Expect the unexpected: patients' and families' expectations and experiences of new clinical procedures.

Background: Early stage clinical innovation often occurs 'under the radar' of governance systems for established procedures. Previously impossible or unavailable techniques still being developed involve additional uncertainty and unknown risks and benefits compared with standard procedures. Patient and family expectations, perceptions and experiences of these new procedures and their possible impacts on aspects of patient safety are under-researched.

The role of patients and their relatives in 'speaking up' about their own safety - a qualitative study of acute illness.

Background: Poor recognition of and response to acute illness in hospitalized patients continues to cause significant harm despite the implementation of safety strategies such as early warning scores. Patients and their relatives may be able to contribute to their own safety by speaking up about changes in condition, but little is known about the factors that influence this. This study examined the experiences and views of patients and their relatives to determine the potential for involvement in promoting their own safety.

Reflections on the implementation of governance structures for early-stage clinical innovation.

Objectives: This paper seeks to further explore the question of how best to monitor and govern innovative clinical procedures in their earliest phase of development. We examine the potential value of proposed governance frameworks, such as the IDEAL model, and examine the functioning of a novel procedures review committee.

Methods: The paper draws upon 20 qualitative, semi-structured interviews.

Donation of 'spare' fresh or frozen embryos to research: who decides that an embryo is 'spare' and how can we enhance the quality and protect the validity of consent?

This paper analyses elements of the legal process of consent to the donation of 'spare' embryos to research, including stem-cell research, and makes a recommendation intended to enhance the quality of that process, including on occasion by guarding against the invalidity of such consent. This is important in its own right and also so as to maximise the reproductive treatment options of couples engaged in in vitro fertilisation (IVF) treatment and to avoid possible harms to them. In Part 1, with reference to qualitative data from three UK IVF clinics, we explore the often delicate and contingent nature of what comes to be, for legal purposes, a 'spare' embryo.