Research Ethics Western University Health Sciences Research Ethics Board Letter of Information & Consent Process Grace Kelly Ethics Officer

Slides:

Advertisements

Similar presentations

Research Methods in Crime and Justice Chapter 3 The Ethical Principles that Guide Researchers.

Advertisements

University Research Ethics Committee Workshop on procedure and data protection issues 30th May 2008.

Human Subjects Protections, Concepts, and Procedures Office of Research and Sponsored Programs Tom Lombardo, Ph.D., Director, Research Integrity & Compliance.

RESEARCH COMPLIANCE Agenda 1. No Destruction of local research documents after scanning 2. Training for shipping biological samples/specimens 3. Regulatory.

THE UW HEALTH SCIENCES IRB S OVERVIEW PRACTICAL REGULATORY ISSUES IN HUMAN SUBJECTS RESEARCH.

Good Clinical Research Practice Guidelines For Informed Consent Presented by Catherine May Acting Research Practice Development Officer The Office of Research.

Tri-Council Policy Statement 2010 Ethical Conduct for Research Involving Humans.

© HRP Associates, Inc. Informed Consent, Parental Permission & Assent Jeffrey M. Cohen, Ph.D., CIP President, HRP Associates, Inc.

Health Insurance Portability Accountability Act of 1996 HIPAA for Researchers: IRB Related Issues HSC USC IRB.

Vicki Hammen, Vice Chair, IRB IRB Brown Bag February 9, 2009.

Grace Kelly Ethics Officer Office of Research Ethics The University of Western Ontario x84692 An Introduction to Research.

TODAY’S TOPIC: Ethics – deconstructing consent and participation with “vulnerable” populations.

FERPA and IRB: Implications for Testing Centers Judith W. Grant, Ph.D.,CIP NCTA Conference San Antonio, Texas August 6, 2009.

DO NO HARM IRRB Presentation Purposes Responsibilities Processes NLU IRRB Home page.

Human Studies Program Office of Research Compliance Vice Chancellor for Research and Graduate Education Key to a Successful Approval of Your Research Denise.

HUMAN RESEARCH ETHICS. TRI-COUNCIL POLICY The University has adopted the Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans.

Human Subjects Issues S005. General principles Avoid risk of unreasonable harm Informed consent (prior to data collection) Risks, benefits, procedures,

Use of Children as Research Subjects What information should be provided for an FP7 ethical review?

©2010 John Wiley and Sons Chapter 14 Research Methods in Human-Computer Interaction Chapter 14- Working with Human Subjects.

Research Compliance Office Consent Form Workshop Kristin B. Frazier HRPP Education Specialist Research Compliance Office January 24, 2008.

ETHICS AND RESEARCH SHARON BESSELL RESEARCH METHODS POGO 8196

FOUNDATIONS OF NURSING RESEARCH Sixth Edition CHAPTER Copyright ©2012 by Pearson Education, Inc. All rights reserved. Foundations of Nursing Research,

Research Ethics An Overview of Research Ethics and the Tri-Council Policy Statement 2 Grace Kelly Ethics Officer Health Sciences.

Research Ethics Western University Health Sciences Research Ethics Board Tri-Council Policy Statement 2 Grace Kelly Ethics Officer

An Overview of Research Ethics & The Tri-Council Policy Statement 2

How to Avoid Problems in the Informed Consent Process Shannon Ontiveros, MS, CIP, CIM Institutional Review Board.

Research Ethics Western University Non-Medical Research Ethics Board Tri-Council Policy Statement 2 Grace Kelly Ethics Officer

Ethical Issues and Treatment Policies. [This document is part of the « Malaria Indicator Survey » toolkit, developed by the RBM-MERG, with contributions.

Cornell Evaluation Network The Use of Human Participants in Research Office of Research Integrity and Assurance ~ May 14, 2007.

Human Research Ethics and Obtaining Ethics Approval

1 Evaluation Taking Care Nico Jabin Senior evaluation officer Last updated: March 2013.

Talk to Us Approach to Evaluation Lindsay Wager 1 st April 2014.

Guidelines for data preparation - ESRC Datasets Policy Louise Corti ESDS/UKDA Social Science Data Archives for Social Historians: creating, depositing.

The Office of Research Ethics October 11, 2013 Office of Research Ethics.

IRB Board Education Session 6 How Consent Regulations are Implemented in INSPIR Mary Banks Director, Office of the IRB June -July 2005.

ESRC Datasets Policy and Qualitative Data Preparation Gill Backhouse Senior Acquisitions and Liaison Officer Qualidata.

May I have your permission please? The consent process: What, Where, When, Who and Why Valerie Smith OHRP IRB Program Manager

Canadian English LING 202, Fall 2007 Dr. Tony Pi Research Ethics.

Institutional Review Board for Human Subject Research: Does Your Research Need One? Merle Rosenzweig Michael Unsworth.

The Office of Research Ethics September 10, 2012 MClSc Physical Therapy Student Orientation Office of Research Ethics.

Research Ethics Research Methods Grace Kelly Ethics Officer Health Sciences Research Ethics Board.

Chapter 18 Ethical Precautions in Music Therapy Research.

Special Consideration in Public Health Practice & Research Delia Wolf, MD, JD, MSCI Associate Dean, Regulatory Affairs and Regulatory Compliance Lecturer,

How to Successfully Apply to the IRB Richard Gordin, IRB Chair True Rubal, Administrator / Director For the Protection of Human Participants in Research.

IRB BASICS: Issues in Ethics and Human Subject Protections Prepared by Ed Merrill Department of Psychology November 12, 2009.

Research Ethics Western University Non-Medical Research Ethics Board Letter of Information & Consent Process Grace Kelly Ethics Officer

IWK Research Ethics - Workshop Series Session #2 REB Review Procedures How to submit … October 24, 2013 Bev White, Manager, Research Ethics Research Services,

Human Subjects Protections Research Ethics. Basic Assumptions about How Research Should be Conducted Subjects should be protected from harm. Subjects.

Alyssa Speier, MS, CIP QA/QI Education Specialist Stanley Estime, MSCI QA/QI Specialist Interview, Survey, and Focus Group Research: IRB Processes and.

INFORMED CONSENT The Ethical Principle The Regulations The Document The Process What Should It All Mean To Me?

Research Ethics Western University & University of Windsor Grace Kelly Ethics Officer

NAVIGATING THE IRB PROCESS University Institutional Review Board California State University, Stanislaus.

TUN IRB: The Basics February 26, IRB Function Review human-subject research Ensure the rights & welfare of human subjects are adequately protected.

Dr. Jacqueline Goodway Human Sciences Tips from the Trenches: Ten Tips from an IRB Reviewer for a Successful IRB Application.

The Office of Research Ethics September 10, 2012 Anatomy & Cell Biology Graduate Student Orientation Office of Research Ethics.

Senta Baker Sharon Moran IU Human Subjects Office Human Subjects Office IRB Submissions and KC Demostration School of Music November 13, 2015.

Paul Hryvniak MS, CIP Alyssa Speier, MS, CIP September 30, 2014 Student Human Research Education Session Tel:

Informed Consent Process Patrick Herbison, MEd, CIP Research Compliance Manager Office of Human Research (OHR)

Avenues of Consent Options available under 45 CFR (d) &

Data Ethics Ethical issues can arise when we collect data from people Difficulties can be more severe for experiments – Impose treatments – Can possibly.

Protecting Human Subjects Overview of the Issues Applications to Educational Research The IRB Process.

Slide 1 Standard Operating Procedures. Slide 2 Goal To review the standard operating procedures Creating the informed consent document Obtaining informed.

Applying for ethical approval

Disclaimer The information provided in this presentation is consistent with the current policies and guidelines laid out within our office, the Research.

Non-Medical Research Ethics Board

Jeffrey M. Cohen, Ph.D. CIP President HRP Associates, Inc.

The Office of Research Ethics

Scholars in Medicine 2015 Student Projects IRB Submission Process

Division of General Internal Medicine

Office of Research Integrity and Protections

Presentation transcript:

Research Ethics Western University Health Sciences Research Ethics Board Letter of Information & Consent Process Grace Kelly Ethics Officer

Upcoming Educational Sessions Forms – Initial submission + Post Approval Forms Surveys and Online Research Teachers’ Research with their own Students ROMEO and electronic submissions

Today’s Agenda Tri-Council Policy Statement (Chapter 3) Letter of Information Consent Form Assent Alternates for Obtaining Consent Question and Answer Period

Tri-Council Policy Statement 2 Chapter 3 1. Consent shall be given voluntarily 2. Consent can be withdrawn at any time 3. *If a participant withdraws consent, the participant can also request the withdrawal of their data or human biological materials

Tri-Council Policy Statement 2 Chapter 3 Undue Influence & Coercion - eg. Being recruited by a boss or supervisor Incentives – eg. Win a prize for participating in research Capacity – eg. Can the person sign for themselves? Presentation Title Here

Tri-Council Policy Statement 2 Chapter 3 Consent shall be informed – eg. Consent Process Consent shall be an ongoing process – eg. Check in Consent shall precede collection of, or access to, research data – i.e. you cannot do ANYTHING with the participant until consent is obtained Consent shall be documented – eg. Verbal consent

Letter of Information

Consent Form

Assent

Children age 0-6 years 12 months (nothing) Children age 7-12 years 12 months (Assent – see sample) Children age years 12 months (Assent using the same letter that their parent will read but sign separate consent forms). In all these cases parents MUST give consent also. A child cannot participate based on their Assent only.

Alternate Procedures for Obtaining Consent Certain types of research require alternate processes for seeking consent, not to be confused with a waiver of consent. –Written Consent (Letter of Information + Consent to sign) –Explicit Consent (Letter of Information + Completion of Survey) –Explicit Verbal Consent (Telephone Script + Agree to Interview) You still need a Letter of Information or script for ALL of these forms of consent. Subjects must be told exactly what is going to happen to them (full disclosure)

Used for retrospective studies, NEVER for clinical trials Sample size is too big to consent everyone Large proportion of individuals have relocated or died Creation of privacy risk by linking ID to de-identified data Risk of psychological, social or other harm Difficulty in contacting individuals Participants are being identified Waiver of Consent

Question & Answer Period Thank you! We are always here to help. If you have any questions please contact Grace Kelly at ext or or Julie Pfeiffer at ext or