Presumptive Inclusion and Legitimate Exclusion Criteria

Kaposy, Chris

doi:10.1007/978-3-319-26512-4_4

Cited by 12 publications

(7 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The American College of Obstetrics and Gynecology instead recommended that pregnant women be categorized under "scientifically complex," and recently the Common Rule, the federal policy for the protection of human subjects, has been revised in 2019 to remove pregnant women from the vulnerable population category [40]. However, despite that, some institutional review boards (IRB) may still feel reluctant given that there is no practical guide to address the risk and benefits of enrolling pregnant women into clinical trials [41]. Two important steps to curtail this is to involve experts in the field of maternal-fetal medicine and obstetrics pharmacology in board meetings and to require justification for exclusion of pregnant women and that this justification may be questioned during review [42].…”

Section: The Effect Of the Regulatory Bodies On Clinical Trials In Pregnancymentioning

confidence: 99%

Pharmacoethics and Pregnancy: Overcoming the drug orphan stigma

Kazma

Anker

Ahmadzia

2021

Preprint

View full text Add to dashboard Cite

There is paucity of evidence to support clinical decision making and counseling related to medication use in pregnancy. Despite multiple efforts from legislative bodies and advocacy groups, the inclusion of pregnant women in clinical drug trials assessing efficacy and safety remains scarce. Pregnancy can be complicated by multiple co-morbidities that require pharmacological intervention; these interventions primarily target the pregnant women but also sometimes have secondary effects for the fetus. The U.S. Food and Drug Administration has issued multiple guidance documents on incorporating pregnant women in clinical trials to aid pharmaceutical companies in designing a protocol to ensure safety and adherence to ethical standards. Advances in pediatric pharmacology studies provide lessons for researchers on the best practice of designing clinical trials with inclusion of patients from special populations. In this review, we present the status of pregnant women in clinical trials, highlighting the ethical stigma and possible future directives.

show abstract

Section: The Effect Of the Regulatory Bodies On Clinical Trials In Pregnancymentioning

confidence: 99%

Pharmacoethics and Pregnancy: Overcoming the drug orphan stigma

Kazma

Anker

Ahmadzia

2021

Preprint

View full text Add to dashboard Cite

show abstract

“…An important change among the revisions to the Common Rule that took effect in January 2019 was the removal of the category “pregnant women” as a “vulnerable population” of research participants 16 . This change reflects concerns that a paternalistic view of pregnant women limits their ability to act as autonomous moral agents in deciding whether to participate in clinical drug trials 17 . Yet while the Common Rule permits pregnant women to participate in clinical research under appropriate conditions, some research sponsors, researchers, and IRBs may still be reluctant to allow them to do so.…”

Section: From Exclusion To Inclusionmentioning

confidence: 99%

“…16 This change reflects concerns that a paternalistic view of pregnant women limits their ability to act as autonomous moral agents in deciding whether to participate in clinical drug trials. 17 Yet while the Common Rule permits pregnant women to participate in clinical research under appropriate conditions, some research sponsors, researchers, and IRBs may still be reluctant to allow them to do so. To make the shift toward inclusion the default when exclusion cannot be justified, IRBs need practical guidance on how to apply the regulations and how to specifically weigh risks and benefits to ensure the ethical acceptability of research with pregnant women as participants.…”

Section: From Exclusion To Inclusionmentioning

confidence: 99%

“…The ethical principles of respect for autonomy and justice both support considering inclusion, rather than exclusion, the "default" position for pregnant women's participation in clinical research trials. 22 The prevailing precautionary view treats pregnant women as being in need of special protection, similarly to how children need to be protected. This paternalistic approach violates the principle of respect for autonomy in that it presumes that pregnant women are somehow less able to act as moral agents to direct their lives and make decisions in reasoned and ethical ways than are adults in general.…”

Section: E R H E R Hmentioning

confidence: 99%

See 1 more Smart Citation

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

Payne

2019

Ethics & Human Research

View full text Add to dashboard Cite

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.

show abstract

“…The exclusion of pregnant women from clinical research is frequently justified as necessary to protect fetuses from unknown harms of in utero exposure to potentially teratogenic drugs [25, 26]. Stakeholders often articulate their protectionist stance as a desire to avoid “the next thalidomide,” a reference to the tragedy in which more than 10,000 children were born with birth defects resulting from in utero exposure to the drug [27, 28].…”

Section: Prevailing Practicesmentioning

confidence: 99%

Ethics, regulation, and beyond: the landscape of research with pregnant women

et al. 2017

View full text Add to dashboard Cite

Scarce research with pregnant women has led to a dearth of evidence to guide medical decisions about safe and effective treatment and preventive interventions for pregnant women and their potential offspring. In this paper, we highlight three aspects of the landscape in which pregnant women are included or, more frequently, excluded from research: international ethics guidance, regional and national regulatory frameworks, and prevailing practices. Our paper suggests that, in some cases, regulatory frameworks can be more restrictive than international ethics guidance, and that even when regulations permit research with pregnant women, practical challenges—as well as the prevailing practices of stakeholders, such as ethics review committees and investigators—may lead to the generalized exclusion of pregnant women from research.

show abstract

Presumptive Inclusion and Legitimate Exclusion Criteria

Cited by 12 publications

References 21 publications

Pharmacoethics and Pregnancy: Overcoming the drug orphan stigma

Pharmacoethics and Pregnancy: Overcoming the drug orphan stigma

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

Ethics, regulation, and beyond: the landscape of research with pregnant women

Contact Info

Product

Resources

About