2016
Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees
Li RH, Wacholtz MC, Barnes M, Boggs L, Callery-D'Amico S, Davis A, Digilova A, Forster D, Heffernan K, Luthin M, Lynch HF, McNair L, Miller JE, Murphy J, Van Campen L, Wilenzick M, Wolf D, Woolston C, Aldinger C, Bierer BE. Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees. Journal Of Medical Ethics 2016, 42: 229. PMID: 26811365, PMCID: PMC4819642, DOI: 10.1136/medethics-2014-102540.Peer-Reviewed Original ResearchConceptsResearch ethics committee reviewResearch ethics issuesCritical ethical issuesEthics committee reviewEthical principlesEthics issuesEthics reviewEthics sectionEthical issuesClinical research protocolsEthics CommitteeProtocol writersCommittee reviewProtocol approvalResearch protocolReview processTool kitIssuesMultinational settingClinical Trial CenterDeliberationHarvardClinical trial protocolSpecific attentionWriters
2015
Gatekeepers for pragmatic clinical trials
Whicher DM, Miller JE, Dunham KM, Joffe S. Gatekeepers for pragmatic clinical trials. Clinical Trials 2015, 12: 442-448. PMID: 26374683, PMCID: PMC4592478, DOI: 10.1177/1740774515597699.Peer-Reviewed Original ResearchMeSH KeywordsBiomedical ResearchClinical Trials as TopicDecision MakingHumansResearch DesignUnited StatesThe ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials
Welch MJ, Lally R, Miller JE, Pittman S, Brodsky L, Caplan AL, Uhlenbrauck G, Louzao DM, Fischer JH, Wilfond B. The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials. Clinical Trials 2015, 12: 503-510. PMID: 26374681, PMCID: PMC4662375, DOI: 10.1177/1740774515597701.Peer-Reviewed Original ResearchConceptsPragmatic clinical trialsClinical trialsPregnant womenVulnerable populationsClinical trial settingsMental disabilitiesPhysical handicapTraditional clinical trialsDisadvantaged personsVulnerable subjectsTrial settingsHealth interventionsClinical settingClinical researchTrialsNeonatesFetusesWomenSubjectsDisabilityChildrenVulnerable research subjectsPopulationSpecific recommendationsPersons