Discussing options between patients and health care professionals in genetic diagnosis: ethical and legal criteria

The specific characteristics of genetic data lead to ethical-legal conflicts in the framework of genetic diagnosis. Several international organisations, including UNESCO and the Council of Europe, have enacted rules referring to the use of genetic information. This paper discusses possible legal and ethical criteria that could be used in genetic testing.     

对病人讲真话与保密的伦理思考

医生对病人讲真话是一种义务，也是尊重病人自主权的表现，但是，在中国的传统文化背景下，对某些病人保密而仅对家其家属讲真话，这与对病人讲真话发生了矛盾，也与病人的自主权发生了冲突。然而，这种矛盾和冲突，可以得到伦理的辩护，也可以得到中国现行法律的支持，尽管如此，也应该逐渐改变。     

Requiring Consent vs. Waiving Consent for Medical Records Research: A Minnesota Law vs. the U.S. (HIPAA) Privacy Rule

The use of medical records in research can yield information that is difficult to obtain by other means. When such records are released to investigators in identifiable form, however, substantial privacy and confidentiality risks may be created. These risks become more common and more serious as medical records move to an electronic format. In 1996, the state of Minnesota enacted legislation with respect to consent requirements for the use of medical records in research. This legislation has been widely criticized because--it is claimed--it creates an unnecessary impediment to research. In this article, we show that these arguments rest upon misinterpretation and/or misrepresentation of the 1996 legislation. A consent requirement had actually been present in Minnesota since 1976 (though codified in a patient rights statute rather than a privacy statute). The 1996 law does not require specific consent, as often claimed, but rather only a general authorization. The campaign against the Minnesota legislation appears to have been motivated by concern with respect to the then impending federal privacy rule. The HIPAA rule, as enacted, is in fact less stringent with respect to consent than the Minnesota consent law. On the other hand, the Minnesota consent law has not been effectively applied or enforced. As we change the way we manage sensitive medical information, new efforts are needed to provide protection against the confidentiality risks in research. Patient consent is an important tool in this regard. New instrumentalities are needed to solicit and document consent.     

Wielding the implement of law: Distilling new rights and responsibilities in the age of the ‘new genetics’

The law has, to date, been slow to respond to advances in genetics, but in many ways this may be propitious. History teaches us that there is an ever-present risk that the law will be used merely to embody knee-jerk reactions to new developments in medicine and science, frequently to the detriment of all interested parties. Adequate and appropriate legal responses to genetic research can only come once a full debate on the problems to be addressed has taken place, and when society as a whole is appraised of the options at hand. This article offers an overview of the problems which are thrown up for the law by 'new genetics', including the problem of reconciling competing claims to genetic information from family members, insurers and employers, as well as the dilemma of determining how to regulate the potential range of uses of new genetic knowledge. The article offers some views on how we might use the law to proceed sensibly and productively in the future.     

Establishing and managing a periodontal biobank for research: the sharing of experience

Periodontal bio‐repositories, which allow banking of clinically validated human data and biological samples, provide an opportunity to derive biomarkers for periodontal diagnosis, prognosis and therapeutic activities which are expected to improve patient management. This article presents the establishing of the Malaysian Periodontal Database and Biobank System (MPDBS) which was initiated in 2011 with the aim to facilitate periodontal research. Partnerships were established with collaborating centres. Policies on specimen access, authorship and acknowledgement policies were agreed upon by all participating centres before the initiation of the periodontal biobank. Ethical approval for the collection of samples and data were obtained from institutional ethics review boards. A broad‐based approach for informed consent was used, which covered areas related to quality of life impacts, genetics and molecular aspects of periodontal disease. Sample collection and processing was performed using a standardized protocol. Biobanking resources such as equipment and freezers were shared with the Malaysian Oral Cancer Database and Tissue Bank System (MOCDTBS). In the development of the MPDBS, challenges that were previously faced by the MOCDTBS were considered. Future challenges in terms of ethical and legal issues will be faced when international collaborations necessitate the transportation of specimens across borders.     

Dream as Transaction: An Exercise in Interpersonal Theory

The author explores the multiple meanings for her of analyst disclosures and the application of a fixed analytic frame. She challenges the idea that most analytic rules, outside of the context of a particular and ever-changing clinical situation, can universally hold true. She believes that questions pertaining to “right” and “wrong” are, perhaps, an inapt line of inquiry in this regard. Drawing material from reflections on her own developmental history in relation to disclosure and risk, as these factors play out in the dyadic interactions of a particular, out-of-the-ordinary, highly charged clinical case, she highlights a distinction between a potentially inappropriate application of generic analytic “rules” and a necessary steadying personal connection with a hierarchy of ethical principles.     

In the absence of hard data,Is soft data better than no data at all?

Where total anonymity and confidentiality were previously respected in drug research, a tendency towards the provision of “hard” data such as verifiable personal details seriously disadvantages researchers working with “hidden groups” who use drugs in a relatively problem free way. This particularly applies to those who use substances generally regarded as highly addictive and problematic, such as heroin. Funding for a follow-up to an earlier research project was sought; the original investigated non-problematic heroin users, whereas the chief aim of the follow-up was to examine “resilience” to the problems commonly associated with the use of heroin. An illustration of attempting to put the gathering of “hard” verifiable data into action is presented here along with the immediate consequences. Unsurprisingly, the response of potential participants to the idea of providing personal details was largely negative, as the perceived consequences of being “outed” as a heroin user were generally regarded as worse than any of the issues associated with the use of the drug itself. An irony of the situation is that this “resilience” may be due to participant refusal to compromise their anonymity. This raises some obvious ethical issues. A number of potential longer term consequences on substance use/misuse research are also discussed.     

Imputation of confidential data sets with spatial locations using disease mapping models

Data that include fine geographic information, such as census tract or street block identifiers, can be difficult to release as public use files. Fine geography provides information that ill‐intentioned data users can use to identify individuals. We propose to release data with simulated geographies, so as to enable spatial analyses while reducing disclosure risks. We fit disease mapping models that predict areal‐level counts from attributes in the file and sample new locations based on the estimated models. We illustrate this approach using data on causes of death in North Carolina, including evaluations of the disclosure risks and analytic validity that can result from releasing synthetic geographies. Copyright © 2014 John Wiley & Sons, Ltd.     

Anonymity Versus Privacy: Selective Information Sharing in Online Cancer Communities

Background

Active sharing in online cancer communities benefits patients. However, many patients refrain from sharing health information online due to privacy concerns. Existing research on privacy emphasizes data security and confidentiality, largely focusing on electronic medical records. Patient preferences around information sharing in online communities remain poorly understood. Consistent with the privacy calculus perspective adopted from e-commerce research, we suggest that patients approach online information sharing instrumentally, weighing privacy costs against participation benefits when deciding whether to share certain information. Consequently, we argue that patients prefer sharing clinical information over daily life and identity information that potentially compromises anonymity. Furthermore, we explore whether patients’ prior experiences, age, health, and gender affect perceived privacy costs and thus willingness to share information.

Objective

The goal of the present study is to document patient preferences for sharing information within online health platforms.

Methods

A total of 115 cancer patients reported sharing intentions for 15 different types of information, demographics, health status, prior privacy experiences, expected community utility, and privacy concerns.

Results

Factor analysis on the 15 information types revealed 3 factors coinciding with 3 proposed information categories: clinical, daily life, and identity information. A within-subject ANOVA showed a strong preference for sharing clinical information compared to daily life and identity information (F _1,114=135.59, P=.001, η²=.93). Also, adverse online privacy experiences, age, and health status negatively affected information-sharing intentions. Female patients shared information less willingly.

Conclusions

Respondents’ information-sharing intentions depend on dispositional and situational factors. Patients share medical details more willingly than daily life or identity information. The results suggest the need to focus on anonymity rather than privacy in online communities.