Do I need IRB Review?

As stated in the FDU policy, research involving human subjects conducted by an agent of FDU must be submitted to the Institutional Review Board for review. This applies to all research, unfunded or funded by an extramural agency (government, foundation, or private sources). Faculty, students, and other investigators are encouraged to consult with the IRB months before submitting a project for review to discuss IRB-related issues that may affect the design or conduct of the investigation. 

The following are activities that typically do NOT represent human subjects research requiring IRB review: 

Case report: the project consists of a case report or a retrospective analysis of one, two, or three medical or educational activities/cases. If more than three cases are involved in the analytical activity, the activity WILL constitute research and will require IRB review. 

Course-Related Activities: the project is limited to course-related activities designed specifically for educational or teaching purposes where data is collected from and about the students as part of a routine class exercise or assignment and is NOT intended for use outside the classroom. Note: IRB approval may be required if an instructor or department has an academic interest in pedagogy, and the classroom is used to test hypotheses/innovations with the goal of contributing to or changing generalizable knowledge about pedagogy. 

Research on Decedents: research that uses only human cadavers, cadaveric tissue, decedent medical/educational record information, or discarded decedent specimens from clinical use is not subject to prior review and approval by the IRB UNLESS the research study includes BOTH living and deceased individuals. 

If the project involves the use/and or collection of PHI (protected health information)HIPAA regulations apply to decedent research. Please contact the Human Research Compliance Manager for more information. 

Oral History: The project is limited to oral history activities, such as open-ended interviews, that only document a specific historical event or the experiences of individuals without the intent to draw conclusions or generalize findings. Note: IRB approval is required when the oral history activities are intended to produce generalizable conclusions (e.g., that serve as a data collection intended to test economic, sociological, or anthropological models/theories). 

Program evaluation/Quality Improvement/Quality Assurance Activities: the project is limited to program evaluation, quality improvement, or quality assurance activities designed specifically to assess or improve performance within the department, organization, or other specified setting. The intention of the project is not to generate conclusions that may be applied universally, outside of the immediate environment where the project occurred.  

Public Use Datasets: The project is limited to analyzing de-identified data contained within a publicly available dataset. Some examples of data sources that do not qualify as research with human subjects, UNLESS the researcher has received restricted-use data, include data files from the Center for Disease Control, Bureau of Economic Analysis, FBI Uniform Crime Reporting Program, Global Health Observatory data repository, etc. 

Coded Private Information and/or Human Biological specimens: The project is LIMITED to the use of existing and/or prospectively collected coded private information and/or human biological specimens. IRB approval is not required if ALL the following conditions apply: 

The private information or specimens were/are not collected specifically for the currently proposed research project through intervention or interaction with living individuals, and, 

The investigators cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example: 

the investigators and the holder of the code key enter into an agreement prohibiting the release of the key to investigators under any circumstances until the individuals are deceased. 

there are IRB-approved written policies and operating procedures for a repository or data management center that prohibits the release of the key to investigators under any circumstances, until the individuals are deceased; or 

there are other legal requirements prohibiting the release of the key to investigators are deceased, and 

specimens are NOT being used to test effectiveness of a medical device or as a control in an investigation of an investigational device and the results of the activity are to be submitted to the FDA. 

De-identified private information or Human Biological Specimens: The project is limited to the use of existing and/or prospectively collected de-identified private information and/or human bio specimens. IRB approval is not required if you confirm and show evidence of the following: 

The private information or specimens were/are not collected specifically for the currently proposed research project through an intervention or interaction with living individuals; and 

the investigator can confirm that the use of the private information and specimens is not in violation of the terms of use under which the information or specimens were/will be collected; and 

the investigator will only receive information or specimens that are fully de-identified.  De-identified means that the materials to be studied are devoid of any of the 18 Protected Health Information elements set forth in the Privacy Rule, as well as any codes that would enable linkage of the information or specimens to individual identifiers. Note:  To be considered de-identified (unidentifiable), nobody, including individuals who are not involved in the conduct of the project, should be able to link the information or specimens back to identifiers; and 

Specimens are not being used to test the effectiveness of a medical device or as a control on an investigation of investigational device and the results of the activity are to be submitted to the FDA or held for inspection by the FDA; and 

The records/images/charts that being collected for this study are NOT from individuals who are or will become recipients of an FDA regulated product (approved or experimental) or act as a control as directed by a research protocol and not by medical practice, and the results of the activity are to be submitted to the FDA or held for inspection by the FDA. 

Please note: a Data Use Agreement (DUA) may be required depending on the type of data being provided to FDU by another entity. A DUA is a written agreement used to govern the transfer of research data between institutions. It describes the data being transferred or shared and addresses the ownership of the data, the permitted use of the data, publication of results, development of inventions, disposal of the data and any liability.  

If data is coming from another Institution or being collected at another Institution, that Institution must know and approve the use of the data for research purposes. IRB review may be required by the data providing Institution. 

If it is a transfer of biological materials, a Material Transfer Agreement (MTA) may be needed. An MTA is a contract that governs the transfer of materials between institutions for use in research. These agreements address issues such as ownership of the transferred material and modifications and derivatives made by the recipient. They also may limit the use and further dissemination of the material by the recipient, address publication rights and confidentiality and rights to inventions and research results. 

Please contact the HRCM for the operating procedure for DUAs and MTAs. 

If you are unsure if your project is human subjects research or want confirmation, you may complete the Human Research Determination Form found here and on the IRB Forms and Templates page. Your form will be reviewed, and a determination made.