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 Methods

We conducted qualitative, in-depth interviews with women enrolled while pregnant at Duke University Medical Center (DUMC) in either of the two randomized H1N1 vaccine trials.[11] In addition to having been enrolled in the vaccine trials, women were also eligible for our study only if they 1) did not have a tragic maternal or fetal complication during pregnancy or the postpartum period, regardless of relationship to involvement in the vaccine trial, and 2) gave voluntary informed consent.

Selection of participants proceeded iteratively to ensure representation across demographic groups and also "saturation" with regard to salient themes.[12] With this sampling technique, characteristic of qualitative research, the general rule is that saturation is reached when no new or relevant data seem to emerge regarding a theoretical category, the theoretical category is well developed in terms of its properties and dimensions, and the relationships among theoretical categories are well established.[13] Twenty-two (49%) out of a total of 45 women who participated in the H1N1 trials at DUMC were enrolled in our study and interviewed.

Interviews took place between February and June 2010. After the participant gave written informed consent, an investigator experienced in qualitative research conducted semistructured, in-depth interviews to assess women's experience of decision-making around their participation in the vaccine trial. We focus here on two sets of questions pertaining to 1) reasoning around participation in the H1N1 vaccine trial and 2) reasoning about research participation generally during pregnancy. Demographic characteristics were collected at the time of the interviews via participant self-report. All interviews were recorded and transcribed verbatim for accuracy.

Structural (question-based) codes were devised and applied to facilitate subsequent analysis of the transcripts.[14] Once all interviews were structurally coded using NVivo qualitative analysis software,[15] all segments of text coded under the sets of questions described above were retrieved for this analysis, and a content codebook was developed. Two investigators then independently coded the transcripts, checking coding agreement on every third, then fifth, transcript. The few discrepancies in code application were resolved through discussion; if necessary, the codebook was revised, and any previously coded interviews were recoded as applicable. The fully coded dataset was then analyzed for prevalence and breadth of themes related to decision-making about participating in research while pregnant. Quotations are attributed by study ID number and are exemplary of noted themes.

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