Back to the Confidentiality flowchart - Is it appropriate or practical to seek explicit consent? or Is the disclosure of identifiable information approved through a statutory process?
Using patient information for research purposes
Dr Kadiri is a clinical research fellow in a teaching hospital in North West England. He is planning a study on adherence to breast screening examinations in the area that the hospital serves. Specifically he wants to establish whether sending a reminder letter results in more individuals attending for their screening.
For the purposes of his research, Dr Kadiri will need data on previous and current attendance levels for breast screening examinations and information enabling him to track the attendance of individuals who have been invited for, and subsequently reminded about, their screening.
What the doctor did.
Dr Kadiri talks to the Clinical Director of the local breast screening service, Dr Clarke. They consider whether Dr Kadiri could use anonymised information for the study. They agree that that this wouldn’t work as he needs to be able to link reminder letters to appointments and so would need to know who the individuals were.
In the circumstances, Dr Clarke thinks the service would need to get explicit consent from individuals to disclose information about them for the purposes of the study. However, Dr Kadiri is concerned that seeking consent could skew the results, because people might be more likely to attend their screening if they know they are part of a study.
Dr Kadiri seeks advice from the hospital’s research governance manager. They talk through his proposed research methodology and she suggests making an application for section 251 approval, for disclosure of the information he will need. Section 251 of the NHS Act 2006 permits the disclosure and temporary use of identifiable patient information without consent for defined medical purposes, where there is sufficient justification for doing so. The manager also directs Dr Kadiri to the Health Research Authority website and other resources that will help him in planning and making his application.
What the doctor had to consider
- Anonymised patient information will usually be sufficient for purposes like medical research and other secondary uses that contribute to the delivery of safe and effective healthcare, (paragraph 79).
- Doctors can disclose identifiable personal information about patients where anonymised information won’t serve the purpose, if the patient has given explicit consent, or the disclosure is approved though a statutory process that sets aside the common law duty of confidentiality (paragraph 80).
- Doctors should use statutory arrangements for approving disclosure and use of confidential information where they are available. In England, Wales and Northern Ireland, statutory arrangements are in place for considering whether disclosing personal information without consent for purposes such as medical research would benefit patients or the public sufficiently to outweigh patient’s privacy rights. (there is no comparable statutory framework in Scotland) (paragraphs 103-105).
- In exceptional circumstances, it might be possible to justify a disclosure for the purposes of research in the public interest (paragraphs 106-112).