Declaration of Helsinki

Since the fi rst version of the Declara-tion of Helsinki (DoH) was adopted in 1964, it has been revised nine times and numerous other bodies have promulgated ethics guidance documents. During this same period, scientifi c research with hu-man subjects has dramatically increased in size, scope, and importance. If the DoH is to continue to play a signifi cant role in regulating the research enterprise, it must convincingly convey a coherent, if highly general, view of the research enterprise and the basic normative requirements nec-essary to preserve its integrity and protect the rights and welfare of participants. In what follows, I argue that the emphasis in the DoH on detailed prescriptive require-ments untethered from general justifi ca-tory grounds means that it is particularly dependent on readers to supply underlying normative justifi cations. Without these normative grounds, its provisions might appear inconsistent, unfounded, or arbi-trary. To make this argument, I provide a read-ing of several revised passages in the 2013 DoH. Th is reading draws on a normative framework that emphasizes a particular view of the proper division of labor be-tween research and medical and public health systems and the threat that biased or poor quality research poses to those systems. It also treats various provisions of the DoH as helping to provide a pub-lic assurance to stakeholders that the re-search enterprise functions as a system of mutually benefi cial social cooperation in which all parties are respected as free and equal contributors [1]. Although these commitments are not expressed within the DoH itself, this reading illustrates strengths and weakness of the new docu-ment and highlights areas for improve-ment. Integrity of Scientifi c Informatio