Full Board Level of Review
Full Board Submissions
Federal regulations and institutional policy require IRB review by the full board for protocol submissions where the research involves greater than minimal risk* to human participants, or where the research has been referred to the full board by the IRB Chair, or designated IRB member. Additionally, if the IRB Chair, or designated IRB reviewers, find the proposed research does not qualify for exempt or expedited review categories, it must be reviewed by the full board.
Regardless of risk level, the ETSU IRB may require full board review when research involves:
- A complex research design requiring the expertise of mulitple board members to evaluate
- Vulnerable populations, particularly prisoners
- Sensitive topics, including illegal behaviors or other information that poses risks to participants
- Research involving genetic testing
- Research presenting ethical concerns
Full board review occurs at a convened meeting where a majority of the members are present. Submissions that require full board review will be placed on the next scheduled IRB Meeting agenda as determined by the submission deadline. The IRB Chair assigns submissions to a primary and secondary IRB review for presentation at the full board meeting. Investigators are invited to attend the meeting to answer questions from the board members. At the conclusion of the meeting, the board votes and issues a determination. The HRPP staff record the meeting deliberation and determinations in the minutes and issues the formal determination in a letter to the investigator in a timely manner following the meeting.
*Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Full Board Procedures
ETSU Campus IRB - Social/behavioral/education research
ETSU/VA Medical IRB - Biomedical/clinical/FDA/HIPAA/VA research