Types of Reviews
The IRB has jurisdiction over all research conducted at Emerson College. The Federal Policy for the Protection of Human Subjects (Common Rule) defines research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” To determine whether or not your project qualifies as research, go to the "Does IRB Review Apply" document and answer the questions on the checklist.
If your project meets the standard for human subjects research activity and falls under the jurisdiction of the IRB, your study might qualify for an exemption. If not, then it will either go through an expedited or full review. The three levels of review are described below.
Exemption from IRB Review
Exemptions can be granted for very low risk studies. If you believe that you might qualify for an exemption, you must still complete the standard IRB application and request the exemption. Failure to request the exemption, even if it turns out that you are entitled to the exemption, would be considered noncompliance. No data collection can begin until the IRB officially grants the exemption.
The Code of Federal Regulations (45 CFR 46.101 b) sets out the following situations where research may be exempted from regular IRB review:
Category 1: Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Category 2: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. Note: This category of exemption is not applicable to research involving minors (45 CFR 46.401 b).
Category 3: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under Category 2 if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
Category 4: 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, directly or through identifiers linked to the subjects.
Category 5: Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
Category 6: Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed 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.
If you do not qualify for an exemption, it may still be possible to have your review expedited rather than waiting for a convened IRB meeting. It is important to note that the standard for expedited review and the materials that you will submit are the same as for regular review. The only difference is that the expedited review is done by a single member of the IRB outside of the regular meeting time.
Expedited review is available for studies that involve minimal risk. The Code of Federal Regulations (CFR) defines minimal risk as meaning 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.
The US Department of Health and Human Services provides descriptions of categories for types of research that can qualify for an expedited review.
Research protocols that are not eligible for either an exemption or expedited review will be placed on the agenda for the next convened meeting of the IRB. A quorum of committee members must be present in order for the committee to vote. All committee members review each protocol placed on the agenda for the convened meeting unless a member has a conflict of interest. The committee then discusses the protocol and votes for approval, modification, deferral pending the receipt of additional information, or disapproval.