1 Ethical issues in clinical research Bernard Lo, M.D. January 25, 2007.

Slides:



Advertisements
Similar presentations
The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects.
Advertisements

Authorship APS Professional Skills Course:
Regulatory Clinical Trials Clinical Trials. Clinical Trials Definition: research studies to find ways to improve health Definition: research studies to.
THE VALUE OF UMKC CRR’S AND SENATE UPDATING 420, 370 AND 320 APRIL 7, 2015 Richard J Arend Professor of Strategy & Entrepreneurship.
A Multi-Disciplinary Approach. Darran Boyer, Moderator Alicia (Ali) Craig-Rodriguez President, Comprehensive Neuroscience, Inc. Kim Lerner Chief Executive.
RESPONSIBLE AUTHORSHIP Office for Research Protections The Pennsylvania State University Adapted from Scientific Integrity: An Internet-based course in.
DAVID R. HOFFMAN Assistant U. S. Attorney 615 Chestnut Street Suite 1250 Philadelphia, PA Phone: (215) Fax: (215)
Ethical Considerations when Developing Human Research Protocols A discipline “born in scandal and reared in protectionism” Carol Levine, 1988.
Promoting Integrity in the Next Generation of Researchers A Curriculum for Responsible Conduct of Research in Occupational Therapy (2005) Funded by the.
Publication Issues GCP for clinical trials in India R.Raveendran Chief Editor Indian Journal of Pharmacology.
Ethical issues in clinical research Bernard Lo, M.D. August 24,
How does the process work? Submissions in 2007 (n=13,043) Perspectives.
1 Authorship Bernard Lo, M.D. August 23 and September 2, 2010.
ETHICAL TREATMENT OF HUMAN SUBJECTS All research projects must be approved by the Institutional Review Board (IRB) Federal law APA (American Psychological.
Research Ethics-Integrity-Governance. University Initiative:The Catalyst? ‘02 Good Research Practice Standards & Procedure to Investigate Potential Research.
ETHICAL ISSUES IN THE PUBLICATION OF RESEARCH Muhammad Taher Abuelma’atti Department of Electrical Engineering King Fahd University of Petroleum and Minerals.
Introduction to Research
Ethics in Research.
1 Why does responsible conduct of research matter? Bernard Lo, M.D. August 18 and 26, 2010.
Ethics in Research.
Reading Science Critically Debi A. LaPlante, PhD Associate Director, Division on Addictions.
1 Authorship Bernard Lo, M.D. August 27, Questions  Looked self up in Pub Med?  Omitted as author?  Co-author didn’t deserve it?  Asked to.
Responsible Conduct of Research Training Research Misconduct Source: Office of Research and Grants (ORG)
By Reaz Uddin, Ph. D. Dr. Panjwani Center for Molecular Medicine and Drug Research, International Center for Chemical and Biological Sciences, University.
Do ethics make a difference? Roger Watson Professor of Nursing University of Hull 12 April 2015.
Research Design. Research is based on Scientific Method Propose a hypothesis that is testable Objective observations are collected Results are analyzed.
Institutional Review Board (IRB) for Human Subject Protections: Working with the IRB Erin McClure, PhD Department of Psychiatry and Behavioral Sciences.
School of Food and Nutritional Sciences
1 Ethical issues in clinical trials Bernard Lo, M.D. February 10, 2010.
1 Why does responsible conduct of research matter? Bernard Lo, M.D. August 21, 2008.
Research Misconduct Adapted with permission from Virginia Tech University Office of the Vice-President for Research.
Ethics Ethics Applied to Research. Ethics in Nursing Research Scientific Misconduct – a fabrication, falsification, plagiarism or other practice that.
1 Ethical issues in clinical trials Bernard Lo, M.D. February 7, 2008.
1 Why does responsible conduct of research matter? Bernard Lo, M.D. August 20, 2009.
Identifying and Protecting Yourself from Research Misconduct Stephen Erickson, Ph.D. Director, Office for Research Integrity and Compliance Director,
Publication ethics Professor Magne Nylenna, M.D., PhD
Publication Ethics R.Raveendran Chief Editor, Journal of Pharmacology & Pharmacotherapeutics.
Process of FDA New Drug Approval: 1- New Compound with promising preclinical data 2- Sponsor applies to FDA for an IND (Investigational New Drug Application)
Tuskegee Study Research Ethics Ethics matters in academic and scientific research. Study of ethics is no less and no more important in research than.
Original Research Publication Moderator: Dr. Sai Kumar. P Members: 1.Dr.Sembulingam 2. Dr. Mathangi. D.C 3. Dr. Maruthi. K.N. 4. Dr. Priscilla Johnson.
$100 $200 $400 $500 $300 $100 $200 $400 $500 $300 $100 $200 $400 $500 $300 $100 $200 $400 $500 $300 $100 $200 $400 $500 $300 Terms Clinical Trial Facts.
1 Future Research Leaders Program Research Integrity and Codes of Conduct : How to add scenery to the roadmap?
Introduction to Research. Purpose of Research Evidence-based practice Validate clinical practice through scientific inquiry Scientific rational must exist.
M6728 Ethics in Research Informed Consent/IRBs Reporting Research Results.
Chapter 5 Ethical Concerns in Research. Historical Perspective on Ethics Nazi Experimentation in WWII –“medical experiments” –Nuremberg War Crime Trials.
What about VIOXX?. Adenomatous Polyp Prevention on Vioxx (APPROVe) Vioxx (rofecoxib) versus Placebo Basic Clinical Trial Objective: Assess whether Vioxx.
Statistical Fundamentals: Using Microsoft Excel for Univariate and Bivariate Analysis Alfred P. Rovai Data Ethics PowerPoint Prepared by Alfred P. Rovai.
Drug Regulation in Controversy: Vioxx November 10, 2004 Sandra L. Kweder, M.D. Deputy Director, Office of New Drugs Center for Drug Evaluation and Research.
Institutional Review Board (IRB) for Human Subject Protections: Working with the IRB Erin A McClure, PhD Department of Psychiatry and Behavioral Sciences.
Challenges in Promoting RCR: Reflections from a Public Funder´s Perspective Secretariat on Responsible Conduct of Research [Canadian Institutes of Health.
Ethical Considerations Dr. Richard Adanu Editor-in-Chief International Journal of Gynecology and Obstetrics (IJGO)
Woo-suk’s Stem Cells Evan Perez, Ann Peterson, Stephen Ratvasky, Lauren Shober, Jarred Stratton
“Scientific Misconduct: Falsification, Fabrication and Plagiarism”
Susan Sonne, PharmD, BCPP Chair, MUSC IRB II
Chapter 3 Ethics in Research
VIOXX WITHDRAWAL: Learning valuable lessons from rofecoxib
© 2010 Jones and Bartlett Publishers, LLC
Mojtaba Farjam, MD PhD, member of ethics committee for research
© 2010 Jones and Bartlett Publishers, LLC
Publication ethics PU 7, March 15, 2017
Ethics for Authors Dr. Bahaty.
Psychology 3450W: Experimental Psychology
Investigator Responsibilities: What should we expect from researchers?
Do ethics make a difference?
Adapted from On Being a Scientist, 3rd Ed.
Chapter 5: Ethical Issues in Research and Scholarship
Science’s Efforts to Ensure Research Integrity
Participants, Measurement & Study Design
Research, Experimentation, & Clinical Trials
Presentation transcript:

1 Ethical issues in clinical research Bernard Lo, M.D. January 25, 2007

2 Timeline of Hwang case 2/04SCNT yielded 30 blastocysts and one stem cell line 5/0511 SCNT cell lines from 185 oocytes, 31 blastocysts 8/05Cloning of dog, Snuppy

3 S. Korean investigation  Could not verify genetic identity of donors and lines  9 lines identical with embryonic stem cell line

4 S. Korean investigation  2261 oocytes from 119 donors  Papers reported only 427 oocytes  66 compensated, contrary to publication  Technicians, grad student donated, contrary to previous statements  Failed to fully explain risks  15/79 treated for ovarian hyperstimulation syndrome

5 Protections for human subjects  IRB review  Assess risks and benefits of research  Independent of researchers

6 Protections for human subjects  Informed and voluntary consent  Respect people’s right to decline to participate in research  Hard to say no if dependent  Exceptions for research with existing records and materials

7 Federal definition of research misconduct  Fabrication  Falsification  Plagiarism  Must be intentional

8 Why is research misconduct problematic?  Question validity of data  Question conclusions of study  Unmerited rewards  Undermines public trust and support

9 Research misconduct excludes  Unintentional “honest” error  Sloppiness, incompetence, laziness  Differences of opinion or interpretation

10 U Pitt investigation of Schatten  Senior author of 2005 paper  Revised paper, negotiated with journal

11 U Pitt investigation of Schatten  “Concerted and deliberate effort to distance self from Dr. Hwang and joint publication”  “In sharp contrast to full participation…in media spotlight following publication”

12 Appropriate authorship  Co-authors took credit for work  Did not meet criteria for authorship  Not willing to take responsibility for work

13 Why have authorship?  Recognition  Job, grants, promotions  Accountability  Prevent fabrication, fraud, plagiarism

14 Criteria for authorship  Conception and design or data analysis and interpretation, and  Drafting or substantially revising article, and  Approving final manuscript

16 VIGOR  Published in NEJM 11/200  Fewer GI side effects on rofecoxib than naproxen (2.1 vs. 4.5)

17 VIGOR  More Mis on refecoxib (0.4 vs 0.1)  Attributed to protective effect of naproxen

18 Rofecoxib  Sales over $2.5 billion annually  80,000 patients

19 VIGOR  3 additional MIs on refecoxib reported to FDA before publication but not to academic authors or to NEJM  Known to 2 employee / authors

20 APPROVe study (2/05)  Thrombotic events 1.50 on rofecoxib vs on placebo  Led to voluntary withdrawal of drug  Increased risk after 18 months

21 Public events  Vioxx withdrawn from market 9/04  Attributable MI, CVA 160,000  Lawsuits by patients  Defense strategy  At high risk for MI  Weren’t taking drug long enough

22 APPROVe problems  Count only events while on Rx or up to 14 days after stopping  Academic authors claimed they were just following the protocol  Presented all events to FDA 5/06  Curves diverge at 4 months, not 18

23 APPROVe problems in peer review  “Going out on limb by emphasizing 18 month issue”  “Hand of sponsor is too evident.. Written consistently in manner designed to support the company’s public positions.”

24 APPROVe problems in peer review  “Aggressively promotes safety of up to 18 months of use … beyond the data of the study”  Journal originally asked authors to drop references to 18 months

25 Ethical issues raised  Must publish all results, both negative and positive  Investigators must control study  Sponsor has self-interest, bias

26 Ethical issues raised  People harmed by unethical research  Evidence base for clinical practice depends on valid research

27 Take home messages  Informed consent  IRB review  Authorship  Publish unfavorable results  Integrity of researcher