Office of the Secretary December 7, 2006 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Jennifer Blaisdell, University of Pennsylvania and Retinal Consultants of Arizona, Ltd.: Based on the report of an investigation conducted by the University of Pennsylvania (UP) and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Ms. Jennifer Blaisdell, former Clinical Coordinator for Retinal Consultants of Arizona, Ltd. (RCA), committed research misconduct in a study sponsored by two cooperative agreements funded by the National Eye Institute (NEI), National Institutes of Health (NIH): U10 EY012261, ``Age-related Macular Degeneration Prevention Trial,'' Dr. Stuart Fine, Principal Investigator (P.I.), and U10 EY012279, ``Coordinating Center for AMD, Complications of Age- Related Macular Degeneration Prevention Trial'' (CAPT), Dr. Maureen McGuire, P.I. Specifically, PHS found that Ms. Blaisdell knowingly and intentionally committed research misconduct by: 1. Fabricating a CAPT data form dated 5/29/02 reporting a 30-month telephone follow-up visit with patient 01-026; this patient died on 5/ 3/02; 2. Fabricating a CAPT data form dated 2/20/03 reporting a 43-month telephone follow-up visit with patient 01-019; this patient died on 2/ 10/03; 3. Falsifying a CAPT data form dated 2/13/01 reporting a visit to the clinic on that date for patient 01-049; this patient's visit was 2/ 20/01; 4. Falsifying the CAPT form for patient 01-055 dated 4/11/01, when no clinic visit took place, by substituting information purportedly obtained at a non-study visit on 2/28/01. Ms. Blaisdell has entered into a Voluntary Exclusion Agreement in which she has voluntarily agreed, for a period of two (2) years, beginning on November 14, 2006: (1) 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; and (2) That any institution that submits an application for PHS support for a research project on which Ms. Blaisdell's participation is proposed or which uses her in any capacity on PHS supported research, or that submits a report of PHS-funded research in which she is involved, must concurrently submit a plan for supervision of Ms. Blaisdell's duties to the funding agency for approval. The supervisory plan must be designed to ensure the scientific integrity of her research contribution. Ms. Blaisdell also agrees to ensure that the institution submits a copy of the supervisory plan to ORI. She further agrees that she will not participate in any PHS- supported research until such a supervisory plan is submitted to ORI.