{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T05:53:38Z","timestamp":1793253218716,"version":"4.5.0"},"reference-count":30,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2021,5,20]],"date-time":"2021-05-20T00:00:00Z","timestamp":1621468800000},"content-version":"unspecified","delay-in-days":19,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute of Health Research, UK","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Glob Health"],"accepted":{"date-parts":[[2021,4,24]]},"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Time-critical neonatal trials in low-and-middle-income countries (LMICs) raise several ethical issues. Using a qualitative-dominant mixed-methods design, we explored informed consent process in Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial conducted in India, Sri Lanka and Bangladesh.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Term infants with neonatal encephalopathy, aged less than 6\u2009hours, were randomly allocated to cooling therapy or usual care, following informed parental consent. The consenting process was audio-video (A-V) recorded in all cases. We analysed A-V records of the consent process using a 5-point Likert scale on three parameters\u2014empathy, information and autonomy. In addition, we used exploratory observation method to capture relevant aspects of consent process and discussions between parents and professionals. Finally, we conducted in-depth interviews with a subgroup of 20 parents and 15 healthcare professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 294 A-V records of the HELIX trial were analysed. Median (IQR) score for empathy, information and autonomy was 5 (0), 5 (1) and 5 (1), respectively. However, thematic analysis suggested that the consenting was a ceremonial process; and parental decision to participate was based on unreserved trust in the treating doctors, therapeutic misconception and access to an expensive treatment free of cost. Most parents did not understand the concept of a clinical trial nor the nature of the intervention. Professionals showed a strong bias towards cooling therapy and reported time constraints and explaining to multiple family members as key challenges.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Despite rigorous research governance and consent process, parental decisions were heavily influenced by situational incapacity and a trust in doctors to make the right decision on their behalf. Further research is required to identify culturally and context-appropriate strategies for informed trial participation.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjgh-2021-005757","type":"journal-article","created":{"date-parts":[[2021,5,21]],"date-time":"2021-05-21T12:15:40Z","timestamp":1621599340000},"page":"e005757","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":13,"title":["Parental and professional perceptions of informed consent and participation in a time-critical neonatal trial: a mixed-methods study in India, Sri Lanka and Bangladesh"],"prefix":"10.1136","volume":"6","clinical-trial-number":[{"clinical-trial-number":"nct02387385","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3912-5965","authenticated-orcid":false,"given":"Stuti","family":"Pant","sequence":"first","affiliation":[{"name":"Centre for Perinatal Neuroscience, Imperial College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3855-0801","authenticated-orcid":false,"given":"Maya Annie","family":"Elias","sequence":"additional","affiliation":[{"name":"Perinatal Trials Unit Foundation, Bengaluru, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kerry","family":"Woolfall","sequence":"additional","affiliation":[{"name":"Institute of Population Health, University of Liverpool, Liverpool, Merseyside, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Moreno","family":"Morales","sequence":"additional","affiliation":[{"name":"Centre for Perinatal Neuroscience, Imperial College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bensitta","family":"Lincy","sequence":"additional","affiliation":[{"name":"Perinatal Trials Unit Foundation, Chennai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ismat","family":"Jahan","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Dhaka District, Bangladesh"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samanmali P","family":"Sumanasena","sequence":"additional","affiliation":[{"name":"Disability Studies Department, University of Kelaniya, Kelaniya, Sri Lanka"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siddarth","family":"Ramji","sequence":"additional","affiliation":[{"name":"Pediatrics, Maulana Azad Medical College, New Delhi, Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seetha","family":"Shankaran","sequence":"additional","affiliation":[{"name":"Neonatal- Perinatal Medicine, Wayne State University, Detroit, Michigan, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sudhin","family":"Thayyil","sequence":"additional","affiliation":[{"name":"Centre for Perinatal Neuroscience, Imperial College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2021,5,21]]},"reference":[{"key":"2025072914555866000_6.5.e005757.1","doi-asserted-by":"crossref","DOI":"10.1136\/bmjpo-2020-000847","article-title":"Informed consent for neonatal trials: practical points to consider and a check list","volume":"4","author":"Aurich","year":"2020","journal-title":"BMJ Paediatr Open"},{"key":"2025072914555866000_6.5.e005757.2","unstructured":"Guidance H . Applying a proportionate approach to the process of seeking consent. 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