What are the 3 types of IRB reviews?

IRB must review all projects that meet the definition of research and that involve human participants prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major levels of human subjects’ research review: Exempt, Expedited, and Full.

What are the 4 relevant criteria for IRB approval?

Selection of subjects is equitable. Inclusion/exclusion criteria are adequate. Research purpose and setting are appropriate. Recruitment process is fair.

What determines type of IRB review that is required?

There are three (3) types of review paths for an IRB application: Full Board, Expedited, and Exempt. The review path is determined by: Level of risk to subjects associated with the project. The type of research being conducted (e.g., an educational intervention, a survey, an ethnographic observation, etc.)

What type of IRB review does not require approval?

Examples of Studies that Generally Do Not Require IRB Review

Data collected for internal departmental or administrative purposes, such as teaching evaluations, student performance data, etc. Activities designed solely for quality improvement or evaluation of a program, course, etc.

What are the IRB standards?

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

What is the IRB review process?

The IRB office utilizes an initial pre-review screening process, during which an IRB analyst reviews each submission for completeness and compliance. The analyst may ask the PI to make changes to the submission before it is reviewed by the IRB (pre-review).

What types of research require IRB approval?

FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements) (21 CFR Part 56).

What is limited IRB review?

What is limited IRB review? Limited IRB review is a process that is required only for certain exemptions, and does not require an IRB to consider all of the IRB approval criteria in §46.111. In limited IRB review, the IRB must determine that certain conditions, which are specified in the regulations, are met.

What is expedited IRB review?

Expedited review: A review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.

What are the minimum elements that are typically required for an IRB protocol?

At a minimum, IRB protocols should contain the Objectives, Methods, Quality Control and Assurance, Ethics/Protection of Human Subjects, and Data Handling and Record Keeping.

What types of research require IRB approval?

FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements) (21 CFR Part 56).

Which of the following is necessary for the IRB committee to approve a research proposal?

To evaluate research adequately, the IRB must be able to (1) identify the risks involved in the study, (2) identify how the risks are minimized, and (3) assess whether the risks are reasonable in relation to the anticipated benefits.

How long is IRB approval valid?

How long is my study approval valid? Approval is valid for no more than one year for research involving minimal risk. For research involving non-minimal risk, IPA IRB will exercise its discretion to determine the duration of approval, which may be for less than one year.

What is limited IRB review?

What is limited IRB review? Limited IRB review is a process that is required only for certain exemptions, and does not require an IRB to consider all of the IRB approval criteria in §46.111. In limited IRB review, the IRB must determine that certain conditions, which are specified in the regulations, are met.

How long does IRB approval take?

How long does IRB review take? An expedited or exempt review may take about two weeks. Studies requiring convened review may take three or more weeks.

When must IRB review occur?

An IRB must conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year (45 CFR 46.109(e)).

What is IRB Continuing review and when should it occur?

What is Continuing Review? If you want to continue working on a study beyond its expiration date, you must submit the study to the IRB for continuing review approval. The IRB re-reviews the study to determine if it is appropriate for the study to continue, as is or with modifications.