Local institutional review board (IRB) review of a multicenter trial: Local costs without local context

Effects of local institutional review board review on participation in national practice-based research network studies.

OBJECTIVE To describe the process and outcomes of local institutional review board (IRB) review for 2 Pediatric Research in Office Settings (PROS) studies. DESIGN Pediatric Research in Office Settings conducted 2 national studies concerning sensitive topics: (1) Child Abuse Recognition Experience Study (CARES), an observational study of physician decision making, and (2) Safety Check, a viole...

Meckel’s Scan for patient groups with and without gastrointestinal bleeding: A 15 years local review

Introduction: To retrospectively analyze the outcome of patients who underwent Meckel’s scan in a local centre in Hong Kong over the past fifteen years. Diagnostic values in different referring indications were also reviewed. Methods: All patients who referred for Meckel’s scan in a local hospital in Hong Kong from 1/1/1996 to 31/12/2010 were identified. Patients’ demographic data, presenting ...

Institutional review board (IRB) and ethical issues in clinical research

Clinical research has expanded tremendously in the past few decades and consequently there has been growing interest in the ethical guidelines that are being followed for the protection of human subjects. This review summarizes historical scandals and social responses chronologically from World War II to the Death of Ellen Roche (2001) to emphasize the lessons we must learn from history. Intern...

IRB Accreditation and Local IRB Operations

Problematic variation in local institutional review of a multicenter genetic epidemiology study.

CONTEXT Sequencing of the human genome provides an immense resource for studies correlating DNA variation and epidemiology. However, appropriately powered genetic epidemiology studies often require recruitment from multiple sites. OBJECTIVES To document the burden imposed by review of multicenter studies and to determine the variability among local institutional review boards (IRBs) in the ap...