New Studies

A “new study” is one that has not been previously submitted via the Kuali Protocols IRB system for review by one of Indiana University’s Institutional Review Boards (IRBs). The level of review your study, or protocol, falls under will determine the type of information you will need to provide in the Kuali Protocols system.

In general, three types of review are used in evaluating research protocols using humans as research subjects—exempt, expedited, and full board.

Exempt review

“Exempt” review means review by one IRB or Human Subjects Office staff member, sometimes in consultation with others. If your research project involves no more than minimal risk and meets the criteria specified in the IU HRPP Policy regarding Exempt Research, it is eligible for review under the Exempt process. “Minimal risk” means that the person participating in your study would experience no more risk that he or she would throughout the course of a normal day or during routine physical exams or psychological tests.

To review the categories of research that qualify for exempt review, refer to the above IU HRPP Policy regarding Exempt Research. Projects eligible for exempt review include:

• Research conducted in established or commonly accepted educational settings
• Research using tests, surveys, or observations
• Research utilizing painless, brief behavioral interventions subjects would not find offensive or embarrassing
• Secondary research uses of identifiable private information or identifiable biospecimens for which consent is not required
• Research involving public benefit or service programs
• Taste and food quality evaluation and consumer acceptance studies

Although federal regulations do not require a signed informed consent form for exempt protocols, subjects’ agreement to participate may be needed. If practical, subjects should receive verbal or written information about the study including the purpose and procedures of the research project, a statement that participation is voluntary, and contact information for the principal investigator.

The documents listed here are required for an exempt review:

• Completed application form in the Kuali Protocols system
• If applicable, Study Information Sheet (Exempt)
• All recruitment materials (advertisements, flyers, phone scripts, etc.)
• All data collection instruments (surveys, questionnaires)

As with all research involving human subjects, before starting your research or contacting any prospective human subjects, your study must be reviewed and approved by the IRB or HRPP. Once reviewed, you will receive notification of determination of exemption which can be downloaded from Kuali Protocols for your records.

If your project is minimal risk but not eligible for exempt review, it may be eligible for expedited review. “Expedited” means review by one or more experienced IRB reviewers. In general, research may qualify for expedited review if it involves only minimal risk and all study procedures fall within one or more of the expedited categories listed in federal regulations.

A full list of the categories of research that may be reviewed as expedited may be found under IU HRPP Policy on IRB Review Process, section 2.5.

The following documents are required for an expedited review:

• Completed application form in the Kuali Protocols system
• Informed consent statement or study information sheet (unless a waiver has been requested in the application form)
• Assent (if children capable of assent are being enrolled and a waiver has not been requested in the application form)
• All recruitment materials (advertisements, flyers, phone scripts, etc.)
• All data collection instruments (surveys, questionnaires)

View related forms

A full board review is required for research that is not eligible for an exempt or expedited review either because it is greater than minimal risk or because the study procedures are outside the exempt and expedited categories. Because of the nature of the full board review process, you should allow ample time to obtain full board approval.

The following documents are required for a full board review:

• Completed application form in the Kuali Protocols system
• A copy of the protocol
• Informed consent statement or study information sheet (unless a waiver has been requested in the application form)
• Assent (if children capable of assent are being enrolled and a waiver has not been requested in the application form)
• All recruitment materials (advertisements, flyers, phone scripts, etc.)
• All data collection instruments (surveys, questionnaires)

View related forms

A humanitarian use device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease that affects fewer than 8,000 individuals in the U.S per year. HUDs are not expected to generate the type of efficacy data required for approval of a new medical device. As a result, the Food and Drug Administration grants a special Humanitarian Device Exemption. Although a HUD is an approved device, the IRB is required to provide oversight of the use of the HUD.

To receive approval for the use of a HUD, you need to create a new submission in the Kuali Protocols system that includes the following documents:

• Completed application form in the Kuali Protocols system
• The HUD manufacturer's product labeling, clinical brochure, and/or instructions for use
• The FDA Humanitarian Device Exemption approval letter
• A protocol, informed consent statement, and HIPAA authorization are not required for HUD submissions