Types of IRB ReviewThere are three (3) types of review paths for an IRB application: Full Board, Expedited, and Exempt. Thereview path is determined by: Show
FullBoard ReviewFederal regulations and institutional policyrequirean IRB Full Board Review for applications where the research involvesmore than minimal riskto human subjects or has been referred to the committee by an expedited reviewer or the Chair. Regardless of risk level, TCNJ IRB may requirefullboardreview when the research involves:
Applications requiring fullboard review are accepted by the submission deadlines and reviewed by the full boardon the scheduled IRB meeting dates. The IRB Chair assigns submissions to a primary and secondary IRB reviewer for presentation at the fullboard meeting. Investigators are welcome to attend the meeting to answer questions from the board. At the conclusion of the meeting, the board votes and issues a determination. When is IRB approval required?IRB approval is required when conducting “research” with “human subjects” Human Subject Definition A human subject is defined as a living individual about whom an investigator (whether professional or student) conducting research (a) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (b) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Research Definition Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Activities that meet this definition constitute research whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. Obtaining IRB Approval or IRB ExemptionIf your proposed project meets the definitions of “research” and “human subjects” then you will need to proceed with the steps outlined on the Obtaining IRB Approval web page. Human Subject Research (HSR) Determination ProcessIf you are not sure if your proposed project meets the definitions of “research” and “human subjects” then you can submit the “IRB HSR Determination Form” to get an official written determination from the FIU Office of Research Integrity to find out if IRB approval is necessary for your study. In some cases, a funding agency or the FIU University Graduate School may also request for a written determination to be made (when it is not clear if IRB approval is necessary). The “IRB HSR Determination Form” can be accessed in the online TOPAZ Electronic Protocol Application System. 1. What other types of activities don’t require IRB review? The following activities typically do not need IRB review:
Activities deemed not to be research (as of January 21, 2019):
2. Does a study involving the analysis of secondary human subject data require IRB approval? IRB approval is required to analyze identifiable or coded private information about human subjects (i.e, data that can be associated to a human subject directly or via a unique code that links back to a master key). IRB approval is not required to analyze completely de-identified “anonymous” information about human subjects (i.e., data that cannot be associated to a human subject directly or via a unique code that links back to a master key). If you are not sure if the data that you will be analyzing needs IRB approval, then you can complete the IRB HSR Determination Form (available in the online TOPAZ Electronic Protocol Application System). This will allow the IRB Office to provide you with a written determination as to whether IRB approval is required. View the following web pages for further guidance on this topic: Note: Please review the Institutional Biosafety Committee (IBC) web page if you will be working with human specimens, since some activities involving human specimens are subject to IBC review and approval. 3. Does the review of medical records for case report publications require IRB review and approval? The review of retrospective medical records for publication of case reports of three or fewer patients is not considered as human research and will not require IRB approval. This is due to the fact that a small series of patients does not involve a systematic investigation with the intent to form a research hypothesis, draw conclusions or generalize findings. However, please note that the review of retrospective medical records for publication of case reports of four or more patients will be considered as human research and will require IRB approval. 4. Does a pilot, feasibility, mock, or dry-run study require IRB review and approval? A pilot study is usually a preliminary investigation of the feasibility of a larger study, usually done on a small scale and is exploratory in nature. It is designed to help the investigator refine data collection procedures and instruments or prepare a better, more precise research design. Sometimes pilot studies are conducted to collect initial data in support of or preparation for a grant submission. Pilot studies, sometimes called feasibility studies, mock studies, or dry-run studies, involving human subjects (no matter how small the sample size is) require the same scrutiny as full-scale research projects and therefore, must be submitted for IRB review and approval. This requirement applies regardless of whether pilot data will be used for publication purposes or not. It is recommended to explicitly identify in an IRB submission when a study is intended as a pilot study. 5. Does a self-experimentation study require IRB review and approval? Federal regulations do not distinguish between self-experimentation and research on subjects recruited for a specific project. Faculty, staff, and students who wish to act as participants in their own research are considered human subjects. All self-experimentation human research activities require IRB review and approval prior to commencing the study. 6. Do I need to submit anything if my study is Exempt? Investigators often confuse studies that “do not require an IRB submission” with “Exempt” studies. These terms are completely different from each other. The term “Exempt” is an actual review category for a study that requires an IRB Exemption Form submission.
Learn more about the types of IRB review. 7. What types of datasets can be used without obtaining IRB approval? Approved Data Sets: Listing of publicly available de-identified data sets that do not require IRB approval (note: “restricted-use” and “limited-use” datasets still need IRB review). Limited Data Sets as defined by the Privacy Rule, may also be used without the need for IRB approval, since OHRP does not consider a limited data set to meet the definition of a “human subject”. 8. Do scholarly and journalistic activities fall under the definition of "research"? As of January 21, 2019, scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship) will not be considered as research, so long as the activity focuses directly on the specific individuals about whom the information is collected and used without extending that information to draw generalizations about other individuals or groups. Note: It is not the particular field that removes the activity from the definition of research, but rather that the purpose and design of the particular activity is to focus on specific individuals only. Which type of IRB review does not require an IRB approval but does require a determination by an individual?“Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.
Which type of review does not require IRB 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 3 types of IRB review?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 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).
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