Overview of the IRB Review Process

This section provides an overview of the three levels of review described in the Federal regulations. The Iona College IRB designates these reviews as Tier I. Most student projects and some faculty projects may not warrant a Tier I review. These projects are classified as Tier II and are subject to a Departmental Review only. Please see the two Decision Tree diagrams to determine which guidelines to follow.

1. Full Committee Review

Full committee review is the standard type of review described in the Federal regulations. It must be used for the initial review of all studies that are not eligible for expedited review or exemption status. The procedures and conditions for full committee review require that:

• The review must be conducted at a convened meeting of the IRB. A majority of the IRB members (a quorum of five) must be present at the meeting.
• At least one member whose primary concerns are in nonscientific areas must be present at the meeting.
• In order to approve research, the IRB must determine that all of the requirements specified in 45 CFR 46.111 are satisfied. A majority of the members present at the meeting must approve the research.
• IRB members who have a conflict of interest in a research project may provide information to the IRB, but cannot participate in the review. Members with a conflict do not count toward the quorum for that review.
• The IRB must notify investigators and the institution in writing of its decision to approve, modify or disapprove the research.
• IRBs must keep detailed documentation of meeting activities including attendance, voting on actions, the basis for the actions, and a written summary of the IRB discussion of controverted issues and their resolution.

Reviewers may contact the investigator with questions or suggestions prior to the meeting. The IRB may ask that investigators attend the IRB meeting or be available by phone to answer questions that may arise at the meeting.

2. Expedited Review

Federal regulations permit the IRB chairperson or one or more experienced members to review a study if it involves no more than minimal risk for the subjects and if it fits within certain categories. The term "Expedited Review" only describes the process by which an IRB submission can be reviewed. The information the expedited reviewer(s) is required to consider is the same as if the submission were receiving Full Committee Review. The Federal Regulations establish two main criteria for an expedited review. They are:

• The research may not involve more than "minimal risk". "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." [45 CFR 46.102(1)]
• The entire research project must be consistent with one or more of the following federally defined categories.

Research Categories that Qualify for Expedited Review

Federal Regulations establish nine categories that IRBs may use to invoke the expedited review process. We may adopt some or all of the categories when determining if a research activity can be appropriately reviewed by an expedited review process. Categories 1 through 7 pertain to both the initial and to the continuing IRB review. Categories 8 and 9 pertain only to continuing review. The nine categories are listed below.

Category 1: Clinical studies on drugs or medical devices for which an investigational new drug (IND) or an investigational device exemption (IDE) application is NOT required. Similarly, a study with a cleared/approved medical device that is being used in accordance with its cleared/approved labeling.

Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture.

Category 3: Prospective collection of biological specimens for research purposes by noninvasive means.

Category 4: Collection of data through noninvasive procedures routinely employed in clinical practice provided that: The noninvasive procedure must not involve general anesthesia or sedation routinely employed in clinical practice or 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 of noninvasive procedures are: 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. Weighing or testing sensory acuity. Magnetic resonance imaging. Electrocardiography, electroencephalography, thermograph, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography. Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given age, weight, and health of the individual.

Category 5: Research involving data, documents, records, or specimens that: Have been collected, or Will be collected solely for non-research purposes (such as for medical treatment or diagnosis). Notes to Category 5: Some research in this category may be exempt from the DHHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt from review, but still may qualify for the expedited review process.

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.

Category 8: Continuing review or research previously approved by the convened IRB where: The research is permanently closed to the enrollment of new subjects; all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up subjects, Or where: No subjects have been enrolled and no additional risks have been identified. Or where: The remaining research activities are limited to data analysis.

Category 9: Continuing review of research not conducted under an investigational new drug (IND) application or investigational device exemption (IDE) and where categories two (2) through eight (8) do not apply.

Expedited Review Process

The IRB chairperson or one or more experienced IRB members, designated by the Chair, can conduct an expedited review. IRB members with a conflict of interest cannot be designated to serve as an expedited reviewer(s). In conducting the review, a determination must be made that the research meets the conditions for expedited review procedures.

The reviewer(s) conducting the expedited review may exercise all of the authorities of the IRB with one important exception: the reviewer may not disapprove research. To approve a research activity, the reviewer must make the determination that all of the requirements specified in Federal regulations (45 CFR 46.111) are satisfied. The reviewer(s) may either approve the research, require modification (to secure approval), or refer the research to a convened IRB meeting for review in accordance with the "full committee review" procedures described in section 2 above, and set forth in DHHS regulations at 45 CFR 46.108(b).

Applications, will be assigned by the Chair to committee members who will return their feedback to her/him. If issues are minor, applicants will be instructed to respond to them via email to the Chair. Approval will be withheld until changes have been received, without a new application needed.

Expedited procedures can also be used to review minor modifications of previously approved research [45 CFR 46.110(b)].

3. Review for exemption status.

Federal regulations specifically define six categories of human subjects research that are exempt from the other provisions of the regulations. Federal Guidance indicates that applying exempt status to a project is a decision to be made by the IRB and that investigators cannot make this determination for themselves. Therefore, institutions/IRBs have established procedures to certify that a project is exempt. The IRB has authority to make the exemption determination. Note: the determination must be made prior to initiation of research or of the activity; it cannot be made retroactively.

Research that is Exempt

Category A: Research conducted in established or commonly accepted educational settings, involving normal educational practices.

Category B: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior. Some Observations studies do not qualify for exemption.

Category C: Research not exempt under "B" above may still qualify for an exemption if the human subjects are elected or appointed public officials or candidates for public office.

Category D: Research involving the collection or study of freely available de-identified existing data, documents, records, pathological specimens, or diagnostic specimens.

Category E: Research and demonstration projects conducted by heads of government departments or agencies which are designed to evaluate public programs.

Category F: Taste and food quality evaluation and consumer acceptance studies.

When Review of Exemption Status in NOT Appropriate According to the DHHS regulations 45 CFR 46: NO research involving prisoners, as subjects, can be exempted.