SCOPE To discuss the rationale behind informed consent in clinical trials focusing on vulnerable patients from a European and German viewpoint. METHODS Scientific literature search via PubMed, Medline, Google. RESULTS Voluntary informed consent is the cornerstone of policies regulating clinical trials. To enroll a patient into a clinical trial without having obtained written and signed cons...

BACKGROUND Given the initiatives of the National Institutes of Health and other agencies to include children in research, it is important to understand the factors that influence their participation. This study was designed to identify factors that influence parents' decisions to consent to their child's participation in clinical research. METHODS This survey study consisted of 505 parents wh...

BACKGROUND Adolescents who self-harm are often unsure how or where to get help. We developed a Web-based personalized decision aid (DA) designed to support young people in decision making about seeking help for their self-harm. OBJECTIVE The aim of this study was to evaluate the feasibility and acceptability of the DA intervention and the randomized controlled trial (RCT) in a school setting....

BACKGROUND Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes ...

Requiring active consent from parents leads to different self-reports by adolescents than when it is not required. The present study compares self-reported demographic, psychosocial, and behavior variables between those students from whom active consent was and was not obtained. As found in previous studies, fewer minorities, fewer persons who were dissatisfied with school, fewer persons whose ...

BACKGROUND Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children's consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors including the developmental stage, the influence of parents and peers, and life experi...

BACKGROUND In order to involve children in the decision-making process about participation in medical research it is widely recommended that the child's assent be sought in addition to parental consent. However, the concept of assent is fraught with difficulties, resulting in confusion among researchers and ethics committees alike. DISCUSSION In this paper, we outline the current internationa...

BACKGROUND Research involving minors has been the subject of much ethical debate. The growing number of longitudinal, pediatric studies that involve genetic research present even more complex challenges to ensure appropriate protection of children and families as research participants. Long-term studies with a genetic component involve collection, retention and use of biological samples and per...

introduction: based on individual independence rights, patients can refrain from being treated or can voluntarily discontinue their treatment after receiving full information. this study aimed to review the reasons of treatment refusal and the status of informed refusals for patients. methods: this was a cross-sectional descriptive study. the study population included 135 patients who refused t...