Progress in precision medicine is being achieved through the design of clinical trials that use genetic biomarkers to guide stratification of patients and assignation to treatment or control groups. Genetic analysis of biomarkers is, therefore, essential to complete their objectives, and this involves the study of biological samples from donor…

Many research institutions and funders have recently stated their commitment to actively support and promote 'Equality, Diversity and Inclusion' (EDI) in various aspects of health research including Patient and Public Involvement (PPI). However, translating this commitment into specific research projects presents significant challenges that…

Simulated standardized patients (SPs) are trained individuals who pose incognito as people seeking treatment in a health care setting. With the method's increasing use and popularity, we propose some standards to adapt the method to contextual considerations of feasibility, and we discuss current issues with the SP method and the experience of…

This paper addresses psychological factors that might interfere with informed consent on the part of stable patients as potential early-phase clinical trial participants. Thirty-six semistructured interviews with patients who had either diabetes or gout were conducted. We investigated stable patients' attitudes towards participating in a…

The Confidentiality Advisory Group (CAG) is a specialised body that advises the Health Research Authority (HRA) and the Secretary of State for Health on requests for access to confidential information, in the absence of informed consent from its owners. Its primary role is to oversee the safe use of such information and to counsel the governing…

Very few attempts have been made to survey patient opinions, particularly regarding the use of residual biospecimens and health information in research, to clarify their values. We conducted a questionnaire survey that targeted outpatients of a university hospital to gauge their awareness levels and understand patient perspectives on research that…

Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics Committees to keep an oversight of ongoing clinical trials including on-site monitoring. In this article,…