Just compensation: a no-fault proposal for research-related injuries

Biomedical research, no matter how well designed and ethically conducted, carries uncertainties and exposes participants to risk of injury. Research injuries can range from the relatively minor to those that result in hospitalization, permanent disability, or even death. Participants might also suffer a range of economic harms related to their injuries. Unlike the vast majority of developed countries, which have implemented no-fault compensation systems, the United States continues to rely on the tort system to compensate injured research participants—an approach that is no longer morally defensible. Despite decades of US advisory panels advocating for no-fault compensation, little progress has been made. Accordingly, this article proposes a novel and necessary no-fault compensation system, grounded in the ethical notion of compensatory justice. This first-of-its-kind concrete proposal aims to treat like cases alike, offer fair compensation, and disburse compensation with maximum efficiency and minimum administrative cost. It also harmonizes national and international approaches—an increasingly important goal as research becomes more globalized, multi-site trials grow in number, and institutions and sponsors in the United States move to single-IRB review.     

Incidental findings in human subjects research: what do investigators owe research participants?

The use of brain imaging technology as a common tool of research has spawned concern and debate over how investigators should respond to incidental findings discovered in the course of research. In this article, we argue that investigators have an obligation to respond to incidental findings in view of their entering into a professional relationship with research participants in which they are granted privileged access to private information with potential relevance to participants' health. We discuss the scope and limits of this professional obligation to respond to incidental findings, bearing in mind that the relationship between investigators and research participants differs fundamentally from the doctor-patient relationship.     

The conduct of socially sensitive research: sex offenders as participants

This article examines some extra-research variables inherent in conducting community-based research with child molesters and other sex offenders. These include such issues as informed consent with court-referred participants, confidentiality when interagency collaboration is necessary, and duty to take proper care. Methods for establishing the scientific credibility of the project, responding to client grievances, dealing with client crises, and protecting staff and the surrounding community also are addressed. Adopting procedures similar to those described here could be an important step in ensuring the viability of other socially sensitive research projects.     

Bad medicine: prescription drugs, preemption, and the potential for a no-fault fix

For decades, federal regulation of pharmaceutical drugs and medical devices has worked hand in hand with state tort claims to protect the health and safety of the American public. Now, a new trend toward preemption endangers this scheme. In recent years, the Supreme Court has given increasing deference to agency assertions about their preemptive authority and has found preemption in an increasing number of cases. In the process, the Supreme Court has preempted claims for medical device injuries and left claims for pharmaceutical harms in a precarious position. The elimination of common law claims for drug and device harms will leave holes in the FDA's regulatory scheme, endangering the health and safety of Americans. It will also prevent ordinary Americans from seeking compensation for their injuries--even those injuries caused by manufacturer malfeasance. This Article proposes that Congress create a no-fault compensation scheme for drugs and medical devices to close these gaps. Such a scheme could be both practical and politically possible, satisfying manufacturers, tort reformers, patients, and plaintiffs' lawyers alike.     

Sealing the cracks: a proposal to update the anti-cybersquatting regime to combat advertising-based cybersquatting

Legal context: Recent years have seen a resurgence in the practice of cybersquatting,and in particular cybersquatting that monetizes domain namesthrough pay-per-click advertisements. Existing statutory andadministrative anti-cybersquatting tools were not designed tocope with the advertising-based model of cybersquatting. Asa result, brand owners lack effective tools to combat moderncybersquatting. Key points: (1) Where cybersquatters originally monetized their domain nameportfolios by ransoming small numbers of domain names to brandowners, they now use pay-per-click advertisements spread overmassive portfolios. Technological advances in the domain namesystem will continue to increase the opportunities for cybersquattersto expand these portfolios. (2) Existing statutory and administrativeanti-cybersquatting tools are out-dated and ineffective. TheUniform Domain Name Dispute Resolution Process is procedurallyincapable of coping with large portfolios of infringing domainnames and substantively out of sync with national IP laws. Traditionallitigation is too expensive and inefficient to offer a workablesolution for brand owners. (3) Both administrative and legalremedies for cybersquatting have inherent flaws that cannotpractically be remedied. A new anti-cybersquatting regime musttherefore allow them to work together. The UDRP should be procedurallyupdated to allow limited discovery and facilitate large-scalecases, and an optional choice of law clause should be introducedto bring UDRP panel decisions more in line with national IPlaws. Likewise, those laws should be revised to give explicitdeference to UDRP decisions in litigation arising from the samefacts as the UDRP action. Practical significance: Cybersquatting can injure a mark's distinctiveness and onlinerecognition, and contextual advertisements can divert customersfrom the targeted brand's website. If anti-cybersquatting toolsdo not keep pace with cybersquatters' strategies, these problemswill make it increasingly difficult for brand owners and customersto connect in the domain name system. The proposed revisionsto the anti-cybersquatting regime will enable brand owners toprotect their domain names more efficiently and to deter cybersquatters.     

Recovering erased digital evidence from CD-RW discs in a child exploitation investigation

The paper describes an innovative method used to recover digital images and videos from an evidentiary CD-RW disc that had been erased. The digital evidence had been erased by the subject of the investigation in an attempt destroy incriminating evidence of the crime. Without the recovery of the digital evidence, there would have been no conviction in the child exploitation case as there was no physical or testimonial evidence.