The proportions of residents and practitioners in obstetrics and gynecology (ob-gyn) who are female have increased in the past 30 years. The objective of this study was to examine trends in gender representation in maternal-fetal medicine (MFM) fellowships and in active practice for this time period. STUDY DESIGN: This observational study involved an examination of complete sets of MFM fellows and active members in the Society for Maternal-Fetal Medicine (SMFM) between 1985 (when accurate record keeping began) and the most recent year, 2016. Databases from SMFM, American College of Obstetricians and Gynecologists (ACOG), and Accreditation Council for Graduate Medical Education (ACGME) were utilized. ANCOVA testing was used to assess the relationship between groups over time. RESULTS: The proportion of MFM fellows who were female increased steadily from 17.1% in 1985 to 72.5% in 2016. This graduak progression was similar for ob-gyn residents, with a time-lag reflecting the length of residency training. The proportion of females rose more among the MFM fellows than residents (2.1% vs. 1.4% per year; p < .001). More than half of all MFM fellows who were female

T he logistical and administrative effort required for institutional review board (IRB) oversight of multisite research studies is widely viewed as an impediment to collaboration among research centers and can act as a significant barrier to conducting multisite research studies that pool resources, maximize the sample size and diversity of the participant population, and ultimately optimize the generalizability of study findings. 1 In response, the National Institutes of Health (NIH) mandated the use of a single IRB (sIRB) of record to provide regulatory oversight for all multisite studies funded by the NIH starting in January 2018. 2 In addition, the 2018 revision of the Common Rule required the use by January 2020 of an sIRB for all cooperative research conducted or supported by the Department of Health and Human Services (DHHS). 3 The sIRB is designated to conduct regulatory review for all relying research sites, including initial and continuing reviews, review of modifications to research protocols, and required reporting for the duration of the

The rising proportion of female MFM fellows is directly related to the high number of female ob-gyn residents. Females comprise slightly more than half of all active SMFM members now and projected to approach two-thirds by 2025.

Objectives We evaluated the efficiency of using the SmartIRB platform compared to other site IRB approval mechanisms in the multi-site Academy and ASPEN Indicators to Diagnose Malnutrition (AAIM) Validation and Staffing Optimization Study. Methods Process data on the time to execute reliance agreements were collected when on-boarding sites for the AAIM Study (ClinicalTrials.gov: NCT03928548). Acute care hospital site recruitment occurred from September 2018 to December 2021. Research sites joined the study by either executing a reliance agreement with the single IRB of Record (sIRB) or by obtaining full local IRB approval from their institution. Reliance agreements were established through the SmartIRB model, an IRB authorization agreement (IAA), or a Letter of Support. Data are presented descriptively as number of observations and respective percentages or means ± standard deviations (SD). Results As of September 2021, 82 sites received IRB approval for the AAIM Study through the submission of 69 individual IRB applications. Sixty sites were affiliated with SmartIRB. Forty-one applications established a reliance agreement with the sIRB: 31 of 69 used the SmartIRB model (44.9%), 7 used an IAA (10.1%), and 3 used a Letter of Support (4.3%). Twenty-eight applications were submitted for full local review (40.6%). For all 69 submissions, the average time from the initial contact to site activation by the sIRB was 496.9 ± 213.6 (SD) days. SmartIRB had the longest review period of 546.1 ± 220 days; followed by full local review (492.6 ± 213.9 days), then IAA (377.4 ± 143.7 days), and Letter of Support (306.3 ± 58.2 days). Conclusions The use of an sIRB and the SmartIRB platform did not to reduce the time required for IRB review of this non-federally funded study. These findings should be interpreted acknowledging several disruptions to IRB activity during the study recruitment timeframe (e.g., accelerated implementation of single IRB review starting in 2018, Common Rule changes in 2019, and the COVID-19 pandemic starting in 2020). Funding Sources The AAIM Study was funded by the Academy of Nutrition and Dietetics Foundation, the Commission on Dietetic Registration, the Pediatric Nutrition Practice Group, the Clinical Nutrition Management Dietetic Practice Group, and the Renal Dietitians Practice Group.