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1.  Harm, hype and evidence: ELSI research and policy guidance 
Genome Medicine  2013;5(3):21.
There has been much investment in research on the ethical, legal and social issues (ELSI) associated with genetic and genomic research. This research should inform the development of the relevant policy. So far, much of the relevant policy - such as in the areas of patents, genetic testing and genetic discrimination - seems to be informed more by speculation of harm and anecdote than by available evidence. Although a quest for evidence cannot always be allowed to delay policy choice, it seems axiomatic to us that policy options are improved by the incorporation of evidence.
doi:10.1186/gm425
PMCID: PMC3707044  PMID: 23534337
2.  Policy recommendations for addressing privacy challenges associated with cell-based research and interventions 
BMC Medical Ethics  2014;15:7.
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.
doi:10.1186/1472-6939-15-7
PMCID: PMC3914710  PMID: 24485220
4.  Reflections on the Cost of "Low-Cost" Whole Genome Sequencing: Framing the Health Policy Debate 
PLoS Biology  2013;11(11):e1001699.
The future clinical applications of whole genome sequencing come with speculation and enthusiasm but require careful consideration of the true system costs and health benefits of the clinical uses of this exciting technology.
Summary
The cost of whole genome sequencing is dropping rapidly. There has been a great deal of enthusiasm about the potential for this technological advance to transform clinical care. Given the interest and significant investment in genomics, this seems an ideal time to consider what the evidence tells us about potential benefits and harms, particularly in the context of health care policy. The scale and pace of adoption of this powerful new technology should be driven by clinical need, clinical evidence, and a commitment to put patients at the centre of health care policy.
doi:10.1371/journal.pbio.1001699
PMCID: PMC3818164  PMID: 24223516
6.  Policy Uncertainty, Sequencing, and Cell Lines 
G3: Genes|Genomes|Genetics  2013;3(8):1205-1207.
doi:10.1534/g3.113.007435
PMCID: PMC3737160  PMID: 23926222
7.  Cancer patient perceptions on the ethical and legal issues related to biobanking 
Background
Understanding the perception of patients on research ethics issues related to biobanking is important to enrich ethical discourse and help inform policy.
Methods
We examined the views of leukemia patients undergoing treatment in clinics located in the Princess Margaret Hospital in Toronto, Ontario, Canada. An initial written survey was provided to 100 patients (64.1% response rate) followed by a follow-up survey (62.5% response rate) covering the topics of informed consent, withdrawal, anonymity, incidental findings and the return of results, ownership, and trust.
Results
The majority (59.6%) preferred one-time consent, 30.3% desired a tiered consent approach that provides multiple options, and 10.1% preferred re-consent for future research. When asked different questions on re-consent, most (58%) reported that re-consent was a waste of time and money, but 51.7% indicated they would feel respected and involved if asked to re-consent. The majority of patients (62.2%) stated they had a right to withdraw their consent, but many changed their mind in the follow-up survey explaining that they should not have the right to withdraw consent. Nearly all of the patients (98%) desired being informed of incidental health findings and explained that the information was useful. Of these, 67.3% of patients preferred that researchers inform them and their doctors of the results. The majority of patients (62.2%) stated that the research institution owns the samples whereas 19.4% stated that the participants owned their samples. Patients had a great deal of trust in doctors, hospitals and government-funded university researchers, moderate levels of trust for provincial governments and industry-funded university researchers, and low levels of trust towards industry and insurance companies.
Conclusions
Many cancer patients surveyed preferred a one-time consent although others desired some form of control. The majority of participants wanted a continuing right to withdraw consent and nearly all wanted to be informed of incidental findings related to their health. Patients had a great deal of trust in their medical professionals and publically-funded researchers as opposed to profit-based industries and insurance companies.
doi:10.1186/1755-8794-6-8
PMCID: PMC3599691  PMID: 23497701
Biobank; Tissue repository; Cancer patient perspectives; Consent; Withdrawal; Anonymity; Incidental findings; Return of results; Ownership; Trust
9.  Open science versus commercialization: a modern research conflict? 
Genome Medicine  2012;4(2):17.
Background
Efforts to improve research outcomes have resulted in genomic researchers being confronted with complex and seemingly contradictory instructions about how to perform their tasks. Over the past decade, there has been increasing pressure on university researchers to commercialize their work. Concurrently, they are encouraged to collaborate, share data and disseminate new knowledge quickly (that is, to adopt an open science model) in order to foster scientific progress, meet humanitarian goals, and to maximize the impact of their research.
Discussion
We present selected guidelines from three countries (Canada, United States, and United Kingdom) situated at the forefront of genomics to illustrate this potential policy conflict. Examining the innovation ecosystem and the messages conveyed by the different policies surveyed, we further investigate the inconsistencies between open science and commercialization policies.
Summary
Commercialization and open science are not necessarily irreconcilable and could instead be envisioned as complementary elements of a more holistic innovation framework. Given the exploratory nature of our study, we wish to point out the need to gather additional evidence on the coexistence of open science and commercialization policies and on its impact, both positive and negative, on genomics academic research.
doi:10.1186/gm316
PMCID: PMC3392762  PMID: 22369790
12.  The Commercialization of Genomic Research in Canada 
Healthcare Policy  2010;6(2):24-32.
The commercialization of academic research has been promoted by North American policy makers for over 30 years as a means of increasing university financing and to ensure that promising research would eventually find its way to the marketplace. The following issues paper constitutes a reflection on the impact of the Canadian commercialization framework on academic research in the field of genomics. It was written following two workshops and two independent studies organized by academic groups in Quebec (Centre of Genomics and Policy) and Alberta (Health Law Institute). The full sets of recommendations are available upon request to the authors.
PMCID: PMC3016633  PMID: 22043221
13.  Supported by science?: what canadian naturopaths advertise to the public 
Background
The increasing popularity of complementary and alternative medicines in Canada has led to regulatory reforms in Ontario and British Columbia. Yet the evidence for efficacy of these therapies is still a source of debate. Those who are supportive of naturopathic medicine often support the field by claiming that the naturopathic treatments are supported by science and scientific research.
Methods
To compare provinces that are regulated and unregulated, we examined the websites of 53 naturopathic clinics in Alberta and British Columbia to gain a sense of the degree to which the services advertised by naturopaths are science based.
Results
There were very few differences between the provinces in terms of the types of services offered and conditions treated. Many of the most common treatments--such as homeopathy, chelation and colon cleanses--are viewed by the scientific community to be of questionable value and have no scientific evidence of efficacy beyond placebo.
Conclusions
A review of the therapies advertised on the websites of clinics offering naturopathic treatments does not support the proposition that naturopathic medicine is a science and evidence-based practice.
doi:10.1186/1710-1492-7-14
PMCID: PMC3182944  PMID: 21920039
14.  Handling ethical, legal and social issues in birth cohort studies involving genetic research: responses from studies in six countries 
BMC Medical Ethics  2010;11:4.
Background
Research involving minors has been the subject of much ethical debate. The growing number of longitudinal, pediatric studies that involve genetic research present even more complex challenges to ensure appropriate protection of children and families as research participants. Long-term studies with a genetic component involve collection, retention and use of biological samples and personal information over many years. Cohort studies may be established to study specific conditions (e.g. autism, asthma) or may have a broad aim to research a range of factors that influence the health and development of children. Studies are increasingly intended to serve as research platforms by providing access to data and biological samples to researchers over many years.
This study examines how six birth cohort studies in North America and Europe that involve genetic research handle key ethical, legal and social (ELS) issues: recruitment, especially parental authority to include a child in research; initial parental consent and subsequent assent and/or consent from the maturing child; withdrawal; confidentiality and sample/data protection; handling sensitive information; and disclosure of results.
Methods
Semi-structured telephone interviews were carried out in 2008/09 with investigators involved in six birth cohort studies in Canada, Denmark, England, France, the Netherlands and the United States. Interviewees self-identified as being knowledgeable about ELS aspects of the study. Interviews were conducted in English.
Results
The studies vary in breadth of initial consent, but none adopt a blanket consent for future use of samples/data. Ethics review of new studies is a common requirement. Studies that follow children past early childhood recognise a need to seek assent/consent as the child matures. All studies limit access to identifiable data and advise participants of the right to withdraw. The clearest differences among studies concern handling of sensitive information and return of results. In all studies, signs of child abuse require reports to authorities, but this disclosure duty is not always stated in consent materials. Studies vary in whether they will return to participants results of routine tests/measures, but none inform participants about findings with unknown clinical significance.
Conclusions
Analysis of how cohort studies in various jurisdictions handle key ELS issues provides informative data for comparison and contrast. Consideration of these and other examples and further scholarly exploration of ELS issues provides insight on how best to address these aspects in ways that respect the well-being of participants, especially children who become research subjects at the start of their lives.
doi:10.1186/1472-6939-11-4
PMCID: PMC2859353  PMID: 20331891
16.  Technology assessment and resource allocation for predictive genetic testing: A study of the perspectives of Canadian genetic health care providers 
BMC Medical Ethics  2009;10:6.
Background
With a growing number of genetic tests becoming available to the health and consumer markets, genetic health care providers in Canada are faced with the challenge of developing robust decision rules or guidelines to allocate a finite number of public resources. The objective of this study was to gain Canadian genetic health providers' perspectives on factors and criteria that influence and shape resource allocation decisions for publically funded predictive genetic testing in Canada.
Methods
The authors conducted semi-structured interviews with 16 senior lab directors and clinicians at publically funded Canadian predictive genetic testing facilities. Participants were drawn from British Columbia, Alberta, Manitoba, Ontario, Quebec and Nova Scotia. Given the community sampled was identified as being relatively small and challenging to access, purposive sampling coupled with snowball sampling methodologies were utilized.
Results
Surveyed lab directors and clinicians indicated that predictive genetic tests were funded provincially by one of two predominant funding models, but they themselves played a significant role in how these funds were allocated for specific tests and services. They also rated and identified several factors that influenced allocation decisions and patients' decisions regarding testing. Lastly, participants provided recommendations regarding changes to existing allocation models and showed support for a national evaluation process for predictive testing.
Conclusion
Our findings suggest that largely local and relatively ad hoc decision making processes are being made in relation to resource allocations for predictive genetic tests and that a more coordinated and, potentially, national approach to allocation decisions in this context may be appropriate.
doi:10.1186/1472-6939-10-6
PMCID: PMC2711094  PMID: 19538750
17.  Commercialization, patenting and genomics: researcher perspectives 
Genome Medicine  2009;1(2):22.
The impact of commercialization and patenting pressure on genomics research is still a topic of considerable debate in academic, policy and popular literature. We interviewed genomic researchers to see if their perspectives offered fresh insights. Regional Genome Canada centers provided us with relevant researcher contact information, and in-depth structured interviews were conducted. Researcher perspectives were sharply divided, with both support and concern for commercialization regimes surfacing in interviews. Data withholding and publication delays were commonly reported, but the aggressive enforcement of patents was not. There are parallels to the Stem Cell community in Canada in these respects. Genomic researchers, as individuals directly implicated in the field of controversy, have developed varied and often novel insights which should be incorporated into the ongoing debates surrounding commercialization and patenting. Many researchers continue to raise concerns, particularly in relation to data withholding, thus emphasizing the need for a continued exploration of the complex issues associated with commercialization and patenting.
doi:10.1186/gm22
PMCID: PMC2664955  PMID: 19341493
18.  Race and ancestry in biomedical research: exploring the challenges 
Genome Medicine  2009;1(1):8.
The use of race in biomedical research has, for decades, been a source of social controversy. However, recent events, such as the adoption of racially targeted pharmaceuticals, have raised the profile of the race issue. In addition, we are entering an era in which genomic research is increasingly focused on the nature and extent of human genetic variation, often examined by population, which leads to heightened potential for misunderstandings or misuse of terms concerning genetic variation and race. Here, we draw together the perspectives of participants in a recent interdisciplinary workshop on ancestry and health in medicine in order to explore the use of race in research issue from the vantage point of a variety of disciplines. We review the nature of the race controversy in the context of biomedical research and highlight several challenges to policy action, including restrictions resulting from commercial or regulatory considerations, the difficulty in presenting precise terminology in the media, and drifting or ambiguous definitions of key terms.
doi:10.1186/gm8
PMCID: PMC2651580  PMID: 19348695
19.  Herbal remedy clinical trials in the media: a comparison with the coverage of conventional pharmaceuticals 
BMC Medicine  2008;6:35.
Background
This study systematically compares newspaper coverage of clinical trials for herbal remedies, a popular type of complementary and alternative medicine, with clinical trials for pharmaceuticals using a comparative content analysis. This is a timely inquiry given the recognized importance of the popular press as a source of health information, the complex and significant role of complementary and alternative medicine in individual health-care decisions, and the trend toward evidence-based research for some complementary and alternative medical therapies. We searched PubMed for clinical trials, Lexis/Nexis for newspaper articles in the UK, US, Australia/New Zealand, and Factiva for Canadian newspaper articles from 1995 to 2005. We used a coding frame to analyze and compare 48 pharmaceutical and 57 herbal remedy clinical trials as well as 201 pharmaceutical and 352 herbal remedy newspaper articles.
Results
Herbal remedy clinical trials had similar Jadad scores to pharmaceutical trials but were significantly smaller and of shorter duration. The trials were mostly studies from Western countries and published in high-ranking journals. The majority of pharmaceutical (64%) and herbal remedy (53%) clinical trials had private sector funding involvement. A minority declared further author conflicts of interest. Newspaper coverage of herbal remedy clinical trials was more negative than for pharmaceutical trials; a result only partly explained by the greater proportion of herbal remedy clinical trials reporting negative results (P = 0.0201; χ2 = 7.8129; degrees of freedom = 2). Errors of omission were common in newspaper coverage, with little reporting of dose, sample size, location, and duration of the trial, methods, trial funding, and conflicts of interest. There was an under-reporting of risks, especially for herbal remedies.
Conclusion
Our finding of negative coverage of herbal remedy trials is contrary to the positive trends in most published research based primarily on anecdotal accounts. Our results highlight how media coverage is not providing the public with the information necessary to make informed decisions about medical treatments. Most concerning is the lack of disclosure of trial funding and conflicts of interest that could influence the outcome or reporting of trial results. This lack of reporting may impact the medical research community, which has the most to lose by way of public trust and respect.
doi:10.1186/1741-7015-6-35
PMCID: PMC2647939  PMID: 19036123
21.  Research Ethics Recommendations for Whole-Genome Research: Consensus Statement 
PLoS Biology  2008;6(3):e73.
Interest in whole-genome research has grown substantially over the past few months. This article explores the challenging ethics issues associated with this work.
doi:10.1371/journal.pbio.0060073
PMCID: PMC2270329  PMID: 18366258
22.  Research ethics and the challenge of whole-genome sequencing 
Nature reviews. Genetics  2008;9(2):152-156.
The recent completion of the first two individual whole-genome sequences is a research milestone. As personal genome research advances, investigators and international research bodies must ensure ethical research conduct. We identify three major ethical considerations that have been implicated in whole-genome research: the return of research results to participants; the obligations, if any, that are owed to participants’ relatives; and the future use of samples and data taken for whole-genome sequencing. Although the issues are not new, we discuss their implications for personal genomics and provide recommendations for appropriate management in the context of research involving individual whole-genome sequencing.
doi:10.1038/nrg2302
PMCID: PMC2225443  PMID: 18087293
23.  Patenting human genetic material: refocusing the debate 
Nature reviews. Genetics  2000;1(3):227-231.
The biotechnology industry has become firmly established over the past twenty years and gene patents have played an important part in this phenomenon. However, concerns have been raised over the patentability of human genetic material, through public protests and international statements, but to little effect. Here we discuss some of these concerns, the patent authorities’ response to them, and ways in which to address these issues and to move the debate forward using current legal structures.
doi:10.1038/35042087
PMCID: PMC2220019  PMID: 11252752
24.  The Future of Personal Genomics 
Science (New York, N.Y.)  2007;317(5845):1687.
doi:10.1126/science.1147475
PMCID: PMC2220016  PMID: 17885116
25.  Obesity, legal duties, and the family physician 
Canadian Family Physician  2007;53(7):1129-1130.
PMCID: PMC1949277  PMID: 17872796

Results 1-25 (38)