Research/Engagement Determination Review Worksheet: ID Title Principal Investigator Submission Type HSR/Engagement Determination Reviewer Date of Review SECTION 1: Research Yes No Does the activity meet the definition of research with human subjects under the Common Rule? Does the activity meet the definition of research with human subjects under the FDA Regulations? If to both, Review is not required. “no” If to #1 but to #2, Proceed to section 2. “yes” “no” SECTION 2: Engagement Yes No Is the institution engaged in research under the Common Rule? See the for more info.* If Review is not required. “no” Determination Research with Human Subjects Submit Application – Research, but no Human Subjects Review not Required – Not Research Review not Required – Not Engaged in Research Review not Required – Office Comments: DO NOT PRINT PAGES 2-4. NOTE APPLICABILITY OF CONDITIONS BELOW IN COMMENTS ON PAGE 1 AND SAVE IN ELECTRONIC FOLDER. *Conditions Under Which an Organization is Not Engaged Even Though a Condition in Applies Section 3 is Met: OSU’s employees or agents perform commercial or trial services for investigators provided that ALL of the following conditions also are met:
Review Worksheet: Research/Engagement Determination ID Title Principal Investigator Submission Type HSR/Engagement Determination Reviewer Date of Review SECTION 1: Research Yes No Does the activity meet the definition of research with human subjects under the Common Rule? Does the activity meet the definition of research with human subjects under the FDA Regulations? If “no” to both, Review is not required. If “yes” to #1 but “no” to #2, Proceed to section 2. SECTION 2: Engagement Yes No Is the institution engaged in research under the Common Rule? See the for more info.* If “no” Review is not required. Determination Research with Human Subjects – Submit Application Research, but no Human Subjects – Review not Required Not Research – Review not Required Not Engaged in Research – Review not Required Office Comments: DO NOT PRINT PAGES 2-4. NOTE APPLICABILITY OF CONDITIONS BELOW IN COMMENTS ON PAGE 1 AND SAVE IN ELECTRONIC FOLDER. *Conditions Under Which an Organization is Not Engaged Even Though a Condition in Section 3 is Met: Applies OSU’s employees or agents perform commercial or services for investigators provided that ALL of the following conditions also are met: trial
reviewer_wkst_hsr-engagement_determination_v05172016.docx