Women's Views About Participating in Research While Pregnant

Anne Drapkin Lyerly, MD, MA; Emily E. Namey, MA; Beverly Gray, MD; Geeta Swamy, MD; Ruth R. Faden, PhD, MPH

Disclosures

IRB. 2012;34(4):1-8. 

In This Article

Discussion

Many commentators have called for better representation of pregnant women and their interests in research, though how to do so responsibly is not yet clear. Important to these efforts is a better understanding of the views of pregnant women themselves about participation in research. Ours was one of the first studies of pregnant women's attitudes about participating in a randomized trial of an intervention aimed at preventing nonobstetrical illness during pregnancy. We found that women participated in order to obtain early access to vaccines, to do so in a situation where they would be closely monitored, and to do so in a way that would produce knowledge that might help other pregnant women.

For the majority of respondents in our study, the opportunity to access the H1N1 vaccine early was a primary reason they enrolled in the vaccine trial. In contrast to the longstanding presumption among researchers and institutional review boards (IRBs) that pregnancy should be regarded as cause for exclusion from research, the women in our study viewed the H1N1 vaccine trial as an important and advantageous opportunity, rather than a risky endeavor from which they needed protection. Their views notably resonate with the rationale underlying the well-documented shift in the early 1990s from protectionist to inclusionary policies governing research, which was prompted in part by AIDS activists and women's health advocates who likewise highlighted unfair denial of research-related benefits as problematic in terms of justice.[16] As Vanessa Merton has pointed out, "participation in a trial can be a benefit,"[17] and in the case of the H1N1 vaccine trial, it was certainly understood as such by many of the women we interviewed.

Perhaps more surprising was that many of the women in our study viewed research participation as "safer" than care in the clinical setting. This stemmed from experiences of more detailed communication about risks and benefits, but also from the idea that they would be monitored closely. The view that research participation is sometimes safer than ordinary care may reflect one assessment of clinical therapeutics during pregnancy as "postmarketing experimentation"[18] on pregnant women, in which therapies that have not been scientifically studied in pregnancy are instituted without the oversight that research usually requires. The presumption that research participation is riskier than clinical care is often questionable. This is particularly so in pregnancy where the opposite may be true: because our evidence base for current treatments is so weak, standard practice can be more like experiment than validated treatment.[19] Women who are pregnant and who are facing decisions about whether to use medications during pregnancy may be aware of the problem and feel safer taking a drug or vaccine in a situation in which they are monitored closely, rather than following medical advice crafted without the benefit of prior pregnancy-specific research.

Many pregnant women in our study viewed research participation as 'safer' than care in the clinical setting.

Our findings resonate with recent analyses questioning the helpfulness of the sharp distinction between research and practice. Some have called for increased flexibility and modification of approaches to clinical research that demand such a bright line.[20] While continued care should be taken to ensure that individuals do not make decisions to participate in research with an inordinate expectation of benefit or a consequential misunderstanding of the aims of the study, there are contexts in which patients are correct in believing that their prospects for net clinical benefit if they participate in research are no worse (and in some cases may even be better) than what they could expect if they elected to receive an intervention in the standard clinical care setting.[21] Worries about therapeutic misconception are particularly apt for studies in which there is no reasonable prospect of direct clinical benefit. However, such studies will be uncommon in pregnant women, whose participation in research that involves more than minimal risk must, according to federal guidelines, hold out the prospect of direct benefit for the pregnant woman, the fetus, or both.[22]

The women we interviewed represent a distinct subset of potential research participants in that they were making decisions about whether to enroll in a vaccine trial in the face of a disease that was potentially life-threatening to them and their fetus/newborn. As such, our findings may be particularly relevant to research involving pregnant women facing other significant illnesses (for example, those with HIV, clinical depression, and diabetes) who may be inclined to participate in clinical trials for similar reasons. Notably, however, our research took place in the context of an intense public health campaign in favor of vaccination with considerable media attention to the risks of H1N1 during pregnancy, which may have biased the women we interviewed toward participating in the vaccine trial. In particular, the influence of this campaign may have countered the tendency in pregnancy to notice the risks of intervening without giving due attention to the risks of not intervening when treating nonobstetrical illness during pregnancy.[23] Studying research contexts without any corrective to this common risk distortion (for instance, treatment of depression during pregnancy) will be important to understanding pregnant women's reasoning about participation in research and may help to delineate the extent to which reasoning about the risks of illness, intervention, and research may shift in response to public messages about the disease or condition at issue. In addition, further research is needed to understand how pregnant women experience and evaluate the burdens of illness or threatened illness, particularly the ways that the combination of pregnancy and illness shape reasoning around risk-benefit trade-offs and participation in research.

In particular, other research contexts may present more difficult dilemmas for pregnant women than were raised by the decision about participating in the H1N1 vaccine trial. The intervention we studied—a novel vaccine—was relatively low risk to both the woman and the fetus, especially in the context of the clear threat of H1N1. Other studies enrolling pregnant women, such as the recently completed randomized trial of prenatal surgery for fetal myelomeningocele,[24] will involve interventions that have clear risks of morbidity or mortality for pregnant women, fetuses, or both. Little is known about why pregnant women agree or decline to participate in clinical trials in the face of research with considerably greater risks and less certain benefits than our study explored,[25] and future studies on women's views are needed as the evidence base for the breadth of interventions develops. Notably, however, risk was a consideration even for vaccination against H1N1, both for the IRB, which deemed that the vaccine study posed more than minimal risk, and for many of the pregnant women who declined vaccination in the context of the pandemic.[26] Furthermore, the majority of studies needed to understand treatment of maternal illness during pregnancy will not involve the high-stakes risk calculations that recent surgical trials have entailed.

In addition, the benefits of this intervention—prevention of influenza during pregnancy and conferred vaccination to the neonate—potentially accrued to both women and fetuses, but other studies will involve interventions where maternal and fetal interests are not as closely aligned. Thus, further research is needed to understand how women reason about participating while pregnant in a study that involves trade-offs between their own health and that of their fetus or child.

Given the clinical characteristics of our study population, as well as the particularities of the research in which they enrolled, it is important to recognize that the attitudes and experiences of respondents in our study may differ from those of pregnant women considering enrolling in clinical trials for which direct benefit is less likely, or in which the threat of illness is remote or unrelated to an individual's participation, such as epidemiological research. A recent study indicated that up to one-third of pregnant women would not participate in what researchers termed "noninvasive" research procedures, such as medical record abstraction or infant examination postpartum, with resistance especially noted among more highly educated women.[27] These findings contrast with ours in interesting ways. Altruism was a common motivation for the women in our study who chose to participate in H1N1 vaccine trials rather to than receive the vaccine in the clinical setting, although the women were also motivated by recognition that doing the latter would not be risk-free. Knowledge about or experience of the threat of disease itself may serve as a more powerful motivator to participate in research than the less familiar and perhaps less personally relevant benefits "to society" of exploratory research. More public awareness of the dearth of information to guide clinical care and policy-making around health and pregnancy may further incline pregnant women toward participating in research. Additionally, in contrast to some epidemiological studies such as the National Children's Study or some pregnancy vaccine studies directed primarily or exclusively at the prevention of illness in children,[28] the H1N1 vaccine trial was explicitly directed at maternal health and thus may have drawn on solidarity among women who are pregnant. Shaping studies in ways that will improve not only the health of future children but also that of women themselves may translate into greater numbers of pregnant women enrolling in clinical trials.

We interviewed a small sample of pregnant women who participated in a research study at a single academic study site, limiting generalizability to other populations. Our participants were fairly homogeneous and had a higher socioeconomic status and level of education than the general population. Therefore, they do not represent the general population, and their views may be different from women of different demographic or socioeconomic strata. For instance, this relatively advantaged group may have been more inclined toward a positive assessment of research, although recent data link more education to reduced willingness to participate in research.[29] It is interesting to note, however, that the themes that emerged in our study were observed among women across socioeconomic strata.

An additional limitation of the study is that interviews were conducted only with women who agreed to participate during their pregnancy in a vaccine trial; future research should address the views of women who decline to enroll in clinical trials while pregnant, as well as the views of pregnant women who consider whether to participate in other types of research with different study designs and in different settings. And finally, given the exploratory nature of our qualitative methods, larger studies involving a diverse national sample and quantitative methodologies are needed to assess the prevalence of the elicited views. In addition to potentially validating our findings, quantitative data will permit an empirical assessment of the relative importance of factors influencing decisions about research participation across groups of pregnant women who consider enrolling in clinical trials and other types of research.

Despite these limitations, our study provides critical information for responsibly moving forward research with pregnant women. One of the strengths of this study is that it explores reasoning around vaccine acceptance in a way that elicits what matters most to pregnant women themselves, providing an important and useful framework for discussing concerns with them in both research and clinical care settings. Our findings counter the entrenched view that pregnant women need to be protected from research; in contrast, our participants construed research participation as a benefit and even articulated reasons that such participation is preferable to clinical care when pregnant. These data thus challenge current notions that de facto exclusion of pregnant women from research is justified. The data also point toward both the feasibility and responsibility of reforming current practices and policies so that they fairly benefit pregnant women—both those who choose to participate in research and those who stand to benefit from the knowledge it generates.

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