General Guidance - Protocol Design

Investigators must design their protocols to ensure that the collection, use, and storage of a subject’s private information are secured from unauthorized review and that the current and future use (as well as potential disclosures) of this information are accurately represented in the subject’s consent form, research authorization documents, and ongoing process of informed consent. The more sensitive the information, the more elaborate the security procedures must be to protect the information and the more steps an investigator must take to ensure that subjects understand the risks and conditions of participating in the research project. More information on the following topics can be found at the link in the box at right.