Types of Review

*Please review to the Determination of Research Worksheet for more information.

1. EXEMPTION REVIEW

The following types of research may be exempted from extensive committee review if proper procedures to assure confidentiality are evident, an informed consent is provided, and participants are exposed to no more than "minimal risk." ORP determines whether a particular research project is exempt. If exempt, the investigator will be so notified by ORP.

a. Research conducted in established or commonly accepted educational settings involving normal educational practices such as research on comparison among instructional strategies, curricula, or classroom management methods. If minor participants are involved, the review level must be at least an expedited review.

b. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if the data are recorded so that participants CANNOT BE IDENTIFIED either by the use of names or special coded identifiers.

c. Research involving surveys, interviews, or observations of public behavior except where the following conditions exist:

1. Information obtained is recorded in a manner that human participants can be identified, directly or through identifiers linked to the participants; AND

2. Any disclosure of the human participants' responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the Participants' financial standing, employability, or reputation.

d. Research using survey or interview procedures where the respondents are elected or appointed public officials or candidates for public office.

e. 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.

f. Taste and food quality evaluation and consumer acceptance studies,

1. if wholesome foods without additives are consumed, or

2. 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.

2.EXPEDITED REVIEW

Participants may not be exposed to more than "minimal risk." Protocols will be reviewed by at least one IRB member. The reviewer may either approve the protocol or refer it for full IRB review. In the event the IRB does not approve the protocol under expedited review, ORP will contact the investigator about the next step in the review process. Expedited review may also be used to approve minor changes in the protocol of an approved project.

Categories of research that may be reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure (obtained from OPRR dated 11/9/99)

Applicability

A. Research activities that (1) present no more than minimal risk to human participants, 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 45 CFR 46.110 and 21 CFR 56.110. 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 participants.

B. The categories in this list apply regardless of the age of participants, except as noted.

C. The expedited review procedure may not be used where identification of the participants and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the Participants' 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.

D. The expedited review procedure may not be used for classified research involving human participants.

E. IRBs are reminded that 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. (See page 4, Item 3 in the Instructions for this packet)

F. Categories one (1) through seven (7) pertain to both initial and continuing IRB review.

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 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.

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 participants, 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 participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, 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 non-invasive means.

Examples: (a) hair and nail clippings in a non-disfiguring 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 non-invasive 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 participants' 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 participants. 45 CFR 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 participants. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

8. Continuing review of research previously approved by the convened IRB as follows:

a. where (i) the research is permanently closed to the enrollment of new participants; (ii) all participants have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of participants; or

b. where no participants 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 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.

3. FULL REVIEW

Any research not covered by the conditions of Exemption Review or Expedited Review, including all research which involves more than "minimal risk," or which could not be approved using other review categories, will be referred to the appropriate IRB committee for full review.