CURRICULUM VITAE October, 2009

Robert J. Levine, M.D.Senior Fellow, Interdisciplinary Center for BioethicsDirector, Law, Policy and Ethics Core, Center for Interdisciplinary Research on AIDSProfessor of Medicine and Lecturer in PharmacologyYale University

Courier Address

Robert J. LevineYale Center for Bioethics 238 Prospect StreetNew Haven, CT 06511

US Mail address (please do not include any titles or departmental affiliations)

Yale Interdisciplinary Center for BioethicsPO Box 208293New Haven, CT 06520-8293

(203) 432-8807(203) 432-8310 fax

levinerj@sbcglobal.net Please note that this is my preferred e-mail address. Answers to e-mail sent to my yale.edu address may be delayed as much as one month.

Born: Wantagh, NY. December 29, 1934

Education:W.C. Mepham High School, Bellmore, New York, 1947-1951Duke University, Durham, North Carolina, 1951-1954The George Washington University School of Medicine, Washington, DC., 1954-1958.

M.D. degree with distinction, 1958.

Uniformed Service:U.S. Public Health Service. Rank: Surgeon, 1960-1964; currently in Inactive Reserve, USPHS

Positions held (including post - graduate education): 1958-1959 Medical House Officer, Peter Bent Brigham Hospital, Boston, MA1959-1960 Assistant Resident in Medicine, Peter Bent Brigham Hospital1960-1962 Clinical Associate, National Heart Institute, Bethesda, MD

1962-1963 Chief Medical Resident, Veterans Administration Hospital, West Haven, CT; Instructor in Medicine, Yale University School of Medicine, New Haven, CT

1963-1964 Investigator, National Heart Institute; Clinical Instructor in Medicine, The George Washington University School of Medicine

1964-1965 Instructor in Medicine and Pharmacology, Yale University School of Medicine; Clinical Assistant in Medicine, Yale-New Haven Medical Center

1964-1966 Clinical Investigator, Veterans Administration Hospital, West Haven, CT1965-1968 Assistant Professor of Medicine and Pharmacology, Yale University

School of Medicine1965-1968 Assistant Attending Physician, Yale-New Haven Medical Center1966-1974 Chief, Section of Clinical Pharmacology, Yale University School of Medicine1966- Attending Physician, Veterans Administration Hospital, West Haven, CT1968-1973 Associate Professor of Medicine and Pharmacology, Yale University School

of Medicine 1968- Attending Physician, Yale-New Haven Medical Center1973- Professor of Medicine and Lecturer in Pharmacology, Yale University School of

Medicine1973-1975 Director, Physician's Associate Program, Yale University School of

Medicine1988-1991 Director: Professional Responsibility (a 43- hour required course for first

year medical students.)1998- Center for Interdisciplinary Research on AIDS; Law, Policy and Ethics

Core; Co- director 1998-1999, Director, 2001- 1998-2005 Yale University Interdisciplinary Bioethics Program, Co-chair,

Executive Committee 1999-2005.2002-2008 Donaghue Initiative in Biomedical and Behavioral Research Ethics,

Director2005-2007 Yale University Interdisciplinary Center for Bioethics, Co-Director2007- Yale University Interdisciplinary Center for Bioethics, Senior Scholar in

Research Ethics Certification: National Board of Medical Examiners, 1959Licensed to Practice - State of Connecticut, 1964American Board of Internal Medicine, 1965

Honors:Outstanding Achievement Medal: Office for Human Research Protection, US

Department of Health and Human Services, for his role in the development of the Belmont Report, 2004.

Lifetime Award for Excellence in Human Research Protection, Health Improvement Institute, 2004

Lifetime Achievement Award for Excellence in Research Ethics, PRIM&R [Public Responsibility in Medicine and Research], 2005

The George Washington University: Distinguished Alumni Scholar Award, 2008.

Academy of Pharmaceutical Physicians and Investigators: Special Recognition Award, 2009.

Honors and Societies (while in medical school):Scholastic standing: First in classPresident: Junior and Senior classAlpha Omega Alpha: Vice PresidentSmith Reed Russell Society: President (local scholastic honorary).St. George Student Cancer Society of DC: (Vice-president)Phi Chi Medical FraternityRoche Award: 1957Fellowships: National Foundation: 1956 American Cancer Society: 1957 National Institutes of Health: 1958Societies: Fellow of the American College of Physicians Fellow of the American College of Cardiology Fellow of the Hastings Center Fellow of the American Association for the Advancement of Science

Council Delegate: Section of Medical Sciences, 1988-91. American Society for Clinical Investigation American Society for Clinical Pharmacology and Therapeutics Board of Directors, 1981-1985 Section on Medico-Legal Matters and R&D Administration Vice-Chairman, 1979-1980; Chairman, 1980-1985 Government Affairs Committee, 1979- ca 1990 Ethics Committee, 1986- ca 1990 American Federation for Clinical Research Councilor, Eastern Section, 1965-1967 Secretary-Treasurer, Eastern Section, 1967-1970 National Council, 1967-1976 Committee on Social Issues Related to Health, 1970-1976 Executive Committee, 1971-1976 Committee on Long Range Goals, 1972-1973 Public Policy Committee, 1972-1976 The Nellie Westerman Prize for Research in Ethics Award Committee,

Chairperson, 1975-1979 Society of Bioethics Consultation, Board of Directors, 1988-1994 American Society of Law, Medicine & Ethics Board of Directors, 1986-1996 President-elect, 1988-1989; 1993-1994 President, 1989-1990; 1994-1995 Council of Biology Editors Committee on Editorial Policy, 1973-1976 World Association of Medical Editors, 1998-1999

Ethics Committee, Chair, 1998-1999 American Society for Pharmacology and Experimental Therapeutics: Division of

Clinical Pharmacology Educational and Professional Affairs Subcommittee, 1968-1970 Executive Committee, 1974-1977 ASPET Award Committee, 1973 Alpha Omega Alpha Histamine Club Sigma Xi Association of Physician Assistant Programs Membership Committee, 1974, Chairman, 1974 American College of Medical Quality, Ethics and Policy Committee; consultant (nonmember)

Miscellaneous Activities:National Heart and Lung Institute Myocardial Infarction Committee, 1969-1972 Miscellaneous ad hoc subcommitteesDepartment of Health, Education and Welfare

Blue Ribbon Panel on Behavior Modification Drugs for School Age Children, 1971National Institute of Mental Health Drug Abuse Research Center Review Committee, 1972Committee for Effective Drug Abuse Legislation, 1972National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Special Consultant, 1974-1978National Heart, Lung, and Blood Institute Lipid Metabolism Advisory Committee, 1977-1979Food and Drug Administration

Workshops on Institutional Review Boards (presented quarterly in various cities in the USA): Resource Panelist, 1978-1979

Commission on the Federal Drug Approval Process, Vice Chairman, 1981-1982National Heart, Lung, and Blood Institute Working Group on Mechanical Circulatory Support, 1983-1986National Institutes of Health

Acquired Immunodeficiency Syndrome Program Advisory Committee, 1989-1995. National Human Subjects Protection Review Panel; a subcommittee of the AIDS

Program Advisory Committee which serves as the National Institutional Review Board for the Parallel Track Program, Chairman, 1992-1995.

World Health Organization, Global Programme on AIDS, Consultant responsible for drafting "Ethical Guidelines for International Testing of HIV Candidate Vaccines and New Drugs for AIDS," 1989-1990

American Foundation for AIDS Research Scientific Advisory Committee, 1990- Public Policy Advisory Committee, 1991-Council for International Organizations of Medical Sciences

Steering Committee for Development of International Guidelines for Epidemiological Research and Ethical Review Procedures, 1990-1992

Steering Committee for the writing of International Ethical Guidelines for Biomedical Research Involving Human Subjects, Co-Chairman, 1991-93;

Chairperson, 1998-2002.AIDS Action Foundation, Steering Committee: HIV Preventive Vaccines: Social, Ethical

and Political Considerations for Domestic Efficacy Trials, 1993-1994.Chair, Working Group on Informed Consent, Community Education and Support, 1993-1994.

National Academy of Sciences, Institute of MedicineCommittee to Review the Fialuridine Clinical Trials, 1994-95

Centers for Disease Control and Prevention (CDC), Ethics Subcommittee of the Director's Advisory Committee, 1997-1999; 2004 - 2008.

CDC, External Review Group for Human Subjects Protection, Chairperson, 2000 (this group was charged with the responsibility to assess CDC’s IRB system and other aspects of their human subjects protection activities and make recommendations for improvement)

Joint United Nations Programme on HIV/AIDS (UNAIDS), Project on Ethics in HIV Vaccine Trials, Consultant responsible for drafting the Guidance Document for Multinational Trials of HIV Preventive Vaccines, 1997- 1998.

National Institutes of Health Office of AIDS Research: Prevention Science Working Group, 1998-2001.

World Medical Association Working Group for Revision of the Declaration of Helsinki, Chair, 1998-1999

AMA Virtual Mentor Project, 1998-National Institute of Mental Health: Human Subjects Research Council Workgroup,

1999-Pan American Health Organization (PAHO): International Bioethics Advisory Board.

2000 – 2004.Department of Health and Human Services: National Human Research Protections

Advisory Committee, 2000-2003.

Data and Safety Monitoring Boards

Collaborative Ocular Melanoma Study (National Eye Institute) Data and Safety Monitoring Committee, 1986-2005.National Heart, Lung and Blood Institute, Data and Safety Monitoring Committee for the Clinical Trial: Infant Heart Surgery; CNS Sequellae of

Circulatory Arrest, 1991-1994National Heart, Lung and Blood Institute, Data and SafetyMonitoring Committee for Clinical Trial of Implantable Cardioverters, 1992-1997Merck & Co., Inc., Fracture Intervention Trial, Data & Safety Monitoring Board, 1992-

1997.Regeneron Pharmaceuticals, Data and Safety Monitoring Board for the Clinical Trial of

Recombinant Human Ciliary Neurotophic Factor in Patients with Amyotrophic Lateral Sclerosis, 1992-1994

American Foundation for AIDS ResearchData and Safety Monitoring Board for the Community-Based Clinical Trials Network,

1995-National Institute of Allergy and Infectious Diseases, Vaccine and Prevention Research

Trials (HIVNET), Prevention Data and Safety Monitoring Board, 1996-1998National Heart, Lung and Blood Institute, National Emphysema Treatment Trial, Data

and Safety Monitoring Board, 1997-2003National Institute of Mental Health, Data and Safety Monitoring Board, 1997-Baxter Corporation, Data Monitoring Committee for the Perioperative DCLHb Study,

1997-1998CIRCE Biomedical Corp., Data and Safety Monitoring Board for the Clinical Trial of the

HepatAssist System, 1998-2001National Heart, Lung and Blood Institute, Magnesium in Coronaries Clinical Trial, Data

and Safety Monitoring Board, 1998-2003VaxGen Corporation, Data and Safety Monitoring Board for the phase III trials of

AIDSVAX, 1999-2004National Institute of Allergy and Infectious Diseases, Vaccine and Prevention Data and

Safety Monitoring Board, 1999-Yamanouchi, USA: YM872 Phase 2b Clinical Trial DSMB, 2001-2003. Altana Inc.: Venticute (rSP-C Surfactant) in patients with all risk levels of acute lung

failure (ARIVAL-Study), Data and Safety Monitoring Board, 2001-Bausch and Lomb Corp. DSMB to monitor various trials of Retisert, 2001-2007Daiichi Pharmaceutical Corporation: Data and Safety Monitoring Board for Phase III

clinical trials in pancreatic cancer using DX-8951f alone or in combination with gemcitabine. 2002-2005.

CDC: AVA000: Anthrax Vaccine Adsorbed: Human Reactogenicity and Immunogenicity Trial to Address Change in Route of Administration and Dose Reduction, 2002-

National Heart, Lung and Blood Institute, Interagency Registry for Mechanically Assisted Circulatory Support, [OSMB], 2006-

CDC: DSMB for the Emergency Use of Anthrax Vaccine (Biothrax) for post-exposure prophylaxis after exposure to aerosolized Bacillus anthracis spores. 2006- 2008.

Schering-Plough Research Institute: DSMB the monitors several trials of Vicriviroc, 2007-

State of Connecticut

State of Connecticut Advisory Committee on Foods and Drugs, 1967- 1983 Secretary, 1969-1971; Chairman, 1971-1973Connecticut Regional Drug Information Services, Advisory Committee, 1973-1974South Central Connecticut Emergency Medical Services Regional Advisory Council, 1974-1975Connecticut Humanities Council, 1983-1989 Chairman, Publications Committee, 1984-1987 Secretary, 1985-1987 Vice-Chairman, 1987-1988 Chairman, 1988-1989

Connecticut Academy of Arts and Sciences, 1995-

Editorial Activities

Biochemical Pharmacology:Honorary Advisory Editorial Board, 1968-1983Associate Editor, 1969-1974

Clinical Research: Editor - 1971-1976Editor Emeritus, 1976-1977

Medical Communications, Inc.: Editorial Consultant, 1968-1972Video Journal of Medicine: Assistant Editor, 1968

The International Encyclopedia of Pharmacology and Therapeutics Editorial Board, 1974-1976 Part C: Clinical Pharmacology and Therapeutics Executive Editor, 1975-1976IRB: A Review of Human Subjects Research

Founding editorEditor, 1978- 2000. Editor emeritus and Chair of Editorial Board 2000-

Bioethics Reporter, National Advisory Board, 1983-1985Encyclopedia of Bioethics, Second edition.

Editorial Advisory BoardBioLaw

National Advisory Board, 1986-Medical Advisor, 1986-

Journal of Clinical Ethics, Associate Editor, 1989-The Journal of Law, Medicine & Ethics, Articles Editor for Medicine, 1993-Ethics & Behavior, Consulting Editor, 1989-1999Journal of Empirical Research on Human Research Editorial Advisory Board. 2005-2007; Associate Editor 2007-

Editorial Boards Bioethics Digest, 1977-1978 Clinical Research Practices and Drug Regulatory Affairs, 1984- Environmental Management and Health, 1989- The American Journal of Medicine, 1997- 2004

Editorial Advisory Boards Journal of Family Practice, 1975-1990 Forum on Medicine, 1977-1980

Non-Governmental boards, councils (selected)

Clinical Resources, Inc.: Advisory Board, 1972-1975Medicine in the Public Interest

Board of Directors, 1976-2003 Secretary, 1984-2003Public Responsibility in Medicine and Research (PRIM&R) Board of Directors, 1986-

Vice-Chair, Board of Directors, 2007-Institute for Health Care Communications (Formerly Bayer Institute for HealthCare Communications)

Advisory Council, 1994-2000Executive Committee, 1997-2000Board of Directors 2003-present; President of the Board 2004-

Committees at Yale University:

Atypical Growth Committee, 1966-1978Pharmacy Committee, Yale-New Haven Hospital, 1966-1974Human Investigation Committee (Institutional Review Board) 1966-2000

Chairperson, 1969-1971; 1973-1975; 1977-Vice-Chairperson, 1975-1977

Department of Internal Medicine, Committee for interviewing and selecting applicants for internship, 1966-1970Council of Non-tenured faculty organization, 1969-1970Committee on Governance (examined the existing system of governance of the Medical

School and recommended in its report what -- after its acceptance -- became the new system of governance), 1969-1970

Curriculum Committee, 1970-1974Chairman: Subcommittee on Multiple Tracks (developed and then supervised and evaluated the Multiple Track Program, the curriculum for the last 3 semesters), 1970-1973

Committee on Continuing Medical Education, 1970-1974Interviewer for the Medical School Admissions Committee, 1970-1975 Study Group on Time and Scope Options in Medical Education, 1972-1974Committee on New Health Professionals, 1974-1974Search Committee for Chairman of Anesthesiology, 1973Advisory Committee on Medical Ethics, 1974-1977Primary Care Center Committee, 1974-1975Humanities in Medicine Study Unit, 1975-1978Committee on Guidelines for Deciding Care of Critically Ill or Dying Patients, Department of Pediatrics, 1976-1977Committee on Policy for Do Not Resuscitate Decisions, Department of Medicine,

Chairperson, 1978-1979Medical School Council, 1978-1981

Chairman, 1979-1981Nursing Ethics Committee, Yale-New Haven Hospital, 1983-Pediatrics Ethics Committee, 1984-Bioethics Committee, Yale-New Haven Hospital, 1985-Health Professions Advisory Board, Yale College, 1987-1996

Basic Science Subcommittee of the Curriculum Committee, 1988-1991IRB Leadership Group, 2001-Medical Humanities Committee 2005-2007Medical Humanities and Arts Council 2007 -

PUBLICATIONS

BOOKS

1. Levine, R.J.: Ethics and Regulation of Clinical Research. Urban & Schwarzenberg, Baltimore, MD, 1981, Second edition, 1986; Paperback printing of the second edition, Yale University Press, New Haven, 1988.

2. Champey, Y., Levine, R.J., Lietman, P.S., Editors: Development of New Medicines: Ethical Questions. Royal Society of Medicine Services, Ltd., London, 1989.

3. Bankowski, Z. & Levine, R.J., Editors: Ethics and Research on Human Subjects: International Guidelines. Proceedings of the XXVIth CIOMS Conference. Council for International Organizations of Medical Sciences (CIOMS), Geneva, 1993.

4. Levine, RJ. & Gorovitz, S. with the assistance of Gallagher, J.(editors): Biomedical Research Ethics: Updating International Guidelines: A Consultation Council for International Organizations of Medical Sciences (CIOMS), Geneva, 2000.

ARTICLES AND CHAPTERS

1. Levine, R.J., Boshell, B.R.: Renal involvement in progressive systemic sclerosis (scleroderma). Ann Int Med 52:517-529, 1960.

2. Levine, R.J., Folse, R.: Hemodynamic observations in a case of carcinoid heart disease associated with an atrial right- to-left shunt. Am Heart J 62:830-834, 1961.

3. Lovenberg, W., Levine, R.J., Sjoerdsma, A.: A sensitive assay of monoamine oxidase in vitro: Application to heart and sympathetic ganglia. J Pharmacol Exp Therap 135:7-10, 1962.

4. Levine, R.J., Sjoerdsma, A.: Monoamine oxidase activity in human tissues and intestinal biopsy specimens. Proc Soc Exp Biol Med 109:225-227, 1962.

5. Levine, R.J. Roberts, W.D., Morrow, A.G.: Traumatic aortic regurgitation. Am J Cardiol 10:752-763, 1962.

6. Levine, R.J.: Inhibition of monoamine oxidase activity in sympathetic ganglia of the cat. Biochem Pharmacol 11:395- 396, 1962.

7. Levine, R.J., Oates, J.A., Vendsalu, A., Sjoerdsma, A.: Studies on the metabolism of aromatic amines in relation to altered thyroid function in man. J Clin Endocrinol Metab 22:1242-1250, 1962.

8. Levine, R.J., Sjoerdsma, A.: Direct measurement of monamine oxidase inhibition in humans. Clin Pharmacol & Therap 4:22-27, 1963.

9. Levine, R.J., Sjoerdsma, A.: Pressor amines and the carcinoid flush. Ann Int Med 58:818-828, 1963.

10. Rivlin, R.S., Levine, R.J.: Hepatic tyrosine transaminase activity and plasma tyrosine concentration in rats with altered thyroid function. Endocrinol 73:103-107, 1963.

11. Levine, R.J., Sjoerdsma, A.: Estimation of monamine oxidase activity in man; techniques and applications. Ann NY Acad Sci 107:966-972, 1963.

12. Levine, R.J.: Laboratory methods in the diagnostic evaluation of hypertension. Connecticut Med 28:99-102, 1964.

13. Lefkowitz, M., Elsas, L.J., Levine, R.J.: Candida infection complicating peptic esophageal ulcer; infection in an aortic-esophageal fistula. AMA Arch Int Med 113:672-676, 1964.

14. Levine, R.J., Elsas, L.J., Duval, C.P., Rice, J.S.: Malignant carcinoid tumors with and without flushing. JAMA 186:905-907, 1963.

15. Levine, R.J., Lovenberg, W., Sjoerdsma, A.: Hydroxylation of tryptophan and phenylalanine in neoplastic mast cells of the mouse. Biochem Pharmacol 13:1283-1290, 1964.

16. Levine, R.J., Nirenberg, P.Z., Udenfriend, S., Sjoerdsma, A.: Urinary excretion of phenethylamine and tyramine in normal subects and in heterozygous carriers of phenylketonuria. Life Sciences 3:651-656, 1964.

17. Levine, R.J., Sjoerdsma, A.: Diagnostic methods for serotonin and histamine abnormalities. Proceedings, Second National Conference on Cardiovascular Diseases. Vol. 1:p. 278, Federation of American Societies for Experimental Biology, Washington, DC, 1964.

18. Levine, R.J., Sjoerdsma, A.: Dissociation of the decarboxylase-inhibiting and the norepinephrine-depleting effects of alpha-methyl-dopa, alpha-ethyl-dopa, 4-bromo-3-hydroxybenzyloxyamine and related substances. J. Pharmacol Exp Therap 146:42-47, 1964.

19. Levine, R.J., Sato, T.L., Sjoerdsma, A.: Inhibition of histamine synthesis in the rat by alpha-hydrazino analog of histidine and 4-bromo-3-hydroxybenzyloxyamine. Biochem Pharmacol 14:139-150, 1965.

20. Levine, R.J.: Diagnosis of the carcinoid syndrome. Clin Medicine 72:285-294, 1965.

21. Lovenberg, W., Levine, R.J., Sjoerdsma, A.: A tryptophan hydroxylase in cell free extracts of malignant mouse mast cells. Biochem Pharmacol 14:887-889, 1965.

22. Levine, R.J.: Stimulation by saliva of gastric acid secretion in the rat. Life Sciences 4:959-964, 1965.

23. Levine, R.J.: Effect of histidine decarboxylase inhibition on gastric acid secretion in the rat. Federation Proceedings 24:1331-1333, 1965.

24. Levine, R.J.: Variation in gastric histamine levels and effects of histidine decarboxylase inhibition in rats from different sources. Biochem Pharmacol 15:403-405, 1966.

25. Levine, R.J., Watts, D.E.: A sensitive and specific assay for histidine decarboxylase activity. Biochem Pharmacol 15:841-849, 1966.

26. Levine, R.J.: Histamine synthesis in man: Inhibition by 4- bromo-3-hydroxybenzyloxyamine. Science 154:1017-1019, 1966.

27. Levine, R.J.: Assessment of drug-induced inhibition of monoamine oxidase activity. Biochem Pharmacol 15:1645-1647, 1967. Editorial.

28. Levine, R.J., Strauch, B.S.: Hypertensive responses to methyldopa. New England J Med 275:946-948, 1966.

29. Levine, R.J., Watts, D.E.: Inhibition of histidine decarboxylase activity in vitro by norepinephrine and related compounds. Biochem Pharmacol 16:993-1000, 1967.

30. Senay, E.C., Levine, R.J.: Synergism between cold and restraint for the rapid production of stress ulcers in rats. Proc Soc Exp Biol Med 124:1221-1223, 1967.

31. Levine, R.J.: Pheochromocytoma: Diagnosis and management. Connecticut Med 31:620-623, 1967.

32. Levine, R.J., Conn. H.O.: Tyrosine metabolism in patients with liver disease. J Clin Invest 46:2012-2020, 1967.

33. Levine, R.J., Senay, E.C.: Histamine in the pathogenesis of stress ulcers in the rat. Am J Physiol 214:892-896, 1968.

34. Clemett, A.R., Fishbone, G., Levine, R.J., James, A.E., Janower, M.: Gastrointestinal lesions in mastocytosis. Am J Roentgenol 103:405-412, 1968.

35. Roth, R.H., Stjarne, L., Levine, R.J., Giarman, N.J.: Abnormal regulation of catecholamine synthesis in pheochromocytoma. J Lab Clin Med 72:397-403, 1968.

36. Gillespie, E., Levine, R.J., Malawista, S.E.: Histamine release from rat peritoneal mast cells: Inhibition by colchicine and potentiation by D20. J Pharmacol Exptl Therap 164:158-165, 1968.

37. Levine, R.J.: Symposium on gastrin and related synthetic peptides; introductory remarks by the chairman. Federal Proceedings. 27:1310-1311, 1968.

38. Levine, R.J.: Histamine and the effect of gastrin on gastric acid secretion in man. Federation Proceedings. 27:1341-1344, 1968.

39. Levine, R.J.: The adrenal medulla and catecholamines. In Duncan's Diseases of Metabolism. Ed. by P.K. Bondy, 6th edition, Chapter 18, pp. 886-903, 1969.

40. Gillespie, E., Levine, R.J.: Histamine release by reserpine from rat peritoneal mast cells in vitro. Biochem Pharmacol 18:934-935, 1969.

41. Floch, M.H., Shearman, D.J.C., Herskovic, T., Levine, R.J., Spiro, H.M.: Iron deficiency anemia and hepatic lesions in weanling rats. AMA Arch Path 87:526-532, 1969.

42. Levine, R.J., Noll, W.W.: Histidine decarboxylase and its inhibition. Ann NY Acad Sci. 166:246-256, 1969.

43. Resnik, R., Levine, R.J.: Plasma diamine oxidase activity in pregnancy: A reappraisal. Am J Obstet Gynecol 104:1061- 1066, 1969.

44. Wustrack, K.O., Levine, R.J.: Assay of histidine decarboxylase inhibitors in human plasma. Biochem Pharmacol 18:2465-2471, 1969.

45. Noll, W.W., Levine, R.J.: Histidine decarboxylase in gastric tissues of primates. Biochem Pharmacol 19:1043- 1053, 1970.

46. Phair, J.P., Eisenfeld, A.J., Levine, R.J., Kantor, F.S.: Effects of pharmacological inhibition of histamine synthesis upon immunological reactions in the guinea pig. Immunology 18:611-619, 1970.

47. Levine, R.J., Senay, E.C.: Studies on the role of acid in the pathogenesis of experimental stress ulcers. Psychosomatic Medicine 32:61-65, 1970.

48. Levine, R.J., Vaidya, A.B., Shearman, D.J.C., Levine, S.M., Hersh, T.: Effects of brocresine (an inhibitor of histidine decarboxylase) on Zollinger-Ellison syndrome. Amer J Digest Dis 15:477-484, 1970.

49. Levine, R.J.: Carcinoid tumors and the carcinoid syndrome. In Current Diagnosis. Ed. H.F. Conn and R.F. Conn, Jr. W.B. Saunders Co., Philadelphia. Third Edition pp. 749-451, 1971.

50. Vaidya, A.B., Levine, R.J.: Recurrent throbmophlebitis and pulmonary emboli in a patient with systemic mastocytosis. Indian J Med Sci 25:166-170, 1971.

51. Levine, R.J.: A method for the rapid production of stress ulcers in rats. In: Peptic Ulcer. Ed. by C.J. Pfeiffer, Munksgaard, Copenhagen, pp. 92-97, 1971.

52. Vaidya, A.B., Levine, R.J.: Hypothermia in a patient with carcinoid syndrome during treatment with para- chlorophenylalanine. New England J Med 284:255-257, 1971.

53. Vaidya, A.B., Wustrack, K.O., Levine, R.J.: Failure of epinephrine to provoke flushing in patients with systemic mastocytosis. Ann Int Med 74:711-713, 1971.

54. Levine, R.J.: Malignant carcinoid syndrome. In Current Therapy. Ed. by H.F. Conn, W.B. Saunders Co., Philadelphia, pp. 468-471, 1972.

55. Van Woert, M.H., Ambani, L.M., Levine, R.J.: Clinical effects of parachlorophenylalanine in Parkinson's disease. Dis Nervous System 33:777-780, 1972.

56. Levine, R.J., Landsberg, L.L.: Catecholamines and the adrenal medulla. In Duncan's Diseases of Metabolism. Ed. by P.K. Bondy and L.E. Rosenberg, 7th Edition, W.B. Saunders Co., Chapter 19, pp. 1181-1224, 1974.

57. Levine, R.J.: Serotonin and carcinoid syndrome; histamine and mastocytosis. In Duncan's Diseases of Metabolism. Ed. by P.K. Bondy and L.E. Rosenberg, 7th Edition, W.B. Saunders Co., Chapter 27, pp. 1651-1684, 1974.

58. Levine, R.J.: Symposium on Ethics of Human Experimentation: Introduction. Clin Research 21:774-776, 1973.

59. Levine, R.J.: Guidelines for negotiating informed consent with prospective human subjects of experimentation. Clin Research 22:42-46, 1974.

60. Levine, R.J., Metz, S.A.: A classification of ectopic hormone producing tumors. Ann NY Acad Sci 230:533-546, 1974.

61. Levine, R.J.: Proposed rules on ethics of human experimentation: Tensions between the biomedical research community and the United States federal government. In Social Research in Conflict with Law and Ethics. Ed. by P. Nejelski, Ballinger, Cambridge, 1976, pp. 67-81.

German edition: Ethische Regeln fur Humanexperimente: Spannungen zwischen der biomedizinischen Forschergemeinschaft und der Us-Bundesregierung. In Forschung im Konflikt mit Recht und Ethik, ed. by A. Eser und K.F. Schumann, Ferdinand Enke Verlag, Stuttgart, Germany, 1976, pp. 379-395.

62. Levine, R.J.: Boundaries between research involving human subjects and accepted and routine professional practices. In Human Experimentation. Ed. by R.L. Bogomolny, Southern Methodist University Press, Dallas, 1976, pp. 3-20.

63. Levine, R.J.: Viability and death of the human fetus: Biologic definitions. Clin Research 23:211-216, 1975.

64. Holder, A.R., Levine, R.J.: Informed consent for research on specimens obtained at autopsy or surgery: A case study in the overprotection of human subjects. Clin Research 24:68-77, 1976.

65. Levine, R.J.: Biomedical research. In Encyclopedia of Bioethics, ed. by W.T. Reich. The Free Press, New York, 1978, pp. 1481-1492.

66. Lebacqz, K., Levine, R.J.: Informed consent in human research: Ethical and legal aspects. In Encyclopedia of Bioethics, ed. by W.T. Reich. The Free Press, New York, 1978, pp. 754-762.

67. Levine, R.J.: The role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects. Bioethics Digest 1 (No. 3):1-17, July 1976.

68. DeBakey, L., Cranefield, P.F., Gupta, A.P., Ingelfinger, F.J., Levine, R.J., Moser, R.H., Porter, J.R., Woodford, F.P.: The Scientific Journal: Editorial Policies and Practices; Guidelines for editors, reviewers and authors. C.V. Mosby, St. Louis, 1976.

69. Levine. R.J.: The impact on fetal research of the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Villanova Law Review 22:367-383, 1977.

70. Lebacqz, K., Levine, R.J.: Respect for persons and informed consent to participate in research. Clin Research 25:101- 107, 1977.

71. Metz, S.A., Levine, R.J.: Neuroendocrine tumors that secrete biologically active peptides and amines. Clinics in Endocrinology and Metabolism 6:719-744, 1977.

72. Hamilton, B.P., Landsberg, L., Levine, R.J.: Measurement of urinary epinephrine in screening for pheochromocytoma in multiple endocrine neoplasia-type II. Am J Med 68:1027- 1032, 1978.

73. Levine, R.J.: Informed consent to participate in research (in 2 parts). Bioethics Digest 1 (no. 11):1-13, March, 1977; 1 (No. 12):1-6, April, 1977.

74. Levine, R.J.: Introduction to the Symposium: Recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Impact on research in pharmacology. Federation Proceedings 36:2341-2343, 1977.

75. Levine, R.J.: Non-developmental research on human subjects: The impact of the recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Fed Proceedings 36:2359-2364, 1977.

76. Levine, R.J., Lebacqz, K.: Some ethical considerations in clinical trials. Clin Pharmacol Therap 25:728-741, 1979.

77. Levine, R.J.: Research involving children: The National Commission's Report. Clinical Research 26:61-67, 1978.

78. Levine, R.J.: Clarifier les concepts de l'ethique de la recherche. In: Medicine et Experimentation, Cahiers de bioethique No. 4, ed. by M.A.M. de Wachter, Les Presses de L'Universite Laval, Quebec, 1982, pp. 251-266.

79. Levine, R.J.: Regulation of the use of human tissues and body fluids as research materials: Current modifications. Biochem Pharmacol 28:1893-1895, 1979.

80. Levine, R.J.: Changing federal regulation of IRBs: The Commission's recommendations and the FDA's proposals. IRB: A Review of Human Subjects Research 1 (No. 1): 1-3 and 12, March, 1979.

81. Levine, R.J.: Advice on compensation: One IRB's response to DHEW's "Interim Final Regulation." IRB: A Review of Human Subjects Research 1 (No. 1): 5, March, 1979.

82. Levine, R.J.: Clarifying the concepts of research ethics. Hastings Center Report 9

(No. 3): 21-26, June, 1979.

83. Levine, R.J.: Advice on compensation: More responses to DHEW's "Interim Final Regulation." IRB: A Review of Human Subjects Research 1 (No. 2): 5-7, April, 1979.

84. Levine, R.J.: Deceiving dentists: Health care providers as "subjects at risk." IRB: A Review of Human Subjects Research 1 (No. 5): 7-8, August-September, 1979.

85. Levine, R.J.: The impact of institutional review boards on clinical research. Perspectives in Biology and Medicine. 23:S98-S114, 1980.

86. Levine, R.J.: Do not resuscitate decisions and their implemtation. Chapter 1 in Dilemmas of Dying: Policies and Procedures for Decisions Not to Treat, ed. by C.B. Wong and J.P. Swazey, G.K. Hall Medical Publishers, Boston, 1981.

87. Levine, R.J.: What should consent forms say about cash payments? IRB: A Review of Human Subjects Research. 1 (No. 6): 7-8, October, 1979.

88. Levine, R.J.: Changing federal regulations of IRBs, Part II: DHEW's and FDA's proposed regulations. IRB: A Review of Human Subjects Research. 1 (No. 7): 1-5 and 12, November, 1979.

89. Levine, R.J.: The Senate's proposed statutory definition of "voluntary and informed consent." IRB: A Review of Human Subjects Research. 2 (No. 4): 8-10, April, 1980.

90. Levine, R.J.: Drug testing in prisons. In Troubling Problems in Medical Ethics, Ed. by M.D. Basson, R.E. Lipson, D.L. Ganos; Alan R. Liss, Inc., New York, 1981, pp. 73-78.

91. Levine, R.J.: A primary reviewer system. IRB: A Review of Human Subjects Research. 3 (No. 6): 9-10, June/July, 1981.

92. Levine, R.J.: Ethics and Regulation of Clinical Research. Urban & Schwarzenberg, Baltimore, MD, 1981; Second edition, 1986.

93. Levine, R.J.: The value and limitations of ethical review committees for clinical research. In: Medical Ethics and Medical Education. Ed. by Z. Bankowski and J.C. Bernardelli, Council for International Organizations of Medical Sciences, 1981, pp. 43-60.

94. Levine, R.J.: What should subjects be told about withdrawing from a protocol? IRB: A Review of Human Subjects Research. 3 (No. 9): 9-10, November, 1981.

95. Levine, R.J.: Can (or should) the IRB assume the FDA's functions at early stages

of the IND process? IRB: A Review of Human Subjects Research. 3 (No. 10): 4-5, December, 1981.

96. Levine, R.J.: Validity of consent procedures in technologically developing countries. In: Human Experimentation and Medical Ethics. Ed. by Z. Bankowski and N. Howard-Jones, Council for International Organizations of Medical Sciences, Geneva, 1982, pp. 16-30.

97. Levine, R.J.: What are the IRB's obligations to review the use of drugs for purposes that FDA has not approved? IRB: A Review of Human Subjects Research. 4 (No. 4): 8-9, April, 1982.

98. Levine, R.J.: Informed consent in research and practice: Similarities and differences. Arch Int Med 143:1229-1231, 1983.

99. Harvey, M., Levine, R.J.: The risk of research procedures: Methodologic problems and proposed standards. Clinical Research 31: 126-139, 1983.

100. Levine, R.J.: Research involving children: An interpretation of the new regulations. IRB: A Review of Human Subjects Research. 5 (No. 4): 1-5, July/August, 1983.

101. Levine, R.J.: Inconsistency and IRBs: Flaws in the Goldman-Katz study. IRB: A Review of Human Subjects Research. 6 (No. 1): 4-6, January/February, 1984.

102. Levine, R.J.: Some ethical considerations of the use of placebos in randomized clinical trials. In: Moral Priorities in Medical Research: The Second Hannah Conference. Ed. by J.M. Nicholas, The Hannah Institute for the History of Medicine, Toronto, 1984, pp. 113-121.

102a. Levine, R.J.: The use of placebos in randomized clinical trials. IRB: A Review of Human Subjects Research. 7 (No. 2): 1-4, March/April, 1985 (a revised version of the same paper).

103. Levine, R.J.: The physician-researcher: Role Conflicts. In: Alzheimer's Dementia: Dilemmas in Clinical Research. Ed. by V.L. Melnick and N.N. Dubler. Humana Press, Clifton, NJ, 1985, pp. 41-50.

104. Levine, R.J.: Institutional review boards and collaborations between academia and industry: Some counterproductive policies and practices. Circulation 72 (suppl. I): I-48-50, 1985.

105. Levine, R.J.: Research that could yield marketable products from human

materials: The problem of informed consent. IRB: A Review of Human Subjects Research. 8 (No. 1): 6-7, January/February, 1986.

106. Levine, R.J.: Referral of patients with cancer for participation in randomized clinical trials. CA-A Cancer Journal for Clinicians 36:95-99, 1986.

Spanish translation: La participacion de pacientes con cancer en esayos clinicos randomizados: consideraciones eticas. Jano: Medicina y Humanidades 23(No. 789):67-73, October 2-8, 1987.

107. Levine, R.J.: The apparent incompatibility between informed consent and placebo-controlled clinical trials. Clinical Pharmacology & Therapeutics 42:247-249, 1987.

108. Levine, R.J.: Treatment use and sale of Investigational New Drugs. IRB: A Review of Human Subjects Research 9 (4): 1-4, July/August, 1987.

109. Levine, R.J.: Children as research subjects. In Children and Health Care: Moral and Social Issues. Ed. by L. M. Kopelman and J. C. Moskop, Kluwer Academic Publishers, Dordrecht, The Netherlands, 1989, pp. 73-87.

110. Levine, R.J.: Protection of human subjects of biomedical research in the United States: A contrast with recent experience in the United Kingdom. Annals of the New York Academy of Sciences 530:133-143, 1988.

111. Melton, G.B., Levine, R.J., Koocher, G.P., Rosenthal, R., Thompson, W.C.: Community consultation in socially sensitive research: Lessons from clinical trials of treatments for AIDS. American Psychologist 43:573-581, 1988.

112. Levine, R.J.: Uncertainty in clinical research. Law, Medicine & Health Care 16:174-182, 1988.

113. Levine, R.J.: Medical ethics and personal doctors: Conflicts between what we teach and what we want. American Journal of Law & Medicine 13:351-364, 1987. Reprinted in: The Journal of Clinical Ethics 1 (No. 1):23-29, 1990.

114. Levine, R.J.: Postmarketing surveillance -- some ethical considerations. Journal of Rheumatology 15 (Suppl. 17):34- 39, 1988.

115. Levine, R.J.: An ethical perspective. In Quality of Life Assessments in Clinical Trials. Ed. by B. Spilker, Raven Press, New York, 1990, Chapter 12, pp. 153-162. Second edition: Quality of Life and Pharmacoeconomics in Clinical Trials, 1996, Chapter 51, pp. 489-495.

116. Levine, R.J.: Respect for children as research subjects. In Child and Adolescent Psychiatry: A Comprehensive Textbook. Ed. by M. Lewis, Williams & Wilkins, Baltimore, 1991, Chapter 117, pp. 1229-1238. Second edition, Chapter 118, in press, 1995, Chapter 1311, Third Edition, 2000, Fourth Edition, In Lewis’ Child and Adolescent Psychiatry: A Comprehensive Textbook. Chapter 2.1.3, Ed. by A. Martin, F. R. Volkmar and M. Lewis, Lippincott, Williams & Wilkins, Philadelphia, Fourth Edition, 2007, pp. 140-149.

117. Levine, R.J.: Human Experimentation: New developments (1986-1989). In BioLaw: A Legal and Ethical Reporter on Medicine, Health Care, and Bioengineering. Ed. by R.D. Gaare, University Publications of America, Frederick, MD, 1990, Section 10.6.

118. Levine, R.J.: Mechanical circulatory support systems: Ethical considerations. Transplantation Proceedings 22:969- 970, 1990.

119. Levine, R.J.: AIDS and the physician-patient relationship. In AIDS and Ethics. Ed. by F.G. Reamer, Columbia University Press, 1991, Chapter 8, pp. 188-214.

120. Levine, C., Dubler, NN, Levine, RJ: Building a new consensus: Ethical principles and policies for clinical research on HIV/AIDS. IRB: A Review of Human Subjects Research 13 (No. 1&2): 1-17, January/April, 1991.

121. Levine, RJ: Informed consent: Some challenges to the universal validity of the Western model. Law, Medicine and Health Care 19: 207-213, 1991.

Reprinted with stylistic changes in: Ethics and Epidemiology: International Guidelines: Proceedings of the XXVth CIOMS Conference, ed by Z. Bankowski, JH Bryant and JM Last, CIOMS, Geneva, 1991, pp. 47-58.

122. Christakis, N.A. and Levine, R.J.: Multinational Research. In Encyclopedia of Bioethics, revised edition, ed. by W.T. Reich, Macmillan, New York, 1995, pp. 1780-1787.

123. Levine, R.J.: Medicalization of psychoactive substance use and the doctor-patient relationship. Milbank Memorial Quarterly 69:623-640, 1991. Reprinted with stylistic changes in: Confronting Drug Policy: Illicit Drugs in a Free Society. ed. by R. Bayer and G.M. Oppenheimer, Cambridge University Press, Cambridge, 1993, pp. 319-336.

124. Levine, R.J.: Research ethics committees. In Encyclopedia of Bioethics, revised edition, ed. by W.T. Reich, Macmillan, New York, 1995, pp. 2266-2270. Revised and published in the third edition, edited by S. G. Post, Macmillan Reference, New York, 2003, pp. 2311-2316

125. Levine, R.J.: Clinical trials and physicians as double agents. Yale Journal of

Biology and Medicine, 65:65-74, 1992.(Spanish Translation) El ensayo clínico y el mèdico como agente doble. Investigación Clínica y Bioètica 19:9-12, julio-septiembre, 1996.

126. Levine, R.J.: Clinical trials in disease prevention: Some ethical considerations. In: Promoting Community Health: The Role of the Academic Health Center, ed. by W. Douglas-Skelton and M. Osterweis, Association of Academic Health Centers, Washington, 1993, pp. 34-45.

127. Lynn, J., Johnson, J., Levine, R.J.: The ethical conduct of health services research: A case study of 55 institutions' applications to the SUPPORT project. Clinical Research 42:3-10, 1994.

128. Levine, R.J.: Informed consent: Consent issues in human research. In Encyclopedia of Bioethics revised edition, ed. by W.T. Reich, Macmillan, New York, 1995, pp. 1241-1250. Revised and published in the third edition, edited by S. G. Post, Macmillan Reference, New York, 2003, pp.1280 – 1290.

129. Levine, R.J.: The impact of HIV infection on society's perception of clinical trials. Kennedy Institute of Ethics Journal. 4 (No. 2):93-98, 1994.

130. Levine, R.J.: The Institutional review board. In Ethics in Epidemiology, ed. by S.S. Coughlin and T.L. Beauchamp, Oxford, New York, 1996, pp. 257-273. Second Edition in press 2007.

131. Levine, R.J.: Adolescents as research subjects without permission of their parents or guardians: Ethical considerations. Journal of Adolescent Health 17: 287-297, 1995.

132. Bankowski, Z., Levine, R.J.: A decade of the CIOMS programme: Health policy, ethics and human values -- An international dialogue. Poverty, Vulnerability, and the Value of Human Life: A Global Agenda for Bioethics. Proceedings of the XXVIIIth CIOMS Conference. CIOMS, Geneva, 1994, pp. 13-25.

133. Levine, R.J.: The international dialogue on health policy, ethics and human values: Recommendations for the next decade. Poverty, Vulnerability, and the Value of Human Life: A Global Agenda for Bioethics. Proceedings of the XXVIIIth CIOMS Conference. CIOMS, Geneva, 1994, pp. 234-242.

134. Levine, R.J.: International codes and guidelines for research ethics: A critical appraisal. In The Ethics of Research Involving Human Subjects: Facing the 21st Century, ed. by H.Y. Vanderpool, University Publishing Group, Frederick, Maryland, 1996, pp. 235-259.

135. Levine, R.J.: Research involving pregnant women as subjects: Ethical considerations. In: European Medicines Research: Perspectives in Clinical Trials, ed. by G.N. Fracchia and K.H. Haavisto, European Conference Publications, Cambridge, U.K., 1996, pp. 181-188.

136. Levine, R.J.: The "best proven therapeutic method" standard in clinical trials in technologically developing countries. IRB: A Review of Human Subjects Research. 20(No. 1):5-9, January/February, 1998. Reprinted in The Journal of Clinical Ethics. 9:167-172, 1998; Monash Bioethics Review. 17(No. 3):1-8, July 1998; AIDS Public Policy Journal 13(No. 1):30-35, 1998.

137. Levine, R.J.: The role of the research ethics committee in the evaluation of the scientific merit of research protocols. International Journal of Pharmaceutical Medicine (in press).

138. Levine, R.J.: Human Subjects Research, Ethics, Principles Governing Research with Human Subjects, Encyclopedia of Ethical, Legal and Policy Issues in Bioetechnology , ed. by T.H. Murray and M.J. Mehlman, John Wiley & Sons, New York, 2000, pp. 622 – 630.

139. Levine, R.J. and Ellenberg, S.: Human Subjects Research, Ethics, Stopping Rules for Randomized Clinical Trials Encyclopedia of Ethical, Legal and Policy Issues in Bioetechnology , ed. by T.H. Murray and M.J. Mehlman, John Wiley & Sons, New York, 2000, pp. 651 – 654.

140. Levine, R.J.: Randomized clinical trials: Ethical considerations. In: Advances in Bioethics, Vol. 5, ed. By R.B. Edwards, VAI Press, Stamford, Ct, 1999, pp. 113-145.

141. Levine, R.J.: The need to revise the Declaration of Helsinki. New England Journal of Medicine 341:531-534, 1999.

142. Levine, R. J.: Institutional Review Boards: A Crisis in Confidence. Annals of Internal Medicine 134: 161 –163, 2001 (Editorial).

143. Levine, R.J.: Some Recent Developments in the International Guidelines on the Ethics of Research Involving Human Subjects. Annals of the New York Academy of Sciences. 918: 170 – 178, 2000.

144. Beauchamp, T.L., Jennings, B., Kinney, E.D., & Levine, R.J.: Pharmaceutical Research Involving the Homeless. The Journal of Medicine and Philosophy 27, no. 5 (Oct. 2002),547-64.

145. Levine, RJ: Revision of the CIOMS International Ethical Guidelines: AProgress Report. In Levine, RJ. & Gorovitz, S. with the assistance of Gallagher, J. (editors): Biomedical Research Ethics: Updating International Guidelines: A Consultation, Council for International Organizations of Medical Sciences (CIOMS), Geneva, 2000, pp. 4 - 15.

146. Levine, RJ, Lasagna, L: Demystifying Central Review Boards: Current Options and Future Directions. IRB: A Review of Human Subjects Research 22(No.6): 1-4, 2000.

147. Levine, RJ: Ethical practices, institutional oversight and enforcement. In, Smelser, NJ & Baltes, PB (editors) 2001 International Encyclopedia of the Social and Behavioral Sciences, pp. 4770-4774.

148. Levine, RJ: Ethics for Biomedical Research Involving Human Subjects. In Smelser, NJ & Baltes, PB (editors) 2001 International Encyclopedia of the Social and Behavioral Sciences. Pp. 4783-4792.

149. Levine, RJ: Research and therapeutic innovation in the field of GI endoscopy. Gastrointestinal Endoscopy. (editorial) 53(No. 7): 826 – 828, 2001.

150. Fisher, C. B., Hoagwood, K., Boyce, C. Duster, T.,Frank, D. A., Grisso, T., Macklin, R., Levine, R. J., Spencer, M. B., Takanishi, R., Trimble, J. E., Zayas, L. H. , (2002). Research ethics for mental health science involving ethnic minority children and youth. American Psychologist, 57, 1024-1040.

151. Levine R J: Placebo controls in clinical trials of new therapies for conditions for which there are known effective treatments. In Guess HA, Kleinman A, Kusek JW and Engel, LW (editors) The Science of the Placebo: Toward an Interdisciplinary Research Agenda BMJ Books, London, 2002, pp. 264-280.

152. Carpenter. W. T., Appelbaum, P.S. and Levine RJ: The Declaration of Helsinki and clinical trials: A focus on placebo-controlled trials in schizophrenia. American Journal of Psychiatry, 2003, 160:356-362.

153. Levine, RJ: , Placebo Controls in Clinical Trials of New Therapies for Osteoporosis. Journal of Bone and Mineral Research, 18:1154-ff , 2003.

154. Brody, BA, Dickey, N, Ellenberg, SS, Heaney, RP, Levine, RJ, O’Brien, RL, Purtilo, RB and Weijer, C: Is the use of placebo controls ethically permissible in clinical trials of agents intended to reduce fracturesin osteoporosis? . Journal of Bone and Mineral Research, 18:1105-1109, 2003.

155. Levine, R.J.: The National Commission’s Ethical Principles with Special Attention to Beneficence. In Belmont Revisited: Ethical Principles for Research with Human Subjects , ed by J. F. Childress, E.M.Meslin and H.T. Shapiro Georgetown University Press, Washington, DC, 2005, pp 126 – 135.

156. Busse, WW, Wanner, A, Adams, K, Reynolds, HY, Castro, M, Chowdhury, B, Kraft, M, Levine, RJ, Peters, SP and Sullivan, EJ: Investigative Bronchoprovocation and Bronchoscopy in Airway Diseases. American Journal of Respiratory and Critical Care Medicine 172: 807-816, 2005.

157. Levine, RJ, Nelson, RM, Fleischman, AR and Sugarman, J: Ethical Issues Related to Bronchoprovocation and Bronchoscopy Research. American Journal of Respiratory and Critical Care Medicine [Appendix to the previous article.].

158. Levine, R.J.: Reflections on “Rethinking Research Ethics”. The American Journal of Bioethics 5 (No. 1): 1-3, 2005.

159. Levine, R. J.: Ethical Issues in International Vaccine Research and Development. Yale J. Biol. Med. 78: 231-237, 2005.

160. Grady, C. and Levine, RJ: Commentary 13.2: Shared Responsibilities for Treatment in the South African Phase I HIV Preventive Vaccine Trials. Ethical Issues in International Biomedical Research: A Case Book. James V. Lavery, Christine Grady, , Elizabeth R. Wahl Ezekiel J. Emanuel (eds). New York: Oxford University Press, 2007, pp. 225-230.

161. LeDuc JW, Barrett DH, Moulton AD, Goodman RA, Kinlaw K, Levine RJ. Ethical and Legal Considerations in Preparing for Pandemic Influenza. In: Institute of Medicine. Ethical and Legal Considerations in Mitigating Pandemic Disease. National Academies Press: Washington, DC. 2007, pp. 90-98.

162. Levine, RJ: On the Relations between Scientists and Journalists: Reflections by an Ethicist. .In Science and the Media: Delgado’s Brave Bulls and the Ethics of Scientific Disclosure, ed by PC, Snyder, LC Mayes and DD Spencer, Academic Press (Elsevier), Amsterdam, London, 2009, pp. 153-161.

163. Fost, N. and Levine, RJ: The Dysregulation of Human Subjects Research. Journal of the American Medical Association. 298: 2196-2198, 2007.

164. Levine, R.J.: The Nature, Scope and Justification of Clinical Research: What is Research? Who is a Subject? In The Oxford Textbook of Clinical Research Ethics, edited by E.J. Emanuel, C. Grady, R.A. Crouch, R. K. Lie, F.M.Miller and D. Wendler, Oxford University Press, Oxford, 2008, Chapter 21, pp. 211-221.

165. Levine, RJ: Research Involving Adolescents as Subjects: Ethical Considerations. Annals of the New York Academy of Sciences 1135, 280-286, 2008.

166. Levine, RJ: Federal Funding and the Regulation of Embryonic Stem Cell Research: The Pontius Pilate Maneuver. Yale Journal of Health Policy, Law & Ethics. 9 (2) 552-564, 2009.

ABSTRACTS

1. Lovenberg, W., Levine, R.J., Sjoerdsma, A.: Sensitive assay of monoamine oxidase activity: Application to sympathetic ganglia and heart. Fed Proceedings 20:318, 1961.

2. Levine, R.J., Sjoerdsma, A.: Direct measurement of monoamine oxidase inhibition in humans. Fed Proceedings 21:179, 1962.

3. Levine, R.J., Oates, J.A., Vendsalu, A., Sjoerdsma, A.: Aromatic amine metabolism in relation to altered thyroid function: Clin Research 10:230, 1962.

4. Rivlin, R.S., Levine, R.J.: Hepatic tyrosine transaminase activity and plasma tyrosine levels in relation to altered thyroid function in rats. Clin Research 10:403, 1962.

5. Levine, R.J., Lovenberg, W., Sjoerdsma, A.: Hydroxylation of tryptophan and phenylalanine by murine neoplastic mast cells. Fed Proceedings 23:563, 1964.

6. Levine, R.J., Sato, T., Sjoerdsma, A.: Inhibition of histamine synthesis in the rat. Pharmacologist 6:194, 1964.

7. Sato, T., Lovenberg, W., Levine, R.J., Sjoerdsma, A.: The properties of a tryptophan hydroxylase from neoplastic mouse cells. Fed Proceedings 24:580, 1965.

8. Levine, R.J.: Effects of hydrazine-analog-of-histidine on gastric acid secretion in the rat. Fed Proceedings 24:578, 1965.

9. Levine, R.J., Conn, H.O.: Tyrosine metabolism in liver disease in man. Clin Research 13:372, 1965.

10. Levine, R.J., Watts, D.E.: Inhibition of histidine decarboxylase activity in vitro by norepinephrine and dopamine. Fed Proceedings 25:691, 1966.

11. Levine. R.J.: Inhibition of histamine synthesis in man by 4-bromo-3-hydroxybenzyloxyamine dihydrogen phosphate. Pharmacologist 8:185, 1966.

12. Gillespie, E., Malawista, S.E., Levine, R.J.: Inhibition by colchicine of histamine release from rat peritoneal mast cells. Fed Proceedings 26:786, 1967.

13. Phair, J.P., Levine, R.J., Kantor, F.S.: Pharmacologic inhibition of histamine synthesis: A new approach to treatment of allergic disease? J Allergy 39:111, 1967.

14. Shearman, D.J.C., Floch, M.H., Herskovic, T., Levine, R.J., Spiro, H.M.: Alimentary tract lesions in rats born of iron deficient mothers. Clin Research 15:243, 1967.

15. Wustrack, K.O., Levine, R.J.: Plasma levels of histidine decarboxylase inhibitors in man. Clin Research 15:473, 1967.

16. Levine, S.M., Shearman, D.J.C., Herskovic, T., Levine, R.J.: Suppression of gastric secretion in patients with Zollinger- Ellison syndrome with brocresine. Clin Research 16:287, 1968.

17. Noll, W.W., Levine, R.J.: Histidine decarboxylase in gastric tissue of primates. Pharmacologist 10:184, 1968.

18. Vaidya, A.B., Levine, R.J.: Inhibition of diamine oxidase activity in human plasma in vitro by hydralazine. Clin Research 17:585, 1969.

19. Gillespie, E., Levine, R.J.: Effects of cyclic adenosine 3',5'-monophosphate and calcium on colchicine binding in tissue slices. Fed Proceedings 29:474, 1970.

20. Hamilton, B.P.M., Landsberg, L., Levine, R.J., Tashjian, A.H., Jr.: Sipple's syndrome: Results of screening a large family. Clin Research 21:979, 1973.

21. Marcy, S.E., Levine, R.J.: Effect of issuing formal guidelines on the activities of an institutional review board for protection of human subjects. Clin Research 23:266A, 1975.

22. Vaidya, A.B., Rajagopalan, T.G., Pimparkar, B.D., Levine, R.J.: Acid secretion by human stomach -- the role of histamine and gastrin. Proceedings: XXVI Int Cong Physiol 11:134, 1974.

23. Hamilton, B.P.M., Landsberg, L., and Levine, R.J.: Sipple's syndrome: Familial medullary carcinoma of the thyroid, hyperparathyroidism, and epinephrine-secreting pheochromocytoma. Endocrinology 94:A-244, 1974.

24. Levine, R.J.: "Do not resuscitate" orders: Pragmatic considerations. Archives of the Foundation of Thanatology 7(No. 1): 33, 1978.

MISCELLANEOUS PUBLICATIONS

1. Diagnosis of pheochromocytoma. NEJM 277:762-763, 1967 (Editorial).

2. Monographs in Allergy. Vol. 2, Tissue Mast Cells in Immune Reactions. Yale J Biol Med 39:273, 1967 (Book review).

3. The Salicylates: A critical Bibliographic Review. Yale J Biol Med 40:75, 1967 (Book review).

4. Anaphylactoid Edema. Yale J Biol Med 41:404-405, 1969 (Book review).

5. Plasma diamine oxidase in pregnancy. Am J Obstet Gynecol 106:1248, 1970; with R. Resnik (Letter to the Editor).

6. Stress ulcers. NEJM 282:978-979, 1970 (Letter to the Editor).

7. On the boardwalk in Atlantic City. The Pharos 33:24-27, 1970.

8. Social issues related to health: Drug abuse. Clin Research 19:595-597, 1971 (Editorial).

9. Registration fees for the Clinical Meetings in Atlantic City. Clin Research 20:1-3, 1972 (Editorial).

10. Listings of available faculty positions. Clin Research 20:123-124, 1972 (Editorial).

11. The AFCR moves toward social and political activism. Clin. Research 20:663-665, 1972 (Editorial).

12. Faculty positions listings. Clin Research 20:830-832, 1972 (Editorial).

13. New subspecialty classifications for the Clinical Meetings. Clin Research 21:10-11, 1973 (Letter from the Editor).

14. Ethical considerations in the publication of the results of research involving human subjects. Clin Research 21:763- 767, 1973 (Editorial).

15. A visitor from Mars. Clin Research 21:793, 1973 (Letter from the Editor).

16. Experiments in Education. Clin Research 21:903-905, 1973 (Editorial). 17. Response to Dr. Katz. Clin Research 22:76, 1974 (Letter from the Editor).

18. Position statement of the American Federation for Clinical Research on the proposed amendment to Subtitle A of the DHEW regulations. Clin Research 22:52-54, 1974.

19. The Hawthorne Effect. Clin Research 22:111-112, 1974; with E.D. Cohen (Editorial).

20. Position statement of the American Federation for Clinical Research on the proposed policies and procedures for protection of human subjects. Clin Research 22:135-138, 1974.

21. Position statement of the American Federation for Clinical Research on the DHEW proposed rules on the protection of human subjects. Clin Research 23:53-60, 1975.

22. Symposium on definitions of fetal life. Clin Research 23:103-105, 1975 (Editorial).

23. Diagnosis and treatment of malignant carcinoid syndrome. JAMA 231:914-915, 1975 (Letter to the Editor).

24. In comment on Experiments on People. JAMA 232:259-261, 1975 (Commentary).

25.* The boundaries between biomedical or behavioral research and the accepted and routine practice of medicine. July 14, 1975, 25 pp.; Addendum: September 24, 1975, 19 pp.

26.* The role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects. October 27, 1975, 58 pp.

27.* The nature and definition of informed consent in various research settings. December 1, 1975, 91 pp.

28.* Appropriate guidelines for the selection of human subjects for participation in biomedical and behavioral research. February 2, 1976, 103 pp.

29.** The Institutional Review Board. April 1, 1976, 73 pp.Reprinted in Appendix to: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Report and Recommendations: Institutional Review Boards. DHEW Publication No. (OS) 78-0009, Washington, 1978.

30.** On the relevance of ethical principles and guidelines developed for research to health services conducted or supported by the Secretary, DHEW. May 28, 1976, 36 pp.

Reprinted in Appendix to: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Ethical Guidelines for the Delivery of Health Services by DHEW. DHEW Publication No. (OS) 78-0011, Washington, 1978.

31.** Similarities and differences between biomedical and behavioral research. July 16, 1976, 27 pp.

32. Commentary on Research and the Law. Terminological inexactitude. In: Legal and Ethical Issues in Human Research and Treatment: Psychopharmacologic Considerations, edited by D.M. Gallant and R. Force, Spectrum Publications, New York, 1978, pp 85-98.

33. Drug evaluation in children: Ethical, legal and regulatory considerations. In: Clinical Pharmacology and Therapeutics: A Pediatric Perspective, edited by B.L. Mirkin, Year Book Medical Publishers, Chicago, 1978, pp. 275-278 (Introduction).

34. Re: Metaethics and the New Biology. Pharos 41(2):36, 1978 (Letter to the Editor).

35. Regulation of drug abuse research involving human subjects. Proceedings of the Fortieth Annual Scientific Meeting, Committee on Problems of Drug Dependence, pp. 45-55, 1978.

36. The Traditional Medical Model. Foreword to Mental Illness and the Problem of Boundaries, by M.G. Miller (edited by M.B. Schworm), Medicine in the Public Interest, Inc., Washington, 1979, pp. v-viii.

37. Welcome to IRB: Plans and policies. IRB: A Review of Human Subjects Research. 1(No. 1):4, March, 1979 (Editorial).

38. The future of clinical research. NEJM 301:1295-1296, 1979 (Occasional note).

39. Medical students as social scientists: Are there role conflicts? IRB: A Review of Human Subjects Research. 2 (No. 1): 6-8, January, 1980 (Case Study).

40. Therapeutic and nontherapeutic research. Hastings Center Report 9 (No. 6): 48, December, 1979 (Letter to the Editor).

41. Ethical considerations in the development and application of compliance strategies for the treatment of hypertension. In: Patient Compliance to Prescribed Antihypertensive Medication Regimens: A Report to the National Heart. Lung, and Blood Institute, Bethesda, 1980, (NIH Publication No. 81-2102), pp. 229-248.

42. Proposed statutory definition of "voluntary and informed consent." Annals Int Med 92:699-700, 1980 (Editorial note).

43. Contemporary Issues in Biomedical Ethics. The Journal of Family Practice 12:550ff, 1981 (Book review).

44. Institutional Review Board. JAMA 244:769-770, 1980 (Letter to the Editor).

45. Risk of injury associated with twenty invasive procedures used in human experimentation and assessment of reliability of risk estimates. In: Compensating for Research Injuries: The Ethical and Legal Implications of Programs to Redress Injured Subjects, Volume 2, President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Washington, 1982, pp. 73-171 (Harvey, M., Levine, R.J.).

46. How general an assurance? IRB: A Review of Human Subjects Research. 3 (No. 5): 8-9, May, 1981.

47. Commentary on the readability of consent forms. IRB: A Review of Human Subjects Research. 4 (No. 1): 8-9, January, 1982.

48. Reply to Capron on the use of the term "therapeutic research." IRB: A Review of Human Subjects Research. 4 (No. 1): 10-11, January, 1982.

49. Research on prisoners: Why not? IRB: A Review of Human Subjects Research. 4 (No. 5): 6, May, 1982.

50. Management of patient compliance in the treatment of hypertension: Report of the NHBLI Working Group. Hypertension 4:415-423, 1982. (R.B. Haynes, M.E. Mattson, A.V. Chobanian, J.M. Dunbar, T.O. Engebretson, Jr., T.F. Garrity, H. Leventhal, R.J. Levine, R.L. Levy).

51. According to protocol. IRB: A Review of Human Subjects Research. 4 (No. 6): 9, June/July, 1982.

52. The Social Context of Medical Research. JAMA 248:1909, 1982 (Book Review).

53. Ethical aspects of clinical trials. In: Statistics in Medical Research: Methods and Issues, with Applications in Cancer Research. ed. by V. Mike and K.E. Stanley, John Wiley & Sons, New York, 1982, pp. 164-168.

55. Commentary: Responses to whistleblowing: The experience of Yale University School of Medicine, Chapter 8 in Whistleblowing in Biomedical Research: Policies and Procedures for Responding to Reports of Misconduct, ed. by J.P. Swazey and S.R. Scher, President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Washington, 1982, pp. 79-83.

56. Reply to Dubler on the burdens of research in prisons. IRB: A Review of Human Subjects Research. 4 (No. 9): 10-11, November, 1982.

57. Consent to incomplete disclosure as an alternative to deception. IRB: A Review of Human Subjects Research. 4 (No. 10): 9-11, December, 1982 (Case Study).

58. The relevance of guidelines developed for the ethical conduct of research involving human subjects to the practice of preventive medicine. In: Biomedical Ethics: Unique Issues for Preventive Medicine, ed. by C.C. Conrad, American College of Preventive Medicine, Washington, 1982, pp. 11-18.

59. Report on do not resuscitate decisions. Connecticut Medicine 47:477-483, 1983. (Report of the Yale-New Haven Hospital Committee on Policy for Do Not Resuscitate Decisions, R.J. Levine, Chair).

60. Do not resuscitate decisions: A Policy. Connecticut Medicine 47:511-512, 1983; with K.A. Nolan (Editorial).

61. Implementing Human Research Regulations: The Adequacy and Uniformity of Federal Rules and of Their Implementation. Intenational Digest of Health Legislation. 34:711-714, 1983 (Book Review).

62. Legal and Ethical Problems in Clinical Research. In: The Clinical Research Process in the Pharmaceutical Industry, ed. by G.M. Matoren, Marcel Dekker, Inc., New York, 1984, pp. 67-88 (R.J. Levine and A.R. Holder).

63. No Code! Bioethics Reporter. Commentary, pp. 10-11, 1983.

64. Where do you stand on the coding question? A doctor responds. Nursing '84: 44-45, 1984 (Commentary).

65. The IRB-IRG conflict. IRB: A Review of Human Subjects Research. 5 (No. 3): 10-11, May/June, 1983 (Letter).

66. Educating IRBs on ethical issues. IRB: A Review of Human Subjects Research. 6 (No. 3): 10-11, May/June, 1984 (Letter).

67. Comment on van Eys's "The concept of the IRB and bureaucratic reality." IRB: A Review of Human Subjects Research. 6 (No. 4): 9-10, July/August, 1984.

68. What kinds of subjects can understand this protocol? IRB: A Review of Human Subjects Research. 6 (No. 5): 6-8, September/October, 1984 (Case Study).

69. Total artificial heart implantation -- eligibility criteria. JAMA 252:1458-1459, 1984 (Editorial).

70. The IRB and the virtuous investigator. IRB: A Review of Human Subjects Research. 7 (No. 1): 8, January/February, 1985 (Commentary).

71. Research Safeguards. The Hartford Courant. Monday, August 5, 1985 (Editorial).

72. Can a healthy subject volunteer to be injured in research? Hastings Center Report. 16 (No. 4): 32, August, 1986 (Commentary).

73. Placebo controls in the evaluation of new drugs for patients with AIDS. Testimony presented to the Intergovernmental Relations and Human Resources Subcommittee, Committee on Government Operations, U.S. House of Representatives, July 1, 1986. Reprinted in BioLaw 1 (No.1): U80-U84, August, 1986.

74. Introduction to "Humanities and the Health Professions". The Connecticut Scholar 8: 1-2, 1986.

75. Emerging technology: Patient protection versus proliferation. J. Clin. Gastroenterol. 9 (3): 258-273, 1987. (Symposium edited by L.F. McMahon).

76. Commentary on McLarty: How many subjects are required for a study? IRB: A Review of Human Subjects Research 9 (No. 5): 3, September/October, 1987.

77. Should I enroll in a randomized clinical trial? Excerpts from a patient's guide. IRB: A Review of Human Subjects Research 10 (No. 2): 10-11, March/April, 1988.

78. Commentary on case study: The doctor's unproven beliefs and the subject's informed choice. IRB: A Review of Human Subjects Research 10 (No. 3): 5, May/June, 1988.

79. Response to Charles Harris, M.D.: Irrepressible Ethicists. Medical Tribune, September 22, 1988, p. 19.

80. An IRB-approved protocol on the use of human fetal tissue. IRB: A Review of Human Subjects Research. 11 (No. 2):7-8, March/April, 1989 (Testimony).

81. Commentary on Marquis and Stephens. IRB: A Review of Human Subjects Research. 11 (No.3):9-11, May/June, 1989.

82. Institutional review boards. British Medical Journal 298:1268-1269, 1989 (Editorial).

83. Research on dead persons. Annals of Internal Medicine 111:89-90, 1989 (letter to the Editor).

84. Fetal research: The underlying issue. Scientific American 261 (No. 2):112, August, 1989 (Essay).

85. Legal and ethical problems in clinical research. Clinical Research Practices & Drug Regulatory Affairs 7:315-370, 1989. (revised version of miscellaneous publication #62) (R.J. Levine and A.R. Holder).

86. Comment on Richard Royall's "Ethics and statistics in clinical trials." Statistical Science 6:71-74, 1991.

87. Some reflections on postgraduate medical ethics education. In Symposium '90 Proceedings: Medical Ethics for Postgraduate Medical Students. Ed. by F.E Baylis and J.G. Downie, Westminster Institute for Ethics and Human Values, London, Ontario, 1990, pp. 39-48. Reprinted with stylistic changes in Ethics and Behavior 7(1): 15-26, 1997.

88. Deferred consent. Controlled Clinical Trials. 12:546-550, 1991 (Editorial).

89. A novelists's view of scientific fraud. Law, Medicine & Health Care 18 (No. 4):422-423, 1990 (Book Review Essay).

90. Commentary on E. Howe's and E. Martin's 'Treating the Troops.' Hastings Center Report 21 (No. 2): 27-29, March-April, 1991.

91. AIDS research and ethical review boards. In Ethics and Law in the Study of AIDS, Ed. by H. Fuenzalida-Puelma, A.M. Linares Parada and D.S. LaVertu. Pan American Health Organization, Washington, DC, 1992, pp. 170-177.

92. Ethical considerations in clinical trials: The U.S.A. perspective. Journal of Clinical Research and Pharmacoepidemiology 5:99-104, 1991.

93. Commentary on the case of "Premature Surrender": Negotiating with George. Ethics and Behavior 2:68-71, 1992.

94. Vaccine and drug trials -- Ethical issues. In: Ethics and Epidemiology: International Guidelines: Proceedings of the XXVth CIOMS Conference, Ed. by Z. Bankowski, J.H. Bryant, and J.M. Last, CIOMS, Geneva, 1991, pp. 104-107.

95. Epidemiology and Ethics: The ethicist's perspective. In: Ethics and Epidemiology: International Guidelines: Proceedings of the XXVth CIOMS Conference, Ed. by Z. Bankowski, J.H. Bryant, and J.M. Last, CIOMS, Geneva, 1991, pp. 146-149.

96. The history of the development of ethical codes for research involving human subjects. In: Annals: Marangopoulos Foundation for Human Rights, ed. by A. Yotopoulos-Marangopoulos, Editions A. Sakkoulas, Athens, 1991, pp. 333-346.

97. Bioethical considerations in the development and use of innovative new drugs: Biotechnology, genetic engineering, etc. Innovation and Regulation: Challenges of a Changing Environment. Proceedings of the fourth annual End-of Summer Science Symposium, American Pharmaceutical Association and Academy of Pharmaceutical Research and Science, APhA, Washington, 1991, pp. 111-122 (lecture and discussion).

98. Research on human populations: National and international ethical guidelines. Law, Medicine & Health Care 19:157-161, 1991. (Editorial by Dickens, B.M., Gostin, L. and Levine, R.J.).

99. A question of anatomy. New York Times April 14, 1992, p. A-24. (letter to the editor).

100. The New Medicine & The Old Ethics: Yale Journal of Biology and Medicine, 65: 147-149, 1992 (Book Review).

101. Situation ethics. The Pharos 55:41, Fall 1992 (letter to the Editor).

102. Applying relevant international ethical principles. AIDS Research and Human Retroviruses 9 (Suppl. 1): S155-S156, 1993. (Presentation at the Symposium on Preparedness for HIV Vaccine Efficacy Trials)

103. Keynote Address, XXVIth CIOMS Conference, in Ethics and Research on Human Subjects: International Guidelines. Ed. by Z. Bankowski & R.J. Levine, Council of International Organizations of Medical Sciences (CIOMS), Geneva, 1993, pp. 4-10.

104. Conclusions and implications for further action, in Ethics and Research on Human Subjects: International Guidelines. Ed. by Z. Bankowski & R.J. Levine, Council of International Organizations of Medical Sciences (CIOMS), Geneva, 1993, pp. 217-220.

105. Ethics of clinical trials: Do they help the patient? Cancer 72 (Suppl. 9):2805-2810, 1993.

106. Monitoring for adherence: Ethical considerations. American Journal of Respiratory and Critical Care Medicine 149:287-288, 1994 (editorial).

107. New international ethical guidelines for research involving human subjects. Annals of Internal Medicine. 119:339-341, 1993. (Editorial).

108. Ethics at INCLEN XI: A Personal Memoir. INCLEN Newsletter. 13 (No. 1):5-6, Spring 1993.

109. Randomized Clinical Trials: Ethical considerations, in Principles of Medical Biology, Vol. 1A. Ed. by E.E. Bittar and N. Bittar, JAI Press, Greenwich, CT, 1994, Chapter 4, pp. 37-63.

110. Recruitment and retention of women in clinical studies: Ethical considerations, In Women and Health Research: Ethical and Legal Issues of Including Women in

Clinical Studies, Volume 2. Ed. by A.C. Mastroianni, R. Faden and D. Federman, Institute of Medicine, National Academy Press, Washington, 1994, pp. 57-64.

111. Kevorkian on shaky ethical ground. New Haven Register June 12, 1994, p. B3 (Op-ed).

112. Research involving children as subjects. In Birth to Death: Science and Bioethics. Ed. by D.C. Thomasma and T. Kushner, Cambridge University Press, Cambridge, 1996, pp. 270-282.

113. Children as research subjects: Ethical and legal considerations. Child and Adolescent Psychiatric Clinics of North America 4: 853-868, 1995.

114. Access to information: Patients and communities; Introduction. In Drug Surveillance: International Cooperation Past, Present and Future; ed. by Z. Bankowski & J.F. Dunne, Council of International Organizations of Medical Sciences (CIOMS), Geneva, 1994, pp. 159-160.

115. Research in emergency situations: The role of deferred consent. Journal of the American Medical Association. 273:1300-1302, 1995 (Editorial).

116. Proposed regulations for research involving those institutionalized as mentally infirm: A consideration of their relevance in 1995. Accountability in Research 4:177-186, 1996. Reprinted with stylistic changes in Ethics in Neurobiological Research with Human Subjects, ed. by A.E. Shamoo, Gordon and Breach Publishers, Amsterdam, 1997, Chapter 2, pp. 45-54 and in IRB: A Review of Human Subjects Research 18 (No. 5):1-5, 1996.

117. Open letter to Ruth R. Faden on the current system for the protection of the rights and welfare of human research subjects. Final Report: Advisory Committee on Human Radiation Experiments. Suppl. Vol. I, US Govt. Printing Office, (stock #061-000-00850-1), Washington, 1995, pp. 816-818.

118. Comment on FDA proposed rule on waiver of informed consent requirement in emergencies. IRB: A Review of Human Subjects Research 17(No. 5 & 6):21-22, 1995.

119. Canavan gene therapy protocol. Science. 272:1085, 1996. (Letter to the Editor).

120. Glossary of Lay Language Synonyms for Common Terms Used in Informed Consent Documents for Clinical Studies: A Handbook for Clinical Researchers. by Deborrah Norris, Publ. by Pharmaceutical Information Associates, Ltd., Levittown, PA, 1966. (Preface by R.J. Levine).

121. Randomized clinical trials in periodontology: Ethical considerations. Annals of Periodontology 2 (No. 1):83-94, 1997 (with David K. Dennison).

122. Response to question in the American Medical News Ethics Forum (untitled). American Medical News, March 24/31, 1997, p. 49.-12-

123. Protecting Human Subjects: Departmental Subject Pools and Institutional Review Boards, ed. by G. Chastain and R.E. Landrum. American Psychological Association, (in press) (foreword by R.J. Levine).

124. Institutional Review Boards. International Journal of Pharmaceutical Medicine. xx:xx-xx, 1997.

125. Global Issues in Clinical Trials. In: Global Dimensions of Domestic Health Issues, ed. by M. Osterweis & D. E. Holmes, Association of Academic Health Centers, Washington, 2000, pp. 119 – 130.

126. Commentary on the decision by the National Bioethics Advisory Commission (NBAC) to employ the illogical distinction between therapeutic and nontherapeutic research, BioLaw 2(Nos. 9 & 10): S:424 – S:428, 1999.

127. On becoming a bioethicist. In: Coming to Medicine in the 21st Century, ed by R. Donaldson, K Lundgren & H Spiro. Yale University Press, New Haven, (in press).

128. Reflections on Chairing an IRB. In: Institutional Review Board: Management and Function, ed. By R. Amdur and E. Blankert, Jones and Bartlett, Boston, 2002, pp. 79 – 81.

129. Clarifying Standards for Using Placebos. Science. 300 (June 13, 2003): 1658-59, 2003.

130. Informed Consent and Consent forms for research participants. American Psychological Society Observer. 17 (No.4): 25-26, April, 2004 (with Joan Sieber).

131. Ethical Principles for the Conduct of Research Involving Human Subjects: Historical Considerations. J. Clin. Ethics 15 (No.1): 13-21, 2004.

132. Introduction to the Conference by the chairperson, Considering Usual Medical Care in Clinical Trial Design: Scientific and Ethical Issues, National Institutes of Health Program on Clinical Research Policy Analysis and Coordination, Office of Science Policy, 2006 10-12.

133. Empirical research to evaluate IRB’s burdensome and, perhaps, unproductive policies and practices: a proposal. Journal of Empirical Research on Human Research Ethics 1 (No. 3): 1-4, 2006 (Editorial)

134. Ethical Guidelines in Pandemic Influenza. [Recommendations of the Ethics Subcommittee of the Advisory Committee to the Director. Centers for Disease

Control and Prevention and approved for release by the Director, February 15, 2007]. (with K. Kinlaw) http://www.cdc.gov/od/science/phec/panFlu_Ethic_Guidelines.pdf

135. Issues in regulatory guidelines for data monitoring committees Clinical Trials 1: 162-169, 2004 (Demets, D, Califf, R., Dixon, D., Ellenberg, S., Fleming, T., Held, P., Julian, D., Kaplan, R., Levine, R J., Neaton, J., Packer, M., Pocock, S., Rockhold, F., Seto, B., Siegel, J., Snappin, S., Stump, D., Temple, R., Whitley, R.) http://ctj.sagepub.com/cgi/content/abstract/1/2/162

*Papers numbered 25-28 are reprinted in Appendix I to: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. DHEW Publication No. (OS) 78-0013, Washington, 1978.

**Prepared for and published in the agenda books of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.