Legal and ethical considerations in processing patient-identifiable data without patient consent: lessons learnt from developing a disease register
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
Journal of Medical Ethics 33 (5):302-307 (2007)
The legal requirements and justifications for collecting patient-identifiable data without patient consent were examined. The impetus for this arose from legal and ethical issues raised during the development of a population-based disease register. Numerous commentaries and case studies have been discussing the impact of the Data Protection Act 1998 and Caldicott principles of good practice on the uses of personal data. But uncertainty still remains about the legal requirements for processing patient-identifiable data without patient consent for research purposes. This is largely owing to ignorance, or misunderstandings of the implications of the common law duty of confidentiality and section 60 of the Health and Social Care Act 2001. The common law duty of confidentiality states that patient-identifiable data should not be provided to third parties, regardless of compliance with the DPA1998. It is an obligation derived from case law, and is open to interpretation. Compliance with section 60 ensures that collection of patient-identifiable data without patient consent is lawful despite the duty of confidentiality. Fears regarding the duty of confidentiality have resulted in a common misconception that section 60 must be complied with. Although this is not the case, section 60 support does provide the most secure basis in law for collecting such data. Using our own experience in developing a disease register as a backdrop, this article will clarify the procedures, risks and potential costs of applying for section 60 support
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
No references found.
Citations of this work BETA
B. Schofield (2013). The Role of Consent and Individual Autonomy in the PIP Breast Implant Scandal. Public Health Ethics 6 (2):220-223.
Bette Anton (1999). CQ Sources/Bibliography. Cambridge Quarterly of Healthcare Ethics 8 (04):348-350.
Similar books and articles
Cicely Roche & Felicity Kelliher (2009). Exploring the Patient Consent Process in Community Pharmacy Practice. Journal of Business Ethics 86 (1):91 - 99.
Mary E. Carr & Alda L. Moettus (2010). Developing a Policy for Sexual Assault Examinations on Incapacitated Patients and Patients Unable to Consent. Journal of Law, Medicine & Ethics 38 (3):647-653.
Richard T. Hull (1985). Informed Consent: Patient's Right or Patient's Duty? Journal of Medicine and Philosophy 10 (2):183-198.
Deborah Bowman (2011). Informed Consent: A Primer for Clinical Practice. Cambridge University Press.
Jerome Bickenbach (2012). Argumentation and Informed Consent in the Doctor–Patient Relationship. Journal of Argumentaion in Context 1 (1):5-18.
David Shaw (2007). Continuous Consent and Dignity in Dentistry. British Dental Journal 203 (11):569-571.
Beverly Woodward (2001). Confidentiality, Consent and Autonomy in the Physician-Patient Relationship. Health Care Analysis 9 (3):337-351.
P. Francis Leslie, P. Battin Margaret & Charles Smith Jay Jacobson (2009). Syndromic Surveillance and Patients as Victims and Vectors. Journal of Bioethical Inquiry 6 (2).
James E. Rosenberg & Bernard Towers (1986). The Practice of Empathy as a Prerequisite for Informed Consent. Theoretical Medicine and Bioethics 7 (2).
J. Vollmann (2001). Advance Directives in Patients with Alzheimer's Disease; Ethical and Clinical Considerations. Medicine, Health Care and Philosophy 4 (2):161-167.
Jennifer Wilson Mulnix (2008). Patient Autonomy and the Freedom to Act Against One's Self-Interest. Clinical Laboratory Science 21 (2):114-115.
Eugene V. Boisaubin (2004). Observations of Physician, Patient and Family Perceptions of Informed Consent in Houston, Texas. Journal of Medicine and Philosophy 29 (2):225 – 236.
Andrea F. Patenaude, Joel M. Rappeport & Brian R. Smith (1986). The Physician's Influence on Informed Consent for Bone Marrow Transplantation. Theoretical Medicine and Bioethics 7 (2).
David B. Resnik, Paul L. Ranelli & Susan P. Resnik (2000). The Conflict Between Ethics and Business in Community Pharmacy: What About Patient Counseling? [REVIEW] Journal of Business Ethics 28 (2):179 - 186.
Kate Jones (2007). Beyond Informed Consent - Part I. Chisholm Health Ethics Bulletin 13 (2):4.
Added to index2010-08-24
Total downloads4 ( #424,619 of 1,726,249 )
Recent downloads (6 months)1 ( #369,877 of 1,726,249 )
How can I increase my downloads?