Open Consent Research Articles

In defence of consent and capacity boards for end-of-life care

In Cuthbertson v. Rasouli, the Supreme Court of Canada (SCC) found that, in Ontario, it is the Consent and Capacity Board (CCB) and not the courts per se who will resolve conflicts between substitute decision-makers (SDMs) and health practitioners regarding the withdrawal of lifesustaining treatment from incapable patients. This finding was based on the SCC’s interpretation of the Ontario Health Care Consent Act (HCCA). Hawryluck et al. express concern about the SCC’s determination that the CCB is charged with resolving such conflicts since, in their view, this body is ill-equipped to fulfill this role. Instead, they take the position that these disputes should be adjudicated by the courts. We disagree with this position and, for the reasons set out in this editorial, take the position that provincial and territorial legislators across the country should follow the lead of the Ontario legislature, revise their health care consent legislation to clarify the law with respect to the unilateral withholding and withdrawal of potentially life-sustaining treatment, and establish open and transparent consent and capacity tribunals to deal with irreconcilable conflicts in this context.

Towards establishing a multiple sclerosis biobank in Jordan

Genome-wide association studies (GWAS) have been a promising approach in unraveling genetic associations to multiple sclerosis (MS), a complex, multifactorial disease. Biobanks are repositories of patient biospecimens and information that can promote GWAS research. However, the success of GWAS and biobanking is dependent on the level of participation of MS patients in genetic research. In order to initiate MS-based biobanking and GWAS research in Jordan, the willingness of MS patients to participate in long-term, genetic research in Jordan and their preferred type of a consent form were investigated. MS patients (289) were recruited for genetic studies. Personal and clinical information were collected from those who enrolled in the study. Approximately 96% of MS patients agreed to participate in genetic studies. The female:male ratio among patients was 2:1 with most patients being diagnosed with relapsing-remitting MS (88%). The mean age of onset was 28.3 years, the mean duration of illness was 6 years, and the mean Expanded Disability Status Scale was 2.8. Relatedness of parents was significantly associated with having secondary-progressive MS. Approximately 85% of the patients preferred open consent with 37% of them preferring to renew their consent. All the patients approved to be recontacted and update their information via accessing their medical files or physicians. These observations support the establishment of a specialized MS biobank in Jordan and pave the way to participate in international large-scale genetic initiatives.

Harvard Personal Genome Project: lessons from participatory public research

BackgroundSince its initiation in 2005, the Harvard Personal Genome Project has enrolled thousands of volunteers interested in publicly sharing their genome, health and trait data. Because these data are highly identifiable, we use an ‘open consent’ framework that purposefully excludes promises about privacy and requires participants to demonstrate comprehension prior to enrollment.DiscussionOur model of non-anonymous, public genomes has led us to a highly participatory model of researcher-participant communication and interaction. The participants, who are highly committed volunteers, self-pursue and donate research-relevant datasets, and are actively engaged in conversations with both our staff and other Personal Genome Project participants. We have quantitatively assessed these communications and donations, and report our experiences with returning research-grade whole genome data to participants. We also observe some of the community growth and discussion that has occurred related to our project.SummaryWe find that public non-anonymous data is valuable and leads to a participatory research model, which we encourage others to consider. The implementation of this model is greatly facilitated by web-based tools and methods and participant education. Project results are long-term proactive participant involvement and the growth of a community that benefits both researchers and participants.

A public resource facilitating clinical use of genomes

Rapid advances in DNA sequencing promise to enable new diagnostics and individualized therapies. Achieving personalized medicine, however, will require extensive research on highly reidentifiable, integrated datasets of genomic and health information. To assist with this, participants in the Personal Genome Project choose to forgo privacy via our institutional review board- approved “open consent” process. The contribution of public data and samples facilitates both scientific discovery and standardization of methods. We present our findings after enrollment of more than 1,800 participants, including whole-genome sequencing of 10 pilot participant genomes (the PGP-10). We introduce the Genome-Environment-Trait Evidence (GET-Evidence) system. This tool automatically processes genomes and prioritizes both published and novel variants for interpretation. In the process of reviewing the presumed healthy PGP-10 genomes, we find numerous literature references implying serious disease. Although it is sometimes impossible to rule out a late-onset effect, stringent evidence requirements can address the high rate of incidental findings. To that end we develop a peer production system for recording and organizing variant evaluations according to standard evidence guidelines, creating a public forum for reaching consensus on interpretation of clinically relevant variants. Genome analysis becomes a two-step process: using a prioritized list to record variant evaluations, then automatically sorting reviewed variants using these annotations. Genome data, health and trait information, participant samples, and variant interpretations are all shared in the public domain—we invite others to review our results using our participant samples and contribute to our interpretations. We offer our public resource and methods to further personalized medical research.

Ethical Endgames: Broad Consent for Narrow Interests; Open Consent for Closed Minds

The ongoing legal and bioethics debates on consent requirements for collecting, storing, and utilizing human biological material for purposes of basic and applied research—that is, genomic research biobanking—have already managed to pass through three ostensibly dissimilar stages

Viewpoint: How to avoid a dichotomy between autonomy and beneficence: from liberalism to communitarianism and beyond

Viewpoint: How to avoid a dichotomy between autonomy and beneficence: from liberalism to communitarianism and beyond

The Infectious Diseases BioBank at King's College London: archiving samples from patients infected with HIV to facilitate translational research

The King's College London (KCL) Infectious Diseases BioBank opened in 2007 and collects peripheral venous blood (PVB) from individuals infected with pathogens including human immunodeficiency virus (HIV). PVBs are fractionated into plasmas, lymphocytes and DNA and are then frozen. All donations are from subjects who have given 'open consent' so samples can be used for virtually any type of biomedical research. The HIV component of the BioBank contains samples from over 400 donations from 138 HIV+ patients. Thus, the KCL Infectious Diseases BioBank - together with establishments such as the Spanish HIV BioBank - is likely to expedite translational research into this infection.

From genetic privacy to open consent

Recent advances in high-throughput genomic technologies are showing concrete results in the form of an increasing number of genome-wide association studies and in the publication of comprehensive individual genome-phenome data sets. As a consequence of this flood of information the established concepts of research ethics are stretched to their limits, and issues of privacy, confidentiality and consent for research are being re-examined. Here, we show the feasibility of the co-development of scientific innovation and ethics, using the open-consent framework that was implemented in the Personal Genome Project as an example.

El consentimiento informado ante los biobancos y la investigación genética

Partially as a consequence of the results of the Human Genome Project, reductionist and determinist positions in genetics have been generally replaced by a more systemic view. In this paper we examine some consequences of this paradigm shift upon biobanks and the way research is to take place through them. Biobanks are shown to challenge to a certain degree the traditional rules in genetic research. Although there are pressing issues concerning privacy and confidentiality, the most visible area of disagreement has to do with informed consent. There is a gap between theory and practice, as most documents and declarations at the global level insist on the need of genuine informed consent, but this requirement faces serious problems of implementation. Thus the demands of research are bringing about new “open consent” models, which are making their way into legislation, as in the new Spanish Law on Biomedical Research.

Pioneers in medicine.

Small countries are taking big steps towards improved genetics-based research and health care with the creation of population databanks

Pioneers in medicine

Sometimes revolutions begin in the most unlikely of places. Iceland is a piece of volcanic rock in the middle of the Atlantic Ocean, inhabited by less than 300,000 people. Estonia is now the easternmost outpost of the European Union, after an overwhelming majority of its people voted on 14 September to join the EU. The country only gained its independence from the former Soviet Union in 1991, and the consequences of Soviet rule are still reverberating. But both countries are leading the way in the next revolution in medicine by establishing DNA and health databases of their populations, something that most larger countries have not yet begun to consider. “Many people are talking about population genetics, but you in Estonia are doing it,” said John Norton, Director and CEO of the UK Biobank Project, at the Gene Forum 2003 conference in Tartu, Estonia, this September. In fact, it seems to be easier for smaller countries, such as Iceland and Estonia, to go ahead with such initiatives. “Establishing a database is of course easier in Estonia with its small population [of 1.4 million people],” agreed Arvo Tikk, chairman of the Ethics Committee of the Estonian Genome Project (EGP) Foundation, not only for logistical reasons but also because it is easier to convince the public, and to adapt the laws and regulations. As of mid‐September, deCODE, the private company that is operating the Icelandic genome and health databases, had collected genetic data for more than 100,000 Icelanders. The EGP finished its pilot phase in March this year and since then has collected biological samples and health data from more than 4,000 Estonians. The aim of both projects is the same, but the similarities end there. deCODE is a high‐tech company based in Iceland's capital, Reykjavik, with more then 600 employees and state‐of‐the‐art …

Competition Necessarily Tends to Produce Excess: The Experience of Free Banking in Switzerland

Abstract According to McCulloch, Longfield and Loyd, a free banking system is always prone to overissues of bank notes. Their view is supported by the free banking era in Switzerland (1826-1907), where, due to competitive pressures within the banking community and the absence of note-brand loyalty on the part of the general public, overissues (causing a rise in the foreign exchange rates above the upper gold and silver points) finally became permanent. Free competition, therefore, had to give way to collusive action and, in 1907 (with the open consent of the issuing banks), to the establishment of the Swiss National Bank.

Is Retail Planning Policy Effective? The Case of Very Large Store Development in the UK

This article examines how major retailers, in their attempts to secure sites for very large stores (over 7000 m2 sales area), have had to adopt new strategies in order to overcome resistance from local authority and central government retail planning policy. These strategies include recycling of old retail developments with ‘open A1 consent’, participation in urban regeneration projects and development or redevelopment of ‘district shopping centres’ in urban areas. Discussion of these strategies reveals weaknesses and inconsistencies in retail planning policy in the UK.

The perceived impact of an off‐centre factory outlet mall: the local community dimension

Revisits a retail development near Stoke on Trent, UK, first reported on in 1998. It draws on recent work by Arnold and Luthra which has called for attention to be paid to the effects of large format (big box) retailing. To do so it draws on the opinions of members of the public who live within view of the Stoke on Trent development. It utilises before and after surveying, supplemented by interviews with a community leader, to show how redevelopment is viewed by those it most affects. Findings suggest that even the redevelopment of an existing site can generate protest. However, post‐opening, the concerns are more muted. The research process also reveals that the case study is one with implications for current concerns regarding future use of sites with A1 or open consent as defined under locally‐applicable land‐use planning regulations.

Patient perspectives on the process of informed consent for DNA testing

The informed consent process (ICP) has long been recognized to be an important component of clinical practice and, more recently, of research as well. Yet limited information is available regarding the impact of ICP on patients and their families. We set out to evaluate patient perceptions of ICP which includes a newly devised DNA testing/banking consent form. In addition to addressing the issues currently recognized to be critical to informed consent, this form allowed individuals to choose between the options of closed consent (sample destroyed after requested testing completed) versus open consent (sample banked for use in ongoing research). Participants completed self-administered questionnaires pre and post ICP. Results are available from 50 completed questionnaires to date. 76% of participants chose open consent and 24% chose closed consent. 72% indicated an interest in a detailed discussion in the pre-counselling questionnaire and 76% responded that ICP was helpful in the post-counselling questionnaire, although 83% indicated that they had decided to proceed with testing prior to ICP. Of note, 68% agreed with the statement “consent forms are mostly to provide legal protection for health care professional”. Anxiety levels ascertained by visual analog scale revealed no significant change in anxiety levels pre and post ICP in half of the respondents. The remaining respondents reported increased or decreased anxiety levels with approximately even distribution. Preliminary findings indicate a positive attitude towards ICP and provide justification for its implementation in clinical practice. More detailed data analysis, from a larger sample size, will be presented and this information will be utilized to develop guidelines to improve ICP to better meet patient needs.