Norway: Researchers Slammed for Secretive Study on Transgender Patients

Regional ethics committee rules the clinic’s work was unlawful research, not mere quality checks, and says patient consent was required — the case can still be appealed.

A storm has erupted around Norway’s national gender incongruence clinic after regional ethics bosses found clinicians conducted unauthorised research on trans patients using a sensitive internal register, not just routine quality control, a decision that could have wide repercussions for published papers and patient trust.

Staff at the Nasjonalt behandlingssenter for kjønnsinkongruens (NBTK) had insisted their work was quality assurance, not research, but the Regional Committees for Medical and Health Research Ethics (REK) concluded the project aimed to produce new knowledge from the start and therefore fell squarely under the Health Research Act.

The row centres on a five‑year quality register where clinicians collected highly sensitive data about patients’ mental health and treatment. REK accepts that setting up the register was lawful, but says using those data for the two academic papers in 2024 and 2025 amounted to research that should have had prior ethical approval and informed consent from participants.

REK’s verdict is blunt: after‑the‑fact approval cannot be granted. The committee points out that the researchers themselves described the work as contributing new knowledge, received research funding, and included the material in a doctoral project — all signs the activity was research from the outset.

Patient groups reacted with relief and anger. Anine Hartmann of the Patient Organisation for Gender Incongruence called the ruling «a crushing condemnation» and said it should not be patients’ job to police research ethics — she urged authorities to ensure this never happens again. REK also highlighted that several people said they recognised themselves in the published articles, underlining the risk to participant integrity when sensitive records are used without active consent.

Oslo University Hospital, speaking for the researchers, said it has received REK’s decision and will consider next steps, including the right to appeal. The hospital stressed that projects on the border between quality work and research can be difficult to classify and that staff acted in good faith based on earlier assessments.

What happens next is procedural but significant. The researchers have three weeks to appeal to REK; if REK upholds its ruling the case moves to the National Research Ethics Committee for Medicine and Health Sciences (NEM), which could forward findings to supervisory bodies such as the Health Inspectorate or Data Protection Authority if warranted. Journals that published the contested articles and the hospital’s own integrity panel may also decide whether the papers should be retracted or corrected.

Key facts to note: REK found the project was research from the start, after‑the‑fact approval denied, and patient consent should have been obtained — a ruling that leaves the clinic facing reputational damage and possible formal sanctions while the appeals process unfolds.