irbbasics

irbbasics内容摘要：

knowledge HUMAN SUBJECT: Research about a living individual either through intervention/ interaction or identifiable private information IRB Review  Questions to ask: – Is it research? – Does it involve human subjects? Scope of the Regulations 11 Levels of IRB Review 1. Exempt review (minimal risk, 6 categories*) 2. Expedited review (minimal risk, 7 categories) 3. Full Board review (Greater that minimal risk) Minimal Risk: the risks of harm anticipated in the proposed research are not greater considering the probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests Examples • Exempt o Common Educational Practices o Educational Tests, Survey Procedures, Interview Procedures, Public Observations o PreExisting (identifiable) Data • Expedited o Surveys, interviews o Prospective collection of data (NonResearch) o Research on individual or group characteristics, Language, Communication o Research employing oral history, focus groups, or program evaluation • Full o Experimental drug or device studies o Most invasive procedures o Surveys/interv。