What are the Role & Purview of the IRB? The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. Research that has been reviewed and approved by an IRB may be subject to review and disapproval by officials of the institution. However, those officials may not approve research if it has been disapproved by the IRB [Federal Policy §46.112]. SOURCE: http://www.hhs.gov/ohrp/archive/irb/irb_chapter1.htm

Does Your Project Require IRB Review? The first two questions the IRB faces is whether the activity involves research, and second, whether it involves human subjects. Research is defined by the regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" [Federal Policy §46.102(d)]. Human subjects are defined by the regulations as "living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information" [Federal Policy §46.102(f)]. (Section 102(f) goes on to define the meaning of such terms as "intervention" and "private information.") SOURCE: http://www.hhs.gov/ohrp/archive/irb/irb_chapter1.htm

Defining Terms: Systematic & Generalizable SYSTEMATIC  DELIBERATE & SCHOLARLY METHODOLOGY: Systematic investigations include observational studies, interview or survey studies, group comparison studies, test development, and interventional research. Projects that are NOT SYSTEMATIC investigations include oral histories, journalism, phenomenological activities. GENERALIZABLE  DESIGNED FOR WIDE DISSEMINATION: Developing or contributing to generalizable knowledge means that intent or purpose (“DESIGN”) of the systematic investigation is dissemination of findings. Common ways of disseminating results include publishing or presenting. In general, activities that contribute to generalizable knowledge are those that • attempt to make comparisons or draw conclusions from the gathered data; • attempt to reach for generalizable principles of historical or social development; • seek underlying principles or laws of nature that have predictive value and can be applied to other circumstances for the purpose of controlling outcomes; • create general explanations about all that has happened in the past; or • predict the future.

For Waiver of IRB Review, Especially, cf. §46.101 Projects that do NOT require IRB review: Any intellectual inquiry that does not meet the federal definition of “human subjects research” Cf. Code of Federal Regulations http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101 For Waiver of IRB Review, Especially, cf.  §46.101

ERAU’s CITI Training Requirement Collaborative Institutional Training Initiative (CITI) Requirements NOTIFICATION FROM DEAN OF RESEARCH, DR. MICHAEL HICKEY: After August 2nd, 2014, everyone involved in human subjects research will need to have completed Collaborative Institutional Training Initiative (CITI) training. The training is completed on-line and can be accessed via http://research.erau.edu Once here, select “Institutional Review Board” in the bottom left-most box “About Research at Embry-Riddle” followed by “Training” on the left side of the page. The reasons for making these changes are to ensure that students, faculty and staff minimize the risk to human subjects and minimize risk to the university. The training will also help to ensure that better prepared…. Finally, CITI training will certainly be a plus for our students not only in their research with human subjects, but also because such certification will strengthen their resumes.

How Do I Get Help? Email M.B. McLatchey, IRB Chair mclatchm@erau.edu Call, visit or email Teri Gabriel, Human Subjects Administrator COAS, room 401.15 386-226-7179 teri.gabriel@erau.edu 3. Check out our website: http://research.erau.edu/faculty-resources/institutional-review-board/index.html (hint: go to research.erau.edu and click on “Faculty Resources” if you lose the link above) Any questions/comments/suggestions?