(Code G1) or ... Decision Tree. Decision Tool: Am I Doing Human Subjects Research? The Office of IRB Operations (IRBO) oversees the day-to-day operations of the National Institutes of Health (NIH) Institutional Review Board (IRB). involve human subjects? More background information can be found in the Federal Register along with the information on the transition provision and implementation timelines. See the main index of Decision Trees or Research Using Human Subjects Content last reviewed on May 23, 2019 attachment. Grants & Contracts > Apply for a Grant > Research with Special Considerations > Human Subjects > Decision Trees share with facebook share with twitter share with linkedin Decision Tree for Inclusion of Minorities Plan, Part 1 of 2 Answer the questions on this form to ascertain whether the Human Subjects Study Record form PDF is needed for your proposal and if so, how much of the form must be completed. Human specimens and/or data: The S2S questionnaire asks, Does the proposed research involve human specimens and/or data? Prevention, Treatment & Control Strategies. NO YES Are participants prospectively assigned to an intervention? Decision Tree for Inclusion of Minorities Plan, Part 1 of 2 -- NIAID Research Funding. Step 3. YES Is the study designed to evaluate the effect of the intervention on the participa YES NO The … If no: Human Subjects Code: N as regards clinical trials. Decision Tree for Protection of Human Subjects from Research Risk Subject: Decision Tree for Protection of Human Subjects from Research Risk Author: Jenny de la Cruz Keywords: Decision Tree for Protection of Human Subjects from Research Risk Last modified by: HeaveneK Created Date: 2/20/2001 6:02:12 PM Document presentation format See NIAID Decision Trees for Human Subjects Requirements to learn how reviewers determine whether you meet requirements. Decision Tree The PHS Human Subjects and Clinical Trials Information form is used to collect information on human subjects research, clinical research, and/or clinical trials, including study population characteristics, protection and monitoring plans, and a protocol synopsis. Start here, and then go to Point 1.2.. Point 1.2: Is the activity a systematic investigation designed to contribute to generalizable knowledge? Human Subject Regulations Decision Charts February 16, 2016 The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving Credit. End. The Office of Extramural Research (OER) has developed a quick decision tool that should assist you with determining if your research involves human subjects, may be considered exempt from Federal regulations, or is not considered human subjects research. Note for ancillary studies: When answering the following questions, take into account only the work being proposed in the ancillary study, not the work being done in the parent project. Human Subjects Research. (Code G1) or NIH Office of Extramural Research - June 25, 2019 Follow NIH instructions and review SPA's tips. Decision Tree for Inclusion of Minorities Plan, Part 1 of 2 -- NIAID Research Funding ... See the main index of Decision Trees or Research Using Human Subjects.