Institutional Review Board (IRB) - Exemptions
The federal regulations identify categories of research methods that can be exempted from IRB review. These categories imply that the protocol is minimally risky and certain aspects of the study do not require the Board's continuous review. This section describes the categories in the federal regulations that specifically relate to the social and behavior sciences and highlights some of the qualifications a protocol must meet in order to satisfy the requirements for common exemptions in Social and Behavioral Sciences:
- Normal Educational Practice
- Educational tests, survey procedures, interview procedures, observation of public behavior
- Archival Data
Why do I submit an exempt protocol?
If a protocol is exempt from IRB review, why does the IRB still review it? In order to determine if a protocol meets the requirements for exemption, a neutral third party experienced in IRB review needs to make this determination and the IRB is equipped to make such a review. Some exempt studies involve participants that are considered risk-sensitive, so it is important that these studies still receive a careful review even if they are ultimately considered minimally risky. An exempt protocol goes through the same pre-review process as an approved study. Our experienced staff often receives protocols that are not exempt but could be if a few changes are made to the study protocol. We work with researchers to help them meet the requirements for exemption where possible by reducing risks, thus saving time and future hassle for the researcher while still protecting participants.
Comparing exempt protocols with full board protocols:
Shorter review time: Exempt protocols go through our expedited review process. An exempt protocol is reviewed by a pre-reviewer and then sent to a Board Member, who gives the final designation of exemption. On average the review can take two weeks, though this can depend on the number of protocols in the queue. A protocol that needs full board review usually requires at least one month for review. For more information about the review process, please see Submission: Review.
Researchers are required to complete the Application for Exemption rather than the Protocol Summary. All other submission requirements are the same.
Modified consent requirements: If a protocol is exempt, the Board does not have to require the researcher to consent participants; however, in many cases, providing the information on a consent form is advisable. If a study is granted exemption from IRB review, the Board determines if consent is necessary. For some exempt studies, consent is generally not necessary. Anonymous archival data, for example, does not require consent, though it usually requires permission from the data's owner to access the data. Anonymous data collection such as using a blind survey does not require consent, but the Board may require that you provide an information sheet explaining the purpose of the study, how the data will be used, and stating that the data are anonymous (for a model of an information sheet, use the General Consent Template and simply remove the signature section at the bottom). Collecting consent documentation in this case would hamper the benefits of collecting the data anonymously. However, providing basic information about the study in the instruction sheet may make the participants feel more comfortable about participating.
No continuous review: Exempt protocols are given a five year "open protocol" status. During that time, our office will contact you once per year via email to find out if you are still collecting data, etc, to which you need only respond. If the exempt study will continue beyond five years, you will be asked to resubmit the protocol with an explanation of the current status of the study.
Categories of Research Eligible for Exemption
- 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. (See more detailed guidance below).
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior3, 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. (See more detailed guidance below)
- 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 paragraph (b)(2) of this section, 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
- 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. [Note: to be eligible for this exemption, all data, documents, records or specimens must exist prior to IRB review and must have been collected for purposes other than the proposed research. To qualify for an exemption in this category, the proposed research must be strictly retrospective.]
- Research and demonstration projects which are conducted by or subject to the approval of department or agency heads. The program must deliver a public benefit or service (e.g., Social Security Act or Older American Act). Such research or demonstration projects must be conducted pursuant to specific federal statutory authority; there must be no statutory requirement that the project be reviewed by an Institutional Review Board and the project must not involve significant physical invasions or intrusions upon the privacy of participants.
- 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 (FDA) or approved by the Environmental Protection Agency (EPA) or the Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA).
Guidance Related to Common Exemption Categories for Social and Behavioral Sciences Research
Educational Tests, Survey Procedures, Interview Procedures, Observations of Public Behavior
In most cases, studies that use the above instruments or procedures to collect data are considered minimal risk studies. The main factor for reducing risk in the studies is that the data are anonymous, thus reducing the most common possibility for harm. Anonymous studies are studies where the participant's identity cannot be linked to their study data.
The federal regulations list the following as situations where exemption cannot be granted:
- 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.
Studies that involve elected or appointed public officials or candidates for public office (using the above instruments and/or procedures) can also be considered for exemption if they do not already qualify under the other designations.
Signed consent is generally not required for studies that involve surveys, observations, educational tests, and interview procedures. Documenting consent via a signed consent form may be the only link between the participant and the data which would thus make the data not anonymous. However, the Board generally requests that you provide some level of instruction to the participants to inform them about the study. This information, for example, could be provided as part of the instructions for survey, covering topics such as the purpose of the study, how long it will take to complete, and assuring the participant that the data are anonymous.
Classroom Observations, Educational Tests, Interviews, and Surveys
Observations in education research generally involve observing classrooms while instruction is being given. The classroom setting is not considered public and will require some level of consent, depending on who is the subject of the observation. If you are only collecting data on the teacher, then you will need to include this activity in the teacher consent form. Although you may observe the interaction of the teacher with the students, only the teacher's identity can be collected (i.e. Mrs. Smith answered student 1's question...). If you need to conduct more detailed observations of the students, it may be considered exempt if the observation protocol is justifiable as normal educational practice. You should describe your observation to the parents in the parental notification you send home. However, if the Board does not deem it normal educational practice, and therefore decides it does not qualify for exemption, you will need to apply for expedited or full board approval and may be required to obtain both parental consent and student assent to observe the student. If the observations are going to be recorded beyond field notes, you will need to consider media use issues, such as a Materials Release Form. Please see the Media Guide for more information.
As noted below, educational tests may qualify for exemption in classroom settings, but surveys and interviews involving children do not (except in the case where they are considered normal educational practice). In addition to federal regulations regarding research in classrooms, there are additional state and federal regulations as well.
Additional instances where a protocol would not be exempted:
- For studies involving minors, please note that only educational tests qualify for exemption. Observation of public behavior can be exempt if the researcher does not participate in the activities being observed. However, all other observations, interviews and surveys of minors will likely require parental consent and minor assent. The only exception to this rule is if the observations, interviews, and surveys are considered normal educational practice.
- The research has the potential to be more than minimal risk for a participant. For example, if an interview or survey involves questions that might upset a participant, the Board may decide that the protocol does not qualify for exemption because it is more than "minimal risk."
- Observational research involves sensitive aspects of subjects' behavior, or is in settings where subjects have a reasonable expectation of privacy.
- Research involves prisoners.
Archival data are any data that are collected prior to the beginning of the research study. The data contains information that can be linked to individuals (though not necessarily to the individual's identity), otherwise it is not considered human subjects research and does not qualify for IRB review. The data are also the primary source (versus a secondary source where the data was analyzed for another publication). The federal regulations allow for IRB's to exempt research using archival data when certain conditions exist, including stripping a participant's identity from the data, so often we talk about archival data from an exemption perspective. However, there are conditions where archival data is not considered exempt. In order for the Board to assess the risks to the participants through the use of archival data sources and make recommendations for ethical use of the data, they will need to know the following:
- How did you obtain access to the data? The Board will need to know if the data are publicly available or if there are restrictions for accessing the data. If the second is true, the Board will need to know how you obtained permission to access the data and you will likely need to complete a "Coded Data Agreement"
- What do the data consist of? The Board will need to know if you are using data sets, video tapes, audio tapes, journal entries, transcripts, etc. If you are using data sets, they will need to know what data fields you will use.
- Can the participants be linked to their data? The Board will need to know in what form you receive the data. Can the data be de-identified? Are the data linked and stripped of identifiers? Who prepared the data for you? Will you merge multiple data sets?
The first two questions are generally determined by the data's source. Archival data generally falls under the following categories:
- Publicly available data sets
- Private data sets
- Private records
In order to answer the final question, it is important to understand what an identifier is and to understand how the data were collected. In addition, there are specific rules for using archival data in an educational setting, particularly in regards to using student records. Please see Education: Archival Data for more information.