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Purpose of the Review: Laboratory-developed tests (LDTs) are essential for the clinical care of immunocompromised individuals. These patients often require specialized testing not available from commercial manufacturers and are therefore dependent on the laboratory to create, validate, and perform these assays. Recent paradigm-shifting legislation could alter the way that LDTs are operationalized and regulated., Recent Findings: On March 5th, 2020 the Verifying Accurate and Leading-Edge In-Vitro Clinical Tests Development Act (VALID) was introduced in the US Congress. This statute would overhaul existing regulatory framework by unifying the oversight of LDTs and commercial in-vitro diagnostic tests (IVDs) through the FDA. If enacted, LDTs would be subject to regulatory requirements like those found in commercial submissions for market review. Stakeholders continue to discuss the details and scope of the proposed legislation in the setting of the Severe Acute Respiratory Syndrome Coronavirus 2 pandemic, where LDTs are integral to the national COVID-19 response., Summary: Congressional lawmakers have introduced legislation to alter the regulatory framework governing LDTs. Moving forward, a balance must be struck to ensure the availability of safe and accurate testing without delays or overregulation that could be harmful to patients. The downstream implications of how VALID and other legislation will impact laboratories, clinicians, and patients warrant close examination.

Competing Interests: Competing interests: None declared.

Despite multiple initiatives in post-acute and long-term nursing home care settings (NHs) to improve the quality of care while reducing health care costs, research in NHs can prove challenging. Extensive regulation for both research and NHs is designed to protect a highly vulnerable population but can be a deterrent to conducting research. This article outlines regulatory challenges faced by NHs and researchers, such as protecting resident privacy as well as health information and obtaining informed consent. The article provides lessons learned to help form mutually beneficial partnerships between researchers and NHs to conduct studies that grow and advance NH research initiatives and clinical care., (Copyright © 2019 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.)

Background: In 2015, following a call for proposals from the Special Programme for Research and Training in Tropical Diseases (TDR), six scoping reviews on the prevention and control of vector-borne diseases in urban areas were conducted. Those reviews provided a clear picture of the available knowledge and highlighted knowledge gaps, as well as needs and opportunities for future research. Based on the research findings of the scoping reviews, a concept mapping exercise was undertaken to produce a list of priority research needs to be addressed., Methods: Members of the six research teams responsible for the "VEctor boRne DiseAses Scoping reviews" (VERDAS) consortium's scoping reviews met for 2 days with decision-makers from Colombia, Brazil, Peru, Pan-American Health Organization, and World Health Organization. A total of 11 researchers and seven decision-makers (from ministries of health, city and regional vector control departments, and vector control programs) completed the concept mapping, answering the question: "In view of the knowledge synthesis and your own expertise, what do we still need to know about vector-borne diseases and other infectious diseases of poverty in urban areas?" Participants rated each statement on two scales from 1 to 5, one relative to 'priority' and the other to 'policy relevance', and grouped statements into clusters based on their own individual criteria and expertise., Results: The final map consisted of 12 clusters. Participants considered those entitled "Equity", "Technology", and "Surveillance" to have the highest priority. The cluster considered the most important concerns equity issues, confirming that these issues are rarely addressed in research on vector-borne diseases. On the other hand, the "Population mobility" and "Collaboration" clusters were considered to be the lowest priority but remained identified by participants as research priorities. The average policy relevance scores for each of the 12 clusters were roughly the same as the priority scores for all clusters. Some issues were not addressed during the brain-storming. This is the case for governance and for access and quality of care., Conclusions: Based on this work, and adopting a participatory approach, the concept mapping exercise conducted collaboratively with researchers from these teams and high-level decision-makers identified research themes for which studies should be carried out as a priority.

This paper starts by establishing a prima facie case that disadvantaged groups or individuals are more likely to get a chronic disease and are in a disadvantaged position to adhere to chronic treatment despite access through Universal Health Coverage. However, the main aim of this paper is to explore the normative implications of this claim by examining two different but intertwined argumentative lines that might contribute to a better understanding of the ethical challenges faced by chronic disease health policy. The paper develops the argument that certain disadvantages which may predispose to illness might overlap with disadvantages that may hinder self-management, potentially becoming disadvantageous in handling chronic disease. If so, chronic diseases may be seen as disadvantages in themselves, describing a reproduction of disadvantage among the chronically ill and a vicious circle of disadvantage that could both predict and shed light on the catastrophic health outcomes among disadvantaged groups-or individuals-dealing with chronic disease., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Complex trends in occupancy determined by many influencing factors, clear state-specific differences in imprisonment practices as well as recently implemented statutory alterations to the appropriate paragraphs in criminal law, underline the necessity for qualitative high-grade concomitant research of German forensic commitment; however, neither the structural prerequisites nor an adequate data situation are currently present in order to do justification to this aim. Not even the total number of patients currently accommodated in forensic commitment can be elucidated from the publicized (partial) statistics. This consensus paper, which was formulated by three research institutes active at the state level, describes the limited possibilities for current forensic healthcare research and raises the demand for a nationwide uniform data situation on patients in forensic commitment. Furthermore, how the appropriate elicitation instrument should be organizationally and structurally achieved, is sketched from a scientific perspective. This article aims at initiating a discussion on a sustainable improvement in the prerequisites for healthcare research in German forensic commitment and targets a sensitization of decision makers in politics and administration for this topic.

The Supreme Court decision in Montgomery v Lanarkshire ([2015] UKSC11) has been hailed as a landmark not least because the Court enshrines the doctrine of informed consent formally into English law for the first time in relation to medical treatment. This paper explores the decision in Montgomery. It examines what its implications may be in the future for the consent process in relation to health research and innovative treatment and whether it may prove a watershed moment leading to changing dialogues and expectations in relation to consent. First, the paper explores the concept of 'informed consent' in clinical research as seen through international, Council of Europe and EU instruments. Second, it considers how English law currently governs the provision of information to research participants in the context of clinical research. It questions whether such an approach will be sustainable in the future. Third, it discusses the decision of the UK Supreme Court in Montgomery v Lanarkshire and asks what might be the impact of this Supreme Court decision in the health research context. It asks whether Montgomery may result in new approaches to consent in health research and innovative treatment.

Objective: To understand health research in Colombia in the context of governmental and legislative agendas related to the health sector between 1990 and 2010., Methods: Official sources were used such as development plans, bills and institutional documents., Results: The National Government, the Ministry of Health and Social Protection (MSPS by its acronym in Spanish) and the Colombian Congress have focused their attention on health research as a public concern at certain presidential periods due to their interest in reducing the gap between research and health needs. In the 1990s, government plans showed greater interest in formulating a Science and Technology (S&T) policy in health led by the Ministry, an entity that had directorates, commissions and committees responsible for promoting and planning health research. In Congress, some health system reform projects included initiatives to formulate a health research policy that were not approved., Discussion: Health research is recognized as a fundamental tool to help solve health problems. However, said recognition by governmental and legislative actors has not been constant and the institutionality in the health sector has been precarious considering that there is no permanent interest in formulating an S&T policy in health.

The EU offers a suitable milieu for the comparison and harmonisation of healthcare across different languages, cultures, and jurisdictions (albeit with a supranational legal framework), which could provide improvements in healthcare standards across the bloc. There are specific ethico-legal issues with the use of data in healthcare research that mandate a different approach from other forms of research. The use of healthcare data over a long period of time is similar to the use of tissue in biobanks. There is a low risk to subjects but it is impossible to gain specific informed consent given the future possibilities for research. Large amounts of data on a subject present a finite risk of re-identification. Consequently, there is a balancing act between this risk and retaining sufficient utility of the data. Anonymising methods need to take into account the circumstances of data sharing to enable an appropriate balance in all cases. There are ethical and policy advantages to exceeding the legal requirements and thereby securing the social licence for research. This process would require the examination and comparison of data protection laws across the trading bloc to produce an ethico-legal framework compatible with the requirements of all member states. Seven EU jurisdictions are given consideration in this critique.

The concluding statement of the Burns Commission, established to evaluate whether changes are needed to the Freedom of Information Act (FOIA), ruled no major legislative changes were required. As such Freedom of Information (FOI) legislation still enables anyone to obtain information from public authorities. In this brief report article we explore arguments regarding FOI as an instrument for healthcare research using an international research programme as a case study., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

This paper discusses health policy and systems research in complex and rapidly changing contexts. It focuses on ethical issues at stake for researchers working with government policy makers to provide evidence to inform major health systems change at scale, particularly when the dynamic nature of the context and ongoing challenges to the health system can result in unpredictable outcomes. We focus on situations where 'country ownership' of HSR is relatively well established and where there is significant involvement of local researchers and close ties and relationships with policy makers are often present. We frame our discussion around two country case studies with which we are familiar, namely China and South Africa and discuss the implications for conducting 'embedded' research. We suggest that reflexivity is an important concept for health system researchers who need to think carefully about positionality and their normative stance and to use such reflection to ensure that they can negotiate to retain autonomy, whilst also contributing evidence for health system change. A research process informed by the notion of reflexive practice and iterative learning will require a longitudinal review at key points in the research timeline. Such review should include the convening of a deliberative process and should involve a range of stakeholders, including those most likely to be affected by the intended and unintended consequences of change., (© 2016 The Authors Developing World Bioethics Published by John Wiley & Sons Ltd.)

This essay presents some elements of analysis for thinking about health research in Colombia as a public policy, something which was formed starting in 1990 with the establishment of Science and Technology regulations. A set of institutional adjustments was carried out which led to the creation of the National Program of Health Science and Technology and the National Council of Health Science and Technology. In addition, it led to the institutionalization of calls for research proposals as a mechanism for selecting research projects and assigning resources in accordance with the needs and priorities of the National System of Science and Technology. Since then, there have been no major changes in the public management of health research, with the exception of the Health Research Fund, created in 2001. However, some efforts have been made to develop some capacities and -so far unsuccessfully- to formulate a national policy on health research. The Statutory Health Act approved in 2015 could be an important opportunity to realize and implement this policy decision.

Multimodal pain treatment programs are widely accepted as the medical treatment standard in the management of patients with chronic pain syndromes. The concepts and treatment strategies are based on the biopsychosocial model of pain and programs for early restoration of function. Although this concept is primarily implemented in the curative field, i.e. in hospitals for the treatment of patients with chronic pain diseases, modified programs based on the International Classification of Functioning (ICF) can now also be found in rehabilitation clinics. Despite the assumed similarities, significant differences in, for example the aims of the therapy and relevant structural and process variables have to be kept in mind when allocating patients to a program as provided by a hospital or a rehabilitation clinic. The aim of this article is to present the framework structures of both treatment levels with respect to the implementation of multimodal pain therapy programs and to elucidate the differential diagnostic approach to the indications.

Background: Federal regulations in the United States have shaped Institutional Review Boards (IRBs) to focus on protecting individual human subjects. Health services research studies focusing on healthcare institutions such as hospitals or clinics do not have individual human subjects. Since U.S. federal regulations are silent on what type of review, if any, these studies require, different IRBs may approach similar studies differently, resulting in undesirable variation in the review of studies focusing on healthcare institutions. Further, although these studies do not focus on individual human subjects, they may pose risks to participating institutions, as well as individuals who work at those institutions, if identifying information becomes public., Discussion: Using two recent health services research studies conducted in the U.S. as examples, we discuss variations in the level of IRB oversight for studies focusing on institutions rather than individual human subjects. We highlight how lack of IRB guidance poses challenges for researchers who wish to both protect their subjects and work appropriately with the public, journalists or the legal system in the U.S. Competing interests include the public's interest in transparency, the researcher's interest in their science, and the research participants' interests in confidentiality. Potential solutions that may help guide health services researchers to balance these competing interests include: 1) creating consensus guidelines and standard practices that address confidentiality risk to healthcare institutions and their employees; and 2) expanding the IRB role to conduct a streamlined review of health services research studies focusing on healthcare institutions to balance the competing interest of stakeholders on a case-by-case basis., Summary: For health services research studies focusing on healthcare institutions, we outline the competing interests of researchers, healthcare institutions and the public. We propose solutions to decrease undesirable variations in the review of these studies.

Electronic Health Records (EHR) promise improvement for patient care and also offer great value for biomedical research including clinical, public health, and health services research. Unfortunately, the full potential of EHR big data research has remained largely unrealized. The purpose of this study was to identify rate limiting factors, and develop recommendations to better balance unrestricted extramural EHR access with legitimate safeguarding of EHR data in retrospective research. By exploring primary, secondary, and tertiary sources, this review identifies external constraints and provides a comparative analysis of social influencers in retrospective EHR-based research. Results indicate that EHRs have the advantage of reflecting the reality of patient care but also show a frequency of between 4.3-86% of incomplete and inaccurate data in various fields. The rapid spread of alternative analytics for health data challenges traditional interpretations of confidentiality protections. A confusing multiplicity of controls creates barriers to big data EHR research. More research on the use of EHR big data is likely to improve accuracy and validity. Information governance and research approval processes should be simplified. Comprehensive regulatory policies that do not exclusively cover health care entities, are needed. Finally, new computing safeguards are needed to address public concerns, like research access only to aggregate data and not to individually identifiable information.

Background: Public quality reports, based on new legislative regulations of 2008, were supposed to offer potential customers the possibility to make a well-informed choice of a care provider., Aim: This empirical study on marks for long-term care is based on the public quality reports of the Medical Service of the Health Insurance Companies (MDK), of 11 884 home care services and 10 310 nursing homes, which corresponds to a comprehensive survey of almost all care providers in Germany., Method: Descriptive statistical methods and discussion of the results concerning the customer benefit., Results: The analysis of transparency reports reveals a limited value for customers, which is particularly caused by very good quality results with low scattering. In addition, a high amount of missing data - especially in the area of home care providers - leads to a growing influence of service criteria on the final grade. Though deficits in nursing might be compensated by good marks in service criteria, it rarely occurs. At present, a more detailed look at risk criteria hardly improves the customer benefit., Conclusion: The marks for nursing need to be improved to increase their informative value for the customer.

Rationale and Objectives: Millions of people use online search engines everyday to find health-related information and voluntarily share their personal health status and behaviors in various Web sites. Thus, data from tracking of online information seeker's behavior offer potential opportunities for use in public health surveillance and research. Google Trends is a feature of Google which allows Internet users to graph the frequency of searches for a single term or phrase over time or by geographic region. We used Google Trends to describe patterns of information-seeking behavior in the subject of dense breasts and to examine their correlation with the passage or introduction of dense breast notification legislation., Materials and Methods: To capture the temporal variations of information seeking about dense breasts, the Web search query "dense breast" was entered in the Google Trends tool. We then mapped the dates of legislative actions regarding dense breasts that received widespread coverage in the lay media to information-seeking trends about dense breasts over time., Results: Newsworthy events and legislative actions appear to correlate well with peaks in search volume of "dense breast". Geographic regions with the highest search volumes have passed, denied, or are currently considering the dense breast legislation., Conclusions: Our study demonstrated that any legislative action and respective news coverage correlate with increase in information seeking for "dense breast" on Google, suggesting that Google Trends has the potential to serve as a data source for policy-relevant research., (Copyright © 2014 AUR. Published by Elsevier Inc. All rights reserved.)

The Agency for Healthcare Research and Quality (AHRQ) has funded systematic reviews of comparative effectiveness research in 17 areas over the last 10 years as part of a federal mandate. These reviews provide a reliable and unbiased source of comprehensive information about the effectiveness and risks of treatment alternatives for patients and clinicians. This article describes comparative effectiveness research, provides an overview of how physicians can use it in clinical practice, and references important contributions made by the Minnesota Evidence-based Practice Center.

The European Union (EU) Data Protection Regulation will have profound implications for public health, health services research and statistics in Europe. The EU Commission's Proposal was a breakthrough in balancing privacy rights and rights to health and healthcare. The European Parliament, however, has proposed extensive amendments. This paper reviews the amendments proposed by the European Parliament Committee on Civil Liberties, Justice and Home Affairs and their implications for health research and statistics. The amendments eliminate most innovations brought by the Proposal. Notably, derogation to the general prohibition of processing sensitive data shall be allowed for public interests such as the management of healthcare services,but not health research, monitoring, surveillance and governance. The processing of personal health data for historical, statistical or scientific purposes shall be allowed only with the consent of the data subject or if the processing serves an exceptionally high public interest, cannot be performed otherwise and is legally authorised. Research, be it academic, government,corporate or market research, falls under the same rule.The proposed amendments will make difficult or render impossible research and statistics involving the linkage and analysis of the wealth of data from clinical,administrative, insurance and survey sources, which have contributed to improving health outcomes and health systems performance and governance; and may illegitimise efforts that have been made in some European countries to enable privacy-respectful data use for research and statistical purposes. If the amendments stand as written, the right to privacy is likely to override the right to health and healthcare in Europe.

While the patients' perspective has been included in health care research, the participation of people with intellectual disabilities in research on their health has been limited, and considered to be difficult. However, they are vulnerable and experience more health problems than the general population. Legal issues regarding inclusion of people with intellectual disabilities are clarified in international and Dutch law, and should be respected. Aside from the legally responsible persons, various other stakeholders also play a role, which should be realized and considered when developing research plans. Inclusion of people with intellectual disabilities themselves in research, not only as subjects but also as advisors, researchers and decision-makers could make research more relevant and attractive for themselves, for health practice and for the research community.

Communication-and-resolution programs (CRPs) in health care organizations seek to identify medical injuries promptly; ensure that they are disclosed to patients compassionately; pursue timely resolution through patient engagement, explanation, and, where appropriate, apology and compensation; and use lessons learned to improve patient safety. CRPs have existed for years, but they are being tested in new settings and primed for broad implementation through grants from the Agency for Healthcare Research and Quality. These projects do not require changing laws. However, grantees' experiences suggest that the path to successful dissemination of CRPs would be smoother if the legal environment supported them. State and federal policy makers should try to allay potential defendants' fears of litigation (for example, by protecting apologies from use in court), facilitate patient participation (for example, by ensuring access to legal representation), and address the reputational and economic concerns of health care providers (for example, by clarifying practices governing National Practitioner Data Bank reporting and payers' financial recourse following medical error).

The assessment of the health state in patients and changes in their health state for the purpose of diagnosis, prognosis and monitoring of treatment response plays a central role in clinical practice. Quality criteria for measurements in medicine include validity, reliability, responsiveness, interpretability, and feasibility. High-quality measurement instruments are a prerequisite for evidence-based medicine. Therefore, international outcomes research groups have developed methods for quality assurance and for the standardisation of measurement instruments. Quality indicators are instruments to measure the quality of care. Due to the increasing relevance of quality assessment for all stakeholders in healthcare and due to the political intention to draw relevant conclusions from the assessment of the quality of care, quality indicators must at least meet the same high standards that are required for clinical trial end points. However, independent researchers and clinicians do not engage in the validation and standardisation of quality indicators in Germany; currently, only the AQUA institute (as assigned by the German GBA) deals with this important issue. Current activities concerning the validation of quality indicators do not meet the requirements of evidence-based healthcare. This is a critical barrier to achieving the political goals of quality medicine. Therefore, the authors propose a multi-step, multi-professional, evidence-driven and evidence-generating consensus process on the basis of established methods of outcomes research for the advancement of quality assessment with quality indicators in Germany. All relevant stakeholders should participate in this process., (Copyright © 2013. Published by Elsevier GmbH.)

External quality assurance has three main aims: to make service provision in medicine and nursing comparable, to systematically identify deficits in service quality and to support the introduction of measures for quality improvement. This article reflects on three major developments in mandatory external quality assurance in the German healthcare system that took place during the last five years. These developments include the implementation of cross-sectoral quality assurance, the utilisation of new data sources and a new focus on quality deficits and practicability. The article highlights the challenges that come along with these developments., (Copyright © 2013. Published by Elsevier GmbH.)

The aim of the WINHO indicators project is to describe and enhance the quality of outpatient oncology care in Germany with indicators. This paper deals with the development of a set of evidence- and consensus-based meaningful indicators to assess the quality of outpatient oncology care in Germany. These indicators are intended to be applied in assessments of quality of patient care in oncology practices, in quality reports and in peer-to-peer benchmarking. A set of 272 already existing indicators was identified through internet and literature searches. After redundancy reduction and addition of newly developed indicators for areas of ambulatory oncology care that were not yet covered, a preliminary set of 67 indicators was established. The further development of the indicator set was based on a modified version of the two-step RAND/UCLA expert evaluation method, which has been internationally established for developing quality indicator sets. The indicators were modified after the first round of ratings. After completing and assessing the second round of ratings, a set of 46 homogeneously positively rated quality indicators is now available for outpatient oncology care in Germany., (Copyright © 2013. Published by Elsevier GmbH.)

Many physicians are referred to state physician health programs (PHPs) for evaluation, monitoring, and treatment of mental health and substance use disorders. Most PHPs are "diversion" or "safe haven" programs, meaning that physicians who suffer from alcohol or drug problems can have their case diverted to the PHP in lieu of being reported to the state licensing board. If the physician agrees to cooperate with the PHP and adhere to any recommendations it might make, the physician can avoid disciplinary action and remain in practice. These programs are therefore quite powerful and yet, to our knowledge, there has not been any systematic scrutiny of the ethical and management issues that arise in standard PHP practice. Given our 20 years of service as associate directors of one state PHP we analyze and evaluate the standard operating procedure of many PHPs and offer ethical critique as well as suggestions for improvement.

The importance of law in the organization and operation of public health systems has long been a matter of interest to public health lawyers and practitioners, but empirical research on law as a factor in health system performance has been limited in quantity and sophistication. The emergence of Public Health Law Research and Public Health Systems and Services Research within a coordinated effort to strengthen public health research and practice has dramatically changed matters. This article introduces Public Health Law Research as an integral part of Public Health Systems and Services Research, discusses the challenges of integrating the 2 fields, and highlights 2 examples of current research that demonstrate the benefits of an integrated approach to improve the use of law in public health practice.

Context: For three decades, experts have been stressing the importance of law to the effective operation of public health systems. Most recently, in a 2011 report, the Institute of Medicine recommended a review of state and local public health laws to ensure appropriate authority for public health agencies; adequate access to legal counsel for public health agencies; evaluations of the health effects and costs associated with legislation, regulations, and policies; and enhancement of research methods to assess the strength of evidence regarding the health effects of public policies. These recommendations, and the continued interest in law as a determinant of health system performance, speak to the need for integrating the emerging fields of Public Health Law Research (PHLR) and Public Health Systems and Services Research (PHSSR)., Methods: Expert commentary., Findings: This article sets out a unified framework for the two fields and a shared research agenda built around three broad inquiries: (1) the structural role of law in shaping the organization, powers, prerogatives, duties, and limitations of public health agencies and thereby their functioning and ultimately their impact on public health ("infrastructure"); (2) the mechanisms through which public health system characteristics influence the implementation of interventional public health laws ("implementation"); and (3) the individual and system characteristics that influence the ability of public health systems and their community partners to develop and secure enactment of legal initiatives to advance public health ("innovation"). Research to date has laid a foundation of evidence, but progress requires better and more accessible data, a new generation of researchers comfortable in both law and health research, and more rigorous methods., Conclusions: The routine integration of law as a salient factor in broader PHSSR studies of public health system functioning and health outcomes will enhance the usefulness of research in supporting practice and the long-term improvement of system performance., (© 2012 Milbank Memorial Fund.)

Adjudicative tribunals are an integral part of health system governance, yet their real-world impact remains largely unknown. Most assessments focus on internal accountability and use anecdotal methodologies; few, studies if any, empirically evaluate their external impact and use these data to test effectiveness, track performance, inform service improvements and ultimately strengthen health systems. Given that such assessments would yield important benefits and have been conducted successfully in similar settings (e.g. specialist courts), their absence is likely attributable to complexity in the health system, methodological difficulties and the legal environment within which tribunals operate. We suggest practical steps for potential evaluators to conduct empirical impact evaluations along with an evaluation matrix template featuring possible target outcomes and corresponding surrogate endpoints, performance indicators and empirical methodologies. Several system-level strategies for supporting such assessments have also been suggested for academics, health system institutions, health planners and research funders. Action is necessary to ensure that policymakers do not continue operating without evidence but can rather pursue data-driven strategies that are more likely to achieve their health system goals in a cost-effective way.

Problem: This paper argues that it is necessary to strengthen Asian American, Native Hawaiian, and Pacific Islander (AA and NHPI) community-based participatory research (CBPR) models that integrate a health policy agenda through dynamic legislative partnerships., Purpose: We utilize a case study approach and examine three health research partnership models that impact legislative design and action: The California Program on Access to Care (CPAC), the California Health Benefits Review Program (CHBRP), and the University of California Asian American and Pacific Islander Policy Multicampus Research Program (UC AAPI Policy MRP)., Key Points: In-depth examination reveals the difficulties of engaging in research that collaborates with multiple parties simultaneously and the specific benefits and challenges in each case., Conclusions: New directions are needed to deepen legislative engagement potential in CBPR and the translation of policy research that considers the health of all AA and NHPI communities.

Introduction: Health research using routinely collected National Health Service (NHS) data derived from electronic health records (EHRs) and health service information systems has been growing in both importance and quantity. Wide population coverage and detailed patient-level information allow this data to be applied to a variety of research questions. However, the sensitivity, complexity and scale of such data also hamper researchers from fully exploiting this potential., Objective: Here, we establish the current challenges preventing researchers from making optimal use of the data sets at their disposal, on both the legislative and practical levels, and give recommendations as to how these challenges can be overcome., Method: A number of projects has recently been launched in the UK to address poor research data-management practices. Rapid Organisation of Healthcare Research Data (ROHRD) at Imperial College, London produced a useful prototype that provides local researchers with a one-stop index of available data sets together with relevant metadata., Findings: Increased transparency of data sets' availability and their provenance leads to better utilisation and facilitates compliance with regulatory requirements., Discussion: Research data resulting from NHS data is often not utilised fully, or is handled in a haphazard manner that prevents full auditability of the research. Furthermore, lack of informatics and data management skills in research teams act as a barrier to implementing more advanced practices, such as provenance capture and detailed, regularly updated, data management strategies. Only by a concerted effort at the levels of research organisations, funding bodies and publishers, can we achieve full transparency and reproducibility of the research.