What is genetic information, and why is it significant? A contextual, contrastive, approach.

Is genetic information of special ethical significance? Does it require special regulation? There is considerable contemporary debate about this question (the 'genetic exceptionalism' debate). 'Genetic information' is an ambiguous term and, as an aid to avoiding conflation in the genetic exceptionalism debate, a detailed account is given of just how and why 'genetic information' is ambiguous. Whilst ambiguity is a ubiquitous problem of communication, it is suggested that 'genetic information' is ambiguous in a particular way, one that gives rise to the problem of 'significance creep' (i.e., where claims about the significance of certain kinds of genetic information in one context influence our thinking about the significance of other kinds of genetic information in other contexts). A contextual and contrastive methodology is proposed: evaluating the significance of genetic information requires us to be sensitive to the polysemy of 'genetic information' across contexts and then examine the contrast in significance (if any) of genetic, as opposed to nongenetic, information within contexts. This, in turn, suggests that a proper solution to the regulatory question requires us to pay more attention to how and why information, and its acquisition, possession and use, come to be of ethical significance.

Over-regulation of clinical research: a threat to public health.

Clinical research is subject to increasing regulation by research ethics committees and research and development offices which are responding to social and political pressures, as well as to new legislation, both European and national, some of which is still being worked out. The resulting bureaucracy, expense and confusion are putting insuperable hurdles in the way of clinical research and clinical care is compromised. What research is still possible will only be done in large organisations and may even be seriously biased. The solutions are to inform and seek the help of the public and to forge alliances with patient groups. Patients have far more to lose than clinical researchers who, if clinically qualified, can more easily pursue a fulfilling career as clinicians rather than researchers.

The requirements of the Data Protection Act 1998 for the processing of medical data.

The Data Protection Act 1998 presents a number of significant challenges to data controllers in the health sector. To assist data controllers in understanding their obligations under the act, the Information Commissioner has published guidance, The Use and Disclosure of Health Data, which is reproduced here. The guidance deals, among other things, with the steps that must be taken to obtain patient data fairly, the implied requirements of the act to use anonymised or psuedonymised data where possible, an exemption applicable principally to records based research, the right of patients to object to the processing of their data, and the interface of the act and the common law duty of confidence.

Learning from experience: privacy and the secondary use of data in health research.

In this fast-moving age of data banking, data are a currency, and often a commodity. Electronic health records are being developed everywhere. Increasingly, data collected for various primary purposes are being re-used for research. With personal mobility, contracting of services, and telemedicine, health care data are crossing national borders, and therefore so are genetic information, biological materials, and reimbursement data. There is much public and legal concern about the implications. This article addresses the question: Under what conditions may data not collected specifically for research, such as primary medical data, be re-used for health research without compromising the privacy of the data-subjects?

The Data Protection Act (1998): implications for health researchers.

AIMS: This paper reports on the methods used in two studies to obtain access to subjects to comply with the common law duty of confidence laid out in the Data Protection Act (1998) and discusses the researchers' problems in interpreting the procedures. RATIONALE: The amendments to the United Kingdom (UK) Data Protection Act (1998) are causing confusion within the health service and academic institutions. There is a need to balance patient confidentiality with the requirement to conduct vital, unbiased research in which health service professionals are not subject to ethical dilemmas. This paper examines the recruitment methods used in two studies in which the researchers' attempts to adhere to the requirements lengthened the study costs and may have produced less reliable results. METHODS: The methodological difficulties in two studies are presented. In Study 1, the difficulties encountered when the Multicentre Research Ethics Committee refused permission for researchers to recruit patients directly to a multicentre randomized controlled trial are discussed. In Study 2, the method used to compile a sampling frame for a national questionnaire survey following the eight principles of the Act are described. FINDINGS: Our experience has shown that health care professionals are increasingly required to recruit patients to intervention trials, and that researchers are not allowed access to the names of patients or other subjects to ask them for consent to participate in a study. The requirement for researchers to use "intermediaries" to obtain consent from and recruit subjects to studies increases the risk of selection bias, may expose the practitioner to ethical difficulties and may compromise the external validity of trial results. There is also a danger that research costs will soar when the Data Protection Act (1998) is fully realized. CONCLUSION: The Data Protection Act (1998) is currently being interpreted in a number of different ways. We conclude there is an urgent need for consensus within the health service and academic communities.

Research, ethics and the data protection legislation.

As nursing research becomes more common, so does the issue of whether or not patients should be involved and, if so, to what extent. This article examines how the data protection legislation helps to protect patients, and whether they have the capability to decide to participate, or not.

Betrayal of confidence in the Court of Appeal.

In overturning Latham J's judgment in R v Department of Health, Ex Parte Source Informatics Ltd. that anonymisation does not obviate breaching a personal confidence, the Court of Appeal holds that where the duty of confidence arises in equity it does not prohibit the confidant using the confided information without the consent of the confider if this does not treat the confider unfairly (relative to the Court's view of the confider's legitimate interests). We argue that this principle--by bringing fairness to bear on the scope of the duty of confidence rather than on whether a breach of it may be lawful--has no authority in usable precedents; that the Court's interpretation of fairness in applying this principle is, in any event, incompatible with the Data Protection Act 1998 (in part because the Court has too narrow a conception of privacy); that the Court errs in holding that neither anonymisation of personal data nor use of anonymous data falls under the Data Protection Act; and that the Court's insensitivity to the vulnerability that leads patients to disclose information about themselves to health professionals for their treatment, leads it to misidentify the basis of the duty of confidence in such disclosures. The Court of Appeal's reasoning does not clarify the duty of confidence, but virtually abolishes it in the face of competing commercial and research interests.

Case commentary: anonymisation is not exoneration.

This case commentary analyses a ruling that any use of information given in confidence for unconsented purposes is a breach of confidence capable of supporting a legal action (even if the information has previously been anonymised and aggregated). The ruling is being appealed. It is argued that, while it is reasonable to delineate a narrower duty of confidentiality (not to disclose personal information, against breach of which anonymisation protects), this must be within a broad duty of confidence (not to use private information, which using anonymous information can still breach). Thus, the ruling is fundamentally correct in holding that anonymisation does not permit information obtained in confidence to be used for unconsented purposes. This, however, implies that information obtained for a patient's treatment may not be used lawfully for medical research or NHS management purposes without consent, even if it is anonymised. Such a consequence is unacceptable as a matter of public policy. However, it is equally unacceptable to seek an exemption through the idea that patients give "implied consent" for medical research and NHS management purposes. It is also unacceptable to maintain that the public interest in medical research (regardless of its aims) justifies unconsented use of information obtained in confidence, even if the information is anonymised. The way in which Section 33 of the Data Protection Act 1998 creates an exemption to its Second Data Protection Principle provides a ready-made model for a public interest based exemption for medical research and statistical NHS purposes.