Informed consent is one of the primary requirements of research involving human participants ... provided the conditions described on the waiver form are fulfilled.

Informed consent ... the nature of the research project, why they are candidates for the research, what risks, benefits, and alternatives are associated with the research, and what rights they have as ...

The Data Provider is responsible for ensuring requirements for informed consent for the proposed uses of the data set are met or waived as follows: For active studies, if the proposed uses of the data ...

Investigators should follow the required elements of informed consent when preparing a Parental Consent Form, except that ... benefit to the research subjects, and the child’s age, maturity, status, ...

Note: The IRB must be provided with “sponsor verification” in the form of a letter ... about any research that involves the collection of identifiable private information or identifiable biospecimens: ...

Furthermore, unless the consent process has been specifically waived by the IRB, no subjects may be included in research unless the investigator has obtained the legally effective informed ... and ...

See the informed consent form template (pdf) for more help and sample language. 1. Title of the Study 2 ... and their probability as a direct result of participation in the research and/or from breach ...