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You are here: Home Section 251 ECC Frequently Asked Questions

ECC Frequently Asked Questions

A PDF version of the FAQ's is available here (PDF,46kB)

What is the role of the Ethics and Confidentiality Committee (ECC)?

What is section 251 support?

What is the difference between section 60 and section 251?

What is the difference between a Research Ethics Committee (REC) and the Ethics and Confidentiality Committee (ECC)?

Does the ECC consider applications for the four UK nations?

When do I need to apply for section 251 support?

How and when should I make an application?

How can I check if I need section 251 support?

What is a medical purpose?

What is meant by the 'clinical care team'?

What data is considered to be identifiable?

What is the fast track process?

I am completing an application and need some advice

What is meant by class support?

Do I need to 'formally' book in my application with the NIGB Office prior to submission??

Can I attend a meeting?

What are the different ways in which section 251 approval can be given?

What supporting information is required?

If I have Section 251 support, what does this mean?

Once my study has section 251 support, does this mean that I am now entitled to the information?

Why have I not received the outcome letter following the meeting?

The outcome letter requested a resubmission. What does this involve?

What are the potential outcomes following a Committee meeting?

Why must I submit an annual review?

What should I do if there are changes to the study?

What is the ECC and section 251?

What is the role of the Ethics and Confidentiality Committee (ECC)?

The ECC advises the Secretary of State for Health on whether applications for support under section 251 of the NHS Act 2006 should be approved. It also advises the Human Fertilisation and Embryology Authority (HFEA) on applications made under section 33 of the Human Fertilisation and Embryology Act 2008 for certain patient information held on the HFEA register. The Committee considers whether certain criteria are met and whether the patient and public interest is sufficiently served by the disclosure of identifiable patient information. It also advises applicants on alternative methods which will not need section 251 support.

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What is section 251 support?

Section 251 support permits the common law duty of confidentiality to be set aside so that information which identifies patients can be used without their consent. To obtain section 251 support the following criteria have to be met:

  • The reason for using the information has to be for the purpose of improving patient care OR in the public interest; and
  • It has to be for a medical purpose; and
  • The purpose cannot be achieved using de-identified data; and
  • Seeking consent for the use of identifiable data is not practicable.

Any conditions of approval set by the ECC also have to be met.

The ECC need to be satisfied that the reason for needing the information is of sufficient quality, and of benefit to the public, to justify disclosing the information. They also need to accept that the use of section 251 is necessary and the reason for using the information cannot be achieved by taking a different approach.

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What is the difference between section 60 and section 251?

None. Section 60 of the Health and Social Care Act 2001 was re-enacted under Section 251 of the NHS Act 2006. The Health Service (Control of Patient Information) Regulations 2002 [SI 1438/2002], which include the class support mechanism, remain in force under the new legislation.

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What is the difference between a Research Ethics Committee (REC) and the Ethics and Confidentiality Committee (ECC)?

The REC's role is to consider the ethical implications of a research study. RECs provide an opinion on the rights, safety, dignity and well-being of people participating in research. The ECC assesses whether it is appropriate to provide legal support to access patient identifiable information without consent. Section 251 support for medical research is conditional on a favourable REC opinion. Other activities which are not medical research do not require REC approval. To streamline approval processes the ECC will consider applications where a REC opinion is pending.

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Does the ECC consider applications for the four UK nations?

Powers under section 251 apply to patient information in England and Wales only. If you require patient information from Scotland and Northern Ireland then you need to contact the Privacy Advisory Committees in those countries. Applicants must be resident or have an organisational base in either England or Wales to be eligible to apply for section 251.The ECC has delegated powers under section 33 of the Human Fertilisation and Embryology Act 2008 to consider applications for data from the HFEA register. These powers are nationwide and include all four UK nations.

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When should an application be made to the ECC?

When do I need to apply for section 251 support?

You should apply for section 251 support if you wish to access patient identifiable information without the patient's consent. This also includes situations where you would like to identify a group of patients to seeking their consent to take part in a study.

We have also produced advice on identifying research participants.

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How and when should I make an application?

Applications for medical research purposes should apply via the Integrated Research Application System (IRAS) (www.myresearchproject.org.uk). Non-medical research applications should use the section 251 form available on the NIGB website. Submission deadlines are readily available on our website at www.nigb.nhs.uk/ecc/meetings . You must submit the application form and ALL supporting documentation by the deadline otherwise the application will not be put forward for the ECC to consider. This could incur a delay to your application of around eight weeks.

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How can I check if I need section 251 support?

The easiest way to check whether you need section 251 support is to contact the NIGB Office on 020 7004 1539, or email eccapplications@nhs.net. You will need to describe to us:

  • how you are intending to use identifiable information;
  • the identifiers required and why; and
  • who will be conducting the study.

In straightforward cases, the NIGB Office can usually advise whether an application is required or not. We might need a copy of your research protocol or further clarification before formally confirming whether section 251 support is necessary.

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If carrying out local clinical audit, do I need section 251 support?

Section 251 approval is not required for local clinical audit as long as:

  • the audit is conducted by one of the organisations that has delivered the patient's care or treatment;
  • the audit is carried out in accordance with clinical governance guidelines;
  • it has been approved by the NHS Trust's medical director and Caldicott Guardian.

For national and regional clinical audits or where third party organisations are used to conduct a clinical audit the use of de-identified data should be considered. If it is not possible to use de-identified data then patient consent should be sought, or if this is not feasible, section 251 approval will be required. The ECC expects to see national audits make reasonable attempts to seek consent and involve patients and service users, where identifiable data is needed.

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What is a medical purpose?

This is broadly defined in the NHS Act 2006 as activities carried out for the purposes of preventative medicine, medical diagnosis, medical research, the provision of care and treatment, and the management of health and social care services. You do not need section 251 support to use patient information in the delivery of direct patient care.

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What is meant by the 'clinical care team'?

The clinical care team refers to health professionals involved in the diagnosis, treatment or care of a patient. This includes pathology and radiology staff whose activities directly support the care of the patient even though usually they have no contact with the patient. A staff member, who is not involved in the direct delivery of care, who is brought in just to carry out a research activity is not considered a member of the clinical care team and so section 251 support would be required for this person to access identifiable information. Members of a clinical care team, accessing the records of another clinical care team who they are not directly treating, would also require section 251 support.

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What data is considered to be identifiable?

Obvious identifiers are name, address, postcode, date of birth, date of death and NHS Number. The combination of data items can sometimes result in the information becoming identifiable. If you are not sure you can contact the NIGB Office for advice.

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What is the fast track process?

If your study clearly fits within the criteria specified in our guidance document then once the paperwork has been submitted and assessed by the NIGB Office, it can be reviewed by ECC Members outside of the formal committee meeting.

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I am completing an application and need some advice

In my application, what should I focus upon in particular?

Your application needs to provide:

  • Explicit details about data flows and who will access what identifiable information.
  • Evidence why consent is not practicable. For example, results of a pilot study which includes the seeking of consent, and consideration of alternative approaches. A simple assertion will not be sufficient.
  • Full justification why someone external to the clinical care team needs to access patient identifiable information.
  • Details of how you have engaged patients and service users or representatives from relevant patient and service user organisations and how have their views influenced the methodology and whether they regard the use of patient information without consent acceptable.
  • Justification why each item of identifiable information is required.
  • Justify why the use of identifiable information achieves the purpose of the study.

Section 251 is only used where the ECC accepts that consent is genuinely not practicable and that de-identified information will not suffice. It cannot be used to simply overcome administrative inconvenience or budgetary constraints.

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What is meant by class support?

There are two types of section 251 support. Specific support where activities using patient information are lawful through regulation and class support which can be gained through application to the ECC. Your application for section 251 support needs to specify one or more of the following classes:

I. To obtain anonymised data from individual identifiable patient records to support medical purposes, i.e. the process of extracting and anonymising the information

II. To look at patient identifiable information in order to:

  • select patients who are to be invited to participate in medical research
  • contact patients to obtain their consent for their information to be used
  • contact patients to obtain their consent for use of tissue and other biological samples.

III. To obtain and use information about past or present geographical location from patient records – e.g. full postcode is needed for precise analysis, but, in some circumstances, it could be used to identify individual patients, so is regarded as patient identifiable information.

IV. To link patient identifiable information obtained from more than one source in order to validate the completeness or quality of the information or to avoid the impairment of the quality of the data through double counting.

V. To process patient identifiable information for the purpose of auditing, monitoring and analysing patient care and treatment.

VI. To process patient identifiable information to provide access to an authorised user for one or more of the purposes outlined above (I – V).

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Do I need to 'formally' book in my application with the NIGB Office prior to submission?

No, you do not need to formally book in your application. The NIGB Office will accept all fully completed applications and supporting documents received by 5pm on the day of the submission deadline. However, ECC members have been very clear that it is not appropriate for them to consider applications which are either incomplete or unclear. We strongly recommend that applicants contact the NIGB Office prior to submission to talk through the application.

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Can I attend a meeting?

Meetings are usually closed. In circumstances when an application is particularly complex, you may be invited to attend. The NIGB Office will make arrangements with you. If research applicants want the ECC to consider further information, there is a section on the NIGB form on IRAS for this. Alternatively, the NIGB Office will accept additional documentation if relevant.

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What are the different ways in which section 251 approval can be given?

1. Approval by full Committee - Application form and supporting information must be submitted a month in advance of the Committee meeting. The dates of the meetings and closing dates to receive applications are on the NIGB website.

2. Fast track approval - Application form and supporting documentation submitted at any point and will be considered by a smaller number of Members. Your study must fit a certain criteria to be considered for the fast track process, these are available on the NIGB website.

3. Extension of existing approval - Applicants should contact the NIGB Office to discuss what is required and how it can best be dealt with.

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Why is the submission deadline a month ahead of the meeting?

The NIGB Office review all applications and supporting documentation before they are sent to ECC Members. The NIGB Office try to ensure that the Committee have all the relevant information and that it is presented clearly so that unnecessary delays to applications are avoided. After they have carried out a review the NIGB Office send applicants a 'questions and comments' sheet which shows where they feel that further information is needed or there is a lack of clarity. This sheet must be returned within a set timescale in order to allow the responses to be considered and the final documents sent to the Committee.

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What supporting information is required?

There is a checklist on IRAS of mandatory documents and also a list on the section 251 application form. As a minimum, research applicants must submit:

  • a research protocol;
  • any patient information leaflets and consent forms (where applicable);
  • a favourable opinion from the REC (if available); and
  • a letter of support from the Caldicott Guardian.
    • The nature of the study will determine any other types of required supporting documentation.

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      What happens after the meeting?

      If I have Section 251 support, what does this mean?

      Section 251 support means that people named in the application can use defined patient identifiable data for the approved purpose as set out in the application form. If your application is approved you are responsible for meeting the standard conditions of approval and any other conditions the ECC may require, including its security. These will be set out in your outcome letter and are also available on the NIGB website. You will also need to submit an annual review.

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      Once my study has section 251 support, does this mean that I am now entitled to the information?

      Section 251 support provides a legal basis for the approved patient information to be provided to you for your study. However, section 251 is only permissive. The data controller can legally provide you with the information but they don't have to. Also, section 251 cannot be used to override patient dissent. If a patient has indicated that they do not want their information to be shared, then section 251 cannot be used to override this.

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      Why have I not received the outcome letter following the meeting?

      Firstly, check that you are named on the application. Outcome letters are normally sent only to the Chief Investigator. Letters are normally sent within 10 working days following the Committee meeting and are sent by both email and post. We send letters to employers email addresses, not private ones.

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      The outcome letter requested a resubmission. What does this involve?

      Typically, unless otherwise indicated in your outcome letter, this means that a fully revised application form must be submitted to the next Committee meeting. Providing a supplementary letter is unlikely to be sufficient. The outcome letter will indicate the main areas requiring revision. The NIGB Office can advise on the details as necessary.

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      What are the potential outcomes following a Committee meeting?

      There are five potential outcomes. An application can be:

      1. Provisionally approved (final approval is always subject to satisfactory security arrangements and these are only reviewed once provisional approval has been given);
      2. Provisionally approved, subject to further clarification.
      3. Rejected, resubmission advised. This is where there are fundamental issues around the application that need to be addressed before resubmitting to the Committee;
      4. Rejected, advised alternative consent-based approach or using anonymised data;
      5. Rejected because section 251 support is not required

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      I have an existing application or need to find out about an existing application

      Why must I submit an annual review?

      It is a condition of approval that all approved applications are reviewed annually to ensure that identifiable data is still required for the purpose and the conditions of approval are being met. An annual review report has to be submitted to confirm that the data is being processed and stored securely and confidentially and that it is only being used for the agreed purposes. The annual review is also used to check that steps are being taken to reduce the need to rely on section 251. Applicants should contact the NIGB Office to obtain the necessary documentation and ensure this is received before the approval expires. It is the applicants' responsibility to provide the documents for the annual review.

      If an annual review has not been submitted, this means that the approval has not been renewed and you should not be processing identifiable information. It is your responsibility to make sure that an annual review is sent to the NIGB Office every 12 months.

      The NIGB Office keeps a register of approved applications which shows the study's details and a summary of what has been approved. The register can be found at

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      What should I do if there are changes to the study?

      You should contact the NIGB Office when there are changes to the study. If a substantial change is necessary, for example to the study design or methodology, you must submit a letter describing the changes. This will be considered initially by the ECC Chair and may be escalated to a full Committee meeting. Additionally you must notify the NIGB Office when there is a change to the lead contact so that the register of approvals can be updated.

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