The “Activity Determination Form” (DET) has been revised to clarify the Department of Health and Human Services (DHHS) Office of Human Research Protections (OHRP) definition of “research” and to remove the stipulation that information gathered from the non-research activity may not be published (to take into account information presented and published from quality improvement projects and case reports, per UHCMC policy).

In addition, clarifications were made to the form’s instructions to state that an investigator must select applicability from all three categories on the form: DHHS (Section A and/or B), Food and Drug Administration (FDA, section C) and HIPAA (Section D) in order for the Center for Clinical Research and Technology to make a determination as to the applicability of the federal regulations pertaining to human subject research.