The moral imperative to approve pregnant women’s participation in randomized clinical trials for pregnancy and newborn complications
Abstract Background There is longstanding consensus on the need to include pregnant women in research. The goal of clinical research is to find highly regulated, carefully controlled, morally responsible ways to generate evidence about how to effectively and safely prevent illness or treat sick peop...
| Main Author: | |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2019-09-01
|
| Series: | Philosophy, Ethics, and Humanities in Medicine |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13010-019-0081-8 |
| _version_ | 1818576266780999680 |
|---|---|
| author | Dan Kabonge Kaye |
| author_facet | Dan Kabonge Kaye |
| author_sort | Dan Kabonge Kaye |
| collection | DOAJ |
| description | Abstract Background There is longstanding consensus on the need to include pregnant women in research. The goal of clinical research is to find highly regulated, carefully controlled, morally responsible ways to generate evidence about how to effectively and safely prevent illness or treat sick people. This manuscripts present a conceptual analysis of the ethicality of clinical trials in 3 scenarios: where the pregnant is involved in clinical trials as a participant during pregnancy for data that addresses pregnancy complications, where the pregnant woman consents to clinical trial participation for an unborn baby that has complications, to generate data on complications at this stage of life, and where the mother may consent for participation of their newborn child in clinical trials. Methods Conceptual analysis. Findings Investigators often choose to exclude pregnant women and newborns from research, even where there is possibility for them to benefit from the study intervention. Objections include vulnerability of pregnant women, altered pharmacokinetics and risk of adverse effects, with a need to balance potential maternal and fetal risks and benefits of research participation. While the objections may be valid, not performing research magnifies what should be a carefully controlled risk during research, pushing this risk into the clinical setting, and subsequently posing a challenge to clinicians who are faced with making treatment decisions for pregnant patients with limited evidence of efficacy and safety. The potential benefits of fair inclusion in clinical trials outweigh the potential risks. Conclusion Research involving pregnant women is necessary to provide women with effective treatment during pregnancy, to promote fetal safety (such as by avoiding the clinical use of drugs that may be harmful to the developing fetus), and to reduce avoidable harm from suboptimal care (such as from underdosing) and to provide pregnant women, their fetuses and newborns (with access to potential benefits of research participation). |
| first_indexed | 2024-12-16T06:11:18Z |
| format | Article |
| id | doaj.art-90baea38ab5944e6a1bb7aad2b25e320 |
| institution | Directory Open Access Journal |
| issn | 1747-5341 |
| language | English |
| last_indexed | 2024-12-16T06:11:18Z |
| publishDate | 2019-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Philosophy, Ethics, and Humanities in Medicine |
| spelling | doaj.art-90baea38ab5944e6a1bb7aad2b25e3202022-12-21T22:41:22ZengBMCPhilosophy, Ethics, and Humanities in Medicine1747-53412019-09-0114111110.1186/s13010-019-0081-8The moral imperative to approve pregnant women’s participation in randomized clinical trials for pregnancy and newborn complicationsDan Kabonge Kaye0College of Health Sciences, Department of Obstetrics and Gynecology, Makerere UniversityAbstract Background There is longstanding consensus on the need to include pregnant women in research. The goal of clinical research is to find highly regulated, carefully controlled, morally responsible ways to generate evidence about how to effectively and safely prevent illness or treat sick people. This manuscripts present a conceptual analysis of the ethicality of clinical trials in 3 scenarios: where the pregnant is involved in clinical trials as a participant during pregnancy for data that addresses pregnancy complications, where the pregnant woman consents to clinical trial participation for an unborn baby that has complications, to generate data on complications at this stage of life, and where the mother may consent for participation of their newborn child in clinical trials. Methods Conceptual analysis. Findings Investigators often choose to exclude pregnant women and newborns from research, even where there is possibility for them to benefit from the study intervention. Objections include vulnerability of pregnant women, altered pharmacokinetics and risk of adverse effects, with a need to balance potential maternal and fetal risks and benefits of research participation. While the objections may be valid, not performing research magnifies what should be a carefully controlled risk during research, pushing this risk into the clinical setting, and subsequently posing a challenge to clinicians who are faced with making treatment decisions for pregnant patients with limited evidence of efficacy and safety. The potential benefits of fair inclusion in clinical trials outweigh the potential risks. Conclusion Research involving pregnant women is necessary to provide women with effective treatment during pregnancy, to promote fetal safety (such as by avoiding the clinical use of drugs that may be harmful to the developing fetus), and to reduce avoidable harm from suboptimal care (such as from underdosing) and to provide pregnant women, their fetuses and newborns (with access to potential benefits of research participation).http://link.springer.com/article/10.1186/s13010-019-0081-8Clinical trialsPregnancyFair inclusionClinical researchMoral imperativeDoctrine of double effect |
| spellingShingle | Dan Kabonge Kaye The moral imperative to approve pregnant women’s participation in randomized clinical trials for pregnancy and newborn complications Philosophy, Ethics, and Humanities in Medicine Clinical trials Pregnancy Fair inclusion Clinical research Moral imperative Doctrine of double effect |
| title | The moral imperative to approve pregnant women’s participation in randomized clinical trials for pregnancy and newborn complications |
| title_full | The moral imperative to approve pregnant women’s participation in randomized clinical trials for pregnancy and newborn complications |
| title_fullStr | The moral imperative to approve pregnant women’s participation in randomized clinical trials for pregnancy and newborn complications |
| title_full_unstemmed | The moral imperative to approve pregnant women’s participation in randomized clinical trials for pregnancy and newborn complications |
| title_short | The moral imperative to approve pregnant women’s participation in randomized clinical trials for pregnancy and newborn complications |
| title_sort | moral imperative to approve pregnant women s participation in randomized clinical trials for pregnancy and newborn complications |
| topic | Clinical trials Pregnancy Fair inclusion Clinical research Moral imperative Doctrine of double effect |
| url | http://link.springer.com/article/10.1186/s13010-019-0081-8 |
| work_keys_str_mv | AT dankabongekaye themoralimperativetoapprovepregnantwomensparticipationinrandomizedclinicaltrialsforpregnancyandnewborncomplications AT dankabongekaye moralimperativetoapprovepregnantwomensparticipationinrandomizedclinicaltrialsforpregnancyandnewborncomplications |