{"id":"https://openalex.org/W1966166136","doi":"https://doi.org/10.1542/peds.2014-3041","title":"Advancing Informed Consent for Vulnerable Populations","display_name":"Advancing Informed Consent for Vulnerable Populations","publication_year":2015,"publication_date":"2015-02-26","ids":{"openalex":"https://openalex.org/W1966166136","doi":"https://doi.org/10.1542/peds.2014-3041","mag":"1966166136","pmid":"https://pubmed.ncbi.nlm.nih.gov/25713286","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/4338326"},"language":"en","primary_location":{"id":"doi:10.1542/peds.2014-3041","doi":"https://doi.org/10.1542/peds.2014-3041","is_oa":false,"landing_page_url":"https://doi.org/10.1542/peds.2014-3041","pdf_url":null,"source":{"id":"https://openalex.org/S77494981","display_name":"PEDIATRICS","issn_l":"0031-4005","issn":["0031-4005","1098-4275"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","dongbi-a","doyens","erih-plus","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315734","host_organization_name":"American Academy of Pediatrics","host_organization_lineage":["https://openalex.org/P4310315734"],"host_organization_lineage_names":["American Academy of Pediatrics"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pediatrics","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/4338326","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5028826375","display_name":"William J. Heerman","orcid":"https://orcid.org/0000-0002-9706-6860","observed_orcids":["https://orcid.org/0000-0002-9706-6860"]},"institutions":[{"id":"https://openalex.org/I901861585","display_name":"Vanderbilt University Medical Center","ror":"https://ror.org/05dq2gs74","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210162197","https://openalex.org/I901861585"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Willliam J. Heerman","raw_affiliation_strings":["Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee; and","aDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee; and"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee; and","institution_ids":["https://openalex.org/I901861585"]},{"raw_affiliation_string":"aDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee; and","institution_ids":["https://openalex.org/I901861585"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5014821968","display_name":"Richard O. White","orcid":"https://orcid.org/0000-0002-4608-3134","observed_orcids":["https://orcid.org/0000-0002-4608-3134"]},"institutions":[{"id":"https://openalex.org/I4210146710","display_name":"Mayo Clinic in Florida","ror":"https://ror.org/03zzw1w08","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1330342723","https://openalex.org/I4210146710"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Richard O. White","raw_affiliation_strings":["Division of Community Internal Medicine, Mayo Clinic, Jacksonville, Florida"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Division of Community Internal Medicine, Mayo Clinic, Jacksonville, Florida","institution_ids":["https://openalex.org/I4210146710"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5051873239","display_name":"Shari L. Barkin","orcid":"https://orcid.org/0000-0003-1585-3818","observed_orcids":["https://orcid.org/0000-0003-1585-3818"]},"institutions":[{"id":"https://openalex.org/I901861585","display_name":"Vanderbilt University Medical Center","ror":"https://ror.org/05dq2gs74","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210162197","https://openalex.org/I901861585"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Shari L. Barkin","raw_affiliation_strings":["Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee; and"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee; and","institution_ids":["https://openalex.org/I901861585"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":3.2123,"has_fulltext":false,"cited_by_count":33,"citation_normalized_percentile":{"value":0.91012131,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":89,"max":99},"biblio":{"volume":"135","issue":"3","first_page":"e562","last_page":"e564"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10582","display_name":"Ethics in Clinical Research","score":0.9976000189781189,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10582","display_name":"Ethics in Clinical Research","score":0.9976000189781189,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T13147","display_name":"Ethics and bioethics in healthcare","score":0.0015999999595806003,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10737","display_name":"Health Literacy and Information Accessibility","score":0.0003000000142492354,"subfield":{"id":"https://openalex.org/subfields/3600","display_name":"General Health Professions"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/informed-consent","display_name":"informed consent","score":1.0},{"id":"https://openalex.org/keywords/health-literacy","display_name":"health literacy","score":0.7860000133514404},{"id":"https://openalex.org/keywords/vulnerable-populations","display_name":"vulnerable populations","score":0.7300000190734863},{"id":"https://openalex.org/keywords/visual-aids","display_name":"visual aids","score":0.7260000109672546},{"id":"https://openalex.org/keywords/research-with-children","display_name":"research with children","score":0.7409999966621399},{"id":"https://openalex.org/keywords/underrepresented-minorities","display_name":"underrepresented minorities","score":0.8629999756813049},{"id":"https://openalex.org/keywords/research-ethics","display_name":"research ethics","score":0.6930000185966492},{"id":"https://openalex.org/keywords/pediatric-research","display_name":"pediatric research","score":0.5090000033378601}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9728870391845703},{"id":"https://openalex.org/C68122502","wikidata":"https://www.wikidata.org/wiki/Q764527","display_name":"Informed consent","level":3,"score":0.7127766609191895},{"id":"https://openalex.org/C512399662","wikidata":"https://www.wikidata.org/wiki/Q3505712","display_name":"Family medicine","level":1,"score":0.40739303827285767},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.139340341091156},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.085539311170578}],"mesh":[{"descriptor_ui":"D002648","descriptor_name":"Child","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D002648","descriptor_name":"Child","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D002648","descriptor_name":"Child","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007258","descriptor_name":"Informed Consent","qualifier_ui":"Q000941","qualifier_name":"ethics","is_major_topic":false},{"descriptor_ui":"D007258","descriptor_name":"Informed Consent","qualifier_ui":"Q000941","qualifier_name":"ethics","is_major_topic":false},{"descriptor_ui":"D007258","descriptor_name":"Informed Consent","qualifier_ui":"Q000941","qualifier_name":"ethics","is_major_topic":false},{"descriptor_ui":"D009765","descriptor_name":"Obesity","qualifier_ui":"Q000453","qualifier_name":"epidemiology","is_major_topic":false},{"descriptor_ui":"D009765","descriptor_name":"Obesity","qualifier_ui":"Q000453","qualifier_name":"epidemiology","is_major_topic":false},{"descriptor_ui":"D009765","descriptor_name":"Obesity","qualifier_ui":"Q000453","qualifier_name":"epidemiology","is_major_topic":false},{"descriptor_ui":"D009765","descriptor_name":"Obesity","qualifier_ui":"Q000517","qualifier_name":"prevention & control","is_major_topic":false},{"descriptor_ui":"D009765","descriptor_name":"Obesity","qualifier_ui":"Q000517","qualifier_name":"prevention & control","is_major_topic":false},{"descriptor_ui":"D009765","descriptor_name":"Obesity","qualifier_ui":"Q000517","qualifier_name":"prevention & control","is_major_topic":false},{"descriptor_ui":"D014943","descriptor_name":"Global Health","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014943","descriptor_name":"Global Health","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014943","descriptor_name":"Global Health","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D015995","descriptor_name":"Prevalence","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D015995","descriptor_name":"Prevalence","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D015995","descriptor_name":"Prevalence","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D035843","descriptor_name":"Biomedical Research","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D035843","descriptor_name":"Biomedical Research","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D035843","descriptor_name":"Biomedical Research","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D035862","descriptor_name":"Vulnerable Populations","qualifier_ui":"Q000523","qualifier_name":"psychology","is_major_topic":false},{"descriptor_ui":"D035862","descriptor_name":"Vulnerable Populations","qualifier_ui":"Q000523","qualifier_name":"psychology","is_major_topic":false},{"descriptor_ui":"D035862","descriptor_name":"Vulnerable Populations","qualifier_ui":"Q000523","qualifier_name":"psychology","is_major_topic":false}],"locations_count":3,"locations":[{"id":"doi:10.1542/peds.2014-3041","doi":"https://doi.org/10.1542/peds.2014-3041","is_oa":false,"landing_page_url":"https://doi.org/10.1542/peds.2014-3041","pdf_url":null,"source":{"id":"https://openalex.org/S77494981","display_name":"PEDIATRICS","issn_l":"0031-4005","issn":["0031-4005","1098-4275"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","dongbi-a","doyens","erih-plus","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315734","host_organization_name":"American Academy of Pediatrics","host_organization_lineage":["https://openalex.org/P4310315734"],"host_organization_lineage_names":["American Academy of Pediatrics"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pediatrics","raw_type":"journal-article"},{"id":"pmh:oai:pubmedcentral.nih.gov:4338326","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/4338326","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pediatrics","raw_type":"Text"},{"id":"pmid:25713286","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/25713286","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pediatrics","raw_type":"Journal Article"}],"best_oa_location":{"id":"pmh:oai:pubmedcentral.nih.gov:4338326","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/4338326","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pediatrics","raw_type":"Text"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being","score":0.9476000070571899},{"id":"https://metadata.un.org/sdg/10","display_name":"Reduced inequalities","score":0.7578999996185303}],"sustainable_development_goals_aurora":[{"id":"https://metadata.un.org/sdg/4","display_name":"Quality education","score":0.8999999761581421}],"study_designs":[],"awards":[{"id":"https://openalex.org/G219020131","display_name":null,"funder_award_id":"UL1-TR000135","funder_id":"https://openalex.org/F4320337472","funder_display_name":"National Center for Advancing Translational Sciences"},{"id":"https://openalex.org/G3015807127","display_name":"Mayo Clinic Center for Clinical and Translational Science (CCaTS)","funder_award_id":"5ul1tr000135-10","funder_id":"https://openalex.org/F4320332161","funder_display_name":"National Institutes of Health"},{"id":"https://openalex.org/G582251131","display_name":null,"funder_award_id":"U01HL103620","funder_id":"https://openalex.org/F4320337338","funder_display_name":"National Heart, Lung, and Blood Institute"},{"id":"https://openalex.org/G592453377","display_name":"THE VANDERBILT PCOR CAREER KNOWLEDGE, EDUCATION AND TRAINING PROGRAM","funder_award_id":"K12HS022990","funder_id":"https://openalex.org/F4320332177","funder_display_name":"Agency for Healthcare Research and Quality"},{"id":"https://openalex.org/G6689842647","display_name":null,"funder_award_id":"U01HL03620-03","funder_id":"https://openalex.org/F4320337338","funder_display_name":"National Heart, Lung, and Blood Institute"},{"id":"https://openalex.org/G6744843878","display_name":null,"funder_award_id":"1K12HS022990","funder_id":"https://openalex.org/F4320332177","funder_display_name":"Agency for Healthcare Research and Quality"},{"id":"https://openalex.org/G7773456091","display_name":"The Vanderbilt Institute for Clinical and Translational Research (VICTR)","funder_award_id":"UL1TR000445","funder_id":"https://openalex.org/F4320332161","funder_display_name":"National Institutes of Health"},{"id":"https://openalex.org/G8213183930","display_name":"Health Communication & Health Literacy to Improve Care for Latinos with Diabetes","funder_award_id":"K23DK092470","funder_id":"https://openalex.org/F4320337357","funder_display_name":"National Institute of Diabetes and Digestive and Kidney Diseases"}],"funders":[{"id":"https://openalex.org/F4320332161","display_name":"National Institutes of Health","ror":"https://ror.org/01cwqze88"},{"id":"https://openalex.org/F4320332177","display_name":"Agency for Healthcare Research and Quality","ror":"https://ror.org/03jmfdf59"},{"id":"https://openalex.org/F4320337338","display_name":"National Heart, Lung, and Blood Institute","ror":"https://ror.org/012pb6c26"},{"id":"https://openalex.org/F4320337357","display_name":"National Institute of Diabetes and Digestive and Kidney Diseases","ror":"https://ror.org/00adh9b73"},{"id":"https://openalex.org/F4320337472","display_name":"National Center for Advancing Translational Sciences","ror":"https://ror.org/04pw6fb54"}],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":7,"referenced_works":["https://openalex.org/W1845083756","https://openalex.org/W2035616688","https://openalex.org/W2060917232","https://openalex.org/W2140245628","https://openalex.org/W2499590469","https://openalex.org/W4243634801","https://openalex.org/W4293154792"],"related_works":["https://openalex.org/W1920035136","https://openalex.org/W2008501802","https://openalex.org/W2052948254","https://openalex.org/W1988735056","https://openalex.org/W3118573882","https://openalex.org/W2740602275","https://openalex.org/W4243614516","https://openalex.org/W2742649941","https://openalex.org/W388299109","https://openalex.org/W2336428847"],"abstract_inverted_index":{"Informed":[0],"consent":[1,16,104,121,199],"is":[2,17,36,91,174],"essential":[3],"for":[4,170],"the":[5,26,84,99,102,128,154,197],"conduct":[6],"of":[7,98,145,156,196,226,245],"ethical":[8],"biomedical":[9],"research.1":[10],"Despite":[11],"its":[12],"importance,":[13],"obtaining":[14],"informed":[15,88,103,198],"often":[18,109,122],"a":[19,95,138,186,224],"complex":[20],"process,":[21],"which":[22,29],"raises":[23],"concerns":[24],"about":[25],"extent":[27],"to":[28,79,87,135,217,234,239],"participants":[30,41,50,116,142],"are":[31,51,108,132,166,190,203,208],"truly":[32,126],"informed.":[33],"Effective":[34],"implementation":[35],"especially":[37],"difficult":[38],"among":[39],"research":[40,115],"who":[42,117],"have":[43,150],"limited":[44],"health":[45],"literacy.":[46],"Often,":[47],"these":[48],"potential":[49],"from":[52],"traditionally":[53],"high-risk":[54],"groups,":[55],"including":[56],"underrepresented":[57],"minorities":[58],"and":[59,76,81,106,112,163,185],"children.":[60],"With":[61],"this":[62],"in":[63,143,153,211],"mind,":[64],"we":[65,177],"suggest":[66],"an":[67,214,227],"innovative":[68],"approach":[69,86,220],"that":[70,130,179],"uses":[71],"low":[72],"health-literacy":[73],"communication":[74],"strategies":[75],"visual":[77],"aids":[78],"augment":[80],"potentially":[82],"replace":[83],"traditional":[85],"consent.\n\nThe":[89],"tension":[90],"clear.":[92],"To":[93],"provide":[94],"comprehensive":[96],"review":[97],"proposed":[100],"research,":[101],"document":[105],"process":[107],"lengthy,":[110],"complex,":[111],"burdensome.2":[113],"Consequently,":[114],"sign":[118],"or":[119],"verbalize":[120],"do":[123],"so":[124],"without":[125],"understanding":[127,152,173],"form":[129],"they":[131],"being":[133,209],"asked":[134],"sign.":[136],"In":[137],"recent":[139],"systematic":[140],"review,":[141],"one-third":[144],"trials":[146],"assessed":[147],"did":[148],"not":[149],"adequate":[151],"areas":[155],"risks,":[157],"benefits,":[158],"randomization,":[159],"study":[160],"aims,":[161],"withdrawal,":[162],"voluntarism.3":[164],"There":[165],"no":[167],"clear":[168],"standards":[169],"\u201chow":[171],"much\u201d":[172],"adequate.":[175],"Furthermore,":[176],"know":[178],"lower":[180,183],"education":[181],"levels,":[182],"literacy,":[184],"participant\u2019s":[187],"primary":[188],"language":[189],"all":[191],"associated":[192],"with":[193],"poor":[194],"comprehension":[195],"process.4":[200],"These":[201],"issues":[202],"particularly":[204],"important":[205],"when":[206],"studies":[207],"done":[210],"children,":[212],"adding":[213],"additional":[215],"dimension":[216],"vulnerable":[218],"populations.\n\nOur":[219],"was":[221],"developed":[222],"as":[223],"part":[225],"ongoing":[228],"randomized":[229],"controlled":[230],"trial":[231],"(RCT)":[232],"designed":[233],"prevent":[235],"\u2026":[236],"\n\nAddress":[237],"correspondence":[238],"William":[240],"Heerman,":[241],"MD,":[242],"MPH,":[243],"Department":[244],"Pediatrics,":[246],"Vanderbilt":[247],"University":[248],"Medical":[249],"Center,":[250],"2146":[251],"Belcourt":[252],"Ave,":[253],"2nd":[254],"Fl,":[255],"Nashville,":[256],"TN":[257],"37212.":[258],"E-mail:":[259],"bill.heerman{at}vanderbilt.edu":[260]},"counts_by_year":[{"year":2026,"cited_by_count":4},{"year":2025,"cited_by_count":1},{"year":2024,"cited_by_count":2},{"year":2023,"cited_by_count":3},{"year":2022,"cited_by_count":2},{"year":2021,"cited_by_count":2},{"year":2020,"cited_by_count":7},{"year":2019,"cited_by_count":3},{"year":2018,"cited_by_count":4},{"year":2017,"cited_by_count":1},{"year":2016,"cited_by_count":4}],"updated_date":"2026-10-29T09:56:32.521200","created_date":"2016-06-24T00:00:00"}
