Principle ethics guidelines for research involving humans

The conduct of research that involves humans, including clinical trials, is guided by a set of ethical principles. These appear as guidelines that outline the duties to those who participate as research subjects. They also outline the duties, rights and norms of those engaged in research. The links below lead to a number of Web resources that offer more details about the duties, rights and norms of participating in human research.

Helsinki Declaration http://www.wma.net/e/policy/b3.htm

Nuremberg Code http://www.ushmm.org/research/doctors/Nuremberg_Code.html

Tri-Council Policy Statement (TCPS): Ethical Conduct of Research Involving Humans. Interagency Advisory Panel on Research Ethics.
The ethics guidelines developed and used by CIHR, National Science and Engineering Council (NSERC), Social Sciences and Humanities Research Council (SSHRC) and others for designing, conducting, and promoting ethical research involving humans. This site also includes the excellent new self tutorial on research ethics and TCPS. www.pre.ethics.gc.ca

Good Clinical Practice: Consolidated Guidelines (GCP) International Conference on Harmonization, (ICH) E6 Adopted by Health Canada as the standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/goodclin_main_e.html
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/goodclin_main_f.html

45cfr46
US Federal Regulations, Title 45 – Public Welfare, Department of Health and Human Services, National Institutes of Health (NIH) Office for Protection from Research Risks, Part 46 – Protection of Human Subjects. http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm

US Food and Drug Administration (FDA) regulations relating to good clinical practice and clinical trials in FDA regulated clinical trials.
http://www.fda.gov/oc/gcp/regulations.html

International Ethical Guidelines for Biomedical Research Involving Human Subjects.
Council for International Organizations of Medical Sciences (CIOMS) CIOMS is affiliated with WHO, UNESCO and others. This informative site provides ethics guidelines and publications on many areas of research ethics.
http://www.cioms.ch

Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research, 1979. US Food and Drug Administration.
This report clearly sets out the ethical principles that ethics guidelines are based upon. Clear and reader friendly, it is an excellent introduction to the subject, and is often said to be the corner stone of Canadian and US ethics codes.
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm

Belmont Report Historical Archive
To aid in understanding the importance of protection for human subjects in research, this site includes a video overview of the Belmont Report, a history and oral history archive.
http://www.hhs.gov/ohrp/belmontArchive.html

Additional sources of information on the ethics of research involving humans:

CIHR Research Ethics.
The Canadian Institutes of Health Research web address for research ethics carries a wide variety of information accessible from the home page, including links to documents and organizations.
http://www.cihr-irsc.gc.ca/e/about/2891.shtml http://www.cihr-irsc.gc.ca/f/about/2891.shtml

US National Institutes of Health (NIH)
This is the NIH Bioresearch Resource site. From the home page a variety of topics can be accessed ranging from Research Ethics to Medicine and Health Care Information.
http://www.nih.gov/sigs/bioethics

The Arthritis Society (TAS)
The Society's site for Clinical Trials Information Service, including useful discussions about what clinical trials are, why they are conducted, and a clinical trial registry.
http://www.arthritis.ca/clinicaltrials

National Institutes of Health (NIH) Human Participant Protections Education for Research Teams
A comprehensive self tutorial on biomedical ethics and on 45cfr46.
http://69.5.4.33/c01/

Accelerating access for patients to best medicine: the system and the challenge, a feasibility study prepared by Monique Begin, Judy Erola, George A. Wells, and J. Andre Potworoski, Industry Canada and Health Canada, 2002.
http://www.uottawa.ca/services/markcom/news/2003/030325-e-report.pdf

Draft Report of the National Placebo Working Committee (NPWC)
Health Canada (HC) and Canadian Institutes of Health Research (CIHR) jointly sponsored the NPWC as an initiative to determine the appropriate use of placebos in clinical trials in Canada and contribute to the ongoing debate on this subject.
http://www.cihr-irsc.gc.ca/e/services/pdf_19320.htm
http://www.cihr-irsc.gc.ca/f/services/5466.shtml