{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T08:15:24Z","timestamp":1787991324411,"version":"build-2784847793"},"reference-count":67,"publisher":"BMJ","issue":"11","license":[{"start":{"date-parts":[[2024,11,23]],"date-time":"2024-11-23T00:00:00Z","timestamp":1732320000000},"content-version":"unspecified","delay-in-days":22,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010269","name":"Wellcome Trust","doi-asserted-by":"publisher","award":["227155\/Z\/23\/Z"],"award-info":[{"award-number":["227155\/Z\/23\/Z"]}],"id":[{"id":"10.13039\/100010269","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001352","name":"National University of Singapore","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001352","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,9,26]]},"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:sec>\n<jats:title>Objectives<\/jats:title>\n<jats:p>Randomised trials for the management of drug-resistant infections are challenging to conduct as target patient populations often lack decision-making capacity, and enrolment windows are typically short. Improving informed consent and risk communication in these trials is especially crucial for protecting patient interests and maximising trial efficiency. This study aimed to understand challenges in risk communication and informed consent in antimicrobial clinical trials.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Design<\/jats:title>\n<jats:p>Scoping review.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Data sources<\/jats:title>\n<jats:p>Searches were conducted in Embase, Medline, CINAHL and Web of Science Core for peer-reviewed English articles that were published from January 2000 to April 2023.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Eligibility criteria<\/jats:title>\n<jats:p>Included articles were empirical studies or expert opinions that sought experts\u2019, patients\u2019 or representatives\u2019 opinions on informed consent in the context of clinical trials involving antibiotic\/anti-infective agents.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Data extraction and synthesis<\/jats:title>\n<jats:p>Abstract screening, full-text review, data extraction and evidence rating were performed by two independent reviewers. Extracted data were summarised and reported qualitatively based on common themes. A total of 2330 records were retrieved, and 29 articles were included in the review.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>Half of the articles involving medical experts and one-third involving patients and representatives reported that full comprehension by patients and representatives was challenging or not achievable. Healthcare providers and consent takers were crucial for the quality of informed consent. The level of trust consent givers placed on healthcare providers had a critical influence on the consent rate. Emotional distress was pervasive among patients\/representatives.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Conclusion<\/jats:title>\n<jats:p>The findings indicate that strengthening consent takers\u2019 communication skills in providing emotional support to patients and their representatives may improve informed consent. More research is needed to understand informed consent in low-income and middle-income and non-English-speaking countries.<\/jats:p>\n<\/jats:sec>","DOI":"10.1136\/bmjopen-2023-082096","type":"journal-article","created":{"date-parts":[[2024,11,29]],"date-time":"2024-11-29T04:58:33Z","timestamp":1732856313000},"page":"e082096","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Informed consent and risk communication challenges in antimicrobial clinical trials: a scoping review"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct03163095","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct13704894","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct46635087","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct15830435","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct7954844","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct7954844","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct53994660","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct53994660","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct15830435","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02800785","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7386-0031","authenticated-orcid":false,"given":"Yiyun","family":"Shou","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joey Elizabeth","family":"Yeo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander Shao-Rong","family":"Pang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David L.","family":"Paterson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0216-9550","authenticated-orcid":false,"given":"Yin","family":"Mo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,11,24]]},"reference":[{"key":"2024112411351098000_14.11.e082096.1","unstructured":"Chorzelski S , Grosch B , Rentmeister H , et al . Report for the german guard initiative: breaking through the wall. In: Enhancing Research and Development of Antibiotics in Science and Industry [Internet]. Berlin, Available: https:\/\/www.bundesgesundheitsministerium.de\/fileadmin\/Dateien\/3_Downloads\/G\/G7\/Qualita_etswettbewerb_Gesundheitssystem_Whitepaper_2015-10-02_Kurz_engl_....pdf"},{"key":"2024112411351098000_14.11.e082096.2","doi-asserted-by":"crossref","first-page":"611","DOI":"10.1056\/NEJMoa2304748","article-title":"Cefepime-Taniborbactam in Complicated Urinary Tract Infection","volume":"390","author":"Wagenlehner","year":"2024","journal-title":"N Engl J Med"},{"key":"2024112411351098000_14.11.e082096.3","doi-asserted-by":"crossref","first-page":"1327","DOI":"10.1056\/NEJMoa2105462","article-title":"Oral Tebipenem Pivoxil Hydrobromide in Complicated Urinary Tract Infection","volume":"386","author":"Eckburg","year":"2022","journal-title":"N Engl J Med"},{"key":"2024112411351098000_14.11.e082096.4","doi-asserted-by":"publisher","DOI":"10.1016\/j.surg.2005.08.014"},{"key":"2024112411351098000_14.11.e082096.5","doi-asserted-by":"crossref","DOI":"10.1186\/s13063-020-04969-w","article-title":"The reality of informed consent: empirical studies on patient comprehension-systematic review","volume":"22","author":"Pietrzykowski","year":"2021","journal-title":"Trials"},{"key":"2024112411351098000_14.11.e082096.6","doi-asserted-by":"crossref","first-page":"1472","DOI":"10.1016\/j.jclinepi.2015.03.002","article-title":"Elements of informed consent and decision quality were poorly correlated in informed consent documents","volume":"68","author":"Brehaut","year":"2015","journal-title":"J Clin Epidemiol"},{"key":"2024112411351098000_14.11.e082096.7","doi-asserted-by":"publisher","DOI":"10.1111\/jnu.12097"},{"key":"2024112411351098000_14.11.e082096.8","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2011-000496","article-title":"Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review","volume":"2","author":"Fletcher","year":"2012","journal-title":"BMJ Open"},{"key":"2024112411351098000_14.11.e082096.9","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1000368","article-title":"Strategies for increasing recruitment to randomised controlled trials: systematic review","volume":"7","author":"Caldwell","year":"2010","journal-title":"PLoS Med"},{"key":"2024112411351098000_14.11.e082096.10","unstructured":"National Library of Medicine . nformed Consent - MeSH - NCBI, 1973. Available: https:\/\/www.ncbi.nlm.nih.gov\/mesh\/68007258"},{"key":"2024112411351098000_14.11.e082096.11","doi-asserted-by":"publisher","DOI":"10.1037\/\/0033-295X.102.2.269"},{"key":"2024112411351098000_14.11.e082096.12","doi-asserted-by":"crossref","unstructured":"Smithson M . Understanding uncertainty. Dealing with uncertainties in policing serious crime. 2010;16:27. doi:10.22459\/DUPSC.05.2010.03","DOI":"10.22459\/DUPSC.05.2010.03"},{"key":"2024112411351098000_14.11.e082096.13","doi-asserted-by":"crossref","first-page":"1945","DOI":"10.1016\/j.pec.2021.01.034","article-title":"The communication of uncertainty in health: A scoping review","volume":"104","author":"Kalke","year":"2021","journal-title":"Pat Educ Couns"},{"key":"2024112411351098000_14.11.e082096.14","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsa021212"},{"key":"2024112411351098000_14.11.e082096.15","doi-asserted-by":"crossref","first-page":"2381468319840322","DOI":"10.1177\/2381468319840322","article-title":"The Challenges of Informed Consent in High-Stakes, Randomized Oncology Trials: A Systematic Review","volume":"4","author":"Nathe","year":"2019","journal-title":"MDM Policy Pract"},{"key":"2024112411351098000_14.11.e082096.16","doi-asserted-by":"publisher","DOI":"10.1177\/1740774520971770"},{"key":"2024112411351098000_14.11.e082096.17","doi-asserted-by":"crossref","DOI":"10.1186\/s13063-020-04591-w","article-title":"Nocebo effects and participant information leaflets: evaluating information provided on adverse effects in UK clinical trials","volume":"21","author":"Kirby","year":"2020","journal-title":"Trials"},{"key":"2024112411351098000_14.11.e082096.18","doi-asserted-by":"publisher","DOI":"10.1007\/s11606-012-2133-2"},{"key":"2024112411351098000_14.11.e082096.19","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(06)70576-9"},{"key":"2024112411351098000_14.11.e082096.20","doi-asserted-by":"publisher","DOI":"10.2471\/BLT.14.141390"},{"key":"2024112411351098000_14.11.e082096.21","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2020.01.008"},{"key":"2024112411351098000_14.11.e082096.22","unstructured":"Veritas Health Innovation . Covidence systematic review software, Melbourne, Australia, Available: www.covidence.org"},{"key":"2024112411351098000_14.11.e082096.23","unstructured":"American Medical Association . JAMA Network Open Instructions for Authors - Ratings of the quality of the evidence. 2023. Available: https:\/\/jamanetwork.com\/journals\/jama\/pages\/instructions-for-authors"},{"key":"2024112411351098000_14.11.e082096.24","doi-asserted-by":"crossref","first-page":"810","DOI":"10.1016\/j.ajog.2015.05.047","article-title":"Should pregnant women be included in phase IV clinical drug trials?","volume":"213","author":"Briggs","year":"2015","journal-title":"Am J Obstet Gynecol"},{"key":"2024112411351098000_14.11.e082096.25","doi-asserted-by":"crossref","unstructured":"Corneli A , Calvert SB , Powers JH , et al . Consensus on Language for Advance Informed Consent in Health Care-Associated Pneumonia Clinical Trials Using a Delphi Process. JAMA Netw Open 2020;3. doi:10.1001\/jamanetworkopen.2020.5435","DOI":"10.1001\/jamanetworkopen.2020.5435"},{"key":"2024112411351098000_14.11.e082096.26","doi-asserted-by":"crossref","DOI":"10.1186\/s13017-019-0259-9","article-title":"Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis","volume":"14","author":"Doig","year":"2019","journal-title":"World J Emerg Surg"},{"key":"2024112411351098000_14.11.e082096.27","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1383\/anes.2006.7.1.5","article-title":"Ethics of clinical trials","volume":"7","author":"Green","year":"2006","journal-title":"Anaesth & Intensive Care Med"},{"key":"2024112411351098000_14.11.e082096.28","doi-asserted-by":"publisher","DOI":"10.1111\/j.1471-8847.2008.00238.x"},{"key":"2024112411351098000_14.11.e082096.29","doi-asserted-by":"crossref","first-page":"S29","DOI":"10.1093\/cid\/ciw258","article-title":"Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team","volume":"63 Suppl 2","author":"Knirsch","year":"2016","journal-title":"Clin Infect Dis"},{"key":"2024112411351098000_14.11.e082096.30","first-page":"421","article-title":"The Era of Valid Informed Consent Informed Consent","volume":"22","author":"Menache","year":"2003","journal-title":"Med & L"},{"key":"2024112411351098000_14.11.e082096.31","doi-asserted-by":"crossref","unstructured":"Monach PA , Branch-Elliman W . Reconsidering minimal risk\u2019 to expand the repertoire of trials with waiver of informed consent for research. BMJ Open 2021;11.","DOI":"10.1136\/bmjopen-2020-048534"},{"key":"2024112411351098000_14.11.e082096.32","doi-asserted-by":"crossref","first-page":"8","DOI":"10.2174\/1574884716666210427115820","article-title":"The Patient Motivation Pyramid and Patient-Centricity in Early Clinical Development","volume":"17","author":"Iersel","year":"2022","journal-title":"Curr Rev Clin Exp Pharmacol"},{"key":"2024112411351098000_14.11.e082096.33","doi-asserted-by":"crossref","DOI":"10.1186\/s13063-020-04357-4","article-title":"Cluster randomised trials of prescribing policy: an ethical approach to generating drug safety evidence? A discussion of the ethical application of a new research method","volume":"21","author":"Rogers","year":"2020","journal-title":"Trials"},{"key":"2024112411351098000_14.11.e082096.34","doi-asserted-by":"crossref","first-page":"805","DOI":"10.1016\/j.ajog.2022.07.037","article-title":"Scientific, ethical, and legal considerations for the inclusion of pregnant people in clinical trials","volume":"227","author":"Sewell","year":"2022","journal-title":"Am J Obstet Gynecol"},{"key":"2024112411351098000_14.11.e082096.35","doi-asserted-by":"crossref","DOI":"10.1186\/1745-6215-14-247","article-title":"Consent, including advanced consent, of older adults to research in care homes: a qualitative study of stakeholders\u2019 views in South Wales","volume":"14","author":"Wood","year":"2013","journal-title":"Trials"},{"key":"2024112411351098000_14.11.e082096.36","doi-asserted-by":"crossref","first-page":"1446","DOI":"10.1513\/AnnalsATS.202203-250VP","article-title":"The Potential for Increasing Risk of Consent Refusal in COVID-19 Trials: Considering Underlying Reasons and Responses","volume":"19","author":"Russell","year":"2022","journal-title":"Ann Am Thorac Soc"},{"key":"2024112411351098000_14.11.e082096.37","doi-asserted-by":"crossref","first-page":"358","DOI":"10.1136\/jme.28.6.358","article-title":"The ethics of prophylactic antibiotics for neurosurgical procedures","volume":"28","author":"Savitz","year":"2002","journal-title":"J Med Ethics"},{"key":"2024112411351098000_14.11.e082096.38","doi-asserted-by":"crossref","DOI":"10.1001\/jamanetworkopen.2018.5816","article-title":"Assessment of the Perceived Acceptability of an Early Enrollment Strategy Using Advance Consent in Health Care-Associated Pneumonia","volume":"1","author":"Corneli","year":"2018","journal-title":"JAMA Netw Open"},{"key":"2024112411351098000_14.11.e082096.39","doi-asserted-by":"crossref","first-page":"33","DOI":"10.1016\/j.conctc.2017.11.005","article-title":"Parents\u2019 perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative","volume":"9","author":"Greenberg","year":"2018","journal-title":"Contemp Clin Trials Commun"},{"key":"2024112411351098000_14.11.e082096.40","doi-asserted-by":"crossref","first-page":"735","DOI":"10.1007\/s00431-019-03555-w","article-title":"Parental preferences in treatment of acute uncomplicated appendicitis comparing surgery to conservative management with antibiotics and their views on research participation","volume":"179","author":"Kyaw","year":"2020","journal-title":"Eur J Pediatr"},{"key":"2024112411351098000_14.11.e082096.41","doi-asserted-by":"publisher","DOI":"10.1002\/art.11057"},{"key":"2024112411351098000_14.11.e082096.42","doi-asserted-by":"publisher","DOI":"10.1136\/qshc.2005.015636"},{"key":"2024112411351098000_14.11.e082096.43","doi-asserted-by":"crossref","DOI":"10.1186\/s12887-020-02040-w","article-title":"Enhancing communication, informed consent and recruitment in a paediatric urgent care surgical trial: a qualitative study","volume":"20","author":"Sherratt","year":"2020","journal-title":"BMC Pediatr"},{"key":"2024112411351098000_14.11.e082096.44","doi-asserted-by":"crossref","first-page":"2042","DOI":"10.1111\/hex.12371","article-title":"Consent revisited: the impact of return of results on participants\u2019 views and expectations about trial participation","volume":"18","author":"Tarrant","year":"2015","journal-title":"Health Expect"},{"key":"2024112411351098000_14.11.e082096.45","doi-asserted-by":"crossref","first-page":"1011","DOI":"10.1007\/s40264-020-00959-8","article-title":"The Effect of Positively Framing Side-Effect Risk in Two Different Formats on Side-Effect Expectations, Informed Consent and Credibility: A Randomised Trial of 16- to 75-Year-Olds in England","volume":"43","author":"Webster","year":"2020","journal-title":"Drug Saf"},{"key":"2024112411351098000_14.11.e082096.46","doi-asserted-by":"publisher","DOI":"10.1177\/1740774512453219"},{"key":"2024112411351098000_14.11.e082096.47","doi-asserted-by":"publisher","DOI":"10.1136\/medethics-2020-106807"},{"key":"2024112411351098000_14.11.e082096.48","doi-asserted-by":"crossref","first-page":"103","DOI":"10.1027\/2512-8442\/a000125","article-title":"What Is the Benefit of Adding Placebo Side-Effect Information to Positively Framed Patient Leaflets?","volume":"30","author":"Saadi","year":"2023","journal-title":"Eur J Health Psychol"},{"key":"2024112411351098000_14.11.e082096.49","doi-asserted-by":"crossref","first-page":"357","DOI":"10.1016\/j.jss.2022.10.089","article-title":"A Video-Based Consent Tool: Development and Effect of Risk\u2013Benefit Framing on Intention to Randomize","volume":"283","author":"Lois","year":"2023","journal-title":"J Surg Res"},{"key":"2024112411351098000_14.11.e082096.50","doi-asserted-by":"crossref","DOI":"10.1186\/1745-6215-11-11","article-title":"Feasibility study to inform the design of a randomised controlled trial to eradicate Pseudomonas aeruginosa infection in individuals with cystic fibrosis","volume":"11","author":"Hickey","year":"2010","journal-title":"Trials"},{"key":"2024112411351098000_14.11.e082096.51","doi-asserted-by":"crossref","first-page":"92","DOI":"10.1310\/7DYD-J14R-X2WJ-VTDN","article-title":"The challenges of human subject research in the new millenium","volume":"9","author":"Kirschner","year":"2003","journal-title":"Top Stroke Rehabil"},{"key":"2024112411351098000_14.11.e082096.52","doi-asserted-by":"publisher","DOI":"10.1007\/s00431-016-2715-9"},{"key":"2024112411351098000_14.11.e082096.53","doi-asserted-by":"publisher","DOI":"10.1037\/0033-2909.127.2.267"},{"key":"2024112411351098000_14.11.e082096.54","doi-asserted-by":"crossref","first-page":"649","DOI":"10.1080\/10615806.2021.1994143","article-title":"Immediate emotions and subjective stakes in risky decision-making under uncertainty","volume":"35","author":"Zhang","year":"2022","journal-title":"Anxiety, Stress, Coping Abbreviated form: A, S, & C"},{"key":"2024112411351098000_14.11.e082096.55","doi-asserted-by":"publisher","DOI":"10.1177\/0272989X14547740"},{"key":"2024112411351098000_14.11.e082096.56","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1037\/xlm0000419","article-title":"Fast or frugal, but not both: Decision heuristics under time pressure","volume":"44","author":"Bobadilla-Suarez","year":"2018","journal-title":"J Exp Psychol Learn Mem Cogn"},{"key":"2024112411351098000_14.11.e082096.57","doi-asserted-by":"crossref","unstructured":"Gilovich T , Griffin D , Kahneman D . Heuristics and biases: the psychology of intuitive judgment. Cambridge, UK; New York: Cambridge University Press, 2002.","DOI":"10.1017\/CBO9780511808098"},{"key":"2024112411351098000_14.11.e082096.58","doi-asserted-by":"crossref","first-page":"e602","DOI":"10.1093\/cid\/ciaa1712","article-title":"Trends in Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia Trials","volume":"73","author":"Bart","year":"2021","journal-title":"Clin Infect Dis"},{"key":"2024112411351098000_14.11.e082096.59","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0248263","article-title":"Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: A systematic review","volume":"16","author":"Patterson","year":"2021","journal-title":"PLoS One"},{"key":"2024112411351098000_14.11.e082096.60","doi-asserted-by":"crossref","DOI":"10.1186\/s12936-021-03732-z","article-title":"From informed consent to adherence: factors influencing involvement in mass drug administration with ivermectin for malaria elimination in The Gambia","volume":"20","author":"Fehr","year":"2021","journal-title":"Malar J"},{"key":"2024112411351098000_14.11.e082096.61","first-page":"26","article-title":"Informed consent in an antiretroviral trial in Nigeria","volume":"4","author":"Manafa","year":"2007","journal-title":"IJME"},{"key":"2024112411351098000_14.11.e082096.62","doi-asserted-by":"crossref","first-page":"248","DOI":"10.1111\/dewb.12069","article-title":"To What did They Consent? Understanding Consent Among Low Literacy Participants in a Microbicide Feasibility Study in Mazabuka, Zambia","volume":"15","author":"Munalula-Nkandu","year":"2015","journal-title":"Dev World Bioeth"},{"key":"2024112411351098000_14.11.e082096.63","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pntd.0005545","article-title":"Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa","volume":"11","author":"Carazo Perez","year":"2017","journal-title":"PLoS Negl Trop Dis"},{"key":"2024112411351098000_14.11.e082096.64","doi-asserted-by":"crossref","first-page":"e145","DOI":"10.1016\/S2214-109X(22)00460-0","article-title":"Expanding access to biotherapeutics in low-income and middle-income countries through public health non-exclusive voluntary intellectual property licensing: considerations, requirements, and opportunities","volume":"11","author":"Morin","year":"2023","journal-title":"Lancet Glob Health"},{"key":"2024112411351098000_14.11.e082096.65","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-444-53501-6.00025-1"},{"key":"2024112411351098000_14.11.e082096.66","unstructured":"NIMHD . Diversity and Inclusion in Clinical Trials, Available: https:\/\/nimhd.nih.gov\/resources\/understanding-health-disparities\/diversity-and-inclusion-in-clinical-trials.html"},{"key":"2024112411351098000_14.11.e082096.67","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1542\/peds.2017-2092","article-title":"Retrospective Consent in a Neonatal Randomized Controlled Trial","volume":"141","author":"Songstad","year":"2018","journal-title":"Pediatrics"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2023-082096","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,29]],"date-time":"2024-11-29T04:59:03Z","timestamp":1732856343000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2023-082096"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11]]},"references-count":67,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2024,11,24]]},"published-print":{"date-parts":[[2024,11]]}},"alternative-id":["10.1136\/bmjopen-2023-082096"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2023-082096","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,11]]}}}