WORKING GROUP ON THE NBAC REPORT
RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS:
ETHICAL
ISSUES AND POLICY GUIDANCE
Lily Engstrom, M.S., Chair
Office of Science Policy
Office of
the Assistant Secretary for Planning and Evaluation
Carol Greene, M.D., Executive Secretary
Office of Science Policy
Office of the Assistant Secretary for Planning and Evaluation
William Freeman, M.D., M.P.H., C.I.P.
Director, IHS Research
Program
Chair, IHS IRB
Indian Health Service
Paul W. Goebel, Jr.
(Formerly) Senior Education Coordinator
Office for Human Research Protections
Office of Public Health and Science
Penny Kyler, MA, OTR
Public Health Analyst, Genetic Services
Branch
Maternal and Child Health Bureau
Health Resources and Services
Administration
Annette Levey, J.D.
Senior Attorney, NIH Branch, Public Health
Division
Office of the General Counsel
John Livengood, M.D., M. Phil.
Deputy Associate Director for
Science
Centers for Disease Control and Prevention
Marian Linde-Serge, R.N.
Nurse Consultant, Office of Compliance
Center for Devices and Radiological Health
Food and Drug Administration
Marie Mann, M.D., M.P.H.
Deputy Chief, Genetic Services Branch
Maternal and Child Health Bureau
Health Resources and Services
Administration
Malcolm Moos, M.D., Ph.D.
Medical Officer, Division of Cellular and
Gene Therapies
Center for Biologics Evaluation and Research
Food and
Drug Administration
Marva Moxey-Mims, M.D.
Medical Officer, Office of Device
Evaluation
Center for Devices and Radiological Health
Food and Drug
Administration
Philip Noguchi, M.D.
Director, Division of Cellular and Gene
Therapies
Center for Biologics Evaluation and Research
Food and Drug
Administration
Thomas Puglisi, Ph.D.
(Formerly) Director, Division of Policy and
Assurance
Office for Human Research Protections
Office of Public Health
and Science
Richard Riseberg, J.D.
Chief Counsel, U.S. Public Health
Division
Office of the General Counsel
Susan Sherman, J.D., M.H.S.
Senior Attorney, Public Health
Division
Office of the General Counsel
Mark E. Sobel, M.D., Ph.D.
(Formerly) Chief, Molecular Pathology
Section, Laboratory of Pathology
National Cancer Institute
National
Institutes of Health
The Working Group thanks John Fanning, L.L.B., Senior Policy Analyst, Office of the Assistant Secretary for Planning and Evaluation, Office of the Secretary, and Julie Kaneshiro, M.A., Policy Analyst, Office of Science Policy and Planning, Office of the Director, National Institutes of Health for providing important background information regarding the Privacy Act and the HIPAA medical privacy regulation.