FAQ

1. What organisations does your approval process cover?

NHS Bristol, NHS North Somerset and NHS South Gloucestershire. Please note that NHS Somerset and NHS Gloucestershire are separate organisations and we do not cover them in our approval process.

2. Who should I send my project documents to?

Rachel Avery (nee Wyson) is in charge of administering the research governance aspect of the Avon Primary Care Research Collaborative (APCRC). If you send the documents to research@apcrc.nhs.uk the governance team will see it through the approval process.

3. How long does the process of obtaining approval take?

Using Integrated Research Application System (IRAS) speeds up the overall process for researchers by eliminating duplication in form-filling, and encouraging parallel applications to review bodies.

Once your project is submitted, the research and development office undertakes the appropriate governance checks and then passes the documents to internal reviewers representing Bristol, North Somerset and South Gloucestershire Clinical Commissioning Groups for approval. The process timescale differs for each project but shouldn’t take more than one month once the project has received ethical approval and a full set of documentation has been received. See approval page for document checklist.

4. How long does ethical approval take?

A Research Ethics Committee (REC) is required to give an ethical opinion on an application within 60 calendar days from receipt of a valid application. Where further information is required to give an opinion, the REC may make a request to you in writing for further information. The clock will be suspended pending receipt of this information. A REC will typically issue an opinion within ten working days after the REC meeting. Further information is on the NRES website.

5. Do I need ethical approval if my study only involves NHS staff and not patients?

From 1st September 2011, under the new requirements known as 'Governance Arrangements for Research Ethics Committees' (GAfREC), research involving NHS staff and not patients or patient data does not need ethical approval. However, NHS research governance approval is still needed so researchers must apply via IRAS as per the usual process.

6. I haven’t even drafted a research proposal yet; where can I get advice for the design phase of my research project?

The Research Design Service can help you with the design phase of your study.

For UWE researchers only, the Research Support Service can provide advice and support on research ethics and governance.

7. How do I generate Site Specific Information (SSI) forms in IRAS?

The Chief Investigator for the study should generate the required number of Site Specific Information Forms (SSI) once the study-wide integrated dataset has been completed. SSI Forms can be generated via the 'Add SSI Form' tab, which is available when the research and development form or REC form is selected on the main project page. The Chief Investigator can choose to generate the required number of forms and immediately transfer them to the Principal Investigators at each site. Alternatively, if the activities at each site will be very similar, the appropriate sections of one SSI form can be completed and the form then duplicated the required number of times before transferring to each Principal Investigator or local collaborator.

8. How do I submit my applications to research and development offices if it is not eligible for the NIHR portfolio?

If you have submitted a CSP (Coordinated System for gaining NHS Permission) Application Form (PAF) and been informed that the study is not eligible for the NIHR portfolio then you cannot use NIHR CSP for your research and development applications. Please go back to the project filter and select 'No' for question 5a to indicate that you are not applying through NIHR CSP, and then click on the 'Navigate' button. When you select the Research and Development Form or SSI Form now, the submission tab will allow you to submit applications to our Research and Development office.

9. Can I obtain electronic authorisations on the IRAS forms?

Yes, the research and development office accepts electronic signatures and guidance of how to submit this is explained in IRAS.

Ink signatures may still be used where preferred. There is no need to obtain both ink signatures and electronic authorisation.

10. What is a research site?

Research sites, as defined in IRAS, are organisations responsible for participant-related research procedures specified in the protocol including recruitment and informed consent. The following are not considered to be research sites: clinicians or clinical units making referrals to the research team. Research units undertaking support functions, e.g. project management, site monitoring, data analysis or report writing.

11. What is a participant identification centre (PIC)?

Participant identification centres (PICs) are organisations from which clinicians or clinical units refer potential participants to the research team based in another organisation, for assessment and possible recruitment to a study. PICs can include research units undertaking support functions, such as project management, site monitoring, data analysis or report writing.

The NHS organisation responsible for the PIC is expected to review the request to refer patients (including any resource implications and other issues such as data protection) and agree to this.

Refer to the leaflet published by the NIHR for further information on PICs.

12. How do I submit amendments to my project?

Any future changes to the research will need to be approved by the relevant Research Ethics Committee (REC) and our office should also be informed. The notification of substantial amendment form should be used. Should this situation occur please send the amended protocol and the new ethics approval letter to us along with the correct revised versions of the documents that were submitted to the ethics committee.

Our office will then review whether the changes have any impact to our Clinical Commissioning Groups.

We will usually review amendments once they are received, but will not be able to provide 'ongoing' approval for the research until a favourable opinion has been received from the RECand/or the Medicines and Healthcare Products Regulatory Agency (MHRA) in the case of a CTIMP (clinical trials of investigational medicinal products).

13. What do I do when my project is completed?

Let the relevant bodies and authorities know.
Complete a 'declaration of end of study' form and send to the REC that granted a favourable ethical opinion for the project.
We ask for a copy of these notifications in all cases.
Please send us a final project report when the project is complete.
When the findings are published please inform us and we will ask for your permission to publicise the results on our website.

14. How do I find out about studies that are open to recruitment?

Visit the Primary Care Research Network South West (PCRN SW) website for the list.

FAQ

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