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Types of IRB Review

The IRB at OCU employees two types of reviews.  A full board review by a quorum of the IRB or a review by a two person team or IRB members if the research is considered exempt or expedited.   

Exempt Review

There are several categories of minimal risk research that are defined as being exempt from Federal Policy for the Protection of Human Research Subjects.  This does not mean that they are exempt from IRB review.  Determining whether a project is exempt is the purview of the IRB, not the individual researcher. All research at OCU needs to go through the IRB. 

Studies that meet the criteria as provided in the may be reviewed using the exempt review process. Studies involving prisoners except for research aimed at involving a broader subject population that only incidentally includes prisoners cannot be exempted. Exempt applications will be reviewed by the IRB Chair or Co-Chair and one experienced member designated by the IRB committee two IRB members to determine, based on federal guidelines, whether a project is exempt from further IRB review. Exempt protocol applications are sent to designated reviewers as soon as they are received by the IRB. In conducting exempt reviews, the IRB member(s) may exercise all of the authorities of the IRB except that they may not disapprove the research. If any of the IRB reviewers have concerns about the research, the research activity will be reviewed at the next convened IRB meeting. The IRB Chair or Co-Chair will communicate the need for full review to the PI. A research activity may be disapproved only after review by the convened IRB committee in accordance with the non-expedited procedure set forth in . Outcomes of exempt reviews are included in quarterly activity reports to the IRB.

Following are examples of research projects that are typically deemed exempt:

  • Investigations of commonly accepted educational practices in established or commonly accepted settings that are not likely to have adverse impacts on students’ opportunity to learn required educational content or the assessment of educators who provide instruction (e.g., a faculty member or teacher is examining a ÃÛÁÄÖ±²¥ method of teaching instruction to determine educational effectiveness.)
  • Analysis of information from educational tests that will be recorded in such a manner that subjects cannot be identified.
  • Surveys or interviews that do not involve vulnerable populations.
  • Surveys or interviews that do not ask questions about sensitive aspects of a subject's behavior (e.g. criminal behavior.)
  • Surveys or interviews in which responses will be recorded in such a manner that a subject cannot be identified directly or through identifiers linked to a subject.
  • Observations of public behavior.
  • Collection or study of publicly available existing data, documents, records, or specimens.
  • Collection or study of existing data, documents, records, or specimens in which information will be recorded or reported in such a manner that a subject cannot be identified directly or through identifiers linked to a subject.

A listing of federally approved exemptions is provided below.

Expedited Review 

Expedited reviews are carried out by the IRB Chair or Co-Chair and one or more (generally two) experienced members designated by the IRB committee. Reviewers are designated based on expertise in disciplines of studies and on a rotating basis when possible. Expedited protocol applications are sent to designated reviewers as soon as they are received by the IRB. In conducting expedited reviews, the IRB member(s) may exercise all of the authorities of the IRB except that they may not disapprove the research. If any of the IRB reviewers have concerns about the research, the research activity will be reviewed at the next convened IRB meeting. The IRB Chair or Co-Chair will communicate the need for full review to the PI. A research activity may be disapproved only after review by the convened IRB committee in accordance with the non-expedited procedure set forth in . Outcomes of expedited reviews are included in quarterly activity reports to the IRB.

Applicability

  1. 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, may be reviewed by the IRB through the expedited review procedure authorized by . The activities listed below 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.
  2. The categories in this list apply regardless of the age of subjects, except as noted.
  3. 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.
  4. The expedited review procedure may not be used for classified research involving human subjects.
  5. The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened-- utilized by the IRB.
  6. Categories one (1) through seven (7) pertain to both initial and continuing IRB review.

Full Review

Studies that cannot be exempted based on the exemption categories or receive a review using the expedited procedures as defined above must be reviewed at a fully convened meeting of the IRB. Full Review application packets including the protocol, consent documents, recruitment materials, and data collection materials are distributed to all IRB members prior to meetings. Full Review applications are reviewed at convened meetings with a majority of members present, including at least one member with concerns in nonscientific areas. The IRB Chair may designate primary reviewer(s) as needed to manage the volume of applications. Primary reviewers are designated by the Chair on a rotating basis. The role of a primary reviewer is to review application materials in detail and submit written recommendations to the committee for discussion on changes or clarifications necessary to approve a protocol.

Category 1 - Education Research: 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. Research involving children is eligible for this exemption.

Category 2 - Interactions (education tests, surveys, observation of public behavior): Research 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: 

  • 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. If the study involves children, this exempt category may only be used when using educational tests or the observation of public behavior if the investigator(s) do not participate in the activities being observed.
  • 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. If the study involves children, this exempt category may only be used when using educational tests or the observation of public behavior if the investigator(s) do not participate in the activities being observed; or
  • 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 ensure that adequate provisions are in place to protect the privacy of subjects and to maintain the confidentiality of data. This criterion may not be used to exempt research involving children.

Category 3 - 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: 

  • 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;
  • 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
  • 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 §ll.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. 

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. 

Exemption Category 3 may not be used for research involving children or persons with impaired decision making ability.

Category 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: 

  • The identifiable private information or identifiable biospecimens are publicly available;
  • 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;
  • 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
  • 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 the EGovernment Act of 2002. 

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. This exemption category can be used for data/specimens from prisoners (as long as the research was not designed to recruit prisoners and prisoners were only incidental subjects of the research), from children, and from persons with decisional impairment.

Category 5 - Federal research and demonstration projects: 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.

Category 6 - Taste and Food quality: 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. 

Research that targets a prisoner population is only eligible for this exemption if the research is aimed at a broader population and only incidentally includes prisoners. Research involving children is eligible for this exemption. Research involving persons with impaired decision making could be allowed if their inclusion was justified. 

Category 7 - Storage or maintenance for which broad consent is required: This category of exemption is ÃÛÁÄÖ±²¥ per the Final Rule. Currently, OCU will not review these studies as exempt and is not adopting the principles of broad consent. 

Category 8 - Secondary research for which broad consent is required: This category of exemption is ÃÛÁÄÖ±²¥ per the Final Rule. Currently, OCU will not review these studies as exempt and is not adopting the principles of broad consent.

Expedited Categories 

  1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
    1. Research on drugs for which an investigational ÃÛÁÄÖ±²¥ 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.) 
    2. 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: 
    1. 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 
    2. 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 18 not occur more frequently than 2 times per week. 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." 
  3. Prospective collection of biological specimens for research purposes by noninvasive means. 
    1. 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. 
  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 ÃÛÁÄÖ±²¥ indications.) 
    1. 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 non-research 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. . 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. This listing refers only to research that is not exempt.) 
  8. Continuing review of research previously approved by the convened IRB as follows: 
    1. where (i) the research is permanently closed to the enrollment of ÃÛÁÄÖ±²¥ 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 
    2. where no subjects have been enrolled and no additional risks have been identified; or
    3. where the remaining research activities are limited to data analysis. 
  9. Continuing review of research, not conducted under an investigational ÃÛÁÄÖ±²¥ drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. 

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