Public Health Genomics, Biobanking, and Ethics

2019 ◽  
pp. 663-677
Author(s):  
Karen M. Meagher ◽  
R. Jean Cadigan ◽  
Gail E. Henderson ◽  
Eric Juengst
Keyword(s):  
Public Health ◽  
Health Care Quality ◽  
Large Scale ◽  
Population Based ◽  
Care Quality ◽  
Health Interventions ◽  
Genomic Research ◽  
Return Of Results ◽  
Public Health Genomics ◽  
Health Care Quality Improvement

As large-scale biobanks are developed for translational genomic research and health care quality improvement, they are also becoming attractive as sites for public health interventions, such as population-based preventive sequencing for actionable variants. With the rapid advance of next-generation sequencing, the feasibility of such population health interventions is also increasing. The resulting confluence of public health norms, fiduciary clinical obligations, and ethical expectations for research creates a number of challenges. This chapter on public health genomics examines three examples of projects facing such challenges, in order to anticipate the ethical and policy issues that public health uses of research biobanks raise for those responsible for their design and governance. The chapter looks at issues of informed consent, return of results, and community engagement.

scholarly journals Adapting research to the 21st century – the Swedish Biobank Register

2012 ◽  
Vol 21 (2) ◽  
Author(s):  
L. Norlin ◽  
M. Fransson ◽  
S. Eaker ◽  
G. Elinder ◽  
J.-E. Litton
Keyword(s):  
Health Care ◽  
Health Care Quality ◽  
Statistical Power ◽  
Large Scale ◽  
Science Research ◽  
Population Based ◽  
Care Quality ◽  
Data Set ◽  
Large Patient ◽  
Medical Health Care

<p>In Sweden, there are currently nearly 600 biobanks. The Swedish Biobank Register (SBR) is an on-going national investment by the county councils working to capture information in one database about all biobank samples collected from patients attending the Swedish medical health care. The aim of the SBR is to gather enough information about biobank samples to be able to physically trace the samples.</p><p>The BioBanking and Molecular Resource Infrastructure of Sweden (BBMRI.se) has been given the task of extending the SBR Information System (IS) with functionality useful for research in connection to health care, quality registers and large patient cohorts. The research extension is called BBMRI catalogue over sample collections for research. To achieve this, the SBR-IS will be extended with attributes useful for both epidemiological and clinical research enabling authorized researchers to search for samples stored at non-clinical biobanks nationwide. The Swedish Biobank Register, together with the BBMRI research catalogue, will be a unique resource for research. SBR-IS will contain information about biobank samples collected by both clinical and population-based biobanks specifically established for research purposes but BBMRI.se researchers will only be granted access to data related to population-based biobanks. As BBMRI.se is the Swedish hub of the pan-European biobank project BBMRI, whose goal is to promote excellence and efficacy in European life science research, the BBMRI research catalogue will also be made compatible with the European register by applying its minimum data set describing biobanks and their objects. In this paper we describe the implementation. Our belief is that it will pave the way for connecting biobanks on an international level as well as stimulate collaborations and optimize usage of biobank samples. In the long run, patients and sample donors will benefit as new results with high statistical power emerge from large scale studies.</p>

scholarly journals ‘CTRL’: an online, Dynamic Consent and participant engagement platform working towards solving the complexities of consent in genomic research

2021 ◽  
Author(s):  
Matilda A. Haas ◽  
Harriet Teare ◽  
Megan Prictor ◽  
Gabi Ceregra ◽  
Miranda E. Vidgen ◽  
...  
Keyword(s):  
Large Scale ◽  
Genomic Medicine ◽  
International Standards ◽  
Security And Privacy ◽  
Genomic Research ◽  
Return Of Results ◽  
Future Research ◽  
Design And Development ◽  
Participant Engagement ◽  
Dynamic Consent

AbstractThe complexities of the informed consent process for participating in research in genomic medicine are well-documented. Inspired by the potential for Dynamic Consent to increase participant choice and autonomy in decision-making, as well as the opportunities for ongoing participant engagement it affords, we wanted to trial Dynamic Consent and to do so developed our own web-based application (web app) called CTRL (control). This paper documents the design and development of CTRL, for use in the Australian Genomics study: a health services research project building evidence to inform the integration of genomic medicine into mainstream healthcare. Australian Genomics brought together a multi-disciplinary team to develop CTRL. The design and development process considered user experience; security and privacy; the application of international standards in data sharing; IT, operational and ethical issues. The CTRL tool is now being offered to participants in the study, who can use CTRL to keep personal and contact details up to date; make consent choices (including indicate preferences for return of results and future research use of biological samples, genomic and health data); follow their progress through the study; complete surveys, contact the researchers and access study news and information. While there are remaining challenges to implementing Dynamic Consent in genomic research, this study demonstrates the feasibility of building such a tool, and its ongoing use will provide evidence about the value of Dynamic Consent in large-scale genomic research programs.

Effect of angiotensin-converting inhibitor or angiotensin receptor blocker on one-year survival in patients ≥65 years hospitalized with a left ventricular ejection fraction ≥50%**The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government. The investigator assumes full responsibility for the accuracy and completeness of the ideas presented. This study is a direct result of the Health Care Quality Improvement Program initiated by the Centers for Medicare & Medicaid Services, which has encouraged identification of quality improvement projects derived from analysis of patterns of care, and therefore required no special funding on the part of this contractor. Ideas and contributions to the investigator concerning experience in engaging with issues presented are welcomed.

2003 ◽  
Vol 91 (3) ◽  
pp. 363-365 ◽  
Author(s):  
Carla A Sueta ◽  
Allison Russo ◽  
Anna Schenck ◽  
David W Brown ◽  
Ross J Simpson
Keyword(s):  
Quality Improvement ◽  
Health Care Quality ◽  
Left Ventricular ◽  
Care Quality ◽  
Left Ventricular Ejection ◽  
Direct Result ◽  
Improvement Program ◽  
Ventricular Ejection Fraction ◽  
Us Government ◽  
Health Care Quality Improvement

Health Technology Assessment of Public Health Interventions Published 2012 to 2016: An Analysis of Characteristics and Comparison of Methods

2019 ◽  
Vol 35 (4) ◽  
pp. 280-290 ◽  
Author(s):  
Stephanie Polus ◽  
Tim Mathes ◽  
Corinna Klingler ◽  
Melanie Messer ◽  
Ansgar Gerhardus ◽  
...  
Keyword(s):  
Public Health ◽  
A Priori ◽  
Health Technology ◽  
Legal Aspects ◽  
Population Based ◽  
Health Interventions ◽  
Economic Evaluations ◽  
Public Health Interventions ◽  
Comprehensive Overview ◽  
Cultural Aspects

AbstractObjectivesThe aim of this study was to provide an overview of the methodological characteristics and compare the assessment methods applied in health technology assessments (HTAs) of public health interventions (PHIs).MethodsWe defined a PHI as a population-based intervention on health promotion or for primary prevention of chronic or nonchronic diseases. HTAs on PHIs were identified by systematically searching the Web pages of members of international HTA networks. We included only full HTA reports published between 2012 and 2016. Two reviewers extracted data on the methods used to assess effectiveness/safety, as well as on economic, social, cultural, ethical, and legal aspects using a-priori standardized tables.ResultsWe included ten HTAs provided by four different organizations. Of these, all reports assessed the effectiveness of the interventions and conducted economic evaluations, seven investigated social/cultural aspects, and four each considered legal and ethical aspects, respectively. Some reports addressed applicability, context/setting, and intervention fidelity issues in different ways. We found that most HTAs adapted their methods to some extent, for example, by including nonrandomized studies, expanding the search strategy, involving stakeholders, or applying a framework to guide the HTA process.ConclusionsOur analysis provides a comprehensive overview of methods applied in HTAs on public health interventions. We found that a heterogeneous set of approaches is used to deal with the challenges of evaluating complex public health interventions.

Employment: Protecting Public Health Abrogates Due Process Requirement for Suspension Proceedings

2003 ◽  
Vol 31 (1) ◽  
pp. 167-168
Author(s):  
Guillermo A. Montero
Keyword(s):  
Civil Rights ◽  
Health Care Quality ◽  
Due Process ◽  
Medical Center ◽  
Care Quality ◽  
Memorial Hospital ◽  
District Court ◽  
Court Of Appeals ◽  
Health Care Quality Improvement ◽  
The U.S

In Patel v. Midland Memorial Hospital & Medical Center, the U.S. Court of Appeals for the Fifth Circuit held that the defendant hospital did not violate the plaintiff's due process rights by suspending his clinical privileges without a pre-suspension hearing, where there were reasonable grounds for assuming that patient safety was at risk. Dr. P.V. Patel, a board-certified cardiologist, brought an action against Midland Memorial Hospital and several of its doctors, alleging that the suspension of his clinical privileges violated his right to a pre-suspension hearing; was the result of racial discrimination; and resulted in anticompetitive behavior in violation of antitrust laws. The U.S. District Court for the Western District of Texas granted Midland's motion for summary judgment. The parties filed cross appeals, Dr. Patel on the ground that there were genuine issues of fact for all of his claims, and Midland on the ground that, with the exception of the civil rights claim, it was immune from all of Dr. Patel's claims under the Health Care Quality Improvement Act of 1986 (HCQIA).

Population-Based Public Health Interventions: Innovations in Practice, Teaching, and Management. Part II

2004 ◽  
Vol 21 (5) ◽  
pp. 469-487 ◽  
Author(s):  
Linda Olson Keller ◽  
Susan Strohschein ◽  
Marjorie A. Schaffer ◽  
Betty Lia-Hoagberg
Keyword(s):  
Public Health ◽  
Population Based ◽  
Health Interventions ◽  
Public Health Interventions ◽  
Practice Teaching
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