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October 20, 2010

Making Research Consent Transparent

Author Affiliations

Author Affiliation: Office for Human Research Protections, Rockville, Maryland.

JAMA. 2010;304(15):1713-1714. doi:10.1001/jama.2010.1492

There is increasing appreciation of the negative consequences that flow from secrecy in clinical research.1 Concern that the integrity of the system might be at risk has led to increased transparency via a number of important reforms, including the US requirement that most drug and device clinical trials must be registered in a public database.2 However, an important aspect of clinical trials—the ethical requirement to obtain a research participant's informed consent—seldom is widely available for public scrutiny. Taking steps to make that aspect of clinical trials more transparent may have several important advantages.