Types of Protocol Reviews and Review Process

There are three types of IRB Review (full board, expedited, and exempt), determined by the nature of the project, level of potential risk to human subjects, and the subject population. The IRB Manager makes the determination of the level of review applicable to a particular study.

• Full Board Review - Generally, research involving human subjects that pose more than minimal risks to subjects, and/or that do not fall into one of the categories of activity eligible for expedited review as specified in the regulations require review by a convened IRB (referred to as Full Board review). Research protocols that require full board approval are forwarded to the IRB in advance of the scheduled meeting date to allow time for the IRB to review the protocol(s). On the scheduled IRB meeting date, the principal investigator presents the protocol to the IRB. The protocol is then discussed and voted on by the full Board.  

• Expedited Review - Expedited review requests are reviewed by the IRB Manager according to the definition and regulatory standards for expedited activities.  Expedited review is allowed when the research poses no more than minimal risk to subjects and falls into one of the categories of activity eligible for expedited review as specified in the regulations. Minimal risk means the probability and magnitude of harm or discomfort anticipated in the research is 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. If the IRB Manager determines that the research falls within the categories for which an expedited review is permitted and involves no more than minimal risk, the Manager can approve the research or conditionally approve with only minor modifications. The IRB Manager will inform the investigator and notify the Board at its next meeting. 

• Exempt Approval – Exempt requests are reviewed by the IRB Manager according to the definition and regulatory standards for exempt activities. Exempt research involves minimal risk to subjects.  Examples of exempt studies include: surveys, questionnaires, secondary analysis of existing data, or data with no identifiable information. The regulations provide six categories of research (below) that may be eligible for exemption.

Minimal Risk

If you feel your study is minimal risk and will meet these qualifications, your application time will be shortened.

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies or (b) research on the effectiveness of or the comparison among instructional techniques, curricula or class room management methods.

2.  Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: Information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects and b. 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 subject's financial standing, employability or reputation.  NOTE: If minors are the proposed subjects in interview/survey research, the project cannot be filed as exempt.

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 paragraph #2 if: The human subjects are elected or appointed public officials or candidates for public office or Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

4.  Research involving the collection or study of existing data, documents, record, pathological specimens or diagnostic specimens, if these sources are publicly available or the information is recorded by the investigator in such a manner that the subjects cannot be identified directly or through identifiers linked to the subjects.

5.  Research and demonstration projects which are conducted by or subject to the approval of (Federal) department or agency heads and which are designed to study, evaluate or otherwise examine: (a) public benefit or service programs, (b) procedures for obtaining benefits or services under those programs,(c) possible changes in or alternative to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.

6.Taste and food quality evaluation and consumer acceptance studies, if: Wholesome foods without additives are consumed or 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.

To submit a protocol for Exempt Review please fill out the Exempt Review Application Form