Ethical Concerns about Psilocybin Intellectual Property.
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ABSTRACT:
SUBMITTER: Gerber K
PROVIDER: S-EPMC8033603 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundLittle is known about communication between patients, families, and healthcare providers regarding ethical concerns that patients and families experience in the course of illness and medical care. To address this gap in the literature, we surveyed patients and family members to learn about their ethical concerns and the extent to which they discussed them with their healthcare providers.MethodsWe surveyed adult, English-speaking patients and family members receiving inpatient care in five hospitals in the Washington DC-Baltimore metropolitan area from July 2017 to March 2020. Descriptive statistics were used to determine the frequency, comfortableness, and helpfulness of discussions regarding ethical concerns experienced when sick or receiving medical care. Univariable and multivariable stepwise logistic regression models were used to identify associations between healthcare provider and respondent characteristics and attitudes and (1) the likelihood of speaking to a healthcare provider about their ethical concern and (2) their level of comfort during these discussions.ResultsOf 468 respondents who experienced ethical issues, 299 (64%) reported discussing the situation with a member of their healthcare team; 74% (197/265) of respondents who had such a discussion found the discussion comfortable, and 77% (176/230) of respondents found the discussion helpful. To make discussions more comfortable and helpful, respondents proposed suggestions in open-ended responses involving (1) content and quality of communication; (2) positive healthcare provider qualities such as empathy, open-mindedness, knowledge, honesty, and trustworthiness; and (3) other contextual factors including having adequate time and available resources.ConclusionsPatients and families often have ethical concerns that they discuss with clinicians, and they want clinicians to be routinely receptive and attentive to such discussions.
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Project description:A pandemic calls for large-scale action across national and international innovation systems in order to mobilize resources for developing and manufacturing crisis-critical products efficiently and in the huge quantities needed. Nowadays, these products also include a wide range of digital innovations. Given that many responses to the pandemic are technology driven, stakeholders involved in the development and manufacturing of crisis-critical products are likely to face intellectual property (IP)-related challenges. To (governmental) decision makers, IP challenges might not appear to be of paramount urgency compared to the many undoubtedly huge operational challenges to deploy critical resources. However, if IP challenges are considered too late, they may cause delays to urgently mobilize resources effectively. Innovation stakeholders could then be reluctant to fully engage in the development and manufacturing of crisis-critical products. This article adopts an IP and innovation perspective to learn from the currently unfolding COVID-19 pandemic using secondary data, including patent data, synthesized with an IP roadmap. We focus on technical aspects related to research, development, and upscaling of capacity to manufacture crisis-critical products in the huge volumes suddenly in demand. In this article, we offer a set of contributions. We provide a structure, framework, and language for those concerned with steering clear of IP challenges to avoid delays in fighting a pandemic. We provide a reasoning why IP needs to be considered earlier rather than too late in a global health crisis. Major stakeholders we identify include 1) governments; 2) manufacturing firms owning existing crisis-critical IP (incumbents in crisis-critical sectors); 3) manufacturing firms normally not producing crisis-critical products suddenly rushing into crisis-critical sectors to support the manufacturing of crisis-critical products in the quantities that far exceed incumbents' production capacities; and 4) voluntary grassroot initiatives that form during a pandemic, often by highly skilled engineers and scientists in order to contribute to the development and dissemination of crisis-critical products. For these major stakeholders, we draw up three scenarios, from which we identify associated IP challenges they face related to the development and manufacturing of technologies and products for 1) prevention (of spread); 2) diagnosis of infected patients; and 3) the development of treatments. This article provides a terminology to help policy and other decision makers to discuss IP considerations during pandemics. We propose a framework that visualizes changing industrial organizations and IP-associated challenges during a pandemic and derive initial principles to guide innovation and IP policy making during a pandemic. Obviously, our findings result only from observations of one ongoing pandemic and thus need to be verified further and interpreted with care.
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Project description:We studied trends in genetic patent applications in order to identify the trends in the commercialization of research findings in genetics. To define genetic patent applications, the European version (ECLA) of the International Patent Classification (IPC) codes was used. Genetic patent applications data from the PATSTAT database from 1990 until 2009 were analyzed for time trends and regional distribution. Overall, the number of patent applications has been growing. In 2009, 152?000 patent applications were submitted under the Patent Cooperation Treaty (PCT) and within the EP (European Patent) system of the European Patent Office (EPO). The number of genetic patent applications increased until a peak was reached in the year 2000, with >8000 applications, after which it declined by almost 50%. Continents show different patterns over time, with the global peak in 2000 mainly explained by the USA and Europe, while Asia shows a stable number of >1000 per year. Nine countries together account for 98.9% of the total number of genetic patent applications. In The Netherlands, 26.7% of the genetic patent applications originate from public research institutions. After the year 2000, the number of genetic patent applications dropped significantly. Academic leadership and policy as well as patent regulations seem to have an important role in the trend differences. The ongoing investment in genetic research in the past decade is not reflected by an increase of patent applications.
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Project description:Intellectual property is associated with the creative work needed to design clinical trials. Two approaches have developed to protect the intellectual property associated with multicentre trial protocols prior to site initiation. The 'open access' approach involves publishing the protocol, permitting easy access to the complete protocol. The main advantages of the open access approach are that the protocol is freely available to all stakeholders, permitting them to discuss the protocol widely with colleagues, assess the quality and rigour of the protocol, determine the feasibility of conducting the trial at their centre, and after trial completion, to evaluate the reported findings based on a full understanding of the protocol. The main potential disadvantage of this approach is the potential for plagiarism; however if that occurred, it should be easy to identify because of the open access to the original trial protocol, as well as ensure that appropriate sanctions are used to deal with plagiarism. The 'restricted access' approach involves the use of non-disclosure agreements, legal documents that must be signed between the trial lead centre and collaborative sites. Potential sites must guarantee they will not disclose any details of the study before they are permitted to access the protocol. The main advantages of the restricted access approach are for the lead institution and nominated principal investigator, who protect their intellectual property associated with the trial. The main disadvantages are that ownership of the protocol and intellectual property is assigned to the lead institution; defining who 'needs to know' about the study protocol is difficult; and the use of non-disclosure agreements involves review by lawyers and institutional representatives at each site before access is permitted to the protocol, significantly delaying study implementation and adding substantial indirect costs to research institutes. This extra step may discourage sites from joining a trial. It is possible that the restricted access approach may contribute to the failure of well-designed trials without any significant benefit in protecting intellectual property. Funding agencies should formalize rules around open versus restricted access to the study protocol just as they have around open access to results.
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Project description:BACKGROUND:Crowdsourcing contests (also called innovation challenges, innovation contests, and inducement prize contests) can be used to solicit multisectoral feedback on health programs and design public health campaigns. They consist of organizing a steering committee, soliciting contributions, engaging the community, judging contributions, recognizing a subset of contributors, and sharing with the community. OBJECTIVE:This scoping review describes crowdsourcing contests by stage, examines ethical problems at each stage, and proposes potential ways of mitigating risk. METHODS:Our analysis was anchored in the specific example of a crowdsourcing contest that our team organized to solicit videos promoting condom use in China. The purpose of this contest was to create compelling 1-min videos to promote condom use. We used a scoping review to examine the existing ethical literature on crowdsourcing to help identify and frame ethical concerns at each stage. RESULTS:Crowdsourcing has a group of individuals solve a problem and then share the solution with the public. Crowdsourcing contests provide an opportunity for community engagement at each stage: organizing, soliciting, promoting, judging, recognizing, and sharing. Crowdsourcing poses several ethical concerns: organizing-potential for excluding community voices; soliciting-potential for overly narrow participation; promoting-potential for divulging confidential information; judging-potential for biased evaluation; recognizing-potential for insufficient recognition of the finalist; and sharing-potential for the solution to not be implemented or widely disseminated. CONCLUSIONS:Crowdsourcing contests can be effective and engaging public health tools but also introduce potential ethical problems. We present methods for the responsible conduct of crowdsourcing contests.
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