The learning healthcare system and cardiovascular care: a scientific statement from the American Heart Association
The learning healthcare system uses health information technology and the health data
infrastructure to apply scientific evidence at the point of clinical care while simultaneously …
infrastructure to apply scientific evidence at the point of clinical care while simultaneously …
Factors influencing harmonized health data collection, sharing and linkage in Denmark and Switzerland: A systematic review
Introduction The digitalization of medicine has led to a considerable growth of
heterogeneous health datasets, which could improve healthcare research if integrated into …
heterogeneous health datasets, which could improve healthcare research if integrated into …
An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics
RR Faden, NE Kass, SN Goodman… - Hastings Center …, 2013 - Wiley Online Library
Calls are increasing for American health care to be organized as a learning health care
system, defined by the Institute of Medicine as a health care system “in which knowledge …
system, defined by the Institute of Medicine as a health care system “in which knowledge …
[HTML][HTML] Paying research participants: regulatory uncertainty, conceptual confusion, and a path forward
EA Largent, HF Lynch - Yale journal of health policy, law, and …, 2017 - ncbi.nlm.nih.gov
The practice of offering payment to individuals in exchange for their participation in clinical
research is widespread and longstanding. Nevertheless, such payment remains the source …
research is widespread and longstanding. Nevertheless, such payment remains the source …
The Research‐Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight
NE Kass, RR Faden, SN Goodman… - Hastings Center …, 2013 - Wiley Online Library
The rise of quality improvement research and comparative effectiveness research in health
care settings constitutes progress toward the goal of what the Institute of Medicine has called …
care settings constitutes progress toward the goal of what the Institute of Medicine has called …
Preparing n-of-1 antisense oligonucleotide treatments for rare neurological diseases in Europe: genetic, regulatory, and ethical perspectives
M Synofzik, WMC van Roon-Mom… - nucleic acid …, 2022 - liebertpub.com
Antisense oligonucleotide (ASO) therapies present a promising disease-modifying treatment
approach for rare neurological diseases (RNDs). However, the current focus is on “more …
approach for rare neurological diseases (RNDs). However, the current focus is on “more …
Informed consent for pragmatic trials: the integrated consent model
SY Kim, FG Miller - 2014 - papers.ssrn.com
The authors argue that informed consent is ethically necessary in pragmatic trials that
randomly assign individual patients to treatments, even when treatment options are within …
randomly assign individual patients to treatments, even when treatment options are within …
Think pragmatically: Investigators' obligations to patient-subjects when research is embedded in care
Growing interest in embedded research approaches—where research is incorporated into
clinical care—has spurred numerous studies to generate knowledge relevant to the real …
clinical care—has spurred numerous studies to generate knowledge relevant to the real …
Data-intensive resourcing in healthcare
LF Hogle - BioSocieties, 2016 - Springer
Big Data promises to heal many of the complex problems in healthcare. Departing from
conventional ways of thinking about what constitutes relevant health data and how to …
conventional ways of thinking about what constitutes relevant health data and how to …
Making the ethical oversight of all clinical trials fit for purpose
Importance With the increase in trials assessing comparative effectiveness of approved
products and alternative care strategies, guidance is needed to ensure ethical oversight is fit …
products and alternative care strategies, guidance is needed to ensure ethical oversight is fit …