External-Outside ERAU Research
Studies initiated from an External/Outside entity need not be reviewed by Embry-Riddle’s IRB unless Embry-Riddle is engaged in the study. The IRB Office will keep a copy of the external/outside entity’s approved IRB on file for the record. Engagement in research is defined as an institution’s employees or agents as individuals who: (1) act on behalf of the institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities. (OHRP Guidance Document) If someone affiliated with the institution serves as a co-investigator, or otherwise performs study tasks (beyond simply forwarding or collecting anonymous study materials, or providing mailing lists), then the study must be reviewed by the IRB. For those studies in which Embry-Riddle is engaged, a faculty/student or administrator must complete the IRB application and materials for submission. IRB review is conducted as per §45 CFR 46 depending on the type of study. [APPM 12.2]
“Engagement” in Research
The Office for Human Research Protections (OHRP) provides guidance on determining whether an organization is either engaged or not engaged in research. Briefly, an "engaged" non-U.S. organization is one whose employees or agents participate in the recruitment of subjects, conduct the consent process, obtain consent from subjects, intervene with human subjects for research purposes, or receive the private, identifiable information of subjects (OHRP 2008).
Collaborative-Cooperative Research
For research that takes place in collaboration with or in cooperation with another institution, an agreement must be instituted that allocates responsibilities between the institution and the reviewing IRB. This agreement can be accomplished through a formal written agreement (“reliance agreement”) and must be documented and maintained as part of the IRB records. (§ 46.114) [APPM 12.2]
This means that only one IRB need review the study. If the non-ERAU/external entity agrees to be the ‘IRB of Record’, the IRB Office will need to be provided with the ‘Reliance Agreement’.
If Embry-Riddle is to be the ‘IRB of Record’ the IRB Office will need the following information:
- Name and Address of the collaborating institution
- Non-ERAU Institution Federalwide Assurance Number (the IRB office will have this)
- Principal Investigator at the Non-ERAU Institution
- Principal Investigator at Embry-Riddle
- Title of the Project
- IRB Contact at the Non-ERAU Institution including name and title, phone number and email address
- Non-ERAU Institution IRB Institutional Official
After all information has been obtained, the IRB Office will process the ‘Reliance Agreement.’
Teri Gabriel
Teri Gabriel joined ERAU in 2006 as the Manager of the Office of Sponsored Programs. She is now the Assistant Director of Research under the direction of the University Dean of Research and Graduate Studies. She is an accomplished grant proposal writer and trainer, formally working with various local governments assisting with environmental and historical preservation projects. She was also the Executive Director for Flagler County’s Habitat for Humanity. She worked with the state’s allocation of housing funds for Flagler County and Habitat for Humanity.
Teri received her Bachelor of Arts (Honors) degree in Psychology in 1995 and her Master of Public Administration degree in 1998 from the University of Central Florida.