Even when research is exempt from regulatory requirements under the Common Rule, institutions and investigators still have a responsibility to adhere to the underlying ethical principles for research involving human subjects.
Although the category is called "exempt," this type of research does require IRB review and the determination of exemption must be made by the IRB. The exempt determination process is much less rigorous than an expedited or full-committee review. To qualify, research must fall into one or more of six (6) federally-defined exempt categories. These categories present the lowest amount of risk to potential subjects because, generally speaking, they involve either collection of anonymous or publicly-available data, or conduct of the least potentially-harmful research experiments. Some examples of Exempt research are:
• anonymous surveys or interviews
• passive observation of public behavior without collection of subject identifiers
• retrospective chart reviews
The six categories are listed below. Research with minors (under the age of 18) can only be exempted under exempt Category b1. All other research with minors cannot be exempted and must either be reviewed by expedited or full board review.
(b) Unless otherwise required by 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 this policy:
(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.
(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 research participants can be identified, directly or through identifiers linked to the participants; and
(ii) any disclosure of the human subject's responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation.
(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 number 2. above, 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.
(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 participants cannot be identified, directly or through identifiers linked to the participants.
(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.
(6) Taste and food quality evaluation and consumer acceptance studies,
(i) if wholesome foods without additives are consumed or
(ii) if the 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.
If there is interaction or intervention with a subject who can consent, there is an appropriate consent process that:
Written documentation of consent is not required.
Expedited review procedures may be used for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
(a) The Secretary, HHS, has established, and published as a Notice in the FEDERAL REGISTER, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The list will be amended, as appropriate, after consultation with other departments and agencies, through periodic republication by the Secretary, HHS, in the FEDERAL REGISTER. A copy of the list is available from the Office for Human Research Protections, HHS, or any successor office.
(b) An IRB may use the expedited review procedure to review either or both of the following:
(1) some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk,
(2) minor changes in previously approved research during the period (of one year or less) for which approval is authorized.
Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in §46.108(b).
(c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals which have been approved under the procedure.
(d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an institution's or IRB's use of the expedited review procedure.
Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure (US Department of Health and Human Services)
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
1 An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.
2 Children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR 46.402(a).
Source: 63 FR 60364-60367, November 9, 1998.
Most applications submitted to the Kenyon College IRB qualify for either exemption or expedited review. Research that does not qualify for these two lower levels of review, often because they involve a protected population, some international research, more than minimal risk, or use deception, must undergo a full IRB review by a quorum of IRB members at a convened meeting. The application process and forms remain the same as for the other levels, but investigators should note that a full review may take longer after receipt of a complete, signed, application. In the event that no additional information, clarifications or modifications are requested, the IRB may approve a study within a short time period, but investigators should be aware that the initial full review process often does not result in an outright approval of the research. Minor or major revisions and written clarifications may be requested, adding time to the review process.
You may discuss your intent to submit an application that may require a full board review with the IRB administrator at any time. Full review applications should be made well in advance of the next scheduled IRB meeting.