material ethical issues. Under the PRS, new applications are reviewed via correspondence, teleconference or at a face to face meeting by a sub-committee (comprised of experienced expert and lay members) rather than at a full meeting of a REC. The final decision will be notified to the applicant by within 14 calendar days of receipt of a valid application. A PRS review is as rigorous as a full REC review and will not affect the opinion you are given. If the Proportionate Review Sub- Committee have any questions during the 14 day review period they may call or the study contact for clarification or further information. To Book a PR application Telephone: nres.cbs@nhs.net (please contact details and an operator will call you)

3 Is My Study Suitable for Proportionate Review? Suitable Research using data or tissue that is anonymous to the researcher or studies in which patient identifiable data is not accessed at any stage of the research Research using existing tissue samples already taken with consent for research. Research using surplus or extra tissue with consent (e.g further blood taken at time of routine sampling, tissue taken during a clinically directed procedure or non- invasive or minimally invasive procedure in non- vulnerable groups) Questionnaire research that does NOT include highly sensitive areas (defined as questions which may cause anxiety because of the nature of the question or of the population being asked. NB the assessment of a question s sensitive nature might be influenced by whether the answers are to be anonymised) or where accidental disclosure would NOT have serious consequence. Sensitive questionnaires that are validated for use in the proposed population are acceptable for PR Research interviews/focus groups that do not include highly sensitive areas or where accidental disclosure would not have serious consequence. Research surveying the safety or efficacy of established non-drug treatments involving limited intervention and NO change to the patients treatment. Minimally invasive basic science studies involving healthy volunteers. Other study which does not have any Material Ethical Issues N.B- Studies involving children may be considered for Proportionate Review if there are no material ethical issues.

4 Not Suitable Clinical Trials of Investigational Medicinal Products Medical Device studies where the device is not CE marked or where a CE marked device is invasive and/or is being used outside of its intended purpose/licence. Studies involving Adults Lacking Capacity who are subject to the MCA (Eng)/AWI (Scot). Research involving exposure to ionising radiation which would be additional to that received in routine clinical care for any participant. Establishment or renewal of Research Tissue Banks. Establishment of Research Databases. Research involving prisoners and people on probation. Studies funded by the United States Department of Health and Human Services Research involving non-validated questionnaires where the questions are highly sensitive Research involving interviews or focus groups where the questions/topics are highly-sensitive. Studies proposing research team members who are not part of direct care team have access to patients identifiable records without consent at any stage of research, including identification of eligible participants.

5 IRAS stands for Integrated Research Application System IRAS is a tool that helps you to build an application What is an IRAS form? The IRAS form distributes information onto the SSI form, NHS REC form and the R&D form No-one can access the IRAS form except you You only need to submit the NHS REC form to the Research Ethics Committee. The REC does not review the R & D form. For further information on the IRAS system follow the below link: For IRAS Training Module follow the below link:

6 What documents do I need to e-submit? CHECKLIST Will be submitted automatically Can be found on IRAS>NHS REC Form>4th tab along NHS REC FORM Must be completed correctly and e-authorised CV Chief Investigator Student Supervisor(s) if part of an educational programme PROTOCOL Only ONE COPY is needed Must have a version number and date INSURANCE CERTIFICATE Needed if the sponsor is not an NHS institution All other study specific supporting documents Patient Information Sheets and Consent Forms Questionnaires, Invitation Letters, GP Letters, Advertising Materials, Supervisors Review/Scientific Critique

7 Completing the IRAS application form and supporting documentation IRAS Application form N.B. Please check the UPDATES page on IRAS to ensure you have the most recent version of the form. REC DETAILS will be given at the time of booking. PROJECT FILTER QUESTIONS generate the questions on the rest of the form so it is important it is filled out correctly. Click on the green in each section of the IRAS form for detailed guidance and information about how to answer the question. Studies from the following categories may be eligible for PR: - Non-invasive medical device (CE marked) - Basic science study with limited interventions - Questionnaires & interviews - Qualitative methods - Tissue samples and data - Data only AUTHORISATIONS/e- SIGNATURES - Only electronic authorisations are accepted - e-signature must be on the form before you call to book the review SUPPORT -The Research and Development department of the Sponsor should check through the application before it is submitted to the REC. Supporting Documents We do not have access to the documents that you have uploaded to your IRAS account until they have been e-submitted. All documents mentioned in the application form need to be submitted for review by the PR Sub- Committee. All documents must have version numbers and dates, ideally in a header or footer. Include any documents that will give the PR Sub- Committee a good picture of what you will be doing with Participants. -If you are having technical problems completing your IRAS form call IRAS helpline on

8 How to authorise/sign your NHS REC form in preparation for PR booking. IRAS offers the facility for electronic authorisations and it is mandatory to use this functionality for the declarations on forms generated in IRAS for submission to REC. Ink signatures are not accepted. The system works by means of a secure transfer between the project owner and the person giving authorisation ( the authoriser ). It is vital that electronic authorisations are obtained before you book your application as you will need to submit your form on the same day as you make your booking. Following the booking, REC reference number and REC name will be ed to applicants for them to retrospectively fill these details on their REC form. These details are the only details which can be inserted post authorisation, which will not cancel the authorisations if done according to instruction sent with the confirmation . The below guidance offers instructions on how to arrange for authorisations/e-signatures of your NHS REC form and indicates the point at which you will be ready to contact Central Booking Service (CBS). Electronic authorisations IRAS ACCOUNT OBTAIN e-authorisations DOUBLE CHECK & CALL CBS Both the applicant and the signatory need to have IRAS accounts To enable the signatory to have access to the application go tothe main navigation page and choose REC Form. Go to Authorisations tab and select the relevant authoriser e.g. sponsor. Click on REQUEST and enter their address You will receive a confirmation once they have authorised the form To double check authorisations, click on NAVIGATE, scroll to Part D- click on project role. (Make sure you do not change anything on the form or you will invalidate the signatures). Now you should see the name of the person who has authorised it There will be a green tick under AUTHORISATIONS tab next to signatory name Call CBS

9 Screening and Booking When all your documents are ready and your REC Form is authorised/signed you will need to contact the Central Booking Service (CBS). You must have authorisations on your NHS REC form before booking can be made. The CBS Operator will check this as part of screening. You must be able to e-submit the application on the day you book to a REC. CBS will not be able to take a booking until you can do this. Once the above criteria are met, the CBS Operator will be able to take your call. You will be asked some questions to ensure that your application is suitable for proportionate review. What details will be taken by CBS? Chief Investigator's name, address and phone number. Study Contact's name, and phone number. This needs to be someone who can be contacte by the Committee for discussion regarding the study. Short title of the research. Your IRAS form in front of you for reference if you are not a member of the research team. How will the meeting slot be allocated? Your study will be allocated to the next available meeting in the country at the time of booking so that an opinion can be issued within 14 calendar days. There is no option to attend the PR- Subcommittee meeting. However, the Study Contact may be contacted for further information or clarification over the 14 day review period and therefore must be available. What happens after the booking? All REC details will be ed to you: REC name and reference number, Submission deadline date, Committee address CBS Line Tel: open 9.30am-4.00pm Mon-Fri OR nres.cbs@nhs.net Submission guidance Leave your name and telephone number Specify a time and date for call back-we will call when you are available

10 Submission Guidance How to insert the REC details following the booking To complete your form with REC details and REC reference number obtained during the booking phone call, follow one of the below processes depending on what kind of authorisations/signatures you have Type the REC details onto the Project Title page of your REC form-(part A of the form-). The actual page is sensitive to changes therefore use the scroll bar to locate the REC details window. Inserting REC reference number will not invalidate the e-authorisations but any other changes to the form will. Once REC number is filled, click Save Now. Return to the E-submission tab to electronically submit your application and all the supporting information you have attached to the checklist. Other points to consider. Once the application has been booked on via the Central Booking Service (CBS) you must be ready to e- submit your application the same day. For committee contact details follow the link provided in the booking confirmation you were sent. The checklist will automatically submit alongside form and docs so no need for instruction to include. Please ensure that version numbers and dates included in the checklist are correct as they are used by NRES and the Research and Development departments to keep track of which documents are approved.

11 Proportionate Review IRAS Application Authorisations Contact PR Validation Process and Criteria On receipt of the application there are several processes that the Committee REC Manager goes through to ensure the application is valid and ready to be reviewed by the committee. 1. The REC Manager will use the checklist you have provided to ensure that all of the documents requiring review have been received. 2. The IRAS form will be checked to make sure that it is the final version and that the DRAFT watermark is not on the forms. 3. The REC Manager will check that all of the declarations have been completed and that the correct electronic signatures have been obtained. The Chief Investigator must be based in the UK and cannot be the same person as the Sponsor s Contact. 4. The submission code on the bottom right hand corner of the form will be checked as this needs to be the same on every page. 5. The REC Manager will check that the filter page to ensure it has been completed correctly. If it has not the sections relevant for your project type will not have been generated making application invalid. 6. If the participant is to be given less than 24 hours to consent, the REC Manager will check that question A31 has been completed. 7. Unless the research involves qualitative methods only, the REC Manager will check that A56 has been completed. 8. The REC Manager will check that the Lead Sponsor and Sponsor Contact have been detailed in sections A64 and A4. We will check that the Sponsor Contact is an authorised signatory for the institution. 9. Insurance and indemnity arrangements need to be detailed in question A76 and insurance documents need to be included with the submission package for non NHS sponsored studies. 10. The REC Manager will check that the Chief Investigators CV has been included. If this is an educational programme, the Student and Academic Supervisor s CV will also need to be included in the application. 11. If any of the collaborators detailed in A63 are members of the REC the Committee Manager will arrange for the application to be sent to a different REC. 12. The REC Manager will check application suitability for proportionate review.

12 Post Validation Process Valid Application Application Valid but Unsuitable for PR Invalid Application If the application is valid you will receive an acknowledgement letter within 2 working days. The application will then be sent to the Committee for review. If at this point the research turns out to be unsuitable for Proportionate Review you will be contacted to arrange for the application to be transferred to a full REC meeting in your region If the application is not valid you will receive a letter detailing the reasons for this. The application will then be withdrawn from the meeting. Once the application has been amended to reflect points raised be the REC Manager you will have to rebook. Proportionate Review IRAS Application Authorisations Contact PR

13 PRS Sub-Committee OPINIONS Favourable Opinion with Conditions Favourable Opinion Provisional Opinion No Opinion Unfavourable Opinion Favourable Opinion- If the PR Sub-Committee issue a favourable opinion the study can start subject to the management permission or approval obtained from each host organisation for each study site. Sponsors are not required to notify the PR Sub- Committee of approvals from host organisations. Favourable Opinion with Conditions- When giving a Favourable Opinion, the REC may specify certain conditions that must be met prior to the start of the study (or the start at each site). In this case, the Favourable Opinion is valid only when the conditions are met. It is the responsibility of the sponsor to ensure that the specified conditions are met prior to the study start. Provisional Opinion- The PR Sub-Committee may decide that a final opinion cannot be issued until further information or clarification is received from the applicant, or until changes or omissions are made to study documentation. Any altered documents will need to be approved by the PR Sub-Committee before a Favourable Opinion can be issued. Unfavourable Opinion- Where the final opinion is Unfavourable, the applicant will be given a full explanation of the REC s reasons including options for further review. No Opinion- If the application is found to contain Material Ethical Issues it will need to be transferred to a full REC meeting for further review. A No Opinion decision letter listing the identified ethical issues will be issued. The letter will contain an indication of the further information or changes likely to be required so that the applicant can begin to address these issues. However, the further information should not be formally submitted at this point as the application will have to be forwarded to full REC unchanged. In parallel to receiving the letter, the REC will contact the applicant to discuss availability to attend a full REC meeting in the researchers region. If the first available slot in their region is accepted by applicant (advisable), the 60 day clock (relevant for applications reviewed in a full REC meeting) will start from the date the valid application was initially received extending the existing clock. If the first available slot cannot be accepted by applicant, the clock on the application will start from the beginning from the cutoff date for the chosen meeting. Proportionate Review IRAS Application Authorisations Contact PR