1. Glasziou P, Scott AM, Chalmers I, et al. Improving research ethics review and governance can improve human health. (under review).
Google Scholar2. Chalmers, I . Regulation of therapeutic research is compromising the interests of patients. Int J Pharmaceut Med 2007; 21: 395–404.
Google Scholar |
Crossref3. Chalmers, I . Well informed uncertainties about the effects of treatments. BMJ 2004; 328: 475–476.
Google Scholar |
Crossref |
Medline4. General Medical Council. Good Medical Practice. London: GMC, 2006.
Google Scholar5. Roberts, I, Chaudhry, B, Chalmers, I. New GMC guidance takes a major, ethically flawed, backward step. BMJ 2013; 346: f3879–f3879.
Google Scholar |
Crossref |
Medline6. Roberts, I, Chaudhry, B, Chalmers, I. Importance of ‘acknowledging and reducing treatment uncertainty’ in appraisal and revalidation. BMJ 2014; 348: g2851–g2851.
Google Scholar |
Crossref |
Medline7. Al-Shahi Salman, R, Beller, E, Kagan, J, et al. Increasing value and reducing waste in biomedical research regulation and management. Lancet 2014; 383: 176–185.
Google Scholar |
Crossref |
Medline |
ISI8. Hemminki, E . Actors involved in the regulation of clinical research: comparison of Finland to England, Canada, and the USA. Health Res Policy Syst 2015; 13: 20–20.
Google Scholar |
Crossref |
Medline9. Hemminki, E . Research ethics committees in the regulation of clinical research: comparison of Finland to England, Canada, and the United States. Health Res Policy Syst 2016; 14: 5–5.
Google Scholar |
Crossref |
Medline10. Hemminki, E, Virtanen, JI, Veerus, P. Varying ethics rules in clinical research and routine patient care – research ethics committee chairpersons' views in Finland. Health Res Policy Syst 2014; 12: 15–15.
Google Scholar |
Crossref |
Medline11. Scott, AM, Kolstoe, S, Ploem, MCC, et al. Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands. Health Res Policy Syst 2020; 18: 11–11.
Google Scholar |
Crossref |
Medline12. Abbott, L, Grady, C. A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn. J Empir Res Hum Res Ethics 2011; 6: 3–19.
Google Scholar |
SAGE Journals |
ISI13. Nicholls, SG, Hayes, TP, Brehaut, JC, et al. A scoping review of empirical research relating to quality and effectiveness of research ethics review. PLoS One 2015; 10: e0133639–e0133639.
Google Scholar |
Crossref |
Medline |
ISI14. Glasziou P and Chalmers I. Ethics review roulette: what can we learn? BMJ 2004; 328: 121–122.
Google Scholar15. Klitzman, R, Appelbaum, PS, Murray, A, et al. When IRBs say no to participating in research about single IRBs. Ethics Hum Res 2020; 42: 36–40.
Google Scholar |
Crossref |
Medline16. Petrova, M, Barclay, S. Research approvals iceberg: how a ‘low-key’ study in England needed 89 professionals to approve it and how we can do better. BMC Med Ethics 2019; 20: 7–7.
Google Scholar |
Crossref |
Medline17. Smithells, RW . Iatrogenic hazards and their effects. Postgrad Med J 1975; 51 Suppl 2: suppl 15:39–52.
Google Scholar |
Medline18. Lantos, J . Ethical issues. How can we distinguish clinical research from innovative therapy? Am J Pediatr Hematol Oncol 1994; 16: 72–75.
Google Scholar |
Medline19. Pappworth MH. Human Guinea Pigs: Experimentation on Man. Abingdon on Thames: Routledge and Kegan Paul, 1967.
Google Scholar20. Pappworth, MH . “Human guinea pigs” – a history. BMJ 1990; 301: 1456–1460.
Google Scholar |
Crossref |
Medline21. Chalmers I and Lindley R. Double standards on informed consent to treatment. In: Doyal L, Tobias JS (eds) Informed Consent in Medical Research. London: BMJ Books, 2001: 266–275.
Google Scholar22. Chalmers, I, Silverman, WA. Professional and public double standards on clinical experimentation. Control Clin Trials 1987; 8: 388–391.
Google Scholar |
Crossref |
Medline23. Pappworth, MH . Medical ethical committees: a review of their functions. World Med 1978; 13: 19–78.
Google Scholar24. Chalmers I. Medical experimentation. World Med 5 April, 1978; p. 18.
Google Scholar25. Chalmers, I . Human guinea pigs. BMJ 1991; 302: 411–411.
Google Scholar |
Crossref26. Chalmers, I, Smeeth, L, Goldacre, B. Personalised medicine using N-of-1 trials: overcoming barriers to delivery. Healthcare (Basel) 2019; 7: 134–134.
Google Scholar |
Crossref27. Mirza R, Punja S, Vohra S, et al. The history and development of N of 1 trials. JLL Bulletin: Commentaries on the history of treatment evaluation. See
www.jameslindlibraryorg/articles/history-development-n-1-trials/ (2017, last accessed 24 September 2021).
Google Scholar28. Scott AM, Chalmers I, Barnett A, et al. ‘The ethics approval took 20 months on a trial which was meant to help terminally ill cancer patients. In the end we had to send the funding back': a survey of views on human research ethics reviews. J Med Ethics 2021 2021/01/13. DOI: 10.1136/medethics-2020-106785.
Google Scholar29. van Staa, TP, Dyson, L, McCann, G, et al. The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials. Health Technol Assess 2014; 18: 1–146.
Google Scholar |
Crossref |
Medline |
ISI30. Savulescu, J, Chalmers, I, Blunt, J. Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. BMJ 1996; 313: 1390–1393.
Google Scholar |
Crossref |
Medline31. Chalmers, I, Glasziou, P. Avoidable waste in the production and reporting of research evidence. Lancet 2009; 374: 86–89.
Google Scholar |
Crossref |
Medline |
ISI32. Evans I, Thornton H, Chalmers I, et al. Testing Treatments: Better Research for Better Healthcare. 2nd edn. London: Pinter & Martin, 2011.
Google Scholar33. Chalmers, I, Bracken, MB, Djulbegovic, B, et al. How to increase value and reduce waste when research priorities are set. Lancet 2014; 383: 156–165.
Google Scholar |
Crossref |
Medline |
ISI34. Goldacre, B, DeVito, NJ, Heneghan, C, et al. Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource. BMJ 2018; 362: k3218–k3218.
Google Scholar |
Crossref |
Medline35. Clarke M. The ethical requirement for systematic reviews for randomized trials. In: Ashcroft RE, Dawson A, Draper H, et al. (eds) Principles of Health Care Ethics Chichester: Wiley, 2007: 697–701.
Google Scholar36. Ashcroft RE. The ethics and governance of medical research. In: Ashcroft RE, Dawson A, Draper H, et al. (eds) Principles of Health Care Ethics. Chichester: Wiley, 2007: 681–687.
Google Scholar37. Roberts, I, Prieto-Merino, D, Shakur, H, et al. Effect of consent rituals on mortality in emergency care research. Lancet 2011; 377: 1071–1072.
Google Scholar |
Crossref |
Medline |
ISI38. Wilkinson D. Please Randomize Me – But Don’t Tell my Family that You Did. See
http://blog.practicalethics.ox.ac.uk/2014/08/please-randomize-me-but-dont-tell-my-family-that-you-did/ (2021, accessed 21 August 2014).
Google Scholar39. Shah A and Coleman MP. Increasing incidence of childhood leukaemia: a controversy re-examined. Br J Cancer 2007; 97: 1009–1012.
Google Scholar40. Ashcroft, R . Giving medicine a fair trial. Trials should not second guess what patients want. BMJ 2000; 320: 1686–1686.
Google Scholar |
Crossref |
Medline41. Meyer, MN, Heck, PR, Holtzman, GS, et al. Objecting to experiments that compare two unobjectionable policies or treatments. Proc Natl Acad Sci 2019; 116: 10723–10728.
Google Scholar |
Crossref |
Medline42. Collins, R, Bowman, L, Landray, M, et al. The magic of randomization versus the myth of real-world evidence. N Engl J Med 2020; 382: 674–678.
Google Scholar |
Crossref |
Medline43. Ashcroft RE, Dawson A, Draper H, et al. Principles of Health Care Ethics. Chichester: Wiley, 2007.
Google Scholar44. Bolland, MJ, Avenell, A, Grey, A. Assessment of research waste part 1: an exemplar from examining study design, surrogate and clinical endpoints in studies of calcium intake and vitamin D supplementation. BMC Med Res Methodol 2018; 18: 103–103.
Google Scholar |
Crossref |
Medline45. Joseph, PD, Caldwell, PH, Barnes, EH, et al. Completeness of protocols for clinical trials in children submitted to ethics committees. J Paediatr Child Health 2019; 55: 291–298.
Google Scholar |
Crossref |
Medline46. Paludan-Müller, AS, Ogden, MC, Marquardsen, M, et al. Do protocols for new randomised trials take previous similar trials into account? Cohort study of contemporary trial protocols. BMJ Open 2019; 9: e026661–e026661.
Google Scholar |
Crossref |
Medline
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