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. Author manuscript; available in PMC: 2022 Sep 1.
Published in final edited form as: Ethics Hum Res. 2021 Sep;43(5):2–17. doi: 10.1002/eahr.500100

Table 4:

Main Factors Impacting Decision-Making to Approve Research Vignettes for Majority of IRB Members

Issues considered “a lot” IRB members selecting this issue (n = 93)
Observational study Survey study PK study
The risks of research participation for the fetus or pregnant woman are truly minimal 80 (86.0 %) 76 (81.7%) 71 (76.3%)
All kinds of people with the condition should be included to best understand the condition 71 (76.3%) 67 (72.0%) n/a*
Access to research should not discriminate against pregnant women 64 (68.8%) 62 (66.7%) 62 (66.7%)
Certain conditions can affect pregnant women and should be studied 62 (66.7%) 65 (69.9%) n/a*
Efforts should be made to fill research gaps on conditions that affect pregnant women 48 (51.6%) 53 (57.0%) 70 (76.1%)
This treatment is already widely being used and should be studied n/a* n/a* 83 (89.2%)
Important biomedical knowledge cannot be obtained without pregnant women n/a* n/a* 80 (86.0%)
All populations at risk for HIV need accurate PK data on available treatments n/a* n/a* 67 (72.0%)
*

n/a = issue was not a selection option