Due to copyright issues, an electronic copy of the thesis must be ordered from the faculty. For the faculty to have time to process the order, the order must be received by the faculty at the latest 2 days before the public defence. Orders received later than 2 days before the defence will not be processed. After the public defence, please address any inquiries regarding the thesis to the candidate.
Trial Lecture – time and place
See Trial Lecture.
Adjudication committee
- First opponent: Professor Marcin Waligora, Medical College, Jagiellonian University, Poland
- Second opponent: Professor Nancy King, School of Medicine, Wake Forest University, USA
- Third member and chair of the evaluation committee: Professor Christoph Gradmann, Faculty of Medicine, University of Oslo
Chair of the Defence
Associate Professor Mekdes Gebremariam, University of Oslo
Principal Supervisor
Professor Rosemarie de la Cruz Bernabe, University of Oslo
Summary
For approximately six decades, Research Ethics Committees (RECs), also known as Institutional Review Boards (IRBs), have played an integral part in the identification of ethical issues before the commencement of clinical research globally. The importance and relevance of the REC/IRB prospective review are widely acknowledged, admired, and critiqued. In many jurisdictions, legislative and policy frameworks are in place to prevent clinical research from taking place without prior review and approval by a REC/IRB. It is, therefore, reasonable to assume that research with a favorable opinion of a REC/IRB is ethically sound and scientifically appropriate. There is evidence, however, that researchers may deviate from the approved protocols. Many of these deviations are ethically relevant yet remain unaddressed. These unaddressed deviations form the basis for this interrogative thesis into the post-approval role of RECs/IRBs. It employs the sociological frame of role theory to illuminate concepts such as role expectations, identity, and behavior concerning REC/IRBs in the post-approval oversight of clinical trials.
Qualitative research methods were employed to explore the main objectives. The primary data sources were regional and international normative documents related to clinical research and REC/IRBs in Europe and the USA and US Academic health center IRBs’ web page content. Stakeholder engagement included REC representatives in Europe using the European Network for Research Ethics Committee (EUREC) member list.
The overarching role expectation of REC/IRBs after the approval of clinical trial protocols is to protect research participants. This may be achieved through post-approval activities such as continuing review, active monitoring, ethics support and education to researchers, and the issuance of an opinion on the final reports at the end of clinical trials. There may be hesitancy in European countries to conduct active follow-up of approved trials due to a lack of supporting legislation/policy, types of organizational structure, lack of expert administrative staff, and other resource limitations. The European Medicines Agency’s new clinical trial information system provides a unique opportunity to reduce bureaucracy and enable the follow-up of approved protocols. To avoid pushback, EU RECs may need stakeholder support and re-branding to shift the perception of RECs from mainly performing prospective reviews towards an end-to-end ethics oversight i.e. an oversight from start to finish.
Additional information
Contact the research support staff.