ReviewJournal of the Royal Society of Medicine2016
The revised Declaration of Helsinki: cosmetic or real change?
Review in Journal of the Royal Society of Medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
32 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A worldwide itinerary of research ethics in science for a better social responsibility and justice: a bibliometric analysis and review.Frontiers in research metrics and analytics · 2025Pooled it
- Evolving ethos of medical research: A retrospective analysis of the declaration of Helsinki (1964-2024).World journal of methodology · 2025Review
- Laparoscopic ultrasound versus intraoperative gastroscopy for tumor localization in laparoscopic gastrectomy: a comparative cohort study.BMC surgery · 2025Article
- Size of Biceps Femoris Long Head Muscle Is Related to Running Economy in Male Recreational Runners.Sports (Basel, Switzerland) · 2025Article
- The Effect of Shoulder Joint Isokinetic Muscle Strength, Endurance and Proprioception on Swimming, Agility and Sprint Performance in Water Polo Players.Journal of musculoskeletal & neuronal interactions · 2025Article
- Chasing 'vulnerability' across six decades of the Declaration of Helsinki.Monash bioethics review · 2025Article
- Preoperative predictors of unplanned conversion in laparoscopic liver resection: a multicenter cohort analysis.Frontiers in oncology · 2025Article
- Integration of Surgical and Coagulation Risk Factors for Predicting Postoperative Pulmonary Embolism in Thoracic Surgery: A Multi-Center Retrospective Study.International journal of general medicine · 2025Article
- Preliminary screening of new biomarkers for sepsis using bioinformatics and experimental validation.PloS one · 2025Article
- Reporting ethical approval in case reports and case series in 12 consecutive years: A systematic review.Health care science · 2024Review
- Exploring the influencing factors of patient safety competency of clinical nurses: a cross-sectional study based on latent profile analysis.BMC nursing · 2024Article
- Patterns of information literacy and their predictors among emergency department nurses: a latent profile analysis based on the person-context interaction theory.BMC nursing · 2024Article
- Causes and predictors of unplanned reoperations within 30 days post laparoscopic pancreaticoduodenectomy: a comprehensive analysis.Frontiers in oncology · 2024Article
- Hepatic Arterial Infusion Chemotherapy Combined Lenvatinib and PD-1 Inhibitor Showed Improved Survival for Infiltrative Hepatocellular Carcinoma: A Multicenter Cohort Study.Journal of hepatocellular carcinoma · 2024Article
- A preliminary study of optimal treatment response rates in patients undergoing hepatic arterial infusion chemotherapy combined with molecular targeting and immunotherapy.Frontiers in immunology · 2024Article
- The association between blood, urine, respiratory, neurobehavioral parameters and occupational exposure to organophosphorus pesticides: a cross-sectional study among formulators.African health sciences · 2022Article
- Robustness of Propofol and Sevoflurane on the Perioperative Immune Function of Patients Undergoing Laparoscopic Radical Nephrectomy.Journal of oncology · 2022Article
- Clinical Efficacy of Tuomin Zhiti Decoction in Allergic Rhinitis.Evidence-based complementary and alternative medicine : eCAM · 2022Article
- Effect of Shenqi Fuzheng Injection on Leukopenia and T-cell Subsets in Patients with Non-small Cell Lung Cancer Undergoing Radiotherapy.Evidence-based complementary and alternative medicine : eCAM · 2022Article
- Study on Correlation between Type 2 Diabetes and No-Reflow after PCI.Disease markers · 2022Article
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The Declaration of Helsinki, adopted by the World Medical Association's General Assembly in 1964, is the most important set of guidelines about research on human participants. It both reflects and shapes the ethos of international research ethics. It is a living instrument and is reviewed and revised regularly. Its latest revision was in 2013. There are four substantial changes, reflected in the new Paragraph 15 (which deals with compensation for trial related injuries), Paragraph 33 (relating to placebos), Paragraph 20 (relating to vulnerable groups) and the new Paragraph 34 (relating to post-trial provisions). This article analyses these changes, and asks whether they indicate any shift in the overall philosophy of the Declaration. We conclude that these changes, though significant, are not tectonic. They accord with the spirit that has motivated the Declaration through all its iterations, and indicate a steady, incremental evolution towards a holistic code of research ethics for research on human participants. Patient autonomy, though crucial, is no longer the only concern of the Declaration; distributive justice and beneficence are motivating forces too. While the Declaration is aware of the need to facilitate research, it is equally aware of the need to protect the vulnerable, and of the practical difficulties involved in that protection.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.