ORI, OHRP find “some human subject issues” in Henschke lung cancer studies, but no evidence of misconduct

We have an update on two papers about lung cancer screening by Claudia Henschke and colleagues that were subject to an Expression of Concern early last year.

The original Expression of Concern in Cancer read, in part:

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.

Cancer referred the matter to the Office of Human Research Protection (OHRP). Apparently the OHRP as well as the Office of Research Integrity (ORI) have completed their investigations, and have decided to close the case. Here’s the “Follow-up to expression of concern,” which ran on April 6:

On January 4, 2012, we published an Editorial Expression of Concern regarding the following articles:

“Early Lung Cancer Action Project: Overall Design and Findings From Baseline Screening” by Claudia I. Henschke (Cancer. 2000 Dec 1;89(11 Suppl):2474-82).

“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, Olli S. Miettinen (Cancer. 2001 Jul 1;92(1):153-9).

This Expression of Concern was 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 (WCMC) 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.

Because the information contained in the Review Committee’s report raised issues that could not be fully investigated by the journal, we referred the matter to the Department of Health and Human Services Office for Human Research Protections (OHRP).

We have now received a letter from the Department of Health and Human Services Office of Research Integrity (ORI) that reads, in part, as follows:

“OHRP has completed its review of concerns at the Weill Cornell Medical College (WCMC) and has provided copies of its correspondence with officials at WCMC. The questions posed by OHRP and the responses provided by WCMC establish to ORI’s satisfaction that although there were some human subject issues that occurred (and have been addressed), there was a lack of evidence of possible research misconduct in the form of falsification or fabrication of data on the part of the study investigators. Therefore, ORI has concluded that further review of this matter is not warranted.”

Accordingly, the Journal is issuing this follow-up to our Expression of Concern.

Fadlo R. Khuri, MD
Editor-in-Chief

When we reported on this case in January 2012, the 2000 paper had been cited 62 times, according to Thomson Scientific’s Web of Knowledge, while now it has been cited 71. Cites for the 2001 paper grew from 267 to 279.