Determining if IRB Review is Needed
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.
- Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes
- Interaction includes communication or interpersonal contact between investigator and subject
- Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
- Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
- Identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
- Systematic investigation is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.
- Generalizable knowledge relates to drawing general conclusions, informing policy, or generalizing findings beyond a single individual or an internal program (e.g., publications or presentations.)
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 Exemption
If 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 Process
If 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.
Frequently Asked Questions (FAQs)
1. What other types of activities don’t require IRB review?
The following activities typically do not need IRB review:
- Service or course evaluations (unless they can be generalized to other individuals)
- Classroom exercises solely to fulfill course requirements or to train students in the use of particular methods (results of study will not leave the classroom)
- Quality assurance activities designed to continuously improve the quality or performance of a department or program (results will not be shared with public)
- Samples or tissues that are collected from deceased individuals
- Data available from datasets containing information about deceased individuals
- Anonymous samples or data available from commercial or public repositories or registries
- Anonymous established human cell lines available from public repositories or registries (although IRB review is not required, please refer to the IBC web page, since IBC review and approval may still apply)
Activities deemed not to be research (as of January 21, 2019):
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focuses directly on the specific individuals about whom the information is collected.
- 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.
- Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security mission even if they are a component of a larger non-research activity (e.g., instruction, demonstration).
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:
OHRP Coded Private Information or Specimens Use in Research, Guidance
Data Sets that Do Not Require IRB Approval
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.
- A study that “does not require an IRB submission” is a study that does not meet the definition of human subject research, and therefore does not require any type of an IRB submission.
- An “Exempt” study is a study that does meet the definition of human subject research, and therefore requires an IRB Exemption Form submission in order to be deemed Exempt.
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.