Electronic Informed Consent to Facilitate Recruitment of Pregnant Women Into Research

Abstract

Methods to obtain informed consent digitally or electronically may increase the participation of racially and geographically diverse pregnant women in prospective research, which is essential to improve the evidence base for maternity care. We evaluated the feasibility and utility of e-consent in the first year of a multiyear clinical trial involving pregnant women. Of the 86 women screened, 71 were eligible, 65 (93% of eligible) agreed to review the e-consent form, and 61 (86% of eligible) completed the e-consent process. Of the interested women who were sent the e-consent link, all were able to complete the e-consent process, even those who reported low health literacy. Women of all racial and ethnic groups were equally likely to consent, and the sample of women who consented was consistent with practice demographics. E-consent is feasible and easy to use with pregnant women and may expedite enrollment of a representative sample.

Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting

“…Study characteristics are summarised in Table 3 . There were 6 cohort studies, [ [39] , [40] , [41] , [42] , [43] , [44] ] 5 qualitative studies [ [45] , [46] , [47] , [48] , [49] ], 4 RCTs [ [50] , [51] , [52] , [53] ], 2 mixed-methods studies [ 54 , 55 ] and 1 case-control study [ 56 ] included in this review. With the exception of 2 studies conducted in the UK [ 45 , 54 ], all other studies were undertaken in the USA.…”

“…The demographics of study participants were generally representative of their local population, although many authors noted a predominance of educated, white females [ 39 , 40 , 44 , 45 , 47 , 50 , 51 , 53 , 55 ]. Five studies targeted a specific population; pregnant women [ 42 ], participants from urban and rural communities [ 48 ], participants under-represented in research in the United States [ 49 ], older adults (65 years or older) [ 55 ] and legal authorised representatives consenting by proxy for medical research [ 43 ].…”

“… E-consent easier to read, more concise and more accessible than paper. Low Philippi et al [ 42 ] (2018) / USA Multi-site cohort study to explore feasibility and utility of the use of telephone discussion and e-consent documentation. Pregnant women (n = 61) consenting for research participation.…”

“…Critical appraisal of the studies suggested they were generally of good methodological quality with large and/or demographically diverse sample populations, [ 39 , 45 , 46 , 48 , 53 ] robust recruitment processes [ 40 , 45 , 51 ], and clear study/data analysis procedures described [ 40 , 43 , 44 , [49] , [50] , [51] , [52] , [53] ]. Three studies were considered to have a high risk of bias because of an unclear recruitment strategy [ 41 ], a long follow-up time [ 54 ], and non-vigorous study procedures [ 42 ]. Details regarding ethical approval were unclear or not provided in 2 studies [ 47 , 52 ].…”

A REDCap-based model for electronic consent (eConsent): Moving toward a more personalized consent

“…Early results using remote eConsent with the Vanderbilt STRIDE exemplar study suggest that utilization of eConsent may increase the participation of minority pregnant women in prospective research. Researchers concluded that eConsent was effective for consenting women with low health literacy [34]. Further work over the course of the STRIDE project and more detailed data capture of participant interactions with the eConsent framework will assess the impact of the framework on recruitment and retention of minority participants in research studies and help to inform best practices for utilizing the framework in remote consenting.…”