Basic to in-depth information for all audiences about how the rights and safety of people who take part in clinical trials are protected. Learn about informed consent, institutional review boards (IRB's), and how trials are closely monitored for safety. Health care professionals can take online training and access tools to help ensure the safety of their patients.
On this page:
Basic Information
- A Guide to Understanding Informed Consent
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
A guide that discusses special issues when young people participate in clinical trials.
Advanced Information
- Monitoring the Safety of Clinical Trials
Information about the ways in which clinical trials participants are protected before and during the conduct of a study. - Data and Safety Monitoring Guidelines
A guide to the formulation of DSM plans for all phases of cancer clinical trials, in accordance with NIH requirements. - Protecting Human Research Participants online course
This free tutorial is for physicians, nurses, and other members of clinical research teams. If you are an extramural researcher obtaining Federal funds, check with your institution to determine if this is the training they use to fulfill the NIH requirement for education on the protection of human research participants. This course is offered by the NIH Office of Extramural Research. - Central Institutional Review Board Initiative
The CIRB provides an innovative approach to human subject protection through a "facilitated review" process that can streamline local IRB reviews of adult and pediatric national multi-center cancer treatment trials. - Simplification of Informed Consent Documents
Information on NCI's recommendations for simplifying informed consent documents, with guidance on how to develop them. - Certificates of Confidentiality
Background information and application procedures for researchers. - Common Terminology for Adverse Events (CTCAE)
Resources for standard terminology used to name and to describe the severity (grade) of adverse events that occur in the treatment of cancer.