Assessing the Quality and Performance of Institutional Review Boards: Impact of the Revised Common Rule.

The Common Rule, revised extensively to enhance human subjects protections and to reduce burdens to investigators and institutional review boards (IRBs), was implemented on January 19, 2019. We analyzed IRB performance metric data from 2016 through 2021 to evaluate the potential impact of the revised Common Rule on the quality and performance of IRBs. From 2016 to 2021, exempt protocols increased by 159% and protocols requiring IRB continuing reviews decreased by 28%. As only 48% of all protocols in 2021 were subjected to the revised Common Rule requirements, numbers of exempt protocols and protocols requiring IRB continuing reviews will continue to increase and decrease, respectively, in the next few years. Among a total of 16 IRB performance metrics studied, 4 improved, 4 deteriorated, and 8 remained unchanged from 2016 through 2021. This study represents the first effort to evaluate the impact of revised Common rule on IRB quality and performance.

Infants of human immunodeficiency virus type 1-infected women in rural south India: feeding patterns and risk of mother-to-child transmission.

BACKGROUND: We assessed the infant feeding choices of HIV-1-infected women in rural Tamil Nadu, India, and risk factors for mother-to-child transmission of HIV-1. METHODS: The study population comprised live born infants of HIV-1-infected women from the antenatal clinics of 2 public hospitals in rural Tamil Nadu, India who were enrolled in a prospective cohort study. All women enrolled in the cohort were offered antiretroviral prophylaxis and infant feeding counseling based on WHO/UNAIDS/UNICEF training materials. Infant study visits were scheduled at birth (within the first 24 hours of life), at 1 week, 1 month, and 2 months after birth, and then every 2 months between 4 and 12 months of age. RESULTS: One-third of women did not breast-feed their infants. Of those who initiated breast-feeding, the median duration of breast-feeding was approximately 3 months. Among those infants who initiated breast-feeding, the proportion exclusively breast-feeding declined from approximately 70% during the first week of life to 0% by the 8 month visit. The observed rate of mother-to-child transmission of HIV-1 in the entire cohort was 6.5% (95% CI: 1.4%-17.9%). The observed HIV-1 incidence among breast-fed infants was 0% (95% CI: 0%-8.9%). CONCLUSION: The overall transmission rate was relatively low, suggesting effectiveness of antiretroviral transmission prophylaxis. The infant feeding choices made may reflect knowledge gained through the educational program and infant feeding counseling provided. Ensuring HIV-1-infected women receive appropriate HIV-1 treatment (for those who meet criteria for treatment) and access to known efficacious interventions to prevent mother-to-child transmission of HIV-1, are essential.

Safety of HIV-1 Perinatal Transmission Prophylaxis With Zidovudine and Nevirapine in Rural South India.

BACKGROUND: The authors assessed acceptance and safety of, and adherence to, perinatal HIV-1 transmission prophylaxis at 2 public hospitals in rural Tamil Nadu, India. METHODS: Eligible HIV-1-infected women were offered zidovudine (ZDV) beginning at 28-weeks gestation until delivery. Their infants received ZDV for 6 weeks. A subsequent revision to the protocol added 1 dose of nevirapine (NVP) for mother and infant. RESULTS: Sixty of 67 women (90%) met inclusion criteria for the cohort study. Thirty-four of 36 eligible women and all 19 eligible live born infants received prophylaxis on study. Infant, but not maternal, adherence to ZDV varied by antiretroviral prophylaxis group (those receiving combined prophylaxis with ZDV and NVP had lower median adherence) (P = .02). Neutropenia (usually transient) was the most common severe adverse event. Only 1 of 5 women with neutropenia possibly related to ZDV permanently discontinued ZDV. ZDV was not discontinued for any infant. CONCLUSION: With the exception of neutropenia, usually transient and always without clinical consequences, long-term ZDV (with or without NVP prophylaxis) is well tolerated.