With the rapid development of immunology, molecular biology, and associated technologies such as next-generation sequencing, cellular immunotherapy has recently become the fourth major cancer treatment. Immunotherapies based on T cells, natural killer cells, and dendritic cells play key roles in cancer immunotherapy. However, their application in clinical practice raises several ethical issues. Thus, studies should focus on proper adherence to basic ethical principles that can effectively guide and solve related clinical problems in the course of treatment, improve treatment effects, and protect the rights and interests of patients. In this review, we discuss cellular immunotherapy-related ethical issues and highlight the ethical practices and current status of cellular immunotherapy in China. These considerations may supplement existing ethical standards in cancer immunotherapy.
China ; Dendritic Cells/immunology* ; Humans ; Immunity, Cellular ; Immunotherapy/methods* ; Killer Cells, Natural/immunology* ; Neoplasms/therapy* ; Patient Selection/ethics* ; T-Lymphocytes/immunology*

In the personalized medicine era, utilizing paraffin blocks in pathology archives for investigating human diseases has come into the limelight. This archived material with clinical data will reduce the research time and could prevent new patient recruitment to obtain tissue for research. However, the clause indicating the necessity of consent from human material providers in the Korean Bioethics and Safety Act has made the Institutional Review Board (IRB) deny permission to use paraffin blocks for research without consent, and alternatively to get the same before starting an experiment. Written consent may be waived off in studies using paraffin blocks with anonymous status or conditions not linked to personal information by applying the paragraph 3, article 16 of the current Bioethics and Safety Act. Also, the IRB should recommend researchers to preserve the blocks as medical records of patients in long-term archives.
Anonyms and Pseudonyms ; Bioethics ; Ethics Committees, Research ; Humans ; Medical Records ; Paraffin ; Pathology ; Patient Selection ; Precision Medicine

Education, Medical ; ethics ; Ethics, Medical ; Humans ; Informed Consent ; Patient Selection ; Risk Assessment ; Teaching Rounds ; ethics

BACKGROUND: Candidate characteristics for hand surgery fellowship training remains unknown, as very little data is available in the literature. This study aims to provide information on the criteria that are employed to select candidates for the hand surgery fellowship match. METHODS: A 38-question survey was sent in April 2015 to all Accreditation Council for Graduate Medical Education recognized hand surgery fellowship program directors (n=81) involved in the U.S. match. The survey investigated factors used for the selection of applicants, including medical school, residency training, research experience, fellowship interview, and candidate characteristics. A 5-point Likert scale was used to grade 33 factors from “not at all important” (1) to “essential in making my decision” (5); or for five controversial factors from “very negative impact” (1) to “very positive impact in making my decision” (5). RESULTS: A total of 52% (42 out of 81) of responses were received from hand surgery fellowship program directors. The most important influential factors were interactions with faculty during interview and visit (4.6±0.6), interpersonal skills (4.6±0.5), overall interview performance in the selection process (4.6±0.6), professionalism and ethics (4.6±0.7), and letters of recommendation from hand surgeons (4.5±0.7). Factors that have a negative impact on the selection process include visa requirement (2.1±1.2), graduate of non-plastic surgery residency program (2.4±1.3), and graduate of a foreign medical school (2.4±1.1). CONCLUSIONS: This study provides data on hand surgery fellowship directors' perception on the criteria important for fellowship applicant selection, and showed that interview-related criteria and letters of recommendation are the important factors.
Accreditation ; Education, Medical, Graduate ; Ethics ; Fellowships and Scholarships* ; Hand* ; Internship and Residency ; Patient Selection* ; Professionalism ; Schools, Medical ; Social Skills ; Surgeons ; Surgery, Plastic

BACKGROUND: Candidate characteristics for hand surgery fellowship training remains unknown, as very little data is available in the literature. This study aims to provide information on the criteria that are employed to select candidates for the hand surgery fellowship match. METHODS: A 38-question survey was sent in April 2015 to all Accreditation Council for Graduate Medical Education recognized hand surgery fellowship program directors (n=81) involved in the U.S. match. The survey investigated factors used for the selection of applicants, including medical school, residency training, research experience, fellowship interview, and candidate characteristics. A 5-point Likert scale was used to grade 33 factors from “not at all important” (1) to “essential in making my decision” (5); or for five controversial factors from “very negative impact” (1) to “very positive impact in making my decision” (5). RESULTS: A total of 52% (42 out of 81) of responses were received from hand surgery fellowship program directors. The most important influential factors were interactions with faculty during interview and visit (4.6±0.6), interpersonal skills (4.6±0.5), overall interview performance in the selection process (4.6±0.6), professionalism and ethics (4.6±0.7), and letters of recommendation from hand surgeons (4.5±0.7). Factors that have a negative impact on the selection process include visa requirement (2.1±1.2), graduate of non-plastic surgery residency program (2.4±1.3), and graduate of a foreign medical school (2.4±1.1). CONCLUSIONS: This study provides data on hand surgery fellowship directors' perception on the criteria important for fellowship applicant selection, and showed that interview-related criteria and letters of recommendation are the important factors.
Accreditation ; Education, Medical, Graduate ; Ethics ; Fellowships and Scholarships* ; Hand* ; Internship and Residency ; Patient Selection* ; Professionalism ; Schools, Medical ; Social Skills ; Surgeons ; Surgery, Plastic

Understanding of a clinical trial is essential in developing clinical guideline and adopting evidence based practice. In designing and executing clinical trials, following ethical requirements should be considered : social value, scientific validity, fair subject selection, informed consent, favorable risk-benefit ratio, institutional review board, and respect for human subjects. According to the stage of drug development, purpose of trials, accumulated scientific data, clinical trials for drug development are classified as phase 1, 2, 3, and 4. Phases of clinical trials can be overlapped and the judgment of entering into the next phase should be considered highly strategically. In reading, evaluating and interpreting clinical trial reports, various skills and challenges exist. Patient sample composition, trial duration, selection of endpoints, responders and non-responders, placebo effect, patient recruitment, and extrapolation to the real world are the examples of those challenges. Treatment success will come from the well balanced approach of evidence based decision making and consideration of specific single case.
Decision Making ; Ethics Committees, Research ; Evidence-Based Medicine ; Evidence-Based Practice ; Humans ; Informed Consent ; Judgment ; Patient Selection ; Placebo Effect

BACKGROUND: In children, laryngeal mask airways (LMA) almost always show a tendency to come out of the mouth too much before and during inflating the cuff. We hypothesized that the selection criteria based on body weight seemed to be set too low or inappropriate in children. METHODS: After IRB approval and informed consent from parents, pediatric patients (n = 63; 42 male, 21 female) weighing less than 20 kg, of ASA physical status 1 or 2, and in whom the use of an LMA was not contraindicated, were studied. LMAs were inserted by an experienced investigator and connected to a volume ventilator, and positive pressure ventilation was initiated. Inspiratory and expiratory tidal volume (V(T)) were measured to calculate the fraction of leakage (F(L), %) as ([inspiratory V(T)-expiratory V(T)]/inspiratory V(T)) 100. The larynx was inspected with a fiberoscope (FOB) located just proximal to the aperture bar. For each size of LMA, we divided each group into two subgroups depending on the body weight (4, 7 or 12 kg) and age (2, 9 or 30 months) and compared the FOB finding and F(L) between the two subgroups. In the other 16 patients, LMAs of two different sizes were applied successively to a patient, and its FOB grades were compared. RESULTS: For size 1 LMAs (n = 22), the FOB finding and F(L) were not different between the subgroups. For size 1.5 LMAs (n = 20), patients weighing 7 to 10 kg or aged < 9 months had a better FOB finding (P = 0.007 and 0.0003) than patients weighing 5 to 7 kg or aged > 9 months. For size 2 LMAs (n = 21), FL was correlated with body weight (P < 0.001, r(2) = 0.448) and age (P < 0.001, r(2) = 0.424). In 8 patients of 5 to 7 kg, use of size 1 LMAs had a better FOB grade than that of size 1.5 LMAs (P = 0.031). In the other 8 patients of 10 to 12 kg, there was no difference of FOB grades between the size 1.5 and 2 LMAs. CONCLUSIONS: For patients weighing 5 to 7 kg, the use of size 1 LMAs is recommended. Contrary to adults, a smaller LMA may have to be tried if an LMA size turns out to be inappropriate.
Adult ; Body Weight* ; Child* ; Ethics Committees, Research ; Humans ; Infant* ; Informed Consent ; Laryngeal Masks* ; Larynx ; Male ; Mouth ; Parents ; Patient Selection* ; Positive-Pressure Respiration ; Research Personnel ; Tidal Volume ; Ventilators, Mechanical