Lenzer and Brownlee hit the nail on the head regarding the important issue of data access.1 We owe all human subjects who volunteer for behavioural and medical research more than they have been getting. For years, the top scientific journals have required that all clinical trials be publicly registered before data collection begins, in order to be eligible for publication. This was an important step designed to reduce publication bias, but it did not go far enough. The recent FDA Amendments Act mandating public access to data summaries is another step in the right direction, but, as Lenzer and Brownlee say, this too may not go far enough. Several examples from the psychopharmacology literature have shown that nothing short of total public access to raw human subject data on efficacy and safety will be enough to ensure that data are independently and thoroughly evaluated.2 3 Issues of distorted or selective publication continue to corrupt our ostensible scientific database.4 5
We urge all institutional review boards to require that, in exchange for the privilege of doing human subject research, researchers make their raw data (not just summaries of the data) accessible (without identifying information) within a reasonable period of time via the internet or in some other suitable fashion. We believe scientists owe this unfettered access to all participants who have ever volunteered for a scientific study with the hope, belief, and promise that their sacrifices would help science advance. We offer the following brief universal commitment to human subjects that can be used by any institutional review board in the world.
“I agree, in exchange for the privilege of doing research with human subjects, to not only register the trial in a publicly accessible clinical trials database, but also to make summaries of the primary results and the actual raw data internet accessible (without identifying information) within 1 year of collecting data on the last human subject, or within 2 years after the start of the study, whichever is sooner. This is my commitment to all human subjects who volunteer with the hope, expectation and promise that their efforts and sacrifices will result in independently verifiable contributions to science. I recognize that failure to follow through on this commitment may jeopardize approval for any future research protocols in which I may participate.”
Competing interests: See bmj.com
References
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