Research as defined by the Department of Health and Human Services means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(d)). Research is considered synonymous with Clinical Investigation as defined by the FDA. The following activities are considered not research by DHHS:

• Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
• Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance.
• Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
• Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

A systematic investigation is an activity that is planned in advance and that uses data collection and analysis to answer a question.

Generalizable knowledge is information that expands the knowledge base of a scientific discipline or other scholarly field of study.

Clinical Investigation, as defined by the FDA, is synonymous with “research” as defined by DHHS and means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA, or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit.

If the answer is “yes”, you need to determine if human subjects are involved.

• Human subject has reference to two definitions by federal agencies.
  • Department of Health and Human Services (DHHS) defines human subjects as a living individual about whom an investigator (whether professional or student) conducting research:
    • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
    • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
  • Food and Drug Administration (FDA) defines human subject as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a health individual or a patient. For research involving medical devices a human subject is also an individual on whose specimen an investigational device is used.
    • When medical device research involves invitro diagnostics and unidentified tissue specimens, the FDA defines the unidentified tissue specimens as human subjects.

• Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.
• Interaction includes communication or interpersonal contact between investigator and subject.
• Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
• Identifiable private information is private information for which the identity of the subject is or may readily be associated with the information or ascertained by the investigator.
• An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

If the answer to this question is also “yes”, then you need IRB approval to conduct research. Otherwise, you need to ask the following questions.

If the answer to the above question is “yes,” then you need IRB approval to proceed.

(Note that medical devices generally include devices intended for the use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals, and devices intended to affect the structure or any function of the body of humans or other animals.)

If the answer to the above question is “yes,” then you need IRB approval to proceed.

If the answer to the above question is “yes,” then you need IRB approval to proceed.

The Office of Human Subjects Protections (OHSP) 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. OHSP 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 OHSP 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 OHSP 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 Office of Human Subjects Protections (OHSP) 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 OHSP. 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 OHSP Specialist will conduct the Pre-review and then initiate Limited Review and forward the application to IRB Reviewers.

Limited Review

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 OHSP.

A template exempt consent form can be obtained on our Forms page.

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 OHSP 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 OHSP 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 OHSP Specialist. Approximate timelines are listed below:

• Exempt Review: 1 week
• Expedited Review: 2 weeks
• Full Board Review: 4 – 6 weeks

Deadline for Submissions requiring Full Board Review: Effective 10/01/2024, applications requiring Full Board Review must be submitted by the 15th day of the month to be included on the meeting agenda for the following month. As an example, an application requiring Full Board Review must be submitted by November 15th to be included on the agenda for the meeting in December. Investigators are encouraged to submit in advance of the deadline to allow sufficient time for the pre-review process to ensure that the submission is complete and ready for IRB review. Meeting the deadline alone does not ensure that the submission will be reviewed as assignment to an agenda is not guaranteed and can depend on factors such as the quality and completeness of the submission, the complexity of the project, necessary ancillary reviews, and the PI’s responsiveness to pre-review requests for clarification. IRB Full Board meetings are typically scheduled for the third Tuesday of the month, but meeting dates are subject to change due to scheduling conflicts or when quorum is not met. The IRB’s decision will be communicated to Investigators within one week of the meeting.