What is Exempt Research? Does the IRB Have to Review It?
Exempt research are projects that meet specific federal criteria and fall into one of the six categories of Exempt research listed below. Exempt research must be initially reviewed by the IRB, but is then exempt from further review. Projects that do not meet the criteria for human subjects research are excluded from IRB review.
Qualified IRB staff or members review applications to determine eligibility for exempt status. Investigators are not authorized to make this determination. Although the IRB may determine that a project is exempt from full-scale IRB review, it must still conduct a modicum of review (“exempt review”) to ensure compliance with the ethical principles embodied in the Belmont Report: respect for persons, beneficence, and justice. If the federal HIPAA Privacy Rule applies to the study, the IRB must ensure compliance with that as well.
The IRB’s exempt review focuses on informed consent and patient authorization materials and processes (which may include a HIPAA waiver). Please note that exempt research does not require a waiver of informed consent or documentation of informed consent from the IRB. On the other hand, only the IRB, acting as a privacy board, can grant a partial or full waiver of HIPAA patient authorization.
If you think your proposal may be exempt from IRB review, please create an application in eIRB as usual, obtain the approval of the PI’s department chair or other authorized approver, and submit. The IRB staff will review the application and follow up with you if more information is needed to make the exempt determination.
Exceptions to Availability of Exemptions
Certain kinds of research with human subjects are not eligible for exempt determinations:
Prisoners: research involving prisoners as human subjects is not eligible for exemption. “Prisoners” are defined as“any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. Detainees in administrative cases (such as immigration or deportation) are not considered detainees for this purpose, according to guidance the Emory IRB has obtained from DHHS.
FDA-regulated Research: Exempt research categories do not apply to research that involves FDA-regulated products (studies using investigational drugs, biologics, or devices for which the FDA has granted an investigational new drug [IND] or investigational device exemption [IDE], or non-significant-risk devices).
VA Studies: For AVAMC Research or other VA-supported research that is not otherwise subject to FDA Regulations, only the categories of research set forth in the VHA Handbook may be classified as exempt research.
Minors (Children): Research involving minor may not be exempted, with one exception. If the research consists solely of observation of public behavior where the investigator does not participate in the activities being observed, the research may be eligible for exemption. All other research involving minors is not eligible for exemption.
Categories of Exemption
Please see note above about restrictions on exemptions for research involving children.
Unless otherwise required by Health and Human Services or other federal department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from IRB review:
- Educational Settings, Practices
Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
- research on regular and special education instructional strategies,
- research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Educational Tests, Surveys, Interviews, Observations*
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 human subjects can be identified, directly or through identifiers linked to the subjects; and
- 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.
*Minors: The Emory IRB may grant an exempt research determination to a protocol that includes minors when the investigator does not participate in the activities being observed.
- Educational Tests, Surveys, Interviews, Observations of Public Officials
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:
- 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.
- Existing Data, Documents, Records, Specimens
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.
- Public Benefit or Service Programs
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:
- Public benefit or service programs;
- procedures for obtaining benefits or services under those programs;
- possible changes in or alternatives to those programs or procedures; or
- or possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and Food Quality and Consumer Acceptance
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.
45 CFR 46.118 Applications and proposals lacking definite plans for involvement of human subjects.
Certain types of applications for grants, cooperative agreements, or contracts are submitted to departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. These applications need not be reviewed by an IRB before an award may be made. However, except for research exempted or waived under §46.101(b) or (i), no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the department or agency.