IRB Dates and Deadlines
Submissions Due: 1st business day of each month
Meetings: 3rd Thursday of each month (Note: dates subject to change due to holiday closures)
Researchers can upon request attend their study’s review at the meeting to answer questions, but will be asked to leave before the discussion.
Applications are placed on a meeting agenda after HRPP staff and the IRB Chair have assessed them, to ensure that they are clear and contain all necessary information. This is called the pre-review screening process.
For questions, please contact utkirb@utk.edu
Research that does not quality for exempt or expedited review must be reviewed by the convened Institutional Review Board (IRB) at a monthly meeting. Typically, research that undergoes full board review is greater than minimal risk, although research may also need to undergo full board review if it does not fit into one of the 9 expedited review categories. While the regulations do not provide a definition of greater than minimal risk, they do provide a definition of minimal risk. In minimal risk research, “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.” [45 CFR 46.102(j)]
When reviewing a study, the IRB must make a determination as to whether the study meets the criteria for approval outlined in the federal regulations. [45 CFR 46.111] These criteria are listed below:
- Risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
- Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
- Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by, §46.116.
- Informed consent will be appropriately documented or appropriately waived in accordance with §46.117.
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.