Welcome to the Green Mountain College Internal Review Board web page. If you are interested in getting a study reviewed, please see the levels of review on this page as you will need to indicate to the committee what level of review you’re seeking.
If you have questions regarding the IRB’s purpose or procedures, please see the frequently asked questions or the “IRB Manual” links on this page. If after viewing this information you still have questions, contact the IRB at: email@example.com.
In order to give your study the review that it deserves, the IRB at Green Mountain College meets and reviews studies on the second Wednesday of each month. The committee reviews studies that are received by the 25th of the preceding month, which gives the committee a chance to thoroughly review your study.
Research projects are reviewed at one of three levels: Exempt, Expedited, and Full review. The level of review depends on the level of risk human subjects are subjected to and the federal guidelines that define the categories of review, which are:
exemption from full IRB review
expedited IRB review
full IRB review
Research investigators who intend to involve human research subjects will not make the final determination of exemption from applicable Federal regulations or provisions of this Assurance. Therefore, the level of review cannot be determined by the investigator.
Investigators do not have the authority to determine whether research involving human subjects is exempt from full review. Researchers must file an application requesting that a project be classified as exempt. If the project does not qualify as exempt, it is referred back to the investigator with the appropriate application forms. Types of research which may fit into exempt categories include:
Research on instructional strategies conducted in established or commonly accepted educational settings
Research, except research involving minors, involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior
Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available, or if the information is recorded by the investigator in such a manner that subjects cannot be identified
Research and demonstration projects, which are conducted by or subject to the approval of department or agency heads
Taste and food quality evaluation and consumer acceptance studies,
(i) if wholesome foods without additives, or
(ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration, or approved by the Environmental Protection Agency, or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. Activities approved in the federal regulations include:
Collection of hair and nail samples;
Collection of excreta and external secretions;
Recording of data from subject 18 years of age or older using noninvasive procedures;
Collection of blood samples in minimal amounts;
Collection of dental plaque and calculus;
Moderate exercise by health volunteers;
Study of existing data;
Research on an individual or group behavior that involves no manipulation of the subjects and is not stressful; and
Certain kinds of research on drugs and devices.
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.
Expedited review means that the research is considered "minimal risk" and does not require full IRB review. The expedited subcommittee, including members of the IRB, reviews and approves the research.
Research that involves greater than minimal risk requires review and approval by a full IRB board composed of members qualified to review research in that field. Risks to research subjects posed by participation in research should be justified by the anticipated benefits to the subjects or society. Research that requires full Board review includes but is not limited to:
Most research that involves children, prisoners, pregnant women, fetuses and other vulnerable populations
Research that involves experimental drugs or devices
Research that involves most invasive procedures
Survey research that involves sensitive questions or is likely to be stressful for the subject