PhD Fellowship in International Research Ethics – Regulatory Ethics
One position as PhD Research Fellow in International Research Ethics is available at Centre for Medical Ethics(CME) at the Institute of Health and Society at the University of Oslo.
The successful PhD candidate will be part of an interdisciplinary research group at CME focusing on International research ethics, global health and human rights, and he/she will be involved in the project Incorporation of Ethics in Pharmaceutical Authorization Regulatory Procedures (Regulatory Ethics). Good Clinical Practice and European Medicines Agency (EMA) documents require clinical trials to be conducted in accordance with ethical principles and that major ethical flaws should have an impact on the final conclusions about approvability of an application. In spite of these requirements, clinical trial regulators frequently encounter ethical issues through the post-clinical trial inspection reports (from several parts of the world, including low and middle income countries) that are submitted to the EMA for the marketing authorization application of a new medicinal products. At the same time, these ethical issues never reach the marketing authorization deliberation processes.To address the gap between what is ethically required and the reality outlined above, this project will investigate how ethics should and could be incorporated in the regulatory procedures leading to marketing authorizations of medicinal products (main objective). The specific aims are:
1. To perform a systematic review of reasons on the place of ethics in the regulation of clinical development programs;
2. To identify regulatory options for action on ethically relevant Good Clinical Practice violation findings;
3. To explore the opinions of relevant stakeholders on what regulatory ethical responsibility means, what it consists of, who ought to be responsible and what the possible courses of action might be given specific types of ethical issues;
4. To develop a normative framework on the ethical responsibility of regulators;
5. To provide recommendations on how ethics should be incorporated in the regulatory procedures leading to marketing authorizations.
The Centre welcomes proposals demonstrating the candidate’s suitability to address issues highlighted in the above mentioned project description (Regulatory Ethics).
Starting date has to be September 15 2019 at latest.
Applicants must satisfy the requirements for admission to the Faculty’s PhD program. This includes:
- Successful completion of an MD degree, or a Master's degree with thesis, or equivalent qualifications, with sufficient relevance to the announced research field
- Minimum grade B (ECTS grading scale) or equivalent on the Master’s degree, and explicit indication of the grade achieved on the thesis part.
- The successful candidate will have background in medicine or pharmacy, and/or a master’s degree in a relevant health or social science programme, as e.g. health care ethics and law.
- Excellent knowledge of everyday and academic English is a requirement.
- salary in line with pay grades 51 – 58 (NOK 449.400,- – 505.800,- per annum depeding on qualifications in position as PhD candidate (position code1017)
- a positive and challenging working environment
- pension arrangements in the Norwegian Public Service Pension Fund
- a position in an inclusive working life enterprise
- attractive welfare arrangements
- The University of Oslo has an Acquisition of Rights Agreement for all employees for the purpose of securing intellectual property rights to research results etc.
For more information click "LINK TO ORIGINAL" below.