Missed Trials, Future Opportunities

Βaylis, Françoise; Ballantyne, Angela

doi:10.1007/978-3-319-26512-4_1

Cited by 5 publications

(8 citation statements)

References 41 publications

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“…Following the ethical principle of autonomy, and given the physiologic unity of the pregnant woman and her fetus, a clinician-researcher could presume that the pregnant woman desires the best for both herself and her fetus and is the most appropriate moral agent to determine if participation agrees with her beliefs and values. 25 This presumption supports the pregnant woman's informed consent to research participation on behalf of both herself and her fetus. 26 The ethical principle of justice calls for research that fairly meets the needs of varied groups.…”

Section: E R H E R Hmentioning

confidence: 90%

“…I n the mid‐twentieth century, thousands of babies (primarily in Canada, Germany, and the United Kingdom) were born with birth defects resulting from their mothers’ use of the prescription sedative thalidomide during their pregnancy. During this same period, increased risks for cancer were identified in persons exposed to diethylstilbestrol (DES) in utero 2 . Years later, when the federal regulations governing research with humans (the Common Rule) were issued, subpart B of the regulations placed emphasis on protecting women and fetuses from the potential harms of trial participation.…”

Section: Protection Precaution and Exclusionmentioning

confidence: 99%

“…When a woman develops a medical condition during pregnancy, she and her clinician face issues of compromised care if there is a lack of data about safe and effective pharmacological treatments. 7 Untreated or suboptimally treated conditions such as hypertension or endocrine disorders place the fetus at significant risk of growth retardation, preterm birth, or damage to the central nervous system, leading to the potential for morbidity or mortality. 8 These medical quandaries call for a new approach to research with pregnant women.…”

Section: E R H E R Hmentioning

confidence: 99%

“…For clinicians to meet ethical duties of beneficence and nonmaleficence, they need information about how medications are beneficial or harmful to a pregnant patient and the fetus. 9 In the past two decades, increased discussion has occurred among some clinicians, researchers, and ethicists that the regulatory classification of all pregnant women as needing additional protection may be overly paternalistic. An emerging consensus suggests that routine exclusion of pregnant women from research participation leaves these women and their fetuses vulnerable to potentially greater harm from the lack of rigorous scientific evidence of the safety of medications and other interventions that are already being used or avoided in pregnancy.…”

Section: From Exclusion To Inclusionmentioning

confidence: 99%

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Including Pregnant Women in Clinical Research: Practical Guidance for Institutional Review Boards

Payne

2019

Ethics & Human Research

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Scanty evidence exists about the safety and effectiveness of drugs—and of their efficacious dosing—that women may need to treat acute and chronic health issues during their pregnancies. This lack of evidence puts pregnant women and their fetuses at risk of harm from the use or avoidance of drugs during pregnancy. In light of the protectionist approach in regulations governing research with pregnant women and fetuses, trial sponsors, researchers, clinicians, and institutional review boards (IRBs) have been reluctant to include pregnant women in clinical drug trials, applying ethical reasoning for exclusions that reflects a default exclusionary approach. Yet in recent years, many clinicians, researchers, bioethicists, and professional societies have called for a reexamination of the routine practice of excluding pregnant women from clinical research. This paper proposes a practical approach to an ethical framework for IRBs that supports fair inclusion, rather than routine exclusion, of pregnant women in clinical research. This guidance will aid IRBs in ethically including and appropriately protecting pregnant women in research.

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Section: E R H E R Hmentioning

confidence: 90%

Section: Protection Precaution and Exclusionmentioning

confidence: 99%

Section: E R H E R Hmentioning

confidence: 99%

Section: From Exclusion To Inclusionmentioning

confidence: 99%

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Including Pregnant Women in Clinical Research: Practical Guidance for Institutional Review Boards

Payne

2019

Ethics & Human Research

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“…There has been a longstanding call for fair inclusion of pregnant women in clinical research, motivated by the need to develop effective treatments for women during pregnancy and prevent suboptimal care of pregnant women with acute or chronic obstetric or non-obstetric illnesses (Lyerly, Little, and Faden, 2008;Baylis and Ballantyne, 2016). Not including pregnant women in clinical research leads to two problems.…”

Section: Introductionmentioning

confidence: 99%

How Should the Precautionary Principle Apply to Pregnant Women in Clinical Research?

Zande

Graaf

Oudijk

et al. 2021

The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine

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The precautionary principle is often invoked in relation to pregnant women and may be one of the underlying reasons for their continuous underrepresentation in clinical research. The principle is appealing, because potential fetal harm as a result of research participation is considered to be serious and irreversible. In our paper, we explore through conceptual analysis whether and if so how the precautionary principle should apply to pregnant women. We argue that the principle is a decision-making strategy underlying risk-benefit decisions in clinical research, which can be applied to pregnant women. However, the current application is a strong one, leading to the promotion of absolute exclusion or, less often, absolute inclusion of pregnant women. In order to change this paralyzing situation, a shift toward weak precautionary thinking is necessary. Instead of automatic extreme precaution, a balance will be found between harms and potential benefits of including pregnant women in clinical research.

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Informed Consent in Clinical Trials of Foetal Therapies

Sheppard¹

2018

Encyclopedia of Life Sciences

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Obtaining informed consent is an essential part of the doctor's duty of care when treating a patient and is governed by English common law. In the case of clinical trials, the duty to obtain consent from prospective trial participants pertains to the researcher and is laid down by statute. Informed consent refers to a duty to provide the person with information about the (experimental) treatment, its likely benefits and risks and any possible alternatives, and requires the information to be understood. While pregnant women used to be largely excluded from clinical trial participation because of a concern for the foetus, international and national regulations now accept the need for clinical trials in pregnancy and envisage special protective measures to safeguard pregnant women and their foetuses. Because of the possible vulnerability of pregnant women in clinical trials of foetal therapies, even more effort must be expended on obtaining properly informed consent. Key Concepts The duty of care of a doctor in common law involves obtaining informed consent from the patient. Clinical trials require the informed consent of the prospective trial participant in statutory law. Informed consent covers information about the experimental treatment, its benefits and risks and possible alternatives. Properly informed consent includes understanding by the trial participant. The concern for the foetus has prevented the inclusion of pregnant women in clinical trials. Pregnant women asked to participate in clinical trials of foetal therapy may be vulnerable in limited circumstances. Statutes provide for protective measures when including pregnant women in clinical trials. In clinical trials of foetal therapy, great care needs to be taken to obtain properly informed consent from the pregnant woman.

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Missed Trials, Future Opportunities

Cited by 5 publications

References 41 publications

Including Pregnant Women in Clinical Research: Practical Guidance for Institutional Review Boards

Including Pregnant Women in Clinical Research: Practical Guidance for Institutional Review Boards

How Should the Precautionary Principle Apply to Pregnant Women in Clinical Research?

Informed Consent in Clinical Trials of Foetal Therapies

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