Here's the text of Wendy's letter, with her permission:
RESTORING STUDY 329
Open access as a requirement for research ethics committee approval
Wendy Rogers professor of clinical ethics, Department of Philosophy, Macquarie University, Sydney, NSW 2109, Australia
Restoring Study 329 has important implications for research ethics.1 Whether clinical trials are considered ethical depends on risk to participants, merit and integrity of the research, potential benefits, whether and how potential participants are respected and offered informed choices, and how justice requirements are met.2 The merit and integrity of the research are linked to potential benefits: high quality research produces valid and reliable results to inform the care of future patients.
This ethical rationale for clinical research was turned on its head by the original study 329. The research was not conducted with integrity, creating unreliable results that led to unquantified harms to future patients. Participants were not respected; instead their data were used for marketing purposes. We do not know how many would have agreed to participate if this aim had been explicit in the information provided before seeking informed consent. Rather than serving the greater good, the original study served financial interests.
Restoring Study 329 is both encouraging and deeply dismaying: encouraging because it shows how a few extremely motivated people can expose research misconduct; dismaying because the ground has shifted. We can no longer be confident in the findings of existing clinical research, but the task of reanalysing trials seems herculean. However, a phoenix may rise from these ashes. Perhaps we now have enough evidence to demand open access to protocols and data as the new norm. Open access could be a requirement for approval by human research ethics committees. Such a proposal might restore confidence in clinical research and ensure that when patients enrol in research for the greater good, there is some chance that good will come to pass.
Competing interests: I have previously published with Jon Jureidini and Melissa Raven and have an ongoing project with them. I am on the Advisory Board of the Critical and Ethical Mental Health research cluster in the Robinson Institute at the University of Adelaide, where Prof Jureidini and Dr Raven are based.
Full response at:
www.bmj.com/content/351/bmj.h4320/rr.
1 Le Noury J, Nardo JM, Healy D, et al. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ 2015;351:h4320. (16 September.)
2 National Health and Medical Research Council. National statement on ethical conduct in human research. 2007; updated 2015.
www.nhmrc.gov.au/guidelines-publications/e72.
Cite this as: BMJ 2015;351:h5299 © BMJ Publishing Group Ltd 2015
