Guidance

Protocol for the release of confidential abortions data for research purposes

Published 23 August 2024

Applies to England and Wales

This document is intended as a guide for academic researchers requiring access to abortion data for scientific research purposes.

For further information or to discuss your requirements, contact the Abortion Statistics Team at the Department of Health and Social Care (DHSC) by emailing [email protected].

Background to releasing abortion data

Registered medical practitioners are legally required to notify the Chief Medical Officer (CMO) of every abortion performed. DHSC receives these notifications on the HSA4 abortion notification form and undertakes statistical processing and analysis. An Abortion statistics for England and Wales statistical bulletin is published each year and contains tables of information derived from the notifications.

The Data Protection Act 1998 places a statutory obligation on DHSC to ensure that the statistics we release on abortion do not relate to a living individual who can be identified from the data alone or in conjunction with other available information, unless the conditions laid out in the act are met. To meet this obligation in recent years, DHSC followed the disclosure guidance for abortion statistics developed by the Office for National Statistics in July 2005.

A judgment handed down in 2011 by the High Court, in a case relating to the release of information on principal medical condition for abortions performed under ground E, showed that the disclosure controls set out in the guidance were overly cautious in some circumstances. The format of the tables in the annual report have therefore been revised, with a more limited degree of suppression applied, where still necessary to avoid the disclosure of personal data.

Further data is released into the public domain in response to ad hoc enquiries, where doing so is in line with legislation.

Releasing confidential abortion data for bona fide scientific research

Under regulation 5(e) of the Abortion Regulations 1991, patient-level data may be released in a controlled manner “for the purposes of bona fide scientific research”, subject to:

• the Chief Medical Officer’s agreement - the CMO must weigh the public interest in research that improves health and healthcare against the public interest in the confidentiality of patient information
• the receipt of a completed and signed confidentiality declaration and non-disclosure agreement form - see the editable confidentiality declaration and non-disclosure agreement form

Additional requirements for the release of data

Before data is considered for release, you must submit:

• details of the study design, including how the data will be used or analysed and published
• a signed copy of the confidentiality declaration and non-disclosure agreement form
• a copy of your ethics approval - this can be authorised by your university Research Ethics Committee (REC)

Send your release request by email to [email protected].

The CMO will then assess whether the information can be disclosed under the regulations of the Abortion Act 1991 and the conditions set out in the confidentiality agreement.

In many cases, to avoid having to submit a release request to the CMO, which can be time consuming, research designs can be revised so that patient-identifiable data is not required and the request can be accommodated within the restrictions on data. For example, it might be possible to use age in place of date of birth, and local authority rather than postcode. Suppressions and aggregations can also be used where small numbers of cases would otherwise prevent release.

Guidelines on applying for and using the data

Keep a copy of all documents for your records. 

Attach a copy of the documentation confirming approval from your REC along with the signed and completed confidentiality declaration and non-disclosure agreement form.

Assistants of the data custodian who wish to access the abortion data supplied must sign and date sections 4 and/or 5 of the form to acknowledge acceptance of the terms and conditions before being allowed access to the data. DHSC may request a copy of the up-to-date list at any time.

The data custodian should take disciplinary action against any assistant breaching the common law duty of confidence with regard to this data.

Data retention and storage

After the work outlined in section 7 of the form has been completed, the data must be destroyed.

You will be sent an email approximately one month before the end of the data retention period. This email will give you the opportunity to either apply for a review to extend the data retention period, after obtaining approval from the CMO, or confirm that the data is destroyed.

The data must not be copied or transferred to any third party. If requested under the Freedom of Information Act 2000, the data is protected by the exemptions in sections 40 and 44 of the act and must not be released.

The data must be stored with proper safeguards to prevent unauthorised access. Note: this condition is subject to unannounced site inspections by DHSC staff to ensure that measures are satisfactory.

Publication of the data

Prior notice of intention to publish abortion data should be given to DHSC along with a copy of the work to be published.

All outputs resulting from access to this data must meet the guarantee contained in the principles of the UK Statistics Authority’s Code of Practice for Statistics and Protocol on Data Access and Confidentiality.

DHSC has the right to refuse permission to publish information arising from abortion data.

Low cell values - values between 0 and 5 - must be suppressed. If only one cell requires cell suppression, at least one other component cell (the next smallest) must be suppressed so as to avoid calculation of suppressed value from the totals. In addition, DHSC must agree any tables of data published so that small numbers cannot inadvertently be derived by using a combination of published data.

Reporting changes of custodianship

DHSC must be informed as soon as possible if custodianship of the data should change. The new data custodian must give assurances in writing that the terms of this document will continue to be followed. The data custodian must also report to the department any changes in the organisation, personnel having access to the data, or systems on which the data would be held.

The data custodian must report immediately to DHSC any instances of breach of any of the terms of this agreement.

No contact will be made with any individual or individuals identified in the information supplied except as agreed in the protocol and associated letters.

Appendix A: the regulations

Notice of termination of pregnancy and information relating to the termination

See regulation 4 of the Abortion Regulations 1991, as amended by the Abortion (Amendment) (England) Regulations 2002 and the Abortion (Amendment) Regulations 2008.

Restriction on disclosure of information

See regulation 5 of the Abortion Regulations 1991, as amended by the Abortion (Amendment) (England) Regulations 2002 and the Abortion (Amendment) Regulations 2008.