Blockchain Papers

Peter Palumbo, Jordan Kruger, Christopher L. Robinson

No abstract is available for this record.

Rajendra Vasantrao Patil, Govind Mohanlal Poddar, Sangita Mahendra Rajput, Deepak Yashwantrao Bhadane · 6 authors

The pharmaceutical industry plays an important role in protecting community health by researching, developing and distributing drugs to prevent and cure illnesses. As an integral part of healthcare industry, it faces several challenges such as rising research and development costs, extended approval timelines, supply chain inefficiencies and low patient involvement. This paper examines role of decentralized autonomous organizations (DAOs) in addressing these challenges. It reviews DAO frameworks, decision-making models, reward mechanism, and roles of stakeholders using case studies such as VitaDAO and Molecule to explain their functioning and adoption of DAOs in pharmaceutical industry. DAOs offer a promising alternative to traditional hierarchical systems by promoting innovation and empowering stakeholders. To advance drug discovery and development, DAOs provide a shared platform for scientists, patients, funding agencies and regulatory authorities to work in a democratic and collaborative way to make decisions and manage operations in drug industry. Despite its several benefits, DAOs also face significant challenges, including regulatory uncertainty, data protection, and ensuring longterm sustainability. Future directions include integration of AI into pharmaceutical DAOs, privacy-enhanced DAOs, and cross-DAO cooperation to promote global collaboration across borders.

Hagar M. Mohamed, Mahmoud Khalifa, Amina Toumi, Muna Ali

Major engineering advances synthetic biology, precision genome editing, nanotechnology, advanced biomaterials, scalable manufacturing, and artificial intelligence are converging to enable therapeutic paradigms that could shift oncology from long-term disease control toward durable cures. Yet technical breakthroughs alone are insufficient. Realizing care-driven care at scale requires adaptive regulatory frameworks, outcome-linked financing models, federated data governance, manufacturing policy for decentralized production, and equity-centered implementation. This paper synthesizes the engineering frontier, maps translational bottlenecks, and proposes a practical policy-aware translational ecosystem the Cure-Driven Partnership Model (CDPM) to accelerate safe, ethical, and equitable deployment of curative cancer interventions. We conclude with prioritized research objectives, governance recommendations, and an implementation checklist for stakeholders.

Ollie Bell, Nabil Hadi, Daniel Strode

In this chapter the transformative power of blockchain technology is unpacked as the foundation for the decentralized internet. The chapter begins by tracing blockchain’s origins with Bitcoin, highlighting its revolutionary approach to solving the double-spending problem through a secure, immutable digital ledger. It explains the core principles of blockchain, including cryptographic hashing, public and private key mechanisms, and consensus protocols such as Proof of Work and Proof of Stake. The discussion extends to blockchain’s unique attributes – immutability, transparency, and decentralization – that enable trustless transactions and challenge traditional centralized systems. Real-world use cases are explored, showcasing blockchain’s impact across various sectors, from decentralized finance and digital identity to supply chain management and healthcare. Ultimately, the chapter provides actionable insights into how blockchain technology underpins Web3, setting the stage for a more secure and efficient digital ecosystem.

Akhil Sharma, Ashish Verma, Akanksha Sharma, Sunita Sunita · 6 authors

The non-fungible tokens (NFTs) mark an evolution in ownership of healthcare data. This chapter provides an overview of healthcare data ownership and its significance in the process of merging NFTs with the healthcare system. NFTs are digital assets built on top of a blockchain with a unique identification number and metadata that cannot be copied, making them arguably very well suited to revolutionising the generation, sharing, and control of healthcare data. The versatility of their application is highlighted by reviewing several patient records, medical images, and research data. The chapter further delves into contemporary issues regarding healthcare data ownership. NFTs can improve data provenance and security, introduce smart contracts allowing for controlled access, and enable health data to be monetised so that patients are active stakeholders in their healthcare journey. The chapter discussed the several advantages provided by NFTs and challenges such as the adoption of technical tools, legal and ethical issues, data security risks, and regulatory compliance, which must be overcome when using NFTs in healthcare. The chapter concluded with a focus on the future prospects of NFTs in healthcare to develop a system that maintains new ideas while protecting the patients.

Peggy Eastman

In response to growing threats on federal funding for the National Institutes of Health (NIH), Sen. Tammy Baldwin (D-WI) and Sen. Peter Welch (D-VT) held a Senate forum on Capitol Hill with speakers, including researchers and patients. The speakers included surgical oncologist Monica Bertagnolli, MD, former Director of the NIH, former Director of the National Cancer Institute (NCI), and a cancer survivor. She stressed the dire consequences of grant freezes, disruptions in funding, staffing cuts, administrative upheaval, confusion, and a chilling effect on young investigators just beginning their scientific careers. “We are here today to sound the alarm,” Baldwin said. “This isn't efficiency; this is cruelty.” She said that “cures for Alzheimer's disease and cancer are not waste, or fraud, or abuse,” and she noted that “biomedical research can't just be turned on and off on a whim. We have heard heartbreaking stories from patients in clinical trials.” Welch noted, “It's an upside-down set of priorities; the cruelty speaks for itself. It's a lack of confidence in our nation. This is an erosion of our spirit.” Senate Minority Leader Chuck Schumer (D-NY) called cuts for NIH research “just appalling. We are going to fight this tooth and nail. The public is on our side; we must win this fight. People's lives are at stake.” The American Association for Cancer Research (AACR), which worked with Senate organizers on the forum, has reported and is fighting the freezing of new NIH grants and blockages of already approved funding; proposed the capping of indirect costs at 15 percent; canceled NIH advisory council meetings, halting final approval of peer-reviewed grants; the ordering of massive layoffs and the imposition of a hiring freeze at the NIH; and continued termination of active NIH grants despite federal court orders. The AACR is urging Americans to contact their members of Congress and tell them to reject any funding cuts to the NIH and NCI, address the instability caused by recent administrative disruptions, and preserve the progress of scientific research by ensuring that early-career scientists have the stable funding necessary to drive the next wave of medical research breakthroughs. “This is a critical time for our nation...the confusion is rampant,” Bertagnolli said. As a cancer survivor, she noted that she would not be here today without the research funded by the NIH over the past 5 decades. She termed NIH research “a great investment for the American people.” She cited the harm caused by “more than 300 grants terminated and about $1.5 billion in funding delays and barriers that are preventing the NIH's role of ensuring that funding is delivered to outstanding researchers across the nation.” Bertagnolli mentioned the case of a young researcher who trained for 16 years and could not get a job because of hiring freezes. She said this is not an isolated story and the nation is being deprived of the promising work of young investigators. Bertagnolli added there was not a day she was at the NIH that people employed there did not ask how they could make sure they were doing the most cutting-edge research. She noted that NIH research funding is the foundation for the work on which most of the new drugs that reach clinical practice are based. Scientific researchers built bridges that have allowed patients to outpace cancer, including Larry Saltzman, MD, a survivor of chronic lymphocytic leukemia diagnosed in 2010, a retired physician, and former Executive Research Director at the Leukemia & Lymphoma Society. He has been on many clinical trials and received many treatments, including CAR T-cell therapy. “Time is everything,” he said. “I am living proof of what the NIH can do. We must speak up, stand up for science,” and protect the future of medical research. Whitney Wharton, PhD, Associate Professor at Emory University and an Alzheimer's disease researcher, noted she has had two NIH grants terminated recently. She said they have been “devastating” for her research team and the patients participating in clinical trials. Wharton stressed the importance of engendering trust in people who enroll in clinical trials and who willingly donate their time and—in many cases—samples from their bodies. “It takes a long time to become a scientist,” said Wharton, and the current concerns about the stability of a scientific career may cause some young scientists to leave research altogether. Sterling Johnson, PhD, Professor of Medicine and Associate Director of the Wisconsin Alzheimer's Disease Research Center at the University of Wisconsin-Madison, agreed. He noted that Alzheimer's disease appears years, if not decades, before the onset of symptoms, and medical research has led to the development of prescription drugs to slow the progression of the disease. He said that 6.9 million Americans have Alzheimer's disease, a number projected to double by 2050 without scientific research advances. Johnson said that, just at a time when young investigators are urgently needed, growing uncertainty is discouraging early-career scientists from entering the biomedical field. “That is stopping progress,” he said. Jessy Ybarra, a veteran living with amyotrophic lateral sclerosis (ALS) and a board member of the ALS Association, noted that veterans are twice as likely to develop ALS and research is urgently needed to make ALS “a livable disease” until a cure can be found. He played a recording from his 10-year-old son at the Senate forum in which the son pleaded for support for medical research, noting, “I am not ready to say goodbye to my best friend, my dad.” Sen. Elizabeth Warren (D-MA) stated that the NIH is the largest biomedical research institution in the world and investing in it pays off financially, as well as medically. “We cannot afford to lose a generation of scientific breakthroughs and a generation of research scientists,” she stressed. Sen. Edward Markey (D-MA) agreed. “The NIH is really the national institutes of hope,” he said. “I'm going to fight for all those young researchers.” Sen. Dick Durbin (D-IL), Democratic minority whip and longtime senator from Illinois, stressed the urgent need for a bipartisan effort to support medical research, noting that what is lacking now is “support from the other side of the aisle.” He said he remembers a time in the past when the NIH received a strong increase in congressional funding due to cooperative bipartisan support. Sen. Catherine Cortez Masto (D-NV) agreed with Durbin on the need for strong bipartisan support of NIH research. “This is about saving lives,” she said. “It is not a red state or blue state issue. It touches so many of us; that's what this is all about.” Sen. Angela Alsobrooks (D-MD) noted that the NIH is in her state's backyard and “an attack on the NIH is, in fact, an attack on the state of Maryland.” She noted she is a member of the “sandwich generation” who is raising a 19-year-old daughter and caring for a mother who has Alzheimer's disease. For women caregivers like her, she said that breakthroughs from medical research are becoming increasingly important. The AACR has vowed to continue the fight to preserve the NIH as the cornerstone of biomedical research. “The administration's ongoing disruptions of and restrictions on the NIH's ability to work in partnership with the broader scientific community are jeopardizing progress and delaying innovations and treatments that are pivotal to improving patient outcomes and saving lives,” the AACR stated. “The stakes could not be higher. The decisions made today will determine whether we accelerate the fight against cancer or allow critical momentum to be lost.” The AACR's work on the Senate forum is “part of our long-standing commitment to ensuring that policymakers understand what is at stake and that they hear directly from those on the front lines.” Peggy Eastman is a contributing writer.

Chigozie Athanasius Nnadiekwe, Ikechi Saviour Igboanusi, Odinachi Udemezuo Nwankwo, Dong-Seong Kim

Using blockchain technology to oversee clinical trials has the potential to drive innovation and significantly improve traditional data management practices. This paper proposes a blockchain-oriented approach to tackle the prevailing issues within clinical trial management frameworks and promote interoperability among clinical trial stakeholders. Our proposed blockchain system is designed to be patient-centric and cost-effective while enhancing data sharing and real-time collaboration in clinical trials. This model aims to address data security, trust, and traceability issues. The smart contract was developed using Remix IDE, we included in the smart contract a mechanism that monitors patient participation during the trial. This function will automatically restrict access to any patient that defaults to the blockchain network. The smart contract we designed registers all participants in clinical trials, including patients, with their consent forms and allows patients to report any adverse effects. All transactions within our smart contract are timestamped to ensure transaction Ordering and mitigate manipulation vulnerabilities. The contract is programmed to grant certain members special authority, as outlined in the system model section. Additionally, our model can be deployed on any Ethereum-based blockchain network, private or public.

Marielle S. Gross, Amelia Hood, William Lancelot Sanchez

Decentralized biobanking “de-bi” applies blockchain technology and web3 values to embed the procedural principles of transparency, accountability, and inclusion into the biomedical research ecosyst...

Ahmed Banafa

A consensus protocol may be defined as the mechanism through which a Blockchain network reaches consensus. Blockchains are built as distributed systems and, since they do not rely on a central authority, the distributed nodes need to agree on the validity of transactions. Proof of Authority is known to bear many similarities to Proof of Stake (PoS) and DPoS, where only a group of pre-selected authorities secure the Blockchain and are able to produce new blocks. New blocks on the Blockchain are created only when a supermajority is reached by the validators. The identities of all validators are public and verifiable by any third party, resulting in the validator’s public identity performing the role of proof of stake. Proof of importance is a consensus algorithm similar to PoS.

Neil Baum

I have tried to stay abreast and on the cutting edge of new technology, ideas, and investments. However, NFTs—or non-fungible tokens—have so far eluded me. I have asked my children and their contemporaries, and no one has been able to explain it to me. When it comes to NFTs, or the emerging form of digital certificate that certifies an asset as one-of-a-kind, the medical community seems to be divided between pro- and anti-NFT camps. Those belonging to the former camp tout it as a novel approach to finance and ownership of digital data. Those against NFTs point to—among many other things—their devastating impact on global climate or their use of tremendous amounts of energy to compute the blockchain transfers of billions of dollars that take place regularly in the metaverse. On the other hand, NFTs represent a unique potential in the digital health age: that of patients, rather than companies, owning their digital healthcare data. With such a level of ownership, physicians and patients could leverage its advantage to monetize their data rather than have companies profit off them, as traditionally has been the case. This article walks you through the basics of NFTs, explains how they can further empower patients in the digital health age, and raises concerns pertinent to the technology.

Zahr Said

In this chapter, I use methods drawn from literary analysis to bear on artificial scarcity and explore how literary and legal storytelling engages in scarcity mongering. I find three particular narrative strategies calculated to compel a conclusion in favor of propertization: the spectacle of need, the diversionary tactic, and the rallying cry. First, I unpack the spectacle of need and its diversionary aspects through several literary accounts of scarcity and starvation. I juxtapose Franz Kafka's "A Hunger Artist," a story explicitly centered on a wasting body, with J.M. Coetzee's The Life and Times of Michael K. Second, to explore how scarcity fables offer diversionary tactics that redirect attention away from actual scarcity, I consider NFTs, or non-fungible tokens. NFTs reflect the arbitrary value scarcity can produce, especially when artificially generated. Yet NFTs offer a spectacle of need that distracts from actual scarcity, riding a wave of expansionist property logic that suggests that more ownership is the answer. Third, to consider the scarcity fable's propertarian rallying cry, I offer an extended close reading of a copyright dispute, Leonard v. Stemtech, involving a pair of microscopic stem cell photographs deemed so scarce they were valued at 100 times their past licensing history. Leonard illustrates how a scarcity fable may look in the context of intellectual property ("IP"). The nature of this chapter is necessarily conceptual and speculative, designed to raise questions rather than attempting conclusively to answer them. Through juxtaposition of literary accounts and one legal case study, fables of scarcity emerge as a genre whose very appearance in certain contexts ought to give scholars and policymakers pause. In copyright litigation, in which expansionist property narratives may be especially harmful to the public domain and subsequent creators, scarcity fables may be made to provide apparent support for potentially dangerous changes. Identifying scarcity fables as such when they appear in copyright cases could trigger review of the asserted scarcity and a more searching inquiry into whether the proposed solution could worsen actual scarcity.

Matthew L. Duenes, Djani Robertson, Jordan Lebovic, Carter J. Boyd · 5 authors

Orthopedic surgery has always been at the leading edge of innovation in medicine, from clinical applications to business practices. Cryptocurrencies have emerged as an exciting new technology where transactions and verification are secured by cryptography rather than a centralized authority, thus creating transparency, security, and immutability to payments. Large industries, including healthcare, have started accepting cryptocurrencies as alternative forms of payment. Insurance companies and private practices in specialties such as plastic surgery and dermatology already accept cryptocurrencies in exchange for services. As such, providers in orthopedic surgery should prepare themselves for inquiries from patients regarding cryptocurrencies. This paper introduces the topic and potential benefits to future orthopedic practices.

Md Al Amin, Amani Altarawneh, Indrajit Ray

No abstract is available for this record.

Marcelo Corrales Compagnucci, Niclas Nilsson, Paul Stankovski, Christoffer Olsson · 7 authors

Research and Development (R&D) in the pharmaceutical sector traditionally occurred in closed, siloed institutional settings. This approach was a function of a rights-oriented intellectual property model which framed access and reuse of data (data sharing) as a threat to rightsholders. However, a closed model of explorative collaboration is less suited to today’s more complex scientific ecosystem, where external engagement and dynamic partnering with multiple actors and diverse information sources has become essential. As such, devising alternative approaches is vital in ensuring that opportunities for scientific advances are not lost or innovation stifled. This article introduces a hybrid contractual framework that combines the benefits of the automated functionality of smart contracts and non-fungible tokens (NFTs) embedded in a blockchain with more traditional rights-based licensing schemes. The presented framework is based on the outcome of an experimental pilot platform that enabled participants to store, find and reuse data following FAIR data principles. The platform documents real-world physical assets in the drug discovery of chemical molecules in an immutable digital ledger. More generally, smart contracts and NFTs point us towards an open and global collaborative platform for exploiting and advancing drug research assets. The resulting platform creates mechanisms for resolving issues regarding standardization, interoperability, and disclosure. As such, it overcomes many of the practical hurdles currently obstructing collaboration in pharmaceutical R&D, as well as providing a framework to address the central conflict in drug discovery, namely the demand for greater data sharing and the protection of rightsholder interests.

Marielle S. Gross, Amelia Hood, Robert C Miller Jr

Henrietta Lacks' deidentified tissue became HeLa cells (the paradigmatic learning health platform). In this article, we discuss separating research on Ms Lacks' tissue from obligations to promote respect, beneficence, and justice for her as a patient. This case illuminates ethical challenges for the secondary use of biospecimens, which persist in contemporary learning health systems. Deidentification and broad consent seek to maximize the benefits of learning from care by minimizing burdens on patients, but these strategies are insufficient for privacy, transparency, and engagement. The resulting supply chain for human cellular and tissue-based products may therefore recapitulate the harms experienced by the Lacks family. We introduce the potential for blockchain technology to build unprecedented transparency, engagement, and accountability into learning health system architecture without requiring deidentification. The ability of nonfungible tokens to maintain the provenance of inherently unique digital assets may optimize utility, value, and respect for patients who contribute tissue and other clinical data for research. We consider the potential benefits and survey major technical, ethical, socioeconomic, and legal challenges for the successful implementation of the proposed solutions. The potential for nonfungible tokens to promote efficiency, effectiveness, and justice in learning health systems demands further exploration.

Garrett S. Booth, Eric A. Gehrie

No abstract is available for this record.

Valérie Racine

No abstract is available for this record.

Rohin Bhatt, Vishnu Subrahmanyam

Photo by Mufid Majnun on Unsplash INTRODUCTION In 2007, the Nuffield Council of Bioethics introduced the “Intervention ladder” as a guiding framework[1] to evaluate the impact on individual liberty of various public health measures. One criticism of the ladder is that it reflects a narrow view of liberty, yet other researchers adapted the intervention ladder to incorporate a more autonomy-based view. Recently, academics and public health officials have used intervention ladders as guides in framing policies, particularly COVID-19 pandemic policies.[2] Analyzing the Indian COVID-19 vaccination drive under these two ladders can illuminate the concepts of liberty underlying those ladders and help determine the best framework on a philosophical basis. ANALYSIS l. Case Study: The Indian COVID-19 Vaccination Drive On January 16, 2021, India attempted a public vaccination drive.[3] The drug regulatory body Central Drugs Standards Control Organization (CDSCO) approved two vaccines, Covishield and Covaxin, for emergency use.[4] The approval was granted despite a clear lack of phase 3 clinical trial data for both of these vaccines.[5] Covishield, produced by the Serum Institute of India, is the Indian variant of the Astra-Zeneca vaccine that has shown an average efficiency of 70.4 percent after trials in the UK.[6] Covaxin, manufactured by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) National Institute of Virology, was developed and manufactured in India. [7] Covishield relied on the safety and efficacy data from large trials conducted in Brazil, South Africa, and the UK with 24,000 participants and a small cohort for the Indian study. Covaxin was given approval based only on phase-1 trial data. [8] An article published in The Lancet called for further efficacy data from the Covaxin study.[9] The officials associated with Bharat Biotech, as well as the Indian Council of Medical Research, maintained that fast production of the vaccine does not indicate a compromise in safety, even though they had little data to produce.[10] However, transparency is key to vaccination policy, which requires public participation. The media reported that the Covaxin clinical trials compromised research integrity by providing a monetary incentive of around 7 euros, to research subjects. People’s University, a private medical college, and hospital, recruited survivors of the Bhopal Gas tragedy for the Covaxin study. The participants were told that they were being provided a vaccine against COVID-19 without clarifying that data was being collected for their clinical study. There was no record of informed consent from these participants for the Covaxin study.[11] The media reported the death of a 42-year-old individual who received his first dose on December 23, 2020. [12] Although it was reported that the cause of death was not linked to the vaccine, the death added to vaccine hesitancy. The vaccines were provided for free to the frontline healthcare workers with no choice on which vaccine the recipients would receive.[13] Similarly, in the US, some people do not have a choice between Pfizer or Moderna. In the UK and the US, data from phase 3 trials are known with a periodic follow-up after the administration of the second dose.[14] The WHO developed a tracking system for COVID-19 vaccine recipients which was updated on March 19, 2021, to reflect the results of Covaxin phase 3 trials.[15] India eliminated choice although the two vaccines approved for emergency use did not have the depth of research that those used elsewhere had. The intervention ladder, discussed below, which uses proportionality and the harm principle to justify the lack of choice between the vaccines in the UK and the US, should not be applied to India’s vaccination policy. ll. The Nuffield Intervention Ladder The foundational principle underlying the Nuffield Intervention Ladder is Mill’s conception of individual liberty from the prominent work, On Liberty.[16] However, the Council recognizes that the intervention ladder is conceived on a broader interpretation of Mill’s liberty, using the principle of proportionality as a tool for justification i.e., the desired effect from the intervention is proportional to the loss incurred in liberty.[17] As shown in Table 1, an ideal intervention that is least infringing would then be no intervention at all. An intervention that would be more difficult to justify would be one that significantly restricts individual liberty. Intuitively, eliminating occupies the topmost rung on the ladder. The metaphor of the ladder suggests that as one climbs up the rungs of the ladder, stronger justifications would be required. Table 1: Examples of interventions at each level of the intervention ladder adapted and improvised from the Nuffield Council of Bioethics Report, 2007. A voluntary vaccination policy is one public health intervention that is acceptable and justifiable in terms of the principle of proportionality as well as Mill’s Harm Principle, with emphasis on diminishing individual liberties when actions might result in harm to others.[18] Although a vaccination policy in the context of a global pandemic seems justifiable through the lens of the intervention ladder, the Indian modus operandi is unique because of inherent problems with the original conception of the intervention ladder. By pausing to elaborate and reflect on the Indian context as a case study, we can demonstrate that individual liberty should not be the sole variable in framing justifiability. lll. Critiquing the Nuffield Intervention Ladder & Adding a Precautionary Approach In his paper, ‘Snakes and Ladders: State Interventions and the Place of Liberty in Public Health Policy’, Angus Dawson criticizes the intervention ladder’s focus on individual liberty,.[19] and its inability to account for the different treatment of incentives and disincentives and the role of information. Public health institutions require public participation to restrict the infectious spread of COVID-19. The lack of transparency and minimal information surrounding the vaccines have been a major hurdle in increasing public participation. It is contradictory to think that the public does not require information about interventions and have the ability of self-determination to guide them, when in fact self-determination presupposes possession of relevant information. A voluntary vaccination policy can be seen as sitting on either the lowest rung (providing information) or the rung of enabling choice, as a vaccination campaign does both. However, in India, the precautionary principle should also be applied as providing the choice should not permit ‘harm’. The precautionary principle holds that anything that poses a risk to human health or the environment should be avoided or accompanied by precautionary measures. In India, because the clinical trials were smaller and there is less proof of safety and efficacy, a vaccination requirement, or a public health campaign to encourage vaccination violates the principle. The proportionality principle governing the intervention ladder only requires that the benefits of the intervention justify the restrictions on liberty. The intervention ladder should prevent requiring healthcare worker vaccination without a choice of vaccine because a free choice requires transparency and more information than is available from the small early-stage clinical trials. Actions surrounding the vaccines in India do not reflect proper precaution or a proportionate and thus acceptable restriction on liberty. If there is no ability to choose between the two possible vaccines, then they should not be mandatory for healthcare workers. The Indian government and its officials have urged healthcare worker compliance by invoking the seriousness of the pandemic and the alarming rates of mortality rather than providing transparent data pursuant to the regulatory mechanisms of the vaccine clinical trial. For a healthcare worker, the duty to provide service and a stronger obligation to do so in the time of a pandemic already imposes certain restrictions on their liberty. The lack of choice in opting for a preferred vaccine puts it on a higher rung on the intervention ladder and thus requires stronger justifications. This case study reveals how the same public health intervention falls on different rungs of the intervention ladder depending on the target group in consideration. Or to put this simply, choice is contextual. Table 2: The ethical values at stake when it comes to “choice” lV. An Autonomy-Based Intervention Ladder Liberty and autonomy differ slightly: liberty revolves around the constraints on the ability to act, whereas autonomy stresses on the independence and the authenticity of the willingness to act.[20] It is thus possible for an individual to be autonomous but unfree, as can be seen from the inability to opt for a preferred vaccine.[21] Figure 1 shows an adapted schematic of an autonomy-based intervention ladder as proposed by Griffiths et al. Figure 1: An adapted schematic of the autonomy-based intervention ladder proposed by Griffiths, P.E and West, C. In comparing the original intervention ladder with their proposal, we see that the autonomy-based model allows for a negative scale in terms of its effects on autonomy. Thus, on this ladder, actions can be autonomy-enhancing or autonomy-diminishing. Such a model challenges the one-directional view of the ladder and rearranges interventions on a scale that ranges from negative to positive. A few interventions that were shown to have restrictive effects on liberty now have reinforcing effects when viewed through the lens of autonomy. Thus, providing information and educating can be seen as positive reinforcements for autonomous choice rather than infringing on individual liberty. The autonomy-based intervention ladder requires the State to implement inte

Niraj Vyas

<p class="abstract">Drug development is a complex and resource intensive endeavor. The average cost of developing a new drug, has been estimated to be $2 to $3 billion. However, the success rate of clinical trials is very low around and is estimated to be between 3-5%. The common reasons for failure of clinical trials include failure to demonstrate efficacy or safety, budgeting and financing, failure of subjects meeting protocol eligibility criteria, poor investigator site selection, patient withdrawals and dropouts. Considering the growing demands to get better and affordable treatment options, there needs to be fundamental shift required in drug development and specifically the clinical trials oversight processes to mitigate risks and reduce failures. The International Council for Harmonisation in the E6 R2 addendumhas now provided guidelines for adaptation of risk based approach to trial conduct and monitoring to implement mitigation strategies for potential risks which might derail the conduct of the trail. The industry is steadily gearing up to put together the required processes, systems and teams to align to the new ways of working. However with the changing landscape of drug development which includes novel therapies like gene therapy, remote/decentralized trials, growing use of wearable technologies, esource, electronic health record/electronic medical records interoperability, implementation of artificial intelligence and machine learning algorithms, the future of risk based approach towards managing clinical trials is going to be very different from what we see now. This paper explores the impact of these new developments on the future of risk based monitoring in clinical trials.</p>

Mahelia Bissassar

Transnational medical tourism is a growing sector of modern global health care, facilitated by globalism and connecting platforms like the Internet, which provides opportunities for health care to those who can afford it. Patients who can afford the steep price (and, very often, those who can't) partake in organ tourism as alternative means of seeking a needed organ, reproductive tourism as a method to treat infertility, in the form of egg donation and surrogacy, as well as stem cell tourism. During the past decade, stem cell research has skyrocketed spurring increased scientific excitement about what the future of stem cell research could hold for regenerative medicine and treatment of untreatable diseases. However, a developing market commercializing in an international setting without regulation and restriction has led to expensive pseudo medical treatments, for which there is no scientific rationale or evidence of efficacy or safety, that threaten the health of patients. Several highly publicized cases including the death of a child in the German1 stem-cell clinic XCell Center, as well as the highly publicized paralysis and cancer-like growth of American patient Jim Gass in stem-cell clinics in Mexico, China, and Argentina have prompted global outcry and a call for increased regulation and implantation of safety standards.[2,3] The prevalence of stem-cell clinics that provide untested and potentially lethal medical interventions threatens the global health and financial security of patients. Stem cell tourism, a growing industry largely advertised online, involves privately owned stem cell clinics, often managed by physicians, fraudulently advertising pseudoscientific stem-cell cures for a variety of untreatable conditions directly to health consumers. Patients looking for stem-cell treatments travel from a diverse range of locations in North America, Europe, the Middle East and Asia.[8] The clinics they travel to are located around the world, the most popular ones in countries at the forefront of medical stem-cell innovation and in nations with lax stem-cell clinic laws. Companies are located in United States, Mexico, Russia, Germany, India, and China, among several other countries.[9] They all rely on weak and subjective claims of improvement, selective anecdotes and testimonials, favorable media reports, untested scientific jargon, and links to unrelated studies to appeal to health consumers.[6] A further study on the data collected from clinics illustrates a therapeutic effect likely due only to a placebo effect.[10] No clinical data or procedures have been released from these clinics, having the most dangerous implications. No data or procedures released means that efficacy cannot be measured, so hurtful experiences are not counted and actual therapeutically valuable data cannot be used or tested for efficacy against other studies of accepted treatment.[6,11] These clinics cannot be held to clinical standards of safety or effectiveness and are not held responsible for futile treatment. This shoddy science threatens the future beneficiaries of such innovative clinical science and weakens proof that stem-cell clinics are anything but a farce. These clinics prey on the hopes and fears of their clients by appealing to a broad array of degenerative, chronic, and fatal diseases.[5,6,7] Unknown risks were withheld from patients, threatening not just their autonomy to make an informed decision about their own health but also violates the primary principle of medicine: to do no harm. Embryonic and other stem cells have tumorigenic potential and have been proposed as a source of common origin for cancer.[2] These clinics exist as an alternative to patients not eligible for clinical trials or otherwise averse to such trials in the US.[16] Patients go abroad in search of treatments unavailable at home, searching for a source of hope. Patients suffering from serious or debilitating conditions, like Alzheimer’s and multiple sclerosis, can’t be cured with modern medical treatments. Their only treatment options include palliative care, symptom management or drugs that temporarily slow the progress of the disease.[6] These situations create similar circumstances of rashness that drive organ tourism and foment human rights violations.[4] Stem-cell companies provided misleading medical information to their consumers, projecting medical authority and expertise in order to frame their stem-cell therapies as new and innovative rather than unproven.[6,13] Doing so is intentionally maleficent and puts patients in harm’s way. Stem cell tourism brings unique intricate ethical concerns where generalized medical knowledge is at odds with patients’ immediate desire to survive, pushing patients to risky treatment many would not consider. This is not simply another case of buyer beware. The potential for serious harm to vulnerable patients is at stake.[17] The stem cell tourism industry is a complex, extensive industry with multiple interlaced causes and contributions. One pronounced contributor is the patient frustration with the lack of treatment in their native country and their immediate healthcare needs. The overselling of stem cell treatments before they have been sufficiently validated and tested for safety has been attributed to the sensationalized attention given to stem cell research in popular media. Stem cell research is portrayed as the next new big thing in medicine, in which the promising research potential is seen as rapidly translatable to cures. With some theatricals, stem cell clinics can extend the applicability of accepted clinical treatments to swindle customers.[13] The perpetrators of the crime are the medical entrepreneurs and brokers who advertise and provide the treatments,[4] but emphasis on communicating openly with patients to understand why patients go abroad for treatment rather than on persecuting brokers and dishonest clinicians carrying out procedures, may be a more effective way of battling unsafe stem cell tourism from the root. Some researchers contribute the growth of stem cell tourism to American scientists and clinicians.[12] They argue that scientists and clinicians underestimate the relevance of hope to patients making the decisions to travel abroad for dubious treatment, proposing that, even unfounded hope is better than no hope at all in the patient’s mind.[12,18] It is imperative for discussion to reflect on why so little hope is found at home rather than just importance of allowing hope to flourish offshore.[12] The paternalistic dismissive attitude of American physicians in the face of patients considering dangerous or futile stem-cell treatment in the hope of some improvement has been argued to push patients away from established medical professionals to dubious stem-cell clinics.18 The lack of health care at home has also been identified as a contributing factor. Salter and colleagues insist that the matter at hand isn’t toning down the hype but rather domestically available health care supply.16 Patients in need don’t care about expanding medical knowledge or the benefit of future suffering patients, they care about is getting better and surviving. Demonizing stem cell tourism will never squelch this vital instinct.[20] Acceptable channels must be made available to seriously ill patients. Constraints such as the proximity of death as well as the specific burdens of a particular disease condition contribute to the stress of the limits of local treatment to impress an immediacy pointing to external care.[16,19] Recognizing the role of health consumer choices in this emerging global market will be essential to discouraging risky and exploitative healthcare decisions. Works Cited 1. Mendick, R. and Hall, A. (2011) Europe’s largest stem cell clinic shut down after death of baby, The Telegraph, 8 May. Available at www. telegraph.co.uk/news/worldnews/europe/germany/8500233/Europes-largest-stem-cell-clinic-shut-down-after-death-of-baby.html (accessed 1 May 2017) 2. Berkowitz ,Aaron L., Miller, Micheal B., Mir Saad A., Daniel Cagney Daniel, Chavakula Vamsidhar, Guleria Indira, Aizer Ayal, Ligon Keith L., Chi John H., N Engl J Med 2016; 375:196-198 3. Kolata Gina, (2016) A Cautionary Tale of ‘Stem Cell Tourism’. The New York Times, 22 June (Accessed May 1, 2017) 4. Shalev, Carmel (2010) Stem Cell Tourism—A Challenge for Trans-National Governance, The American Journal of Bioethics, 10:5, 40-42, 5. Alan Petersen, Kate Seear and Megan Munsie Sociology of Health & Illness Vol. 36 No. 5 2013 ISSN 0141-9889, pp. 670–685 6. Sipp, Douglas. The unregulated commercialization of stem cell treatments: a global perspective. Front. Med. 2011, 5(4): 348–355 7. Lau D, Ogbogu U, Taylor B, Stafinski T, Menon D, Caulfield T. Stem cell clinics online: the direct-to-consumer portrayal of stem cell medicine. Cell Stem Cell 2008; 3(6): 591–594. China Stem Cell News. http://www.stemcellschina.com 8. Ibid 9. ALSUntangled Group. ALSUntangled update 4: investigating the XCell-Center. Amyotroph Lateral Scler 2010; 11(3): 337–338 10. D. Lau et al., Cell Stem Cell 3, 591 (2008). 11. Devereaux, Mary and Loring, Jeanne F. (2010) Growth of an Industry: How U.S. Scientists and Clinicians Have Enabled Stem Cell Tourism, The American Journal of Bioethics, 10:5, 45-46, 12. Patra PK, Sleeboom-Faulkner M. Bionetworking: Between Guidelines and Practice in Stem Cell Therapy Enterprise in India. (2010) 7:2 SCRIPTed 295, http://www.law.ed.ac.uk/ahrc/script-ed/vol7-2/patra.asp 13. R. Alta Charo, Alta R. On the Road (to a Cure?) — Stem-Cell Tourism and Lessons for Gene Editing, N Engl J Med 2016; 374:901-903 14. Clinicaltrials.gov 15. Salter, Brian, Zhou, Yinhua ,Datta, Saheli. Making Choices: Health Consumers, Regulation and the Global Stem Cell Therapy Market. BioDrugs (2014) 28:461–464 16. Hyun, Insoo (2013) Bioethics and the Future of Stem Cell Research, Print Cambridge University Press, pg.186-204 17. Murdoch, C.E. and Scott,

Sebastian Porsdam Mann, Julian Savulescu, Philippe Ravaud, Mehdi Benchoufi

Recent advances in medical and information technologies, the availability of new types of medical data, the requirement of increasing numbers of study participants, as well as difficulties in recruitment and retention, all present serious problems for traditional models of specific and informed consent to medical research. However, these advances also enable novel ways to securely share and analyse data. This paper introduces one of these advances-blockchain technologies-and argues that they can be used to share medical data in a secure and auditable fashion. In addition, some aspects of consent and data collection, as well as data access management and analysis, can be automated using blockchain-based smart contracts. This paper demonstrates how blockchain technologies can be used to further all three of the bioethical principles underlying consent requirements: the autonomy of patients, by giving them much greater control over their data; beneficence, by greatly facilitating medical research efficiency and by reducing biases and opportunities for errors; and justice, by enabling patients with rare or under-researched conditions to pseudonymously aggregate their data for analysis. Finally, we coin and describe the novel concept of prosent, by which we mean the blockchain-enabled ability of all stakeholders in the research process to pseudonymously and proactively consent to data release or exchange under specific conditions, such as trial completion.

Hans H. Jung, Franz Pfister

1. Introduction to Subject: Participation in Research Trial1.1 Relevance of the Subject Conducting clinical studies includes an obligation to publish results to participants, sponsors, colleagues, and the public (Antes, 2009). ClinicalTrials.gov lists over 304,000 studies with locations in 208 countries (ClinicalTrials, 2019). The German Register of Clinical Trials (Deutsches

Onat Kibaroğlu

As a technology that can be traced back to the late 1990s in its structural fundamentals, ‘blockchain’ came into mainstream public discourse as of 2017. Previously discussed in the fringes of the technology-savvy circles, blockchain has now become a global phenomenon and indeed an industry that is rapidly growing and capturing a notable share of the public imagination along with academic discourse. Blockchain’s emergence in the realm of technology is essentially thanks to the invention of bitcoin as both a speculative asset and as a digital store of value. Many governments around the world have made public claims regarding their enthusiasm for adopting ‘blockchain’ in various ways; varying from Russia, Estonia, and Ukraine in Europe all the way to Venezuela in Latin America and even the Marshall Islands in the Pacific Ocean. This paper puts out the objective of achieving self-sovereign identities on the blockchain is a promise that has not yet manifested on the ground, albeit it disproportionately captures a significant share of the contemporary discourse on the three larger concepts of self-sovereignty, digital identity, and the blockchain. A key reason for the lack of manifestation of this promise is that there is little agreement as to what is actually meant by ‘self-sovereign identities’ —in stark comparison to the major consensus over the concepts of ‘blockchain’ or ‘cryptocurrencies’. In order to explore the genealogy of the core concept of ‘identity’, the theoretical genesis of ‘biopolitics’ is consulted, demonstrating that our contemporary technological epoch is best defined as an era of the emergence of ‘bio digital’ power. The paper ultimately argues that the reason for this disproportional share of discourse is created by certain actors to utilize the growing rhetoric on ‘blockchain’ and the libertarian notion of ‘self-sovereignty’ as façades to potentially pursue capitalist objectives. Keywords: blockchain, self-sovereignty, bitcoin, capitalism, digital identity, privacy, data, cryptocurrencies.

Nicholas Mamo, Gillian M. Martin, Maria Desira, Bridget Ellul · 5 authors

Dynamic consent aims to empower research partners and facilitate active participation in the research process. Used within the context of biobanking, it gives individuals access to information and control to determine how and where their biospecimens and data should be used. We present Dwarna-a web portal for 'dynamic consent' that acts as a hub connecting the different stakeholders of the Malta Biobank: biobank managers, researchers, research partners, and the general public. The portal stores research partners' consent in a blockchain to create an immutable audit trail of research partners' consent changes. Dwarna's structure also presents a solution to the European Union's General Data Protection Regulation's right to erasure-a right that is seemingly incompatible with the blockchain model. Dwarna's transparent structure increases trustworthiness in the biobanking process by giving research partners more control over which research studies they participate in, by facilitating the withdrawal of consent and by making it possible to request that the biospecimen and associated data are destroyed.