PhD-student Research Ethics

Are you interested to study how we can speed up knowledge generation for children with cancer in an ethically responsible way? In this PhD position we will study pressing ethical issues in pediatric oncology research.

Dit ga je doen

This project will study pressing issues in research ethics in the domain of pediatric oncology. Clinical research is essential to develop and improve treatments for children with cancer. At the same time, pediatric oncology research raises ethical issues. This project focuses on a number of pressing issues in this field.

First, for 10-15% of children with B-cell acute lymphoblastic leukemia (B-ALL), CAR-T cell therapy is offered as a last resort. Its therapeutic potential could however increase if accepted as frontline/standard therapy, but this is currently considered ethically problematic if children have other options. Moreover, the subsidiarity requirement is often strictly interpreted, implying that adults or adolescents should be enrolled before younger children. The revised Declaration of Helsinki has widened possibilities for research with vulnerable populations, but it is not yet common practice to “drop the age”. You will perform an ethical-legal analysis on ethical frameworks, laws and guidelines and conduct a series of focus groups with adolescents, parents, clinician-researchers, regulators, ethical committees, guideline developers, payers, industry employees and policy makers to study under which conditions CAR-T cell therapy could be studied as frontline therapy for children with cancer.

Second, harmonization of clinical trial procedures for pediatric oncology research is essential to speed up clinical trial innovation in Europe. Unlike many other countries in Europe, in the Netherlands research ethics committees take an integrated approach to ethical and scientific review and review so-called part I and II of a clinical trial simultaneously. One of the open issues is whether an integrated review reduces the number of requests for information (RFIs) and also leads to more adequate ethical questions, specifically related to pediatric oncology. The PhD student will perform quantitative and qualitative work to ethically assess the RFIs for pediatric oncology. This part of the project will be done in close collaboration with Dutch research ethics committees.

Third, adaptive designs are promising new methodologies to speed up knowledge generation in early dose-finding studies, but also require dedicated statistical expertise in the research team and raise ethical questions about informed consent. Together with researchers from the Oncode Accelerator project, we will study how adaptive platform studies in early phase dose-finding trials should be communicated to participants, specifically to parents and children, and what level of understanding is necessary to support valid consent. We will develop a vignette study with different forms of informed consent to study how informed consent for adaptive trials should be formulated.

Hier ga je werken

• You will be appointed at the Department of Bioethics & Health Humanities at the Julius Center of the UMC Utrecht. This is an inter- and transdisciplinary department, combining bioethics, health law, history of medicine, narrative medicine, medical anthropology, and patient involvement in education, research and consultation. We have a vibrant community of PhD students.
• You will be supervised by Prof. dr. Rieke van der Graaf, bioethicist at the Julius Center, and Prof. dr. Michel Zwaan, who is a pediatric oncologist at the Princes Maxima Center.
• You will collaborate closely with statisticians involved in the Oncode Accelerator project.
• You will collaborate closely with Dutch research ethics committees.

Dit neem je mee

We are looking for a researcher with a background in health sciences and/or expertise in bioethics. Strong proficiency in Dutch is essential for carrying out surveys and qualitative interview research. Affinity with (pediatric) oncology is a plus. The ideal candidate is a motivated, ambitious, and creative student with a high level of curiosity and autonomy who can work and position him/her self in a multidisciplinary team. We highly prefer flexible candidates with a collaborative working style, as this project combines multiple disciplines.