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Who needs to be listed in the "People" section of my protocol?

Any person who is an investigator on the project should be listed.  This includes internal SIUE personnel, or people external to SIUE.

The HHS regulations at 45 CFR part 46 use the term “investigator” to refer to an individual performing various tasks related to the conduct of human subjects research activities.  For the purposes of the HHS regulations, OHRP interprets an “investigator” to be any individual who is involved in conducting human subjects research studies.  Such involvement would include:

  • obtaining information about living individuals by intervening or interacting with them for research purposes;
  • obtaining identifiable private information about living individuals for research purposes;
  • obtaining the voluntary informed consent of individuals to be subjects in research; and
  • studying, interpreting, or analyzing identifiable private information or data for research purposes.

Generally, if a person is obtaining informed consent from subjects, interacting with subjects, or communicating with the IRB about the project, they are an investigator and need to be listed on the protocol.

Also, all investigators are required to have active CITI training.  For information on how to access our CITI training, you can check out our CITI webpage.

For students, your faculty advisor will also need to be listed on the protocol.