Access to medical records for research purposes:Varying perceptions across research ethics boards

Introduction: Variation across research ethics boards (REBs) in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy. Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction. Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study with open-ended responses. Interviews were recorded, transcribed and coded manually. Results: Fourteen sites (47%) required individual patient consent for the study to proceed as proposed. Three (10%) indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites (38%) did not require consent. Two (7%) suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites (60%) required full committee review. Sixteen (53%) allowed an external research assistant to abstract information from the health record. Conclusions: Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions.

Who's minding the shop?:the role of Canadian research ethics boards in the creation and uses of registries and biobanks

Abstract. Background. The amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and biobanks. Methods. Chairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank. Results. There was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied. Conclusion. Participants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation.

Respecting autonomy without disclosing information

There is widespread agreement that it would be both morally and legally wrong to treat a competent patient, or to carry out research with a competent participant, without the voluntary consent of that patient or research participant. Furthermore, in medical ethics it is generally taken that that consent must be informed. The most widely given reason for this has been that informed consent is needed to respect the patient’s or research participant’s autonomy. In this article I set out to challenge this claim by considering in detail each of the three most prominent ways in which ‘autonomy’ has been conceptualized in the medical ethics literature. I will argue that whilst these accounts support the claim that consent is needed if the treatment of competent patients, or research on competent individuals, is to respect their autonomy, they do not support the claim that informed consent is needed for this purpose.

Food Labels, Autonomy and the Right (Not) to Know

Food labelling has been overlooked in the emerging body of literature concerning the normative dimensions of food and drink policies. In this paper, I argue that arguments normally advanced in bioethics and medical ethics regarding the “right to know” and the “right not to know” can provide useful normative guidelines for critically assessing existing and proposed food labelling regimes. More specifically, I claim that food labelling ought to respect the legitimate interests and the autonomy of both consumers who seek knowledge about their food in order to make informed dietary choices and consumers who prefer to remain ignorant about the contents and effects of their food in order to avoid the emotional and psychological harm, or more simply the loss of enjoyment, which may result from receiving that information.

The obligation to provide information where valid consent is not needed

Accounts of consent in medical ethics typically assume that consent plays the same role irrespective of the type of treatment. In this paper I argue that this assumption is false. Because of this, obligations to provide information to patients that stem from the need for consent to be valid will not apply to all types of treatment. This does not mean that there are no reasons to provide such information. The second part of the paper maps out what these reasons are and argues that they are grounded in the obligation of beneficence and a duty to warn, not in considerations of respect for autonomy.

The EU Clinical Trials Regulation: Key Priorities, Purposes and Aims and the Implications for Public Health

The replacement of the European Union (EU) Clinical Trials Directive by the new Clinical Trials Regulation (CTR), which entered into force on 16 June 2014 but will not apply before 28 May 2016, provides an opportunity to review the legal and political context within which this important aspect of research law and policy sits and to reflect on the implications for public health. My aim in this article is to relate the context to the key purposes and aims of EU law and policy on clinical trials in order to explain and clarify its orientation. On that basis, I argue that the CTR and the changes it introduces to the law on clinical trials are part of the EU's continued focus on market optimisation. It is this focus that orients and directs the wider pharmaceutical development pipeline, but that undermines the achievement of key public health objectives.

Ageing, Justice, and Resource Allocation

Around the world the population is ageing in ways that pose new challenges for health care providers. To date these have mostly been formulated in terms of challenges created by increasing costs, and the focus has been squarely on life prolonging treatments. However, this focus ignores the ways in which many older people require life enhancing treatments to counteract the effects of physical and mental decline. This paper argues that in doing so it misses important aspects of what justice requires when it comes to older people.

Research ethics committees: values and power in higher education

The rise of research governance structures in universities has created huge disquiet amongst academic researchers. The unquestioning adoption of a medical model of ethical review based upon positivist methodological assumptions has created for many a mismatch between their own ongoing ethical research practice and the process of obtaining clearance from Research Ethics Committees (REC). This paper examines the issues that have contributed to dissatisfaction with the ethical review model that is prevalent within the modern university. Using examples from the authors’ own experiences, the dynamics of values, interests and power in research governance is examined from multiple perspectives including that of REC member and applicant; lecturer/student supervisor; researcher; and
university administrator. The paper reveals a rift between the values and objectives of the key players in research governance within the modern university and concludes by asking whether differences can be resolved so that a collaborative approach to ethical review may be incorporated into a renewed academic research culture. It is suggested that the alternative is increasing alienation from anything to do with ‘ethics’, with potentially serious consequences for the ethical standards of social research.

Multi-centre research in Australia:analysis of a recent National Health and Medical Research Council-funded project

BACKGROUND AND OBJECTIVE: Human research ethics committees provide essential review of research projects to ensure the ethical conduct of human research. Several recent reports have highlighted a complex process for successful application for human research ethics committee approval, particularly for multi-centre studies. Limited resources are available for the execution of human clinical research in Australia and around the world.

METHODS: This report overviews the process of ethics approval for a National Health and Medical Research Council-funded multi-centre study in Australia, focussing on the time and resource implications of such applications in 2007 and 2008.

RESULTS: Applications were submitted to 16 hospital and two university human research ethics committees. The total time to gain final approval from each committee ranged between 13 and 77 days (median = 46 days); the entire process took 16 months to complete and the research officer's time was estimated to cost $A34 143.

CONCLUSIONS: Obstacles to timely human research ethics committee approval are reviewed, including recent, planned and potential initiatives that could improve the ethics approval of multi-centre research.