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4.14 The process: Resources on some of the ethical issues you may encounter

Information prescribing raises a number of ethical issues which you will need to consider. This short set of resources will point you to sources of information.

In working to identify the ethical implications of your IP project, it may be useful to:

1. Talk to your Caldicott Guardian

‘A Caldicott Guardian is a senior person responsible for protecting the confidentiality of patient and service-user information and enabling appropriate information-sharing. The Guardian plays a key role in ensuring that the NHS, councils with social services responsibilities and partner organisations satisfy the highest practicable standards for handling patient identifiable information.’ DH, 2008 ^[1]

The most recent version of the Caldicott Guardian manual can be accessed via the Connecting for Health website: http://www.connectingforhealth.nhs.uk/systemsandservices/infogov/caldicott/caldresources/guidance  

Printed copies can be ordered from:
DH Publications Orderline
PO Box 777
London
SE1 6XH

Alternatively, you can email the Department to obtain a copy by quoting the title 277311/The Caldicott Guardian Manual 2006" in an email to dh@prolog.uk.com ^[2]

2. Identify the relevant legislation

The Information Commissioner's Office website www.ico.gov.uk  provides comprehensive guidance on data protection; privacy and electronic communications; freedom of information; and, the environmental information regulations. For each of the key pieces of legislation, the links for which are provided below, the site provides information for the public and for organisations, as well as ‘tools and resources’ to support these groups.

• Data Protection Act
  Data Protection Act 1998, The Stationery Office, Crown Copyright.
  http://www.opsi.gov.uk/Acts/Acts1998/ukpga_19980029_en_1
• Privacy and Electronic Communications Regulations
  The Privacy and Electronic Communications (EC Directive) Regulations 2003, The Stationery Office, Crown Copyright
  http://www.opsi.gov.uk/si/si2003/20032426.htm
• The Privacy and Electronic Communications (EC Directive) (Amendment) Regulations 2004,
  The Stationery Office, Crown Copyright.
  Available at: http://www.opsi.gov.uk/si/si2004/20041039.htm
• Freedom of Information Act
  Freedom of Information 2000, The Stationery Office, Crown Copyright
  http://www.opsi.gov.uk/Acts/acts2000/ukpga_20000036_en_1
• Environmental Information Regulations
  Environmental Information Regulations 2004
  http://www.opsi.gov.uk/si/si2004/20043391.htm

3. Consider working with the NHS Information Centre

 The NHS Information Centre ‘is a special health authority that provides facts-and-figures to help the NHS and social services run effectively’. The IC gathers and analyses data and will work with organisations who ‘wish to develop or enhance services to the NHS and social care sectors’ in respect of data-gathering and collation. (NHS IC, 2007, online)

http://www.ic.nhs.uk/work-with-us/commercial-management/data-access-policy

The IC site states that information and guidance on data-gathering is currently being collated and will soon be available via the website.

4. Contact the National Research Ethics Service (NRES)

‘The National Research Ethics Service works with colleagues in the UK to maintain a UK-wide system of ethical review that protects the safety, dignity and well-being of research participants, whilst facilitating and promoting ethical research within the NHS.’ — National Patient Safety Agency ^[3]

NRES provides advice to organisations and individuals wishing to apply for ethics committee approval for research.  Guidance for applicants, the relevant forms to complete and details of the process can be found within the ‘Applicants’ area of the NRES website, which sits in the National Patient Safety Agency’s domain. The website also provides information about how patients and the public can become involved in ethical review, and about the direction of travel for research ethics work in the NHS. The site also provides support for the ‘research ethics community’. http://www.nres.npsa.nhs.uk/home/  

5. Be clear about governance

Delineate clearly the governance arrangements for any research being undertaken, considering honorary contracts, where appropriate

The Department of Health 'Research Governance Framework for Health and Social Care' (2005) sets out the standards to which you must adhere if you are undertaking research that might have an impact on the quality of care that is provided. It defines the principles of good governance and provides information on responsibilities, lines of accountability, delivery systems, and monitoring involved in delivering research in health and social care environments.

Department of Health (2005) Research Governance Framework for Health and Social Care. 2nd Edition.  London: DH. Crown Copyright. Available at:
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4108965.pdf

The framework also stipulates  (page 39) when honorary contracts should be used:
‘A researcher not employed by any NHS organisation who interacts with individuals in a way that has direct bearing on the quality of their care should hold an NHS honorary contract.’ (DH, 2005, p39)

 

On the next page: sustaining and expanding your information prescribing.