Can Research On Children Be Exempt? Research involving observation of public behavior is exempt only if the researcher does not participate in the activities being observed. … Both exempt and not exempt research must be reviewed by Research Compliance Services and/or the CPHS/IRB. What makes a research study exempt? Research can be approved as “exempt”
What Studies Do Not Require IRB Approval? Data collected for internal departmental or administrative purposes, such as teaching evaluations, student performance data, etc. Activities designed solely for quality improvement or evaluation of a program, course, etc. Which type of research does not need to get an IRB approval? Publicly available data do not require IRB
Is The Research Exempt From Federal Regulations? Who may determine that research is exempt? The regulations do not specify who at an institution may determine that research is exempt under 45 CFR 46.101(b). Can federally funded research be exempt? Research regulated by the Food and Drug Administration (FDA): With the exception of Category 6, FDA-regulated
Is My Research IRB Exempt? Research can be approved as “exempt” if it is no more than “minimal risk” and fits one of the exempt review categories as defined by federal regulation 45 CFR 46. Studies that may qualify for “Exempt” must be submitted to the IRB for review. Exempt reviews are conducted by a
What IRB Exempt? Education research. Surveys, interviews, educational tests, public observations (that do not involve children) Benign behavioral interventions. Analysis of previously-collected, identifiable info/specimens. Federal research/demonstration projects. Taste and food evaluation studies. What makes a research study exempt? Research can be approved as “exempt” if it is no more than “minimal risk” and fits one
What Is Considered Exempt Research? Research can be approved as “exempt” if it is no more than “minimal risk” and fits one of the exempt review categories as defined by federal regulation 45 CFR 46. Studies that may qualify for “Exempt” must be submitted to the IRB for review. Exempt reviews are conducted by a
Does Hipaa Apply To Research? Does Hipaa apply to research? A: Yes. Under the HIPAA Privacy Rule, covered entities may use or disclose protected health information from existing databases or repositories for research purposes either with individual authorization as required at 45 CFR 164.508, or with a waiver of individual authorization as permitted at 45
Do Research Studies Go To The Full Board If They Are Greater Than Minimal Risk? Do research studies go to the full board if they are greater than minimal risk? Human subjects research that is not Exempt or eligible for Expedited Review must be reviewed at a convened meeting of the IRB. Full board review
Does All Research Need IRB Approval? Does all research need IRB approval? Federal regulations require that research projects involving human subjects be reviewed by an IRB. The IRB must approve or determine the project to be exempt prior to the start of any research activities. The IRB cannot provide approval or determinations for research that