Identify research benefits

In the absence of three possible conditions - 1) that patient consent for your proposed research use of the data exists, or 2) that the data has been anonymised, or  3) that there exists a particular obligation under the law (for example for the purposes of a criminal investigation) any decision as to whether patient identifiable information can be disclosed must be made on a case by case basis and must be justified by being in the public interest.

Making a case for the public benefits of your research project

Scientifically sound and ethically robust research is in the interest of protecting the health of the public. The objective of SHIP is to facilitate scientifically sound and ethically robust research through the appropriate use of health data.   The rights of individuals should be respected with adequate privacy protection, while at the same time the benefits for all in the appropriate use of health data for research purposes should be recognised.

It is the data custodian’s responsibility to ensure the development of transparent policies that demonstrate their understanding of public interest and the basis upon which they will use and disclose health data.  However it is your responsibility as an applicant for data use in research to make a robust case for the value to the public of your proposed research project. Essentially this means that you must be able to demonstrate the benefits to society that the results of your research project will bring.

There are clearly benefits to society in conducting research for the future development of healthcare in the UK. As such, the GMC advises that a disclosure of identifiable information without consent can be justified in the public interest to enable medical research. Society has an interest in promoting research within an acceptable and workable framework. Such a framework must give due consideration to confidentiality, however at the same time it must not impose impossibly high standards as this would have the effect of hindering research and pushing some research out of the UK.

Balancing confidentiality and research benefits

In order to determine whether identifiable information may be disclosed without the consent of an individual, we must determine whether it serves the interests of the public to disclose or not to disclose. This determination involves the balancing of two public interests: the public interest in maintaining confidentiality and the public interesting in disclosing information to further medical research.

The decision as to what is in the public interest must be made on a case by case basis, by taking into consideration the specific qualities and risks of the proposed research project. As such, it is not possible to provide definitive guidance on which way the balance should be struck. However, generally you must consider:

  • The nature and sensitivity of the information to be disclosed,
  • The use to be made of the information,
  • The context in which the information was generated,
  • The reasonable expectations of the individual whose information it is,
  • Any harm which could be caused to the individual or others,
  • The purpose of the request for information,
  • The number of people to have access to the information,
  • The confidentiality and security arrangements in place to protect the information from further disclosure,
  • The advice of a Caldicott Guardian or similar expert advisor who is not directly connected with the use for which the disclosure is being considered,
  • The advice of a Research Ethics Committee,
  • The advice of the Privacy Advisory Committee,
  • The potential for harm or distress to patients,
  • The importance of the information to be obtained from the research output.

If, after considering these factors, it is decided that the information should be disclosed, the disclosing body must only disclose the minimum of information necessary to achieve the objective of the research project.

SHIP Guiding Principles and Best Practice

Principles

  • Scientifically sound and ethically robust research is in the interest of protecting the health of the public.
  • The objective of SHIP is to facilitate scientifically sound and ethically robust research through the appropriate use of health data.
  • The rights of individuals should be respected with adequate privacy protection, while at the same time the benefits for all in the appropriate use of health data for research purposes should be recognised.
  • Data sharing and use should be carried out under transparent controls and security processes, and the purposes and protection mechanisms should be communicated publicly and to oversight bodies/individuals with responsibility for data processing.
  • The responsible use of health data should be a stated objective of all organisations adhering to this instrument.

Best Practice

  • It is the data controller's responsibility to ensure the development of transparent policies that demonstrate their understanding of public interest and the basis upon which they will use and disclose health data; equally importantly this must include the protection mechanisms under which use will take place. It is possible that these policies may not be developed solely by data controllers, but in conjunction with others, e.g. lawyers, but ultimate responsibility for implementation of such policies will lie with the data controller.

Please see the guidance page on public interest for more information.

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