Tag Research Governance

Can you explain how we are able to collect patient details without their consent (and why this is necessary)?

We collect the patient identifiers for only one reason and that is so we can link your patients to the NHS Medical Research Information Service (MRIS). This is so we can determine 90 day survival which is a big improvement in quality on hospital mortality. MRIS can only match using name, dob, postcode and NHS number is used by them to confirm the match (but by itself will not do).

To use this information in most instances requires patient consent, and to do so without consent requires an application to the Ethics and Confidentiality Committee (ECC) at the National Information Governance Board (NIGB). This body is authorised under the NHS Act 2006 (Section 251) to grant permission to use this data when seeking consent would be impracticable. Because the deteriorating ward patients are frequently confused and therefore lack capacity; because the population has a high mortality and seeking retrospective consent would be very difficult; and, because only using data from patients who can consent would exclude the sickest patients from the study and therefore introduce bias we have been granted time limited access to this data without consent.

Once we have completed the matching and ascertained 90 day survival then we destroy all identifiers.

We also have to pass a very extensive security check to ensure that the data is held securely.

All these documents and procedures have been reviewed by R&D and the ethics committee.

NIHR portfolio link

(SPOT)light has now been published on the NIHR portfolio.

(SPOT)light receives approval from National Information Governance Board

(SPOT)light has received approval from the National Information Governance Board who have agreed that the study had a strong public interest, and that we had the necessary security arrangements in place to hold patient information for the purposes of record linkage to determine 90 day outcomes.

The study will be listed on their public site in due course.

NIHR Portfolio Adoption Confirmed

NIHR Portfolio Logo

We have just received confirmation that SPOT(light) has been adopted as a National Institute of Health Research portfolio study.  This is great news!  More details about some of the benefits of portfolio adoption are available here.  We will post more details including information about the available funding as it becomes available.

 

Template CV for R&D submissions

Local collaborators and other people named on the Site Specific Information (SSI) will need to submit a curriculum vitae with their application. You can download a suggested template here.

Site Specific Information (SSI) Paperwork

We have made available the site specific information pro-formas we are using to help populate the R&D forms.  Please download them using the following links

SPOT(light) SSI Proforma

SPOT(light) – Other Research Team Members – Firstname LastName

You will need Adobe Acrobat 7.0 or better.  Please e-mail (spot@icnarc.org) us if you need a form compatible with older versions.

Can independent sector hospitals join SPOT(light)?

 

The short answer is Yes –  you can join.

However there are a number of issues worth pointing out.

- Site Specific Approval: We have ethics approval centrally and normally local Site Specific Approval is handled by the NHS R&D.  From the available guidance, it appears that we would need to submit approval to a local ethics committee (local NHS ethics committees should be happy to help)

- You would not be eligible for NHS funding for the time/work involved.  So participating in the study is ‘free’, but it does take some time and you would have to decide whether you could find this time in your working week.  We estimate an average hospital would recruit 3 patients per week for the year of the study.  There is one screen of data to enter per patient plus sometime helping provide us with some other administrative data. We hope that this is not too onerous.

We’d be happy to have you if this sounds feasible to you!