
Director, Office of Human Use and Ethics, Physician Scientist, Ethicist & Research Integrity Officer
Washington D.C. Metro Area

Director, Office of Human Use and Ethics, Physician Scientist, Ethicist & Research Integrity Officer
Washington D.C. Metro Area
Performance Objectives [2007 04-30 - Present]:
1. Director, Office of Human Use and Ethics and Research Integrity Officer: (a.) Participate in the development of Institute Policy on Ethics in Research. (b.) Nurture the Human Subjects Protection Program. (c.) Advise senior officials on ethics-sensitive issues that impact institute operations. (d.) Supervise the Human Protection Administrator and other office staff. (e.) Serve as the point of contact for HIPAA compliance. (f.) Conduct inquiries and investigations upon receipt of allegations of scientific misconduct or improper researcher behavior.
2. Member, Human Use Committee (IRB): (a.) Attend and participate in all convened IRB meetings. (b.) Prepare timely and intensive fact-finding reviews of minimal risk protocols that qualify for expedited review; (c.) Advise senior officials in writing of the approvability of protocols, and addenda; (d.) Conduct substantive continuing review of active protocols; (e.) Investigate issues arising during conduct of studies; and (f.) Participate in Local and National Meetings of Organizations whose focus is Protecting the Rights and Welfare of Human Volunteer Subjects.
3. Collaborating Investigator (a.) Design research protocols that elucidate the mechanisms of immunity for existing vaccines and second generation recombinant products, particularly the forms of immunity which are essential for protection against aerosol exposure. (b.) Consult with other investigators on technologies which may be applied to improve vaccine efficacy. (c.) Initiate intramural and extramural collaborations for novel research approaches to institute research programs.
Regulatory Affairs, Medical Research Oversight, International Medical Ethics Development, Research Integrity, Basic Immunology Research related to vaccines, Viral Pathogenesis
(Government Agency; 501-1000 employees; Research industry)
April 2007 — Present (1 year 6 months)
Director, Office of Human Use and Ethics and Research Integrity Officer: (a.) Participate in the development of Institute Policy on Ethics in Research. (b.) Nurture the Human Subjects Protection Program. (c.) Advise senior officials on ethics-sensitive issues that impact institute operations. (d.) Supervise the Human Protection Administrator and other office staff. (e.) Serve as the point of contact for HIPAA compliance. (f.) Conduct inquiries and investigations upon receipt of allegations of scientific misconduct or improper researcher behavior.
(Government Agency; 501-1000 employees; Research industry)
1986 — Present (22 years)
According to principles discussed at PRIM&R and Promulgated by Accreditation Standards of AAHRPP, my office oversees the institute Human Research Protection Program
(Research industry)
July 1992 — March 2007 (14 years 9 months)
a. Maintained an outstanding clinical laboratory, accredited by the College of American Pathologists according to CLIA88 standards, that supported patient care, clinical research involving human subjects and preclinical studies of products in animal models. b. Engaged Clinical Laboratory Personnel in development, testing and validation of new diagnostic tests according to CAP/CLIA88 and FDA medical device standards. c. Provided effective communication and quality control review for reporting the results of research diagnostics during epidemics and occurrences requiring institute participation.
(Government Agency; 501-1000 employees; Research industry)
July 1983 — July 1996 (13 years 1 month)
The Department of Respiratory and Mucosal Immunity developed and tested candidate vaccines for protection against aerosol disseminated pathogens, and studied adjuvants and recombinant antigens to continue to improve protection by vaccines prior to advanced development.
With Kouji Matsushima & Chris Larsen, identified the first chemokine IL-8 (1989 Science 243 1464-1466) and & the 2nd MCP-1 (1990 J.Exp.Med. v171 p2177) in what would become an entirely new field of immunology, inflammation and infectious diseases.
The fibroblastic reticular cell conduit FRCC which I briefly described in 1975 (Amer. J. Path. 80:387-418) provided a novel mechanism for distribution of soluble antigens and/or chemokines to HEV and DC in lymph nodes. The role of the FRCC in immunity was further elaborated by J Elizabeth Gretz and Stephen Shaw at NCI whose collaboration brought the observation into the 21st century where its function in transporting chemokines and <70KDa solutes was discovered.
(Educational Institution; 1001-5000 employees; Research industry)
1980 — 1983 (3 years)
I held joint appointments at the University. My primary appointment was in the Department of Pathology in the Medical School where I instructed Residents Autopsy Pathology, Held Medical Pathology Conferences with various Medical and Surgical Services and reviewed and signed out autopsy cases with my residents. My secondary appointment was in the Biology Department of the Faculty of Arts and Sciences. It was here that I did laboratory research on basic mechanisms of Mucosal Immunity along with my Biology Chairman, Dr. John Cebra and his graduate and postdoctoral students. I collaborated with scientists in the department of surgery, and served as an advisor to the Rotavirus Vaccine Project in the Wistar Institute. I conducted pathology tutorials, taught the sections on cardiovascular, endocrine and lymphatic systems in Biology 101/102, I lectured on the lymphatic system in Immunology 404, and I had my own advanced undergraduate course in Immunology Methods.
(Government Agency; 201-500 employees; Research industry)
July 1974 — June 1980 (6 years)
Created a research program aimed at discovery and development of molecularly-defined adjuvants for enhancing vaccine immunogenicity and effectiveness based on the hypothesis that materials that increase the rate of lymphocyte recirculation through lymph nodes would stochastically increase an immune response to vaccine by exposing more migrating cells to antigen presenting cells.
This work stimulated research in: a. Molecular Mechanisms of lymphocyte homing and recirculation; b. the role of chemotaxis in lymphocyte homing and recirculation; c. the role of angiogenesis in immunity and inflammatory conditions, especially high endothelial venules; d. discovered the Fibroblastic Reticular Conduit function while studying lymph node vasculature in 1975.
The program also identified a family of molecules in leukocyte dialysates (molecules that were less than 10 KDa) as being a source of chemotactic factors that regulated traffic of lymphocytes in lymph nodes.
(Educational Institution; 1001-5000 employees; Research industry)
1970 — 1974 (4 years)
Residency training in anatomic pathology, surgical pathology and cytology. My concentration was in Medical Biopsies, especially Renal, Gut and Liver. During elective research, I developed a transplantation research program under Dr. Norman D. Anderson that involved electron microscopy, cytochemistry and immunohistochemistry of lymph nodes. This was part of a program project grant that explored the role of microvasculature in immune responses initiated by alloantigens released by transplanted tissues. These studies began my quest to understand lymphatic tissue microenvironments and the mechanisms that control lymphocyte recirculation and cell interactions within lymph nodes, spleen and mucosal lymphatic tissue.
(Educational Institution; 10,001 or more employees; Higher Education industry)
1969 — 1969 (less than a year)
In 1968 I examined an emaciated patient at Baltimore City Hospital before her 50 lb ovarian cyst was removed surgically. I drew her standing naked by the bed. This drawing and one I made of the cyst at surgery were kept in her chart. Seven months later she saw Dr. Gaylord Clark for a hand problem. He arranged for me to become a special student in Art as Applied to Medicine after seeing my drawings. Dr. Clark, a hand surgeon, is also a medical illustrator who trained at JHU. During the two month elective, Ms. Ranice Crosby sat beside me and provided an accelerated training in the pen and ink techniques perfected by Max Brodel in addition to instruction on the special materials used in medical illustration.
postdoctoral fellow, Pathology, Transplant Immunology, 1970 — 1974
I participated in a transplantation research program with Dr. Norman Anderson while a pathology resident, supported by a Training Grant at Johns Hopkins University. Our project was aimed at understanding how vascular endothelium may be involved in immune responses to alloantigens. I used light and electron microscopy, cytochemistry and immunohistochemistry to explore effects of alloantigenic stimulation on microvasculature and lymphocyte recirculation in rat lymph nodes. My electron microscopic and cytochemical analyses of lymph node structures like the fibroblastic reticular cell stroma, microvasculature, and high endothelial venules resulted in 4 seminal publications appearing between 1975 and 1976 which jump started my career as interest in lymphocyte homing and dendritic cells was becoming important in the new field of cellular immunology.
I also served as a Master's Thesis Instructor in the Department of Art As Applied to Science during my last year of training (1973-1974)
MD, Medicine, 1966 — 1970
The medical curriculum integrated the disciplines in the preclinical didactic education. Biochemistry, Biophysics and Physiology was completely integrated. Microbiology, Pharmacology and Pathology also contained some integrated sections. Students conducted a year long research project and submitted a manuscript on the results.The decision about what project to conduct was by consensus of the four assigned lab partners. Our project dealt with the effects of chemically variable forms of barbiturates on evoked cortical responses in cat brains using encephisole perfusion techniques. I was challenged to "invent" a perfusion system that oxygenated and warmed the fluids. I also did the microvascular procedure of inserting a glass microcannula into a pial arteriole and ligation of anastomotic branches. This experience was very useful in the research I later performed.
The clinical rotations were as expected for a patient care oriented medical school.
Bachelor of Science, Biology, 1962 — 1966
Degree: Bachelor of Science
Major: Biology
GPA: 2.94
Semester Hours: 124
Description: My objective was to meet the requirements for entry into medical school. I also found courses in Religion and Philosophy personally valuable. I found reading the works of great philosophers, principles of logic and decisional ethics extraordinarily important to work I did later on in 1975 when I was asked to create a system for reviewing for approval/disapproval all research involving human subjects at USAMRIID. I loved Biology and did an independent research study of human immunoglobulins using current technology. Both of these disciplines were indispensible to my future. On 16 May 2003 Wagner College awarded me an honorary doctorate in philosophy, I believe, to recognize my accomplishments in research and research ethics.
Financial Support: NY State Regents College Scholarship, plus jobs in Language Lab, Campus Book Store, Biology Lab Assistant and Summer Employment.
in vivo Immunology, intravital microscopy, digital photography, medical ethics, international travel, architectural history, sailing, crosscountry skiing, SCUBA diving, bicycling
American Association for Advancement of Science, American Society for Investigative Pathology, American Association of Immunologists, Society for Mucosal Immunology (Charter Member), Applied Research Ethics National Association [ARENA], ARENA Council - Regional Representative for Mid-Atlantic, 2000-03 ARENA Treasurer, 2007- present member Public Responsibility in Medicine and Research (PRIM&R), Frederick Kiwanis Club, (Vice President 1986-87, President 1988-89).
Legion of Merit U.S. Army Career Citation, signed by Surgeon General; Doctor of Philosophy, honoris causa Wagner College, Staten Island, NY; Order of Military Medical Merit #5883; Meritorious Service Medal; Army Commendation Medal x 3; "A" Proficiency Designator,(U.S. Army equivalent of Full Professor); Omicron Delta Kappa (Leadership Honor Society; Beta Beta Beta (Biology Honor Society).