New England Journal of Medicine
September 5, 2013  Vol. 369 No. 10
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Risks (and Benefits) in Comparative Effectiveness Research Trials
Chris Feudtner, M.D., Ph.D., M.P.H., Mark Schreiner, M.D., and John D. Lantos, M.D.
N Engl J Med 2013; 369:892-894September 5, 2013DOI: 10.1056/NEJMp1309322
http://www.nejm.org/doi/full/10.1056/NEJMp1309322

To provide ethically appropriate oversight and informed consent for randomized, controlled comparative effectiveness research trials, investigators should consider, manage, and inform potential participants about at least nine different types of potential risk.