Educational and Professional Resources
Joint Centre for Bioethics Research Ethics Education Portal, University of Toronto
Contains research ethics educational materials from the Toronto Academic Health Sciences Network and the University of Toronto.
Developing a Framework for Social Science Research Ethics, York University
Provides links to a variety of international resources dealing with research ethics in the social sciences.
Social Science Research Ethics, Lancaster University
Provides a range of resources designed to help new social science researchers increase their knowledge and understanding of the processes and practices involved in undertaking ethically sound research. Designed for UK researchers, but many of the resources are relevant to all social science researchers.
Interagency Advisory Panel on Research Ethics (PRE)
Promotes the ethical conduct of research involving human participants. Develops, interprets and implements the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS).
Ethics Office of the Canadian Institutes of Health Research (CIHR)
Responsible for developing and implementing policies and guidelines to fulfill the ethical and legal responsibilities that CIHR holds as a research sponsor.
Institute of Translational Health Sciences (ITHS)
A partnership among the University of Washington, Seattle Children’s, and the Fred Hutchinson Cancer Research Center. Provides academic programs, short courses, and both live and archived online seminars on issues relevant to those conducting research involving human subjects.
Health Canada Web Sites
Clinical Trial Application (CTA)
Sponsors must file a Clinical Trial Application (CTA) to conduct clinical trials in Phases I through III of drug development and comparative bioavailability trials. This includes applications to conduct clinical trials involving marketed products where the proposed use of the product is outside the parameters of the authorized Notice of Compliance (NOC) or Drug Identification Number (DIN) application (e.g. using a marketed product for a 'new' indication or using an unauthorized dose, etc).
Food and Drug Regulations
Health Canada Regulations Amending Food and Drug Regulations 1024 Clinical Trials - Division 5 - Drugs For Clinical Trials Involving Human Subjects
Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada. This site includes guidance documents and forms and regulations regarding medical device applications and listings of advisories and warnings for health professionals.
Health Products and Food Branch Inspectorate Compliance and Enforcement
The Health Products and Food Branch Inspectorate (Inspectorate) has the responsibility for the inspections and investigations of clinical trials. These inspection and investigation functions have as main objective to reduce risks to subjects enrolled in clinical trials, while encouraging sponsors in their research activities for new therapies.
U.S. Regulatory Sites
Office for Human Research Protections
Code of Federal Regulations, Title 45, Part 46, Protection of Human Subjects
US Food and Drug Administration
Code of Federal Regulations, Title 21, Part 50, Protection of Human Subjects
Canadian Association of Research Ethics Boards (CAREB)
A grassroots national organization intended to represent the interests of all Canadian REBs and to reflect REB perspectives and concerns.
Public Responsibility in Medicine & Research (PRIM&R)
Advances the highest ethical standards in the conduct of biomedical, social science, behavioral, and educational research.
Society of Clinical Research Associates (SOCRA)
A non-profit, professional organization dedicated to the continuing education and development of clinical research professionals. Provides training, continuing education, and an internationally recognized certification program that promote quality clinical research to protect the welfare of research participants and improve global health.
World Medical Association Declaration of Helsinki
A statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Tri-Council Policy Statement (TCPS)
The electronic version of the TCPS constitutes the official version of this policy document. (Available in English and French)
ICH-GCP (Good Clinical Practice Guideline) - Health Canada Regulation as of Sep 2001. An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
CIHR Guidelines for Health Research Involving Aboriginal People
Prepared by the CIHR Ethics Office in conjunction with its Institute of Aboriginal Peoples' Health, to assist researchers and institutions in carrying out ethical and culturally competent research involving Aboriginal people.