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.

Objective:To explore the safety and efficacy of retrograde machine perfusion of kidneys from deceased donors.Methods:From January 1, 2020 to July 1, 24 renal transplant recipients underwent organ donation.All grafts were preserved by Kidney Transporter machines(LifePort). Through a random number table, they were divided into two groups of retrograde perfusion(RP group, 12 cases)and anterograde perfusion group(AP group, 12cases). The incidence of delayed recovery of kidney/graft function was compared between two groups.Results:During a follow-up period of 1 month, kidney resistance remained stable in RP group during perfusion.No primary non-function occurred in neither groups.No inter-group difference existed in the incidence of delayed graft function (3 in RP and 2 in AP, P=0.62). At all timepoints within 30 days, both groups had comparable values of urine output, serum creatinine, estimated glomerular filtration rate, cystatin c and blood urea nitrogen.RP group with a resistance index of <0.4 had numerically better kidney function than those with a resistance index of ≥0.4. Conclusions:This novel technique may be an effective and safe alternative for kidney preservation.