Documentation of ethical conduct of human subject research published in Saudi medical journals

ABSTRACT

We evaluated the documentation of ethical conduct [obtaining institutional review board approval and consent and following ethical guidelines] of human subject research studies published in Saudi Arabian medical journals between 1979 and 2007. Studies were classified as retrospective, prospective noninterventional, interventional or survey/interview. Of 1838 studies published in 286 journal issues of 11 Saudi Arabian medical journals, only 0.9% documented the ethical guidelines followed, with a significantly higher rate for studies published after year 2000 [1.7%]. Of 821 studies requiring institutional review board approval, 8.6% documented obtaining the approval and informed consent, with a significantly higher rate for interventional studies [19.4%], post-year 2000 studies [19.7%] and studies performed outside Saudi Arabia [15.9%]. The low documentation rate suggests editor's lack of rigor and/or investigators' ignorance of guidelines. The higher documentation rate after year 2000 suggests an ongoing improvement