Guidelines for the ethical review of laboratory animal welfare People’s Republic of China National Standard GB/T 35892-2018 [Issued 6 February 2018 Effective from 1 September 2018]

These Chinese National Guidelines(GB/T 35892-20181)were issued February 06,2018 and became effective September 01,2018.The authors recognized the urgent need for an authentic English translation to inform the international community of the compliance requirements in China.It was appreciated that the final translation must reflect the specialist understanding of those working under the Guideline whilst remaining faithful to the meaning of the original Chinese text.A three-step translation process was therefore determined.Step 1:A professional interpretation service(KL Communications,UK)was commissioned to prepare a literal translation of the Chinese text.Supportive documents were provided which explained specialist terminology.This translation was checked by two bilingual experts.Step 2:A workshop was held in Nanjing in May 2019 to which were invited experts in laboratory animal welfare and ethical use.These included international native English-speaking and Chinese-speaking delegates.The delegates worked in multilingual teams to review sections of the literal translation ahead of the workshop,and to agree an authentic interpretation during the workshop.Step 3:Following the workshop,three bilingual experts(two native Chinese speakers and one native English speaker)reviewed the entire document to ensure consistency of terminology and general accuracy.This document is thus not a“literal translation”but an“accurate interpretation”of the original text.Any challenge of work being performed under these Guidelines should rely on the Chinese text in the first place.However,this translation may be used as mitigating evidence,especially where those performing the work are non-Chinese speakers.

Photodynamic Therapy with Phthalomethyl D: Perspectives against SARS-CoV-2

Background: Photodynamic therapy (PDT) is the generation of cytotoxic agents through the dynamic interaction between a photosensitizer excited by light at a specific wavelength. When associated with phthalocyanines, they are efficient in incorporating target cells and exhibiting high rates of triplet generation. This study aimed to characterize PDT associated with the phototherapeutic agent Phthalomethyl D, developed by the authors, in the process of repair, healing and immune improvement for possible application against SARS-CoV-2. Methods: Sixty-nine mice were used, divided into 2 groups: GI, treated with ILIB laser, without a phototherapeutic agent, and subjected to surgery for viral induction;GII, same as GI plus association of Phthalomethyl D. They were divided into subgroups and reevaluated at 7, 14, and 21 days, and then divided into 3 subgroups of 6 animals each, subjected to treatment at 24 h, 48 h, 72 h, 5 and 7 days. Results: Both groups had a high rate of partial incision closure and acute inflammatory control. Microscopically, there was a greater amount of amorphous fundamental substance, fibrocytes, fibroblasts, and giant cells and reduction in the number of keratinocytes, in the amount of keratin, and epidermal thickness in GII than in GI. Conclusions: PDT with Phthalomethyl D stimulates the processes of healing/repair and immunomodulation during viral infection, initially favoring the inflammatory response and, after 21 days, contributing to the anti-inflammatory response profile, making this approach possible in the treatment of individuals infected with SARS-CoV-2.

Prevalence of Family History of Cancer among Gastric Cancer Patients at Brazilian National Cancer Institute

Background: Gastric cancer is the third most incident malignancy and the fifth leading cause of death in the world. In Brazil, it is the fourth most common tumour in men and the fifth in women. Familial aggregation of this tumour is being studied and discussed by experts. Aim: Determine the frequency of family history of cancer in patients with gastric cancer, suggesting familial aggregation or increased risk for hereditary cancer syndromes. Methods: This is a retrospective cross-sectional study carried out from January 2011 to March 2015 at the Department of Abdominal and Pelvic Surgery of the Brazilian National Cancer Institute (INCA). Data were collected from electronic medical records and analyzed using SPSS Statistics? version 20. Results: 873 patients with gastric adenocarcinoma were analyzed. A family history of cancer was reported by 451 patients (51.6%), which reported cancer in 878 relatives, of which 110 (12.6%), reported having more than three relatives with any type of cancer. The most prevalent malignancies among these relatives were gastric cancer (21.3%) and breast cancer (9.5%). Conclusion: Most of the patients had cancer family history, being gastric cancer the most common. The high percentage of cancer family history confirms the importance of collecting this information, whose lack reflects professional negligence, as family history study can serve as a low-cost tool, favoring prevention and early diagnosis, situations where morbidity and mortality are smaller, thus reducing health costs and assistance and preserving lives.

Cohort Study on Prognosis of Patients with Metastatic Colorectal Cancer Treated with Integrated Chinese and Western Medicine

Objective： To investigate the efficacy of integrated Chinese and Western medicine（IM） in the treatment of metastatic colorectal cancer（m CRC） in a cohort study.Methods： The survival outcome of patients receiving IM was compared with that of patients receiving Western medicine alone.The study design was adopted with ＂continuous administration of Chinese medicine for 3 months＂ as the exposure factor.Patients who met this exposure factor were assigned to the IM cohort（Group A,110 patients）.Patients who did not meet this exposure factor were assigned to the Western medicine cohort（Group B,225 patients）.The overall survival（OS）,progression-free survival（PFS）,and 1 st year,2 nd year,and 3 rd year survival in the two cohorts were compared.Results： The median OS in Group A and B were 18 months [95% confidence interval（CI） 15-21] and 16 months（95% CI 14-18）,respectively,and the median PFS in Group A and B were 6 months（95% CI 4-7） and 5 months（95% CI 4-6）,respectively.No statistically significant differences were observed between the groups（P=0.186,P=0.223）.Group A demonstrated significantly longer OS and PFS than Group B in the following subgroups： female patients,patients with lesions in the right half of the colon,and those who received first-line treatment（P〈0.05）.In the subgroup of elderly patients（age〉65 years）,the OS in Group A was longer than that in Group B（P〈0.05）.Conclusion： IM could prolong the survival of patients with m CRC.（Registry No.Chi CTR-IOR-17010497）

Discussion of solutions to ethical issues in real-world study

In recent years, the paradigm of real-world study （RWS） has been at the forefront oI climcal research worldwide, particularly in the field of traditional Chinese medicine. In this paper, basic features and nature of real- world clinical studies are discussed, and ethical issues in different stages of RWS are raised and reviewed. Moreover, some preliminary solutions to these issues, such as protecting subjects during the process of RWS and performing ethical review, are presented based on recent practices and basic ethical rules to improve the scientific validity and ethical level of RWS.

The concepts of assent and parental permission in pediatrics

The recently published article by Narchi et al[1]brings an important empirical insight into a very complex issue of parental consent for lumbar puncture(LP)in children;quite worrisome observation from authors'clinical practice that almost half of the parents refused to give consent for the LP is confirmed.[1]However,the concept of(parental)consent,used by Narchi et al,[1]would need to be further elaborated with introduction of two other important concepts in pediatrics-child's assent and parental permission.The concepts were endorsed by the policy statement of the American Academy of Pediatrics(published in 1995;reaffirmed in 2011).[2]Accordingly,only the patients with appropriate decisional capacity could give their informed consent.In all other situations,parents provide informed permission for an intervention on their child,with assent of the child if appropriate.[2]Most of children from age seven are thought to understand basic information if adequately presented,[3]The need for assent was also supported by the Confederation of European Specialists in Pediatrics,stating that all children have a right to give their assent(or dissent)and may refuse interventions that are not necessary to save their lives or prevent serious harm.[4]Furthermore,the responsibility to make decision in children is shared between physicians and parents.The later should provide informed permission before interventions(except in emergency situations),which includes all the elements of informed consent,reflecting the child's best interests.

Ethical issues in innovative clinical research

In today’s world,medical science has entered an era of rapid development.Numerous new drugs,devices,technologies,and diagnosis and treatment methods continue to emerge,bringing great benefits to our human health.However,there are potential risks in the above innovative research and development process,and some can even endanger the health or life of the test subjects.As a result,medical ethics plays an increasingly important role during the rapid development of innovative clinical research,acting as a“brake”on this high-speed vehicle.This article will illustrate some medical problems and solutions that are common in today’s clinical research in the following aspects.

科研道德委员会面临的挑战:一些实际建议

本文要点地方性科研道德委员会面临几个挑战:研究的规模、类型和复杂性不断增加;建立一个多中心科研道德委员会系统;缺乏对研究结果的汇总;发现科研失误和欺骗。面对这些挑战,地方性委员会必须有受过良好训练、具备多种技能的会员,充足的人力及财力资源,以及一个监督已批准的研究项目进程的体系。在多中心研究中,道德评估由多中心委员会和地方性委员会共同承担,后者只保留本地承认的决定权。假如地方性和多中心科研道德委员会采用共同的道德审查标准,其效果和效率将得到提高。