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Concept: Legal documents


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.

Concepts: Clinical trial,, Law, Clinical research, The Trial, Trial, Intellectual property law, Legal documents


Recent legal cases before the Supreme Court of the United States were challenging federal definitions of marriage created by the Defense of Marriage Act and California’s voter approved Proposition 8 which limited marriage to different-sex couples only. Social science literature regarding child well-being was being used within these cases, and the American Sociological Association sought to provide a concise evaluation of the literature through an amicus curiae brief. The authors were tasked in the assistance of this legal brief by reviewing literature regarding the well-being of children raised within same-sex parent families. This article includes our assessment of the literature, focusing on those studies, reviews and books published within the past decade. We conclude that there is a clear consensus in the social science literature indicating that American children living within same-sex parent households fare just, as well as those children residing within different-sex parent households over a wide array of well-being measures: academic performance, cognitive development, social development, psychological health, early sexual activity, and substance abuse. Our assessment of the literature is based on credible and methodologically sound studies that compare well-being outcomes of children residing within same-sex and different-sex parent families. Differences that exist in child well-being are largely due to socioeconomic circumstances and family stability. We discuss challenges and opportunities for new research on the well-being of children in same-sex parent families.

Concepts: Psychology, Sociology, Supreme Court of the United States, Same-sex marriage, Legal documents, Amicus curiae, Brief, American Civil Liberties Union


Psychiatric advance directives (PADs) provide a legal mechanism for competent adults to document care preferences and authorize a surrogate to make treatment decisions. In a controlled research setting, an evidence-based intervention, the facilitated psychiatric advance directive (FPAD), was previously shown to overcome most barriers to PAD completion. This study examined implementation of the FPAD intervention in usual care settings as delivered by peer support specialists and nonpeer clinicians on assertive community treatment (ACT) teams.

Concepts: European Union, Mental health, Setting, Peer group, Legal documents, Advance health care directive


A complaint of insomnia may have many causes. A brief tool examining contributing factors may be useful for nonsleep specialists. This study describes the development of the Insomnia Symptoms Assessment (ISA) for examining insomnia complaints.

Concepts: Developmental biology, Complaint, Legal documents


This study explored low-income older adults' willingness to (i) complete advance directives, legal documents, whereby an individual designates decision-makers in the event that they cannot make their own decisions about end-of-life treatment preferences, and (ii) the role of social support and other predictors that impact their willingness. This study was conducted as part of a larger study exploring behaviours of advance care planning among low-income older adults. Out of a total of 255 participants from the original study, this study included 204 participants who did not complete an advance directive for data analysis. A cross-sectional study using probability random sampling stratified by ethnicity was used. Older adults residing in two supportive housing facilities or who were members of a senior centre in San Diego, California, USA, were interviewed in person between December 2010 and April 2011. Hierarchical logistic regression analysis revealed that the majority of participants (72.1%) were willing to complete advance directives and the factors significantly predicting willingness to complete included self-rated health, attitudes towards advance decision-making and social support. Participants with a poorer health status (OR = 1.43, 95% CI = 1.07-1.90) were more willing to complete advance directives. Conversely, participants with higher positive attitudes (OR = 1.18, 95% CI = 1.00-1.39) and greater social support (OR = 1.07, 95% CI = 1.00-1.15) were also more willing to complete advance directives. The findings suggest the importance of ongoing support from healthcare professionals in end-of-life care planning. Healthcare professionals can be a source of support assisting older adults in planning end-of-life care. Initiating ongoing communication regarding personal value and preference for end-of-life care, providing relevant information and evaluating willingness to complete as well as assisting in the actual completion of advance directives will be necessary.

Concepts: Health care, Regression analysis, Logistic regression, Medicine, Death, Prediction, Consumer theory, Legal documents


The Patient Self-Determination Act was created to enhance awareness and use of advance directives. Several states also have created registries where the advance directives can be easily retrieved when needed. Quick retrieval is especially important in critical access hospitals where patients are often transferred to other facilities. This article describes an innovative project designed to improve the advance directives request and retrieval process on admission to a critical access hospital.

Concepts: Improve, Patient, Hospital, Physician, Patience, Access control, Admission to an event or establishment, Legal documents


As the population ages, end-of-life care (EOLC) becomes an increasingly pressing issue. Advance directives (ADs) are legal documents that allow individuals to convey their decisions about EOLC. Although ADs have been shown to reduce EOLC costs, most people do not have ADs. To address this issue, we recently proposed that Congress instruct the Centers for Medicare and Medicaid Services (CMS) to collect ADs from Medicare beneficiaries. Herein, we outline how to implement this solution.

Concepts: Medicare, Centers for Medicare and Medicaid Services, Medicaid, Medicare and Medicaid, Legal documents


The basic systems of any society rarely can operate independently. Instead, they are dependent and often interdependent upon other entities. Such entities control the resources within their respective systems. Thus, coordination and control agencies require contracts or memoranda of understanding with these entities in order to assure access to the resources required during a crisis. These administrative structures include: (1) governmental institutions and agencies, including the military; (2) intergovernmental organisations; (3) nongovernmental organisations; (4) commercial private sector organisations; and (5) academic institutions. These dependencies create potential barriers to the provision of coordination and control including: (1) the complexity of the administrative structures with which coordination and control must interact; (2) the location of resources; (3) finding responsible person(s); (4) the competence and compatibility; (5) methods of access; (6) payment; (7) contracts and memoranda of understanding; (8) inventories of accessible resources; (9) competition for the mandate, power, and resources; and (10) jealousy. The need for potential interactions between administrative structures requires that agreements for the sharing of resources during crises be reached as part of planning and preparedness. Gaining an understanding of these relationships is an important area for research.

Concepts: Structure, Management, Organization, United Nations, Contract, Business terms, International organization, Legal documents