Cancer is publishing an Editorial Expression of Concern regarding the following articles:
“Early Lung Cancer Action Project: Initial Findings on Repeat Screenings” by Claudia I. Henschke, David P. Naidich, David F. Yankelevitz, Georgeann McGuinness, Dorothy I. McCauley, James P. Smith, Daniel Libby, Mark Pasmantier, Madeline Vazquez, June Koizumi, Douglas Flieder, Nasser Altorki, and Olli S. Miettinen (Cancer. 2001;92:153-159).
This Expression of Concern is based on an April 29, 2011, article in The New York Times as well as the April 29, 2011, issue of The Cancer Letter, both of which disclosed details of a report of an Independent Scientific Review Committee (Review Committee) convened by Weill Cornell Medical College to investigate the scientific research conducted as part of the International Early Lung Cancer Action Program (I-ELCAP). The Review Committee reported, among other things, that the I-ELCAP lacked positive confirmation of valid informed consent for all subjects at all sites by the coordinating center.
The information contained in the Review Committee's report raises issues that cannot be fully investigated by the journal. We have therefore referred this matter to the Department of Health and Human Services Office for Human Research Protections.
Based on the information we have received thus far, we are issuing this Expression of Concern to alert our readers.
In addition, we would like to point readers to the Publisher's Note published in Cancer online on April 11, 2008 (available at: http://onlinelibrary.wiley.com/doi/10.1002/cncr.23540/pdf), which included additional disclosures made by Dr. Henschke that directly relate to these articles.