- Social and Scientific Values - Social and Scientific Values - Scientific Validity - Scientific Validity - Fair Subject Selection - Fair Subject Selection.

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

Respect for participants Dr Enoka Corea. maintaining the privacy of the participant by ensuring confidentiality ensuring that participants may withdraw.
Research involving adults lacking the capacity to consent Legal, ethical and practical issues Dr Mikey Dunn Senior Research Associate in Health and Social.
Ethics Relating to Children in Research in FP7
Tri-Council Policy Statement 2010 Ethical Conduct for Research Involving Humans.
Ethical Considerations when Developing Human Research Protocols A discipline “born in scandal and reared in protectionism” Carol Levine, 1988.
TODAY’S TOPIC: Ethics – deconstructing consent and participation with “vulnerable” populations.
Evaluating Risk 1 IRB CELT Presentation Colleen Donaldson – IRB Administrator Julie Wilkens – IRB Coordinator.
THE ETHICS OF HUMAN PARTICIPANT RESEARCH Office for Research Protections The Pennsylvania State University.
Subject Selection and Recruitment David Wendler Department of Clinical Bioethics NIH, USA.
Use of Children as Research Subjects What information should be provided for an FP7 ethical review?
PPA 501 – Research Methods in Administration Lecture 2b - Ethics.
Ethical Guidelines for Research with Human Participants
8 Criteria for IRB Approval of Research 45 CFR (a)
Fair participant selection Dr Enoka Corea. Inclusion criteria Exclusion criteria Where the study will be conducted How the participants will be recruited.
Ethics in research involving human subjects
Research Ethics John Porter London School of Hygiene and Tropical Medicine.
Human Subject Research Ethics
1 Wheaton College INSTITUTIONAL REVIEW BOARD (IRB)
Idara C.E.. Three ethical principles guides research with human participants. principle of Autonomy 1. The principle of Autonomy requires investigators.
A History of Human Research Protections and Institutional Review Boards Roger L. Bertholf, Ph.D. Associate Professor of Pathology Chair, University of.
The Goals and Principles of Human Participant Protection Part 4: Vulnerable Populations.
What makes Clinical Research Ethical? Dr Enoka Corea Co-secretary, ERC Faculty of Medicine, Colombo.
INSTITUTIONAL REVIEW BOARD HISTORY AND ETHICS. 2 Ethical History : Holocaust : Nuremburg Trials 1964: Declaration of Helsinki :
Is Your Research Ethical? The application of Research Ethics Guidelines to Regional Health Authority Research Dr Alan Katz Need to Know: June 9, 2003.
Effectiveness in Review & Oversight of Human Subjects Research Steven Joffe, MD, MPH Assistant Professor of Pediatrics.
GCP & ETHICS COMMITTEES Ravi Rengachari Vector Control Research Centre PONDICHERRY.
The Global Health Network Marijke Geldenhuys 19 September 2014 Adhering to the GCP Principles.. what does that even mean?
1 Protection of Vulnerable Subjects in Research Melody Lin, Ph.D. December 2012.
Legal & Ethical Issues. Objectives At the completion of this session the participant will be able to: ◦ Describe the ethical principles associated with.
The Institutional Review Board: A Community College Toolkit Dr. Geri J Anderson.
IRB BASICS: Issues in Ethics and Human Subject Protections Prepared by Ed Merrill Department of Psychology November 12, 2009.
Ethical Challenge & Solution in Social Behavioral Research Melody Lin December 2012.
Institutional Review Board (IRB) What is our Purpose and Role for Ethical Research.
Human Subjects Protections Research Ethics. Basic Assumptions about How Research Should be Conducted Subjects should be protected from harm. Subjects.
The ethical conduct of research with human participants Nancy E. Kass, ScD Department of Health Policy and Management Johns Hopkins Berman Institute of.
Chapter 5 Conducting & Reading Research Baumgartner et al Chapter 5 Ethical Concerns in Research.
Introducing Communication Research 2e © 2014 SAGE Publications Chapter Three Ethics: What Are My Responsibilities as a Researcher?
Institutional Review Board Issues for Classroom Research Sharon McWhorter IRB Administrator, The University of Akron (With assistance from Phil Allen,
NAVIGATING THE IRB PROCESS University Institutional Review Board California State University, Stanislaus.
1 [INSERT SPEAKER NAME DATE & LOCATION HERE] Ethics of Tuberculosis Prevention, Care and Control MODULE 10: RESEARCH IN TB CARE AND CONTROL Insert country/ministry.
Applicability of principles Reidar K. Lie, MD, PhD Department of Clinical Bioethics, NIH and University of Bergen, Norway.
Identifying current and potential ethical challenges and Dilemmas in HIV prevention Research Ethics in clinical research: challenges linked.
TUN IRB: The Basics February 26, IRB Function Review human-subject research Ensure the rights & welfare of human subjects are adequately protected.
What Institutional Researchers Should Know about the IRB Susan Thompson Senior Research Analyst Office of Institutional Research Presented at the Texas.
APPROVAL CRITERIA AN IRB INFOSHORT MAY CFR CRITERIA FOR IRB APPROVAL OF RESEARCH In order for an IRB to approve a research study, all.
Idara C.E.. Three ethical principles guides research with human participants. principle of Autonomy 1. The principle of Autonomy requires investigators.
ETHICAL ISSUES AND INFORMED CONSENT Juan M. Lozano, MD, MSc Department of Paediatrics and Clinical Epidemiology Unit School of Medicine, Javeriana University.
HPTN Ethics Guidance for Research: Community Obligations Africa Regional Working Group Meeting, May 19-23, 2003 Lusaka, Zambia.
Chapter 5 Ethical Concerns in Research. Historical Perspective on Ethics Nazi Experimentation in WWII –“medical experiments” –Nuremberg War Crime Trials.
Pediatric Research Ethics and the Research Subject Advocate Tomas Jose Silber, MD, MASS RSA and Director, Office of Ethics, CNMC Professor of Pediatrics,
Quality Metrics of Performance of Research Ethics Committees Cristina E. Torres, PhD FERCAP Coordinator.
Investigator Initiated Research Best Practices for IRB: SBER Corey Zolondek, Ph.D. IRB Operations Manager Wayne State University.
Research Ethics Dónal O’Mathúna, PhD Senior Lecturer in Ethics, Decision-Making & Evidence
Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO)
GCP (GOOD CLINICAL PRACTISE)
Research Ethics Dr Nichola Seare Aston Health Research & Innovation Cluster.
Back to Basics – Approval Criteria
IRB BASICS Ethics and Human Subject Protections Summer 2016
Research on Populations Prone to Being Vulnerable
The Importance of Ethical and Human Rights Issues in Global Health
Protection of Human Subjects In Research
Jeffrey M. Cohen, Ph.D. CIP President HRP Associates, Inc.
Ethical Principles of Research
ETHICAL CONSIDERATIONS IN THE CONDUCT OF HEALTH SCIENCES RESEARCH
IRB BASICS: Ethics and Human Subject Protections
Rieke van der Graaf PhD UMC Utrecht, Julius Center
Greg Nezat CRNA, PhD CDR/NC/USN Chairman, IRB II
Research with Human Subjects
Ethical Theories and Principles in Clinical and Research
Presentation transcript:

- Social and Scientific Values - Social and Scientific Values - Scientific Validity - Scientific Validity - Fair Subject Selection - Fair Subject Selection - Favorable Risk-Benefit Ratio - Favorable Risk-Benefit Ratio - Informed Consent - Respect for Enrolled Subjects - Informed Consent - Respect for Enrolled Subjects - Independent Review - Independent Review - Community Perspective - Community Perspective “What Makes Clinical Research Ethical ?” “What Makes Clinical Research Ethical ?” Guidelines for Research Ethics القيم الاجتماعية والعلمية الصلاحية العلمية العدل فى اختيار الأشخاص محل البحث تغليب المنافع على المخاطر الموافقة المستنيرة احترام الأشخاص محل البحث المراجعة المستقلة منظور المجتمع Prof. Dr. Wafaa E. Abdel-Aal National Research Centre, Cairo, Egypt

Social Value To be ethical clinical research must lead to improvements in health or advancement in generalizable knowledge It is not justifiable to expose subjects to risks of a study if it lacks social value

Research must be conducted with an appropriate methodology to ensure that the results will answer the original research questions Invalid research: underpowered studies studies with inappropriate endpoints or statistical tests studies that cannot enroll sufficient subjects Scientific Validity

Selection of subjects is equitable Convenient (vulnerable) groups should not be targeted. CIOMS #13 – Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. – More formally, they may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests Equitable Selection of Subjects

Risks are identified Risks are minimized Potential benefits enhanced Risks are reasonable to potential benefits to subject and society Favorable Risk-Benefit Ratio

Physical Psychological Social Legal Economic Community What are the types of harm?

Favorable Risk-Benefit Analysis POTENTIAL BENEFITS Participants + Society RISK OF HARMS Participants

Analysis of Risks and Benefits Risk Level Minimal Above Minimal Too RISKY Heba Kassem, Alexandria University

Informed consent الموافقة المستنيرة

Informed consent ensures that individuals themselves decide: – whether to enroll in research and – whether research fits with their own values, interests, and goals. Research on individuals who cannot decide requires surrogate consent – children and mentally impaired Informed Consent

informationVoluntary Decision- Making Capacity Understanding and Appreciation Cognitive Abilities Expression of a Choice The CIOMS Guidelines have defined informed consent as consent given by a competent individual who:

Respecting enrolled subjects includes: ‣ Permitting withdrawal ‣ Protecting confidentiality ‣ Monitoring welfare throughout the study Respect for Enrolled Subjects The ethical requirements of research do not end with a signed consent document.

Independent Review Research Ethics Committees

REC Purpose and Function “...contribute to safeguarding the dignity, rights, safety, and well-being of all actual or potential research participants.” WHO Guidelines

Why Research Ethics and RECs? Obtain External Funding Publish International Journals Enhance Global Health Protect human rights Protect human welfare Minimize harms Ensure Justice Public Trust

Research Ethics Committees  The role of the Research Ethics Committee (REC) as an independent “agent” protecting human research participants is well described in key international guidelines. ◦ Declaration of Helsinki ◦ CIOMS Regulations WHO: Operational Guidelines for Ethics Committees that Review Biomedical Research

What are Barriers? Perceptions that RECs hinder research Decisions – Approve – Require Modifications – Deferred – Disapprove Less than 5% of protocols were disapproved

“A collaborative approach to research that equitably involves all partners in the research process to enhance the understanding of community needs and make more likely the enabling of action for social change” What is Community-Based Participatory Research? Community/social change focus

Growing realization that “traditional” research approaches have failed to solve complex health problems. Address locally identified needs. Renewed focus on the social, political, and economic behaviors that influence health behavior. Enhance potential for social change Motivation for Community Input

Build trust/acceptance of research/respect – Voice for study participants and community – Share research results with community Allow for community role in development of research agenda and specific studies – Encourage recruitment (trial participation) – Enhances Informed Consent Bridges cultural gaps between researchers and communities Why Community? Overall Goals

- Social and Scientific Values - Social and Scientific Values - Scientific Validity - Scientific Validity - Fair Subject Selection - Fair Subject Selection - Favorable Risk-Benefit Ratio - Favorable Risk-Benefit Ratio - Informed Consent - Respect for Enrolled Subjects - Informed Consent - Respect for Enrolled Subjects - Independent Review - Independent Review - Community Perspective - Community Perspective “What Makes Clinical Research Ethical ?” “What Makes Clinical Research Ethical ?” Guidelines for Research Ethics القيم الاجتماعية والعلمية الصلاحية العلمية العدل فى اختيار الأشخاص محل البحث تغليب المنافع على المخاطر الموافقة المستنيرة احترام الأشخاص محل البحث المراجعة المستقلة منظور المجتمع Prof. Dr. Wafaa E. Abdel-Aal National Research Centre, Cairo, Egypt