The Interagency Advisory Panel on Research Ethics (PRE) has announced the launch of their new web site. It can be found at www.pre.ethics.gc.ca
The PRE is a body of external experts established in November 2001 by Canada’s three Federal Granting Agencies (the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council) to support the development and evolution of their joint research ethics policy, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS).
An electronic version of the
Tri-Council Policy Statement: Ethical
Conduct for Research Involving Humans
is available online for your review at
the following website. All protocols submitted to the board must be consistent
with these guidelines.
This is the primary national policy document regarding research ethics.
ICH Harmonised Tripartite Guideline - Guideline for Good Clinical Practice is available at the following website http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php
This is an international document adopted by Health Canada which applies to drug and device studies undertaken by industry or with industry support.
Health Canada Division 5, Drugs for Clinical Trials Involving Human Subjects
- Canada's Food and Drugs Act: Regulations Amending the Food & Drugs Act
- Clinical Trials Published in the Canada Gazette, Part II: SOR/DORS/2001-203,
pp34-71 (June 7, 2001):
National Council on Ethics in Human Research (NCEHR) also has a website,
and a link to the
Tri-Council Policy Statement: Ethical Conduct for Research Involving
is also available here.
The National Institutes of Health also has a page of Human Subjects protections
and Research Ethics resources that you may find interesting.
The Office for Human Research Protections (OHRP) in the U.S. Department of Health and Services (DHSS) provides valuable information for IRBs http://www.hhs.gov/ohrp/
The Canadian Bioethics Society website provides information on this group
and upcoming conferences as well as some helpful resources.
The Belmont Report
The Declaration of Helsinki
National Bioethics Advisory Commission