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) survey, interview, observation of public behavior or Category (4) collection or study of existing data. 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, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
45 CFR 46.101 (b) (1)
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 involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
45 CFR 46.101 (b) (2)
The key point here is the “AND” in this category subsection. This means that a study using educational tests, survey procedures, interview procedures or observation of public behavior CANNOT identify subjects AND the responses or information disclosed CANNOT place the subject at harm. Special consideration must be made when designing the research protocol to maintain the data de-identified and confidential, and that the procedures/information will not harm the subject to be eligible for this Exempt category.
- Data collected from the educational tests, survey or interview procedures must be obtained in a manner that the subject cannot be identified. Anonymous surveys may not directly identify subjects but consider other identifiers asked. Depending on the subject sample size, a combination of demographic or other identifiers (found in subject’s responses) could indirectly link the subject to the data.
- 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.
(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under category (2), if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
45 CFR 46.101 (b) (3)
- This category allows for the inclusion of those research studies which did not fall under category (2) because of the collection and use of identifiable data. However this category ONLY applies to research studies involving subjects who are elected or appointed public officials, candidates for public office. Investigators can report identifying data such as participant’s name or survey responses and still qualify as exempt. “Public‘s right to know” allows for officials’ identifiable data to be disclosed.
- The second part of this category addresses all data including personal identifiers collected from educational tests, survey procedures, or observation of public behavior are protected under federal statute(s) throughout the research and after completion. Investigators must maintain confidentiality at all times. Projects that usually fall under this subsection are specific to federal programs conducted or supported by the Department of Justice or the National Center for Education Statistics of the United States Department of Education.
The following are some examples of Research under Category (3):
- A survey administered to Texas mayors that contain questions regarding their stance on illegal immigration as Texas is one of the leading states with illegal immigrants.
- A survey supported by the Department of Justice questioning about Homeland Security.
- Observing body language of appointed judges in North Texas during criminal cases to see if judges have a (subconscious) inclination for a defendant or prosecutor during the trial.
(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
45 CFR 46.101 (b) (4)
Documents, data, records, or specimens being used for the study must be in existence prior to ORC review.
- 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.
- Biological or pathological specimens and/or data obtained prospectively DO NOT qualify as Exempt under this category. For example, a research protocol calls for an investigator to receive a week later a blood sample taken during an anonymous patient’s physical exam. This does not qualify as an existing specimen because it was collected during the research period and does not fall under Exempt.
- Data collected from documents, records or specimens must be used and analyzed in a manner that subjects cannot be identified (anonymous). Research studies needing to keep a master’s list of existing data for continuous access may not qualify as exempt.
- For example, if an investigator needs to keep a master list of patient’s name, date of birth and patient’s number for a month in order to access their medical record, this study may not qualify as Exempt. The master list can directly link a subject to their medical information compromising confidentiality.
- ALL aspects of research activities must involve EXISTING data, specimens, and records. A combination of prospective and retrospective elements (i.e. comparison research study) will not qualify as Exempt.
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.
(5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
45 CFR 46.101 (b) (5)
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.
45 CFR 46.101 (b) (6)
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. 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 (3)-(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)-(6). 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.
- The original SIGNED and dated Exempt review application
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)
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 located in Center of BioHealth (CBH) Suite 160, 3500 Camp Bowie Fort Worth, TX 76107. Please contact us at 817-735-0409 if you have any questions regarding research submission. back to top
How (and When) Will I know that a Protocol has been Approved?
Once a protocol has been reviewed and approved, a formal written notice of approval will be sent to the Principal Investigator.
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 to the Principal Investigator. back to top