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 except for research aimed at involving a broader subject population that only incidentally includes prisoners. “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: research using a drug, device or biologic, approved for marketing or not, outlined under 21 CFR 312 (drugs), 21 CFR 812 (devices), and 21 CFR 600 (biologics). FDA regulations for informed consent (21 CFR 50) and Institutional Review Boards (21 CFR 56) also apply.
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): Most of the exemption categories can apply to research with minors, except for secondary research involving identifiable data or specimens, surveys, and interviews. Also, research involving educational tests or observations of public behavior can only be exempt when there is no interaction with the researcher.
Categories of Exemption
Please see note above about restrictions on exemptions for research involving children and prisoners.
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, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Educational Tests, Surveys, Interviews, Observations*
Research that only includes interactions involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, (including visual or auditory recording) if at least one of the following criteria is met:
(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(ii) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
(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 §46.111(a)(7).
*Minors: When the study involves educational tests or the observation of public behavior, 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.
- Research involving Benign Behavioral Interventions
Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
(A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(B) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
(C) 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 §46.111(a)(7).
For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.
Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
(iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
- Secondary Research Studies using Identifiable Private Information or Biospecimens
Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
(i) The identifiable private information or identifiable biospecimens are publicly available;
(ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
(iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); (not applicable at Emory) or
(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
- Educational Tests, Surveys, Interviews, Observations of Public Officials
Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal website or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
- 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.
Broad consent exempt categories (D7 and D8): Emory as an institution will not implement these categories at this time due to practicability issues.
- Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).
- Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met: (i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d); (ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117; (iii) An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.
Modifications are only required for exempt studies when substantive changes are being made that could alter the original review determination.
Examples of substantive changes are changes to:
- subject populations (like adding a vulnerable population category, such as minors or prisoners),
- data collection methods, or
- identifiability of data (where data were previously de-identified).
Examples of changes unlikely to alter the Exempt determination (so can be done without further IRB review):
- altering study instruments or recruitment materials
- changing the target enrollment number
- adding fully trained staff (unless a new staffmember needs access to the study record in eIRB)
- removing staff
If unsure, log a comment or email your study analyst. (Remember to check the box to notify the IRB coordinator if logging a comment.)
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.