Women’s Views About a Paternal Consent Requirement for Biomedical Research in Pregnancy

Sullivan, Kristen; Little, Maggie; Rosenberg, Nora E.; Mtande, Tiwonge; Zimba, Chifundo; Jaffe, Elana; Anderson, Jean; Coleman, Jenell S.; Gilbert, Sappho Z.; Wolf, Marielle S. Gross; Hoffman, Irving; Rahangdale, Lisa; Faden, Ruth R.; Lyerly, Anne Drapkin

doi:10.1177/1556264618783834

Cited by 15 publications

(51 citation statements)

References 18 publications

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“…The data for this analysis were collected as part of a larger project, PHASES, which aims to develop guidance for ethically acceptable research on HIV treatment and prevention during pregnancy. We conducted qualitative, in-depth interviews using a semi-structured guide, as described previously [20]. The data for this analysis, collected between August 2016 and April 2017, pertain to women’s opinions about common contraception requirements for women participating in clinical trials.…”

Section: Methodsmentioning

confidence: 99%

“…The analytic approach was informed by thematic analysis [28], and described in detail elsewhere [20]. Interviews were recorded, transcribed verbatim, and translated as necessary.…”

Section: Methodsmentioning

confidence: 99%

“…To address this void, we elicited women’s views on contraception requirements as part of a larger qualitative study conducted by the Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) project [20]. Our study interviewed pregnant and recently pregnant women living with or at risk of HIV/AIDS, exploring their views about and experiences around clinical trial participation.…”

Section: Introductionmentioning

confidence: 99%

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Women’s views about contraception requirements for biomedical research participation

et al. 2019

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The scientific and ethical importance of including women of reproductive age in biomedical research is widely acknowledged. Concerns about preventing fetal exposure to research interventions have motivated requirements for contraception among reproductive aged women in biomedical studies–often irrespective of risks and benefits or a woman’s actual potential for pregnancy, raising important questions about when such requirements are appropriate. The perspectives of women themselves on these issues are largely unexplored. We conducted 140 interviews, 70 in the U.S. and 70 in Malawi, with women either living with or at-risk for HIV, exploring their views about the practice of requiring contraception in clinical trials. A majority of women interviewed from both countries indicated overall support for the practice, with seven themes characterizing advantages and disadvantages raised: reproductive control, health effects, prevention of fetal harm, burden on women, deferral to authority, autonomy regarding enrollment and birth control method, and relationship concerns. While women in the US frequently raised prevention of fetal harm as a key advantage, many other positives noted by women in both countries were related to contraception use in general, not specific to a trial context. With regard to disadvantages, U.S. women tended to focus on biomedical risks such as side effects and impact on fertility, whereas Malawian women focused on the social risks of contraception requirements, including violations of trust in marital relations and suspicions of potential infidelity. Given the potential benefits and burdens highlighted, contraception in research should be sensitive to actual fetal risk assessments; directed where justified at optimizing effective pregnancy prevention; responsive to women’s reproductive preferences; and made available as an ancillary benefit even where risk thresholds do not justify requirement–in order to facilitate trials that are both ethical and robustly oriented around the interests and lives of women who will participate in them.

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Section: Methodsmentioning

confidence: 99%

“…The analytic approach was informed by thematic analysis [28], and described in detail elsewhere [20]. Interviews were recorded, transcribed verbatim, and translated as necessary.…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Women’s views about contraception requirements for biomedical research participation

et al. 2019

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“…Work in the social sciences has demonstrated the ways in which human agency, and in this case women's agency, is in practice bounded by the views and influences of important others (Burkitt, 2016;Duncan, 2015). For example, a recent study reported that a majority of women supported the requirement for paternal consent for pregnant women's participation in clinical trials that offer the prospect of direct benefit solely to the unborn baby (Sullivan et al, 2018). What remains challenging, even with these more nuanced models of socially situated decision making, is how to distinguish between mutually valued social support for women's decisions and more problematic, paternalistic norms that view women as unable to make decisions over their health and body once they become pregnant.…”

Section: Discussionmentioning

confidence: 99%

Perceived Social Influences on Women's Decisions to use Medications not Studied in Pregnancy. A Qualitative Ethical Analysis of Preexposure Prophylaxis Implementation Research in Kenya

Ngure

Trinidad

Beima‐Sofie

et al. 2021

Journal of Empirical Research on Human Research Ethics

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Implementation research ethics can be particularly challenging when pregnant women have been excluded from earlier clinical stages of research given greater uncertainty about safety and efficacy in pregnancy. The evaluation of human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) during pregnancy offered an opportunity to understand important ethical considerations and social influences shaping women's decisions to participate in the evaluation of PrEP and investigational drugs during pregnancy. We conducted interviews with women ( n = 51), focus groups with male partners (five focus group discussions [FGDs]), interviews with health providers ( n = 45), four FGDs with pregnant/postpartum adolescents and four FGDs with young women. Data were analyzed using thematic content analysis, including ethical aspects of the data. Our study reveals that women navigate a complex network of social influences, expectations, support, and gender roles, not only with male partners, but also with clinicians, family, and friends when making decisions about PrEP or other drugs that lack complete safety data during pregnancy.

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“…The published studies identified differed in many ways from this paper, which focuses on the conditions under which the informed consent of the biological, legal and social father should be required in prenatal research on unproven but promising stem cell therapies. A recent, but rare, exception is a general study of women's views on a paternal consent requirement for biomedical research in pregnancy(Sullivan et al 2018).…”

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confidence: 99%

Paternal consent in prenatal research: ethical aspects

Johansson

Hermerén

Sahlin

2019

Med Health Care and Philos

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The role of mothers in prenatal research has been discussed extensively. Significantly less work has been done on the father's role. In this article, focusing on ethical issues, we seek to redress this imbalance. Examining the father's position in research conducted on pregnant women, we ask whether or not paternal consent ought to be required in addition to that of the pregnant woman. Having distinguished between different concepts of father and mother, we proceed by giving an overview of the reasons for requiring consent of the woman who is carrying the child. We then examine which of these reasons apply to the biological father, and show that some of them are relevant to the father. The case, roughly speaking, revolves around privacy issues, the father's future legal responsibilities, and the likelihood that he will care about the health and wellbeing of his future child. These factors in the decision problem should all be recognized, as should the fact that they can in principle be trumped by other considerations.

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Women’s Views About a Paternal Consent Requirement for Biomedical Research in Pregnancy

Cited by 15 publications

References 18 publications

Women’s views about contraception requirements for biomedical research participation

Women’s views about contraception requirements for biomedical research participation

Perceived Social Influences on Women's Decisions to use Medications not Studied in Pregnancy. A Qualitative Ethical Analysis of Preexposure Prophylaxis Implementation Research in Kenya

Paternal consent in prenatal research: ethical aspects

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