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  • IRB: ETHICS & HUMAN RESEARCH

Clarification, Continued

We appreciate the letter submitted by Zarin and Tse (“Clarification about ClnicalTrials.gov,” May-June 2013) in response to our article, “The Presidential Bioethics Commission’s Database of Human Subjects Research” (March-April 2013), and agree that reporting project-level data to ClinicalTrials.gov is one way in which federal departments and agencies could implement the commission’s recommendation for improved accountability through public access to data about federally supported human subjects research. Indeed, as the commission noted in its report, Moral Science: Protecting Participants in Human Subjects Research, “[f]or agencies without existing systems today, data could be submitted to ClinicalTrials.gov or another existing online registry, provided the core data elements are available (p.52).” ClinicalTrials.gov collects more data than legally required. It is an expansive database that could serve a central role in implementing the commission’s recommendation. What remains necessary is the will to mandate reporting of a core set of data elements—title, investigator, location, and funding source and amount—for all federally supported human subjects research, as the commission recommended. Only then, as Zarin and Tse observe, can we continue to build on the “enormous opportunities for assessing and improving ethical and scientific oversight of human research (p. 19).”

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The Hastings Center has never shied away from the toughest ethical challenges faced by society.

LET US SHARE OUR EXPERIENCES WITH YOU!

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