Types of Review
The Code of Federal Regulations, Title 45, Part 46, published by the Office for Human Research Protections defines the following review levels and definitions:
Research in which there is essentially no risk to subjects is exempt from the requirement that it be reviewed by full committee (Code of Federal Regulations, Part 46, section 104). If your research involves minors, pregnant women, prisoners or other vulnerable populations, it is not eligible under the "Exempt" category.
|1.||Examples of such research are:|
|(b) (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.|
|(b) (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; (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; and (iii) the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by section 16.111(a)(7).|
|(b) (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 (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.|
|(b) (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 the subjects cannot be identified, directly or through identifiers linked to the subjects.|
|(b) (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.|
|(b) (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 FDA, or approved by the EPA, or the Food Safety and Inspection Service of the USDA.|
|2.||If the research is believed to be exempt, the investigator should submit the form entitled Request for Designation of Research as Exempt. These applications must still be accompanied by documentation that all investigators involved in the research have received education and instruction in the protection of the rights of human subjects and the ethical conduct of human research.|
Requests for exemption will be reviewed by the IRB Chair and/or IRB Administrator. If this review determines the research to be exempt, a memorandum of concurrence will be sent to the investigator. The title of the research and the decision will be reported to the IRB at its next meeting. Any member of the IRB may request that the investigator submit a full application for expedited or full IRB review.
Certain kinds of research involving minimal risks may be approved by expedited review or by the IRB Chair according to the policies and procedures in section 110 of the federal policy. Research with minimal risks involving minors may qualify to be reviewed by expedited review.
|1.||Such applications will be reviewed by at least two members of the Committee with the following possible outcomes:|
|a.||The reviewers will unanimously approve or disapprove the proposal. Either reviewer may require that modifications to the proposal be made prior to approval.|
|b.||Reviewers can recommend that the application be reviewed by the full IRB, in which case it will be considered at the next meeting.|
|2.||The decision of the reviewers will be presented to the full IRB for approval at the next meeting. Should the IRB wish to add restrictions or clarifications, the investigators will be asked, in writing, to suspend the research until these adjustments have been made. Continuing review of expedited applications will be the same as for applications reviewed by the full committee.|
Minor changes in previously approved research may be reviewed and approved by the Chair.
Full Committee Review
Research involving more than minimal risk and/or vulnerable populations (i.e., children, economically or educationally disadvantages persons, severely ill or mentally ill persons, veterans, pregnant women, or prisoners) must be reviewed by the full committee. Applications received which require full committee review will be reviewed at the next scheduled meeting.