If it’s exempt why do I need an IRB review anyhow?

surveyThere is often confusion about “exempt review” among researchers, and this is entirely understandable. Sometimes we are asked: “well, I’ve already determined that this is an exempt study—so why do I need an IRB to do a review?” Projects that involve human subjects can be reviewed at one of three levels according to the federal regulations. The levels are exempt, expedited, and full committee.  The IRB does not actually approve an exempt study but makes a determination that the project meets at least one of the federal exempt categories criteria. 45 CFR 46.101(b) tells us that the categories for exempt human subjects research include:

 

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.

 

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 paragraph (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) 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.

 

Each one of the categories requires additional explanation.

 

CATEGORY 1 The research conducted in the educational setting must only involve accepted and normal educational practices—so this would not include a comparison of an accepted method to a new and untested educational practice. It also must take place in normal educational settings.

 

CATEGORY 2 The individuals participating in the surveys, interviews, educational tests, or observations cannot be children, nor can they be part of a vulnerable or protected population. Also, they cannot be asked questions that increase the level of risk for participation in the study. Note: The section of this category pertaining to standardized educational tests may be applied to research involving children. This category may also apply to research with children when the investigator observes public behavior but does not participate in that behavior or activity. This section is not applicable to survey or interview research involving children.

 

CATEGORY 3 Under this category, the program The program must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act). In addition, there can be no significant physical invasions or intrusions of the privacy of the participants.

 

CATEGORY 4 “Existing” means existing before the research is proposed to the institutional review board to determine whether the research is exempt. If the investigator will record the data so that no individuals can be identified, a step by step plan is required. Previously collected data can range from large data sets that are created by government-funded studies that occur at research institutions across the United States, to data that is recorded during the normal course of doing business in a setting such as a school, hospital or a corrections agency.

 

CATEGORY 5 This research involves organizations that provide a public benefit (such as broadcasting or public transportation) or service programs (such as Medicaid). No physical invasion or intrusion of privacy is allowable.

 

CATEGORY 6 This research involves consumer acceptance of products or services or taste and food quality studies—keeping in mind that these must normally be accepted foodstuffs!

 

As you can tell, after reading this blog, the determination of what is exempt and what requires a higher level of review is actually quite nuanced. This is the reason, an IRB is tasked with making the determination. If you have questions about a possibly exempt study—don’t hesitate to contact us and ask!

OHRP provides decisions charts for exempt and expedited reviews.