A Qualitative Study into Dependent Relationships and Voluntary Informed Consent for Research in Pediatric Oncology.

Background: In pediatric oncology, many oncologists invite their own patients to participate in research. Inclusion within a dependent relationship is considered to potentially compromise voluntariness of consent. Currently, it is unknown to what extent those involved in pediatric oncology experience the dependent relationship as a threat to voluntary informed consent, and what they see as safeguards to protect voluntary informed consent within a dependent relationship.

Voluntary Informed Consent in Paediatric Oncology Research.

In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context.

Is a New Protocol for Acute Lymphoblastic Leukemia Research or Standard Therapy?

In the United States, doctors generally develop new cancer chemotherapy for children by testing innovative chemotherapy protocols against existing protocols in prospective randomized trials. In the Netherlands, children with leukemia are treated by protocols that are agreed upon by the Dutch Childhood Oncology Group. Periodically, the Dutch Childhood Oncology Group revises its protocols.

Balancing research interests and patient interests: a qualitative study into the intertwinement of care and research in paediatric oncology.

Background: Traditionally, in ethical guidelines and in research ethics literature, care and research are clearly separated based on their different objectives. In contrast, in paediatric oncology, research and care are closely combined. Currently, it is unknown how relevant actors in paediatric oncology perceive this combination of research and care.

Strengths and weaknesses of guideline approaches to safeguard voluntary informed consent of patients within a dependent relationship.

Background: It is thought that a dependent relationship between patients and physicians who enroll their own patients in research compromises voluntary informed consent. Therefore, several ethical guidelines for human subject research provide approaches to mitigate these compromises. Currently, these approaches have not been critically evaluated.