Cross-listed as: MHHS M504 C907

Website: http://www.iupui.edu/~histwhs/G504.dir/G504SYLLABUS.htm

Background: Beginning in 1990, the National Institutes of Health (NIH) required all pre-doctoral and postdoctoral trainees supported by training grants (T-32 grants) to receive formal training in the responsible conduct of research. This course was developed and offered for the first time in the fall of 1996 in order to meet the federal requirements for these trainees. Since that time, a number of schools and departments at IUPUI have chosen to require their graduate students to take this course. In December of 2000, the Office of Research Integrity (ORI) announced a new federal policy that all research staff on NIH-supported grants would be required to document formal training in research ethics. The original deadline was October 2003 for all research staff to have received a program of instruction. On February 5, 2001, the Bush Administration suspended the implementation policy. Implementation is now occurring on a piecemeal basis, (e.g. the current requirement for all key personnel on projects involving research with human subjects to document training in human subjects research). However, there is a high likelihood that the policy will be implemented at some point in the future.

The course covers historical and contemporary issues related to scientific integrity and the responsible conduct of research including policies and procedures related to scientific misconduct, authorship and peer review, conflicts of interest, the use of humans and animals in biomedical research, the ownership of data, intellectual property, international research and ethical issues related to genetic technology.

Purpose: One definition of the word ìethicalî is ìconforming to accepted standards, especially professional standards, of conduct.î The purpose of this class is not to inculcate virtue, nor to determine whether or not you are ethical; rather, the purpose is to inform you about the rules and the accepted standards of behavior and to help you develop skills for dealing with hard problems on your own. I believe that this is important because all too often there are no hard and fast rules for determining what is the proper thing to do. Standards of conduct may vary from community to community, or even from discipline to discipline. While students often find this fact frustrating, it also means that one must learn to think through these issues for oneself in order to develop a plan of action that is defensible to oneself in the event that one may have to explain it to others.

About the Course Director: Dr Kimberly Quaid is the course director for G504. She organized the course in 1995 and has taught in and directed the course since that time. Dr. Quaid was the Executive Secretary for the Chair of the IUPUI Committee on Ethics in Research from 1995-1998 and was Chair of the Committee from 1998-2002. She is a psychologist by training and is currently a Professor in the Departments of Medical and Molecular Genetics, Psychiatry and Medicine. She is also Core Faculty of the IU Center for Bioethics established in 2001.

Course Goals: The goals are that at the end of this course, students will be able to:

Demonstrate the skills needed to solve problems involving relevant topic areas of the responsible conduct of research.
Clearly articulate both verbally and in writing ethical and legally acceptable solutions to problems that arise in the conduct of science.
Propose and critically analyze solutions to problems in the context of relevant written codes and unwritten conventions.
Develop an interest in and a positive attitude toward lifelong learning in matters of scientific integrity and the responsible conduct of their chosen profession.

Course Objective: The primary objective of this course is to provide graduate students, postdoctoral students, and faculty with skills and resources valuable for survival. The primary goals of this course are:

To refine and define expected standards of conduct.
To increase your confidence in dealing with difficult issues.
To meet current NIH requirements for formal training in research ethics.

Texts:

Macrina FL (Ed.) Scientific Integrity: An Introductory Text with Cases. Washington, D.C., ASM Press, Second Edition, 2000.

The following readings will be handed out in class.

Bebeau MJ Developing a well-reasoned response to a moral problem in scientific research in Moral Reasoning in Scientific Research: Cases for Teaching and Assessment developed by MJ Bebeau, KD Pimple, KMT Muskavitch, SL Borden, and DH Smith, 1995.

Grading:

This course may be taken either for a grade or Pass/Fail. If you wish to take the course Pass/Fail, you will need to register for this option with the registrar when you sign up for the course or during the first few weeks in class. The deadline for choosing the Pass/Fail option is September 14, 2004. If you do not register for this option, you will receive a grade.

In order to meet the needs of the various constituents on campus, this course can be taken for variable credit ranging from 2-3 credits. The expectations for each of these credit options are explained below. Attendance will be taken.

1. Two Credits

Students who are taking this class for two credits are expected to attend and to participate actively in all sessions. In addition there will be two written case analyses and a final examination. For those of you who wish to take the course for a grade, the grading for the course is as follows:

Attendance/Class Participation 10%

Written Assignments 30%

Final Examination 60%

2. Three Credits

Students who are taking this class for three credits are expected to attend and to participate actively in all sessions. In addition to two written assignments and a final examination, there will be an 8-10 page paper. Paper topics must be approved by me by mid-semester. For those of you who wish to take the course for a grade, the grading for the course is as follows:

Attendance/Class Participation 10%

Written Assignments (Cases) 20%

Paper 20%

Final Examination 50%

Case Analysis: One way to learn to think through these issues is through case analysis. We will be discussing various cases in class. Most will be short cases from your book and are listed as cases for discussion for that day. For most days, the last part of the class will consist of a discussion of cases related to the topic of the day. You will occasionally be asked to break into groups to discuss the cases amongst yourselves and then present your conclusions to the class in an organized manner. When we break into groups, I suggest that each group choose one presenter to present the case to the rest of the class and one recorder to take notes of the discussion.

The second week of class you will be given a monograph: Bebeau MJ Developing a well-reasoned response to a moral problem in scientific research in Moral Reasoning in Scientific Research: Cases for Teaching and Assessment developed by MJ Bebeau, KD Pimple, KMT Muskavitch, SL Borden, and DH Smith, 1995. Please read through this carefully. This monograph is to be used as a guide for discussing cases and for writing up the cases.

Each case will be evaluated on the basis of the following criteria:

1. Identification of issues and points of conflict presented in the case.

2. Identification of interested parties

3. Identification of possible actions and consequences

4. Identification of obligations of interested parties

5. Conclusion and rationale: In other words, you must come to a conclusion regarding what is the proper thing to do and justify your conclusion. This justification should refer to specific moral principles (Dr. Eberlís lecture should be helpful), should be logical, and should flow from your conclusion.

Written Assignments: All written assignments must be typed and must be handed in as a paper copy on the day of class that the assignment is due. If there is a problem handing in a paper on time, I must be informed of this fact prior to the due date for the paper. I know that you are all busy and I try my best to be flexible so do not hesitate to ask.

I. Topic-Oriented Projects (Choose either A or B) Due 10/12/04

A. Scientific Misconduct Paper

For this paper, I would like you to present and analyze a recent case that represents an issue of scientific misconduct or a dispute about misconduct. You can use books, newspapers, scientific magazines and journals or cases you can find on the web. Examples include: David Baltimore and Thereza Imanishi-Kari, Robert Gallo, cold fusion, or the Kennedy Krieger Case (Johns Hopkins), the death of Jessie Gelsinger (University of Pennsylvania), third party subjects (Virginia Commonwealth.) etc. Papers should be 4-5 pages (at least 1000 words) in length excluding references.

B. Analysis of ethical issues

For this paper, I would like you to present and analyze an ethical issue in an area of scientific activity that is of particular interest to you in your own work. Examples might include ethical issues in public health, research with cognitively impaired subjects, research with children, research with human biological materials, genetic research on autopsy specimens etc. The focus should be on the issues in professional ethics for scientists.

II. Case analysis Due 11/23/04

For this assignment, I would like you to write and analyze a scenario that poses a problem in one of the topics in research ethics covered in this class. Scenarios should be similar in length and format to those presented in your textbook at the end of each chapter, but should be your own work and, preferably, reflect some of your own experience. The scenarios should be suitable for discussion in class and if they are based in fact, should contain no identifying information. Your analysis can follow that presented in the Bebeau monograph handed out in class or you may wish to ask questions that arise from your scenario and then answer the questions. Papers should be 4-5 pages (at least 1000 words) in length excluding any references.

III. Final Examination

The final exam will be a take-home open book final that is handed out on the last day of class. You should complete the final on your own. A word to the wise: It is not a good thing to plagiarize answers to a final exam for a class in research ethics. The final should be typed and handed in to me at my office in the Department of Medical and Molecular Genetics, IB130, Room 159.

Final Paper

For those taking the class for three credits, a final paper is expected. You may look through the text for a particular topic in research ethics that interests you and may be especially relevant to your particular specialty. The paper should be 8-10 pages in length excluding references.
Please discuss the paper topic you have chosen with me prior to embarking on writing the paper. The paper is due any time before the last day of class.

Section I : Introduction and Background

Week 1:8/31/04 - General Orientation to Course

Kimberly A. Quaid, Ph.D.

Professor

Departments of Medical and Molecular Genetics, Psychiatry and Medicine

Also, if you want to understand why anyone really cares about this stuff, I suggest the following: Go to

http://www.healtoronto.com/gallodocs.html

Read the Executive Summary. Robert Gallo is the scientist who claimed to have discovered the AIDS virus. As you might imagine, this was a really big deal in the science world. Gallo was accused of stealing the virus from a group of French scientists. Believe me, it is fascinating reading.

Walter Stewart and Ned Feder are the Click and Clack of research integrity. Drs. Stewart and Feder were NIH employees who took it as their sacred mission to ferret out research misconduct. In the process, they made many enemies and they were eventually ordered to cease these activities by NIH.

Week 2: 9/7/04 Introduction to Ethical Theory

Speaker: Jason Eberl, Ph.D.

Assistant Professor

Department of Philosophy

Readings:

1. Fuchs BA and Macrina FL, Chapter 2: Ethics and the Scientist in Scientific Integrity pages 17-27.

Week 3: 9/14/04 Scientific Misconduct: Current Definitions, Policies and Procedures

Speaker: Kimberly A. Quaid, Ph.D.

Professor

Departments of Medical and Molecular Genetics, Psychiatry and Medicine

Core Faculty, Indiana University Center for Bioethics

Readings:

1. Macrina F. Chapter 1: Methods, Manners and Mandates. In Scientific Integrity pages 1-16.

2. Guidelines for the Conduct of Research at the National Institutes of Health. In Scientific Integrity, pgs. 289-295.

3. Go to: http://www.indiana.edu/~resrisk/mispol.html

Print policies and procedures and bring to class.

Proposed revised federal regulation can be found at: http://ori.hhs.gov.

Week 4: 9/21/04 History of Science and Misconduct

Speaker: William Schneider, Ph.D.

Professor, Department of History

Core Faculty, Indiana University Center for Bioethics

Readings:

1."The Establishment Of Institutional Review Boards In The U.S.:

Background History"

http://www.iupui.edu/~histwhs/G504.dir/irbhist.html

Section II : General Topics

Week 5: 9/28/04 Authorship, Collaboration, Publication and Reviewing Practices

Speaker: Kimberly A. Quaid, Ph.D.

Professor

Departments of Medical and Molecular Genetics, Psychiatry and Medicine

Core Faculty, Indiana University Center for Bioethics

Readings

2. Macrina FL Chapter 4: Authorship and Peer Review. In Scientific Integrity pages 49-66.

2. Macrina FL, Chapter 8: Collaborative Research in Scientific Integrity pages 157-170.

3. Go to: http://www.onlineethics.org

Scroll down to Research Ethics and click. Scroll down to educational resources and click. Scroll down and click on Responsible Authorship

Scroll down to Readings for Biomedical Research. Read Uniform Requirements for Manuscripts Submitted to Biomedical Journals- Updated May 2000 by International Committee of Medical Journal Editors (ICMJE)

4.ORI Working Definition of Plagiarism – Go to http://ori.dhhs.gov

Go to the ORI newsletter for December 1994, Vol.3, No.1, page 5.

For discussion: Case: 4.5 p 67 in Scientific Integrity

Week 6: 10/05/04 Animal Rights and Animal Welfare

Speaker: Lisa Pampos

Assistant Director, Laboratory Animal Resource Center

Readings:

1. Fuchs BA. Chapter 6: Use of animals in biomedical experimentation. In Scientific Integrity pages 101-121.

2. Go to : http://www.iupui.edu/~resgrad/

Click on Research and Sponsored Programs. Click on Research Compliance. Find Animal Care and Welfare (IACUC) and click on Policy on Research Involving Animals. Print and bring to class.

Week 7 - 10/12/04 .Implications of HIPAA for Research

Speaker: Marcia Gonzalez, J.D.

Compliance Office and Privacy Officer

Indiana University School of Medicine

Go to: http://www.iupui.edu/~resgrad/

Click on HIPAA information. Print Glossary. Bring to class.

Topic Oriented Paper Due TODAY!!!!!!!!!

Week 8: 10/19/04 Genetic Technology and Research on Human Specimens

Speaker: Kimberly A. Quaid, Ph.D.

Professor

Departments of Medical and Molecular Genetics, Psychiatry and Medicine

Readings

1. Munro CL Chapter 10: Genetic technology and scientific integrity. In

Scientific Integrity pages 211-223.

2. National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance

http://www.georgetown.edu/research/nrcbl/nbac/[Read the Executive Summary]

Week 9: 10/26/04 History of Research with Human Subjects

Speakers: William Schneider, Ph.D.

Professor, Department of History

Core Faculty, Indiana University Center for Bioethics

Readings: Will be handed out the week before.

1. Brandt AM (1978) Racism and Research: The case of the Tuskegee Syphilis Study. The Hastings Center 8:21-29.

2. Rothman DJ (1982) Were Tuskegee and Willowbrook ëStudies in Natureí?

The Hastings Center 12:5-7.

3. Vonderlehr RA, Clark T, Wenger OC and Heller JR (1936) Untreated syphilis in the male negro. Venereal Disease Information 17:260-265.

4. Pesare PJ, Bauer TJ, Gleeson GA (1950) Untreated syphilis in the male negro: Observation of abnormalities over sixteen years. American Journal of Syphilis, Gonorrhea, and Venereal Diseases. 34:201-213.

You may also want to browse the following:

1. Go to: http://www.med.virginia.edu/hs-library/historical/apology

Read Report on Tuskegee and President Clinton's apology.

2. The Nuremberg Code for Research with Human Subjects:

http://www.med.umich.edu/irbmed/ethics/Nuremberg/NurembergCode.html

3. World Medical Association. Declaration of Helsinki

"Ethical Principles for Medical Research Involving Human Subjects"

(1964, revised through 2000) at:

http://www.wma.net/e/policy/b3.htm

4.Go to the Belmont Report: http://ohsr.od.nih.gov/mpa/belmont.php3.

Week 10: 11/02/04-- Research with Human Subjects: Governmental Regulations and The Role of the IRB

Speakers: Shelley Bizila

Director, Research Compliance Administration, IUPUI

Readings:

1. Swerdlow PS. Chapter 5: Use of Humans in Biomedical Experimentation. In Scientific Integrity pages 73-90.

2. National Bioethics Advisory Commission Go to: http://www.georgetown.edu/research/nrcbl/nbac/

Go to REPORTS, Go to: Ethical and Policy Issues in Research Involving Human Participants. Read Final Recommendations,August 2001.

Activity: Think you know everything about Human Subjects?

Log on to: http://www.iupui.edu/~resgrad

Click on Research and Sponsored Programs, then click on Human Subjects Certification

Read: IU Important Notice 00-5

Click on Test and take it.

For discussion: Case 5.9, p 92, Scientific Integrity

Case 5.12, p 93-94 Scientific Integrity

Case 5.2, p 90, Scientific Integrity

Week 11: 11/09/04 Ownership of Data, Intellectual Property and Copyright

Speaker: Kenneth Crews

Readings:

1. Mays TD Chapter 9: Ownership of data and intellectual property. In Scientific Integrity pages 179-200.

3. Take a general look at the website for the Office of Copyright Management at http://www.copyright.iupui.edu

4. Also look at: http://www.umi.com/umi/dissertations/copyright/

The only 15 letter word that can be spelled without replicating a letter is: UNCOPYRIGHTABLE

Week 12: 11/16/04- International Research Ethics

Speaker: Eric M. Meslin, Ph.D.

Director, Indiana University Center for Bioethics

Professor of Medicine, Medical and Molecular Genetics, and Philosophy

Assistant Dean for Bioethics

Readings:

National Bioethics Advisory Commission, Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries

Go to http://www.georgetown.edu/research/nrcbl/nbac/ [Read the Executive Summary]

Nuffield Council on Bioethics, The Ethics of Research Related to Healthcare in Developing Countries

Go to: http://www.nuffieldbioethics.org/publications/pp_0000000013.asp [Read the Executive Summary]

Week 13: 11/23/04 – Science, Industry and Conflict of Interest

Speaker - Rose F. Fife, M.D.

Associate Dean for Research

Barbara F. Kampen Professor of Womenís Health

Professor of Medicine, Biochemistry and Molecular Biology

Chair, Conflict of Interest Committee

Readings:

1. Bradley SG Chapter 7: Managing Conflicting Interests in Scientific Integrity pages 131-151.

2. Go to: http://www.iupui.edu/~resgrad/

Click on Research and Sponsored Programs. Click on Policies. Click on

ìPolicies on Conflict of Interestî. Print and bring to class.

Week 14: 11/30/04 - Mentoring

Speaker – Deborah Cullen, Ed. D.

Professor, Department of Health Sciences

School of Health and Rehabilitation Sciences

Reading:

1. Macrina FL Chapter 3: Mentoring in Scientific Integrity pages 29-48.

Case Analysis Paper Due

Week 15: 12/7/04

Case Presentations

Handout Final Examination

On-Line Resources on Research Ethics

http://www.lemoyne.edu/OTRP/otrpresources/otrp_sci-misc.html

http://www.indiana.edu/~poynter/tre-onln.html#syllabi

http://www.research.umn.edu/ethics/

http://www.onlineethics.org