As artificial intelligence technology rapidly advances, its deployment within the medical sector presents substantial ethical challenges. Consequently, it becomes crucial to create a standardized, transparent, and secure framework for processing medical data. This includes setting the ethical boundaries for medical artificial intelligence and safeguarding both patient rights and data integrity. This consensus governs every facet of medical data handling through artificial intelligence, encompassing data gathering, processing, storage, transmission, utilization, and sharing. Its purpose is to ensure the management of medical data adheres to ethical standards and legal requirements, while safeguarding patient privacy and data security. Concurrently, the principles of compliance with the law, patient privacy respect, patient interest protection, and safety and reliability are underscored. Key issues such as informed consent, data usage, intellectual property protection, conflict of interest, and benefit sharing are examined in depth. The enactment of this expert consensus is intended to foster the profound integration and sustainable advancement of artificial intelligence within the medical domain, while simultaneously ensuring that artificial intelligence adheres strictly to the relevant ethical norms and legal frameworks during the processing of medical data.
Artificial Intelligence/legislation & jurisprudence* ; Humans ; Consensus ; Computer Security/standards* ; Confidentiality/ethics* ; Informed Consent/ethics*

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

OBJECTIVE: According to the current guidelines, arterial hyperenhancement for diagnosis of hepatocellular carcinoma (HCC) is determined using the arterial phase only. We investigated the optimal definition of arterial hyperenhancement in patients with HCC using computed tomography (CT) and magnetic resonance imaging (MRI). MATERIALS AND METHODS: The Institutional Review Board approved this retrospective study. The requirement for informed consent was waived. Between January 2011 and September 2013, 147 consecutive patients with surgically proven HCCs with both pre-operative CT and MRI were included. Identification rates of arterial hyperenhancement on CT and magnetic resonance (MR) images using arterial phase only, dual phase (unenhanced and arterial phases), and also subtraction MR images were assessed qualitatively. RESULTS: The identification rates for arterial hyperenhancement on CT were significantly different between arterial phase and dual phase (72.8% vs. 90.5%; p < 0.001), whereas the rates were similar on MRI (91.8% vs. 93.9%; p = 0.257). The identification rate of arterial hyperenhancement in MRI increased to 98.6% using subtraction MR images. CONCLUSION: Visual comparison of arterial and unenhanced phases could be recommended instead of conventional qualitative arterial phase alone assessment to determine arterial hyperenhancement of HCCs, especially when using CT.
Carcinoma, Hepatocellular ; Diagnosis ; Ethics Committees, Research ; Humans ; Informed Consent ; Magnetic Resonance Imaging ; Retrospective Studies

OBJECTIVE: To assess whether virtual expiratory (VE)-computed tomography (CT)/ultrasound (US) fusion imaging is more effective than conventional inspiratory (CI)-CT/US fusion imaging for hepatic interventional procedures. MATERIALS AND METHODS: This prospective study was approved by the Institutional Review Board, and informed consent was obtained from each patient. In total, 62 patients with focal hepatic lesions referred for hepatic interventional procedures were enrolled. VE-CT images were generated from CI-CT images to reduce the effects of respiration-induced liver motion. The two types of CT images were fused with real-time US images for each patient. The operators scored the visual similarity with the liver anatomy upon initial image fusion and the summative usability of complete image fusion using the respective five-point scales. The time required for complete image fusion and the number of point locks used were also compared. RESULTS: In comparison with CI-CT/US fusion imaging, VE-CT/US fusion imaging showed significantly higher visual similarity with the liver anatomy on the initial image fusion (mean score, 3.9 vs. 1.7; p < 0.001) and higher summative usability for complete image fusion (mean score, 4.0 vs. 1.9; p < 0.001). The required time (mean, 11.1 seconds vs. 22.5 seconds; p < 0.001) and the number of point locks (mean, 1.6 vs. 3.0; p < 0.001) needed for complete image fusion using VE-CT/US fusion imaging were significantly lower than those needed for CI-CT/US fusion imaging. CONCLUSION: VE-CT/US fusion imaging is more effective than CI-CT/US fusion imaging for hepatic interventional procedures.
Ethics Committees, Research ; Humans ; Informed Consent ; Liver ; Prospective Studies ; Respiration ; Ultrasonography ; Weights and Measures

OBJECTIVE: To assess the diagnostic value of combining diffusion-weighted imaging (DWI) with conventional magnetic resonance imaging (MRI) for differentiating between pathologic and traumatic fractures at extremities from metastasis. MATERIALS AND METHODS: Institutional Review Board approved this retrospective study and informed consent was waived. This study included 49 patients each with pathologic and traumatic fractures at extremities. The patients underwent conventional MRI combined with DWI. For qualitative analysis, two radiologists (R1 and R2) independently reviewed three imaging sets with a crossover design using a 5-point scale and a 3-scale confidence level: DWI plus non-enhanced MRI (NEMR; DW set), NEMR plus contrast-enhanced fat-saturated T1-weighted imaging (CEFST1; CE set), and DWI plus NEMR plus CEFST1 (combined set). McNemar's test was used to compare the diagnostic performances among three sets and perform subgroup analyses (single vs. multiple bone abnormality, absence/presence of extra-osseous mass, and bone enhancement at fracture margin). RESULTS: Compared to the CE set, the combined set showed improved diagnostic accuracy (R1, 84.7 vs. 95.9%; R2, 91.8 vs. 95.9%, p < 0.05) and specificity (R1, 71.4% vs. 93.9%, p < 0.005; R2, 85.7% vs. 98%, p = 0.07), with no difference in sensitivities (p > 0.05). In cases of absent extra-osseous soft tissue mass and present fracture site enhancement, the combined set showed improved accuracy (R1, 82.9–84.4% vs. 95.6–96.3%, p < 0.05; R2, 90.2–91.1% vs. 95.1–95.6%, p < 0.05) and specificity (R1, 68.3–72.9% vs. 92.7–95.8%, p < 0.005; R2, 83.0–85.4% vs. 97.6–98.0%, p = 0.07). CONCLUSION: Combining DWI with conventional MRI improved the diagnostic accuracy and specificity while retaining sensitivity for differentiating between pathologic and traumatic fractures from metastasis at extremities.
Cross-Over Studies ; Diffusion ; Ethics Committees, Research ; Extremities ; Fractures, Spontaneous ; Humans ; Informed Consent ; Magnetic Resonance Imaging ; Neoplasm Metastasis ; Retrospective Studies ; Sensitivity and Specificity

It aimed to present the definition of personal information based on Korean laws that protect personal information and the process of protection of personal information in journal publishing based on the guidelines of the International Committee of Medical Journal Editors and Committee of Publication Ethics. Two Korean laws relate to the protection of personal information in human subject research: the Personal Information Protection Act and the Bioethics and Safety Act. These laws were enacted to prevent the unauthorized use of Koreans’ personal information including medical information. Personal information can be divided into personally identifiable information including resident registration numbers and sensitive information including health information. To protect personal information in journal publishing, institutional review board (IRB) approval and obtaining informed consent from patients is recommended or mandatory in clinical studies. However, retrospective chart reviews may be exempted from IRB approval, while obtaining informed consent is recommended for all case reports. Journal policies may vary with regard to whether a copy of the informed consent form is collected from authors, since the Committee of Publication Ethics guideline does not specifically recommend collecting it. In discussions of adopting clinical data-sharing policies, transfer of data including nonidentifiable personal information to another country is an unresolved issue. Furthermore, a public data repository site should be established in Korea for data to be deposited. To protect subjects’ privacy and to prevent legal issues potentially arising from privacy concerns, editors and publishers should do their best to publish articles with appropriate oversight on subjects’ personal information.
Bioethics ; Computer Security ; Consent Forms ; Ethics ; Ethics Committees, Research ; Humans ; Informed Consent ; Jurisprudence ; Korea ; Personally Identifiable Information ; Privacy ; Publications ; Republic of Korea ; Retrospective Studies

“This study was reviewed and approved by the Institutional Review Board (IRB approval no., 2019-02-095) and informed consent was waived” is to be added at the end of methods section.
Coronary Artery Bypass ; Coronary Vessels ; Ethics Committees, Research ; Informed Consent ; Transplants ; Ventricular Dysfunction, Left

OBJECTIVE: To compare the elasticity of the supraspinatus tendon (SST) and infraspinatus tendon (IST) in patients with idiopathic adhesive capsulitis of the shoulder (ACS) with those in the control groups and to evaluate the relationship between age and tendon elasticity. MATERIALS AND METHODS: The Institutional Review Board approved this prospective, case-control study, which was conducted between November 2017 and March 2018, and informed consent was obtained from all participants. Control groups comprised healthy individuals or those with asymptomatic contralateral shoulders. Twenty-five shoulders in 20 participants in the ACS group (14 women; 53.5 ± 7.9 years) and 24 shoulders in 18 participants in the control group (6 women; 52.6 ± 10.5 years) were included. Elastography was performed in the oblique coronal plane at the neutral shoulder position. Mean/maximum/minimum velocity and stiffness from the shear-wave ultrasound elastography (SWE) and strain ratio (subcutaneous fat/target-tendon) from the strain ultrasound elastography (SE) of the SST and IST were evaluated. Statistical analyses were performed using the Mann-Whitney U test, receiver operating characteristic (ROC) curve, and Spearman correlation. RESULTS: Both velocity and stiffness in SWE were higher, and the strain ratio in SE was lower in participants with symptomatic shoulders than in those with normal shoulders (p < 0.001). SST- and IST-mean velocity, mean stiffness, and strain ratios showed excellent area under the ROC curve (> 0.970). The elastic modulus was little correlated with age (ρ = −0.340–0.239). CONCLUSION: SWE and SE indicated that SST and IST were stiffer in patients with ACS than in those with normal shoulders regardless of aging.
Adhesives ; Aging ; Bursitis ; Case-Control Studies ; Elastic Modulus ; Elasticity ; Elasticity Imaging Techniques ; Ethics Committees, Research ; Female ; Humans ; Informed Consent ; Prospective Studies ; ROC Curve ; Rotator Cuff ; Shoulder ; Tendons ; Ultrasonography

OBJECTIVE: To evaluate the incidence, types and association of systemic reactions after an epidural steroid injection (ESI) with patient demographics, ESI factors and repeated occurrence of an ESI. MATERIALS AND METHODS: This prospective observational study was approved by the Institutional Review Board of our hospital, and written informed consent was obtained from all the participants. From October to December 2011, systemic reactions at 2 weeks after 960 ESIs among 885 patients were measured. Patients were evaluated by phone interviews to obtain the patients' demographics, history of previous ESI, ESI factors, and ESI reoccurrence. Statistical analyses were performed using the chi-square tests, Fisher's exact tests and a binary logistic regression analysis. RESULTS: Overall, 557 types of systemic reactions occurred after 292 injections (30.4%) of a total of 960 ESIs in which facial flushing was most common (131/557, 23.5%) and 144 ESIs were followed by a mixed form of systemic reactions (49.3%). Age of 62 years or younger (odds ratio [OR], 2.361), female sex (OR, 1.674), and history of diabetes mellitus (OR, 1.681) were significant risk factors in the occurrence of systemic reactions after an ESI. In 73 patients with repeated ESI, 14 patients re-experienced systemic reactions (19.2%), of which twelve re-experienced the same systemic reaction as the previous one. CONCLUSION: Systemic reactions followed about 30% of ESIs, and more commonly occurred in patients 62 years of age or younger, women, and diabetic patients. Half of the patients experienced a mixed form of systemic reactions. Patients with recurring systemic reactions tend to re-experience the same systemic reaction as the prior one after an ESI.
Chronic Pain ; Demography ; Diabetes Mellitus ; Ethics Committees, Research ; Female ; Flushing ; Humans ; Incidence* ; Informed Consent ; Logistic Models ; Observational Study* ; Prospective Studies* ; Risk Factors ; Spine

PURPOSE: Recently a controversy has arisen about so-called “ghost surgery” practices, and people have voiced their opinions for legal sanction against such practices, which clearly undermine the foundation of medical ethics. However, there has been a lack of legal basis for punishing those actions. The present study aims to examine which pre-existing legal provisions could be applied to regulate ghost surgery. METHODS: The Korean Medical Service Act has a provision relating to informed consent to inhibit ghost surgery but does not include penalty provisions prohibiting ghost surgery itself. Also, the Korean Supreme Court precedents on this issue have not been settled as of yet. Therefore, this study referred to U.S precedents, law books, and related papers. RESULTS: With respect to ghost surgery, we expect the charges of bodily harm, assault and battery, and fraud could be applied under Korean law, in addition to charges regarding the violation of medical law, such as the omission of entries or false entries in medical records. A patient provides consent to bodily harm prior to surgery, and only the person who is entrusted with such permission can become the operating surgeon in the operating room. CONCLUSION: In other words, even if other medical professionals are present in the operating room, the operating surgeon who received consent must take overall responsibility for the whole process of the surgery. A surgeon should bear in mind that a violation of such duty can constitute a criminal offense.
Criminals ; Ethics, Medical ; Fraud ; Humans ; Informed Consent ; Jurisprudence ; Korea* ; Medical Records ; Operating Rooms ; Punishment* ; Surgical Procedures, Operative