Application and Review Process

The Human Subjects application and review process is a multi-step process that can take up to six weeks to complete. Since no data can be collected before a proposal has been approved, it is imperative that applicants submit their proposal far in advance of the date they intend to collect data. It is also important to note that the application process is the same for any application receiving either a Waived, Expedited, or Full Committee review. The steps for applications requiring one of these review types are described in detail below.

Application Process

The first step toward obtaining approval is to complete the Human Subjects application, which can be found in the Application Guidelines for Research Involving Human Subjects packet (available both online and in the Office of Research and Sponsored Projects, 6th floor of the Unitus Building). The application consists of the following:

• Investigator's Assurance form
• Outline for Application Proposal (Sections I-IX)
  Note: Section IX includes all survey instruments, telephone and introductory scripts, interview questions and informed consent documents that will be used during the project.

Next, the completed application must be submitted, along with the appropriate number of copies (two additional copies for non-federally funded projects, 10 additional copies for federally funded projects), to the Office of Research and Sponsored Projects, 6th floor of the Unitus Building.

Review Process

Once in receipt of the application, the Compliance Specialist in ORSP will determine which type of review the application will undergo. It is important to note that this cannot be determined prior to submission. Again, the application process is the same regardless of which type of review an application undergoes. It is therefore imperative that all components of the Application for Research Involving Human Subjects are submitted so that the Compliance Specialist can move forward with the review process.

Waived Review

If the application qualifies for a Waived review, it is reviewed only by the Compliance Specialist, who may request more information, clarifications, or revisions ("conditions"). Once these conditions are met, an exemption claim is certified by the Compliance Specialist, a waiver memo is issued, and the file is closed.

Expedited Review

If the application more appropriately qualifies for an Expedited review, the Compliance Specialist will send the application to a subcommittee consisting of two members of the Human Subjects Research and Review Committee (HSRRC) for review. The subcommittee may require additional conditions to be met prior to approval, in which case a conditional memo is issued to the applicant. The applicant's response to the conditional memo is sent, along with the file, to the HSRRC chair who may also request additional information, clarifications, or revisions. Once the application is approved, an approval memo is issued. Approval lasts only for one year. The approval memo contains the date the approval status expires as well as general procedures for continuing review. Detailed instructions for renewing the approval status can be found here.

Full Committee Review

The Full Committee Review procedures are the same as those of the Expedited Review, with the exception that the application is sent to one of two monthly full committee meetings. All members of the HSRRC contribute to the review process.

After the Review

Applicants are typically contacted by e-mail or phone when there are additional conditions that must be met or their application has been approved. A hard-copy of the conditional or approval memo will always be sent as well. Once the applicant has been notified of approval by e-mail or phone, it is not necessary to wait for the hard-copy of the approval memo to start collecting data.

Review Not Required

Some studies do not require a Waived, Expedited, or Full Committee review. If a project involves secondary data analysis and meets all four of the following criteria, applicants may submit the Review Not Required form. A one-page summary of the project must be included with the form. Additional copies are not necessary.

The following four criteria must be met in order to qualify:

• All identifying information has been removed and data cannot be linked back to individuals.
• No contact with subjects is/was involved.
• Data has been previously collected by another investigator.
• Data already exists.

Note: If a project involves secondary data but does not meet all four criteria, a complete application must be submitted.