INTRODUCTION

Documenting a research participant’s awareness of the bill of rights is achieved with an informed consent. In recent years, the informed consent document has increasingly become confounding to research participants in its complexity. As such, the awareness of research participants’ bill of rights has emerged as a lingering issue since studies that test awareness of research participants’ bill of rights are limited. Hence, this study aimed to determine the participants’ awareness of the bill of rights after an educational intervention.

A quasi-experimental study was done where participants’ awareness of clinical trial participants’ bill of rights was determined after an educational intervention.

There was a significant difference (pCONCLUSIONS

Significant difference in the awareness of bill of rights was observed after the educational intervention. Additional intervention could be given to participants who are females, of older age group (middle age and older), did not complete high school, and the unemployed when they participate in clinical trials to ensure their awareness of the bill of rights of clinical trial participants. Varied learning materials must be given to participants to emphasize the clinical research objectives and activities as well.

Humans ; Informed Consent

At present, medical disputes are still widely-concerned social problems and occasionally evolve into severe social events. In the dispute settlement mechanism, forensic identification opinion is the important technical support. Due to the high professionalism and complexity of medicine, the identification of medical malpractice has become major and difficult problem in the identification. This paper systematically analyze the concept of medical malpractice and five legal theories of malpractice determination, pointing out that China's forensic identification of medical damage should be led by the theory of "medical standards", supplemented by "prudent patient" standard and strengthen "peer review" in form. At the same time, seven main identification principles should be followed in practice: (1) take "obligation of diagnosis and treatment" as the basic principle of medical malpractice identification; (2) take whether to fulfill the obligation of diagnosis and treatment corresponding to current medical level as the specific principle; (3) take diagnosis and treatment routine, norms and guidelines as the main basis; (4) the principle of "peer review"; (5) the principle of "the generality of medical emergency action"; (6) the principle of "notification-informed-consent"; (7) the principle of "review of complications". This paper also puts forward the corresponding identification ideas in view of the above principles, hoping this helps standardize medical damage forensic identification activities.
Dissent and Disputes ; Forensic Medicine ; Humans ; Informed Consent ; Malpractice

The Vaccine Administration Law of the People's Republic of China and other relevant laws require that vaccine recipients or their guardians be educated about vaccines and how they work, and described in general the methods and contents of such vaccination education. With the new law and "Standard Operational Procedures for Immunization" as foundation documents, and in consultation with experts at home and abroad, the Chinese Preventive Medicine Association developed a consensus statement about informed consent for vaccination. This consensus statement is written for disease control and prevention health care personnel in vaccination services and describes the educational content of informed consent, a theoretical framework for immunization and immunization knowledge, the informed consent processes, principles of planning for vaccination, and an informed consent form. Part Two of the consensus includes influenza vaccine, pneumococcal vaccine, haemophilus influenzae type b containing vaccine, enterovirus type 71 inactivated vaccine, rotavirus vaccine, varicella attenuated live vaccine, herpes-zoster vaccine, human papillomavirus vaccine, rabies vaccine, hemorrhagic fever with renal syndrome vaccine, leptospira vaccine, anthrax vaccine, hepatitis E vaccine, cholera vaccine, typhoid vaccine, and tick-borne encephalitis vaccine.
China ; Consensus ; Humans ; Influenza Vaccines ; Informed Consent ; Vaccination

informed consent and establishing realistic outcome expectations are imperative for successful postoperative outcomes.]]>
Congenital Abnormalities ; Contracture ; Erectile Dysfunction ; Humans ; Informed Consent ; Male ; Penile Induration ; Penile Prosthesis ; Penis ; Rehabilitation ; Sensation ; Standard of Care ; Surgeons ; Transplants

BACKGROUND: Sickle cell disease is an autosomal recessive condition that results from the presence of a mutated form of hemoglobin. Some genetic variants of BCL11A are amenable to therapeutic manipulation. The present study investigated the relationship of a BCL11A variant (rs1427407) and its plasma levels with vaso-occlusive crises and stroke complications among patients in Sudan with sickle cell disease. METHODS: This cross-sectional study was performed between June 2014 and October 2016. The subjects included 166 patients who were diagnosed with sickle cell disease and 35 healthy control subjects, who were grouped according to sex and age ( < 15 years, 15–25 years, and >25 years). All patients and/or their guardians provided informed consent. Blood samples were collected from the patients and controls under aseptic conditions. RESULTS: Plasma BCL11A levels were elevated in cases with vaso-occlusive crises that lasted for >3 years. In addition, plasma BCL11A levels were high in cases with the GG genotype (vs. GT and TT) at rs1427407. Furthermore, the BCL11A rs1427407 GG/GT genotypes increased the risk of vaso-occlusive crisis and stroke in the patients with sickle cell disease. CONCLUSION: The BCL11A variant (rs1427407) and its plasma levels were associated with vaso-occlusive crisis and stroke in patients with sickle cell disease.
Anemia, Sickle Cell* ; Cross-Sectional Studies ; Genotype* ; Humans ; Informed Consent ; Plasma ; Stroke* ; Sudan*

OBJECTIVE: To evaluate the current status of managing adverse reactions to iodinated contrast media (ICM) for computed tomography in referral hospitals in South Korea compared with hospitals in other countries. MATERIALS AND METHODS: This survey investigation involved 59 Korean and 15 overseas hospitals using guideline-based questionnaires consisting of 24 items in 7 main categories related to managing adverse reactions to ICM. RESULTS: Informed written consent with risk factor evaluation was appropriately performed in most of the Korean hospitals. There was considerable variability in assessing renal function across the hospitals; serum creatinine level was used as a reference in 76.4% of Korean hospitals. The Korean hospitals preferred a more stringent approach to determining normal renal function (p = 0.01), withholding metformin (p = 0.01), and fasting before ICM exposure (p < 0.001) compared with overseas hospitals. All the Korean hospitals had an emergency protocol and in-hospital system for adverse reactions to ICM. The Korean (87.7%) and overseas hospitals (100%) were similarly equipped with epinephrine (p = 0.332), but only 38.6% of Korean hospitals were equipped with a bronchodilator (p = 0.004). For patients with a previous hypersensitivity reaction to ICM, 62.3% of Korean hospitals pre-medicated with anti-histamine and corticosteroid according to the severity of the previous reaction, and changed the culprit ICM in 52.8%, while skin test was performed in 17%. CONCLUSION: In general, Korean referral hospitals were well-prepared regarding informed consent, protocol, and an in-hospital system for managing adverse reactions to ICM. Nevertheless, there was considerable variability in details and management, thus requiring standardization by reflecting current guidelines.
Asthma ; Contrast Media* ; Creatinine ; Drug Hypersensitivity ; Emergencies ; Epinephrine ; Fasting ; Humans ; Hypersensitivity ; Informed Consent ; Korea ; Metformin ; Referral and Consultation* ; Risk Factors ; Skin Tests

“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

PURPOSE: In general, the prevalence of metabolic syndrome (MS) and tooth loss increases with age. We investigated the relationship between the presence of MS, its elements, and tooth loss in middle-aged Korean adults. MATERIALS AND METHODS: This study included Korean adults between 30 and 64 years of age who resided in the capital area of Seoul. From January to June 2014, individuals interested in participating in the oral health survey among those who visited the university hospital's cardiovascular center and provided informed consent were selected. Among 748 subjects who responded to the oral health questionnaires, 30 were excluded due to unclear responses; therefore, a total of 718 were included in the final analysis. RESULTS: The crude odds ratio (OR) of ≥one MS component affecting tooth loss was 1.45 [95% confidence interval (CI), 1.06–2.00]. After adjusting for sex, age, education, income level, occupation, smoking status, kidney disease, chronic obstructive pulmonary disease, and rheumatic disease, the adjusted OR was 1.47 (95% CI, 1.06–2.05), which was statistically significant (p<0.05). The OR for tooth loss was higher in the presence of ≥one component of MS (50–64 years of age) in females. CONCLUSION: This study suggests that female aged 50–64 years may have higher likelihood of tooth loss upon the presence of at least one MS component. Prevention against MS among female of older age could contribute to maintenance of remaining teeth. Further well-designed studies are needed.
Adult ; Education ; Female ; Humans ; Informed Consent ; Lung Diseases, Obstructive ; Middle Aged ; Occupations ; Odds Ratio ; Oral Health ; Prevalence ; Renal Insufficiency, Chronic ; Rheumatic Diseases ; Seoul ; Smoke ; Smoking ; Tooth Loss ; Tooth

BACKGROUND/AIMS: The abdominal pain-related functional gastrointestinal disorders (AP-FGIDs) affect a significant proportion of the pediatric population and consist 1 of the most frequent causes for seeking medical advice. In this study, we aimed to assess the relation of dietary habits with the likelihood of AP-FGIDs. METHODS: This was a school-based, cross-sectional study approved by the Greek Government authorities, after obtaining informed consent by the legal representatives of the children. Diagnoses of AP-FGIDs were based on the Greek official translation of the Rome III questionnaire. Demographic, socioeconomic and dietary data were collected through self-reporting or parent-reporting questionnaires. Associations between the probability of AP-FGIDs and dietary practices were assessed after adjusting for known confounders through a multiple logistic regression analysis. RESULTS: A total of 1365 children (147 AP-FGIDs and 1218 controls, 52.4% females, mean age: 12.8 ± 2.8 years) were included. Multiple regression analysis identified the following statistically significant confounders: victimization, the presence of a person with a severe health problem at home, female sex, engaging in limited physical exercise, and living in a single adult family. Subsequently, logistic regression, adjusted for the abovementioned confounders, showed that reduced fish and increased junk food consumption were related to a higher likelihood of AP-FGIDs. CONCLUSIONS: Children with AP-FGIDs report excessive junk-food and reduced fish intake compared to controls. Further studies are needed in order to clarify the nature of this observation.
Adolescent ; Adult ; Child ; Crime Victims ; Cross-Sectional Studies ; Diagnosis ; Exercise ; Feeding Behavior ; Female ; Food Habits ; Gastrointestinal Diseases ; Humans ; Informed Consent ; Logistic Models