Department of Health and Human Services October 13, 2011 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Nicola Solomon, Ph.D., University of Michigan Medical School: Based on an investigation conducted by the University of Michigan Medical School (UMMS) and a preliminary analysis conducted by ORI, ORI found that Dr. Nicola Solomon, former postdoctoral scholar, Department of Human Genetics, UMMS, engaged in research misconduct in research supported by the National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), grants R37 HD030428 and R01 HD034283. Specifically, the Respondent did not perform DNA sequencing on 202 cDNA clones of homeobox genes to confirm their identity and integrity. Through multiple revision of the manuscript, the Respondent did not discuss this with the corresponding author or question and correct the corresponding author's addition of text indicating that the clones had been fully sequenced and were full length or longer (as indicated in Table 3) when compared to NCBI Mus musculus Unigene. This text supported the use of the Cap-Trapper technique to produce full length clones for the discovery of new genes without polymerase chain reaction (PCR). Both the Respondent and the U.S. Public Health Service (PHS) are desirous of concluding this matter without further expenditure of time and other resources and have entered into a Voluntary Settlement Agreement to resolve this matter. This settlement is not an admission of liability on the part of the Respondent. Respondent and ORI agreed to settle this matter as follows: (1) Respondent agreed that for a period of two (2) years beginning on September 16, 2011, prior to the submission of an application for PHS support for a research project on which her participation is proposed in a research capacity, and prior to her participation in this capacity on PHS-supported research, Respondent shall ensure that a plan for supervising her duties is submitted to ORI for approval; the supervision must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agreed that she shall not participate as a researcher in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan; and (2) Respondent agreed to exclude herself from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant, for a period of two (2) years, beginning on September 16, 2011.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public meeting via teleconference. The meeting is open to the public.