We have published the report of our investigation into concerns raised with the HRA about the study 'Early pubertal suppression in a carefully selected group of adolescents with gender identity disorders'.
The investigation was carried out in line with our processes for complaints and concerns, using all information available to the HRA, and considered issues raised with us related to the research study. The HRA has no remit to investigate the clinical service provided by the Tavistock and Portman NHS Foundation Trust, where the research took place.
The investigation did not find any significant problems with the study or the research team, though it makes some suggestions which could help to prevent confusion in the future. These include better version labelling of documents used in research, and for researchers to consider carefully the terms used to describe studies. Overall the research team involved in the design and delivery of the study, worked in accordance with recognised practice for health research, and we find no cause for concern about the oversight of the study by the sponsor or Chief Investigator.
The report also recommends that the HRA reviews the requirement for research teams to produce annual progress reports, and how declarations of interest by REC members are managed and seen to be managed. Both of these pieces of work are underway, and the outcomes will be communicated on the HRA website.
The full report is available here.
The HRA is grateful to the individuals and organisations who raised concerns with us about this study. We are committed to protect and promote the interests of people taking part in health and social care research by reviewing how they are recruited, informed and cared for through the studies they take part in.