Research that poses very minimal to no risk to subjects may qualify for exempt status if it fits into one or more of the exempt categories of research (45 CFR 46.104). The IRB considers projects in this category to be human subjects research requiring IRB review and oversight. There are eight categories of exemption in the federal regulations, however, the University of Iowa has only adopted the first six categories. Use the Exemption Tool on the Human Subjects Office website for guidance on assessing whether a project may qualify for exempt status. 

In Section I.5 of the HawkIRB application, select “Exempt Status.” Additional questions will open in Section IV to select the category (or categories) of exempt status and describe the study procedures. Some exempt categories require a Limited IRB Review. This limited review focuses on privacy and security measures in place to protect the confidentiality and integrity of the study information.

When an IRB Chair determines that a research project meets the criteria for exempt status, that means the project is not required to comply with the full set of regulations for human subjects research, including (but not limited to): documentation of informed consent and continuing review on an annual basis. HawkIRB Modification forms are not required for minor modifications to exempt projects. For guidance on which modifications require or are exempt from IRB review, see the UI IRB Standard Operating Procedures and Researcher Guide,  Section I, Part 13 (Modifications to an Exempt Application).

Expedited review is allowed for research projects that are no more than minimal risk to subjects. The name of this type of review does not refer to the speed of the review process. There are nine categories of research that qualify for expedited review. The IRB reviews HawkIRB submissions  in the order that they were received. In Section I.5 of the HawkIRB application, select one of the following:

• Regular Review - Select this option for Expedited and Full Board review. Select this option to request a waiver of an element of consent and provide justification in Section IV (studies involving deception). Select this option to request a temporary waiver of consent and provide justification in Section IV (studies when research activities occur prior to consent, and informed consent is obtained later). Select this option to request a waiver of documentation of consent (signature on consent document) and provide justification in Section VII.D.*
• Regular review with no informed consent document or consent process – Select this option to request a full waiver of informed consent. There will be no consent document and no consent process. The IRB can only grant this waiver with proper justification in Sections IV.6 through IV.19.* [Note: A retrospective record review or secondary data analysis typically qualifies for exempt status under category 4.]

*See additional information about waivers of consent.

Expedited review may be conducted by a single person, rather than by the full, convened board. The IRB Chair or a Chair Designee  retains the discretionary right to require full board review even when the project appears to meet the criteria for expedited review.

Human subjects research that must be reviewed by the IRB at a convened meeting if it involves more than minimal risk (more than the amount of risk participants face in their everyday life). In Section I.5 of the HawkIRB application, select one of the following:

• Regular review– Select this option for clinical trials and any other study that requires review by the convened board. Select this option to request a waiver of an element of consent and provide justification in Section IV. Select this option to request a waiver of documentation of consent (signature on consent document) and provide justification in Section VII.D.*
• Regular review in compliance with ICH-GCP – Select this option if the study sponsor will not accept standard contract language regarding the UI IRB compliance with International Conference on Harmonization – Good Clinical Practice (ICH-GCP) requirements as adopted by the Food and Drug Administration (FDA). Verify the contractual agreement with your departmental grant administrator or the Division of Sponsored Programs. 

*See additional information about waivers of consent.

IRB meetings are considered closed; not open to the public. On occasion, a PI may be invited to attend an IRB meeting to provide additional information about a project and answer questions from board members.

Full board review is required in the following instances:

• The study involves investigational drugs, devices or biologics that require an Investigational New Drug (IND) or Investigational Drug Exemption (IDE) from the FDA
• Continuing review for studies that were initially reviewed by the full board (except when the board has determined that there is no more than minimal risk and no additional risks have been identified)
• There is greater than minimal risk of criminal or civil liability to subjects
• Participation in the research poses a greater than minimal risk to subjects as it may be damaging to their financial standing, employability, insurability, reputation or it may be socially stigmatizing (unless appropriate protections are implemented)
• Classified research involving human subjects
• The study needs a Non-Significant Risk Determination (for an investigational device)
• There is a research-related Conflict of Interest that needs to be managed
• IRB Chair discretion

The IRB can grant concept approval if the funding agreement (grant or contract) includes a development period for protocol design, creation of instruments or other materials to be used in the study. IRB approval allows the Division of Sponsored Programs to release the funds but does not approve the conduct of human subjects research. Concept approval does not allow for any subject recruitment or other direct or indirect contact with subjects.  In Section I.5 of the HawkIRB application, select “Concept approval.” In Section I.4, provide the section title and page number of the grant or contract that describes the development period.

After the development period, submit a HawkIRB Modification form to fully describe the study and obtain IRB approval to conduct the research.

• Introduction to the IRB
• UI IRB Standard Operating Procedures and Researcher Guide: 
  • Section I, Part 5.C (Waiver of Informed Consent)
  • Section I, Part 13 (Exempt Human Subjects Research)
  • Section I, Part 14 (Expedited Review)
  • Section I, Part 16 (Concept Approval)
  • Section I, Part 18 (Full Board Review)
• UI Exemption Tool
• Waivers of Informed Consent