Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit
Abstract Background The aim of the study was to determine opinions and knowledge regarding the process of obtaining informed consent to participate in observational research in pediatric intensive care. Methods Survey 1 asked decision makers what model(s) of consent was acceptable for each type of o...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2019-12-01
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| Series: | Journal of Intensive Care |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40560-019-0411-3 |
| _version_ | 1819061078196224000 |
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| author | Jessica Hodson Christiana Garros Jodie Jensen Jonathan P. Duff Gonzalo Garcia Guerra Ari R. Joffe |
| author_facet | Jessica Hodson Christiana Garros Jodie Jensen Jonathan P. Duff Gonzalo Garcia Guerra Ari R. Joffe |
| author_sort | Jessica Hodson |
| collection | DOAJ |
| description | Abstract Background The aim of the study was to determine opinions and knowledge regarding the process of obtaining informed consent to participate in observational research in pediatric intensive care. Methods Survey 1 asked decision makers what model(s) of consent was acceptable for each type of observational research both before and after background information. Survey 2 asked decision makers about the experience of being asked for consent to observational research, and knowledge regarding the consent process both before and after background information. Results Cooperation rate was 100/117 (85%). The proportion in favor of any of the offered alternatives to signed informed consent for observational research, after receiving all the background information, was 74-80%, lowest for observational prospective research with a minimal risk intervention 37/50 (74%; 95% CI 60–84%). The proportion who agreed they felt overwhelmed by being approached for consent to observational research was 26 (52%; 95% CI 39-65%). Most respondents (from 60 to 74%) felt they understood the concepts regarding observational research; however, after reading background information, most (from 60 to 74%) felt their understanding had improved “a great deal”. Conclusion Understanding of risk, practical difficulties, consent bias, and Research Ethics Board safeguards was poor. Future study is needed to confirm our finding that most agreed with alternative methods of consent for observational research. |
| first_indexed | 2024-12-21T14:37:10Z |
| format | Article |
| id | doaj.art-30c6143768b8437cad364aebc5f99df5 |
| institution | Directory Open Access Journal |
| issn | 2052-0492 |
| language | English |
| last_indexed | 2024-12-21T14:37:10Z |
| publishDate | 2019-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Intensive Care |
| spelling | doaj.art-30c6143768b8437cad364aebc5f99df52022-12-21T19:00:18ZengBMCJournal of Intensive Care2052-04922019-12-01711810.1186/s40560-019-0411-3Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unitJessica Hodson0Christiana Garros1Jodie Jensen2Jonathan P. Duff3Gonzalo Garcia Guerra4Ari R. Joffe5Division of Pediatric Critical Care Medicine, Department of Pediatrics, Stollery Children’s Hospital and University of AlbertaDivision of Pediatric Critical Care Medicine, Department of Pediatrics, Stollery Children’s Hospital and University of AlbertaDivision of Pediatric Critical Care Medicine, Department of Pediatrics, Stollery Children’s Hospital and University of AlbertaDivision of Pediatric Critical Care Medicine, Department of Pediatrics, Stollery Children’s Hospital and University of AlbertaDivision of Pediatric Critical Care Medicine, Department of Pediatrics, Stollery Children’s Hospital and University of AlbertaDivision of Pediatric Critical Care Medicine, Department of Pediatrics, Stollery Children’s Hospital and University of AlbertaAbstract Background The aim of the study was to determine opinions and knowledge regarding the process of obtaining informed consent to participate in observational research in pediatric intensive care. Methods Survey 1 asked decision makers what model(s) of consent was acceptable for each type of observational research both before and after background information. Survey 2 asked decision makers about the experience of being asked for consent to observational research, and knowledge regarding the consent process both before and after background information. Results Cooperation rate was 100/117 (85%). The proportion in favor of any of the offered alternatives to signed informed consent for observational research, after receiving all the background information, was 74-80%, lowest for observational prospective research with a minimal risk intervention 37/50 (74%; 95% CI 60–84%). The proportion who agreed they felt overwhelmed by being approached for consent to observational research was 26 (52%; 95% CI 39-65%). Most respondents (from 60 to 74%) felt they understood the concepts regarding observational research; however, after reading background information, most (from 60 to 74%) felt their understanding had improved “a great deal”. Conclusion Understanding of risk, practical difficulties, consent bias, and Research Ethics Board safeguards was poor. Future study is needed to confirm our finding that most agreed with alternative methods of consent for observational research.https://doi.org/10.1186/s40560-019-0411-3ConsentObservational researchPediatric intensive care unitSurvey |
| spellingShingle | Jessica Hodson Christiana Garros Jodie Jensen Jonathan P. Duff Gonzalo Garcia Guerra Ari R. Joffe Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit Journal of Intensive Care Consent Observational research Pediatric intensive care unit Survey |
| title | Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit |
| title_full | Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit |
| title_fullStr | Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit |
| title_full_unstemmed | Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit |
| title_short | Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit |
| title_sort | parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit |
| topic | Consent Observational research Pediatric intensive care unit Survey |
| url | https://doi.org/10.1186/s40560-019-0411-3 |
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