Publication Source Type
  
Document Type
  
Topics
  
  
Keywords
Affiliation
Authors
Count= 151
  
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
Ryan; Implementation Science; Clinician engagement; Practice-based research; Translational research; Community relations
RAND Health, Santa Monica, CA, USA. kahn@rand.org.
Ryan G, et al.
  
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
Beckett; Implementation Science; Community-based participatory research; Clinician engagement; Practice-based research
RAND Health, Santa Monica, California, USA. kahn@rand.org.
Beckett M, et al.
  
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
Kahn; Implementation Science; Clinician engagement; Translational research; Community practitioners; Basic science
RAND Health, Santa Monica, California, USA. kahn@rand.org.
Kahn K, et al.
  
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
Weijer; Ottawa Statement; Ottawa Ethics of Cluster Randomized Trials Consensus Group; Cluster randomized trial; CRT; Gatekeepers; Gatekeeping; Vulnerable populations; Research ethics; Institutional review board; IRB; PLOS Medicine
Rotman Institute of Philosophy, Department of Philosophy, Western University, London, Ontario, Canada; Department of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
Weijer C, et al.
  
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
Marquis; Randomization; Risk assessment; Journal of Medical Philosophy
Department of Philosophy, University of Kansas, Lawrence, KS, 66045, U.S.A
Marquis D
  
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
Largent; Hastings Center Report; Human subject protection; Risk assessment
Harvard University, USA
Largent EA, et al.
  
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
Truog; New England Journal of Medicine; NEJM; Randomized controlled trial; RCT; Risk assessment; Human subject protection; Institutional review board; IRB; Nuremburg Code; Declaration of Helsinki; Waiver of informed consent
Children’s Hospital, Boston, MA 02115 (Truog, Robinson, Randolph)
University of Utah School of Medicine, Salt Lake City, UT 84143  (Morris)
Truog RD, et al.
  
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
Greene; Group Health Cooperative; Learning healthcare system; Patient-centered research; Patient-centered healthcare; Annals of Internal Medicine; Healthcare delivery
Group Health Cooperative
Greene SM, et al.
  
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
Rein; AcademyHealth; Patient-centered research; Comparative effectiveness research; CER; Policy research
AcademyHealth; Electronic Data Methods (EDM) Forum; Agency for Healthcare Research and Quality (AHRQ)
Rein A, et al.
  
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
Pladevall; HMO Research Network; HMORN; Cluster randomized trial; CRT; Randomization; Multi-site trial
HMO Research Network (HMORN); Group Health Cooperative, 320 Westlake Avenue North, GHQ E2N, Seattle, WA 98109, USA., Thompson.e@ghc.org.; Center for Health Services Research, Henry Ford Health System, University of Western Ontario, London, Ontario
Pladevall M, et al.
  
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
Ridpath; Group Health Research Institute; Plain language; Readability; Patient education; Health literacy; Template
Group Health Research Institute
Ridpath JR, et al.
  
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
Multicenter researchHealth Care Systems Research Network; HCSRN
Health Care Systems Research Network (HCSRN), formerly the HMO Research Network (HMORN)
  
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
Ottawa Hospital Research Institute; OHRI; Clinical equipoise; Cluster randomized trial; CRT; Gatekeeping; Vulnerable populations; Guidelines
Ottawa Hospital Research Institute (OHRI)
Ottawa Hospital Research Institute (OHRI)
  
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
Human subject protection; Ethical oversight; Hastings Center Report; Beauchamp; Data collection; Data monitoring; Learning healthcare system
Multiple affiliations, see article.
Beauchamp TL, et al.
  
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
Ascher; Early Human Development; Cohort study; Sepsis/complications; Heart defects/congenital; Neonatal intensive care unit; NICU; Congenital heart disease; CHD
Duke University
Ascher SB, et al.
  
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
Learning healthcare system; Large simple trials; Patient engagement; Comparative effectiveness research; CER
Institute of Medicine (IOM)
Institute of Medicine (IOM)
  
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
Sonnad; Center for Medical Technology Policy; CMTP; Pragmatic clinical trial; PCT; Guidance; Phase 3; Ethics issues
Center for Medical Technology Policy (CTMP) www.cmtpnet.org
Sonnad S, et al.
  
This is a CDISC-sponsored webinar highlighting the ESTEL initiative.External SourceVideoLearning healthcare system; Data standards and interoperability; Electronic phenotypes3/1/2013
Friedman; Clinical Data Interchange Standards Consortium; CDISC; Data standards; Learning healthcare system
CDISC; University of Michigan; NorthShore University Health System; Joseph A Kanter Family Foundation; Oz Systems

Friedman C, et al.
  
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
Human subject protection; Ethical principles; Voluntary consent
  
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
World Medical Association; WMA; Human subject protection; Ethical principles; Helsinki Declaration
World Medical Association (WMA)
World Medical Association (WMA)
  
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
Council for International Organizations of Medical Sciences; CIOMS; Human subject protection; International guidelines
Council for International Organizations of Medical Sciences
(CIOMS)
Council for International Organizations of Medical Sciences
(CIOMS)
  
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
Getz; Applied Clinical Trials; Informed consent; Good clinical practice; GCP; Institutional review board; IRB
Getz KA
  
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
Mackintosh; Applied Clinical Trials; Informed consent; Readability of consent forms; Code of Federal Regulations; CFR; Good clinical practice; GCP; Case report form
Mackintosh DR; Molloy VJ
  
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
National Cancer Institute; NCI; Cancer trials; Informed consent form; Consent form template
National Cancer Institute (NCI)
National Cancer Institute (NCI)
  
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
National Human Genome Research Institute; NIH; Informed consent; Genomic; Research ethics
  
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
National Cancer Institute; NCI; Biorepositories; Tool; Template; Informed consent; Patient education; Cancer clinical trials
National Cancer Institute (NCI)
National Cancer Institute (NCI)
  
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
McGuire; Annual Review of Genomics and Human Genetics; Genomics research; Genetics research; Informed consent; Biospecimen management; Biorepository; Data sharing; Privacy; DNA
McGuire AL; Beskow LM
  
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
Beskow; PLOS One; Informed consent form; Biorepository; Biospecimen management; Genomic research; DNA; Population-based biospecimen bank; Common rule; HIPAA; Privacy
Beskow LM, et al.
  
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
Agency for Heatlhcare Research and Quality; AHRQ; Regulatory requirements; Human subject protection; Informed consent form; Protected health information; PHI; HIPAA; Health literacy
Agency for Heatlhcare Research and Quality (AHRQ)
Agency for Heatlhcare Research and Quality (AHRQ)
  
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
National Institutes of Health; Plain language; Health literacy; Patient education; Low-literate readers
National Institutes of Health
National Institutes of Health
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