Application process

Each application to the NIGB ECC goes through a number of validation and review phases before a recommendation is made by the committee to the Secretary of State for Health.

The first validation stage will determine whether there is sufficient information for the application to be presented to the committee. The NIGB office will explore any issues or queries which may arise from the information presented to them. This may involve a telephone interview being scheduled and/or a query sheet being sent to the applicant. It is the applicant’s responsibility to ensure these take place at the scheduled time and that queries responded to within the given timescales. In some instances applicants may be asked to revise their application form to ensure the information presented to the committee is clear. At the first validation stage the NIGB office may provide advice regarding potential alternatives to the use of patient identifiable data without consent and, if necessary, you will be advised to speak to other parties potentially involved in the activity about the application.

Following the first validation stage the applicant will be advised whether the application will be submitted for full committee review or processed via proportionate review and given details of the timescales involved.

A high level process map of the application process is available on our website, as is a process map of the proportionate review process.

Before submission

You are advised to consult the proportionate review criteria if you intend to submit a proportionate review application. If you do not consult the criteria or are unsure whether your application can be handled under the proportionate review process you must ensure that you submit your application to meet one of the meeting deadlines. Applications submitted after a meeting deadline which do not meet any proportionate review criteria will be scheduled to the next meeting date and you are advised that this will cause a delay in your application being considered.

If you intend to make an application to the NIGB you must consult the pre-application checklist prior to submitting your application. This will ensure that you are aware of the minimum requirements of the Health Service (Control of Patient Information) Regulations 2002 under which the committee provide advice to the Secretary of State.

If you still have questions about our process and criteria after reviewing our website please telephone the Office on 0207 004 1539.  We are only able to take queries regarding potential applications during clinic times, 1-4pm on Tuesdays and Thursdays.

Application form

Research applicants – Integrated Research Application System – IRAS

Applicants completing a research project should use IRAS to make an application for section 251 support. IRAS is a single, integrated application system that has been developed to simplify applying for approval or permission to conduct a piece of research in the Health Service. For more information please see the IRAS https://www.myresearchproject.org.uk/ website.

Please note that with immediate effect, where the application involves research ECC advice letters will be automatically shared with the appropriate research ethics committee in order to facilitate a streamlined review process.

Please note, we are not yet set up to receive applications direct from the IRAS system. You MUST save your application form and email it to eccapplications@nhs.net

Non – research applications (audit or service evaluation) – Section 251 form.

Non – research applicants can either use IRAS or continue to use the section 251 application form.

Download the section 251 application form (Word, 68Kb)

Proportionate review process

Applicants fulfilling certain criteria can use the proportionate review process.

Please see criteria and guidance on proportionate review process (PDF, 77Kb)

Section 251 security arrangements

Approved applications to use section 251 powers need to provide evidence of suitable security arrangements. Applicants will need to submit a System Level Security Policy (SLSP).

The SLSP applies the organisational confidentiality and security arrangements to the study. It is more specific than an organisational security policy. It covers the security and confidentiality measures across the whole duration of the study from data collection to analysis/onward disclosure.

Download the SLSP template (Word, 54Kb)

Important changes to Security Assessment procedures linked to Section 251 applications

It is currently Department of Health policy for all bodies that process NHS patient information to provide assurance over the security of this information through annual completion and publication of an information governance performance assessment using the Information Governance Toolkit (IGT). The Department now wishes to extend this requirement and in particular to seek this assurance from bodies that obtain NHS patient information in circumstances approved by the Secretary of State for Health under the powers provided to him by Section 251 NHS Act 2006 and by application to the NIGB Ethics and Confidentiality Committee.

Up until now, IG assurance from applicants seeking Section 251 support has been limited to a desk based review of security documentation. As a consequence, where approval has been for a study that lasts a number of years, there has been no continuing assurance. At the same time, those seeking new Section 251 approvals have had to complete the same form each time and go through the same time consuming security review process which is recognised as being of limited value as an assurance mechanism. By replacing the security review and the associated elements of the application process with a requirement for applicants to provide assurance through the IGT on an annual basis it is the Department’s aim to reduce the bureaucracy of the application process whilst obtaining broader and more up to date assurance aligned with the 35,000 health service bodies currently working with the IGT. The publication of IGT performance assessments also supports transparency by enabling both those asked to release data to a study and members of the public to have sight of the performance details.

The aim is to achieve this change to the current application process with as little bureaucracy as possible and the plan is to introduce this in a phased approach from 1st April 2012 with the intention of full implementation by 1st October 2012. Any enquiries regarding this procedure should be sent to Andy Dickinson, from the DH IG Policy Team: andy.dickinson@dh.gsi.gov.uk.

Standard conditions of approval

All approved applications will have to agree to the Ethics and Confidentiality standard conditions of approval.

Download ECC standard conditions of approval (PDF, 9Kb)

Appeals and complaints

Download the NIGB appeals and complaints process (PDF, 17Kb)