Canadian Cancer Trials Group Bulletins

Required Ethics Education

Currently the Canadian Cancer Trials Group, as a recipient of funding from the U.S. National Cancer Institute (NCI US), is required to certify that all investigators participating NCI-US affiliated studies have completed educational training with respect to human subjects protection. The NIH release concerning this policy can be viewed at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html

**As of October 31, 2002, Canadian Cancer Trials Group has extended this educational requirement to all investigators in our member centres participating on any trial.**

Available Resources

1. The NIH Office of Extramural Research has made available a web-based tutorial titled "Protecting Human Research Participants" which Canadian Cancer Trials Group considers to be the most relevant to the conduct of NCI US affiliated trials. This has been specifically developed by the NIH with researchers working on NCI US studies in mind and may be accessed at no cost. Although the tutorial is heavily based on U.S. regulations concerning the protection of human subjects, many of the fundamental concepts are generally applicable to any clinical trial. The tutorial should take approximately 1 to 1.5 hours to complete and at the end of the session a "Completion Certificate" is issued. The link to the website is: http://phrp.nihtraining.com

2. An alternative to this web-based tutorial is to purchase a book titled Protecting Study Volunteers in Research (by David Forster). This book costs approximately $US60 and can be ordered via the following website: http://www.centerwatch.com. Although the text may be shared, there is an exam which accompanies the book (apparently only one can be completed per purchaser) which must be completed to certify the educational requirement has been met.

Effect on Investigator participation on Canadian Cancer Trials Group trials

Investigators on NCI US affiliated trials and investigators from member centres on Canadian Cancer Trials Group trials, who have not provided proof of completion of this requirement to Central Office are not permitted to register and/ or treat patients on Canadian Cancer Trials Group studies. Therefore, Investigators are encouraged to make certain that a copy of their Completion Certificate reaches Central Office at their earliest convenience.

We are also strongly recommending that clinical research associates complete this ethics education, although it is not a requirement at this time. Any CRA's who complete this training can forward their certificates to Central Office and they will be also tracked in our database for future reference.

When you have completed the web-based tutorial or the exam offered with the Protecting Study Volunteers in Research text, please send us a copy of the Completion Certificate and ensure it includes all of the following information:

Title of the program completed
Your name
Your center name and code
The date the program was completed

The certificate should be directed to the following address (by mail or fax):

Operations Office
NCIC Clinical Trials Group
10 Stuart St., Queen's University
Kingston, Ontario
K7L 3N6
Fax No. 613-533-6511

If you have any questions regarding this ethics education please contact the Operations Office.

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