The learning healthcare system and cardiovascular care: a scientific statement from the American Heart Association

TM Maddox, NM Albert, WB Borden, LH Curtis… - Circulation, 2017 - Am Heart Assoc
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 …

Factors influencing harmonized health data collection, sharing and linkage in Denmark and Switzerland: A systematic review

LD Geneviève, A Martani, MC Mallet, T Wangmo… - PloS one, 2019 - journals.plos.org
Introduction The digitalization of medicine has led to a considerable growth of
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 …

[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 …

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 …

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 …

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 …

Think pragmatically: Investigators' obligations to patient-subjects when research is embedded in care

S Morain, E Largent - The American Journal of Bioethics, 2023 - Taylor & Francis
Growing interest in embedded research approaches—where research is incorporated into
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 …

Making the ethical oversight of all clinical trials fit for purpose

NE Kass, RR Faden, DC Angus, SR Morain - JAMA, 2024 - jamanetwork.com
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 …