Policy forum. Data, privacy, and the greater good.

Large-scale aggregate analyses of anonymized data can yield valuable results and insights that address public health challenges and provide new avenues for scientific discovery. These methods can extend our knowledge and provide new tools for enhancing health and wellbeing. However, they raise questions about how to best address potential threats to privacy while reaping benefits for individuals and to society as a whole. The use of machine learning to make leaps across informational and social contexts to infer health conditions and risks from nonmedical data provides representative scenarios for reflections on directions with balancing innovation and regulation.

Policy recommendations for addressing privacy challenges associated with cell-based research and interventions.

BACKGROUND: The increased use of human biological material for cell-based research and clinical interventions poses risks to the privacy of patients and donors, including the possibility of re-identification of individuals from anonymized cell lines and associated genetic data. These risks will increase as technologies and databases used for re-identification become affordable and more sophisticated. Policies that require ongoing linkage of cell lines to donors' clinical information for research and regulatory purposes, and existing practices that limit research participants' ability to control what is done with their genetic data, amplify the privacy concerns. DISCUSSION: To date, the privacy issues associated with cell-based research and interventions have not received much attention in the academic and policymaking contexts. This paper, arising out of a multi-disciplinary workshop, aims to rectify this by outlining the issues, proposing novel governance strategies and policy recommendations, and identifying areas where further evidence is required to make sound policy decisions. The authors of this paper take the position that existing rules and norms can be reasonably extended to address privacy risks in this context without compromising emerging developments in the research environment, and that exceptions from such rules should be justified using a case-by-case approach. In developing new policies, the broader framework of regulations governing cell-based research and related areas must be taken into account, as well as the views of impacted groups, including scientists, research participants and the general public. SUMMARY: This paper outlines deliberations at a policy development workshop focusing on privacy challenges associated with cell-based research and interventions. The paper provides an overview of these challenges, followed by a discussion of key themes and recommendations that emerged from discussions at the workshop. The paper concludes that privacy risks associated with cell-based research and interventions should be addressed through evidence-based policy reforms that account for both well-established legal and ethical norms and current knowledge about actual or anticipated harms. The authors also call for research studies that identify and address gaps in understanding of privacy risks.

How anonymous is 'anonymous'? Some suggestions towards a coherent universal coding system for genetic samples.

So-called 'anonymous' tissue samples are widely used in research. Because they lack externally identifying information, they are viewed as useful in reconciling conflicts between the control, privacy and confidentiality interests of those from whom the samples originated and the public (or commercial) interest in carrying out research, as reflected in 'consent or anonymise' policies. High level guidance documents suggest that withdrawal of consent and samples and the provision of feedback are impossible in the case of anonymous samples. In view of recent developments in science and consumer-driven genomics the authors argue that such statements are misleading and only muddle complex ethical questions about possible entitlements to control over samples. The authors therefore propose that terms such as 'anonymised', 'anonymous' or 'non-identifiable' be removed entirely from documents describing research samples, especially from those aimed at the public. This is necessary as a matter of conceptual clarity and because failure to do so may jeopardise public trust in the governance of large scale databases. As there is wide variation in the taxonomy for tissue samples and no uniform national or international standards, the authors propose that a numeral-based universal coding system be implemented that focuses on specifying incremental levels of identifiability, rather than use terms that imply that the reidentification of research samples and associated actions are categorically impossible.

Genetic privacy and non-discrimination

El Comité Interinstitucional de las Naciones Unidas sobre Bioética se reunió con ocasión de su décima asamblea en la sede de las UNESCO, en París, los días 4 y 5 de marzo de 2011. Las organizaciones que son miembro (OMS y la UNESCO), estuvieron presentes junto a los miembros asociados (Consejo de Europa, la Comisión Europea, la Organización para la Cooperación y el Desarrollo Económico y la Organización Mundial del Comercio). La discusión se centró en torno al tema . El Consejo Económico y Social de Naciones Unidas (ECOSOC) previamente había tomado en consideración, desde una perspectiva jurídica y ética, las implicaciones de las, cada vez más sofisticadas, tecnologías para la privacidad genética y la no discriminación en campos como la medicina, el empleo y los seguros. De esta forma, el Consejo Económico y Social pidió que la UNESCO elaborase un informe sobre los avances más relevantes en el ámbito de la privacidad genética y la no discriminación. En paralelo con un proceso de consultas con los estados miembros, la UNESCO dirigió una consulta al Comité Interinstitucional de las Naciones Unidas sobre Bioética. En este artículo se analiza el informe presentado por el autor sobre el análisis jurídico en torno a las controversias actuales en este ámbito e ilustra los intentos, en aras de responder a nivel normativo, a una amenaza percibida hacia la privacidad genética y la no discriminación (AU)

The UN Inter-Agency Committee on Bioethics met for its tenth meeting at the UNESCO headquarters in Paris on 4-5th March 2011. Member organisations such as the WHO and UNESCO were in attendance alongside associate members such as the Council for Europe, the European Commission, the Organisation for Economic Co-operation and Development and the World Trade Organisation. Discussion centred on the theme “genetic privacy and non-discrimination”. The United Nations Economic and Social Council (ECOSOC) had previously considered, from a legal and ethical perspective, the implications of increasingly sophisticated technologies for genetic privacy and non-discrimination in fields such as medicine, employment and insurance. Thus, the ECOSOC requested that UNESCO report on relevant developments in the field of genetic privacy and non-discrimination. In parallel with a consulation process with member states, UNESCO launched a consultation with the UN Interagency Committee on Bioethics. This article analyses the report presented by the author concerning the analysis of the current contentions in the field and illustrates attempts at responding on a normative level to a perceived threat to genetic privacy and non-discrimination (AU)

The views of genitourinary medicine (GUM) clinic users on unlinked anonymous testing for HIV: evidence from a pilot study of clinics in two English cities.

A study was undertaken of the views of users of two genitourinary medicine (GUM) clinics in England on unlinked anonymous testing (UAT) for HIV. The UAT programme measures the prevalence of HIV in the population, including undiagnosed prevalence, by testing residual blood (from samples taken for clinical purposes) which is anonymised and irreversibly unlinked from the source. 424 clinic users completed an anonymous questionnaire about their knowledge of, and attitudes towards, UAT. Only 1/7 (14%) were aware that blood left over from clinical testing may be tested anonymously for HIV. A large majority (89%) said they would agree to their blood being tested, although 74% wanted the opportunity to consent. These findings indicate broad support for UAT of blood in a group of patients whose samples are included in the HIV surveillance programme. The findings suggest the need for greater attention to be given to the provision of information and, if replicated in a larger survey, may justify a reappraisal of UK policy on UAT.

Primary antiretroviral drug resistance in newly human immunodeficiency virus-diagnosed individuals testing anonymously and confidentially.

The purpose of this study was to determine if anonymous and confidential testers differ in recency of human immunodeficiency virus (HIV) infection at time of testing and prevalence of antiretroviral drug (ARV) resistance. We examined data from the Centers for Disease Control and Prevention-sponsored Antiretroviral Drug Resistance Testing project, which performed genotypic testing on leftover HIV diagnostic serum specimens of confidentially and anonymously tested ARV-naïve persons newly diagnosed with HIV in Colorado (n = 365 at 11 sites) and King County, Washington (n = 492 at 44 sites). The serologic testing algorithm for recent HIV seroconversion was used to classify people as likely to have been recently infected or not. Type of testing, anonymous or confidential, was not significantly associated with either timing of HIV testing by serologic testing algorithm for recent HIV seroconversion or resistance rates. Mutations conferring any level of ARV resistance were present in 17% of testers, and high-level resistance mutations were present in 10%. Anonymous testers were significantly more likely to have CD4+ counts >500 cells per mm(3) (45% vs. 28%; p = 0.018), indicative of an early infection. This study indicates that anonymous testers have demographic differences relative to confidential HIV testers but were not more likely to exhibit drug resistance. Findings related to when in the course of disease anonymous testers are tested are inconsistent, but anonymous testers had higher CD4 counts, which indicates early testing and is consistent with other studies.

The ethics of HIV testing and disclosure for healthcare professionals: what do our future doctors think?

AIM: This study examined future medical professionals' attitudes and beliefs regarding mandatory human immunodeficiency virus (HIV) testing and disclosure. METHOD: A total of 54 US medical students were interviewed regarding mandatory testing and disclosure of HIV status for both patient and health care professional populations. Interviews were qualitatively analyzed using thematic analysis by the first author and verified by the second author. RESULTS: Medical students considered a variety of perspectives, even placing themselves in the shoes of their patients or imagining themselves as a healthcare professional with HIV. Mixed opinions were presented regarding the importance of HIV testing for students coupled with a fear about school administration regarding HIV positive test results and the outcome of a student's career. Third- and fourth-year medical students felt that there should be no obligation to disclose one's HIV status to patients, colleagues, or employers. However, most of these students did feel that patients had an obligation to disclose their HIV status to healthcare professionals. CONCLUSION: This study gives medical educators a glimpse into what our future doctors think about HIV testing and disclosure, and how difficult it is for them to recognize that they can be patients too, as they are conflicted by professional and personal values.

Patients' views on identifiability of samples and informed consent for genetic research.

It is unclear whether the regulatory distinction between non-identifiable and identifiable information--information used to determine informed consent practices for the use of clinically derived samples for genetic research--is meaningful to patients. The objective of this study was to examine patients' attitudes and preferences regarding use of anonymous and identifiable clinical samples for genetic research. Telephone interviews were conducted with 1,193 patients recruited from general medicine, thoracic surgery, or medical oncology clinics at five United States academic medical centers. Wanting to know about research being done was important to 72% of patients when samples would be anonymous and to 81% of patients when samples would be identifiable. Only 17% wanted to know about the identifiable scenario but not the anonymous scenario (i.e., following the regulatory distinction). Curiosity-based reasons were the most common (37%) among patients who wanted to know about anonymous samples. Of patients wanting to know about either scenario, approximately 57% would require researchers to seek permission, whereas 43% would be satisfied with notification only. Patients were more likely to support permission (versus notification) in the anonymous scenario if they had more education, were Black, less religious, in better health, more private, and less trusting of researchers. The sample, although not representative of the general population, does represent patients at academic medical centers whose clinical samples may be used for genetic research. Few patients expressed preferences consistent with the regulatory distinction between non-identifiable and identifiable information. Data from this study should cause policy-makers to question whether this distinction is useful in relation to research with previously collected clinically derived samples.