BE PART OF THE CONSULTATION ON THE REVISED TCPS

The Tri-Council Policy Statement (TCPS) is undergoing its first comprehensive revision, since it was adopted by Canada’s three federal research funding agencies in 1998.

The Principles: The eight principles outlined in the original document have been condensed into 3 core principles; concern for welfare, respect for autonomy, and respect for the equal moral status of all humans.
Structure: More explicit explanation is provided about the scope of the TCPS, including clarification on which types of activities are not subject to research ethics board review, such as creative practice activities.
The document’s organization has changed from the previous introduction with 10 sections to a chapter format with a total of 13 chapters, two of which are completely new and cover qualitative research and research with Aboriginal people.
Updated guidelines are provided in the areas of human tissue and human genetic research as well as privacy and confidentiality, secondary use of research data or materials, and adoption of CIHR guidelines.
The new edition also addresses researcher and REB concerns such as the expanded discussion of models for review of multi-jurisdictional research and includes responses to interpretation questions developed over the last few years and recommendations from working committee reports based on previous public consultations. Within each chapter, numbered articles are now followed by an application section that offers further guidance to researchers and REBs. Cross references are integrated across the document to assist interpretation. A Table of Concordance identifies where no comparable article or commentary existed in the 1998 edition of the TCPS.
Definitions and Terminology: A new definition of research is more inclusive of social sciences and humanities research and additional definitions associated with clinical trials, and different categories of information are included.  Changes to terms such as “research participant”, rather than “subject” and “delegated review” rather than “expedited review” and “departmental review” are introduced. More inclusive language that takes in all types of research involving humans and a broad range of approaches is reflected throughout the draft edition.

McMaster Consultation: The Panel and Secretariat on Research Ethics are eager to hear from those who use the TCPS, in order to improve this draft before presenting a final version to the three Agencies for approval and adoption.

Have your say:
A McMaster consultation is scheduled for the following times. Please come to as many sessions as you like and voice your questions, suggestions and critique. Faculty, staff, graduate and undergraduate students are all welcome. A compilation of comments from the McMaster research community will be made and sent to the Panel on Research Ethics. You can also choose to send your comments individually on the draft 2nd edition of the TCPS to draft2e@pre.ethics.gc.ca  The consultation period ends March 31, 2009.
To obtain a copy of the draft TCPS document electronically go to:  http://www.pre.ethics.gc.ca/english/pdf/newsandevents/TCPS_Dec_4_en.pdf     
The table of concordance is available electronically at   www.pre.ethics.gc.ca/english/pdf/newsandevents/TOC_-_Old_to_New_Version.pdf
A small number of print copies are available from the McMaster Research Ethics board at ethicsoffice@mcmaster.ca or call ext. 23142

McMaster Consultation Dates: (To cover the full document, each day will cover specific chapters.)
February 26, 2-4pm, MDCL 3024
Facilitators: HHS/FHS REB Chair: Jack Holland and St. Joseph’s REB Chair Raelene Rathbone
Chapter 7: Conflict of interest
Chapter 8: Multi-jurisdictional research
Chapter 11: Clinical trials
Chapter 12: Human tissue
Chapter 13: Human genetic research

March 2, 2-4pm, MUSC 311-313
Facilitators: McMaster REB chair, Daphne Maurer & St. Joseph’s REB chair, Raelene Rathbone
Chapter 1: Ethics framework
Chapter 2: Scope and approach
Chapter 3: Free and informed consent
Chapter 4: Inclusion in research
Chapter 5: Privacy and confidentiality
Chapter 6: Governance of REBs

March 6, 1-3pm, HSC 1K10E (Blue room)
Facilitator: McMaster REB Chair, Daphne Maurer
Chapter 9: Research involving aboriginal peoples
Chapter 10: Qualitative research

March 9, 2-4pm, SJHH, Martha Wing H320
Facilitators: St. Joseph’s REB Chair, Raelene Rathbone & McMaster REB chair, Daphne Maurer
Chapter 7: Conflict of interest
Chapter 8: Multi-jurisdictional research
Chapter 11: Clinical trials
Chapter 12: Human tissue
Chapter 13: Human genetic research

NEW AT THE LIBRARY

The Handbook of Social Research Ethics Mertens, D.M. and Ginsberg, P.E., (2008). Thousand Oak: Sage.
The editors bring together 37 original chapters by researchers from around the world and from a variety of disciplines. The historical and philosophical context of human research ethics in the social sciences provides the foundation of the text.  Subsequent sections present an overview and comparison of ethical regulations, examine ethical issues that arise due to methodologies, and address ethical concerns from a range of contexts from race, age, religion gender and disability.  This handbook is an excellent research ethics reference text and could be set as a required or supplementary text in courses on qualitative research methods.

Case Studies in Ethics and HIV Research Loue, S. and Pike, E.C.  Boston: Springer Science and Business Media (2007) McMaster Library e-book
Loue and Pike’s collection begins with 6 chapters that explore ethical principles and regulations that guide HIV research in addition to relations established between researchers and the participants and communities they study. The remaining twelve chapters focus on methodological issues, ethical issues for HIV specific populations, and training researchers and communities and address such topics as data ownership and confidentiality especially in community based participatory research (CBPR) which is common in the study of HIV. A particularly valuable training bonus of this volume is the corresponding case study that follows each theoretical chapter and provides practical discussion of actual studies. Researchers and students in the health and social sciences will find this volume provocative and practical.

NEW RESEARCH ETHICS OFFICER FOR HHS/FHS REB and St. Joseph’s REBs

Oliver Klimek is the new Research Ethics Officer with the Hamilton Health Sciences/Faculty of Health Sciences Research Ethics Board and the St. Joseph’s Healthcare Hamilton REB.  Oliver can be reached at klimeko@mcmaster.ca or ext. 22577 to assist researchers with questions about the ethics review process.

NEED HELP WITH ETHICS?

Are you are preparing an application for human ethics review and have questions about the process? Help is a phone call or email away. 

For assistance with submissions to the McMaster Research Ethics Board (MREB) related to non-medical research contact Karen Szala-Meneok or Michael Wilson (See the “REB CONTACTS” column in this newsletter for their contact information).

The monthly MREB monthly ethics drop-in consultations are Monday March 02 - MUSC 214 12:00pm - 1:30pm and Monday April 06 - MUSC 214 12:00pm - 1:30pm but you can contact the ethics office at any time to ask for advice or to look over a draft of your application.  Help is a telephone extension away. 

For assistance with submissions to the HHS/FHS REB and /or SJHH REB please contact the research ethics officer, Oliver Klimek or the REB Coordinators, Deborah Mazzetti (HHS/FHS), or Leigh Mahan (SJHH) who will be happy to assist you with the process and answer your questions (See the “REB CONTACTS” column in this newsletter for their contact information).

The “Nuts and Bolts Workshop” or How to complete the McMaster Research Ethics Board ApplicationForm 
Dr. Daphne Maurer (McMaster Research Ethics board Chair) is offering a workshop providing practical advice about how to complete the McMaster Research Board (MREB) Ethics Application. Come to this 2 hour workshop presented on Wednesday February 25 1:00 - 3:00 Student Centre 311/313.  No registration is required.  Please feel free to display or distribute this poster in your area.  <Download PDF Poster>

CIHR Aboriginal Guidelines Online Tutorial
The Canadian Institutes of Health Research (CIHR) is planning an online tutorial on the CIHR Aboriginal Guidelines that should be available later this year.  The CIHR is encouraging research ethics boards, community health committees and researchers to complete this tutorial and hope that it will be recognized as Continuing Medical Education (CME) or course credits at the university level. Information about the new tutorial will be disseminated through CIHR E-Alerts and University Research Administration Offices in the coming months. Enquiries can be emailed to the Aboriginal Ethics Guidelines inbox at aeg-lda@cihr-irsc.gc.ca.

Bioethics Interest Group (B.I.G) The Bioethics Interest Group is a monthly seminar series concerning a variety of ethical issues. The seminars are held the second THURSDAY each month 12:00 - 1:00. The format of these discussions is a brief presentation or lecture followed by a round table discussion. On March 13 Deirdre DeJean will discuss ethics in health technology assessment in MDCL 3022, and on April 10 Arlene MacDonald will discuss ethics, religion and organ transplantation in MDCL 3304.

Canadian Bioethics Society will be holding their annual conference in Hamilton this year from June 11-14th 2009 at the Hamilton Convention Centre. This year’s theme is “Just Evidence?”  Check out their website for details about speakers, sessions, posters and much more.   http://www.bioethics.ca/index-ang.html or http://fhs.mcmaster.ca/bioethicsconference/index.html