Search tips
Search criteria

Results 1-13 (13)

Clipboard (0)

Select a Filter Below

more »
Year of Publication
Document Types
author:("bubel, mania")
1.  Use and Misuse of Material Transfer Agreements: Lessons in Proportionality from Research, Repositories, and Litigation 
PLoS Biology  2015;13(2):e1002060.
Material transfer agreements exist to facilitate the exchange of materials and associated data between researchers as well as to protect the interests of the researchers and their institutions. But this dual mandate can be a source of frustration for researchers, creating administrative burdens and slowing down collaborations. We argue here that in most cases in pre-competitive research, a simple agreement would suffice; the more complex agreements and mechanisms for their negotiation should be reserved for cases where the risks posed to the institution and the potential commercial value of the research reagents is high.
The material transfer agreements designed to facilitate the exchange of materials between researchers are unnecessarily burdensome and obstructive and in most cases could be replaced by simpler tools.
PMCID: PMC4315468  PMID: 25646804
2.  Value-Engineered Translation for Regenerative Medicine: Meeting the Needs of Health Systems 
Stem Cells and Development  2013;22(Suppl 1):89-93.
Despite high expectations of economic returns, large investments in regenerative medicine technology have yet to materialize, partly due to a lack of proven business and investment models, regulatory hurdles, and a greater focus on cost-effectiveness for reimbursement decisions by payors. Adoption of new economic modeling methods will better link investment decisions to value-based criteria of health systems.
PMCID: PMC3883180  PMID: 24304083
3.  Ocular gene transfer in the spotlight: implications of newspaper content for clinical communications 
BMC Medical Ethics  2014;15:58.
Ocular gene transfer clinical trials are raising hopes for blindness treatments and attracting media attention. News media provide an accessible health information source for patients and the public, but are often criticized for overemphasizing benefits and underplaying risks of novel biomedical interventions. Overly optimistic portrayals of unproven interventions may influence public and patient expectations; the latter may cause patients to downplay risks and over-emphasize benefits, with implications for informed consent for clinical trials. We analyze the news media communications landscape about ocular gene transfer and make recommendations for improving communications between clinicians and potential trial participants in light of media coverage.
We analyzed leading newspaper articles about ocular gene transfer (1990-2012) from United States (n = 55), Canada (n = 26), and United Kingdom (n = 77) from Factiva and Canadian Newsstand databases using pre-defined coding categories. We evaluated the content of newspaper articles about ocular gene transfer for hereditary retinopathies, exploring representations of framing techniques, research design, risks/benefits, and translational timelines.
The dominant frame in 61% of stories was a celebration of progress, followed by human-interest in 30% of stories. Missing from the positive frames were explanations of research design; articles conflated clinical research with treatment. Conflicts-of-interest and funding sources were similarly omitted. Attention was directed to the benefits of gene transfer, while risks were only reported in 43% of articles. A range of visual outcomes was described from slowing vision loss to cure, but the latter was the most frequently represented even though it is clinically infeasible. Despite the prominence of visual benefit portrayals, 87% of the articles failed to provide timelines for the commencement of clinical trials or for clinical implementation.
Our analysis confirms that despite many initiatives to improve media communications about experimental biotechnologies, media coverage remains overly optimistic and omits important information. In light of these findings, our recommendations focus on the need for clinicians account for media coverage in their communications with patients, especially in the context of clinical trial enrolment. The development of evidence-based communication strategies will facilitate informed consent and promote the ethical translation of this biotechnology.
PMCID: PMC4107594  PMID: 25027482
Gene transfer; Gene therapy; Media; Newspaper coverage; Therapeutic misconception; Ethics; Informed consent
4.  Patents and Misplaced Angst: Lessons for Translational Stem Cell Research from Genomics 
Cell stem cell  2013;12(5):508-512.
PMCID: PMC3776312  PMID: 23642360
5.  Legal Agreements and the Governance of Research Commons: Lessons from Materials Sharing in Mouse Genomics 
Omics research infrastructure such as databases and bio-repositories requires effective governance to support pre-competitive research. Governance includes the use of legal agreements, such as Material Transfer Agreements (MTAs). We analyze the use of such agreements in the mouse research commons, including by two large-scale resource development projects: the International Knockout Mouse Consortium (IKMC) and International Mouse Phenotyping Consortium (IMPC). We combine an analysis of legal agreements and semi-structured interviews with 87 members of the mouse model research community to examine legal agreements in four contexts: (1) between researchers; (2) deposit into repositories; (3) distribution by repositories; and (4) exchanges between repositories, especially those that are consortium members of the IKMC and IMPC. We conclude that legal agreements for the deposit and distribution of research reagents should be kept as simple and standard as possible, especially when minimal enforcement capacity and resources exist. Simple and standardized legal agreements reduce transactional bottlenecks and facilitate the creation of a vibrant and sustainable research commons, supported by repositories and databases.
PMCID: PMC3976585  PMID: 24552652
6.  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.
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.
PMCID: PMC3818164  PMID: 24223516
7.  When Pictures Waste a Thousand Words: Analysis of the 2009 H1N1 Pandemic on Television News 
PLoS ONE  2013;8(5):e64070.
Effective communication by public health agencies during a pandemic promotes the adoption of recommended health behaviours. However, more information is not always the solution. Rather, attention must be paid to how information is communicated. Our study examines the television news, which combines video and audio content. We analyse (1) the content of television news about the H1N1 pandemic and vaccination campaign in Alberta, Canada; (2) the extent to which television news content conveyed key public health agency messages; (3) the extent of discrepancies in audio versus visual content.
We searched for “swine flu” and “H1N1” in local English news broadcasts from the CTV online video archive. We coded the audio and visual content of 47 news clips during the peak period of coverage from April to November 2009 and identified discrepancies between audio and visual content.
The dominant themes on CTV news were the vaccination rollout, vaccine shortages, long line-ups (queues) at vaccination clinics and defensive responses by public health officials. There were discrepancies in the priority groups identified by the provincial health agency (Alberta Health and Wellness) and television news coverage as well as discrepancies between audio and visual content of news clips. Public health officials were presented in official settings rather than as public health practitioners.
The news footage did not match the main public health messages about risk levels and priority groups. Public health agencies lost control of their message as the media focused on failures in the rollout of the vaccination campaign. Spokespeople can enhance their local credibility by emphasizing their role as public health practitioners. Public health agencies need to learn from the H1N1 pandemic so that future television communications do not add to public confusion, demonstrate bureaucratic ineffectiveness and contribute to low vaccination rates.
PMCID: PMC3656930  PMID: 23691150
8.  Access and benefits sharing of genetic resources and associated traditional knowledge in northern Canada: understanding the legal environment and creating effective research agreements 
International Journal of Circumpolar Health  2013;72:10.3402/ijch.v72i0.21351.
Research in northern Canada focused on Aboriginal peoples has historically benefited academia with little consideration for the people being researched or their traditional knowledge (TK). Although this attitude is changing, the complexity of TK makes it difficult to develop mechanisms to preserve and protect it. Protecting TK becomes even more important when outside groups become interested in using TK or materials with associated TK. In the latter category are genetic resources, which may have commercial value and are the focus of this article.
This article addresses access to and use of genetic resources and associated TK in the context of the historical power-imbalances in research relationships in Canadian north.
Research involving genetic resources and TK is becoming increasingly relevant in northern Canada. The legal framework related to genetic resources and the cultural shift of universities towards commercial goals in research influence the environment for negotiating research agreements. Current guidelines for research agreements do not offer appropriate guidelines to achieve mutual benefit, reflect unequal bargaining power or take the relationship between parties into account.
Relational contract theory may be a useful framework to address the social, cultural and legal hurdles inherent in creating research agreements.
PMCID: PMC3754551  PMID: 23986896
northern Canada; access and benefits sharing; genetic resources; research agreements
9.  Is belief larger than fact: expectations, optimism and reality for translational stem cell research 
BMC Medicine  2012;10:133.
Stem cell (SC) therapies hold remarkable promise for many diseases, but there is a significant gulf between public expectations and the reality of progress toward clinical application. Public expectations are fueled by stakeholder arguments for research and public funding, coupled with intense media coverage in an ethically charged arena. We examine media representations in light of the expanding global landscape of SC clinical trials, asking what patients may realistically expect by way of timelines for the therapeutic and curative potential of regenerative medicine?
We built 2 international datasets: (1) 3,404 clinical trials (CT) containing 'stem cell*' from and the World Health Organization's International Clinical Trials Registry Search Portal; and (2) 13,249 newspaper articles on SC therapies using We compared word frequencies between the CT descriptions and full-text newspaper articles for the number containing terms for SC type and diseases/conditions. We also developed inclusion and exclusion criteria to identify novel SC CTs, mainly regenerative medicine applications.
Newspaper articles focused on human embryonic SCs and neurological conditions with significant coverage as well of cardiovascular disease and diabetes. In contrast, CTs used primarily hematopoietic SCs, with an increase in CTs using mesenchymal SCs since 2007. The latter dominated our novel classification for CTs, most of which are in phases I and II. From the perspective of the public, expecting therapies for neurological conditions, there is limited activity in what may be considered novel applications of SC therapies.
Given the research, regulatory, and commercialization hurdles to the clinical translation of SC research, it seems likely that patients and political supporters will become disappointed and disillusioned. In this environment, proponents need to make a concerted effort to temper claims. Even though the field is highly promising, it lacks significant private investment and is largely reliant on public support, requiring a more honest acknowledgement of the expected therapeutic benefits and the timelines to achieving them.
PMCID: PMC3520764  PMID: 23131007
stem cell therapy; clinical trials; public expectations; newspaper coverage; commercialization; ethics
11.  Herbal remedy clinical trials in the media: a comparison with the coverage of conventional pharmaceuticals 
BMC Medicine  2008;6:35.
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.
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.
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.
PMCID: PMC2647939  PMID: 19036123
12.  Do the print media “hype” genetic research? A comparison of newspaper stories and peer-reviewed research papers 
The public gets most of its information about genetic research from the media. It has been suggested that media representations may involve exaggeration, called “genohype.” To examine the accuracy and nature of media coverage of genetic research, we reviewed the reporting of single-gene discoveries and associated technologies in major daily newspapers in Canada, the United States, Great Britain and Australia.
We used neutral search terms to identify articles about gene discoveries and associated technologies hosted on the Dow Jones Interactive and Canadian NewsDisk databases from January 1995 to June 2001. We compared the contents, claims and conclusions of the scientific journal article with those of the associated newspaper article. Coders subjectively assigned the newspaper articles to 1 of 3 categories: moderately to highly exaggerated claims, slightly exaggerated claims or no exaggerated claims. We used classification tree software to identify the variables that contributed to the assignment of each newspaper article to 1 of the 3 categories: attention structure (positioning in the newspaper and length of the article), authorship, research topic, source of information other than the scientific paper, type and likelihood of risks and benefits, discussion of controversy, valuation tone (positive or negative), framing (e.g., description of research, celebration of progress, report of economic prospects or ethical perspective), technical accuracy (either omissions or errors that changed the description of the methods or interpretation of the results) and use of metaphors.
We examined 627 newspaper articles reporting on 111 papers published in 24 scientific and medical journals. Only 11% of the newspaper articles were categorized as having moderately to highly exaggerated claims; the majority were categorized as having no claims (63%) or slightly exaggerated claims (26%). The classification analysis ranked the reporting of risks as the most important variable in determining the categorization of newspaper articles. Only 15% of the newspaper articles and 5% of the scientific journal articles discussed costs or risks, whereas 97% of the newspaper articles and 98% of the scientific journal articles discussed the likelihood of benefits of the research.
Our data suggest that the majority of newspaper articles accurately convey the results of and reflect the claims made in scientific journal articles. Our study also highlights an overemphasis on benefits and under-representation of risks in both scientific and newspaper articles. The cause and nature of this trend is uncertain.
PMCID: PMC400292  PMID: 15111473
13.  “Is a cure in my sight?” Multi-stakeholder perspectives on phase I choroideremia gene transfer clinical trials 
Genetics in Medicine  2013;16(5):379-385.
Ocular gene transfer clinical trials are raising patient hopes for the treatment of choroideremia – a blinding degenerative retinopathy. Phase I choroideremia gene transfer trials necessitate communicating about the risks of harm and potential benefits with patients while avoiding the sensationalism that has historically undermined this field of translational medicine.
We conducted interviews between June 2011 and June 2012 with 6 choroideremia patient advocates, 20 patients, and 15 clinicians about their hopes for benefits, perceived risks of harm, and hopes for the time frame of clinical implementation of choroideremia gene transfer.
Despite the safety focus of phase I trials, participants hoped for direct visual benefits with evident discrepancies between stakeholder perspectives about the degree of visual benefit. Clinicians and patient advocates were concerned by limited patient attention to risks of harm. Interviews revealed confusion about the time frames for the clinical implementation of choroideremia gene transfer and patient urgency to access gene transfer within a limited therapeutic window.
Differences in stakeholder perspectives about choroideremia gene transfer necessitate strategies that promote responsible communications about choroideremia gene transfer and aid in its translation. Strategies should counter historical sensationalism associated with gene transfer, promote informed consent, and honor patient hope while grounding communications in current clinical realities.
PMCID: PMC4018498  PMID: 24071795
choroideremia; gene therapy; gene transfer; informed consent; phase I

Results 1-13 (13)