Beginning of Protocol Decision Tree

¹Private information includes information about behavior which the individual can reasonably expect that no observation or recording is taking place or information that has been provided for specific purposes that the individual can reasonably expect will not be made public (e.g., medical record, employee or student records).

²Private information or biospecimens are considered identifiable if (1) the person’s identity may be readily ascertained by the investigator; or (2) the identity of the individual from whom the information was obtained may be readily associated with the information. Private information is individually identifiable when it can be linked to specific individuals by the investigator either directly or indirectly through coding systems.

³A substance manufactured via chemical process and intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or (other than food) intended to affect the structure or any function of the body of man.

⁴A substance manufactured via biological process and otherwise meets the above definition of a drug; includes a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

⁵An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.