“Exempt” research are human subjects studies that present no greater than minimal risk to subjects and fit into one or more exempt categories. Research that qualifies for an exempt determination do not have the same federal requirements for research found in expedited or full board review. However, investigators still have a responsibility to protect the rights and welfare of their subjects, adhere to UMBC procedures, and conduct their research in accordance with the ethical principles described in the Belmont Report.
These definitions are based on the Revised Common Rule that went into effect July 18, 2018. Many for the details are information courtesy of and extracted from the of the Office for Protection of Human Subjects, University of California, Berkeley, https://cphs.berkeley.edu/exempt.pdf
Category 1 – Education research
Research conducted in established or commonly accepted educational settings, involving normal educational practices that are not likely to adversely impact students’ opportunity to learn or assessment of educators who provide instruction such as:
- research on regular and special education instructional strategies; or
- research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods.
Additional information:
Commonly accepted educational settings include but are not limited to K-12 schools and college classrooms. They may also include after-school programs, preschools, vocational schools, alternative education programs, and other sites where educational activities regularly occur.
Normal educational practices include established teaching methods, curriculum content, commonly accepted classroom management techniques that are planned and implemented by the classroom teacher, and, on a case-by-case basis, projects conducted with teachers for professional development purposes. Normal educational practices are activities that would occur regardless of whether the research is conducted.
Examples include:
A study evaluating the effectiveness of a commonly accepted science curriculum. For the study, researchers will observe classroom instruction and collect quizzes and class evaluations that are part of the curriculum and classroom practices.
A study comparing two curricula that are currently being implemented in a school. Researchers will observe classrooms as well as interview instructors about their experiences implementing the instructional materials (but not about specific students).
Category 2 – Surveys, interviews, educational tests, public observations
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior if:
- Recorded information cannot readily identify the subject (directly or indirectly/linked) or
- Any disclosure of responses outside of the research would NOT reasonably place subject at risk (criminal, civil liability, financial, employability, educational advancement, reputation)
Additional information:
This exempt category applies only to interactions involving the activities listed above (research involving interventions may not be reviewed under this category). 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 public plaza or park, a street, a building lobby, a government building).
Research involving surveys or interviews with children or observation of public behavior when investigators interact with the children does not qualify for exemption.
Examples include:
Surveying teachers, nurses, or doctors about a technique or an outcome
Interviewing managers about a management style or best practice
Conducting a focus group about an experience or an opinion of a community program
An observational study of pedestrians crossing a street; the researcher takes notes of what occurs, recording sex, race, and type of clothing of pedestrians, but does not interact with subjects.
Category 3 – Benign Behavioral Interventions
Research involving benign behavioral interventions by obtaining verbal, written responses, (including data entry or audiovisual recording) from adult subjects who prospectively agrees and meets ONE of following:
- Recorded information cannot readily identify the subject (directly or indirectly/linked) or
- The disclosure of responses outside of the research would NOT reasonably place subject at risk (criminal, civil liability, financial, employability, educational advancement, reputation)
Additional information:
Benign behavioral interventions are brief in duration (should last a few minutes to a few hours), 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. While it does not have to occur in a single session, the entire time for the intervention should occur on a single day and not exceed a few hours in its entirety. Deception under this category is not allowed unless the participant prospectively agrees.
Examples include:
Solving puzzles under various noise conditions taking about two hours
Playing an online game taking about 30 minutes
Taking part in two 2 hour-long assessments of memory, attention and information processing speed before and after 1 hour of cognitive enhancement exercise using specially designed computer software.
Category 4 – Secondary Research Uses of Identifiable Private Information or Identifiable Biospecimens where Consent is not Required
Research using secondary sources with identifiable Information/specimens collected for some other initial activity may be performed provided at least one of the criteria are met:
- the sources are publicly available
- the Information is recorded so subject cannot readily be identified (directly or indirectly/linked); investigator does not contact subjects and will not re-identify the subjects
- the information is collected by or on behalf of federal government using government generated or collected information obtained for non-research activities
Additional information:
This data must be recorded in such a way that the information can no longer be connected to the identity of the subjects (although investigators may initially have access to private identifiable data). When data is abstracted for use, there cannot be direct identifiers (names, social security numbers, addresses, phone numbers, etc.) or indirect identifiers (codes or pseudonyms that are linked to the subject’s identity). Investigators must have the ability to abstract/record the data in such a manner before proceeding with a protocol submission. The terms and conditions of use from the data source or in the original research consent document may impact the application of this exemption. Be sure to describe these specifics in the protocol application.
NOTE: The use of publicly available, de-Identified sources of data would not require an IRB application.
The collection and analysis of protected health information (PHI) and personally identifiable information is not allowed under this exempt category. This study would likely fall under an Expedited Category #5 and would require a data use agreement (DUA).
Category 5 – Not implemented at UMBC
Public Benefit / Service Program Research
Category 6 – Taste and food quality evaluation studies
Research that poses no more than minimal risk to participants and involves “taste and food quality evaluation and consumer acceptance studies” where:
- wholesome foods without additives are consumed or
- 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.
Examples include:
Taste-testing different types of fruits or vegetables in order to determine consumers’ preference
Examining a consumers’ preference among three different types of chewable vitamins
Category 7 – Not implemented at this time
Storage or maintenance for secondary research for which broad consent is required.
Category 8 – Not implemented at this time
Secondary research for which broad consent is required. Research involving the use of identifiable private information or identifiable biospecimens for secondary research use.