The Level of review an application receives is based on the risk assessment conducted during the pre-review process. The levels of review are outlined below.
The Human Subjects Research Office (HSR) conducts an administrative assessment of all applications submitted via Cayuse. The pre-review process serves to identify common issues and ensure the application is ready for Reviewers. By doing so at the administrative level, we are able to reduce the overall time the application is with Reviewers. HSR Specialists are in tune with Reviewer requirements and can provide PIs guidance to expedite the approval process. Pre-review takes place within one week of the submission date. If the HSR Specialist determines additional information is needed, they will make comments in the application and return it to the PI. Upon resubmission by the PI, the HSR Specialist will determine the type of review that is most appropriate (Exempt, Limited, Expedited, or Full) and initiate corresponding review process.
Most exempt studies are not subject to Federal regulations, however must go through an administrative review process to confirm their exemption status. The Human Subjects Research Office (HSR) is responsible for determining whether research involving human subjects meets the criteria for exemption as outlined in the Federal regulations. Investigators may not make this determination.
There is not a separate application for an exempt study. All applications are submitted through Cayuse. Studies that qualify for an exempt status are reviewed and approved internally by the HSR Office. Once a study’s status is confirmed, an exemption category is assigned and approval documents are released to the PI (and Faculty Sponsor, if appropriate). Once designated as exempt, a study is approved for a 3-year period. No research activities can be initiated until approval documents are released.
Although the HHS regulations list eight exemption categories, UTD has opted to implement six of those categories at this time (see the list here). Of the six exemption categories listed below, only exemption category 6 (for taste and food quality evaluation and consumer acceptance studies) applies to studies that are FDA-regulated.
HHS regulations include exemption categories that require that the exemption determination is made by the IRB (categories 2 & 3). If such review is required, the HSR Specialist will conduct the Pre-review and then initiate Limited Review and forward the application to IRB Reviewers.
Not all exempt studies qualify for administrative review and approval. HHS regulations (45 CFR 46) introduce exemption categories that require IRB review as a condition of their exemption determination. These studies qualify for exemption category 2 or 3 and typically involve benign behavioral interventions and collection of personally identifiable information. However, the IRB determines there are adequate provisions for protecting privacy and confidentiality. Once a study’s status is confirmed, an exemption category is assigned and approval documents are released to the PI (and Faculty Sponsor, if appropriate). Once designated as exempt, a study is approved for a 3-year period. The IRB has the authority to suspend or terminate IRB approval of research approved through Limited Review.
Evaluation of Exempt Studies
UTD and IRB policy requires exempt studies to fulfill UTD’s ethical standards. To be designated as exempt, a study is evaluated and the following are found to be true:
- The research holds no more than minimal risk to participants;
- Selection of participants is equitable; and
- If identifiers are collected, there are adequate provisions to protect participant privacy and maintain confidentiality of the data.
The Belmont principle of Respect for Persons generally requires that subjects be given the opportunity to choose whether or not to participate in research. For this reason, informed consent should be obtained, though signatures are not required for exempt studies. Researchers of exempt studies are expected to provide participants with consent information that includes, at a minimum:
- Clear communication that the activities and procedures are research;
- Name and contact information of Investigator(s);
- Indication that this is a UTD study (institution affiliated with the research);
- Complete description of the research activities;
- Statement indicating participation is voluntary;
- Provisions taken to maintain the privacy of research participants;
- Name and contact information of the UTD HSR Office.
A template exempt consent form can be obtained on our Forms page. An annual continuing review is not required for exempt studies.
Class Projects are research studies undertaken by student investigators for the sole purpose of obtaining course credit (Experimental Projects in Psychology, Research Methods, etc.). Class Projects (CL) should pose a less than minimal risk to human participants and are processed through Cayuse IRB. Once approved, the studies expire at the end of the current semester. Studies that involved data collection needed for or used in dissertations or thesis projects do not qualify as Class Projects and need to be reviewed as Exempt Studies or Expedited Review, as appropriate.
Expedited Review is conducted when studies are determined to be less than minimal risk (defined below) to research participants. These applications are reviewed by three (3) members of the IRB Committee. The HSR Specialist will notify the PI of the IRB’s determination (approval or modifications needed). Approval documents and stamped consent forms are released in Cayuse after the study is approved.
Full Board Review is reserved for those studies determined to be minimal to more than minimal risk to research participants. These applications are reviewed by all members of the IRB Committee at a convened meeting. An HSR Specialist will notify the PI of the IRB’s determination (approval, modifications needed, or disapproval). Once the study is approved, approval documents and stamped consent forms are released in Cayuse.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Timeline from submission of an application to approval starts after the pre-review process is finalized and the review process is initiated by the HSR Specialist. Approximate timelines are listed below:
- Exempt Review: 1 week
- Expedited Review: 2 weeks
- Full Board Review: 4 – 6 weeks
Plan ahead: It is important that you have all required supporting documents in place before you submit your application so as not to delay the review process. Some documents such as site authorization, approval from other compliance components, or relevant agreements with collaborating institutions may take extra time to acquire.
Once you have received a notice of approval from the HSR Specialist, you may begin conducting the research as approved.