LSUHSC-NO Institutional Review Board
Federal Wide Assurance 00002762 IRB Registration # 00000177
Information Sheet - Exempt Research Categories
This is not a fillable form. It is an explanation of categories to assist in the planning and preparation of research applications. Investigators do not have the authority to determine whether research involving human subjects is exempt from full review as stated in 45CFR46.101(b) and (c) or 21CFR56.104(c) and (d). Research that involves only minimal risk to human subjects may be exempt from full board review, however, it is still subject to IRB review. Researchers must file an application. The determination will be made by the IRB Chair.
DEFINITIONS OF CATEGORIES
Category 1- Research conducted in established or commonly accepted educational settings, involving normal educational practices.
Established or commonly accepted educational settings Normal Educational Practices
K-12 and college classrooms. This term may also apply to after school programs, preschools, day care centers, vocational schools, or alternative education programs which are affiliated with K-12 schools or colleges.
Research on regular and special education instructional strategies or research on the effectiveness of or the comparison of instructional techniques, curricula, or classroom management methods. That includes curriculum or instruction that is planned and implemented by the classroom teacher. It may also include surveys or tests that teachers commonly give to measure the effectiveness of an educational practice. Any material, intervention, activity, etc. suggested or implemented solely by the researcher is NOT considered to be a normal educational practice.
Researchers must seek prior approval from the specific school or school district before applying to the IRB. Documentation of approval from the site(s), on their letterhead must be submitted with the IRB application.
Parental Permission, Informed Consent and Assent regulations apply.
Project Description for Category 1
In the application form in the activities section:
1. Describe what research activities will take place.
2. Will the activity/activities occur during class time or outside of class time ?
3. Implementation of a novel educational method (Describe how it differs from the standard method
4. Testing Frequency
5. Review and collection of student grades and standardized test scores
6. Observing and recording data on the teacher
7. Observing and recording data on students
8. Is the educational activity itself part of your research or will the activity occur regardless of whether you are conducting research or not?
9. Describe what non-participants will do during this period (activities and supervision)
The study design cannot penalize students who will not be participating if not all students will be participating.
Category 2 - Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior *, unless:
Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
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.
*Public behavior refers to behavior taking place in a publicly accessible location in which the subject does not have an expectation of privacy (e.g., a sports arena, a public plaza or park, a street, a building lobby, a government building). If subjects have a reasonable expectation of privacy at the location where the researcher is conducting the observation, the project may not be considered exempt.
The data is collected anonymously (which means that no identifiers can be connected to the data, either directly or through a coding system). Any data collection that involves audio recordings, video recordings, or photographs of subjects would not be considered anonymous. It is also possible that multiple pieces of information, none of which are identifiable on their own, may uniquely identify a person when brought together; in this case, the data would be identifiable and would not be considered anonymous.
The information collected is not anonymous (because, for example, the researcher has a key linking respondents’ names to coded identifiers), but the information is so innocuous that, in the event of disclosure outside of the research, there would be no significant detrimental consequences to the subject. The significance of “detrimental consequences” depends in part on context.
Note: Surveys on extremely sensitive or personal topics which may cause stress to study participants are not eligible for exempt IRB review.
Only the section of this category pertaining to standardized educational tests may be applied to research involving children. This category may also apply to research with children when the investigator observes public behavior but does not participate in that behavior or activity.
Note: This section is not applicable to survey or interview research involving children.
Project Description for Category 2
The description and methods section of the application must discuss the following issues as they relate to the type of research in this category:
Indicate how the information regarding research on standardized tests will be obtained
Researchers must make every effort to make surveys anonymous especially if sensitive questions are asked. The consent form must clarify how anonymity will be accomplished.
The consent must provide information on where to seek counseling if applicable.
A signed consent form is not required for this category however consent should be obtained verbally or through participation such as returning the survey. An explanation of the study may be done through a general introduction to the participants before the workshop, training or focus group begins. A consent form can be provided to individuals. No signature lines should be on that form.
Examples of Category 2 Research:
Surveying librarians, teachers or nurses about a technique or outcome
Interviewing project managers about best practices in constructing highways
Conducting a focus group regarding a community program such as the Library Bookmobile Service to nursing homes or asking opinions about their experience using the Main Library
On game day asking sports fans if they dress in team colors for every game and if they have different outfits for the “playoffs” and their need for fan shops.
A study involving focus groups with expectant mothers regarding their perceptions of comforting techniques for fussy newborns
When survey procedures involve sensitive questions, there should be provisions to make sure that the procedure provides anonymity. If anonymity is promised, there must be a clear explanation of how this will be accomplished.
The consent form must provide information on how to obtain counseling if there are sensitive or distressing questions asked.
Category 3 Research using Educational Tests, Survey Procedures, Interview Procedures or Observation of Public Behavior (Public Officials)
The activities are the same as Category 2 except that public officials are the subjects.
Category 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
Existing Data is information that is on the shelf at the time of application, often referred to as retrospective.
*Public use data sets can be found in libraries and are also posted on the Internet. This includes de-identified data sets prepared by other investigators such as SEER. Other public data sets are the National Center for Health Statistics and the Bureau of the Census.
Examples of Category 4 research using public data sets:
Housing density and available housing for the elderly
Zipcodes most heavily prone to flooding.
Exempt Chart Review Studies [45CFR46.101] A review of existing records may be considered exempt if the records are collected without identifiers or a link to identifiers. There can be no method for re-linking the data to a subject at a later date. The review must be done by the investigator who would normally have access to the records as part of the patient’s routine clinical care. Access can be performed but recording identifiers or maintaining a link will require an expedited application.
A de-identified electronic record search requested through normal hospital/clinic channels could be approved under this category. The data set must be provided per HIPAA regulations for research use of PHI.
The research plan for the Chart Review must be submitted as part of the application whether it is Exempt or Expedited.
Existing Tissue Definition
Waste Tissue cannot have any patient identifiers attached. Pathological or diagnostic specimens must have been previously stored. Specimens must be in existence prior to the submission of an application for Exempt Research.
Category 5 Not Available – Restricted to Federal Agencies
Category 6 Category (6) Taste and food quality evaluation and consumer acceptance studies
As a reminder the following items must be considered prior to submitting an application for the Exempt pathway
Screening Questions to assist in determining if the application can be considered as Exempt
For research involving special populations or interventions
Does your research:
Surveys of children or interviews with children
Interaction with children during observational research
Does the research data collection involve:
Videotape, audio recording, or photography that could potentially place an identifiable subject at risk
Recording of information about illegal activities
Recording of information about identifiable subjects that would embarrass them or place them at social, financial or emotional risk
If the answer to any of these questions is yes, the project does not qualify for Exempt Status
Examples of non-research activities that may not require human subjects’ protection oversight by the IRB include:
Quality Assurance Activities
Literature searches at the library
Public forums regarding neighborhood development or land use
Interviews regarding waste management, transportation, crime
Literacy programs such as “Each One Teach One”
Evaluation of programs such as “Angel Food” or the Box Project
This determination of “non-research” is conducted by the Chair of the IRB. Information can be forwarded to the IRB through email to start the evaluation of research/non-research. This is not the same as a determination of exempt research.
Use the Exempt Application Form and submit the hard copy as directed on the application for consideration of the protocol.