Flying Blind: How Thorough are IRBs when Assessing Scientific Value?

Background: Institutional Review Boards (IRBs) in the United States play a crucial role in ensuring the ethical conduct of clinical trials, including assessing the scientific merit of studies to justify the risks to participants. However, prior research suggests that many IRBs do not systematically evaluate scientific merit, raising concerns about the approval of low-quality trials.

Objective: To investigate whether IRBs provide adequate guidance on assessing scientific merit in their Standard Operating Procedures (SOPs) and other relevant materials.

''Minor'' BCL2 breakpoints in follicular lymphoma: frequency and correlation with grade and disease presentation in 236 cases.

Follicular lymphomas are frequently associated with the t(14;18)(q32;q21). This translocation can be detected by karyotype, polymerase chain reaction (PCR), and fluorescence in situ hybridization (FISH). In addition to the breakpoints currently used for diagnosis located in the major breakpoint region (MBR) and the minor cluster region (mcr), recent studies have reported the existence of other breakpoints (3' BCL2, 5'mcr, and icr).

Emergence of drug-resistant cytomegalovirus retinitis in the contralateral eyes of patients with AIDS treated with ganciclovir.

The purpose of the present study was to examine the emergence of ganciclovir-resistant virus in the contralateral eyes of patients who received treatment for cytomegalovirus retinitis with either a ganciclovir implant plus oral placebo, a ganciclovir implant plus oral ganciclovir, or intravenous (iv) ganciclovir. Viral DNA was amplified from vitreous specimens and was assayed for UL97 and UL54 resistance mutations. Resistant viral genotypes were found in the contralateral eyes of 0 of 28 patients treated with a ganciclovir implant plus oral placebo, in 5 of 23 patients treated with a ganciclovir implant plus oral ganciclovir, and in 1 of 6 patients treated with iv ganciclovir.

Genotypic analysis of cytomegalovirus retinitis poorly responsive to intravenous ganciclovir but responsive to the ganciclovir implant.

Purpose: To determine whether cytomegalovirus (CMV) retinitis that responded poorly to intravenous ganciclovir therapy but responded to the ganciclovir implant was caused by virus with resistance mutations in the viral UL97 and UL54 genes.

Design: Retrospective chart review and laboratory-based experimental study.

Methods: Regions of the CMV UL97 and UL54 were amplified from the vitreous and analyzed for resistant mutations by a combination of DNA sequencing and restriction digestion.