{"id":"https://openalex.org/W3004718596","doi":"https://doi.org/10.1186/s12961-019-0520-4","title":"Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands","display_name":"Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands","publication_year":2020,"publication_date":"2020-01-28","ids":{"openalex":"https://openalex.org/W3004718596","doi":"https://doi.org/10.1186/s12961-019-0520-4","mag":"3004718596","pmid":"https://pubmed.ncbi.nlm.nih.gov/31992320","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/6986069"},"language":"en","primary_location":{"id":"doi:10.1186/s12961-019-0520-4","doi":"https://doi.org/10.1186/s12961-019-0520-4","is_oa":true,"landing_page_url":"https://doi.org/10.1186/s12961-019-0520-4","pdf_url":"https://health-policy-systems.biomedcentral.com/track/pdf/10.1186/s12961-019-0520-4.pdf","source":{"id":"https://openalex.org/S201446958","display_name":"Health Research Policy and Systems","issn_l":"1478-4505","issn":["1478-4505"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-scientific","cwts-core","doaj","dongbi-c","jufo-2","ki-jl-1","medline","norway-1","oarl","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320256","host_organization_name":"BioMed Central","host_organization_lineage":["https://openalex.org/P4310320256","https://openalex.org/P4310319965"],"host_organization_lineage_names":["BioMed Central","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Health Research Policy and Systems","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://health-policy-systems.biomedcentral.com/track/pdf/10.1186/s12961-019-0520-4.pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5059857721","display_name":"Anna Mae Scott","orcid":"https://orcid.org/0000-0002-0109-9001","observed_orcids":["https://orcid.org/0000-0002-0109-9001"]},"institutions":[{"id":"https://openalex.org/I120125038","display_name":"Bond University","ror":"https://ror.org/006jxzx88","country_code":"AU","type":"education","lineage":["https://openalex.org/I120125038"]}],"countries":["AU"],"is_corresponding":true,"raw_author_name":"Anna Mae Scott","raw_affiliation_strings":["Institute for Evidence-Based Healthcare, Bond University, 14 University Drive, Robina, QLD, 4226, Australia. ascott@bond.edu.au","Institute for Evidence-Based Healthcare, Bond University, 14 University Drive, Robina, QLD, 4226, Australia"],"raw_orcid":"https://orcid.org/0000-0002-0109-9001","affiliations":[{"raw_affiliation_string":"Institute for Evidence-Based Healthcare, Bond University, 14 University Drive, Robina, QLD, 4226, Australia. ascott@bond.edu.au","institution_ids":["https://openalex.org/I120125038"]},{"raw_affiliation_string":"Institute for Evidence-Based Healthcare, Bond University, 14 University Drive, Robina, QLD, 4226, Australia","institution_ids":["https://openalex.org/I120125038"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5000213185","display_name":"Simon Erik Kolstoe","orcid":"https://orcid.org/0000-0003-1472-3966","observed_orcids":["https://orcid.org/0000-0003-1472-3966"]},"institutions":[{"id":"https://openalex.org/I63072094","display_name":"University of Portsmouth","ror":"https://ror.org/03ykbk197","country_code":"GB","type":"education","lineage":["https://openalex.org/I63072094"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Simon Kolstoe","raw_affiliation_strings":["University of Portsmouth, Portsmouth, UK"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Portsmouth, Portsmouth, UK","institution_ids":["https://openalex.org/I63072094"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5082183178","display_name":"M.C. Ploem","orcid":"https://orcid.org/0000-0003-1466-0619","observed_orcids":["https://orcid.org/0000-0003-1466-0619"]},"institutions":[{"id":"https://openalex.org/I4210151833","display_name":"Amsterdam University Medical Centers","ror":"https://ror.org/05grdyy37","country_code":"NL","type":"healthcare","lineage":["https://openalex.org/I4210151833"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"M. C. ( Corrette) Ploem","raw_affiliation_strings":["Amsterdam University Medical Centre, Amsterdam, The Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Amsterdam University Medical Centre, Amsterdam, The Netherlands","institution_ids":["https://openalex.org/I4210151833"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5012901113","display_name":"Zo\u00eb H. Hammatt","orcid":"https://orcid.org/0000-0003-1960-785X","observed_orcids":["https://orcid.org/0000-0003-1960-785X"]},"institutions":[{"id":"https://openalex.org/I117965899","display_name":"University of Hawai\u02bbi at M\u0101noa","ror":"https://ror.org/01wspgy28","country_code":"US","type":"education","lineage":["https://openalex.org/I117965899"]},{"id":"https://openalex.org/I1331384533","display_name":"University of Hawaii System","ror":"https://ror.org/03tzaeb71","country_code":"US","type":"education","lineage":["https://openalex.org/I1331384533"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Zo\u00eb Hammatt","raw_affiliation_strings":["John A. Burns School of Medicine, University of Hawaii, Honolulu, USA","Z Consulting LLC, Denver, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"John A. Burns School of Medicine, University of Hawaii, Honolulu, USA","institution_ids":["https://openalex.org/I117965899","https://openalex.org/I1331384533"]},{"raw_affiliation_string":"Z Consulting LLC, Denver, USA","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5005751643","display_name":"Paul Glasziou","orcid":"https://orcid.org/0000-0001-7564-073X","observed_orcids":["https://orcid.org/0000-0001-7564-073X"]},"institutions":[{"id":"https://openalex.org/I120125038","display_name":"Bond University","ror":"https://ror.org/006jxzx88","country_code":"AU","type":"education","lineage":["https://openalex.org/I120125038"]}],"countries":["AU"],"is_corresponding":false,"raw_author_name":"Paul Glasziou","raw_affiliation_strings":["Institute for Evidence-Based Healthcare, Bond University, 14 University Drive, Robina, QLD, 4226, Australia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Institute for Evidence-Based Healthcare, Bond University, 14 University Drive, Robina, QLD, 4226, Australia","institution_ids":["https://openalex.org/I120125038"]}]}],"institutions":[],"countries_distinct_count":4,"institutions_distinct_count":5,"corresponding_author_ids":["https://openalex.org/A5059857721"],"corresponding_institution_ids":["https://openalex.org/I120125038"],"apc_list":{"value":2680,"currency":"USD","value_usd":2680},"apc_paid":{"value":2680,"currency":"USD","value_usd":2680},"fwci":6.0359,"has_fulltext":true,"cited_by_count":49,"citation_normalized_percentile":{"value":0.97148553,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":93,"max":99},"biblio":{"volume":"18","issue":"1","first_page":"11","last_page":"11"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10582","display_name":"Ethics in Clinical Research","score":0.9955999851226807,"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":0.9955999851226807,"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/T13417","display_name":"Biomedical Ethics and Regulation","score":0.003000000026077032,"subfield":{"id":"https://openalex.org/subfields/2910","display_name":"Issues, ethics and legal aspects"},"field":{"id":"https://openalex.org/fields/29","display_name":"Nursing"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T13147","display_name":"Ethics and bioethics in healthcare","score":0.00039999998989515007,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/research-ethics-review","display_name":"research ethics review","score":0.8309999704360962},{"id":"https://openalex.org/keywords/research-waste","display_name":"research waste","score":0.7829999923706055},{"id":"https://openalex.org/keywords/research-regulation","display_name":"research regulation","score":0.5860000252723694},{"id":"https://openalex.org/keywords/randomized-controlled-trials","display_name":"randomized controlled trials","score":0.7639999985694885},{"id":"https://openalex.org/keywords/post-marketing-studies","display_name":"post-marketing studies","score":0.7649999856948853},{"id":"https://openalex.org/keywords/research-ethics-committees","display_name":"research ethics committees","score":0.4959999918937683},{"id":"https://openalex.org/keywords/australia","display_name":"Australia","score":0.6610000133514404},{"id":"https://openalex.org/keywords/united-kingdom","display_name":"United Kingdom","score":0.996999979019165},{"id":"https://openalex.org/keywords/united-states","display_name":"United States","score":1.0},{"id":"https://openalex.org/keywords/netherlands","display_name":"Netherlands","score":1.0}],"concepts":[{"id":"https://openalex.org/C153997805","wikidata":"https://www.wikidata.org/wiki/Q42240","display_name":"Research ethics","level":2,"score":0.6280213594436646},{"id":"https://openalex.org/C138816342","wikidata":"https://www.wikidata.org/wiki/Q189603","display_name":"Public health","level":2,"score":0.5906189680099487},{"id":"https://openalex.org/C199521495","wikidata":"https://www.wikidata.org/wiki/Q181487","display_name":"Audit","level":2,"score":0.5804988145828247},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.5398918390274048},{"id":"https://openalex.org/C2780877353","wikidata":"https://www.wikidata.org/wiki/Q2518253","display_name":"Health services research","level":3,"score":0.5333224534988403},{"id":"https://openalex.org/C39549134","wikidata":"https://www.wikidata.org/wiki/Q133080","display_name":"Public relations","level":1,"score":0.4390195906162262},{"id":"https://openalex.org/C2780378061","wikidata":"https://www.wikidata.org/wiki/Q25351891","display_name":"Service (business)","level":2,"score":0.4350982904434204},{"id":"https://openalex.org/C2992130261","wikidata":"https://www.wikidata.org/wiki/Q1331083","display_name":"Human research","level":2,"score":0.4338516891002655},{"id":"https://openalex.org/C137992405","wikidata":"https://www.wikidata.org/wiki/Q1137608","display_name":"Health administration","level":3,"score":0.4133555293083191},{"id":"https://openalex.org/C47344431","wikidata":"https://www.wikidata.org/wiki/Q1519812","display_name":"Health policy","level":3,"score":0.4116972088813782},{"id":"https://openalex.org/C99454951","wikidata":"https://www.wikidata.org/wiki/Q932068","display_name":"Environmental health","level":1,"score":0.3837089538574219},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.3419150114059448},{"id":"https://openalex.org/C159110408","wikidata":"https://www.wikidata.org/wiki/Q121176","display_name":"Nursing","level":1,"score":0.25747379660606384},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.23129069805145264},{"id":"https://openalex.org/C121955636","wikidata":"https://www.wikidata.org/wiki/Q4116214","display_name":"Accounting","level":1,"score":0.15529203414916992},{"id":"https://openalex.org/C15744967","wikidata":"https://www.wikidata.org/wiki/Q9418","display_name":"Psychology","level":0,"score":0.12087064981460571},{"id":"https://openalex.org/C118552586","wikidata":"https://www.wikidata.org/wiki/Q7867","display_name":"Psychiatry","level":1,"score":0.0},{"id":"https://openalex.org/C188147891","wikidata":"https://www.wikidata.org/wiki/Q147638","display_name":"Cognitive science","level":1,"score":0.0},{"id":"https://openalex.org/C162853370","wikidata":"https://www.wikidata.org/wiki/Q39809","display_name":"Marketing","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D001315","descriptor_name":"Australia","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004526","descriptor_name":"Efficiency","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006113","descriptor_name":"United Kingdom","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006302","descriptor_name":"Health Services Research","qualifier_ui":"Q000941","qualifier_name":"ethics","is_major_topic":true},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D009426","descriptor_name":"Netherlands","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011634","descriptor_name":"Public Health","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012107","descriptor_name":"Research Design","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D017408","descriptor_name":"Guidelines as Topic","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D018570","descriptor_name":"Risk Assessment","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D028744","descriptor_name":"Ethics Committees, Research","qualifier_ui":"Q000458","qualifier_name":"organization & administration","is_major_topic":true},{"descriptor_ui":"D028744","descriptor_name":"Ethics Committees, Research","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D035843","descriptor_name":"Biomedical Research","qualifier_ui":"Q000941","qualifier_name":"ethics","is_major_topic":true}],"locations_count":7,"locations":[{"id":"doi:10.1186/s12961-019-0520-4","doi":"https://doi.org/10.1186/s12961-019-0520-4","is_oa":true,"landing_page_url":"https://doi.org/10.1186/s12961-019-0520-4","pdf_url":"https://health-policy-systems.biomedcentral.com/track/pdf/10.1186/s12961-019-0520-4.pdf","source":{"id":"https://openalex.org/S201446958","display_name":"Health Research Policy and Systems","issn_l":"1478-4505","issn":["1478-4505"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-scientific","cwts-core","doaj","dongbi-c","jufo-2","ki-jl-1","medline","norway-1","oarl","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320256","host_organization_name":"BioMed Central","host_organization_lineage":["https://openalex.org/P4310320256","https://openalex.org/P4310319965"],"host_organization_lineage_names":["BioMed Central","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Health Research Policy and Systems","raw_type":"journal-article"},{"id":"pmh:oai:pubmedcentral.nih.gov:6986069","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/6986069","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":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Health Res Policy Syst","raw_type":"Text"},{"id":"pmid:31992320","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/31992320","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":"Health research policy and systems","raw_type":"Journal Article"},{"id":"pmh:oai:pure.amsterdamumc.nl:openaire/a5c7f0d0-544f-4884-880c-340c5472fa6c","doi":null,"is_oa":true,"landing_page_url":"https://pure.amsterdamumc.nl/en/publications/a5c7f0d0-544f-4884-880c-340c5472fa6c","pdf_url":null,"source":{"id":"https://openalex.org/S7407055222","display_name":"Pure Amsterdam UMC","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Scott, A M, Kolstoe, S, Ploem, M C, Hammatt, Z & Glasziou, P 2020, 'Exempting low-risk health and medical research from ethics reviews: Comparing Australia, the United Kingdom, the United States and the Netherlands', Health research policy and systems / BioMed Central, vol. 18, no. 1, 11. https://doi.org/10.1186/s12961-019-0520-4","raw_type":"info:eu-repo/semantics/article"},{"id":"pmh:oai:https://pure.bond.edu.au/:openaire/1b1e3198-1d95-459a-834c-441b6ed88c37","doi":null,"is_oa":true,"landing_page_url":"https://research.bond.edu.au/en/publications/1b1e3198-1d95-459a-834c-441b6ed88c37","pdf_url":null,"source":{"id":"https://openalex.org/S4306402608","display_name":"Bond University Research Portal (Bond University)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I120125038","host_organization_name":"Bond University","host_organization_lineage":["https://openalex.org/I120125038"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Scott, A M, Kolstoe, S, Ploem, M C, Hammatt, Z & Glasziou, P 2020, 'Exempting low-risk health and medical research from ethics reviews: Comparing Australia, the United Kingdom, the United States and the Netherlands', Health Research Policy and Systems, vol. 18, no. 1, 11. https://doi.org/10.1186/s12961-019-0520-4","raw_type":"info:eu-repo/semantics/article"},{"id":"pmh:amcpub:oai:pure.amc.nl:publications/d8a43c4a-4531-4c1c-8e5f-6037e4cd3e92","doi":null,"is_oa":true,"landing_page_url":"https://pure.amc.nl/en/publications/exempting-lowrisk-health-and-medical-research-from-ethics-reviews-comparing-australia-the-united-kingdom-the-united-states-and-the-netherlands(d8a43c4a-4531-4c1c-8e5f-6037e4cd3e92).html","pdf_url":null,"source":{"id":"https://openalex.org/S4306401843","display_name":"Data Archiving and Networked Services (DANS)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1322597698","host_organization_name":"Royal Netherlands Academy of Arts and Sciences","host_organization_lineage":["https://openalex.org/I1322597698"],"host_organization_lineage_names":[],"type":"repository"},"license":"other-oa","license_id":"https://openalex.org/licenses/other-oa","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Health research policy and systems / BioMed Central, 18(1):11. BioMed Central","raw_type":"info:eu-repo/semantics/article"},{"id":"pmh:oai:doaj.org/article:41224e209a5747cc916294737ad52ab7","doi":null,"is_oa":true,"landing_page_url":"https://doaj.org/article/41224e209a5747cc916294737ad52ab7","pdf_url":null,"source":{"id":"https://openalex.org/S4306401280","display_name":"DOAJ (DOAJ: Directory of Open Access Journals)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-sa","license_id":"https://openalex.org/licenses/cc-by-sa","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Health Research Policy and Systems, Vol 18, Iss 1, Pp 1-8 (2020)","raw_type":"article"}],"best_oa_location":{"id":"doi:10.1186/s12961-019-0520-4","doi":"https://doi.org/10.1186/s12961-019-0520-4","is_oa":true,"landing_page_url":"https://doi.org/10.1186/s12961-019-0520-4","pdf_url":"https://health-policy-systems.biomedcentral.com/track/pdf/10.1186/s12961-019-0520-4.pdf","source":{"id":"https://openalex.org/S201446958","display_name":"Health Research Policy and Systems","issn_l":"1478-4505","issn":["1478-4505"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-scientific","cwts-core","doaj","dongbi-c","jufo-2","ki-jl-1","medline","norway-1","oarl","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320256","host_organization_name":"BioMed Central","host_organization_lineage":["https://openalex.org/P4310320256","https://openalex.org/P4310319965"],"host_organization_lineage_names":["BioMed Central","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Health Research Policy and Systems","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.4043000042438507,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[{"id":"https://openalex.org/F4320334626","display_name":"Medical Research Council","ror":"https://ror.org/03x94j517"},{"id":"https://openalex.org/F4320334705","display_name":"National Health and Medical Research Council","ror":"https://ror.org/011kf5r70"}],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W3004718596.pdf","grobid_xml":"https://content.openalex.org/works/W3004718596.grobid-xml"},"referenced_works_count":26,"referenced_works":["https://openalex.org/W1593948158","https://openalex.org/W1962742475","https://openalex.org/W1966640106","https://openalex.org/W1990997033","https://openalex.org/W1996361420","https://openalex.org/W2035678416","https://openalex.org/W2050436486","https://openalex.org/W2052818669","https://openalex.org/W2063092020","https://openalex.org/W2072951333","https://openalex.org/W2087730640","https://openalex.org/W2110764899","https://openalex.org/W2116218164","https://openalex.org/W2116842641","https://openalex.org/W2124674666","https://openalex.org/W2129167322","https://openalex.org/W2156812612","https://openalex.org/W2165324769","https://openalex.org/W2166557932","https://openalex.org/W2169495394","https://openalex.org/W2169877598","https://openalex.org/W2186574084","https://openalex.org/W2275558578","https://openalex.org/W2791780666","https://openalex.org/W2810653172","https://openalex.org/W2912638152"],"related_works":["https://openalex.org/W3127785573","https://openalex.org/W3119551060","https://openalex.org/W2296926894","https://openalex.org/W7155754467","https://openalex.org/W203441751","https://openalex.org/W1756309210","https://openalex.org/W2586905956","https://openalex.org/W2309279202","https://openalex.org/W4310598468","https://openalex.org/W2765632391"],"abstract_inverted_index":{"BACKGROUND:":[0],"Disproportionate":[1],"regulation":[2],"of":[3,14,16,29,42,115,135,159,196,238],"health":[4,45],"and":[5,32,46,61,84,102,113,124,127,176,179,185,212,214,236,251,255,264],"medical":[6,47],"research":[7,10,17,34,48,72,116,136,168,205,239,242],"contributes":[8],"to":[9,26,39,262],"waste.":[11,35],"Better":[12],"understanding":[13],"exemptions":[15],"from":[18,50,119,139,241],"ethics":[19,51,73,120,140,243,256],"review":[20,30],"in":[21,53,74,171,189,208],"different":[22],"jurisdictions":[23],"may":[24],"help":[25],"guide":[27],"modification":[28],"processes":[31],"reduce":[33],"Our":[36],"aim":[37],"was":[38],"identify":[40],"examples":[41,126],"low-risk":[43],"human":[44],"exempt":[49,118,138,188,240],"reviews":[52,121,141,244],"Australia,":[54],"the":[55,58,62,81,94,103,143,248],"United":[56,59],"Kingdom,":[57],"States":[60],"Netherlands.":[63],"METHODS:":[64],"We":[65],"examined":[66],"documents":[67],"providing":[68],"national":[69],"guidance":[70,267],"on":[71,106,253,268],"each":[75],"country,":[76],"including":[77],"those":[78],"authored":[79],"by":[80,220,229],"National":[82,89],"Health":[83,90],"Medical":[85],"Research":[86,98,107],"Council":[87],"(Australia),":[88],"Service":[91],"(United":[92,100],"Kingdom),":[93],"Office":[95],"for":[96],"Human":[97],"Protections":[99],"States)":[101],"Central":[104],"Committee":[105],"Involving":[108],"Humans":[109],"(the":[110],"Netherlands).":[111],"Examples":[112,235],"types":[114,128,237],"projects":[117],"were":[122,129,137,147,187,218,227],"identified,":[123],"similar":[125],"grouped":[130],"together.":[131],"RESULTS:":[132],"Nine":[133],"categories":[134,193,226],"across":[142],"four":[144],"countries;":[145],"these":[146],"existing":[148],"data":[149,184],"or":[150,153,162,199,231],"specimen,":[151],"questionnaire":[152],"survey,":[154],"interview,":[155],"post-marketing":[156],"study,":[157],"evaluation":[158,195,216],"public":[160,197],"benefit":[161,198],"service":[163,177,200,215],"programme,":[164,201],"randomised":[165,202],"controlled":[166,203],"trials,":[167,204],"with":[169,206,271,273],"staff":[170,207],"their":[172,209],"professional":[173,210],"role,":[174,211],"audit":[175,213],"evaluation,":[178],"other":[180],"exemptions.":[181],"Existing":[182],"non-identifiable":[183],"specimens":[186],"all":[190],"countries.":[191,233],"Four":[192],"-":[194,217],"exempted":[219,228],"one":[221],"country":[222],"each.":[223],"The":[224],"remaining":[225],"two":[230],"three":[232],"CONCLUSIONS:":[234],"varied":[245],"considerably.":[246],"Given":[247],"considerable":[249],"costs":[250],"burdens":[252],"researchers":[254],"committees,":[257],"it":[258],"would":[259],"be":[260],"worthwhile":[261],"develop":[263],"provide":[265],"clearer":[266],"exemptions,":[269],"illustrated":[270],"examples,":[272],"transparent":[274],"underpinning":[275],"rationales.":[276]},"counts_by_year":[{"year":2026,"cited_by_count":4},{"year":2025,"cited_by_count":7},{"year":2024,"cited_by_count":5},{"year":2023,"cited_by_count":11},{"year":2022,"cited_by_count":10},{"year":2021,"cited_by_count":10},{"year":2020,"cited_by_count":2}],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2020-02-14T00:00:00"}