Exempt Research
Six categories of research may qualify for exempt status. In order to be considered exempt, the research must present very little, if any, associated risk.
An exemption means that the research does not need to meet certain regulations and requires less ongoing oversight by the HPRB.
Only the HPRB has the authority to determine whether research involving human subjects is exempt from full review. Exemptions are not guaranteed and may be denied by the HPRB, if warranted. Certain kinds of research are never eligible for exemption (i.e., FDA-related research and incarcerated persons).
The six categories of exempt research include:
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.
Category 1 applies to research utilizing normal educational processes only, such as comparing the effectiveness of a particular curriculum.
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.
That is, the research must be anonymous and minimal risk (and in one of the categories listed in the first sentence).
Research with minors may only be considered for this category if the investigator is observing public behavior and not participating in the activities being observed.
Not all interviews require HPRB review. For example, if a historian is interviewing a holocaust survivor about her memories and how it impacted her life it is not research because it is not generalizable knowledge and hence not “human subject research.” However, if the researcher is researching several holocaust survivors regarding their experience and how it impacted their subsequent relationships, it would probably be categorized as generalizable knowledge thus requiring IRB review and approval.
Note that if a task is involved in addition to the survey or interview, this makes a study ineligible for Category 2. Activities that are simply part of answering the survey or interview, such as writing responses, will not be considered tasks.
Examples of tasks include:
- asking participants to physically manipulate an object (not including asking subjects to click through survey or use a pencil to write survey answers, etc.)
- asking participants to play a game
- asking participants to complete a specific physical action
- manipulating whether a participants’ thoughts, emotions, behaviors, or performance can be manipulated or changed by activities.
Examples of activities that are typically not considered tasks:
- Asking participants to reflect on their thoughts about a topic
- Asking participants to respond to an essay prompt.
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 participants 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.
Research involving the collection or study of existing data, documents, records, pathology specimens, or diagnostic specimens, if:
- these sources are publicly available OR
- the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the subjects.
In order for the data to be analyzed as “existing,” it must have been collected prior to HPRB review. Examples include analysis of existing medical records, data collected from previous studies, or audio recordings that were collected for a purpose other than research.
In order to be considered human subject research, the existing data must include private information. If a data set is accessible to the public without special permissions, such as some portions of U.S. Census data, the data available is not private and thus would not need to be reviewed by the HPRB.
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.
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.