Although decentralized research is being used more frequently, few data are available regarding barriers for potential subjects related to engaging in decentralized research with remote biospecimen collection, especially within pregnancy and birth cohorts that include individuals of diverse racial and ethnic backgrounds.

Focus groups and individual interviews with pregnant and postpartum women were conducted in English and Spanish. Thematic analysis was used to identify motivators and barriers to participation in decentralized research involving biospecimens.

Sixty women (35% Hispanic/Latino, 23% Black, 18% Asian, 15% non-Hispanic White) participated in 10 focus groups (English = 8, Spanish = 2) and 11 individual interviews (English = 7, Spanish = 4). Three themes emerged about factors that could promote participation in decentralized biospecimen collection: 1) convenience, 2) autonomy, and 3) benefit (to self, community or society). Four themes emerged about potential barriers: 1) lack of interaction with trained professionals, 2) inability to coordinate with existing clinical care, 3) discomfort and invasiveness, and 4) concerns about data transparency and security. Overall, participants felt more comfortable providing biospecimens for themselves compared to their child and with biospecimens perceived as less painful or invasive to obtain.

Our findings suggest that transparency about the purposes and use of collecting biospecimen and clear instructions (such as written and instructional videos) could improve biospecimen collection in decentralized pregnancy and birth cohorts. Additionally, opportunities for virtual interaction with study staff and options related to collection of certain biospecimens such as blood (mobile collection unit with trained staff versus a self-collection device) may also improve participant engagement.

Disparities in the recruitment of minority populations in research are well-documented. However, the degree of participation and retention of minorities following enrollment is less known, particularly in decentralized studies. Although decentralized clinical research methods may allow researchers to engage broader study populations with less participation burden, they may present different retention challenges. To evaluate racial and ethnic differences in the degree of participation after enrollment in a decentralized study, we analyzed data from a cohort of patients with inflammatory bowel diseases following COVID-19 immunization.

We compared by race and ethnicity the following post-enrollment participation metrics: response to > 50% of follow-up surveys, donation of a blood sample for antibody testing, consent to use of bio samples for future research, and withdrawal prior to study completion.

Overall, we observed higher levels of post-enrollment study participation among non-Hispanic White (NHW) participants as compared to Black or Hispanic participants: 95% of NHW participants completed follow-up versus 87% of Black participants and 91% of Hispanic participants, 73% of NHW participants provided bio samples versus 64% Black participants and 67% Hispanic participants, and 65% of NHW participants provided consent for future research versus 62% of Black participants and 52% of Hispanic participants.

Our findings demonstrate that the degree of study participation after enrollment in this decentralized study differed by race and ethnicity, indicating that attention to diversity, equity, and inclusion is needed not only in clinical research recruitment but also throughout study administration.

During the COVID-19 pandemic, research organizations accelerated adoption of technologies that enable remote participation. Now, there’s a pressing need to evaluate current decentralization practices and develop appropriate research, education, and operations infrastructure. The purpose of this study was to examine current adoption of decentralization technologies in a sample of clinical research studies conducted by academic research organizations (AROs).

The setting was three data coordinating centers in the U.S. These centers initiated coordination of 44 clinical research studies during or after 2020, with national recruitment and enrollment, and entailing coordination between one and one hundred sites. We determined the decentralization technologies used in these studies.

We obtained data for 44/44 (100%) trials coordinated by the three centers. Three technologies have been adopted across nearly all studies (98–100%): eIRB, eSource, and Clinical Trial Management Systems. Commonly used technologies included e-Signature (32/44, 73%), Online Payments Portals (26/44, 59%), ePROs (23/44, 53%), Interactive Response Technology (22/44, 50%), Telemedicine (19/44, 43%), and eConsent (18/44, 41%). Wearables (7/44,16%) and Online Recruitment Portals (5/44,11%) were less common. Rarely utilized technologies included Direct-to-Patient Portals (1/44, 2%) and Home Health Nurse Portals (1/44, 2%).

All studies incorporated some type of decentralization technology, with more extensive adoption than found in previous research. However, adoption may be strongly influenced by institution-specific IT and informatics infrastructure and support. There are inherent needs, responsibilities, and challenges when incorporating decentralization technology into a research study, and AROs must ensure that infrastructure and informatics staff are adequate.