Curriculum Guide

Mary Faith Marshall and Jerry Menikoff,
Course Directors Kansas University Medical Center

PRVM 806 (07207) Fall 2002
Time: Tuesdays 5:00-6:50 pm
Location: B018 School of Nursing
Education Specialist: Linda Puetz, BA, BSN, RN
Credit Hours: 2.0
Graduate Teaching Assistant: TBA CME, CNE, and CEU provided

This 2-credit hour course is for candidates in the Master of Public Health program. The course is open to other students or auditors by permission of the course directors.

GOALS AND OBJECTIVES: The principal goal of this course is to examine the ethical and public policy questions that arise in research with human subjects. Following participation in the course, participants will be able to:

Describe the history of human subjects research and the development of its ethical norms. Describe an overview of the regulatory framework and the oversight mechanisms which govern human subjects research. Identify and promote elements of the research environment that promote research integrity at both the individual and institutional levels. Engage in productive and collegial interactions with investigators, research subjects, mentors and trainees. Discuss the normative and other philosophical questions arising in human subjects research. Identify distinguishing features of clinical science as a moral enterprise and of investigators as moral agents.

FACULTY: The multidisciplinary faculty is comprised of local and national experts. Course directors are:

Jerry Menikoff, M.D., J.D. Associate Professor of History and Philosophy of Medicine 913-588-7662 jmenikoff@kumc.edu

COURSE SCHEDULE:

August 27: The Evolution of the Ethics of Human Subjects Research and Current Mechanisms of Federal Oversight Faculty: Robert Levine, MD, Professor of Medicine, Yale University School of Medicine

September 3: The Theory and Practice of Research Ethics Faculty: Mary Faith Marshall, PhD, Professor of Medicine and Bioethics, Kansas University Medical Center

September 10: Responsible Conduct in Research: Promoting Scientific Integrity and Preventing Scientific Misconduct Faculty: Chris Pascal, PhD, Director, Office of Research Integrity, Department of Health and Human Services

September 17: Ethical Issues in Genetics Research David Grainger, MD, MPH, FACOG Director, The Center for Reproductive Medicine, University of Kansas School of Medicine – Wichita

September 24: Ethical Issues in Behavioral and Social Sciences Research Faculty: John Colombo, Ph.D., Associate Dean, Graduate Division, College of Liberal Arts and Sciences, Professor of Psychology, Chairman, Human Subjects Committee, The University of Kansas-Lawrence

October 1: Legal Issues in Research Faculty: Jerry Menikoff, MD, JD, Associate Professor, History and Philosophy of Medicine, Chairman, Institutional Review Board Kansas University Medical Center

October 8: Ethical Issues in Assisted Reproductive Technologies Faculty: David Grainger, MD, MPH, FACOG Director, The Center for Reproductive Medicine University of Kansas School of Medicine – Wichita

October 15: The Good Colleague: Ideals for Mentoring and Collaboration Faculty: Robert Klein, PhD, Professor of Anatomy and Cell Biology, Associate Dean for Academic Affairs, School of Medicine Kansas University Medical Center

October 22: Data Management/ Data Safety and Monitoring Faculty: Rebecca Clark-Snow, RN, BSN, KUMC Cancer Center Research Coordinator, Kansas University Medical Center

October 29: The Ethics of Peer Review, Authorship and Publication Faculty: K. Michael Welch, MB, ChB, FRCP, Vice Chancellor for Research and President, KUMC Research Institute, Inc.

November 5: Informed Consent and Research with Children Faculty: Eric Kodish, MD, Associate Professor of Medical Ethics, Pediatrics and Oncology, School of Medicine, Case Western University

November 12: The Community Model of Research Methodology Faculty: Kim Kimminau, PhD, Vice President for Research, Kansas Health Institute, Topeka, KS

November 19: Representing Research Dilemmas in 20th Century Popular Media Faculty: Chris Crenner, Ph.D., MD Acting Chairman, Department of History and Philosophy of Medicine, Kansas University Medical Center and Representing Research Dilemmas in Stories and Novels Faculty: Martha Montello, Ph.D. Assistant Professor, History and Philosophy of Medicine Kansas University Medical Center

November 26: Promoting Objectivity, Eliminating Bias and Managing Conflicts of Interest Faculty: Harold N. Godwin, MS, RPh, Professor of Pharmacy Practice and Associate Dean, Pharmacy School, Chairman, Conflict of Interest Committee, Kansas University Medical Center

December 3: Research with Vulnerable Subjects Faculty: Nancy Neveloff Dubler, Director, Division of Bioethics, Montefiore Medical Center, Professor of Epidemiology & Social Medicine, Albert Einstein College of Medicine and Travis Thompson PhD, Director, Institute for Child Development, KUMC

December 10:NO CLASS (Thanksgiving Week)

December 17: No Presentation Written Paper Due Extra Hour Credit Papers Due Paper Presentations Course Evaluation

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