Determining if IRB Review is Needed

When is IRB approval required?

IRB approval is required when conducting “research” with “human subjects”

Human Subject is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.

  • Intervention includes both physical procedures by which data 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

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.)

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

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.

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.

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.

Activities That Do Not Need 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 cell lines available from public repositories or registries

Clarification on Exempt Review

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 Exempt 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 Exempt Form submission in order to be deemed Exempt.

Learn more about the types of IRB review.

Obtaining a Written Determination

Investigators that are working with funding agencies or the FIU Graduate School will often need a written determination from the IRB Office to confirm that the proposed activities do not require any level of IRB review (i.e., that the activities do not involve research with human subjects). In such cases, the investigator can optionally complete the “IRB HSR Determination Form”, which is available in the online TOPAZ Electronic Protocol Application System.

Additional Resources

Approved Data Sets: Listing of publicly available data sets that do not require IRB approval.