III. IRB Review Process
To apply for IRB approval, the principal investigator must submit an application to the IRB. There are two types of application that may be submitted based on the categories of research determined by state and federal codes. Type 1: If a researcher believes her/his project meets the requirements for exemption, s/he may submit an application for exemption. The Chair or designee of the IRB will review the application to make sure that it meets the criteria for exemption. Type 2: If a project does not meet the criteria for exemption, an application for Expedited or Full Board Review must be submitted.
The Chair or designee makes one of three decisions regarding applications submitted for IRB review: (1) Approval, (2) Provisional Approval (pending required changes or the receipt of clarifying information or rationales, as specified on the review form), or (3) Hold for Committee. When the decision is made to refer the application to the full IRB, the Chair or designee gives the reason(s) on the review form.
A. Exempted from Review
Determinations regarding exemption from IRB review are made by the Chair or designee and not by investigators. Investigators can apply for an exemption by completing an exemption form. In making determinations on exemptions, the Chair or designee evaluates whether the narrative description of the research is consistent with the categories for exemption contained in federal and state regulations.
Exemptions are in force for a maximum of five years after approval. To continue research after that time period, investigators must apply for another exemption or complete a regular IRB application.
1. Exempt Categories
Category a. The research must be conducted in a commonly accepted educational setting (e.g., classroom, conference facility) as opposed to a laboratory or similar setting and involve commonly accepted educational practices (e.g., forms of instructional methods) as opposed to psychological manipulations or non-instructional interventions.
Category b. The research (educational tests, surveys, interviews, observations of public behavior) is conducted anonymously (names and identifying information are not recorded) and involves the collection of benign information that could not be damaging to a person. “Public behavior” is defined as behavior in places that any person can visit without special permission (e.g., street corners, parks, restaurants, theaters) or Internet communications in public forums. Observations of the public behavior of children do not qualify for exemption if the investigator interacts with them.
Category c. The research (educational tests, surveys, interviews, or observations of public behavior) is conducted among elected or appointed public officials or candidates for office.
Category d. The research involves the study of data (in existence prior to the research) that are publicly available or that are recorded in a manner in which they cannot be linked with individuals (e.g., there is not a master list of subjects that linksparticipants to identification numbers).
Category e. The research to be conducted has been approved by federal departments or agency heads and determined to be exempt by those departments and agencies. To qualify for exemption under this category, investigators would be required to provide the IRB with appropriate documentation from the relevant federal departments or agencies.
Category f. Research involving food (taste, quality, or consumer acceptance) which is wholesome and contains no additives or foods with ingredients (type and amount) that meet federal safety standards.
2. Responsibilities of Investigators Conducting Exempt Research
Since exempted studies are still considered human subjects research, investigators are expected to adhere to ethical standards for the conduct of research. Specifically, investigators are expected to obtain Informed Consent Releases (when appropriate, given the nature of the research), take all necessary steps to minimize risks and maximize research benefits, and ensure the equitable selection of participants (when warranted). Investigators of exempt studies may not make substantive changes in the design of their studies, including changes involving investigators, research instruments and procedures, the location of their research, and sources of participants or data, without written approval by the IRB before any such changes are made. Changes must be requested in writing.
B. Expedited Review
Research activities that present no more than minimal risk may be eligible for expedited IRB approval. Determinations regarding expedited IRB approval are made by the Chair or his/her designee. The Chair or designee may seek the advice of another IRB member or consultant who has specific expertise in the area of research described in the application.
For purposes of Expedited Review, minimal risk refers to the risks of everyday life (e.g., providing information to others about one’s attitudes and other non-confidential issues) or those associated with routine medical and psychological tests. The expedited review procedure may not be used where identification of participants or their responses would reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, reputation, or be stigmatizing unless reasonable protections will be implemented to minimize these risks. Expedited approval may not be given for classified research.
1. Overview of Expedited Research
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 seven categories may be reviewed by the IRB through the expedited review procedure. The activities listed are not deemed to be of minimal risk simply because they are included on this list; rather, inclusion on this list means that the activity is eligible for expedited review because the specific circumstances of the proposed research are seen to involve no more than minimal risk to human participants.
Categories 1 – 7 below apply regardless of the age of participants, except as noted. These seven categories pertain to both initial and continuing IRB review.
Standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review–Expedited or Full Board–utilized by the IRB.
2. Expedited Review Categories
Category 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 l
Category 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 eight (8) week period and collection may not occur more frequently than two (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 three (3) ml per kg in an eight (8) week period and collection may not occur more frequently than two (2) times per week.
Category 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); (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.
Category 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 particpant or an invasion of the participant’s privacy; (b) determining body weight 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.
Category 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).
Category 6. Collection of data from voice, video, digital, or image recordings made for research purposes.
Category 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.
C. Full Board Review
Human research not eligible for Exemption or Expedited Review is evaluated by the IRB at a convened meeting. A majority of the IRB members, including at least one member whose primary concerns are not scientific, must be present to conduct a convened meeting. For research to be approved, it must receive the approval of a majority of those members present at the meeting where a quorum is in attendance.
Convened meetings are scheduled at least once a semester. The deadline for submission of materials for full IRB review is 10 workdays prior to the scheduled meeting. IRB members are sent applications and other materials for review immediately after the deadline for submission. Members are expected to review all materials prior to the meeting.
IRB meetings are conducted by the Chair or designee. The Chair presents an initial review of the research proposal, indicating preliminary questions or concerns, if any, about the proposal followed by a discussion among all IRB members present. In its review, the IRB considers the following review criteria: (1) adequacy and completeness of the application, (2) research design, (3) participant selection, (4) risks and benefits, (5) minimization of risks, (6) privacy and confidentiality, (7) additional safeguards for vulnerable participants, (8) consent, and (9) additional considerations. Whenever possible, the IRB attempts to reach consensus on reviewed research. IRB decisions are recorded as unanimous when consensus has been achieved. When members are unable to reach consensus on a decision, the decision is made by majority vote, with members voting for approval or disapproval (or abstaining), or required changes, as identified in the minutes.
The IRB makes one of four decisions on reviewed research: (1) Approval, (2) Provisional Approval (the IRB authorizes the Chair or another member to review and approve required revisions), (3) Postponed (tabled, pending further information), or (4) Withheld (disapproved). In a case where the research proposal is not fatally flawed or devoid of merit, but might be able to be strengthened, the IRB may provide recommendations or suggestions to investigators to improve their research design or methodology.
The Chair may permit persons not affiliated with the IRB (e.g., consultants) to attend meetings, upon request. Investigators or their collaborators are not permitted to be present at IRB meetings during actual deliberations on their research proposals. However as needed, the IRB may decide to invite investigators to the meeting to answer questions about their proposed research.