Clinicopathological Correlation and Recurrence Outcome of Adnexal Involvement on Primary Extramammary Paget's Disease (EMPD).

Introduction Primary extramammary Paget's disease (EMPD) is a rare neoplasm that manifests as well-defined erythematous plaques, often misdiagnosed due to its similarity with different dermatoses. It may exhibit invasive features, involving adnexal invasions. The study aims to assess and compare the clinicopathological correlation of primary EMPD with adnexal features. Materials and methodology The monocentric observational retrospective study observed 43 confirmed primary EMPD cases in patients aged 45-95, excluding those with infectious dermatoses, pseudo-tumors, secondary lesions, or survived less than a month. Demographical, clinical and pathological observations were recorded. Expert dermatopathologists, blinded to the initial diagnosis, conducted a comprehensive histopathological evaluation yielding differential pathological diagnosis. Statistical analysis involved Pearson's Chi-square, Mann-Whitney U, and Spearman's Correlations for clinicopathological concordance and adnexal features. Recurrence was evaluated using Kaplan-Meier and log-rank tests, while multivariate recurrence analyses include Cox regression. A p-value < 0.05 was deemed significant. Results There was a significant association between adnexal involvement and the site of lesion (p < 0.05). There was a significant association (p < 0.05) between involved adnexal depth and primary EMPD subtypes. Adnexal involvement has a significant association with the concordance rates derived from clinicopathological correlations (p < 0.05). Smaller lesions and non-invasive EMPD significantly predict longer recurrence onset (p < 0.01). The primary EMPD subtype was the only independent predictor for recurrence time using the Cox regression model. Conclusion Adnexal proliferation in primary EMPD is considered vital on clinicopathological correlations and recurrence predictions, suggestive of its utility on both diagnosis and prognosis.

Mimicry unveiled: The challenging diagnosis of pigmented purpura-like mycosis fungoides initially misdiagnosed as pigmented purpura.

Key Clinical Message: Unlike most cases, the lesions were localized to the dorsum of the hand, lacked pruritus (itching), and did not exhibit "sperm-like blood vessels," which are typically pathognomonic to classical MF. Abstract: The study presents a rare case involving a 44-year-old woman who developed a skin condition on the base of her left thumb. Initially misdiagnosed as pigmented purpura, the need for further investigation arose to determine the nature of the condition accurately. The medical evaluation encompassed a comprehensive analysis of the patient's skin ailment. A series of diagnostic examinations were conducted to ascertain the underlying cause. Although routine blood tests yielded unremarkable results, the distinct characteristics of the rash prompted a more thorough investigation. Subsequent assessment revealed that the skin condition was not pigmented purpura, as initially presumed, but rather a manifestation of cutaneous T-cell lymphoma (CTCL) known as mycosis fungoides (MF). MF is an infrequent lymphoma predominantly affecting individuals aged 45-65, exhibiting a male-to-female sex ratio of 2:1. The annual incidence of MF ranges from 0.3 to 0.96 cases per 100,000 individuals. The woman's skin exhibited discrete patches adorned with colored dots, progressively thickening and pigmentation. Notably, the absence of pruritus did not dispel suspicion. This case underscores the significance of accurately diagnosing uncommon dermatological disorders to facilitate appropriate medical intervention. The unique appearance of the rash and its distinctive features, despite normal blood results, enabled the identification of MF. The patient's treatment encompassed a combination of steroids and narrowband UV therapy. Vigilance, continued research, and heightened awareness are paramount for early intervention and improved patient outcomes. Such efforts contribute to an enhanced understanding of the complexities of this condition.

Eruptive Pruritic Papular Porokeratosis (EPPP) Presenting as a Rare Facial Manifestation Associated With COVID-19: A Case Report.

This case report presents a rare instance of Eruptive Pruritic Papular Porokeratosis (EPPP) in a 71-year-old Chinese male, emerging on atypical sites (face, scalp, and ears) following a COVID-19 infection, and explores the potential link between viral infections and EPPP onset. The patient's lesions, characterized by annular brown patches with hyperkeratotic ridges, showed significant improvement following treatment with Baricitinib and Acitretin. This case underscores the need for awareness of unusual presentations of EPPP and suggests the potential efficacy of Janus Kinase (JAK) inhibitors in treatment, prompting further research into the pathophysiological connections between EPPP and viral infections. Adherence to the SCARE 2023 guidelines ensures a comprehensive and transparent case presentation.

Lessons from an elderly patient with pulmonary embolism caused by protein S deficiency: a case report.

BACKGROUND: Lower limb deep vein thrombosis (DVT) concurrent with pulmonary embolism (PE) is perilous, particularly in the elderly, exhibiting heterogeneity with thrombophilia mutations. Tailored treatment is essential, yet sudden deaths complicate causative factor elucidation. This report emphasizes genetic testing necessity in PE patients with thrombophilia indicators, facilitating cause identification, personalized treatment guidance, and family education. CASE PRESENTATION: This study details a 75-year-old Chinese woman with DVT and PE, where genetic testing identified thrombophilia, guiding personalized treatment decisions. RESULTS: Upon admission, the patient, after over 10 days of bed rest, presented chest tightness, shortness of breath, and unilateral leg swelling. Diagnostic measures revealed DVT and a substantial PE. Genetic testing identified a PROS1 gene C200A>C mutation, reducing protein S activity. Following 2 weeks of anticoagulation and inferior vena cava filter insertion, the patient, discharged, initiated lifelong anticoagulant therapy. A 1-year follow-up showed no recurrent thrombotic events. Family members carrying the mutation received informed and educational interventions. CONCLUSION: Genetic testing for thrombophilic predisposition post-PE is crucial, elucidating etiology, guiding individualized treatment, and playing a pivotal role in family education.

Current Situation of Human Experience of Traditional Chinese Medicine and the Key Point of Ethical Review / 中国医学伦理学

In order to speed up the review and approval of new drugs of Traditional Chinese Medicine (TCM) in China, it is accelerating the construction of TCM registration review evidence system, which combines the theory of TCM, human experience and clinical trials, and optimizing the technical requirements for the review of and approval of new drugs of TCM based on ancient classic prescriptions, famous old Chinese medicine prescriptions, and medical institution preparations. The United States has strict requirements on the application for the marketing of herbal medicines. According to the characteristics of herbal medicines and combined with human experience, the European Union has classified registration management, reflecting the regulatory concept of inheritance and innovation. TCM has a long history of human use experience in China, its application has a scope of application, basic requirements, and it is necessary to classify and exempt the declaration materials according to the evidence grading evaluation standards. When the ethics committee reviews the research scheme of human experience of TCM, it should pay attention to the review points such as scientific basis for new drugs or prescriptions of TCM, clinical positioning, applicable population, effectiveness and safety information, research design, sample size, conflict of interest management and informed consent. Finally, Human experience is helpful to formulate the research scheme of new drugs of TCM, which can not only improve the success rate of research and development, but also reduces the cost of research and development, accelerate the marketing of new drugs of TCM, and can benefit more patients.

Innovative insights into extrachromosomal circular DNAs in gynecologic tumors and reproduction

Originating but free from chromosomal DNA, extrachromosomal circular DNAs (eccDNAs) are organized in circular form and have long been found in unicellular and multicellular eukaryotes. Their biogenesis and function are poorly understood as they are characterized by sequence homology with linear DNA, for which few detection methods are available. Recent advances in high-throughput sequencing technologies have revealed that eccDNAs play crucial roles in tumor formation, evolution, and drug resistance as well as aging, genomic diversity, and other biological processes, bringing it back to the research hotspot. Several mechanisms of eccDNA formation have been proposed, including the breakage-fusion-bridge (BFB) and translocation-deletion-amplification models. Gynecologic tumors and disorders of embryonic and fetal development are major threats to human reproductive health. The roles of eccDNAs in these pathological processes have been partially elucidated since the first discovery of eccDNA in pig sperm and the double minutes in ovarian cancer ascites. The present review summarized the research history, biogenesis, and currently available detection and analytical methods for eccDNAs and clarified their functions in gynecologic tumors and reproduction. We also proposed the application of eccDNAs as drug targets and liquid biopsy markers for prenatal diagnosis and the early detection, prognosis, and treatment of gynecologic tumors. This review lays theoretical foundations for future investigations into the complex regulatory networks of eccDNAs in vital physiological and pathological processes.

Lateral Retinacular Release for Treatment of Excessive Lateral Pressure Syndrome: The Capsule-Uncut Immaculate (CUI) Technique.

Lateral retinacular release of the patella is the main surgical treatment for excessive lateral pressure syndrome. It was first described by Merchant and Mercer in 1974. The main complications of arthroscopic lateral retinacular release are hemarthrosis and medial patellar instability. The main causes of these complications are the disturbance of the synovial membrane of the joint capsule and excessive release of the lateral retinaculum. In this article, we introduce a method for arthroscopic lateral retinacular release that maintains the overall structure of the joint capsule: capsule-uncut immaculate (CUI) lateral retinacular release.

A Case Report on Mid-Dermal Elastolysis: A Distinctive Presentation on the Neck.

Mid-dermal elastolysis (MDE) is a very rare and acquired skin condition. MDE has a variety of clinical manifestations that can be presented with a reticular erythematous patch with telangiectasis, perifollicular popular protrusions, or finely wrinkled skin. A biopsy is always necessary to rule out other potential elastic fiber disorders. In this case study, a 33-year-old female with an odd MDE presentation in her neck area is examined. No contributing factors, apart from exposure to sunlight, could be gleaned from the patient's history. The patient didn't benefit from the application of various types of topical agents or any other therapies to lessen the size and advancement of the lesion. In this distinct case, we discuss clinical and histological findings and the treatment plan offered, as well as include a concise review of specific past literature.

Novel heterotopic continental ileal reservoir based on the Mitrofanoff principle: a case report and review of the literature.

For patients undergoing radical cystectomy with standard lymphadenectomy for bladder cancer, appropriate urinary diversion (with a pouch and conduit) improves postoperative quality of life, reduces postoperative complications, and prolongs survival. We developed a novel heterotopic ileal reservoir to achieve these goals. This report describes the methodology involved and the incidence of intraoperative and postoperative complications. Three patients who underwent novel heterotopic ileal reservoir creation following radical cystectomy and standard lymphadenectomy (for bladder cancer) were evaluated. The ileum served as a pouch in which the ureters and appendix were implanted by extramural tunnelling. The appendix served as a conduit and pelvic reperitonealization was performed. Operative times, intraoperative blood loss, time to intestinal function recovery, incidence of intestinal obstruction and ureteric reflux, and bladder volumes and continence levels were evaluated. The surgical intervention was successful with operation times ranging 410-525 min, blood loss ranging 300-700 ml, and recovery time for intestinal function ranging 3-5 days. The postoperative hospitalization time was 11-15 days. Subileus occurred in patient B, who recovered after fasting and fluid replacement. Patients B and C achieved complete continence 6 weeks after surgery, while patient A experienced umbilical urine leakage with catheterization time intervals that exceeded 4 h. At 3 months after surgery, the bladder capacities of all patients ranged 250-370 ml. Follow-up cystography suggested the presence of bilateral ureteral reflux in patient A, with mild and moderate reflux on the left right sides, respectively. All patients achieved complete continence. Patients were followed for 3-9 months postoperatively; chest and abdominal computed tomography and cystography showed absence of hydronephrosis, recurrence, or distant metastasis during this period. The novel heterotopic continent ileal reservoir described in this study may be suitable for selected patients. The surgical procedure is safe when performed by well-trained and highly experienced urologists.

HUVECs affect HuT-78 cell apoptosis and cytokine production via the HIF-1α-PD-L1/PD-1 pathway under hypoxia.

We investigated whether human umbilical vein endothelial cells (HUVECs) under hypoxic conditions can suppress the production of cytokines in Hut-78 cells via the HIF-1α/PD-L1/PD-1 pathway, and the intervention effect of Nivolumab. HUVECs and HuT-78 cells were monocultured or cocultured in a tri-gas incubator with or without Nivolumab pretreatment. Real-time PCR, western blotting, and protein chips were used. Transcriptional regulation of PD-L1 and PD-1 by HIF-1α was analyzed by ChIP-qPCR and luciferase reporter gene assays. Apoptosis was assessed by flow cytometry. In HuT-78 cells, hypoxic monoculture significantly increased the expression of HIF-1α, PD-1, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-α, IFN-α, and Bax, decreased the expression of Bcl-2, and resulted in increased apoptosis. In comparison to hypoxic monoculture, hypoxic coculture significantly reduced the expression of IL-2, IL-4, IL-6, IL-8, IL-10, TNF-α, and IFN-α, as well as Bcl-2, in HuT-78 cells. Meanwhile, Bax expression was significantly increased with elevated apoptosis in HuT-78 cells. However, pretreatment with Nivolumab significantly antagonized the reduction in cytokines and the elevation in apoptosis in HuT-78 cells. Chip-qPCR and luciferase reporter gene assays demonstrated that hypoxia significantly increased the binding of HIF-1α to the upstream regulatory regions of PD-1 at -63 and -66 bp and PD-L1 at -571 bp, promoting their transcription. Therefore, HUVECs under hypoxia can reduce cytokine production and inhibit their own apoptosis in co-culture with HuT-78 cells via the HIF-1α/PD-L1/PD-1 pathway. These findings provide new clues for exploring the combined use of immune checkpoint inhibitors and anti-angiogenic drugs in clinical settings.

Automatic localization of target point for subthalamic nucleus-deep brain stimulation via hierarchical attention-UNet based MRI segmentation.

BACKGROUND: Deep brain stimulation of the subthalamic nucleus (STN-DBS) is an effective treatment for patients with advanced Parkinson's disease, the outcome of this surgery is highly dependent on the accurate placement of the electrode in the optimal target of STN. PURPOSE: In this study, we aim to develop a target localization pipeline for DBS surgery, considering that the heart of this matter is to achieve the STN and red nucleus segmentation, a deep learning-based automatic segmentation approach is proposed to tackle this issue. METHODS: To address the problems of ambiguous boundaries and variable shape of the segmentation targets, the hierarchical attention mechanism with two different attention strategies is integrated into an encoder-decoder network for mining both semantics and fine-grained details for segmentation. The hierarchical attention mechanism is utilized to suppress irrelevant regions in magnetic resonance (MR) images while build long-range dependency among segmentation targets. Specifically, the attention gate (AG) is integrated into low-level features to suppress irrelevant regions in an input image while highlighting the salient features useful for segmentation. Besides, the self-attention involved in the transformer block is integrated into high-level features to model the global context. Ninety-nine brain magnetic resonance imaging (MRI) studies were collected from 99 patients with Parkinson's disease undergoing STN-DBS surgery, among which 80 samples were randomly selected as the training datasets for deep learning training, and ground truths (segmentation masks) were manually generated by radiologists. RESULTS: We applied five-fold cross-validation on these data to train our model, the mean results on 19 test samples are used to conduct the comparison experiments, the Dice similarity coefficient (DSC), Jaccard (JA), sensitivity (SEN), and HD95 of the segmentation for STN are 88.20%, 80.32%, 90.13%, and 1.14 mm, respectively, outperforming the state-of-the-art STN segmentation method with 2.82%, 4.52%, 2.56%, and 0.02 mm respectively. The source code and trained models of this work have been released in the URL below: https://github.com/liuruiqiang/HAUNet/tree/master. CONCLUSIONS: In this study, we demonstrate the effectiveness of the hierarchical attention mechanism for building global dependency on high-level semantic features and enhancing the fine-grained details on low-level features, the experimental results show that our method has considerable superiority for STN and red nucleus segmentation, which can provide accurate target localization for STN-DBS.

Research progress on new antiplatelet therapeutic targets for the treatment of acute coronary syndrome / 中国临床药理学与治疗学

Acute coronary syndrome (ACS) is a cardiac acute ischemic syndrome caused by the rupture or erosion of unstable atherosclerotic plaques within the coronary artery, leading to thrombus formation. Antiplatelet therapy is a key strategy in treating ACS, and although some success has been achieved, there are still limitations, such as thrombus recurrence and bleeding side effects, which limit the long-term use of drugs. Future antiplatelet therapies may achieve more effective or safer treatment methods by targeting novel targets involved in platelet function. This article focuses on potential target inhibitors, including GPVI, protease -activated receptor (PAR) - 4, GPIb, 5-hy-droxytryptamine receptor subtype 2A (5-HT2A), protein disulfide isomerase, P-selectin, and phosphatidylinositol 3-kinase β inhibitors.

Bendamustine combined with pomalidomide and dexamethasone in relapsed multiple myeloma with extramedullary disease: a multicenter study / 中华血液学杂志

Objective: To evaluate the efficacy and safety of bendamustine combined with pomalidomide and dexamethasone (BPD regimen) in the treatment of relapsed multiple myeloma (MM) with extramedullary disease. Methods: This open, single-arm, multicenter prospective cohort study included 30 relapsed MM patients with extramedullary disease diagnosed in seven hospitals including Qingdao Municipal Hospital. The patients were treated with BPD regimen from February 2021 to November 2022. This study analyzed the efficacy and adverse reactions of the BPD regimen. Results: The median age of the 30 patients was 62 (47-72) years, of which 18 (60% ) had first-time recurrence. The overall response rate (ORR) of the 18 patients with first-time recurrence was 100%, of which three (16.7% ) achieved complete remission, 10 (55.5% ) achieved very good partial remission (VGPR), and five (27.8% ) achieved partial remission (PR). The ORR of 12 patients with recurrence after second-line or above treatment was 50%, including zero patients with ≥VGPR and six patients (50% ) with PR. Three cases (25% ) had stable disease, and three cases (25% ) had disease progression. The one-year progression free survival rate of all patients was 65.2% (95% CI 37.2% -83.1% ), and the 1-year overall survival rate was 90.0% (95% CI 76.2% -95.4% ). The common grade 3-4 hematology adverse reactions included two cases (6.7% ) of neutropenia and one case (3.3% ) of thrombocytopenia. The overall adverse reactions are controllable. Conclusions: The BPD regimen has good efficacy and tolerance in relapsed MM patients with extramedullary disease.

Correlation between postoperative visual acuity and macular morphological structure and blood flow density in patients with idiopathic macular epiretinal membrane / 国际眼科杂志(Guoji Yanke Zazhi)

AIM: To observe the postoperative changes in macular morphological structure and blood flow density of patients with idiopathic macular epiretinal membrane(IMEM)by optical coherence tomography angiography(OCTA), and explore their correlation with visual acuity.METHOD: Prospective study. A total of 45 cases(45 eyes)with IMEM admitted to our hospital from January 2020 to July 2021 were included. The best corrected visual acuity(BCVA), central macular area thickness(CMT), foveal avascular zone(FAZ)area and changes in blood flow density of superficial capillary plexus(SCP)were observed at 1mo, 1, 3 and 6mo before and after operation.RESULT: The BCVA at 1wk after operation had no significant change compared with preoperative data(P>0.05), while it was improved at other time points(P<0.05). The CMT measured at 1wk after operation was thickened significantly(P<0.05), while it was significantly decreased at 1mo, 3mo and 6mo after operation(P<0.05). The FAZ area measured at 1wk and 1mo after operation had no significant change(P>0.05), while it was significantly enlarged at 3 and 6mo after operation(P<0.05). The SCP measured at 1wk, 1 and 3mo after operation had no significant change(P>0.05), while it was significantly decreased at 6mo after operation(P<0.05). BCVA measured at 3 and 6mo after operation was positively correlated with CMT(r=0.457, 0.615, P=0.032, 0.012).CONCLUSION: The visual acuity of patients with IMEM recovered quickly within 1mo after operation, and then it tended to be stable. However, the recovery of macular foveal morphology and blood flow distribution was slower than that of visual acuity, and there was no obvious correlation with visual acuity.

Berberine might block colorectal carcinogenesis by inhibiting the regulation of B-cell function by Veillonella parvula / 中华医学杂志(英文版)

BACKGROUND@#Colorectal carcinogenesis and progression are related to the gut microbiota and the tumor immune microenvironment. Our previous clinical trial demonstrated that berberine (BBR) hydrochloride might reduce the recurrence and canceration of colorectal adenoma (CRA). The present study aimed to further explore the mechanism of BBR in preventing colorectal cancer (CRC).@*METHODS@#We performed metagenomics sequencing on fecal specimens obtained from the BBR intervention trial, and the differential bacteria before and after medication were validated using quantitative polymerase chain reaction. We further performed ApcMin/+ animal intervention tests, RNA sequencing, flow cytometry, immunohistochemistry, and enzyme-linked immunosorbent assays.@*RESULTS@#The abundance of fecal Veillonella parvula ( V . parvula ) decreased significantly after BBR administration ( P = 0.0016) and increased through the development from CRA to CRC. Patients with CRC with a higher V. parvula abundance had worse tumor staging and a higher lymph node metastasis rate. The intestinal immune pathway of Immunoglobulin A production was activated, and the expression of TNFSF13B (Tumor necrosis factor superfamily 13b, encoding B lymphocyte stimulator [BLyS]), the representative gene of this pathway, and the genes encoding its receptors (interleukin-10 and transforming growth factor beta) were significantly upregulated. Animal experiments revealed that V. parvula promoted colorectal carcinogenesis and increased BLyS levels, while BBR reversed this effect.@*CONCLUSION@#BBR might inhibit V. parvula and further weaken the immunomodulatory effect of B cells induced by V. parvula , thereby blocking the development of colorectal tumors.@*TRIAL REGISTRAION@#ClinicalTrials.gov, No. NCT02226185.

Distribution and health risk of residual trihalomethane in regional drinking water / 上海预防医学

ObjectiveTo explore the variation rules and health risks of trihalomethane in regional drinking water， and to provide evidence for the innovative water processing technology and the optimization of drinking water quality. MethodsBased on regional drinking water sanitation monitoring， non-parametric rank sum test was used to analyze the effects of residual trihalomethane production in different periods and with disinfection methods. The United States environmental protection agency （USEPA） classic "four-step" health risk assessment model was used to evaluate the carcinogenic risk and non-carcinogenic risk of trihalomethane through drinking water exposure. ResultsThe yield of trichloromethane in wet season was 6.3 μg·L-1， which was higher than that in dry season. Compared with chlorination pretreatment， ozone pretreatment reduced the content of bromomethane dichloromethane. Compared to liquid chlorine disinfection， sodium hypochlorite treatment incresed the levels of trichloromethane and bromomethane chloride. Although the total carcinogenic and non-carcinogenic risks of trihalomethane in drinking water in the region were at safe levels， they were above the acceptable limits occasionally. The highest carcinogenic risk of trihalomethane were dichlorobromomethane and chlorodibromomethane，and the highest non-carcinogenic risk was trichloromethane. The health risk of children was 1.2 times higher than that for adults. ConclusionThe production of residual trihalomethane in drinking water in this area is relatively low， which is less harmful to the health of adults and children. Monitoring， including other disinfection byproducts， should continue and appropriate disinfection techniques for drinking water should be explored.

CRP is an important factor affecting the timing of surgical drainage of ureteral calculi with upper urinary tract infection / 现代泌尿外科杂志

【Objective】 To explore the timing of surgical drainage for ureteral calculi with upper urinary tract infection. 【Methods】 Clinical data of 117 cases of ureteral calculi with upper urinary tract infection treated in our hospital during Jan.2018 and Jan.2020 were retrospectively analyzed. According to different treatment methods, the patients were divided into surgical drainage group and non-surgical drainage group. The patients’ age, gender, side of calculi, peak body temperature, time of onset, white blood cell (WBC) count, C-reactive protein (CRP) and other clinical indicators were compared between the two groups. The cutoff value of surgical drainage was determined with receiver operator characteristic (ROC) curve. 【Results】 The patients’ age, peak body temperature, WBC count and CRP level were the influencing factors of surgical drainage (P<0.05). Regression analysis showed that CRP (P<0.001), age (P=0.003) and WBC count (P=0.014) were independent risk factors for surgical drainage. The area under the ROC curve (AUC) of CRP, age, and WBC count were 0.923, 0.601, and 0.796, respectively. The cutoff value of CRP was 29.87 mg/L (sensitivity 79.4%, specificity 90.0%). Logistic regression model showed CRP was a significant clinical predictor. 【Conclusion】 Ureteral calculi with upper urinary tract infection need to be diagnosed and treated in time. Positive anti-infection should be performed during emergency treatment, and surgical drainage could be selected according to the value of CRP.

Guidelines for Ethical Review Entrustment Contract of Life Science and Medical Research Involving Humans / 中国医学伦理学

The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans. At present, some medical and health institutions have no or insufficient ethical review capabilities. The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans. According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, Opinions on Strengthening the Ethical Governance of Science and Technology, institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review. Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics (review) committee or the ethics (review) committee is not competent to review. To conduct the entrustment ethical review, the entrustment between the principal and the trustee is required. According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions, the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law. Signing the entrustment ethical review contract, implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal, and protect the research participants.

Guidelines for Ethical Review Project Entrustment of Life Science and Medical Research Involving Humans / 中国医学伦理学

The seventh article of Measures for the Ethical Review of Biomedical Research Involving Humans (2016) stipulated that medical and health institutions without an ethics committee shall not carry out biomedical research involving Humans. The Opinions on Strengthening the Governance of Ethics in Science and Technology, issued in March 2022, clearly stated that the institutions that do not meet the conditions for establishing a scientific and technological ethics (review) committee should entrust other institutions to conduct the review. The fourteenth article of Measures for Ethical Review of Life Science and Medical Research Involving Humans (2023) proposes that if an institution, which carries out life science and medical research involving humans, has not established an ethics committee or its ethics committee is not competent for ethics review, it can entrust a competent ethics committee or regional ethics committee in writing to carry out ethical review. Most medical institutions at or above the second level in China have set up ethics committees. While most universities and colleges, scientific research institutions, enterprises and grass-roots medical and health institutions have not set up ethics committees, which lack a working system to protect the safety and interests of the participants, and is difficult to conduct life sciences and medical research involving humans. At present, there is a need for some research institutions that do not have the conditions to establish ethics committees to entrust their projects of life science and medical research involving humans to other institutions for ethical review. The entrusted review is still in the exploratory stage, and there is no relevant specification. The hasty implementation of entrusted review may not achieve the goal of effectively protecting the safety and interests of the participants, and even cause legal disputes. Based on the thematic discussion, with reference to the relevant laws and regulations, departmental rules, ethical standards, and the experience of the ethics committees of some domestic institutions in implementing the entrusted review, the guideline was formulated for the reference of the current entrusted review to ensure the safety and interests of the participants.