The process for accessing patient-identifying data
The HFEA has welcomed the historic shift represented by the new statutory provisions set out in new legislation. These will enable valuable research to be carried out using HFEA Register data, and from linking this to other datasets. We believe that powerful social and health benefits can be derived from such work.
Clear safeguards will be in place. Researchers will be bound by the same confidentiality restrictions as the HFEA and licensed clinics. They will need to meet a number of tests set out in statute to demonstrate why their research will be in the public interest and why such research cannot be carried out without access to information that identifies patients, partners and children born as a result of treatment.
Only recognised research institutions may apply for access to Register data. Applicants will need to have secured research ethics committee approval for their proposed projects prior to submission to the HFEA. In addition, all medical research projects will also be considered by the National Information Governance Board. Researchers wishing to link HFEA data to Scottish or Northern Irish medical datasets will need to seek approval from the Privacy Advisory Committees (PACs) in those countries too.
Applications will be considered by a new HFEA group – the Register Research Panel. However, the Authority will have oversight of the entire application and disclosure process.
For medical research
For medical research, the HFEA acknowledges the expertise of the National Information Governance Board (NIGB) and its ethical oversight arrangements and therefore delegates the handling of these applications to the NIGB.
This is also a more helpful arrangement for researchers because they will have to apply to the NIGB anyway in order to be granted access to any other dataset they want to link HFEA Register data to. This simplifies the process and the aim is to ask researchers to fill in only one application form and to resolve their application through one, joined-up process.
- IRAS Integrated Research Application System
- NIGB National Information Governance Board
- NIGB Ethics & Confidentiality Committee
Researchers who want to perform a study that does not ask medical or health-related questions of the HFEA data (and does not want to link our data to a health-related database) cannot use the NIGB route because the NIGB does not handle non-medical applications.
The HFEA has developed a straightforward application process. This will respond to the requirements set out in the Regulations that come into force in April 2010.
Applying for access to Register data
Researchers can request access to HFEA Register data under one of two routes:
- They can request access to data collected since 1 October 2009 where patients and partners have given their consent for its disclosure for research purposes (section 33A[h] HFE Act)
- They can request data about patient and partners collected between August 1991 and September 2009, or data about children born as a result of treatment collected at any time since August 1991 (section 33D HFE Act)
To ensure consistency and transparency, the HFEA has adopted the same application processing and fees regime regardless of the access route taken by researchers. However, because of the distinctions set out in statute between research for medical purposes and research for other purposes, there are two distinct application forms to be used.
Applications for medical research purposes need to be submitted to the National Information Governance Board via the Integrated Research Application System (IRAS).
Applications for non-medical purposes need to be submitted directly to the HFEA via a bespoke application form which will be published in April 2010.
All applications will need to provide the following information:
- The name, contact details and qualifications of the applicant (usually the lead researcher on the research project)
- Details of the research establishment responsible for the project
- Details of the research project
- Description of the Register data required for use in the research project
- Justification for why the research project cannot be carried out using anonymised data and why it cannot be accessed by any other means
- The favourable opinion of a research ethics committee for the research project.
In the case of projects where researchers wish to link HFEA Register data to another dataset, it will usually be the case that researchers will be required to carry out this linkage work in the HFEA offices in London. However, if the HFEA's Register Research Panel is asked to consider whether linkage work can be carried out on the premises of the research establishment, applicants will be required to supply details of the security arrangements in place at those premises particularly with regards to the safeguarding of personal data.
Approval and monitoring
The HFEA's Register Research Panel has decision-making powers regarding the granting of access to Register data by researchers. The Panel can authorise or deny applications, as well as suspend, revoke or place conditions upon authorisation to access Register data.
The Panel will work closely with the National Information Governance Board with which it has a Memorandum of Understanding. It will also work with Privacy Advisory Committees in Scotland and Northern Ireland as required, as well as experts in the field of social science research.
The Panel will publish lay summaries of all approved research project to the HFEA web site. It will also receive and review annual reports from all research establishments authorised to access Register data.
The HFEA Authority, in its capacity of an Oversight Committee, will oversee the work of the Register Research Panel. It will monitor the granting of authorisations and appeals against the decisions of the Panel. The Oversight Committee will receive regular updates from the Panel, as well as annual reports from authorised research establishments.
The HFEA will not charge a fee for processing applications to access Register data or for the use of office space when researchers carry out linkage work on the HFEA premises.
Fees will be charged for the preparation of HFEA data for use by researchers. Fees are based on a rate of:
- £250 for the first half working day or part thereof (3.75 hours or less)
- £250 for any subsequent half working day
- A cap of £5,000 for a single application.
Fees must be paid before researchers can access Register data. If the HFEA's Register Research Panel estimates that the fees cap will be exceeded it can refuse the application to access Register data. In such a scenario, we will endeavour to work with researchers to refine the scope of their application.
Conditions for using patient identifying information
Research involving patient identifiers is always a last resort. It can only happen:
- if the research is of high quality and is approved by an ethics committee
- if consent to disclosure cannot effectively be obtained
- if the research cannot happen (not even in an amended form) with anonymised data.
Even if release is approved, it will only be:
- for the smallest possible number of patients
- for the smallest possible number of identifiers (date of birth or name, for example)
- for the shortest time period possible (i.e. identifiers have to be removed once data from our Register has been linked to another dataset).
Page last updated: 06 May 2010