ALL research projects involving human subjects require a review by the North Texas Regional Institutional Review Board (IRB). Note that this review process may involve several stages or levels of review, depending on the various features of the research project and the potential risk to the subjects.
What is Exempt Category Review of Research Studies?
Under federal regulations, certain types of research studies can be considered Exempt from Full Board (IRB) review. To fall under this research category, research studies must be deemed minimal risk to subjects. Minimal risk is defined by federal regulations to be:
“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.” 45 CFR 46. 102 (i)
The term “exempt” can be misleading. Exempt does not mean studies are automatically excused from IRB submission and review but rather are exempt from FULL BOARD REVIEW. All research protocols involving human subjects must still be submitted to the North Texas Regional IRB for proper review and determination of review category. If a protocol is deemed Exempt, the research study is no longer under IRB monitoring and the investigator does not have to report to the IRB. UNLESS…Any modification to the research protocol must be reported to the IRB as certain changes can increase risk to subject or change the type of review (Expedited or Full Board).
Most Exempt category studies reviewed fall under Category (2) educational tests (cognitive, diagnostic, aptitude, achievement), survey, interview, observation of public behavior (including visual or auditory recording) or Category (4) Secondary research for which consent is not required. To access the Exempt Review Application, please follow this link or visit “IRB Forms” on our website. back to top
Who decides whether or not a project has “minimal risk”?
Risk to subject assessment is evaluated by the North Texas Regional IRB. Although the project’s Principal Investigator may indicate that the project is a “minimal risk” activity, federal regulations and guidelines, as well as institutional policies, specify that a third party make this determination: in our case, the North Texas Regional IRB.
If the IRB concurs that a project is “minimal risk“, it is then assessed for a specific category of research, again, based on federal regulations. If this category meets the regulations for Exempt Review, a determination notice is sent to the Principal Investigator. back to top
According to the federal regulations, which research studies fall under Exempt Category Review?
The following categories are considered Exempt research and to be minimal risk. The determination is done by the North Texas Regional IRB and should NOT be solely determined by the investigator. Therefore, investigators must submit an Exempt application to the North Texas Regional IRB for appropriate review.
(1) 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, curricula, or classroom management methods.
This involves research being conducted in educational settings such as (but not limited to) schools, colleges, day schools or any other site where educational activities normally occur. The research study should be instructional in nature with the research procedures conducted in a manner typical to the situation. In other words, would the investigator normally carry out this activity or practice regardless of research intention? If so, the research may fall under this category. However, if the research involves any activity, procedure or practice that involves a novel approach (e.g. comparing a new study approach to an established practice) will NOT qualify as Exempt under this category.
In addition, it is important for investigators to note that to qualify as human subject research under Exempt category (1) the data collected are intended for presenting or publishing and not for internal use only.
Some examples of Research under Category (1):
- An investigator at X Medical Center wants to determine the effectiveness of an interactive anatomy/physiology DVD used to help medical students study for exams. This CD-rom is established course material for X Medical Center.
- A research study evaluating the effects of a health literacy curriculum on first-year physician assistant students.
- A research study involving an anonymous survey of students and faculty regarding the need for basic research training in medical school curriculum.
(2) Research that only includes interactions involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
(i) the information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(ii) any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement or reputation; OR
(iii) 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, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
The key point here is the “OR” in this category subsection. In order to qualify for this category, only one of the criterion needs to be met.
- The investigators must still provide an appropriate data security plan to manage any potential informational risks involved with the study.
- The information collected/used in the research activities MUST NOT place the subject at harm. Harm does not necessarily mean physical harm but can encompass the risk of losing employment or criminal/civil liability, or risk of damaging subject’s financial standing or reputation. Therefore, harm to subject can involve informational risk. Breach of confidentiality or accidental disclosure of subject responses or information can potentially lead to an unwanted outcome.
The following are examples of Research under Category (2):
- Purpose of the study is to survey women at a local hospital regarding their knowledge and attitudes of the Human Papillomavirus (HPV) Vaccine. The anonymous survey contains non-sensitive questions and no personal identifiers are requested.
- A research project interviewing subjects about the influence of religion on their health (no personal identifiers requested).
- Surveying parents regarding parental awareness and understanding of over the counter products containing Acetaminophen (Tylenol) in children under the age of 5. The anonymous survey contains no personal identifiers.
Note: Many studies at UNTHSC fall under this category.
- A longitudinal survey that evaluates adult eating habits within a stressful work environment (investigators will need to retain contact information in order to follow-up with subjects in a year).
(3)(i) 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 tot he intervention and information collection and at least one of the following criteria is met:
(A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(B) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
(C) 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, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7)
(ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
(iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
The following are examples of Research under Category (3):
- Subjects play an online game
- Subjects solve puzzles under various noise conditions
- Subjects decide how to allocate a nominal amount of received cash between themselves and someone else
(4) Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
(i) The identifiable private information or identifiable biospecimens are publicly available;
(ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
(iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
- Research on publicly available data (i.e. National Health Interview Study) qualifies for Exempt under this category. Data must be easily accessible to all, not just to a limited few.
- Data collected from documents, records or specimens must be used and analyzed in a manner that maintains the subject’s confidentiality.
The following are some examples of Research under Category (4):
- A study analyzing data in an already existing de-identified database to evaluate the relationship between BMI and healthy behaviors.
- A research study examining which demographic variables are strongly associated with disability in elderly Hispanics by using the publicly available (de-identified) 2006 National Health Interview Survey (Center for Disease Control).
- A research project involving a retrospective chart review examining pattern of symptoms for X disease. No master list is needed to carry-out the study; and no follow-up visits or future chart reviews will occur.
Note: Most studies at UNTHSC fall under this category.
- A project which involves both prospective and retrospective chart review (for data which have been or will be collected for some other purpose), and the investigators will keep a master list for follow-up reviews of the medical records.
(5) Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
This category applies to federal driven/sponsored research projects. Programs doing research studies under the Social Security Act, Department of Health and Human Services, any Secretary belonging to the Federal Departments, or any other federal statutory public benefit/services qualify for Exempt under this category.
The following are some examples of Research under Category (5):
- Department of Health and Human Services wants to conduct a study analyzing the effectiveness of various government sponsored programs in decreasing obesity in the United States.
- A researcher sponsored by the Department of Agriculture- Food and Nutrition Service wants to compare the current use of the Supplemental Nutrition Assistance Program (i.e. food stamps) by Americans compared to ten years ago.
- The Department of Justice wants to conduct a research study analyzing the effectiveness of their National Public Awareness Campaign part of the Project Safe Childhood to minimize sexual predators over the internet.
(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
To qualify for Exempt under subsection (i), the research study must involve food products with no additives (wholesome).
Any additive used in the research study must have been already deemed safe by the Food and Drug Administration (FDA) prior to IRB review. If the research study is preliminary in nature and being done to receive FDA approval, it will NOT qualify as Exempt.
The second subcategory exempts research studies involving food ingredients or additives that have been determined as safe (GRAS-generally recognized as safe) or effective (GRAE-generally recognized as effective) by the FDA.
- This subcategory also allows for research studies evaluating human consumption of food containing safe levels of environmental contaminants. The levels of environmental contaminants must be deemed safe by the FDA, the Environmental Protection Agency, or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
The following are some examples of Research under Category (6):
- A taste-testing study evaluating the differences in taste of various types of apples grown nationally.
- A taste-testing study analyzing the effects of a safe (FDA determined) additive on beef.
- The tasting effects of a low level environmental contaminant on a food product which has been deemed safe by the FDA and EPA.
(7) 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 if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).
(8) 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:
(i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d);
(ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;
(iii) An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.
PLEASE NOTE OUR INSTITUTION WILL NOT BE IMPLEMENTING BROAD CONSENT AT THIS TIME [45 CFR 46.104 (d) (7) & (8)]. back to top
Do research studies involving Children, Prisoners, Pregnant women and Fetuses qualify for Exempt Category Research?
The inclusion of children in a research study can qualify as Exempt under Categories (1) and (4)-(6). For Category (2), ONLY research activities involving educational testing and observation of public behavior where investigators DO NOT participate in research procedures can be considered Exempt. Research involving children engaging in surveys or interviews CANNOT be approved under Exempt category.
Under federal regulations certain studies involving pregnant women and neonates/fetuses may be considered Exempt under Categories (1)-(8). However, these studies must meet the definition of minimal risk and may be subject to full board review, if the IRB Chair deems it necessary.
The inclusion of prisoners in research is NOT considered to qualify for Exempt category research. Federal regulations are specific in regard to prisoner research and the manner to which it must be reviewed. back to top
What do I submit to the IRB for an Exempt Category Research?
This is the simplest and often the quickest process if the following are submitted and the information given is complete and clear. In most cases, review of Exempt category research may take from 1-5 business days. Review time depends on the completeness of the packet and clarity of the information. Submit all documents to the North Texas Regional IRB via IRBNet. Please contact us at 817-735-0409 if you have any questions regarding research submission.
Student investigators must have their advisor or a faculty member sign and date the Exempt application as the principal investigator. Per North Texas Regional IRB policy, a student cannot be the principal investigator.
- CITI certificates for ALL key personnel
- The cover letter (in lieu of informed consent) or informed consent
- Application for a Waiver of Documentation of Informed Consent, or a Waiver of Informed Consent (must meet criteria)
- Any of the data collection tools (e.g. survey, educational tests, etc.)
- Include interview/phone script
- Website address and a page print out for studies involving publicly available data (e.g. National Center for Health Statistics www.cdc.gov/nchs/about/major/nhis/hisdesc.htm)
- Recruitment/advertisement material (flyers, ads, etc.)
- Letter of collaboration or permission and/or approvals from other IRBs
- A waiver of HIPAA authorization for studies involving protected health information (call the IRB for further guidance regarding HIPAA regulations)
How (and When) Will I know that a Protocol has been Approved?
Once a protocol has been reviewed and approved, a formal notification of approval will be sent to the Principal Investigator (and those designated by the PI to receive these notifications in IRBNet).
As soon as the project is approved as “Exempt”, a Letter of Approval from the Office of Research Compliance – North Texas Regional IRB will be sent (through IRBNet) to the Principal Investigator (and those designated by the PI to receive these notifications in IRBNet). back to top
This page was last modified on March 19, 2019