MEDICAL ETHICS: INTRODUCTION AND HISTORY OF BIOETHICS

Size: px
Start display at page:

Download "MEDICAL ETHICS: INTRODUCTION AND HISTORY OF BIOETHICS"

Transcription

1 MEDICAL ETHICS: INTRODUCTION AND HISTORY OF BIOETHICS DR.MAHJABEEN KHAN Assistant Professor MCPS, MS, MHSc in Bioethics (Canada) Research Department, Clinical Trials Unit DUHS LEARNING OBJECTIVES At the end of this module the students will be able to: 1. List the common practical examples from Medical Ethics 2. Describe Medical Ethics 3. Describe Bioethics 4. Discuss the importance of Bioethics 5. Describe the milestones in the history of Medical Ethic Plan of Module A didactic discussion in the following order with the students: 1. Common practical examples from Medical Ethics 2. What is Medical Ethics? 3. What is Bioethics? 4. What is the importance of Bioethics? 5. Describe the milestones in the history of Medical Ethic 6. Summary 7. References MEDICAL ETHICS: Doctor-patient relationships Experimentation with human subjects and animals

2 Organ transplant Resources allocation in health care system Human cloning Stem cell research WHAT IS ETHICS? A science which judges human conduct to be right or wrong, to be good or bad. Socrates 360 BC, 352d WHAT IS ETHICS? Medical Ethics and Practical Applications Medical Ethics is all about relationship and choices of person in the form of conduct Medical Ethics provide the standard for human actions to be right or wrong Medical Ethics provides validity and trust on these standards Medical Ethics and Practical Applications Who has the final authority in medical decision making?

3 Patient / individual Family Physician(s) Medical Ethics Medical ethics are concerned with the ethics of the health care professionals and their relationship with the patient Medical Ethics: Patients have their rights for: Standard of medical care Autonomous / informed choice Decision making Privacy / confidentiality Health Education PHYSICIANS AND PATIENTS RELATIONSHIP To save the patient s life To promote and protect the patient s health To respect the patient s autonomy /dignity To protect privacy / confidentiality

4 CLINICAL ETHICS A practical discipline that provides a structured approach for identifying,analyzing, and resolving ethical issues in clinical medicine / Practice A practical and applied discipline that aims to improve patient care and health outcomes by focusing on reaching a right and good decision in individual cases. It focuses on the doctor-patient relationship and takes account of the ethical and legal issues What is Bioethics?

5 Bioethics is the branch of ethics that studies problems in life sciences, medicine, and biotechnology. Clinical Ethics, Research ethics, organization Ethics and Environmental Ethics are some of the topics that are considered branches within bioethics. What is Bioethics? Bioethics in medical practice is defined as the study of ethical issues and decision-making associated with the living organisms Bioethics is learning how to balance different benefits, risks and duties in medical practice What is Bioethics? Major branch in Applied Ethics The study of the ethical issues arising from health care, biological and medical sciences. Practical Applications of Bioethics Major branch in Applied Ethics The study of the ethical issues arising from health care, biological and medical sciences. Why is Bioethics Important? Behaving ethically can improve patient care Behaving ethically can improve the quality of staff work life

6 Quality health care requires behaving ethically Most bioethical issues relate human beings MILESTONES IN THE HISTORY OF MEDICAL ETHICS The repulsions of many "experiments on human subjects were exposed during and after World War II. THE NUREMBERG TRIAL 1946 TUSKEGEE STUDY ( ) In the 1950s, Thalidomide was approved and German manufacturer of the drug had collected no systematic human safety data. The drug was recommended for use to treat morning sickness during pregnancy. Thalidomide trial The Nuremberg Code became the first international code of ethics for research involving human subjects THE MILLIGRAM STUDY:

7 The "learners, actual members of the research team were seated in an electric chair. The "teachers" actual research subjects were told by the researcher to give electric shocks of increasing intensity. After each wrong answer to a question the electric shock was given. Study subjects did not know that the learner was actually an actor who received no shocks, but acted as if he/she had. OBEDIENCE TO AUTHORITY In the 1950s, Thalidomide was approved and German manufacturer of the drug had collected no systematic human safety data. The drug was recommended for use to treat morning sickness during pregnancy. THE MILLIGRAM STUDY: OBEDIENCE TO AUTHORITY The "learners, actual members of the research team were seated in an electric chair. The "teachers" actual research subjects were told by the researcher to give electric shocks of increasing intensity. After each wrong answer to a question the electric shock was given. Study subjects did not know that the learner was actually an actor who received no shocks, but acted as if he/she had. THE BELMONT REPORT Ethical Principles and Guidelines for the Protection of Human Subjects was written by the National Commission and published in The three principles of The Belmont Report govern all research supported by the U.S. government.

8 Chronology of events impacting human subjects research Oath of Hippocrates (4th c BC) 1930's-1960'sTuskegee Syphilis Study 1946 Nuremberg Doctors Trial 1947 Nuremberg Code (Issue of human experimentation) 'sThalidomide Tragedy 1960 Milgram tudy Chronology of events impacting human 1964 Declaration of Helsinki (Issue of human experimentation) 1974 National Commission for the Protection of Human Subjects 1974 U.S. Human Subjects Regulation 1979 Belmont Report 1993 The Council for International Organizations of Medical Sciences, CIOMS Guidelines 2005 Universal Declaration on Bioethics and Human Rights (UNESCO: United Nations Educational, Scientific, and Cultural Organisation) Summary of the Module on Medical Ethics

9 Ethics is a science which judges human conduct to be right or wrong, to be good or bad Medical ethics is concerned with the ethics of the health care professionals and their relationship with the patient Bioethics A practical discipline that provides a structured approach for identifying,analyzing, and resolving ethical issues in clinical medicine / Practice Bioethics is the branch of ethics that studies problems in life sciences, medicine, and biotechnology. Summary of the Module on Medical Ethics The repulsions of many "experiments on human subjects were exposed during and after World War II. The Nuremberg Code is the first international code of ethics for research involving human subjects Tuskegee Study Thalidomide trial The Milligram study: obedience to authority The Belmont report The Council for International Organizations of Medical Sciences, CIOMS Guidelines Universal Declaration on Bioethics and Human Rights References Beauchamp TL, Childress JF. Principles of Biomedical Ethics, Third Edition. New York: Oxford University Press, 1989: Ethics as Process and Practice by A.W. Frank.

10 Internal Medicine Journal 2004, 34: Four Appointments with a Discus Thrower. In: The Doctor Stories by R. Selzer. New York: Picador USA, 1998, Finely Aware and Richly Responsible : moral attention and the moral task of imagination by M. Nussbaum. Journal of Philosophy : Beauchamp TL, Childress JF. Principles of Biomedical Ethics, Third Edition. New York: Oxford University Press, 1989: Ethics as Process and Practice by A.W. Frank. Internal Medicine Journal 2004, 34: Four Appointments with a Discus Thrower. In: The Doctor Stories by R. Selzer. New York: Picador USA, 1998, Finely Aware and Richly Responsible : moral attention and the moral task of imagination by M. Nussbaum. Journal of Philosophy : THANK YOU

S A I N T M A RY S E M I N A RY O C T O B E R 1 9,

S A I N T M A RY S E M I N A RY O C T O B E R 1 9, IRB BASICS FOR ADMINISTRATORS S A I N T M A RY S E M I N A RY O C T O B E R 1 9, 2 0 1 6 JOHN CARROLL UNIVERSITY Catherine Anson, MA, CRA, CIM Director of Sponsored Research Assistant IRB Chair Carole

More information

Human Subjects Research

Human Subjects Research Human Subjects Research Learning Objectives Discuss key ethical concerns The role of the IRB Principles and origin of Belmont Report Principle of informed consent & considerations surrounding this Responsibilities

More information

Ethical Issues in Clinical Trial & Development of Regulation Policy on Clinical Research

Ethical Issues in Clinical Trial & Development of Regulation Policy on Clinical Research Ethical Issues in Clinical Trial & Development of Regulation Policy on Clinical Research Melody Lin, Ph.D. Deputy Director, Office for Human Research Protections Director, International Activities Department

More information

Ethical, Legal and Social Issues arising out of Advancements in New Biology. Seyed E. Hasnain

Ethical, Legal and Social Issues arising out of Advancements in New Biology. Seyed E. Hasnain Ethical, Legal and Social Issues arising out of Advancements in New Biology Seyed E. Hasnain Importance of Ethics in Infectious Diseases/Clinical Research Ethics: separate right from wrong as a principle

More information

Chapter 2: Ethical Research Practices

Chapter 2: Ethical Research Practices Chapter 2: Ethical Research Practices 1. Which of the following statements best describes the attitude of the American public toward biomedical and mental health research during the 20th century? a. There

More information

How did it evolve? o Public disasters, serious fraud and abuse of human rights. o Trials of War criminals-nuremberg code 1949

How did it evolve? o Public disasters, serious fraud and abuse of human rights. o Trials of War criminals-nuremberg code 1949 ICH GCP Overview What is ICH? ICH is a joint initiative involving both the regulators and the industry as equal partners in the scientific and technical discussions of the testing procedures which are

More information

Amanda A. Hastings, MSHL Education Specialist USF Division of Research Integrity & Compliance

Amanda A. Hastings, MSHL Education Specialist USF Division of Research Integrity & Compliance Amanda A. Hastings, MSHL Education Specialist USF Division of Research Integrity & Compliance 813-974-5452 Research Ethics: Historical Events Syphilis Study in Tuskegee Begins Inoculation Studies in Guatemala

More information

Vicki Rigolo Stecher, M.A., CIP IRB Education Coordinator USF Division of Research Integrity & Compliance

Vicki Rigolo Stecher, M.A., CIP IRB Education Coordinator USF Division of Research Integrity & Compliance Vicki Rigolo Stecher, M.A., CIP IRB Education Coordinator USF Division of Research Integrity & Compliance 813-974-3216 Research Ethics: Historical Events Syphilis Study in Tuskegee Begins Inoculation Studies

More information

Composition of Ethics Committees

Composition of Ethics Committees Composition of Ethics Committees TEMIDAYO O OGUNDIRAN MBBS (IBADAN), MHSC (TORONTO), FACS, FRCS ( EDINBURGH), FWACS DIVISION OF ONCOLOGY, DEPARTMENT OF SURGERY, UNIVERSITY OF IBADAN AND UNIVERSITY COLLEGE

More information

Life is all about choices. Human Subjects Research Ethics

Life is all about choices. Human Subjects Research Ethics Life is all about choices Human Subjects Research Ethics Welcome to the Ethical Time Join me as we journey back to an age where Machine The field of Medicine comes into its own, and Optimism, Progress,

More information

Introduction & History of Research Ethics

Introduction & History of Research Ethics Introduction & History of Research Ethics Temidayo O Ogundiran MBBS (Ibadan), MHSc (Toronto), FACS, FRCS (Edinburgh), FWACS Division of Oncology, Department of Surgery, University of Ibadan and University

More information

How the Past Influenced Human Research Protection Regulations

How the Past Influenced Human Research Protection Regulations How the Past Influenced Human Research Protection Regulations Shirley J. Hicks Director, Division of Education and Development Office for Human Research Protections U.S. Department of Health and Human

More information

Mohammed Al Jumah. King Abdullah International Medical Research Center KSAU-HS NGHA

Mohammed Al Jumah. King Abdullah International Medical Research Center KSAU-HS NGHA Mohammed Al Jumah King Abdullah International Medical Research Center KSAU-HS NGHA Introduction Research Ethics NCBE Research & Ethics Interactions Clinical practice and Research Fair Access of research

More information

Clinical Trials How, Why and When? Candidate to Market 16 th May 2012 Kirsty Kwiatkowski

Clinical Trials How, Why and When? Candidate to Market 16 th May 2012 Kirsty Kwiatkowski Clinical Trials How, Why and When? Candidate to Market 16 th May 2012 Kirsty Kwiatkowski Agenda Why are clinical trials conducted? History Guidelines and Regulations When are trials conducted? Requirements

More information

Ethics of Radiation Protection in Medicine

Ethics of Radiation Protection in Medicine Ethics of Radiation Protection in Medicine Richard J. Vetter, Ph.D. CHP Professor Emeritus Mayo Clinic First IRPA North American Workshop on the Ethics of Radiological Protection Baltimore, Maryland, USA

More information

University of the Virgin Islands Institutional Review Board (IRB) IRB Basics for Social Science Senior Seminar (STT/STX)

University of the Virgin Islands Institutional Review Board (IRB) IRB Basics for Social Science Senior Seminar (STT/STX) University of the Virgin Islands Institutional Review Board (IRB) IRB Basics for Social Science Senior Seminar (STT/STX) Ethics and Human Subject Protections Presented by: Olusola Ewulo, M.S. Director,

More information

Biomedical Research on Human Participants

Biomedical Research on Human Participants Ethical Guidelines for Biomedical Research on Human Participants Dr P Paul Kumaran MBBS, BA (Psychology), MPH Scientist E [Deputy Director Medical] National Institute for Research in Tuberculosis (ICMR)

More information

Revision of Helsinki Declaration

Revision of Helsinki Declaration World Medical Association Revision of Helsinki Declaration Post Study Access or What Happens once Research is Over? Dr Fazel Randera Cape Town December 2012 Context In 2000 the WMA added a new provision

More information

Ethics Review Ethical Considerations of the Past & Present. Olivia Hart, MPA, CIP

Ethics Review Ethical Considerations of the Past & Present. Olivia Hart, MPA, CIP Ethics Review Ethical Considerations of the Past & Present Olivia Hart, MPA, CIP Research Ethics: Historical Events Monster Study: 1939 Termed the Monster Study by peers of the PI, Wendell Johnson from

More information

50 SHADES OF GRAY: WHY AND WHEN IS IRB APPROVAL REQUIRED?

50 SHADES OF GRAY: WHY AND WHEN IS IRB APPROVAL REQUIRED? 50 SHADES OF GRAY: WHY AND WHEN IS IRB APPROVAL REQUIRED? Kevin L. Nellis, MS, CIP Executive Director, Human Research Protections and Quality Assurance Kathleen E. Powderly, CNM, PhD Director, John Conley

More information

History of Evolution of Ethical Guidelines and Clinical Research Regulations

History of Evolution of Ethical Guidelines and Clinical Research Regulations History of Evolution of Ethical Guidelines and Clinical Research Regulations Dr P Paul Kumaran MBBS, BA (Psychology), MPH Scientist E [Deputy Director Medical] National Institute for Research in Tuberculosis

More information

Functional Classification of Medicine

Functional Classification of Medicine Research on Humans Functional Classification of Medicine Medicine and medical intervention can take any of five forms: (1) Therapeutic (curative): seeks to cure a disease or ailment. (2) Palliative: seeks

More information

Ethical Principles in Clinical Research

Ethical Principles in Clinical Research Ethical Principles in Clinical Research Christine Grady NIH Clinical Center Department of Bioethics No conflicts of interest. Views presented are mine and do not necessarily represent positions or policies

More information

BO STO N MEDTECH. More Experience Better Results. Ethics in Clinical Research. Zvi Ladin, Ph.D.

BO STO N MEDTECH. More Experience Better Results. Ethics in Clinical Research. Zvi Ladin, Ph.D. BO STO N MEDTECH A D VI SO RS More Experience Better Results Ethics in Clinical Research Zvi Ladin, Ph.D. Historical Infamy Tuskegee syphilis study (1930s 1972) 399 black men signed with the US PHS for

More information

Ethical Principles in Clinical Research. Disclaimer. Christine Grady Department of Bioethics NIH Clinical Center

Ethical Principles in Clinical Research. Disclaimer. Christine Grady Department of Bioethics NIH Clinical Center Ethical Principles in Clinical Research Christine Grady Department of Bioethics NIH Clinical Center Disclaimer The views expressed are mine and do not necessarily represent the positions or policies of

More information

Principles Of Biomedical Ethics (Beauchamp) 6th (sixth) Edition By Tom L. Beauchamp

Principles Of Biomedical Ethics (Beauchamp) 6th (sixth) Edition By Tom L. Beauchamp Principles Of Biomedical Ethics (Beauchamp) 6th (sixth) Edition By Tom L. Beauchamp Edition/Format: Print book : English : 6th edview all editions and formats. Database: WorldCat. Summary: Principles of

More information

Institutional Review Board

Institutional Review Board Institutional Review Board Overview & Minimal Risk Research Jon Mark Hirshon, MD, MPH Vice-Chairman University of Maryland Institutional Review Board May 18, 2006 Jon Mark Hirshon, MD, MPH 1 Presentation

More information

Institutional Review Board Compliance Elizabeth City State University

Institutional Review Board Compliance Elizabeth City State University Institutional Review Board Compliance Elizabeth City State University Michelle Moore, MBA Research Compliance Officer/IRB Administrator Office of Sponsored Programs, Contracts & Grants 110 McLendon Hall

More information

NHS Research Ethics Approval the process

NHS Research Ethics Approval the process NHS Research Ethics Approval the process Dr Sheila A Simpson 27 May 2008 ETHICS The process of determining what is right and wrong Personal code of conduct based on respect for one's self, others, and

More information

The role of the European Commission in protecting human participants in biomedical research

The role of the European Commission in protecting human participants in biomedical research European Group on Ethics in Science and New Technologies (EGE) Bureau of European Policy Advisers (BEPA) The role of the European Commission in protecting human participants in biomedical research Disclaimer:

More information

The Development & Expectation of Bioethics in China

The Development & Expectation of Bioethics in China COMPANY LOGO The Development & Expectation of Bioethics in China Prof Qing-Li Hu Director, Ethics Committee, Shangai Clinical Research Center Emeritus Professor, Senior Advisor,Shanghai Jiaotong University

More information

Biomedical Research in. Developing Countries:

Biomedical Research in. Developing Countries: Biomedical Research in Developing Countries: The Promotion of Ethics, Human Rights and Justice Alice Paola Brizi Researcher, Justice Protection and Ethics Unit,, UNICRI Rome,, 15-16 16 December 2008 The

More information

Frank D. Lewis Ph.D., CBIST National Director of Clinical Outcome Services NeuroRestorative, Mentor Network

Frank D. Lewis Ph.D., CBIST National Director of Clinical Outcome Services NeuroRestorative, Mentor Network Frank D. Lewis Ph.D., CBIST National Director of Clinical Outcome Services NeuroRestorative, Mentor Network Organization of this talk I. Definition/Points to Ponder II. Historical Events III. Guiding Principles

More information

Ethics in Clinical Practice Frank D. Lewis Ph.D., CBIST, National Director of Clinical Outcome Services, NeuroRestorative

Ethics in Clinical Practice Frank D. Lewis Ph.D., CBIST, National Director of Clinical Outcome Services, NeuroRestorative Ethics in Clinical Practice Frank D. Lewis Ph.D., CBIST, National Director of Clinical Outcome Services, NeuroRestorative Organization of this talk I. Definition/Points to Ponder II. Historical Events

More information

Institutional Review Board. Ensuring that the rights and welfare of participants in research are protected.

Institutional Review Board. Ensuring that the rights and welfare of participants in research are protected. Institutional Review Board Ensuring that the rights and welfare of participants in research are protected. Michael Linke, PhD, CIP Presenters Health Science Officer, Veterans Affairs Medical Center Associate

More information

Clinical Research: Straight Talk about When Expectations Meet Reality

Clinical Research: Straight Talk about When Expectations Meet Reality Clinical Research: Straight Talk about When Expectations Meet Reality Reina Hibbert, CCRC Regulatory Manager Phase 1 & RCC/Melanoma Clinical Trials Agenda Fundamentals The scientific method Phases of trials

More information

Compliance mechanisms available in Russia to ensure adherence to ethical guidelines

Compliance mechanisms available in Russia to ensure adherence to ethical guidelines Compliance mechanisms available in Russia to ensure adherence to ethical guidelines Prof. Olga Kubar, Saint Petersburg Pasteur Institute, Russia 1 Project full title: Project acronym: Type of funding scheme:

More information

Human Subjects Protection: Training for Research Teams

Human Subjects Protection: Training for Research Teams Human Subjects Protection: Training for Research Teams Walter L. Calmbach MD MPH South Texas Ambulatory Research Network (STARNet) Dept. of Family & Community Medicine Univ. of Texas Health Science Center

More information

GOOD SCIENTIFIC PRACTICE AND ETHICAL PRINCIPLES IN SCIENTIFIC RESEARCH AND HIGHER EDUCATION

GOOD SCIENTIFIC PRACTICE AND ETHICAL PRINCIPLES IN SCIENTIFIC RESEARCH AND HIGHER EDUCATION Central European Journal of Sport Sciences and Medicine : 2529 GOOD SCIENTIFIC PRACTICE AND ETHICAL PRINCIPLES IN SCIENTIFIC RESEARCH AND HIGHER EDUCATION Joanna Kruk Faculty of Physical Culture and Health

More information

MEDICAL ETHICAL ASPECTS. Eric van Roon September EAHP Academy Seminar

MEDICAL ETHICAL ASPECTS. Eric van Roon September EAHP Academy Seminar MEDICAL ETHICAL ASPECTS Eric van Roon September 30 2017 EAHP Academy Seminar CONFLICT OF INTEREST THERE ARE NO CONFLICTS OF INTEREST TO DECLARE QUESTIONS - Yes or no: respect for autonomy, non-maleficence,

More information

A Four Point Guidance to Analyse Ethical Issues in Serious Game Development

A Four Point Guidance to Analyse Ethical Issues in Serious Game Development A Four Point Guidance to Analyse Ethical Issues in Serious Game Development Vivekananda-Schmidt, P 1.; Romano, D 2. 1 Corresponding Author: Pirashanthie Vivekananda-Schmidt, The Medical School, University

More information

Ethics of pragmatic trials: Considerations for informed consent

Ethics of pragmatic trials: Considerations for informed consent Ethics of pragmatic trials: Considerations for informed consent KCE Trials Symposium, 28 November 2017 Shona Kalkman, MD MA PhD Julius Center for Health Sciences and Primary Care University Medical Center

More information

The Current Status and its Challenge of the Ethics Committee in China. Prof. Qingli Hu

The Current Status and its Challenge of the Ethics Committee in China. Prof. Qingli Hu The Current Status and its Challenge of the Ethics Committee in China Prof. Qingli Hu Ⅰ The Development of Biotechnology and the Bioethics As it was indicated by UNESCO on the Bioethics : Stem cell research,

More information

TOP 10 INVESTIGATOR RESPONSIBILITIES WHEN CONDUCTING HUMAN SUBJECTS RESEARCH

TOP 10 INVESTIGATOR RESPONSIBILITIES WHEN CONDUCTING HUMAN SUBJECTS RESEARCH Investigators Responsibility #1: Design and Implement Ethical Research Consistent with the Three Ethical Principles Delineated in The Belmont Report. The Belmont Report: Three Basic Ethical Principles:

More information

ETHICAL ISSUES IN CANCER CLINICAL TRIALS

ETHICAL ISSUES IN CANCER CLINICAL TRIALS ETHICAL ISSUES IN CANCER CLINICAL TRIALS ROSEMARY MAKAR, M.D. ABSTRACT Results from cancer clinical trials make valuable contributions to medical care for cancer patients. Two important ethical dilemmas

More information

Experimentation on Human Subjects

Experimentation on Human Subjects introductory lectures in bioethics Experimentation on Human Subjects Paul Menzel Pacific Lutheran University (philosophy, emeritus) Visiting Professor of Bioethics, CUHK 5 December 2015 Centre for Bioethics,

More information

Ethical Issues of Drug Research on Children. By: Tatiana Arzumanov

Ethical Issues of Drug Research on Children. By: Tatiana Arzumanov Ethical Issues of Drug Research on Children By: Tatiana Arzumanov Today it is hard to imagine health care without medications. As a nation, Americans bought 3.1 billion prescriptions in the year of 2001

More information

3. Human Biomedical Research. Defining Human Biomedical Research

3. Human Biomedical Research. Defining Human Biomedical Research PART B: SECTION III: HUMAN BIOMEDICAL RESEARCH HUMAN BIOMEDICAL RESEARCH 3. Human Biomedical Research Defining Human Biomedical Research 3.1. In this section, we consider what kinds of human biomedical

More information

INSPECTION OF INDEPENDENT ETHICS COMMITTEES (IEC) The Italian Experience

INSPECTION OF INDEPENDENT ETHICS COMMITTEES (IEC) The Italian Experience INSPECTION OF INDEPENDENT ETHICS COMMITTEES (IEC) The Italian Experience Umberto Filibeck Former Head of AIFA GCP Inspectorate and GCP Promotion Unit UNICRI Consultant for Projects on GCP of CTs in developing

More information

Research, Human Subject Protection & Institutional Review Board (IRB) Jed Delmore, MD

Research, Human Subject Protection & Institutional Review Board (IRB) Jed Delmore, MD Research, Human Subject Protection & Institutional Review Board (IRB) Jed Delmore, MD Please pass the Red Bull! History of Human Subjects Protection Nuremberg Code (1947) Unethical Research in the U.S.

More information

Ethical Review and Ethical Issues in. Science Research. Doug Wassenaar PhD. Initiative

Ethical Review and Ethical Issues in. Science Research. Doug Wassenaar PhD. Initiative Ethical Review and Ethical Issues in Health & Social Science Research Doug Wassenaar PhD South African Research Ethics Training Initiative SARETI http://shsph.up.ac.za/sareti/ Fogarty International Center,

More information

HCCA Compliance Institute

HCCA Compliance Institute HCCA Compliance Institute Implementing a Clinical Research Compliance Program Kendra Dimond, Partner Epstein Becker & Green Washington, DC 202-861-0900 F. Lisa Murtha, J.D. Chief Audit and Compliance Officer

More information

Current Issues Regarding Data and Safety Monitoring Committees in Clinical Trials

Current Issues Regarding Data and Safety Monitoring Committees in Clinical Trials Current Issues Regarding Data and Safety Monitoring Committees in Clinical Trials Discussion: Emerging Challenges in the Practice of Clinical Trial Data Monitoring Committees Maureen G. Maguire, PhD Carolyn

More information

We are IntechOpen, the first native scientific publisher of Open Access books. International authors and editors. Our authors are among the TOP 1%

We are IntechOpen, the first native scientific publisher of Open Access books. International authors and editors. Our authors are among the TOP 1% We are IntechOpen, the first native scientific publisher of Open Access books 3300 105,000 1.7 Mio Open access books available International authors and editors Downloads Our authors are among the 151

More information

5DGLDWLRQSURWHFWLRQ *XLGDQFHRQPHGLFDO H[SRVXUHVLQPHGLFDODQG ELRPHGLFDOUHVHDUFK (XURSHDQ&RPPLVVLRQ

5DGLDWLRQSURWHFWLRQ *XLGDQFHRQPHGLFDO H[SRVXUHVLQPHGLFDODQG ELRPHGLFDOUHVHDUFK (XURSHDQ&RPPLVVLRQ 5DGLDWLRQSURWHFWLRQ *XLGDQFHRQPHGLFDO H[SRVXUHVLQPHGLFDODQG ELRPHGLFDOUHVHDUFK (XURSHDQ&RPPLVVLRQ European Commission 5DGLDWLRQSURWHFWLRQ *8,'$1&(210(',&$/(;32685(6,10(',&$/$1'%,20(',&$/5(6($5&+ 1998 Directorate-General

More information

National Health Research Systems and Regulations for Ethical Research in Indonesia

National Health Research Systems and Regulations for Ethical Research in Indonesia National Health Research Systems and Regulations for Ethical Research in Indonesia 1 SURIADI GUNAWAN NATIONAL COMMISSION ON ETHICS OF HEALTH RESEARCH, JAKARTA Priorities of the National Programme for Research

More information

The Tuskegee Syphilis Study. Dr. Joseph Costa. Health Policy and Management MPH 525. Erika McKenzie

The Tuskegee Syphilis Study. Dr. Joseph Costa. Health Policy and Management MPH 525. Erika McKenzie The Tuskegee Syphilis Study Dr. Joseph Costa Health Policy and Management MPH 525 Erika McKenzie August 2014 1 Table of Contents Chapter Page 1. The Tuskegee Syphilis Study. 2 Introduction and Overview..2

More information

Ethical, Political and Social Issues in Joint Ethics Review: Lessons from the Indiana University/Moi University Academic Research Ethics Partnership

Ethical, Political and Social Issues in Joint Ethics Review: Lessons from the Indiana University/Moi University Academic Research Ethics Partnership Ethical, Political and Social Issues in Joint Ethics Review: Lessons from the Indiana University/Moi University Academic Research Ethics Partnership Eric M. Meslin, Ph.D. Director, Indiana University Center

More information

Managing Conflicts of Interest in the Pharmaceutical Sector

Managing Conflicts of Interest in the Pharmaceutical Sector Managing Conflicts of Interest in the Pharmaceutical Sector Marc A. Rodwin, J.D., Ph.D. Professor of Law, Suffolk University Law School Boston, MA 02140, U.S.A. marcrodwin@gmail.com Implementing the access

More information

General Guidelines. In this sense, contribution of distinct individuals to the outcome of scientific analysis needs to be properly acknowledged.

General Guidelines. In this sense, contribution of distinct individuals to the outcome of scientific analysis needs to be properly acknowledged. PUBLICATIONS GUIDELINES FOR RETROSPECTIVE STUDIES, NON-INTERVENTIONAL PROSPECTIVE TRIALS, AND PROSPECTIVE CLINICAL TRIALS OF THE EUROPEAN GROUP FOR BLOOD AND BONE MARROW TRANSPLANTATION. VERSION JUNE/2012

More information

PARTICIPANT RIGHTS AND PRIVACY. Tammy Stewart, CHRC & Jenny Bernhard, CHPC, CHC

PARTICIPANT RIGHTS AND PRIVACY. Tammy Stewart, CHRC & Jenny Bernhard, CHPC, CHC PARTICIPANT RIGHTS AND PRIVACY Tammy Stewart, CHRC & Jenny Bernhard, CHPC, CHC Presentation Outline By the end of this presentation, you will have an understanding of: The history which lead to current

More information

Effective Date: April 2014 Revision: September 29, 2017

Effective Date: April 2014 Revision: September 29, 2017 TITLE: Standard Operating Procedure (SOP) Statement of Authority and Purpose NUMBER: NSHA REB-SOP-1-001 Effective Date: April 2014 Revision: September 29, 2017 Applies To: All REB members and Office Personnel

More information

Outline 18/11/14. Implementation of the DoH in the Americas: Challenges and successes. ! Background and context. ! United States. !

Outline 18/11/14. Implementation of the DoH in the Americas: Challenges and successes. ! Background and context. ! United States. ! Implementation of the DoH in the Americas: Challenges and successes Dr. Jeff Blackmer Director of Ethics Canadian Medical Association 1 Outline! Background and context! United States! Canada! South America

More information

Medical Practitioner. Medical Practitioner. Medical Practitioner. Medical Practitioner. Medical Practitioner. Medical Practitioner

Medical Practitioner. Medical Practitioner. Medical Practitioner. Medical Practitioner. Medical Practitioner. Medical Practitioner Local GP - Trusted Doctor providing stem cell therapy for patients willing to pay even though the treatment is yet to be proven. Local specialist performing a case study with patients funding their own

More information

MRC. Clinical Trials. Series MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS. Medical Research Council

MRC. Clinical Trials. Series MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS. Medical Research Council MRC Clinical Trials Series MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS 1998 Medical Research Council MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS 1998 MRC GUIDELINES FOR

More information

Ethical Principles of Research Ethics

Ethical Principles of Research Ethics Ethical Principles of Research Ethics Soraj Hongladarom Philosophy, Chulalongkorn University Training Session on Introductory Bioethics: Research Ethics, November 23-25, 2005, Chulalongkorn University

More information

Research Within Bounds

Research Within Bounds Programme University of Kent, Great Britain University of Erlangen-Nürnberg, Germany University of Neuchâtel, Switzerland Research Within Bounds Protecting Human Participants in Modern Medicine and the

More information

Ethical Considera0ons. Scien0fic Responsibility. Scien0fic Responsibility. History Ethical Guidelines Animal Research

Ethical Considera0ons. Scien0fic Responsibility. Scien0fic Responsibility. History Ethical Guidelines Animal Research Ethical Considera0ons History Ethical Guidelines Animal Research Scien0fic Responsibility Researchers power over subjects Young students uncertain of their rights Trust in the integrity of the scien0st

More information

UCI ADMINISTRATIVE POLICIES & PROCEDURES

UCI ADMINISTRATIVE POLICIES & PROCEDURES UCI ADMINISTRATIVE POLICIES & PROCEDURES RESEARCH AND SPONSORED ACTIVITIES Human Stem Cell Research Oversight Program Section 484-1: Review of Human Stem Cell Activities Responsible Office: Office of Research

More information

Good Clinical Practice. Martin Rose, MD, JD February 8, 2018 ASQ

Good Clinical Practice. Martin Rose, MD, JD February 8, 2018 ASQ Good Clinical Practice Martin Rose, MD, JD February 8, 2018 ASQ Disclaimer The views expressed in this presentation are those of the presenter and do not necessarily represent the official position of

More information

GS1 Healthcare US November 2010

GS1 Healthcare US November 2010 GS1 Healthcare US November 2010 Capturing and Communicating the Data Speaker: Joe Dudas, Mayo Clinic Now is the time to think about changing the Healthcare Supply Chain Objectives Providing Solutions and

More information

Ethical Issues, Community Perspective and Standards of Care for Clinical Research on Women & Children in Africa

Ethical Issues, Community Perspective and Standards of Care for Clinical Research on Women & Children in Africa Ethical Issues, Community Perspective and Standards of Care for Clinical Research on Women & Children in Africa Holly Rawizza, M.D. Harvard PEPFAR Nigeria/APIN Plus ICASA Dakar, Senegal 3 December 2008

More information

Guiding Principles on the Sharing of Clinical Trial Data. DNDi POLICIES

Guiding Principles on the Sharing of Clinical Trial Data. DNDi POLICIES Guiding Principles on the Sharing of Clinical Trial Data DNDi POLICIES May 2017 I. Preamble DNDi s vision is to improve the quality of life and health of people suffering from neglected tropical diseases

More information

Privacy in Ethics and Ebola: Public Health Planning and Response

Privacy in Ethics and Ebola: Public Health Planning and Response Privacy in Ethics and Ebola: Public Health Planning and Response Contents I. Introduction... 1 III. Background... 2 A. Privacy and the Collection, Use, and Sharing of Ebola Biospecimens for Research2 B.

More information

Human Research Protection Program. Plan

Human Research Protection Program. Plan Human Research Protection Program Plan Revised September 6, 2017 HRP-101 9/6/17 2 of 13 Table of Contents Scope... 3 Purpose... 3 Definitions... 3 Agent... 3 Clinical Trial... 3 Engaged in Human Research...

More information

Doktorski studij na FSB: Uvod u znanstveno istraživački rad 2015/2016 ENGINEERING AND BIOETHICS. Summary

Doktorski studij na FSB: Uvod u znanstveno istraživački rad 2015/2016 ENGINEERING AND BIOETHICS. Summary Doktorski studij na FSB: Uvod u znanstveno istraživački rad 2015/2016 Petra Bonačić Bartolin ENGINEERING AND BIOETHICS Summary UDC Essay This paper outlines the issues in ethics and bioethics in engineering.

More information

An ethical dilemma: Moving medical research to the developing countries. By: Qianyao Qiu

An ethical dilemma: Moving medical research to the developing countries. By: Qianyao Qiu An ethical dilemma: Moving medical research to the developing countries By: Qianyao Qiu Collaboration among peoples from different nations, whether in the form of engaging in trade, providing material

More information

Research ethics and ethical principles. Dr Aceme Nyika Head: Graduate Support Department of Research and Innovation University of Pretoria

Research ethics and ethical principles. Dr Aceme Nyika Head: Graduate Support Department of Research and Innovation University of Pretoria Research ethics and ethical principles Dr Aceme Nyika Head: Graduate Support Department of Research and Innovation University of Pretoria http://www.takealot.com/nikon-10x42-aculon-a211- binoculars/plid30765979?gclid=coxz6yqamdmcffmw0wodwdkd0a

More information

Ethics. Seek to determine what a person should do, or the best course of action, and provides reasons why.

Ethics. Seek to determine what a person should do, or the best course of action, and provides reasons why. Ethics in Genetics Ethics Seek to determine what a person should do, or the best course of action, and provides reasons why. Help people discuss issues that need to be decided by individuals & as members

More information

Annual Research Administrators Symposium IRB Compliance. Thursday, July 31, 2014

Annual Research Administrators Symposium IRB Compliance. Thursday, July 31, 2014 Annual Research Administrators Symposium IRB Compliance Thursday, July 31, 2014 Why IRB Compliance Is Required for Grant Submissions Topics to Cover Today What is an IRB? Why IRB review is required? Regulatory

More information

Internal Audit Charter

Internal Audit Charter Internal Audit Charter 1. Preamble These terms of reference are based on the Institute of Internal Auditors International Standards for the Professional Practice of Internal Auditing and endeavours to

More information

Formación Ética y Responsabilidad Social

Formación Ética y Responsabilidad Social BIOETHICAL REASONING AND CORPORATE SOCIAL RESPONSIBILITY ORIENTATION: A COMPARATIVE STUDY OF THE BUSINESS ADMINISTRATION AND HEALTH PROFESSIONS STUDENTS IN PUERTO RICO Formación Ética y Responsabilidad

More information

Ethics. A. As a Statistician / Statistical Consultant B. Human Subjects Research Protections

Ethics. A. As a Statistician / Statistical Consultant B. Human Subjects Research Protections Ethics A. As a Statistician / Statistical Consultant B. Human Subjects Research Protections Statistical Ethics Professional conduct of statistical analyses essential to society Use statistics in Medical

More information

The Tuskegee Syphilis Study. Dr. Joseph Costa, D.H.Sc., PA-C. Health Policy and Management MPH 525. Dr. Adeniyi Mofoluwake Adijolola

The Tuskegee Syphilis Study. Dr. Joseph Costa, D.H.Sc., PA-C. Health Policy and Management MPH 525. Dr. Adeniyi Mofoluwake Adijolola The Tuskegee Syphilis Study Dr. Joseph Costa, D.H.Sc., PA-C Health Policy and Management MPH 525 Dr. Adeniyi Mofoluwake Adijolola June 2013 1 Introduction The United States Public Health Service collaborated

More information

Ethics Gone Awry The US Public Health Service Studies in Guatemala

Ethics Gone Awry The US Public Health Service Studies in Guatemala Ethics Gone Awry The US Public Health Service Studies in Guatemala 1946-48 Jonathan Zenilman MD Johns Hopkins University School of Medicine Technical Consultant US Presidential Commission for the Study

More information

Good Clinical Practice

Good Clinical Practice Dublin Academic Medical Centre Good Clinical Practice Patrick Murray, MD, FASN, FRCPI Professor, University College Dublin, Mater Misericordiae University Hospital, Dublin, Ireland patrick.murray@ucd.ie

More information

Collaborative Science

Collaborative Science Collaborative Science Team: Veena Shetty, Sanjeev, Sitwat Zehra, De-Ming Chau, Abid Azhar Facilitators : Anwar Nasim, Clarissa Dirk, Lida Anestidou Goal To educate the researchers regarding collaborative

More information

Institutional Review Board for the Protection of Human Subjects

Institutional Review Board for the Protection of Human Subjects University of Michigan Deep Blue deepblue.lib.umich.edu 2012-10-16 Institutional Review Board for the Protection of Human Subjects Rosenzweig, Merle; Zeylikovich, Irina http://hdl.handle.net/2027.42/94130

More information

Clinical Research: A Multifaceted Discipline

Clinical Research: A Multifaceted Discipline Clinical Research: A Multifaceted Discipline Anuradha Kulkarni a, Arun Bhatt b* a Senior Associate - Medical & Regulatory Affairs, Clininvent Research Pvt Ltd, A-302, Everest Chambers, Marol Naka, Andheri

More information

Research Professionals Network Workshop Series

Research Professionals Network Workshop Series Research Professionals Network Workshop Series SO YOU THINK YOU KNOW GCP? Mary-Tara Roth Director, CRRO mtroth@bu.edu Gina Daniels Human Research Quality Manager gdaniels@bu.edu What is [ICH] GCP? an

More information

Situation analysis of local ethical committees in medical sciences in Iran

Situation analysis of local ethical committees in medical sciences in Iran Received: 8.8.21 Accepted: 13.1.21 Original Article Situation analysis of local ethical committees in medical sciences in Iran Yousef Fakour a, Monir Baradaran Eftekhari * b, Zohre Haghighi c, Najmeh Khosravan

More information

Research Ethics Committee Administration in Uganda: The Research Ethics Committee (REC) Administrators Perspective

Research Ethics Committee Administration in Uganda: The Research Ethics Committee (REC) Administrators Perspective Research Ethics Committee Administration in Uganda: The Research Ethics Committee (REC) Administrators Perspective MAKERERE UNIVERSITY Aida Nakawunde, MSc. CEB, REC Administrator School of Medicine, Makerere

More information

Receive Pharmaceutical Stock

Receive Pharmaceutical Stock Level: 3 Credit value: 3 Unit aim This unit enables learners to receive and store pharmaceutical stock. This unit requires learners to show that they understand current legislation and good practice when

More information

Corporate Governance Statement 2016/17

Corporate Governance Statement 2016/17 Corporate Governance Statement 2016/17 The Trust is required to complete its Corporate Governance self-assessment and make its associated statement by 30 June 2017. From July 2017, NHSi will contact a

More information

CODE OF PRACTICE FOR RESEARCH

CODE OF PRACTICE FOR RESEARCH CODE OF PRACTICE FOR RESEARCH Dr Diana Leighton REF Manager Professor Andy Young Director of Research & Innovation Services Version 1.0 - September 2010 First approved Academic Board 27 September 2010

More information

Introduction This is an exam style question on stem cells that might be useful towards the end of the topic.

Introduction This is an exam style question on stem cells that might be useful towards the end of the topic. Teacher Notes Introduction This is an exam style question on stem cells that might be useful towards the end of the topic. Suggested mark scheme (a) (i) a non-specialised cell any 1 for 1 a cell that can

More information

Writing a Convincing Dossier on Impurities and Method Validation. Dr. Hans Ulrich Gally Swissmedic Swiss Agency for Therapeutic Products

Writing a Convincing Dossier on Impurities and Method Validation. Dr. Hans Ulrich Gally Swissmedic Swiss Agency for Therapeutic Products Writing a Convincing Dossier on Impurities and Method Validation Dr. Hans Ulrich Gally Swissmedic Swiss Agency for Therapeutic Products 1 Writing a Convincing Dossier on Impurities and Method Validation

More information

Institutional Review Board

Institutional Review Board Institutional Review Board Policies and Procedures for the Protection of Human Subjects in Research Naval Medical Research Center Research Services Directorate Office of Research Administration Code 025,

More information

Protecting Human Research Participants

Protecting Human Research Participants Overview... i Introduction... 1 History... 3 Codes and Regulations... 16 Respect for Persons... 37 Beneficence... 62 Justice... 88 Conclusion... 109 Glossary... 111 PHRP Website Protecting Human Research

More information

Guidelines and Recommendations for European Ethics Committees

Guidelines and Recommendations for European Ethics Committees Guidelines and Recommendations for European Ethics Committees European Forum for Good Clinical Practice A Place to Meet Revised Edition 1997 All rights in this document are reserved by the, a not-for-profit

More information