Factors influencing informed consent for participation in CTIMPs.
Research type
Research Study
Full title
Factors influencing the giving of informed consent for participation in oncology and haematology Clinical Trials of an Investigational Medicinal Product in North-East Scotland.
IRAS ID
261364
Contact name
Anita Weidmann
Contact email
Sponsor organisation
The Robert Gordon University
Duration of Study in the UK
0 years, 3 months, 26 days
Research summary
Clinical Trials (CTs) of new and existing pharmaceuticals (Investigational Medicinal Products – IMPs) are the foundation of developing medical care. Difficulties in trial recruitment are the most common causes for not starting a study or its premature termination. Patients need to express informed voluntary consent to participate in a trial and due to multiple reasons they do not wish to be enrolled. It is particularly challenging for trials in oncology and haematology where due to a relatively small pool of potential participants, one patient can make a difference between a trial going or not going ahead. Those diseases are often potentially fatal or significantly debilitating with treatment that carries serious adverse effects burden – hence the decision making process behind giving consent is more complex.
This qualitative research aims to investigate decision making factors for giving or not giving consent to participate in such CTs. The outcome could be used as a foundation for future work to improve the effectiveness and fairness of the obtaining informed consent processes.
REC name
Social Care REC
REC reference
19/IEC08/0032
Date of REC Opinion
8 Aug 2019
REC opinion
Further Information Favourable Opinion