FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 25, Number 15, May 10, 1996 P.T. 34 Keywords: Ethics/Values in Science & Technol Grants Administration/Policy+ Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made final findings of scientific misconduct in the following case: Andrew Friedman, M.D., Harvard Medical School: Based on a report from Harvard Medical School and Dr. Friedman's admission, ORI found that Andrew Friedman, M.D., former Harvard Medical School Associate Professor of Obstetrics, Gynecology, and Reproductive Biology at the Brigham and Women's Hospital, committed scientific misconduct by falsifying and fabricating data in research supported in part by a Public Health Service (PHS) grant to the Brigham and Women's Hospital General Clinical Research Center. Between 1992 and 1995, Dr. Friedman altered and fabricated information in permanent patient medical records and notes by changing dates, changing and adding text, and fabricating notes for clinical visits that did not occur. Dr. Friedman admitted that he had falsified and fabricated approximately 80 percent of the data in research reports published in Fertility and Sterility (Friedman, A.J. and Thomas, P.P. "Gonadotrophin-releasing hormone agonist plus estrogen-progestin 'add-back' therapy for endometriosis-related pelvic pain." Fertility and Sterility 30:236-41, 1993.), in Obstetrics and Gynecology (Friedman, A.J. and Thomas P.P. "Does low- dose combination oral contraceptive use affect uterine size or menstrual flow in premenopausal women with leiomyomas?" Obstetrics and Gynecology, pp. 631-635, 1995.), and in an unpublished manuscript. Dr. Friedman has entered into a Voluntary Exclusion Agreement with ORI in which he has voluntarily agreed: (1) to exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement transactions (e.g., grants and cooperative agreements) of the United States Government, as defined in 45 C.F.R. Part 76 and 48 C.F.R. Subparts 9.4 and 309.4 (Debarment Regulations) for a period of three years beginning April 19, 1996; (2) that for a period of two years immediately following the three year voluntary exclusion above, any institution that submits an application for PHS support for a research project on which Dr. Friedman's participation is proposed or that uses him in any capacity on PHS supported research must concurrently submit a plan for supervision of his duties; the supervisory plan must be designed to ensure the scientific integrity of Dr. Friedman's research contribution, and the institution must submit a copy of the plan to ORI; and (3) to exclude himself 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 three years beginning April 19, 1996. The voluntary exclusion in (1) above shall not apply to Dr. Friedman's future training or practice of clinical medicine whether as a medical student, resident, fellow, or licensed practitioner, as the case may be, unless that practice involves research or research training. A statement retracting the article entitled "Gonadotrophin-releasing hormone agonist plus estrogen-progestin 'add-back' therapy for endometriosis-related pelvic pain." (Fertility and Sterility 30:236- 41, 1993) has been published in Fertility and Sterility (65(1):211, January 1996), and a statement retracting the article entitled "Does low-dose combination oral contraceptive use affect uterine size or menstrual flow in premenopausal women with leiomyomas?" (Obstetrics and Gynecology, pp. 631-635, 1995) has been published in Obstetrics and Gynecology (85(5):728, November 1995). INQUIRIES For further information, contact: Director, Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 .
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