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

Study Results

The 22 participants ranged in age from 19 to 39, with a mean age of 31. Most (18/22) had at least one previous birth. Eleven of the participants were white, five were black, four were Hispanic, and two were Asian. Nearly all of the participants were from "advantaged" socioeconomic backgrounds: 18/22 had completed college or graduate school, and all had medical insurance. Fourteen of the participants had pregnancies that were considered "high risk," and 19 had received the seasonal flu vaccine (Table 1).

Risk and the Threat of H1N1

Respondents universally articulated a positive or neutral valuation of risks and benefits associated with H1N1 influenza vaccination. Most were acutely aware of the threat (to them) of H1N1 influenza and confident in the vaccine's ability to protect them from it. One woman stated that she participated because of "the great benefit of inoculation against this" (V02, emphasis added). Reflecting on public messages and media attention surrounding H1N1, many women participated in the trial having already concluded that the risks of contracting H1N1 flu outweighed any theoretical risk from vaccination:

I think just kind of weighing the risk of the vaccine as opposed to actually getting sick with H1N1, and the risk factors that went along with that, [it] was definitely safer to go ahead and get the vaccine than to risk getting sick. (V05)

Refining our focus to the specific circumstance of receiving the vaccine as part of a research study revealed a trio of considerations influencing women's decision-making about entering the trial. These included early access to vaccination, perceived safety advantages of research participation, and an altruistic desire to participate in efforts to redress the dearth of data regarding perinatal therapeutics.

Early Access to the Vaccine

The opportunity for early access to the H1N1 vaccine was a central consideration in several women's decisions to enroll in the vaccine trial. More than half of respondents indicated they enrolled in the study in order to receive the vaccine in advance of when they could have received it under regular circumstances, i.e., outside of the research context. As one woman noted, "I would say the pro was obviously getting the vaccine early … at the time it seemed like a scarce commodity" (V04). Another recounted responding with enthusiasm to the offer to participate, since she "wasn't going to be able to get it any other way" (V13).

For women who participated in the vaccine trial, the related notions of a growing pandemic and the finite supply of vaccine imparted urgency to their desire for early vaccination:

I was very excited to be able to participate, just because at that point in time the vaccine wasn't really widely available. And so I was able to get it … at least two or three weeks prior to when … the H1N1 cases started ramping up. (V05)
I knew that there weren't a lot of vaccines out there at that time and that pregnant women were considered high risk, so I wanted to be protected. (V07)

Early access via research was particularly attractive to some women who were nearing the end of their pregnancy and appreciated in particular the benefit of conferred immunity to the neonate if they were vaccinated during pregnancy, rather than after delivery:

I was hoping to be able to get the H1N1 vaccine soon, and it was probably going to be coming out around the time I delivered. So I wanted to have immunity before I delivered. So I was excited to hear I could get it a few weeks before. (V15)

Vaccine Safety

Most respondents indicated they would have enrolled in the H1N1 vaccine trial even if the vaccine had been available outside the study, with several indicating that they felt safer being a part of a research study than not:

I felt like, because I was in the study I was … more closely looked at. Watched. And followed, rather than somebody who was just given the flu shot or an H1N1 shot. (V04)

Despite general anxiety about the potential for fetal harm from drugs and vaccines, many respondents were attuned to the harms of inadequate data for correct dosing in pregnancy. For them, concerns about vaccine safety centered on the possibility of underdosing.

I made a decision because … when I get my regular vaccination, they don't draw blood to check and see if it's doing right [sic]. And I wanted them to check and make sure that it's doing something for me and that I just ain't taking it for no reason. (V06)

Others felt reassured by the nature of the research question itself, which they understood to be primarily focused on dosing rather than vaccine-related harm:

[The research question] made it feel like they already felt the vaccine itself was safe. And they were just trying to tweak it so that everyone's getting the proper amount and it can be distributed equitably. So the fact that it was this specific about the doses made me more inclined to do it, because for them to be trying to determine the doses, it seemed to me that that meant that they were already pretty confident it was safe. (V12)

Other women perceived that trial participation also meant better care because, for instance, they would receive more detailed information about the vaccine than in the clinical setting: "I did the research because I feel like [the researchers] explained it to me better than the doctors did." (V14)

Altruism

Many women said that altruistic considerations motivated them to participate in the vaccine trial. Several were affiliated with Duke University or had been part of biomedical research teams and felt willing, and in some cases even obligated, to take on the burdens of participating in research that might benefit others:

I believe in someone being willing to take on a small risk because it benefits a population. I appreciate that other people were willing to do that and that I benefit from it in a lot of ways. (V01)
With very, very little effort I can do something pretty good. The same thing with the donating cord blood. It's no skin off my nose. (V02)

Others focused in particular on the dearth of evidence for therapeutics in pregnancy and were motivated by the idea that participating in pregnancy studies addresses a particularly pressing need:

[I] was hearing a lot of very educated people expressing uninformed opinions about the swine flu vaccine. So I was glad to be in a trial that could hopefully get rid of those fears. (V15)
I would have [participated if vaccine were available outside the trial], just because we need to document it. There needs to be some sort of aggregate results, and it can't be these spontaneous reports here and there. The only way to do that is in some sort of either trial or registry, some sort of study, a clinical study where they take note of the dose, they know the date it's given, and it's all in one spot. (V13)

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