A step by step guide to using IRAS to apply to conduct research in or through the NHS/HSC.

Transcription

1 A step by step guide to using IRAS to apply to conduct research in or through the NHS/HSC. 28 June 2017 Summary All project-based research conducted in or through the NHS/HSC in England, Northern Ireland, Scotland and/or Wales use the IRAS Form to seek: HRA Approval for research led from England. NHS/HSC R&D Permission and NHS REC review (where required) for research led from Northern Ireland, Scotland or Wales. Where projects were created in IRAS prior to 28 June 2017 and separate NHS R&D and/or NHS REC applications have been created then you should continue using these separate applications. You do not need to change your application form type to the IRAS Form.! Project-based research includes research that fits any of the IRAS Filter Question 2 categories except Research Tissue Banks and Research Databases! The IRAS Form and information in this guide only applies to research conducted in or through the NHS/HSC. This step by step guide is divided into sections. Please refer to the section that applies to your project: Research led from England: Using the IRAS Form to apply for HRA Approval Research led from Northern Ireland, Scotland or Wales: Using the IRAS Form to seek NHS/HSC Management Permission and NHS/HSC Research Ethics Committee (REC) review Research led from Northern Ireland, Scotland or Wales: Using the IRAS Form to apply only for NHS/HSC Management Permission (NHS/HSC Research Ethics Committee (REC) review not required) Projects created prior to 28 June 2017 IRAS Form: a step by step guide (v1.0; 28 June 2017) 1

2 Research led from England: Using the IRAS Form to apply for HRA Approval What is HRA Approval? HRA Approval is the process for the NHS in England that comprises a review by a NHS Research Ethics Committee (REC), where required, as well as an assessment of regulatory compliance and related matters undertaken by dedicated HRA staff. It replaces the need for NHS permission by each participating organisation in England.! You can only apply for HRA Approval if your project involves the NHS and is led from England. You should apply for HRA Approval if: The lead NHS R&D Office for your project is in England; and Your research is described by any of the IRAS filter question 2 categories (except those for "Research Tissue Bank" and "Research Database"). Before you begin your application for HRA Approval: Before you start activities to prepare and submit your application for HRA Approval you should: Check that your project is eligible to apply for HRA Approval Refer to the HRA website for detailed applicant guidance Contact your local NHS/HSC R&D Office for advice and support. Contact details are available at: Check if your project is eligible for support via the NIHR Clinical Research Network Prepare your application for HRA Approval:! Your application for HRA Approval must be prepared in IRAS. 1. Fully complete your project filter in IRAS. At filter question 4 ensure you select the option for IRAS Form. This is the application for HRA Approval. When you select IRAS Form the options for separate applications to NHS/HSC Research and Development and Research Ethics Committee will be disabled if they were initially available for selection. Ensure that you complete all the filter questions as accurately as possible for your study. This will ensure you enable appropriate further options and forms. Please refer to the question specific guidance (click the icons) for further information and to help you select appropriate options and complete your dataset 2. When you go to the Navigation Page, your application for HRA Approval will appear in the Project Forms list labelled as IRAS Form. Remember when you use the IRAS Form you will not have separate NHS R&D and NHS REC Form applications. IRAS Form: a step by step guide (v1.0; 28 June 2017) 2

3 3. Complete your dataset The IRAS Form dataset is accessed by selecting the IRAS Form and then the Navigate tab associated with the form. Selecting a question number opens that part of the dataset. 4. Upload the supporting documentation for your application to the Checklist tab for the IRAS Form.! NHS research sites in England: With HRA Approval you will not need to complete and submit Site Specific Information (SSI) forms for these sites but: For non-commercial studies you will usually need to complete Statement of Activities and Schedule of Events templates. For commercially sponsored studies you will need to provide a validated Industry Costing Template and a template of the agreement you plan to use with sites. Please refer to the HRA website for more information and to access the templates. The Checklist tab for the IRAS Form sets out supporting documentation for this application. Refer to the IRAS step by step guidance on uploading documents Prepare to submit your application for HRA Approval:! Your application for HRA Approval must be electronically submitted to the HRA from IRAS. 1. Start by selecting the IRAS Form while in the Navigation page for the project 2. Check that your application (i.e. the IRAS Form) is complete. IRAS Form: a step by step guide (v1.0; 28 June 2017) 3

4 a. Review the form page by page and/or Print draft version from Save/print tab b. Use! This function only works if you used the completion tracking tool icons next to questions 3. Ensure that all necessary supporting documents have been uploaded to the Checklist for the IRAS Form (see point 4 of Prepare your application for HRA Approval above). 4. Gather electronic authorisations for all declarations in the IRAS Form.! Electronic authorisation of declarations is mandatory for application for HRA Approval Refer to the IRAS step by step guidance on electronic authorisation Electronic authorisations will invalidate if you change the data after it has been authorised, so: Only seek electronic authorisations once the form is complete and ready for submission Do not make any changes to dataset after gaining authorisations Remember some questions are shared across multiple forms. If you change data in another form or in the integrated dataset your form may be updated and invalidate authorisations Booking and submitting your application for HRA Approval:! Booking and submission must be completed on the same day; late submissions will usually be rejected 1. Prepare for booking your application by gathering information ready to make booking. You ll need: Your IRAS Project ID To be ready to answer questions about your application You may find it helpful to have your project in IRAS open in front of you when you telephone to book 2. Book your application for review. You will need to telephone the Central Booking Service (CBS) to book your application. 3. After completing the booking, you will receive an confirming the details of your booking; enter these details into page 1 of the IRAS Form.! Do not amend or add to any other fields in your IRAS Form as this will invalidate your electronic authorisations. 4. In IRAS, return to the E-submission tab IRAS Form: a step by step guide (v1.0; 28 June 2017) 4

5 This tab is located to the right, so depending on your screen, you may need to use scroll to it using arrows: Click on button to electronically submit application. This will send the application form and the files that you uploaded to the Checklist. Check submission history, at bottom of E-submission tab, to make sure your application has: Successfully submitted; and Been accepted for processing by the HRA It may take a few minutes for the status to update and you may need to refresh your browser! Submissions will be automatically rejected if the application has not been booked Once you have electronically submitted your application, the E-submit application button will be disabled. This ensures that only one copy of your form and supporting documentation is submitted. You will need to contact HRA if you: Have made a mistake and/or need to withdraw your application Need to supply additional supporting documents Need to submit a response to a request from the HRA IRAS Form: a step by step guide (v1.0; 28 June 2017) 5

6 Research led from Northern Ireland, Scotland or Wales: Using the IRAS Form to seek NHS/HSC Management Permission and NHS/HSC Research Ethics Committee (REC) review Project-based research conducted in, or through, the NHS/HSC and led from Northern Ireland, Scotland or Wales use the IRAS Form to apply for: NHS/HSC Management Permission; and NHS/HSC Research Ethics Committee (REC) review, if required This applies to new projects created in IRAS after 28 June As the IRAS Form combines the datasets for the above the same single IRAS Form is submitted for both NHS/HSC management permission and ethical review.! While a single IRAS Form is used, different routes of submission apply. This section of the guide provides information for projects where the study is led from Northern Ireland, Scotland or Wales and the project requires REC review. Before you begin your IRAS Form: Before you start activities to prepare and submit your application you should: Check whether your research needs review by a Research Ethics Committee (REC) within the UK Health Departments Research Ethics Service. If REC review is not needed you should refer to the next section of this step by step guide. Contact your local NHS/HSC R&D Office for advice and support. Contact details are available at: Prepare your application: 1. Fully complete your project filter in IRAS. At filter question 4 ensure you select the option for IRAS Form. This is the combined application for seeking NHS/HSC R&D Permission and NHS REC review. When you select IRAS Form the options for separate applications to NHS/HSC Research and Development and Research Ethics Committee will be disabled if they were initially available for selection. Ensure that you complete all the filter questions as accurately as possible for your study. This will ensure you enable appropriate further options and forms. Please refer to the question specific guidance (click the icons) for further information and to help you select appropriate options and complete your dataset 2. When you go to the Navigation Page, the IRAS Form will be shown under the Project Forms list. IRAS Form: a step by step guide (v1.0; 28 June 2017) 6

7 Remember when you use the IRAS Form you will not have separate NHS R&D and NHS REC Form applications. 3. Complete your dataset The IRAS Form dataset is accessed by selecting the IRAS Form and then the Navigate tab associated with the form. Selecting a question number opens that part of the dataset. 4. Upload the supporting documentation for your application to the Checklist tab for the IRAS Form. The Checklist tab for the IRAS Form sets out supporting documentation for this application. Refer to the IRAS step by step guidance on uploading documents Prepare to submit your application for NHS/HSC R&D Permission and ethical review:! You will need to submit the IRAS Form twice: first you need to electronically submit for ethical review and then secondly you will need to submit for NHS/HSC R&D Permission. Please carefully follow steps below and in the E-Submission tab for the IRAS Form. 1. Start by selecting the IRAS Form while in the Navigation page for the project. IRAS Form: a step by step guide (v1.0; 28 June 2017) 7

8 2. Check that your application (i.e. the IRAS Form) is complete. a. Review the form page by page and/or Print draft version from Save/print tab b. Use! This function only works if you used the completion tracking tool icons next to questions 3. Ensure that all necessary supporting documents have been uploaded to the Checklist for the IRAS Form.! The files uploaded to the checklist will be electronically submitted for ethical review. When you your submission for NHS/HSC R&D Permission you will need to the supporting documents and provide a copy of the checklist alongside the IRAS Form.. 4. Gather electronic authorisations for all declarations in the IRAS Form.! Electronic authorisation of declarations is mandatory for application for HRA Approval Refer to the IRAS step by step guidance on electronic authorisation Electronic authorisations will invalidate if you change the data after it has been authorised, so: Only seek electronic authorisations once the form is complete and ready for submission Do not make any changes to dataset after gaining authorisations Remember some questions are shared across multiple forms. If you change data in another form or in the integrated dataset your form may be updated and invalidate authorisations Booking and electronically submitting your application for ethical review:! Booking and submission must be completed on the same day; late submissions will usually be rejected 1. Prepare for booking your application by gathering information ready to make booking. You ll need: Your IRAS Project ID To be ready to answer questions about your application You may find it helpful to have your project in IRAS open in front of you when you telephone to book 2. Book your application for review. You will need to telephone the Central Booking Service (CBS) to book your application. IRAS Form: a step by step guide (v1.0; 28 June 2017) 8

9 3. After completing the booking, you will receive an confirming the details of your booking; enter these details into page 1 of the IRAS Form.! Do not amend or add to any other fields in your IRAS Form as this will invalidate your electronic authorisations. 4. In IRAS, return to the E-submission tab This tab is located to the right, so depending on your screen, you may need to use scroll to it using arrows: Click on button to electronically submit application. This will send the application form and the files that you uploaded to the Checklist. Check submission history, at bottom of E-submission tab, to make sure your application has: Successfully submitted; and Been accepted for processing by the REC It may take a few minutes for the status to update and you may need to refresh your browser! Submissions will be automatically rejected if the application has not been booked Once you have electronically submitted your application, the E-submit application button will be disabled. This ensures that only one copy of your form and supporting documentation is submitted. You will need to contact the REC if you: Have made a mistake and/or need to withdraw your application Need to supply additional supporting documents Need to submit a response to a request from the REC Submitting your application for NHS/HSC R&D Permission: 1. Once you have electronically submitted your application for ethical review you will need to use the final version of the IRAS Form that has been saved in your submission history to apply for NHS/HSC R&D Permissions. PDF and XML versions of the IRAS Form are available in this area and should be saved ready to include as part of your ed application package for NHS/HSC R&D Permission. IRAS Form: a step by step guide (v1.0; 28 June 2017) 9

10 Scroll down E-submission tab 2. Your application package should also include a copy of the completed checklist. This should have been populated as you uploaded files for the electronic submission for ethical review. To obtain a PDF copy of the completed checklist you should select the IRAS Form and then go to the Checklist tab. Scroll to the bottom of this tab and click the print button. Scroll down Checklist tab 3. your complete application package for NHS/HSC R&D Permission (IRAS Form (PDF and XML versions), checklist and supporting documents) according to the route that is appropriate for your project. Detailed information is provided at: IRAS Form: a step by step guide (v1.0; 28 June 2017) 10

11 Research led from Northern Ireland, Scotland or Wales: Using the IRAS Form to apply only for NHS/HSC Management Permission (NHS/HSC Research Ethics Committee (REC) review not required) Project-based research conducted in, or through, the NHS/HSC and led from Northern Ireland, Scotland or Wales use the IRAS Form to apply for: NHS/HSC Management Permission; and NHS/HSC Research Ethics Committee (REC) review, if required This applies to projects created in IRAS after 28 June This section of the guide provides information for projects where the study is led from Northern Ireland, Scotland or Wales and the project does not require REC review. Before you begin your application: Before you start activities to prepare and submit your application you should: Check whether your research needs review by a Research Ethics Committee (REC) within the UK Health Departments Research Ethics Service. If REC review is needed you should refer to the previous section of this step by step guide. Contact your local NHS/HSC R&D Office for advice and support. Contact details are available at: Prepare your application for NHS/HSC R&D Permission:! Your application must be prepared in IRAS. 1. Fully complete your project filter in IRAS. a. At filter question 4 ensure you select the option for IRAS Form. This is the application form you will use to seek NHS/HSC R&D Permission. b. If you have selected one of the project category options where it is possible that you may not need ethical review you will get an additional question in red font as shown below. When you click yes a further question will be enabled. IRAS Form: a step by step guide (v1.0; 28 June 2017) 11

12 The secondary question about exemption from REC review only enables when you have selected a project category where it is possible that REC review may not be needed. If this question does not enable please check how you have answered the other filter questions and/or recheck whether REC review is needed for your project. Ensure that you complete all the filter questions as accurately as possible for your study. This will ensure you enable appropriate further options and forms. Please refer to the question specific guidance (click the icons) for further information and to help you select appropriate options and complete your dataset 2. When you go to the Navigation Page, your application will appear in the Project Forms list labelled as IRAS Form. 3. Complete your dataset The IRAS Form dataset is accessed by selecting the IRAS Form and then the Navigate tab associated with the form. Selecting a question number opens that part of the dataset. 4. Gather the supporting documentation for your application and complete the checklist. The Checklist tab for the IRAS Form sets out supporting documentation for this application. Prepare to submit your application for NHS/HSC R&D Permission:! Your application must be submitted by Start by selecting the IRAS Form while in the Navigation page for the project. IRAS Form: a step by step guide (v1.0; 28 June 2017) 12

13 2. Check that your application (i.e. the IRAS Form) is complete. a. Review the form page by page and/or Print draft version from Save/print tab b. Use! This function only works if you used the completion tracking tool icons next to questions 3. Ensure that you have all the supporting documents for your application as identified on Checklist for the IRAS Form and that you have a printed copy of the completed checklist to submit with your form and documents. You add information to the checklist by clicking the row edit button in right hand column ( icon). To print the checklist use the print button at the bottom of the tab. 4. Gather electronic authorisations for all declarations in the IRAS Form.! Electronic authorisation of declarations is mandatory Refer to the IRAS step by step guidance on electronic authorisation Electronic authorisations will invalidate if you change the data after it has been authorised, so: Only seek electronic authorisations once the form is complete and ready for submission Do not make any changes to dataset after gaining authorisations Remember some questions are shared across multiple forms. If you change data in another form or in the integrated dataset your form may be updated and invalidate authorisations 5. Create final version of your IRAS Form. Go to the Submission tab and click Proceed to Submission button. Your resulting PDF has a numeric code ( submission code ) added in the footer of each page and does not have a watermark. A copy of the PDF and XML of the form will be stored in the submission history area at the bottom of the Submission tab. Submit your application: your complete application package for NHS/HSC R&D Permission (IRAS Form (PDF and XML versions), checklist and supporting documents) according to the route that is appropriate for your project. Detailed information is provided at: IRAS Form: a step by step guide (v1.0; 28 June 2017) 13

14 Projects created prior to 28 June 2017 If you created your project in IRAS prior to 28 June 2017 and selected the IRAS Form (e.g. you have prepared or are preparing an application for HRA Approval) then you should continue to use the project as it is. If you created your project in IRAS prior to 28 June 2017 and used separate NHS REC and/or NHS R&D Form(s) then when you open the project you will see the pop-up message as shown below: You can dismiss this pop-up and you will see the Navigation Page for your project as usual. In this situation the next step depends on where you are in the application process. If you have already submitted the NHS/HSC R&D Form or the NHS REC Form or both, or if you are about to submit the separate forms (e.g. you have uploaded documents and/or sought electronic authorisations) then you should continue to use the separate form(s). If you have not yet started or only partially started to complete the dataset and not yet submitted the NHS/HSC R&D Form or the NHS REC Form then you can choose to change to the IRAS Form at this point. To do this select the Project Filter link while on the Navigation Page for the project. Once in the Project Filter you can amend your form selections at filter question 4 and review/update the remainder of the project filter as appropriate. Any data you had entered in the dataset will be retained.. IRAS Form: a step by step guide (v1.0; 28 June 2017) 14