Links to NCI Materials
The mission of the National Cancer Institute is to improve human health through biomedical and behavioral research. Conducting research involving human participants is a necessary and important part of that mission. Therefore, the NIH is committed to assuring that all of its research activities involving human participants are conducted in a way that promotes their rights and welfare.
The resources listed on this page provide information about the ways in which those who participate in clinical trials are protected before and during the conduct of a study.
A Guide to Understanding Informed Consent
(Posted: 08/30/2001, Reviewed: 03/24/2006) - A guide to the process of informed consent, in which people considering participation in a trial learn about potential risks and benefits of the trial as well as their rights and responsibilities. Includes sample forms and templates.
Children's Assent to Clinical Trial Participation
(Posted: 01/11/2001, Reviewed: 05/26/2005) - A guide that discusses special issues when young people participate in clinical trials.
Monitoring the Safety of Clinical Trials
(Posted: 02/06/2001, Reviewed: 05/01/2006) - Information about the ways in which clinical trials participants are protected before and during the conduct of a study.
Simplification of Informed Consent Documents
(Posted: 12/30/1999, Updated: 05/23/2006) - Information on NCI's recommendations for simplifying informed consent documents, with guidance on how to develop them.
Protecting Human Research Participants
A free, on-line tutorial offered by the National Institutes of Health (NIH) Office of Extramural Research, for physicians, nurses, and other members of clinical research teams. This online course satisfies the NIH human subjects training requirement for extramural researchers obtaining Federal funds.
Clinical Trials: Questions and Answers
(Reviewed: 05/19/2006) - This fact sheet covers types of clinical trials, who sponsors them, how they are conducted, how participants are protected, and who pays for the patient care costs associated with a clinical trial. Includes some questions to ask a health care provider before entering a clinical trial. National Cancer Institute Fact Sheet 2.11