Michael J. Madison

Creativity and Craft

I revisit the distinction between intangible works of authorship and tangible objects, which is a fundamental proposition of modern copyright law. I suggest that reconsidering that distinction, at least in part, may expand the range of possibilities for aligning modern copyright as an economic construct with the historical roots of copyright and with ethical claims about authorial expression. Revisiting that distinction also may provide contemporary lawyers and policymakers with a much-needed tool for managing challenges posed by digital technology.

The Application of User Innovation and Knowledge Commons Governance to Mental Health Intervention

User innovation has been applied in many fields (von Hippel 2005), including those related to health care. This chapter describes what is, to our knowledge, the first application of user innovation to the mental health field. We apply user innovation and knowledge commons governance to a mental health problem of considerable importance: child traumatic stress. As we detail, user innovation provides a unique opportunity to develop and adapt interventions that meet the needs of children with traumatic stress and their families. Knowledge commons governance provides a way to share, vet, and improve these user innovations. This approach provides a solution to a critical problem related to the delivery of effective interventions in the mental health field, where the development of effective treatments often is impeded by the inflexibility of evidence-based treatments (Saxe and Acri 2016). First, we describe the problem of child traumatic stress and the imperative to provide effective treatments for children who suffer from it. Second, we detail the problem within the mental health field about adapting interventions so that they meet the needs of individuals with mental health problems and can be delivered in a variety of typical care settings. Third, we describe how we encourage user innovation and harness it in a knowledge commons by creating an intervention model for traumatized children that is flexible enough to address their needs in a variety of typical care settings and by providing infrastructure for sharing and vetting the innovations made by users in adapting the model to their particular circumstances. This intervention model is called Trauma Systems Therapy. It is currently disseminated in 14 states and has been adapted to work in a wide variety of service settings via the process of user

Knowledge Commons and the Road to Medical Commons

This book picks up where Governing Knowledge Commons, our 2014 collection of perspectives and case studies of knowledge commons governance, left off. Governing Knowledge Commons (GKC) laid down a research program that contributes to evidence-based policymaking about innovation and creative knowledge production, as well as the creation, preservation, and uses of existing and new knowledge. The cases presented in GKC are, in a word, diverse. They range from arts to sciences, from the professions to popular culture, from historical to contemporary. Governing Medical Knowledge Commons sustains that research program but with a specific, thematic focus. This book collects and presents a series of case studies of knowledge commons centered on recent and emerging experience in the life sciences, medical research, and medical practice.

Governance of Biomedical Research Commons to Advance Clinical Translation: Lessons from the Mouse Model Community

The translation of laboratory and clinical research into interventions that improve individual and population health is an iterative process with systemic directionality from basic research through preclinical research, clinical research, clinical implementation, and population health outcomes research (National Center for Advancing Translational Sciences 2015). Engaged in translation are patients and patient advocacy organizations, researchers from public and private sectors and from multiple disciplinary backgrounds, clinical practitioners, as well as a myriad of ancillary support professionals, from business executives, accountants, and marketing/sales staff to venture capitalists and public and philanthropic fund administrators to health and safety regulators. New models of collaboration within this complex ecosystem are required to overcome waste and inefficiencies in current research and development (R&D)

Population Biobanks’ Governance: A Case Study of Knowledge Commons

The term “biobank” refers to a variety of research infrastructures that involve the collection, storage, and analysis of genetics samples that are linked to data regarding the health and lifestyle of the sample sources. Population biobanks are a particular type of biobank as they focus primarily on a population or a large subset of a population and permit research to explore the relationship between genes, environment, and lifestyle on large cohorts. Population biobanks are also an emerging knowledge commons: they are infrastructures made of pooled resources that researchers from all over the world can access for uses that are not predetermined by the biobank managers. In this chapter, I discuss how population biobanks are increasingly managed as commons, what role biobank governance experts have played in overcoming regulatory obstacles and in managing negative externalities, and areas of governance that need further refinement for population biobanks to be fully managed as commons. The case study traces the history of biobanking governance and discusses the process that has led to a convergence toward a commons approach. My analysis draws from the literature on biobank governance and on knowledge commons theory as well as my experience as a scholar who participated in the governance shift toward a commons approach to biobank governance. This case study provides important lessons to scholars of knowledge commons as it shows the importance of expertise in managing pooled resources as commons.

Challenges and Opportunities in Developing and Sharing Solutions by Patients and Caregivers: The Story of a Knowledge Commons for the Patient Innovation Project

The Patient Innovation project is an initiative that aims to create a knowledge commons for patients and nonprofessional caregivers to share and further develop their innovative solutions to medical care–related problems through an online platform, https://patient-innovation.com. Patients and nonprofessional caregivers are the largest, and most important, group of stakeholders in the health care value chain. After all, the system exists for their benefit. Traditionally, however, they have been perceived as passive recipients of medical care, merely buying and consuming the solutions and products that “medical producers” create and provide. This perspective has influenced the development of an entire health care ecosystem that reinforces the passive position of patients and caregivers. The assumption of passivity is highly flawed, as demonstrated by research aimed at studying innovation activity by “users” in health care and understanding the role of patients of chronic diseases (or their nonprofessional caregivers) in developing innovative solutions to help them cope with their health conditions (e.g., Oliveira et al. 2015; Oliveira and Canhão 2016). That collaborative and interdisciplinary research effort demonstrated that patients and their nonprofessional caregivers are major sources of health care product and service “user innovations” (e.g., Oliveira and von Hippel 2011; Oliveira et al. 2015; von Hippel 1988, 2005). Most of the studies of innovation activity by patients build on several decades of “user innovation” research. This research demonstrated that ordinary users, not only commercial entities and research laboratories, are an important source of innovation. In his seminal work in this area, Eric von Hippel, defined user innovators as firms and

Governing Knowledge Commons: An Appraisal

How, where, and why do innovation and creativity occur? What influences the design and development of productive and sustainable knowledge production and preservation institutions? And what lessons, if any, should public policy and law derive from answers to these questions? These are the macro questions that inform empirical research on knowledge commons, including the 15 case studies gathered inGoverningMedical Knowledge Commons and the 11 case studies published in 2014 in Governing Knowledge Commons (GKC). Knowledge commons governance is one strategy for overcoming social dilemmas regarding the production, stewardship, preservation, distribution of, access to, and consumption and other use and re-use of knowledge and information resources. That strategy may often be as important and powerful as strategies grounded in law and related public policy, including intellectual property law, competition law, communications law, and security and privacy law. For its potential to be realized, “knowledge commons” should be more than a rallying cry for the public domain or a piece of rhetoric deployed in political battles about access to knowledge and information. Empirical investigation, of the sort reported in this book, is a critical prerequisite for sound knowledge commons policy. The social dilemmas encountered in deploying knowledge commons governance are extremely diverse. Moreover, knowledge commons governance is intertwined, in varied and context-specific ways, with publicly enacted law and other government initiatives. As a result, empirical research must be modest. The world of knowledge commons governance is too diverse, both today and in historical context, to permit

The North American Mitochondrial Disease Consortium: A Developing Knowledge Commons

Because the number of people affected with any particular rare disease is relatively small and the number of rare diseases is so large, a host of challenges complicates the development of safe and effective drugs, biologics, and medical devices to prevent, diagnose, treat, or cure these conditions. These challenges include difficulties in attracting public and private funding for research and development, recruiting sufficient numbers of research participants for clinical studies, appropriately using clinical research designs for small populations, and securing adequate expertise at the government agencies that review rare diseases research applications or authorize the marketing of products for rare conditions.

Understanding Access to Things: A Knowledge Commons Perspective

This chapter explores the related ideas of access to knowledge resources and shared governance of those resources, often known as commons. Knowledge resources consist of many types and forms. Some are tangible, and some are intangible. Some are singular; some are reproduced in copies. Some are singular or unique; some are collected or pooled. Some are viewed, used, or consumed only by a single person; for some resources, collective or social consumption is the norm. Any given resource often has multiple attributes along these dimensions, depending on whether one examines the resource’s physical properties, its creative or inventive properties, or its natural, factual, or ideational properties. Access questions are, accordingly, diverse. That diversity is compounded by the proposition that access is itself a property of a resource, in the sense that resource characteristics are, to a substantial extent, socially and culturally constructed. Social construction means not only that boundaries among properties of a resource may be blurred but also that those properties and boundaries may change over time. By virtue of that diversity, investigating access to knowledge resources creates the risk of producing a conceptually fragmented and unhelpful landscape of theory and application on a resource-by-resource basis. This chapter suggests that the investigation of access to knowledge resources may be unified under the umbrella concept of knowledge commons, the study of governance of shared knowledge resources. It presents a framework for understanding knowledge commons and illustrates its application to several questions of access to the material and immaterial dimensions of specific knowledge resources.

Information abundance and knowledge commons

Standard accounts of IP law describe systems of legal exclusion intended to prompt the production and distribution of intellectual resources, or information and knowledge, by making those things artificially scarce. The argument presented here frames IP law instead as one of several possible institutional responses to the need to coordinate the use of intellectual resources given their natural abundance, and not necessarily useful or effective responses at that. The chapter aims to shift analytic and empirical frameworks from those grounded in law to those grounded in governance, and from IP law in isolation to IP law as part of resource management. Knowledge commons is proposed as a framework for examining and understanding governance of shared knowledge resources. Examples and illustrations are drawn from several domains of information and knowledge governance.