Types of IRB Review
Forms are available at IRB Forms.
Some human participant is exempt from full board IRB review. Researchers must complete a “Request for Research Exemption” form. The research study may begin as soon as the PI receives the approval for exemption, or within five business days after the PI receives e-mail confirmation from ORSP of receipt of a complete request. Requests for exemption are reviewed once a week by the IRB chair or designee. Exempt projects must still comply with the requirements for obtaining participant consent. The determination of whether a proposed study qualifies as “exempt” will be made by the IRB chair or designee, not the researcher.
Research projects that are exempt from full board review are described in 45CFR46.101(b) as follows:
- 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.
- 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 participants can be identified, directly or through identifiers linked to the participants; and (ii) any disclosure of the human participants’ responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation.
- 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 (b)(2) of this section, if: (i) the human participants 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.
- 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 participants cannot be identified, directly or through identifiers linked to the participants.
- Research and demonstration projects which are conducted by or participant 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.
- 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.
Note: However, the exemptions at do not apply to research involving prisoners, fetuses, pregnant women, or human in vitro fertilization. Research involving survey, interview procedures, or observation of public behavior, does not apply to research with children, unless the research involves observations of public behavior when the investigator(s) do not participate in the activities being observed.
Expedited Review refers to a level of IRB review defined by the federal regulations. In this case “expedited” does not refer to the length of the IRB review and approval process.
To request an expedited review, please complete and submit a Request for Review form and attach the required materials.
The IRB chair or designee determines when an expedited review is appropriate.
Back to Top
Full Board Review
If a project does not fall in an exempt category and is not eligible for an expedited review or if otherwise determined by the IRB Chair or designee, the project will be reviewed by the full IRB board at a convened meeting.
Projects that fall in this category include but are not limited to:
- research involving more than minimal risk; techniques which expose the participant to physical or emotional harm beyond the levels in everyday life;
- research involving minors, prisoners, pregnant women; and
- research involving deception
To request a full board review, please complete and submit a Request for Review form and attach the required materials. The form and materials should be submitted two weeks before the next scheduled IRB meeting.
Back to Top
An IRB approval is in granted for a maximum of one year. If an approved research project will continue for longer than one year it must be reviewed again by the IRB. In the case of a continuance the researcher must submit a Continuing Review form at least four weeks prior to the anniversary date of the original approval and provide the following information:
- any proposed modifications to the research protocol;
- a copy of the letter of consent;
- the total number of human participants participating to date and the expected number of human participants to participate in the next year;
- a summary of the research findings to date; and
- verification of training.
A continuing review must occur within one calendar year after the date of the original review. It is the responsibility of the researcher to initiate the review.
Modifications and Amendments
If a researcher anticipates any modifications to an approved protocol the IRB must be notified in writing and the modifications must be reviewed and approved by the IRB before implementation. If the research project cannot be conducted without the necessary modifications, the researcher may have to temporarily suspend the project until the changes are approved.
A modification is defined as any deviation from the approved research protocol, including (but not limited to): change in the approved informed consent language; changes in the process of informed consent; content changes in testing instruments, surveys, or interview questions; adding new subjects to the study; change in participant recruitment method; change in location of research study; change in level of compensation; and change that increases risk to the participants.
Modifications to a previously approved protocol may be reviewed as expedited or by the full IRB at a convened meeting. The IRB chair or designee determines the type of review that is appropriate.