Barbara Mishkin's practice focuses on matters relating to the federal regulation of biomedical research, particularly scientific misconduct, research involving human subjects, care and use of laboratory animals, conflicts of interest, university/industry relations, and grants administration.
Prior to joining Hogan & Hartson, Barbara served as Deputy Director of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research from 1980 to 1983. Her previous positions at the U.S. Department of Health, Education, and Welfare included: Staff Director, HEW Ethics Advisory Board; Assistant Staff Director, National Commission for the Protection of Human Subjects; and Research Psychologist, Section on Neuropsychology, National Institute of Mental Health. Barbara has also served as Special Assistant for Health Sciences to The Honorable David L. Bazelon (then, Chief Judge, U.S. Court of Appeals, D.C. Circuit).
Barbara has written and lectured extensively on the regulation of biomedical research, scientific misconduct, and biomedical ethics, and is a frequent consultant to the federal government on legislative and regulatory matters.
- Counseled several universities and research institutes during government investigations concerning research involving human subjects or the care and use of laboratory animals.
- Provided regulatory assistance in defending the Fred Hutchinson Cancer Research Center and four of its physicians against claims, including lack of informed consent, conflicts of interest, and various torts related to bone marrow clinical trials conducted in the mid-1980s to the early 1990s. The jury returned a verdict for the defense on April 8, 2004 (with the exception of one claim involving a defective device).
- Successfully appealed a qui tam case on behalf of the University of Alabama, Birmingham and four of its faculty, arising from allegations of scientific misconduct. United States ex rel. Berge v. Univ. of Alabama, et al., 104 F.3d 1453 (4th Cir.), cert. denied, 522 U.S. 916 (1997).
- Conducted performance audits for dozens of universities and research institutes to assess compliance with federal regulations governing research with human subjects.
- Conducted performance audits for a number of research entities to assess compliance of institutional policies and procedures with federal rules governing the care and use of laboratory animals.
01 March 2002
"Federal Research Compliance: Biomedical & Research Integrity Issues." Briefing Papers No. 02-4, West Group
- Pharmaceutical and Biotechnology
- Government Contracts
- Litigation, Arbitration and Employment
- Life Sciences and Healthcare
Areas of Focus
- Federal Regulation of Biomedical Research
- Research Involving Human Subjects and Animals
- Scientific Misconduct
- Conflicts of Interest
- J.D., cum laude, American University Washington College of Law, 1981
- M.A., Yale University, 1958
- A.B., cum laude, Mount Holyoke College, 1957
- Fellow, American Association for the Advancement of Science (AAAS)
- Former Chair, Committee on Regulating Research, American Bar Association (ABA)
- Former Co-Chair, National Conference of Lawyers and Scientists, AAAS/ABA
- Former Committee Member, Program on Scientific Freedom and Responsibility, AAAS
- Former Contributing Editor, AAAS Professional Ethics Report
- Former Trustee, Mount Holyoke College
- Former Member, Board of Managers, Bon Secours Health System, Inc.
- Former Board Member, Hebrew Home of Greater Washington
- Former Vice-Chair, Legal Counsel for the Elderly
- Former Chair, Health and Environmental Rights Committee, ABA
- The Health Improvement Institute's Life-time Achievement Award for Excellence in Human Research Protection, 2004
- Who's Who in America
- Who's Who in American Law
- Who's Who in American Women
- Who's Who in the World
- Pro Bono Attorney of the Year, District of Columbia Bar, 1988
Bar Admissions/ Qualifications
- U.S. Court of Appeals, Fourth Circuit
- U.S. Supreme Court