Please contact the Human Research Protection Program (HRPP) office by phone at (317) 274-8289 or send an email to irb@iu.edu if you need accessibility help with the protocol decision tree.
Beginning of Protocol Decision Tree
Review the following multiple choice options and select the best option that applies to your new study submission. Your selections on each proceeding page will help identify the most likely level of review.
In the course of your research, will you:
- A: Interact or intervene with a living individual (includes online surveys), or obtain/use private1, identifiable information or identifiable biospecimens2
Select option A - B: Conduct research on a drug3, biologic4, or device5 for which some aspect of administration is dictated by a study protocol
Select option B - A & B:
Select options A & B - C: Do none of the above
Select option C
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.