Any research activity involving human participants that is conducted by The University of Texas at Dallas (UTD) faculty, staff, and/or students must be reviewed and approved by the IRB, or determined to qualify for exempt status by the Office of Research Integrity and Outreach.
There are three levels of IRB review (Minimal, Expedited and Full). The IRB Office or designated member of the IRB is responsible for determining the level of review required for each application submitted. PIs may NOT determine the type of review required.
Please contact the IRB Office if you have questions.
Minimal Review Criteria
All research projects involving human subjects require IRB approval. To qualify for Minimal Review, research must fall into one of eight (8) federally-defined categories, which exempt research from full or expedited IRB review. These categories represent the lowest level of risk to potential participants.
The following research projects are examples of research studies eligible for Minimal Review:
- Anonymous tests, surveys, or interviews. To be anonymous, participants cannot be identified or traced to the research study.
- Evaluation or examination of a public benefit or service program (welfare, Medicaid, unemployment, etc.) when no participants are identified, contacted, or interviewed.
- Analysis of pre-existing data routinely complied by a public office administering the program.
- Archival data, only if publicly available and de-identified so no subjects can be linked to the data.
- Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques.
To be eligible for Minimal Review a research project cannot involve any of the items listed below. These items require Expedited Review:
- Vulnerable Participants: Children under the age of 18, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
- Surveys dealing with sensitive and/or private aspects of behavior such as sexual orientation, substance abuse, or illegal activity when participants are linked to the study.
- Review or use of de-identified medical records.
- Use of data that contains identifiable information, one-way identifiers, etc. that can be used to identify a participant.
Please contact the IRB Office if you have questions.
To qualify for an expedited review, research must fall into one of the federally-defined expedited categories or exemption categories that require IRB review (see below). The expedited categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects. Some examples of expedited research are:
- studies involving collection of hair, saliva, or dental plaque samples
- studies of blood samples from healthy volunteers
- studies of existing pathological specimens with identifiers
Expedited review as defined by federal regulations allows the IRB chairperson or one or more experienced reviewers designated by the chairperson from among members of the IRB to evaluate and approve specific types of research. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When a subcommittee cannot approve the research under expedited review, the study is referred to the full Committee for review.
Applicability of Expedited Review
- Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the federally-defined categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
- The categories in this list apply regardless of the age of subjects, except as noted.
- The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
- The expedited review procedure may not be used for classified research involving human subjects.
- IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review utilized by the IRB (i.e., expedited or full committee review).
Expedited Review as a Condition of Exemption
Expedited Review is also used when a limited IRB review of the research protocol is a required condition of exemption in accordance with 45 CFR 46.104. Examples include:
- Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects;
- Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects;
- Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use; and
- Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:
- Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with federal regulation;
- Documentation of informed consent or waiver of documentation of consent was obtained in accordance with federal regulation;
- An IRB conducts a limited IRB review and makes the determination that the research to be conducted is within the scope of the broad consent; and
- The investigator does not include returning individual research results to subjects as part of the study plan.
Proposed human subject research which does not fall into either the exempt or expedited review categories must be submitted for full committee review.