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Criteria for Level I Review (CFR 46.101)
Level I review involves no risk; research may begin immediately upon approval of the reviewer. An application may be classified as "Level I" if the only involvement of human subjects will be in one or more of the following categories:
| 1. | EDUCATIONAL SETTINGS. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: |
| a. Research on regular and special education instructional strategies; or | |
| b. Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. | |
| 2. | EDUCATIONAL TESTS, SURVEY, INTERVIEW and OBSERVATION. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless: |
| a. Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and | |
| b. 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. | |
| 3. | PUBLIC OFFICIALS AND FEDERAL STATUTES. 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 category #2, if |
| a. The human subjects are elected or appointed public officials or candidates for public office; or | |
| b. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. | |
| 4. | EXISTING DATA. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if |
| a. These sources are publicly available; or | |
| b. The information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. | |
| 5. | SERVICE PROGRAMS. Research and demonstration projects which are: |
| a. Conducted by or subject to the approval of department or agency heads; and | |
| b. Designed to study, evaluate, or otherwise examine: | |
| (i) Public benefit or service programs; or | |
| (ii) Procedures for obtaining benefits or services under those programs; or | |
| (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. | FOOD QUALITY. Taste and food quality evaluation and consumer acceptance studies, if |
| a. Wholesome foods without additives are consumed; or | |
| b. A food is consumed that contains a food ingredient at or below the level for a use found to be safe, or an 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. |
Research may be reviewed through an expedited review procedure authorized by 45 CFR 46.119 and 21 CFR 56.110 if they involve:
| A. | Research activities that (1) present no more than minimal risk to human subjects and (2) involve only procedures listed in one or more of the following categories. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects. |
| B. | The categories in the list apply regardless of the age of subjects, except as noted. |
| C. | 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 risk related to invasion of privacy and breach of confidentiality are no greater than minimal. |
| D. | The expedited review procedure may not be used for classified research involving human subjects. |
| E. | Standard requirements for informed consent (or its waiver, alteration or exception) apply regardless of the type of review - expedited or convened - utilized by the HSRB. |
Research Categories:
| 1. | CLINICAL STUDIES of drugs and medical devices only when condition (a) or (b) is met. |
| a. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (NOTE: Research on marketed drugs that significantly increases the risk or decreases the acceptability of the risk associated with the use of the product is not eligible for expedited review.) | |
| b. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling. | |
| 2. | COLLECTION OF BLOOD SAMPLES by finger stick, heel stick, ear stick or venipuncture as follows: |
| a. from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed (550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or (b) from other adults and children[1], considering the age, weight and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week. | |
| 3. | PROSPECTIVE COLLECTION OF BIOLOGICAL SPECIMENS for research purposes by noninvasive means. 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); (3) 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 sub-gingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process in 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. |
| 4. | COLLECTION OF DATA THROUGH NONINVASIVE PROCEDURES (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) 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. | |
| 5. | RESEARCH INVOLVING MATERIALS (DATA, DOCUMENTS, RECORDS OR SPECIMENS) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45CFR 46.101(B)(4). This listing refers only to research that is not exempt.) |
| 6. | COLLECTION OF DATA FROM VOICE, VIDEO, DIGITAL, OR IMAGE RECORDINGS MADE FOR RESEARCH PURPOSES. |
| 7. | RESEARCH ON INDIVIDUAL OR GROUP CHARACTERISTICS OR BEHAVIOR (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45CFR 46.101(B)(4). This listing refers only to research that is not exempt.) |
| 8. | CONTINUING REVIEW OF RESEARCH PREVIOUSLY APPROVED BY THE CONVENED HSRB as follows: |
| a. where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long term follow up of subjects; or | |
| b. where no subjects have been enrolled and no additional risks have been identified; or | |
| c. where the remaining research activities are limited to data analysis | |
| 9. | CONTINUING REVIEW OF RESEARCH, not conducted under an investigational new drug application or investigational device exemption where categories 2 through 8 do not apply but the HSRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. |
Maximum Aerobic Capacity of Healthy Volunteers
Applied Physiology has been granted approval by the Human Subjects Review Board to have projects that determine the maximum physical working capacity of healthy volunteers reviewed as Level II #4 when the following criteria are followed:
| 1. | That the determination of maximum aerobic capacity (maximum physical working capacity, VO2max or however it is defined by the principal investigator in the application) is the only aspect of the study for which the standard informed consent procedure is to be applied; |
| 2. | that the risk inherent in such a procedure is no greater than the risk inherent in participation in a basic instruction class in physical education; |
| 3. | that provision is made (as is presently the case) for an individual trained in cardiopulmonary resuscitation to be present at the testing, and; |
| 4. | that the written (and signed) letter of informed consent contain statement(s) indicating: |
| a. compliance with the procedure, as well as, | |
| b. the standard paragraph relative to lack of financial compensation for injury. |
Full Board Review (Level III Review)
Projects designated under Level III require full Board review because they deal with sensitive issues, vulnerable populations, and are considered to be high risk. An invitation to the meeting will be sent to the project director. If the project director is a student, the faculty advisor may also attend. At the meeting the project director may be asked questions by the Board members, after which he/she will be asked to leave so that further discussion and voting may take place. The project director will be notified in writing of the Board's decision. The notice will be sent to the project director or to the project director in care of his/her advisor. If revisions were requested they must be submitted and approved before the project begins.
The Board will review research at intervals appropriate to the degree of risk but not less than once per year. A third person may be appointed to observe the consent process and the research procedure.
Projects lasting more than one year will be reviewed automatically each year. The project director will receive a Periodic Review/End of Project Form for annual review from the Research Subjects Administrator, which is to be filled out completely, signed, and returned with any new attachments. If there are no changes in procedures the Board will be notified that annual review of the project has taken place and approval has been given.
If there are changes in procedures, instruments, or forms, a Change Form must be filled out and submitted. The RSA will review the project unless the protocol is a Level III, in which case the full Board will review and approve the change(s). Only four substantive changes are permitted. The fifth change will require a new protocol form to be submitted.
In order to assure that the investigation is being conducted in compliance with applicable regulations and University policy, the Board may require continuing reviews to be done at various intervals during the research. This will be done if the Board feels there may be a change in the level of risk. The time of the continuing review may be determined at the time of initial review; however, the Board reserves the right to spot check projects for adherence to approved procedure. The Board may ask a Board member or another person(s) to review the research procedure and submit his/her findings in writing. These findings will be presented at a meeting of the full Board.
Explanation of Minor and Major Changes
| 1. | No change form needed |
| |
| 2. | Minor changes |
| Minor changes have no substantive effect upon an approved protocol or reduce the protocol risk already approved by the full Board as acceptable research risks. | |
| Examples of minor changes are: | |
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| 3. | Major changes |
| Major changes are changes that may increase the research population's risk or are of questionable risk. These will be reviewed by two reviewers if the original protocol was a Level II or by the full Board if originally reviewed as a Level III. | |
| Examples of major changes are: | |
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