Common Issues in the Initial Review of the Clinical Trial Ethics Committee / 中国医学伦理学

Objective:To analyze that if the quality of ethics review is closely related to the protection of human subjects' right and interest. Methods:This article has analyzed all the issues raised by local Ethics Committee in the process of review in recent two years since guideline of ethical review of drug clinical trials was published, summed up the most common problems occurred in protocols and informed consents. Results:Total 94 new drug or medical device clinical trial projects were reviewed by the local ethics committee, among which 29 projects were ap-proved through regular full board meeting, the approval rate in the initial review was 31%. The most common prob-lems in protocols include: the research backgrounds, design, and risk-benefit ratio; Main issues raised on in-formed consent focused on the contents, language and signature terms. Conclusions:The protection of subjects needs more improvement of capability of investigator, sponsor, drug clinical trial institution and the ethics commit-tee.

Visual improvement and pain resolution in traumatic optic nerve sheath meningocele treated by optic nerve sheath fenestration.

PURPOSE: There is no consensus as to the optimum treatment for traumatic optic neuropathy (TON). The decision to intervene medically or surgically, or simply observe was recommended to be on an individual basis. The purpose of this study is to test whether optic nerve sheath fenestration (ONSF) could improve vision in patients with traumatic optic nerve sheath meningocele, although it was reported to be effective in patients with traumatic optic nerve sheath hematoma. METHODS: ONSF was performed on two traumatic patients with dilated optic nerve sheath from MRI. RESULTS: Both patients initially suspected as traumatic optic nerve sheath hematoma were diagnosed as traumatic optic nerve sheath meningocele by intraoperative findings of the enlarged optic nerve sheath and clear fluid drained without evidence of blood in the subdural space. Moreover, significant orbit/head pain resolution and visual improvement within a week after ONSF was found. CONCLUSIONS: When TON presents with an enlarged optic nerve/sheath on CT or MRI with visual loss, an optic nerve sheath meningocele should be considered with the consideration that ONSF may benefit both visual acuity and post-traumatic pain, if present.