Faculty Bibliography

In a 2022 consultation, the UK public highlighted the need to disseminate trial results to participants. We assess whether the information provided to trial participants in publicly available participant information sheets (PISs) of trials conducted in the UK is helpful for future trials. This cross-sectional study is based on a search conducted on 18 August 2023 on ClinicalTrials.gov looking for UK completed or terminated phase 2-4 medicine trials. The posted PIS (or the protocol, if the PIS was unavailable) were reviewed checking the text used to inform participants on how results will be disseminated to participants. Of the 48 records retrieved, 32 were included: 23 and 9 had the PIS or the protocol posted, respectively. Seven (22%) did not mention dissemination of results to participants. Thirteen (41%) used the same short "common, standard text" of four sentences to inform participants. This text mentioned ClinicalTrials.gov as the source for further information and US Law as the reason for it. Twelve (38%) used different texts with different scopes and lengths. These results showed that publicly available PISs of medicinal product trials conducted in the UK are very limited and of scarce utility for investigators aiming to start a new trial.

The World Health Organization's (WHO) Framework of Engagement with Non-State Actors (FENSA), established in 2016, is designed to enhance transparency, impartiality, and conflict-of-interest safeguards by setting rigorous guidelines for WHO's interactions with private entities, particularly those in high-risk industries such as tobacco, alcohol, and arms. This paper briefly reviews the implementation and impact of FENSA, observing that, despite these safeguards, its application in academic contexts poses specific challenges. Universities, often reliant on diverse funding sources, may find the rules restrictive and misaligned with independent funding needs. The creation of the WHO Foundation in 2020 further complicates this landscape by enabling engagements with previously restricted private sector entities through an "arm's length" model. The authors advocate for a reassessment of FENSA to resolve inconsistencies and support essential academic collaborations, while upholding WHO's commitment to ethical standards.

Infertility patients and patient advocates have long argued for classifying infertility as a disease, in the hopes that this recognition would improve coverage for and access to fertility treatment. However, for many fertility patients, including older women, single women and same-sex couples, infertility does not represent a true disease state. Therefore, while calling infertility a 'disease' may seem politically advantageous, it might actually exclude patients with 'social' or 'relational' infertility from treatment. What is needed is a new conceptual framing of infertility that better reflects the profound significance of being infertile for many people and the importance of addressing infertility in order to improve their lives. In this paper, we argue that the capability approach provides this moral underpinning. The capability approach is concerned with what people are able to do, and whether they are able to act in a way that is in keeping with their own values and goals. The ability to procreate and build a family is a fundamental capacity and can be a major part of self-fulfilment, regardless of sexual orientation or family arrangement. Since the capability approach asks us to conceive of equality in terms of equal capabilities, it provides a strong ethical impetus for society to help those who cannot conceive on their own to do so with assisted reproduction.