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Anne Lyerly

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Suzanne Newcombe

The Open University

RANJAN KUMAR PRUSTY

NIRRH

Northwestern University

Hela Ouaili-Mallek

Ecole Supérieure de la Statistique et de l'Analyse de l'Information

Kaduna State University

University of Michigan

Henning Schneider

University of Bern, Switzerland

Sanjay Gandhi Postgraduate Institute of Medician Sciences, Lucknow

Koç University

University of Amsterdam

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Papers by Anne Lyerly

Reframing Conscientious Care: Providing Abortion Care When Law and Conscience Collide

Hastings Center Report, 2016

While the concept of conscience has broad philosophical underpinnings relating to moral judgment,... more While the concept of conscience has broad philosophical underpinnings relating to moral judgment, agency, and discernments of right and wrong, debates in bioethics have tended to engage the concept primarily vis-à-vis rights of conscientious refusal. Here, we suggest a broader frame for thinking about claims of conscience in healthcare. Drawing on empirical findings from our research with abortion providers in North Carolina, we elucidate an empirically grounded approach to ethically justified care when healthcare providers face legal or institutional policy mandates that raise possible moral conflicts. We highlight, in particular, how providers may be motivated by matters of conscience, including relational concerns, in the active provision of certain forms of care. In so doing, we challenge the dichotomy between conscientious refusal and morally compromised action, demonstrating how providers may work within the constraints of laws or institutional policies that raise moral challenges and act in accordance with conscience. "It's almost like putting salt in a wound, for this person who's already made a very difficult decision," offered Dr. Meghan Patterson, 1 a licensed obstetrician/gynecologist whom we interviewed in our qualitative study of the experiences of North Carolina abortion providers practicing under the 2011 "Woman's Right to Know" (WRTK) Act (HB 854

Diagnostic yield and psychological outcomes among women pursuing trio‐exome sequencing: Do women with recurrent anomalous fetal phenotypes experience more negative psychological outcomes?

Prenatal Diagnosis

The association between pregnancy management and psychological outcomes among patients pursuing trio-exome-sequencing (ES) for diagnosis

American Journal of Obstetrics and Gynecology, 2022

Where are the pregnant and breastfeeding women in new pre-exposure prophylaxis trials? The imperative to overcome the evidence gap

The Lancet HIV, 2022

Pregnant and breastfeeding populations are at substantial risk of acquiring HIV in some settings,... more Pregnant and breastfeeding populations are at substantial risk of acquiring HIV in some settings, yet are underrepresented in clinical trials of new pre-exposure prophylaxis (PrEP) agents. Several PrEP formulations are in development (eg, vaginal rings, long-acting injectables, and other modalities). Pregnant and breastfeeding populations are typically excluded from initial clinical trials. We identified 14 PrEP trials of novel agents in non-pregnant or non-breastfeeding populations, and six phase 1-3 trials and open label extensions among pregnant and breastfeeding populations, that are currently ongoing or complete. A framework shift is needed to consider the ethical costs of excluding pregnant and breastfeeding populations at risk for HIV in PrEP clinical trials and promote inclusion to maximise the benefits from PrEP tools in the pipeline. Research on new PrEP agents should include pregnant and breastfeeding populations to avoid delays in reaching those who could benefit from PrEP after efficacy is established.

Communication regarding adverse neonatal birth events: Experiences of parents and clinicians

Journal of Patient Safety and Risk Management, 2021

ObjectivesCommunicating with parents about adverse birth outcomes is challenging. We sought to de... more ObjectivesCommunicating with parents about adverse birth outcomes is challenging. We sought to describe attitudes and experiences of parents and providers regarding communication about adverse newborn birth events.MethodsFrom 2011–2012, we conducted semi-structured in-depth interviews with parents who believed they had experienced an adverse birth-related neonatal outcome and focus groups with healthcare providers who have communicated with parents about adverse newborn birth events from three geographically diverse US academic medical centers. We conducted qualitative thematic analysis to identify key themes.ResultsParents and providers described unique communication challenges around adverse neonatal outcomes in six categories: 1) High expectations for a positive delivery experience and the view that birth is a life event, not a medical encounter; 2) Powerful emotions associated with birth, amplified when an adverse event occurs; 3) Rapid changes when expectations for a normal bir...

791 Psychological outcomes among women pursuing Trio-Exome-Sequencing (ES) in the setting of recurrent anomalous fetal phenotypes

American Journal of Obstetrics and Gynecology, 2021

551: Impact of prenatal exome-sequencing (ES) for fetal diagnosis on maternal psychological outcomes: a prospective cohort

American Journal of Obstetrics and Gynecology, 2020

High willingness to delay pregnancy for the purposes of biomedical research participation among malawian women living in a high HIV prevalence setting

American Journal of Obstetrics and Gynecology, 2019

Ethical and counseling challenges in prenatal exome sequencing

Prenatal Diagnosis, 2018

Objective: Ethical and counseling challenges are expected with the introduction of prenatal whole... more Objective: Ethical and counseling challenges are expected with the introduction of prenatal whole exome sequencing. In this study, we describe specific challenges identified through the UNC-Chapel Hill Prenatal Exome Sequencing Study. Methods: Participants were a subset of women participating in the fetal exome study, which has enrolled 73 mother-father-fetus trios in pregnancies diagnosed with structural anomalies and normal standard genetic testing results. In this descriptive study, cases were reviewed by members of the research team, including a bioethicist, to identify counseling challenges. Illustrative cases were chosen by group consensus. Results: Four illustrative cases were identified for further analysis. Challenges included: need for adequate counseling and informed consent, challenges in prenatal variant interpretation, performing prenatal diagnosis in subsequent pregnancies, inability to identify a genetic etiology, and identifying parental secondary findings. Conclusion: Our study illustrates several challenges identified in an ongoing prenatal exome study. While genomic medicine is a powerful tool for prenatal diagnosis, it is important that clinicians understand the ethical implications and parental perceptions of this testing modality.

Rubella Vaccine-Reply

JAMA pediatrics, 2018

Specific Populations

Oxford Handbooks Online, 2015

It is estimated that more than 500,000 women annually experience a mental illness during pregnanc... more It is estimated that more than 500,000 women annually experience a mental illness during pregnancy. Although approximately a third of these women will be prescribed medication, the majority receives no treatment, partly because ethical challenges to including pregnant women in research protocols have impeded studies necessary to establish maternal and fetal effects of medication, appropriate dosing, and the relative risks of undertreated mental illness. Because mental illness is a frequent complication of pregnancy (particularly anxiety and depression), clinicians will be called upon to ethically navigate uncertain treatment recommendations with sensitivity to patient values. The following discussion reviews the history of current guidelines to research with pregnant women, common clinical presentations of women experiencing mental illness in the perinatal context, and relevant ethical frameworks to inform patient care.

Reframing Conscientious Care: Providing Abortion Care When Law and Conscience Collide

Carolina Digital Repository (University of North Carolina at Chapel Hill), 2016

While the concept of conscience has broad philosophical underpinnings relating to moral judgment,... more While the concept of conscience has broad philosophical underpinnings relating to moral judgment, agency, and discernments of right and wrong, debates in bioethics have tended to engage the concept primarily vis-à-vis rights of conscientious refusal. Here, we suggest a broader frame for thinking about claims of conscience in healthcare. Drawing on empirical findings from our research with abortion providers in North Carolina, we elucidate an empirically grounded approach to ethically justified care when healthcare providers face legal or institutional policy mandates that raise possible moral conflicts. We highlight, in particular, how providers may be motivated by matters of conscience, including relational concerns, in the active provision of certain forms of care. In so doing, we challenge the dichotomy between conscientious refusal and morally compromised action, demonstrating how providers may work within the constraints of laws or institutional policies that raise moral challenges and act in accordance with conscience. "It's almost like putting salt in a wound, for this person who's already made a very difficult decision," offered Dr. Meghan Patterson, 1 a licensed obstetrician/gynecologist whom we interviewed in our qualitative study of the experiences of North Carolina abortion providers practicing under the 2011 "Woman's Right to Know" (WRTK) Act (HB 854

Administering vaccines to pregnant women in an outbreak or epidemic: what factors and circumstances influence considerations of acceptable and recommended use?

American Journal of Obstetrics and Gynecology, Dec 1, 2017

to better understand care and referral of pregnant women with suspected and confirmed ZIKV infect... more to better understand care and referral of pregnant women with suspected and confirmed ZIKV infection. CONCLUSIONS: Tools are currently in use in five countries and results will inform recommended referral pathways for pregnant women with suspected and confirmed cases of ZIKV infection. Surveys will continue to be updated based on user experience as part of ongoing QI programs. Ultimately, these tools will be available in a variety of settings for use by Ministries of Health and/or Social Welfare for adaptation as a supervision checklist and use outside of this program.

Research with Pregnant Women

Oxford University Press eBooks, Apr 1, 2019

Access to Pregnancy-Related Services: Public Health Ethics Issues

Advancing fair access to evidence-based pregnancy-related services is a critical public health pr... more Advancing fair access to evidence-based pregnancy-related services is a critical public health priority. It is widely recognized that there are inequalities in lifesaving interven tions. This chapter however addresses issues raised by services whose value or utility are contested. Using illustrative examples of prenatal genetic testing and modes of child birth, the chapter highlights the ways in which issues of access are complicated by social and cultural ideas about what is valued; discusses contested questions about what is ethi cally responsible or required of patients, providers, and public health systems in these re productive health contexts; and addresses areas of needed research and further ethical analysis. It concludes that issues of access in pregnancy-related care must attend both to broad issues of justice and access and to particular ways that pregnancy services are val ued, debated, and made available to women who might-or might not-benefit from them.

Pregnant women and vaccines against emerging pathogens: ethics guidance on an inclusive and responsive research agenda and epidemic response

American Journal of Obstetrics and Gynecology, Dec 1, 2018

46.3% agreed most people would support the rights of an HIVpositive person to live and work where... more 46.3% agreed most people would support the rights of an HIVpositive person to live and work where they wanted. Women's perceived HIV risk was not significantly associated with these discriminatory attitudes (p>0.05). However, 80.3% of women with self-perceived low HIV risk believed most people think individuals infected with HIV via sex exchange or drug use got what they deserve, versus 6.7% of women with self-perceived high HIV risk (p¼0.009). CONCLUSIONS: Despite multiple sexual and other risk behaviors significantly associated with level of perceived HIV risk in a high-risk population of largely minority women, the NBHS survey demonstrates many women with high risk behaviors still perceive themselves to be at low risk. Our findings highlight a complex interaction of risk perception, risk behaviors and stigma surrounding HIV in urban minority women.

U.S. women's views on delaying pregnancy for the purpose of participating in biomedical research

American Journal of Obstetrics and Gynecology, Dec 1, 2019

Research with Pregnant Women: New Insights on Legal Decision‐Making

Hastings Center Report, May 1, 2017

Although pregnant women rely on medical interventions to treat and prevent a wide variety of heal... more Although pregnant women rely on medical interventions to treat and prevent a wide variety of health conditions, they are frequently excluded or underrepresented in clinical research. The resulting dearth of pregnancy-specific evidence to guide clinical decisionmaking routinely exposes pregnant women, and their future offspring, to risk of uncertain harms for uncertain benefits. The two legal factors regularly cited as obstacles to such research are the federal regulatory scheme and fear of liability. This article reveals a far more nuanced and complex view of the legal context. First, legal professionals may-at any time from product conception to marketing-influence decisions about research with pregnant women. Second, factors not previously articulated in the literature may prompt legal professionals to slow or halt such research. They include: financial interests, regulatory ambiguity, obstacles to risk management, and site-specific laws unrelated to research. Any efforts to promote the ethical inclusion of pregnant women in research must acknowledge the role of legal decisionmakers and address their professional concerns.

IRB Decision‐Making about Minimal Risk Research with Pregnant Participants

Ethics & human research, Sep 1, 2021

Pregnant women are often excluded from research without clear justification, even when the resear... more Pregnant women are often excluded from research without clear justification, even when the research poses minimal fetal risk. Little is known about institutional review board (IRB) decision-making practices when reviewing such research. We conducted a survey of IRB personnel in the US to elicit their interpretations of “minimal risk” – a formal regulatory category -- and to identify factors that may influence IRB decisions to approve or disapprove research involving pregnant participants. Study results revealed some consensus among IRB members about the risk level of individual research procedures and hypothetical study vignettes. However, we uncovered important variations not only in the assessment of risk but also in the willingness of IRB members to approve minimal risk research that includes pregnant women. Based on our findings, guidance is needed to assist IRB members in characterizing risk, applying federal regulations, and appropriately ensuring the inclusion or justified exclusion of pregnant women in research.

Advancing HIV research with pregnant women: navigating challenges and opportunities

Carolina Digital Repository (University of North Carolina at Chapel Hill), 2016

Objective-Concerns about including pregnant women in research have led to a dearth of evidence to... more Objective-Concerns about including pregnant women in research have led to a dearth of evidence to guide safe and effective treatment and prevention of HIV in pregnancy. To better understand why these evidence gaps persist and inform guidance for responsible inclusion of pregnant women in the HIV research agenda, we aimed to learn what HIV experts perceive as barriers and constraints to conducting this research. Methods-We conducted a series of group and one-on-one consultations with 62 HIV investigators and clinicians to elicit their views and experiences conducting HIV research involving pregnant women. Thematic analysis was used to identify priorities and perceived barriers to HIV research with pregnant women. Results-Experts discussed a breadth of needed research, including safety, efficacy and appropriate dosing of: newer ARVs for pregnant women, emerging preventive strategies, and treatment for co-infections. Challenges to conducting research on pregnancy and HIV included ethical concerns, such as how to weigh risks and benefits in pregnancy; legal concerns, such as restrictive interpretations of current regulations and liability issues; financial and professional disincentives, including misaligned funder priorities and fear of reputational damage; and analytical and logistical complexities, such as challenges recruiting and retaining pregnant women to sufficiently power analyses. Conclusions-Investigators face numerous challenges to conducting needed HIV research with pregnant women. Advancing such research will require clearer guidance regarding ethical and legal uncertainties; incentives that encourage rather than discourage investigators to undertake such research; and a commitment to earlier development of safety and efficacy data through creative trial designs.

Reframing Conscientious Care: Providing Abortion Care When Law and Conscience Collide

Hastings Center Report, 2016

While the concept of conscience has broad philosophical underpinnings relating to moral judgment,... more While the concept of conscience has broad philosophical underpinnings relating to moral judgment, agency, and discernments of right and wrong, debates in bioethics have tended to engage the concept primarily vis-à-vis rights of conscientious refusal. Here, we suggest a broader frame for thinking about claims of conscience in healthcare. Drawing on empirical findings from our research with abortion providers in North Carolina, we elucidate an empirically grounded approach to ethically justified care when healthcare providers face legal or institutional policy mandates that raise possible moral conflicts. We highlight, in particular, how providers may be motivated by matters of conscience, including relational concerns, in the active provision of certain forms of care. In so doing, we challenge the dichotomy between conscientious refusal and morally compromised action, demonstrating how providers may work within the constraints of laws or institutional policies that raise moral challenges and act in accordance with conscience. "It's almost like putting salt in a wound, for this person who's already made a very difficult decision," offered Dr. Meghan Patterson, 1 a licensed obstetrician/gynecologist whom we interviewed in our qualitative study of the experiences of North Carolina abortion providers practicing under the 2011 "Woman's Right to Know" (WRTK) Act (HB 854

Diagnostic yield and psychological outcomes among women pursuing trio‐exome sequencing: Do women with recurrent anomalous fetal phenotypes experience more negative psychological outcomes?

Prenatal Diagnosis

The association between pregnancy management and psychological outcomes among patients pursuing trio-exome-sequencing (ES) for diagnosis

American Journal of Obstetrics and Gynecology, 2022

Where are the pregnant and breastfeeding women in new pre-exposure prophylaxis trials? The imperative to overcome the evidence gap

The Lancet HIV, 2022

Pregnant and breastfeeding populations are at substantial risk of acquiring HIV in some settings,... more Pregnant and breastfeeding populations are at substantial risk of acquiring HIV in some settings, yet are underrepresented in clinical trials of new pre-exposure prophylaxis (PrEP) agents. Several PrEP formulations are in development (eg, vaginal rings, long-acting injectables, and other modalities). Pregnant and breastfeeding populations are typically excluded from initial clinical trials. We identified 14 PrEP trials of novel agents in non-pregnant or non-breastfeeding populations, and six phase 1-3 trials and open label extensions among pregnant and breastfeeding populations, that are currently ongoing or complete. A framework shift is needed to consider the ethical costs of excluding pregnant and breastfeeding populations at risk for HIV in PrEP clinical trials and promote inclusion to maximise the benefits from PrEP tools in the pipeline. Research on new PrEP agents should include pregnant and breastfeeding populations to avoid delays in reaching those who could benefit from PrEP after efficacy is established.

Communication regarding adverse neonatal birth events: Experiences of parents and clinicians

Journal of Patient Safety and Risk Management, 2021

ObjectivesCommunicating with parents about adverse birth outcomes is challenging. We sought to de... more ObjectivesCommunicating with parents about adverse birth outcomes is challenging. We sought to describe attitudes and experiences of parents and providers regarding communication about adverse newborn birth events.MethodsFrom 2011–2012, we conducted semi-structured in-depth interviews with parents who believed they had experienced an adverse birth-related neonatal outcome and focus groups with healthcare providers who have communicated with parents about adverse newborn birth events from three geographically diverse US academic medical centers. We conducted qualitative thematic analysis to identify key themes.ResultsParents and providers described unique communication challenges around adverse neonatal outcomes in six categories: 1) High expectations for a positive delivery experience and the view that birth is a life event, not a medical encounter; 2) Powerful emotions associated with birth, amplified when an adverse event occurs; 3) Rapid changes when expectations for a normal bir...

791 Psychological outcomes among women pursuing Trio-Exome-Sequencing (ES) in the setting of recurrent anomalous fetal phenotypes

American Journal of Obstetrics and Gynecology, 2021

551: Impact of prenatal exome-sequencing (ES) for fetal diagnosis on maternal psychological outcomes: a prospective cohort

American Journal of Obstetrics and Gynecology, 2020

High willingness to delay pregnancy for the purposes of biomedical research participation among malawian women living in a high HIV prevalence setting

American Journal of Obstetrics and Gynecology, 2019

Ethical and counseling challenges in prenatal exome sequencing

Prenatal Diagnosis, 2018

Objective: Ethical and counseling challenges are expected with the introduction of prenatal whole... more Objective: Ethical and counseling challenges are expected with the introduction of prenatal whole exome sequencing. In this study, we describe specific challenges identified through the UNC-Chapel Hill Prenatal Exome Sequencing Study. Methods: Participants were a subset of women participating in the fetal exome study, which has enrolled 73 mother-father-fetus trios in pregnancies diagnosed with structural anomalies and normal standard genetic testing results. In this descriptive study, cases were reviewed by members of the research team, including a bioethicist, to identify counseling challenges. Illustrative cases were chosen by group consensus. Results: Four illustrative cases were identified for further analysis. Challenges included: need for adequate counseling and informed consent, challenges in prenatal variant interpretation, performing prenatal diagnosis in subsequent pregnancies, inability to identify a genetic etiology, and identifying parental secondary findings. Conclusion: Our study illustrates several challenges identified in an ongoing prenatal exome study. While genomic medicine is a powerful tool for prenatal diagnosis, it is important that clinicians understand the ethical implications and parental perceptions of this testing modality.

Rubella Vaccine-Reply

JAMA pediatrics, 2018

Specific Populations

Oxford Handbooks Online, 2015

It is estimated that more than 500,000 women annually experience a mental illness during pregnanc... more It is estimated that more than 500,000 women annually experience a mental illness during pregnancy. Although approximately a third of these women will be prescribed medication, the majority receives no treatment, partly because ethical challenges to including pregnant women in research protocols have impeded studies necessary to establish maternal and fetal effects of medication, appropriate dosing, and the relative risks of undertreated mental illness. Because mental illness is a frequent complication of pregnancy (particularly anxiety and depression), clinicians will be called upon to ethically navigate uncertain treatment recommendations with sensitivity to patient values. The following discussion reviews the history of current guidelines to research with pregnant women, common clinical presentations of women experiencing mental illness in the perinatal context, and relevant ethical frameworks to inform patient care.

Reframing Conscientious Care: Providing Abortion Care When Law and Conscience Collide

Carolina Digital Repository (University of North Carolina at Chapel Hill), 2016

While the concept of conscience has broad philosophical underpinnings relating to moral judgment,... more While the concept of conscience has broad philosophical underpinnings relating to moral judgment, agency, and discernments of right and wrong, debates in bioethics have tended to engage the concept primarily vis-à-vis rights of conscientious refusal. Here, we suggest a broader frame for thinking about claims of conscience in healthcare. Drawing on empirical findings from our research with abortion providers in North Carolina, we elucidate an empirically grounded approach to ethically justified care when healthcare providers face legal or institutional policy mandates that raise possible moral conflicts. We highlight, in particular, how providers may be motivated by matters of conscience, including relational concerns, in the active provision of certain forms of care. In so doing, we challenge the dichotomy between conscientious refusal and morally compromised action, demonstrating how providers may work within the constraints of laws or institutional policies that raise moral challenges and act in accordance with conscience. "It's almost like putting salt in a wound, for this person who's already made a very difficult decision," offered Dr. Meghan Patterson, 1 a licensed obstetrician/gynecologist whom we interviewed in our qualitative study of the experiences of North Carolina abortion providers practicing under the 2011 "Woman's Right to Know" (WRTK) Act (HB 854

Administering vaccines to pregnant women in an outbreak or epidemic: what factors and circumstances influence considerations of acceptable and recommended use?

American Journal of Obstetrics and Gynecology, Dec 1, 2017

to better understand care and referral of pregnant women with suspected and confirmed ZIKV infect... more to better understand care and referral of pregnant women with suspected and confirmed ZIKV infection. CONCLUSIONS: Tools are currently in use in five countries and results will inform recommended referral pathways for pregnant women with suspected and confirmed cases of ZIKV infection. Surveys will continue to be updated based on user experience as part of ongoing QI programs. Ultimately, these tools will be available in a variety of settings for use by Ministries of Health and/or Social Welfare for adaptation as a supervision checklist and use outside of this program.

Research with Pregnant Women

Oxford University Press eBooks, Apr 1, 2019

Access to Pregnancy-Related Services: Public Health Ethics Issues

Advancing fair access to evidence-based pregnancy-related services is a critical public health pr... more Advancing fair access to evidence-based pregnancy-related services is a critical public health priority. It is widely recognized that there are inequalities in lifesaving interven tions. This chapter however addresses issues raised by services whose value or utility are contested. Using illustrative examples of prenatal genetic testing and modes of child birth, the chapter highlights the ways in which issues of access are complicated by social and cultural ideas about what is valued; discusses contested questions about what is ethi cally responsible or required of patients, providers, and public health systems in these re productive health contexts; and addresses areas of needed research and further ethical analysis. It concludes that issues of access in pregnancy-related care must attend both to broad issues of justice and access and to particular ways that pregnancy services are val ued, debated, and made available to women who might-or might not-benefit from them.

Pregnant women and vaccines against emerging pathogens: ethics guidance on an inclusive and responsive research agenda and epidemic response

American Journal of Obstetrics and Gynecology, Dec 1, 2018

46.3% agreed most people would support the rights of an HIVpositive person to live and work where... more 46.3% agreed most people would support the rights of an HIVpositive person to live and work where they wanted. Women's perceived HIV risk was not significantly associated with these discriminatory attitudes (p>0.05). However, 80.3% of women with self-perceived low HIV risk believed most people think individuals infected with HIV via sex exchange or drug use got what they deserve, versus 6.7% of women with self-perceived high HIV risk (p¼0.009). CONCLUSIONS: Despite multiple sexual and other risk behaviors significantly associated with level of perceived HIV risk in a high-risk population of largely minority women, the NBHS survey demonstrates many women with high risk behaviors still perceive themselves to be at low risk. Our findings highlight a complex interaction of risk perception, risk behaviors and stigma surrounding HIV in urban minority women.

U.S. women's views on delaying pregnancy for the purpose of participating in biomedical research

American Journal of Obstetrics and Gynecology, Dec 1, 2019

Research with Pregnant Women: New Insights on Legal Decision‐Making

Hastings Center Report, May 1, 2017

Although pregnant women rely on medical interventions to treat and prevent a wide variety of heal... more Although pregnant women rely on medical interventions to treat and prevent a wide variety of health conditions, they are frequently excluded or underrepresented in clinical research. The resulting dearth of pregnancy-specific evidence to guide clinical decisionmaking routinely exposes pregnant women, and their future offspring, to risk of uncertain harms for uncertain benefits. The two legal factors regularly cited as obstacles to such research are the federal regulatory scheme and fear of liability. This article reveals a far more nuanced and complex view of the legal context. First, legal professionals may-at any time from product conception to marketing-influence decisions about research with pregnant women. Second, factors not previously articulated in the literature may prompt legal professionals to slow or halt such research. They include: financial interests, regulatory ambiguity, obstacles to risk management, and site-specific laws unrelated to research. Any efforts to promote the ethical inclusion of pregnant women in research must acknowledge the role of legal decisionmakers and address their professional concerns.

IRB Decision‐Making about Minimal Risk Research with Pregnant Participants

Ethics & human research, Sep 1, 2021

Pregnant women are often excluded from research without clear justification, even when the resear... more Pregnant women are often excluded from research without clear justification, even when the research poses minimal fetal risk. Little is known about institutional review board (IRB) decision-making practices when reviewing such research. We conducted a survey of IRB personnel in the US to elicit their interpretations of “minimal risk” – a formal regulatory category -- and to identify factors that may influence IRB decisions to approve or disapprove research involving pregnant participants. Study results revealed some consensus among IRB members about the risk level of individual research procedures and hypothetical study vignettes. However, we uncovered important variations not only in the assessment of risk but also in the willingness of IRB members to approve minimal risk research that includes pregnant women. Based on our findings, guidance is needed to assist IRB members in characterizing risk, applying federal regulations, and appropriately ensuring the inclusion or justified exclusion of pregnant women in research.

Advancing HIV research with pregnant women: navigating challenges and opportunities

Carolina Digital Repository (University of North Carolina at Chapel Hill), 2016

Objective-Concerns about including pregnant women in research have led to a dearth of evidence to... more Objective-Concerns about including pregnant women in research have led to a dearth of evidence to guide safe and effective treatment and prevention of HIV in pregnancy. To better understand why these evidence gaps persist and inform guidance for responsible inclusion of pregnant women in the HIV research agenda, we aimed to learn what HIV experts perceive as barriers and constraints to conducting this research. Methods-We conducted a series of group and one-on-one consultations with 62 HIV investigators and clinicians to elicit their views and experiences conducting HIV research involving pregnant women. Thematic analysis was used to identify priorities and perceived barriers to HIV research with pregnant women. Results-Experts discussed a breadth of needed research, including safety, efficacy and appropriate dosing of: newer ARVs for pregnant women, emerging preventive strategies, and treatment for co-infections. Challenges to conducting research on pregnancy and HIV included ethical concerns, such as how to weigh risks and benefits in pregnancy; legal concerns, such as restrictive interpretations of current regulations and liability issues; financial and professional disincentives, including misaligned funder priorities and fear of reputational damage; and analytical and logistical complexities, such as challenges recruiting and retaining pregnant women to sufficiently power analyses. Conclusions-Investigators face numerous challenges to conducting needed HIV research with pregnant women. Advancing such research will require clearer guidance regarding ethical and legal uncertainties; incentives that encourage rather than discourage investigators to undertake such research; and a commitment to earlier development of safety and efficacy data through creative trial designs.