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Count= 143
  
This is a proposal to support community clinicians using research support organizations, community outreach, a web-based registry of clinicians and studies, web-based training services, quality audits, and a feedback mechanism.External Source; PubMedJournal ArticleClinical research; Stakeholder engagement; Provider-health system interactions4/1/2011
  
The authors outline approaches that healthcare organizations can use to encourage clinicians to participate in research.External Source; PubMedJournal ArticleClinical research; Stakeholder engagement; Provider-health system interactions4/1/2011
  
Acknowledgement of the value of clinicians in the context of community research, establishment of a stable infrastructure, and incentives to encourage participation in clinical research.External Source; PubMedJournal Article4/1/2011
  
The Ottawa Statement sets out 15 recommendations for the ethical design and conduct of cluster randomized trials.External Source; PubMedJournal ArticleCluster randomized trial; Informed consent and human subjects protection; Research ethics11/1/2012
  
The author argues that prerandomization must be either unsuccessful or unethical.External Source; PubMedJournal ArticleClinical research; Informed consent and human subjects protection; Research ethics11/1/1986
  
Discussion on the current ethical boundaries between clinical research and medicine and how integration may improve patient care.External Source; PubMedJournal ArticleResearch ethics; Clinical research8/1/2011
  
Authors argue that the current approach to informed consent is at least partially off target; patients are often “protected” from clinical trials under circumstances in which the risks are virtually nil.External Source; PubMedJournal ArticleClinical research; Informed consent and human subjects protection; Research ethics3/1/1999
  
This article describes an evolving learning health system at Group Health Cooperative, the 6 phases characterizing its approach, and examples of organization-wide applications.External Source; PubMedJournal ArticleElectronic health records; Learning healthcare system; Implementation8/1/2012
  
This framework for patient and consumer engagement sets forth expanded opportunities for involving patients and consumers in comparative effectiveness research (CER), patient-centered outcomes research (PCOR), and Quality Improvement (QI).External Source; ePublicationPresentation; TextPatient engagement; Stakeholder engagement; Patient-centered research9/1/2012
  
This guide was developed to help investigators and project coordinators in the HMO Research Network organize and conduct cluster randomized trials (CRTs). It highlights key planning and operational challenges in multi-site CRTs and offers recommendations.External Source; ePublicationToolkitCluster randomized trial; Network policies & governance; Research ethics; Provider-health system interactions; Study design3/1/2008
  
The PRISM Readability Toolkit is a compendium of strategies, real-world examples, and related resources to aid researchers and others in the healthcare setting create materials that potential study participants can easily understand.External Source; ePublicationToolkitInformed consent and human subjects protection; Patient-centered research6/1/2010
  
The HCSRN brings together the research departments of some of the nation's best and most innovative health care systems. External Source; ePublicationWebsiteClinical research; Data privacy & security; Data sharing; Electronic health records10/1/2012
  
These are documents from the Ottawa Hospital Research Institute (OHRI), whose goal is to produce international consensus guidelines for the ethical conduct and ethics review of CRTs.External SourceWebsite; VideoCluster randomized trial; Informed consent and human subjects protection; Research ethics12/1/2007
  
This special supplement is dedicated to articles and commentaries with a focus on research in health care by considering changes to the current ethical framework. External SourceReport1/1/2013
  
This study evaluated the impact of sepsis on mortality in a large multicenter cohort of infants with congenital heart disease admitted to the NICU.External Source; PubMedJournal ArticleData analysis5/1/2012
  
These are reports on a series of workshops on the topic of Learning Healthcare, including the pivotal 2007 report.External Source; ePublicationReport; WebsiteLearning healthcare system; Pragmatic clinical trial; Provider-health system interactions; Stakeholder engagement9/1/2013
  
The goal of this effectiveness guidance document is to provide specific recommendations to guide the implementation of more pragmatic study designs for phase 3 pharmaceutical trials.External Source; ePublicationReportComparative effectiveness research; Pragmatic clinical trial; Study design; Stakeholder engagement9/1/2010
  
This is a CDISC-sponsored webinar highlighting the ESTEL initiative.External SourceVideoLearning healthcare system; Data standards and interoperability; Electronic phenotypes3/1/2013
  
This code is a set of research ethics principles for experiments involving human subjects.External SourceReportClinical research; Informed consent and human subjects protection; Research ethics12/1/1947
  
This is the 7th revision of the Helsinki Declaration, adopted by the World Medical Association in 1964 (revised October 2013).External SourceReportInformed consent and human subjects protection; Research ethics10/1/2013
  
This is the revised and updated edition of the Council for International Organizations of Medical Sciences' International Ethical Guidelines for Biomedical Research Involving Human Subjects.External SourceReportInformed consent and human subjects protection; Research ethics12/1/2002
  
This article discusses shortcomings in the consent process and possible ways to address them.External SourceJournal ArticleClinical research; Informed consent and human subjects protection; Research ethics11/1/2002
  
Improving the informed consent process and consent forms not only helps subjects better understand clinical research but also reduces the number of invalid consents obtained.External SourceJournal ArticleClinical research; Informed consent and human subjects protection5/1/2003
  
This document provides a template to follow when developing consent forms for the majority of oncology trials. External SourceReportClinical research; Informed consent and human subjects protection; Research ethics2/1/2013
  
These online materials assist the research community with development of informed consent materials for genomics-related research projects such as genome-wide association (GWA) and genome sequencing studies.External SourceText; WebsiteInformed consent and human subjects protection; Research ethics5/1/2012
  
These documents were developed by members of the Group Banking Committee and already are in use in some Cooperative Group trials.External SourceTemplateInformed consent and human subjects protection; Research ethics3/1/2011
  
This article discusses the challenges of informed consent for genetic and genomic research and considers alternative consent models.External SourceJournal ArticleRegistries and biorepositories; Informed consent and human subjects protection; Research ethics11/1/2010
  
This article discusses the feasibility of creating a simplified consent form for biobanking that comprises the minimum information necessary to meet ethical and regulatory requirements.External Source; PubMedJournal ArticleInformed consent and human subjects protection; Research ethics; Registries and biorepositories; Regulatory issues10/1/2010
  
This toolkit is designed to facilitate the process of obtaining informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization from potential research subjects. External SourceToolkitInformed consent and human subjects protection; Research ethics; Regulatory issues11/1/2009
  
A process outlined by the National Institutes of Health to assist writers in effectively communicating health information to people with limited-literacy skills.External SourceText; WebsiteImplementation; Informed consent and human subjects protection; Research ethics9/1/2015
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