The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care
Abstract Background Research guidelines generally recognize vulnerable populations to include neonates with the aim of enhancing protections from harm. In practice, such guidance results in limiting participation in randomized clinical trials (RCTs). Yet while medical care of neonates should be base...
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| Format: | Article |
| Language: | English |
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BMC
2019-07-01
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| Series: | BMC Pediatrics |
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| Online Access: | http://link.springer.com/article/10.1186/s12887-019-1600-x |
| _version_ | 1818081353355231232 |
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| author | Dan Kabonge Kaye |
| author_facet | Dan Kabonge Kaye |
| author_sort | Dan Kabonge Kaye |
| collection | DOAJ |
| description | Abstract Background Research guidelines generally recognize vulnerable populations to include neonates with the aim of enhancing protections from harm. In practice, such guidance results in limiting participation in randomized clinical trials (RCTs). Yet while medical care of neonates should be based on best research evidence to ensure that safe, efficacious treatment or procedures are used, this seldom happens in contemporary practice. Discussion The compelling need to generate information on effectiveness and safety of procedures and medications that are already in use during neonatal care has led to increase in calls for pragmatic randomized clinical trials (PCTs). This raises ethical concerns as to whether exclusion of the vulnerable populations from research participations constitutes harm. First, neonates are denied access to both potentially beneficial research outputs and an opportunity to generate data on how interventions or medications perform in diverse clinical settings and inform clinical decision-making. Secondly, risks and harms in PCTs may differ from traditional RCTs, and can be reduced by modifications in study designs. The latter may involve assessment of effectiveness of comparable medication, devices or practices (whose safety data is available), randomization at the group level rather than at the individual level, avoidance of invasive and innovative study procedures, reliance on locally available data on relevant patient outcomes, and employment of procedures that tend to meet the criteria of minimal risk for human subject research. Thirdly, informed consent procedures should be modified from those of traditional RCTs, as neonates in traditional RCTs may be vulnerable to different extents in PCTs. Lastly, regulatory and oversight procedures designed for traditional RCT settings need modification, as they may not be translatable, feasible, appropriate or even ethical to apply in PCTs. Conclusion The principle of justice, commonly interpreted as preventing an inequitable burden of research, should also allow fair access to potential benefits from PCTs for neonates and other vulnerable populations. Under certain conditions, prospective randomized trials involving neonates should be ethically permissible to allow inclusion of neonates in research. This may require modification of the research design, consent procedures or regulations for research oversight. |
| first_indexed | 2024-12-10T19:04:51Z |
| format | Article |
| id | doaj.art-e48f47fe2a0d44488446bf8ba0967c18 |
| institution | Directory Open Access Journal |
| issn | 1471-2431 |
| language | English |
| last_indexed | 2024-12-10T19:04:51Z |
| publishDate | 2019-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pediatrics |
| spelling | doaj.art-e48f47fe2a0d44488446bf8ba0967c182022-12-22T01:36:56ZengBMCBMC Pediatrics1471-24312019-07-011911810.1186/s12887-019-1600-xThe ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn careDan Kabonge Kaye0College of Health Sciences, Department of Obstetrics and Gynecology, Makerere UniversityAbstract Background Research guidelines generally recognize vulnerable populations to include neonates with the aim of enhancing protections from harm. In practice, such guidance results in limiting participation in randomized clinical trials (RCTs). Yet while medical care of neonates should be based on best research evidence to ensure that safe, efficacious treatment or procedures are used, this seldom happens in contemporary practice. Discussion The compelling need to generate information on effectiveness and safety of procedures and medications that are already in use during neonatal care has led to increase in calls for pragmatic randomized clinical trials (PCTs). This raises ethical concerns as to whether exclusion of the vulnerable populations from research participations constitutes harm. First, neonates are denied access to both potentially beneficial research outputs and an opportunity to generate data on how interventions or medications perform in diverse clinical settings and inform clinical decision-making. Secondly, risks and harms in PCTs may differ from traditional RCTs, and can be reduced by modifications in study designs. The latter may involve assessment of effectiveness of comparable medication, devices or practices (whose safety data is available), randomization at the group level rather than at the individual level, avoidance of invasive and innovative study procedures, reliance on locally available data on relevant patient outcomes, and employment of procedures that tend to meet the criteria of minimal risk for human subject research. Thirdly, informed consent procedures should be modified from those of traditional RCTs, as neonates in traditional RCTs may be vulnerable to different extents in PCTs. Lastly, regulatory and oversight procedures designed for traditional RCT settings need modification, as they may not be translatable, feasible, appropriate or even ethical to apply in PCTs. Conclusion The principle of justice, commonly interpreted as preventing an inequitable burden of research, should also allow fair access to potential benefits from PCTs for neonates and other vulnerable populations. Under certain conditions, prospective randomized trials involving neonates should be ethically permissible to allow inclusion of neonates in research. This may require modification of the research design, consent procedures or regulations for research oversight.http://link.springer.com/article/10.1186/s12887-019-1600-xNeonatesVulnerable populationsVulnerabilityRandomized clinical trialsPragmatic randomized clinical trials |
| spellingShingle | Dan Kabonge Kaye The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care BMC Pediatrics Neonates Vulnerable populations Vulnerability Randomized clinical trials Pragmatic randomized clinical trials |
| title | The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care |
| title_full | The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care |
| title_fullStr | The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care |
| title_full_unstemmed | The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care |
| title_short | The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care |
| title_sort | ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care |
| topic | Neonates Vulnerable populations Vulnerability Randomized clinical trials Pragmatic randomized clinical trials |
| url | http://link.springer.com/article/10.1186/s12887-019-1600-x |
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