At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). The "Consensus" is formulated in accordance with the requirements of relevant documents such as but not limited to "the opinions on deepening the reform of the evaluation and approval system to encourage the innovation of pharmaceutical medical devices", "the regulations of ethical review of biomedical research involving human subjects". The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.
Biomedical Research ; Clinical Trials as Topic ; Consensus ; Drugs, Chinese Herbal ; Ethical Review ; Humans ; Medicine, Chinese Traditional ; Multicenter Studies as Topic ; Pharmaceutical Preparations

The elements of ethical review related to clinical research of acupuncture and moxibustion is discussed to provide ideas for various institutions to carry out relevant ethical review. It is believed that the ethical review of clinical research of acupuncture and moxibustion needs to focus on the specificity of acupuncture and moxibustion. Starting from the basic theory of traditional Chinese medicine, the theory of meridians and acupoints and the theory of syndrome differentiation along meridians, the key contents of ethical review such as intervention methods, grouping design and placebo control should be considered, so as to standardize the clinical research of acupuncture and moxibustion and protect the health and rights and interests of participants.
Acupuncture Points ; Acupuncture Therapy ; Biomedical Research ; Ethical Review ; Humans ; Meridians ; Moxibustion

High-quality clinical study on traditional Chinese medicine is of great significance to effectively control new public health emergencies represented by outbreaks of infectious diseases and ensure people's health and safety, but it still faces a series of ethical issues. Based on the seven core values of equity, good deeds, effectiveness, respect for individuals, freedom, reciprocity, and solida-rity proposed in the Guidelines for Management of Ethical Issues in Outbreaks of Infectious Diseases, this article emphasizes the characteristics and laws of clinical studies on traditional Chinese medicine. Main points of ethical review of traditional Chinese medicine were summarized in the aspects of overall concept, syndrome differentiation and treatment, prevention before disease onset, cultural value, and clinical basis. Based on the outbreak of coronavirus disease 2019(COVID-19), we collected relevant registered Chinese medicine clinical studies, summarized the core issues of the ethics review for COVID-19, and further improved the traditional Chinese medicine ethics review system and resources, so as to better serve ethical review and scientific studies in public health emergencies.
Betacoronavirus ; Coronavirus Infections ; Emergencies ; Ethical Review ; Humans ; Medicine, Chinese Traditional ; Pandemics ; Pneumonia, Viral ; Public Health

OBJECTIVE: To analyze the complications of percutaneous transthoracic needle biopsy using CT-based imaging modalities for needle guidance in comparison with fluoroscopy in a large retrospective cohort. MATERIALS AND METHODS: This study was approved by multiple Institutional Review Boards and the requirement for informed consent was waived. We retrospectively included 10568 biopsies from eight referral hospitals from 2010 through 2014. In univariate and multivariate logistic analyses, 3 CT-based guidance modalities (CT, CT fluoroscopy, and cone-beam CT) were compared with fluoroscopy in terms of the risk of pneumothorax, pneumothorax requiring chest tube insertion, and hemoptysis, with adjustment for other risk factors. RESULTS: Pneumothorax occurred in 2298 of the 10568 biopsies (21.7%). Tube insertion was required after 316 biopsies (3.0%), and hemoptysis occurred in 550 cases (5.2%). In the multivariate analysis, pneumothorax was more frequently detected with CT {odds ratio (OR), 2.752 (95% confidence interval [CI], 2.325–3.258), p < 0.001}, CT fluoroscopy (OR, 1.440 [95% CI, 1.176–1.762], p < 0.001), and cone-beam CT (OR, 2.906 [95% CI, 2.235–3.779], p < 0.001), but no significant relationship was found for pneumothorax requiring chest tube insertion (p = 0.497, p = 0.222, and p = 0.216, respectively). The incidence of hemoptysis was significantly lower under CT (OR, 0.348 [95% CI, 0.247–0.491], p < 0.001), CT fluoroscopy (OR, 0.594 [95% CI, 0.419–0.843], p = 0.004), and cone-beam CT (OR, 0.479 [95% CI, 0.317–0.724], p < 0.001) guidance. CONCLUSION: Hemoptysis occurred less frequently with CT-based guidance modalities in comparison with fluoroscopy. Although pneumothorax requiring chest tube insertion showed a similar incidence, pneumothorax was more frequently detected using CT-based guidance modalities.
Biopsy ; Biopsy, Needle ; Chest Tubes ; Cohort Studies ; Cone-Beam Computed Tomography ; Ethics Committees, Research ; Fluoroscopy ; Hemoptysis ; Image-Guided Biopsy ; Incidence ; Informed Consent ; Lung Neoplasms ; Multivariate Analysis ; Needles ; Pneumothorax ; Referral and Consultation ; Retrospective Studies ; Risk Factors

PURPOSE: A cross-sectional survey was conducted to explore the current awareness and use of complementary and alternative medicine (CAM), as well as attitudes toward CAM, in patients with cancer and their family members in South Korea. MATERIALS AND METHODS: Between September 21 and October 31, 2017, a 25-item questionnaire regarding CAM experiences among cancer patients and their family members was conducted in 10 oncology clinics in South Korea after institutional review board approval at each institution. RESULTS: In total, 283/310 patients were analyzed. The median age was 60 years, and 60% were male. Most of the patients were actively receiving anticancer treatment at the time of the survey. A total of 106 patients (37%) had experienced a median of two types (interquartile range, 1 to 3) of CAM. Belief in CAM (odds ratio [OR], 3.015; 95% confidence interval [CI], 1.611 to 5.640) and duration of disease (OR, 1.012; 95% CI, 1.004 to 1.020) were independent factors for using CAM in multivariable analysis. Belief in CAM was significantly associated with current use of CAM (OR, 3.633; 95% CI, 1.567 to 8.424). Lay referral was the most common reason for deciding to use CAM, and only 25% of patients (72/283) discussed CAM with their physicians. CONCLUSION: Patient attitudes toward and confidence in CAM modalities were strongly associated with their CAM experiences, and only a small number of patients had an open discussion about CAM with their physicians. A patient education program for CAM is needed.
Complementary Therapies ; Cross-Sectional Studies ; Ethics Committees, Research ; Humans ; Korea ; Male ; Patient Education as Topic ; Referral and Consultation

No abstract available.
Ethical Review

BACKGROUND/AIMS: Due to a lack of scientific evidence and unstandardized protocols, the correct use of personal protective equipment (PPE) is not always easy for healthcare personnel (HCP). This study aimed to generate experimental evidence to reduce contaminations during PPE doffing. METHODS: With institutional review board approval, 4 standardized HCP were recruited to examine selected PPE protocols based on consultations with 10 invited Korean infection control leaders. Using fluorescent powder and ultraviolet light, each PPE protocol was evaluated for contaminations by comparing methods or steps. Pictures of contaminated areas and videos of HCP practice were evaluated for case analysis by linking all collected data using assigned study experiment codes. RESULTS: A total of 38 simulation experiments were conducted during December 14–20, 2016. No significant difference was found among minor variations in PPE protocols. Rather, after an intensive, 1-minute patient care simulation (e.g., physical assessment), severe powder contaminations on the front and under the sleeves of coveralls were found. Even after the outer-glove surface was wiped clean, partial contaminations still remained, especially between fingers and on fingertips. Moreover, after cleaning glove surface contaminations using wipes, each doffing step caused different contaminations. Among different types of N95 respirators, the foldable N95 type was the most stable during doffing processes, with less possibility of contamination. CONCLUSIONS: Based on this study's findings with visual evidence of contaminations during PPE doffing processes, some meaningful recommendations were feasible, such as the use of disposable long-sleeve aprons over coveralls. Further study is necessary to evaluate these recommendations.
Delivery of Health Care ; Equipment Contamination ; Ethics Committees, Research ; Fingers ; Health Personnel ; Humans ; Infection Control ; Patient Care ; Personal Protective Equipment ; Referral and Consultation ; Ultraviolet Rays ; Ventilators, Mechanical

BACKGROUND: Artificial insemination by donor (AID) is important to chance the pregnancy in male infertile couples by requiring appropriate medical, legal and ethical reviews. The purpose of this study was to investigate the perception changes of AID to collect the basic information for establishing the sperm donation, cryopreservation and artificial insemination management system. METHODS: We evaluated the people's thought of sperm donation, cryopreservation, and artificial insemination by donor by means of national inquiry survey from 247 infertile couples for 4 weeks from October 2016. The questionnaires were composed of 4 areas, and each questionnaire consisted of 15 items. Changes in the perception of AID by year were investigated after review of domestic journals. RESULTS: 67.6% of respondents knew the growth of couples with difficulty getting pregnant due to male infertility. 82.2% of respondents replied the necessary of sperm bank as a treatment option for infertility and 40.5% knew the donation and receipt system of sperm. In the survey of change perception of AID according to year, 37.5% and 39.5% of respondents were got information about AID from doctor in 2003 and 2004, but 49.6% from broadcasting in 2016. As a child grows up, 4.0% (2003), 9.0% (2014), and 42.8% (2016) of respondents answered to tell the child about AID. CONCLUSIONS: Infertile couple's thought of AID about the extension of opportunities for male infertility treatment is changed. In conclusion, it is necessary to establish institutional system of sperm donation, cryopreservation and artificial insemination prior to public sperm bank operation.
Child ; Cryopreservation ; Ethical Review ; Family Characteristics* ; Humans ; Infertility ; Infertility, Male ; Insemination, Artificial* ; Male ; Pregnancy ; Sperm Banks ; Spermatozoa* ; Surveys and Questionnaires ; Tissue Donors*

PURPOSE: There are many forest and outdoor programs being offered but systematic reviews of effects are lacking. This study was done to identify content, format, and strategies of forest therapy programs for elementary school students. METHODS: Literature search using keywords in English and Korean was performed using 6 electronic databases in December 2016. Search participants were elementary school students and interventions conducted in the forest. Seventeen forest therapy studies were selected for evaluation. Risk of Bias Assessment tool for non-randomized study was used for quality assessment. RESULTS: All studies were quasi-experimental designs. Forest therapy programs included various activities in forests such as experience of five senses, meditation in the forest, walking in the forest, ecological play, observation of animals and insects. All studies used psychosocial health variables and forest healing programs had positive effects on sociality, depression, anxiety, self-esteem, stress, aggression, anger, and school adjustment. Limitations of these studies were vague reporting of the study, lack of ethical review and rigorous research designs. CONCLUSION: Forest therapy for elementary school child can be an effective way to improve psychosocial health. Future studies with rigorous study designs are needed to assess long-term effects of forest therapy on physical and psychosocial health.
Aggression ; Anger ; Animals ; Anxiety ; Bias (Epidemiology) ; Child ; Depression ; Ethical Review ; Forests* ; Humans ; Insects ; Meditation ; Research Design ; Walking

OBJECTIVES: The objectives of the research study were to determine ethical guidelines and principles applicable in the practice and research of eHealth and telehealth in the Philippines, how these are applicable to the Philippines, and to differentiate between the ethical issues in research and in clinical practice of eHealth.

METHODS: This research study used: 1) review of ethics manuscripts, guidelines and literature; 2) focused group discussion and key informant interviews of experts; and 3) triangulation. The information sought for the review were- 1) relevant policies, guidelines in eHealth that are pertinent to the discussion of eHealth ethics in the Philippines; 2) components of ethics in eHealth research; and 3) components of ethics in eHealth practice. The framework of the consultation with experts was to identify mechanisms and strategies in incorporating ethics in both eHealthpractice and eHealth research within the following- 1) in reference to existing laws, policies, and guidelines on ethics in medicine and health; and 2) in the context of the Philippine setting.

RESULTS: Based on the review, there are pertinent codes of ethics, applicable laws, policies and guidelines in eHealth, both in the international and local settings. The focus group discussion and key informant interview with experts yielded significant and deeper understanding on how to address the gaps and lapses of ethics applied to eHealth in the country. These recommendations were given which distinguish between the ethics in clinical practice and ethics in the planning and implementation of eHealth systems. There is also a need to resolve the problem of whose primary responsibility the patient is- the referring, commonly referred to as the attending physician in the local community, or the specialist from the center. The proposed resolution was also presented.

CONCLUSION: The study has shown how important eHealth in potentially promoting timely and improved health care access. However, there are still lapses and gaps in the implementation of policies and guidelines on and relating to eHealth in the Philippines as shown by the data culled from the review and the focus group discussions with the experts. With more specific ethical guidelines and relevant policies, the development and practice of eHealth and telehealth will be on its way in bridging the gap and aiding in health systems development in the Philippines, especially with the support of the national government and collaboration of various agencies and stakeholders.