IRB Review Types

Full Board Review

Some types of research must be reviewed at a convened IRB meeting with a quorum for all studies to be voted upon. Types of research may include, but are not limited to:

  • Studies where identifiable information is collected or coded information with an existing code key, and the subjects’ responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing.
  • Studies that request identifiable or coded sensitive information such as drug use, illegal/criminal activity, sexual practices, political, religious beliefs, abuse, etc.
  • Studies that request sensitive information such as drug use, illegal/criminal activity, sexual practices or beliefs, abuse, etc.
  • Studies of employees where information may be collected about his/her perspective on working conditions or supervisory conditions where the supervisor may access the information.
  • Studies involving a clinical trial with an investigational new drug or device that is greater than minimal risk or does not meet an exempt or expedited review category.
  • Studies involving vulnerable populations where a convened IRB must make required determinations, and/or they do not meet an exempt or expedited review category.
  • Research not meeting the specific categories for an exempt determination and/or expedited review of research.
  • Research involving PRISONERS must be reviewed at a Full Board convened meeting, except if certain conditions apply. Please contact the Human Research Compliance Manager for guidance at dicciann@fdu.edu.

Expedited Review

Expedited review procedures can be used according to 45 CFR 46.110 for certain kinds of research involving no more than minimal risk, subject responses would NOT reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing,  employability, insurability, reputation, or be stigmatizing and for minor changes in previously approved research. For more information from the Office for Human Research Protection, see here and the list of categories of research that may be reviewed by the IRB through an expedited review procedure. Under these circumstances, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. Please note that this does not mean a “fast review”. It means that the project does not require review at a convened IRB meeting.

Exempt Determinations

Some types of research with human subjects may be exempt from following the regulations of 45 CFR 46 and certain IRB policies and procedures. This does not mean exempt from IRB review. It is a determination that is made by the University Exempt reviewer, consisting of the Human Research Compliance Manager (HRCM), IRB Chair/Vice Chair, or an IRB member. The reviewer must assess the submission to ensure the documentation contains information that the research study meets one (or more) of six categories as outlined in 45 CFR 46. The list of categories may be found here:  Exempt Category under 45 CFR 46.101(b). Exempt does NOT mean that the research can proceed without IRB review. The research may proceed once the HRCM has completed the review or received the IRB member’s review confirming that the exempt category has been met. Once that occurs, the HRCM will provide the exempt determination correspondence to the Principal Investigator. Please note: categories listed with the term LIMITED REVIEW are reviewed via an expedited review process and must be submitted as an expedited review process.  

Projects that are determined to be exempt are not required to submit for continuing review or continuation of approval. The HRCM must be notified if the Principal Investigator or research team is to make MAJOR changes to the study, where the study NO LONGER meets the category of exemption. These MAJOR changes must be reviewed before being implemented unless the change was made quickly to protect or ensure no harm to an enrolled subject. Examples: a survey must now collect identifiable information, and an interview must now be recorded with a visual or audio recording when sensitive, identifiable information is to be collected. The study must be reviewed in accordance with the type of review the changes now qualify for.