Review Categories

Projects need to be submitted to the IRB for review when research involving human interaction is about a person or group, and includes a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102.d). 

For a detailed breakdown of whether your research may require IRB review or at what review category it should be submitted, please see the OHRP Human Subjects Regulations Decision Charts.  Please note that individual institution’s IRB’s may interpret regulations differently and it is important to check with your institution’s IRB for the appropriate interpretation for your institution.  Also, all Exempt studies MUST be submitted to the RU IRB for review.  For further information, please contact the IRB Office at 540-831-5290 or irb-iacuc@radford.edu.

CLASSROOM EXERCISES (DOES NOT INCLUDE INDEPENDENT STUDIES OR OTHER INDIVIDUALIZED RESEARCH ACTIVITIES)

Classroom exercises are those activities that are designed to provide classroom instruction concerning research methodology and that involve human interaction, but that are not intended to generate data for publication beyond presentation at the Radford University Undergraduate/Graduate Student Engagement Forum and the Masters of Social Work Poster Presentation.

However, please note the following limitations/exclusions from Classroom Exercises:

  • No minors or vulnerable populations,
  • No sensitive topics,
  • No more than minimal risk activities,
  • No intervention with the subjects,
  • No deception of the subjects,
  • No audio or video recordings
  • Not for independent or directed studies, dissertations, theses, honors theses, or any other individualized learning experience

Please contact the IRB Office PROMPTLY if you have any questions about your proposed project.

It is the instructor's responsibility to ensure that the criteria are met appropriately. Please read and review the entire Classroom Exercise Guidelines [PDF] and, if desired, the optional Classroom Exercise Agreement [PDF] may be used between student and instructor to ensure that the criteria are appropriately discussed and understood.

Review Method: Those human subjects activities meeting the criteria of Classroom Exercises are not submitted to the IRB for review.

Exempt - Updated to reflect the Common Rule revisions

Exempt research must be of minimal risk.  According to 45 CFR 46.102(i), minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

1. 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.

Most educational research on regular and special educational instructional strategies, and research on the effectiveness of, or comparison among, instructional techniques, curricula, or classroom management methods may be exempt under this category.

Changes to this exempt category include the caveat that there must not be any impact of subject’s opportunity to learn or any negative impact if the research involves an evaluation of the instructors. If the research involves significant time and attention away from the delivery of regular curriculum or withholding of standard educational content, this exemption would not apply. Also, there must be protection against negative impact on employment if instructors are being evaluated. Research involving randomization to a unproven educational technique, or research conducted by supervisors involved in employment decisions may not be approvable under this exemption.

Applicability to vulnerable populations:

- Pregnant women may be included in this type of research

- Research that targets a prisoner population is not eligible for this exemption

    - The exemption is allowable if the research is aimed at a broader population and only incidentally includes prisoners

- Research involving children is eligible for this exemption

2Research that only includes interactions involving 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.

This exemption category involves several changes from pre-2018 rules. The wording of this exemption was changed to clarify that the category applies to research that only involves interactions. Additionally, the use of potentially sensitive information might be allowable if appropriate protections are in place and the IRB conducts a new process called ‘limited IRB review.’

This category involves interactions (verbal and written responses) and data collection only. The data collection can include audio or video recordings. Research involving “interventions” would not be approvable under this category. Interventions include manipulation of the environment or physical procedures to collection information, such as a cheek swab.

Applicability to vulnerable populations

- Pregnant women may be included in this type of research

- Research that targets a prisoner population is not eligible for this exemption

- The exemption is allowable if the research is aimed at a broader population and only incidentally includes prisoners.

- Research involving children is eligible for this exemption only when it related to educational tests or observations in which the investigators don’t participate in the activities being observed

- Children are not eligible for this exemption if the project requires limited IRB review

3. 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:

(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 Effective January 19, 2018 Page 2 of 6

(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.

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.

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.

Applicability to vulnerable populations:

- Pregnant women who are adults may be included in this type of research

- Research that targets a prisoner population is not eligible for this exemption

- Research that could include children is not eligible for this exemption.

- The exemption is allowable if the research is aimed at a broader population and only incidentally includes prisoners.

- Research involving decisionally-impaired persons is not eligible for this exemption. 

4. 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); 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 non-research 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 applicable federal privacy standards found in the E-Government Act, Privacy Act and the Paperwork Reduction Act.

It is important to note the Exemption Category 4 only applies to the re-use of data and specimens that were or will be collected for non-research purposes or from research studies other than the proposed research study. The research materials typically will be publicly available materials, medical records or existing repositories of clinical specimens. No contact between investigator and subject is allowed. If an investigator wants to collect information/specimens directly from research subjects, then another approval path would be required.

Applicability to vulnerable populations:

- Data/specimens from pregnant women would be allowed

- Data/specimens from prisoners could be allowed as long as the research wasn’t designed to recruit prisoners and prisoners were only incidental subjects of the research

- Data/specimens from children would be allowed

- Data/specimens from persons with decisional impairment would be allowed

5. 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. 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 Effective January 19, 2018 Page 4 of 6 or demonstration project must be published on this list prior to commencing the research involving human subjects.

The scope of this category has been broadened. Prior rules required that the Federal demonstration projects be conducted by the Federal agency. This category has been updated to allow projects that are simply funded by a Federal agency. The scope has been expanded to include purposes not only to study and evaluate but also to improve these programs. Note that projects eligible for this exemption will be posted on a Federal website. 

6. 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.

This exemption category was not changed in the revised Common Rule. Note that it is the only exemption that is allowable for FDA-regulated research.

Applicability to vulnerable populations:

- Pregnant women may be included in this type of research

- Research that targets a prisoner population is not eligible for this exemption

- The exemption is allowable if the research is aimed at a broader population and only incidentally includes prisoners

- Research involving children is eligible for this exemption

- Research involving decisionally-impaired persons could be allowed if their inclusion was justified. 

7. 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 §__.111(a)(8).

Applicability to vulnerable populations:

- Pregnant women may be included in this type of research

- Research that targets a prisoner population is not eligible for this exemption

- The exemption is allowable if the research is aimed at a broader population and only incidentally includes prisoners

- Research involving children is eligible for this exemption

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 §__.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 §__.117;

(iii) An IRB conducts a limited IRB review and makes the determination required by §__.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 479

(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 any legal requirements to return individual research results.

Applicability to vulnerable populations:

- Pregnant women may be included in this type of research

- Research that targets a prisoner population is not eligible for this exemption

- The exemption is allowable if the research is aimed at a broader population and only incidentally includes prisoners

- Research involving children is eligible for this exemption

Review Method: Exempt research submissions are not reviewed at convened meetings. They are reviewed individually as they are received.

Limited Review: Limited review is designed to ensure that the research plan includes adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data, as well as other criteria as applicable. Expedited review may be used when limited IRB review is a requirement for exemption (Categories 2(iii), 3(i)(C), 7, and 8).

Expedited

Protocols determined to be minimal risk, but not falling into any exempt category, may be considered for Expedited review.

Review Method: Expedited research submissions are not reviewed at convened meetings.  They are reviewed individually as they are received via the Expedited review process, as allowed by federal law.

Research must meet all of the following criteria in order to be reviewed by the IRB through an Expedited review procedure (45 CFR 46 §110):

1. Be of minimal risk to the subjects

2. Must not involve prisoners or mentally impaired persons

3. Must be in one or more of the following categories:

A. Clinical studies of : (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 risks or decreases the acceptability of the risks 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.

B. 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, 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.

C. 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); (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.

D. 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 subjects 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.

E. 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).

F. Collection of data from voice, video, digital, or image recordings made for research purposes.

G. 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. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

Full Board Review

All protocols determined by the IRB Administrator, Reviewer, or Board to be more than minimal risk (e.g., failing to meet the requirements of Exempt or Expedited Review) are required by federal and state regulation to be reviewed and approved by a fully convened IRB. 

If your protocol is greater than minimal risk, you will be notified by the IRB Office with any required changes/corrections to the protocol prior to distributing the protocol documents to the committee. 

Full board review protocols must be submitted 3 weeks in advance of the IRB meeting for all faculty submissions, and two weeks in advance for all graduate student protocols.

Review Method: Full Board submissions are reviewed at convened meetings of the IRB.  The PI and/or research team is usually encouraged and invited to present and defend their research and to be available for any questions that the Board may have.