Process Error Rates in General Research Applications to the Human Research Ethics Committee (Medical) at the University of the Witwatersrand: A Secondary Data Analysis (Report‪)‬

Anyone who joins a health research ethics committee (HREC) soon notices that few applications for ethics clearance are approved at the first evaluation. In a recent audit of a total of 1 180 applications to the HREC (Medical) of the University of the Witwatersrand (Wits) in 2003 and in 2007, 21% were approved on first submission, 72% required minor or major revision, 5% were not approved and 2% were withdrawn. (1) Angell and Dixon-Woods (2) recently reported on an analysis of a total of 141 letters written by UK National Health Service RECs in 4 months from July 2005 to April 2006. The initial decision rates were: approved 15%, revision needed 64%, not approved 8% and withdrawn 13%, rates similar to those at Wits. (1) The British investigators looked at what they termed process errors in the letters sent to researchers whose applications were not approved at initial submission. Four types of process errors, alone or in combination, were identified: procedural violations (74%), missing information (68%), slip-ups (44%) and discrepancies (25%).