Research & Economic Development

Office of the Vice Chancellor

exempt-well-maybe

Research activities in which the only involvement of human subjects will be in one or more of the exempt categories defined by the Federal regulations, will be given an exempt determination, rather than an IRB approval. Exempt studies are so named because they are exempt from some of the Federal regulations. However, they are not exempt from state laws, institutional policies, or for the requirements for ethical research.

  • Research with prisoners cannot be exempt.
  • Audio/video recording is not considered in the application of these exempt categories and is a permitted activity in most cases.

As of January 21, 2019 with the implementation of the revised Common Rule, the current federally-defined exemption categories for human subjects research(link is external) has changed, with:

  • Modification to most existing categories
  • Expansion in scope to several existing categories
  • Addition of new categories

Exemption Category Changes - Overview

The following lists the high-level changes for each exemption category and identifies the potential exemption review paths at UMKC based on criteria for that exemption category. 

#1 - EDUCATIONAL EXEMPTION

What's New:  A new ineligibility criterion will be added to this interaction/intervention exemption for research that involves possible "adverse effects" on student learning of the required education content and/or on the assessment of educators.

line, colored green, used to divide items in a list of content

#2 - SURVEYS, INTERVIEWS, EDUCATIONAL TESTS, AND OBSERVATION OF PUBLIC BEHAVIOR

What's New: The scope will be expanded to include the collection of sensitive and identifiable data.  However, the following is not allowed:

  • Interventions
  • The collection of biospecimens
  • Linking to additional personally-identifiable data
  • Research with children (except for educational tests or some public observation)

image of a line colored gold, used to separate items in a list

# 3 - BENIGN BEHAVIORAL INTERVENTION (NEW)

A "benign intervention" is defined as one that is brief in duration, harmless, not physically invasive, painless, not embarrassing or offensive, and not likely to have a lasting adverse impact.

What's New:  This new exemption permits data collection via an interaction (e.g., survey, interview, audio/visual recording) from adult subjects with prospective agreement.  However, the following is not allowed:

  • Research with children
  • Deception, unless prior agreement obtained
  • Physiological data collection methods (e.g., EEG; wearable devices, such as FitBitTM; blood pressure monitors)
  • Linking to additional personally-identifiable data

line, colored green, used to divide items in a list of content

#4 - SECONDARY RESEARCH (IDENTIFIABLE PRIVATE INFORMATION/BIOSPECIMENS) 

What's New: The scope of this exemption will be expanded to allow:

  • Prospective data review
  • Maintenance of identifiers, if all study data is protected health information (PHI)
  • Research that is conducted by, or on behalf of, a Federal department/agency or using government-generated or government-collected information obtained for non-research activities

image of a line colored gold, used to separate items in a list

#5 - PUBLIC BENEFIT/SERVICE PROGRAM RESEARCH (FEDERAL DEMONSTRATION PROJECTS)

What's New:  A new eligibility criterion for this interaction/intervention exemption will be that the project must be published on a federal website.

line, colored green, used to divide items in a list of content

#6 - TASTE/FOOD QUALITY EVALUATION & CONSUMER ACCEPTANCE

What's New:  Unchanged

Exempt Categories Table


Category  Federal Definition  Conditions and Examples
 1  

Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. 

(45 CFR 46 101 (b)(1))

 

This category does NOT apply to studies involving surveys, interviews, questionnaires, or focus groups. However, those activities may be covered under category 2 so long as children (under 18 years old) are excluded from those activities.

A normal educational setting and practice may include a cooking class in a grocery store, professional development workshops or skills development in children’s summer camps, etc. It is not necessary limited to primary and secondary public/private educational settings.

“A study that involves evaluation of radically new instructional strategies or use of random assignment of subjects to different instructional methods is usually not exempt because the methods employed in the studies deviate from normal educational practice” (Prentice & Oki, 2006).

This category may NOT apply to research on physical education on exercises that have been significantly altered or pose a level of risk to participants (Prentice & Oki, 2006).

Studies involving deception will not be considered under this category because deception is not a “normal educational practice.”

 2  

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met: 

(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; 

(ii) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or 


(45 CFR 46 101 (b)(2))

 

This category does NOT apply if the research involves surveys or interviews with minors (under 18 years old).

This category only applies to observations of public behavior involving children if study team members do NOT participate in the activities being observed.

Observations must be of a public behavior and in a public setting. Classrooms and medical settings are not considered public.

If 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 AND the data are completely anonymous, this category may apply.

Studies qualifying for an exemption in this category may NOT include any tasks used to supplement or help to inform procedures in this category including watching a video, looking at pictures, or listening to an audio file.

 3  

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met: 

(A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; 

(B) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation;


(45 CFR 46 101 (b)(3))

     

A "benign intervention" is defined as one that is brief in duration, harmless, not physically invasive, painless, not embarrassing or offensive, and not likely to have a lasting adverse impact.

What's New:  This new exemption permits data collection via an interaction (e.g., survey, interview, audio/visual recording) from adult subjects with prospective agreement.  However, the following is not allowed:

  • Research with children
  • Deception, unless prior agreement obtained
  • Physiological data collection methods (e.g., EEG; wearable devices, such as FitBitTM; blood pressure monitors)
  • Linking to additional personally-identifiable data
 4 Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: 

(i) The identifiable private information or identifiable biospecimens are publicly available; 

(ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; 

(iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or 

(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.


(45 CFR 46 101 (b)(4))
 

The scope of this exemption will be expanded to allow:

  • Prospective data review
  • Maintenance of identifiers, if all study data is protected health information (PHI)
  • Research that is conducted by, or on behalf of, a Federal department/agency or using government-generated or government-collected information obtained for non-research activities

Determination is required; however, if PHI is used then a Privacy Board review (HIPAA) is conducted with the Determination.

 
 5  

Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

(45 CFR 46 101 (b)(5))

 

A program must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act).

The research or demonstration project must be conducted pursuant to specific statutory authority.

There must be no statutory requirement that the project be reviewed by an IRB.

Rarely applicable to research at OSU.

 6  

Taste and food quality evaluation and consumer acceptance studies, if:

a) wholesome foods without additives are consumed, OR

b) 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))

 

The food must be wholesome with no additives, OR

The consumed food ingredients must meet federal agency safety standards for amount and type.

Research under this category must be evaluating taste, food quality, or consumer acceptance. Other types of research involving food will be reviewed by the expedited or full board procedure.


What process is followed for an exempt review?

If your research meets criteria that qualify for an exempt review, you must submit an application for exemption. To apply for an exempt review, the Principal Investigator must submit a complete application to the Research Compliance Office through the eProtocol system. This includes all supporting documentation such as:

  • Protocol
  • Exempt Research Information Sheet (consent form)
  • Surveys or interview questions
  • Test forms
  • Subject screening forms
  • Recruitment materials (posters, phone scripts, etc.)
  • Letters of agreement, or other supporting documentation to assure the IRB that appropriate coordination has been done with outside organizations or institutions (clearances to perform research or distribute surveys, etc., at any facility or institution where the research will be conducted).
Click here for the Questions on an Exempt Application

Does your research or project qualify for an “Exempt” determination?


All Research Activities Must Fit Within Six Federal Categories

For a study to be eligible for exemption all of the research activities must fit in one or more of the six categories.

Risk Assessment Considerations

Research eligible for exemption usually involves little or no risk to subjects. Some determinations apply the “minimal risk” standard when conducting exempt determination. When determining “minimal risk” all the risks associated with the study must be identified. Department of Health & Human Services defines “minimal risk” to mean “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(2)(i)].

Exemption Applications that Do Not Meet the Definition of Human Research

The exemption process is further complicated because occasionally an activity that is sent to the Research Compliance Office for an Exempt Determination does not meet the federal definitions of “research”, “human subject” or both.

In analyzing whether activities involve human subjects research, it is important to focus on the federal definitions of “human subject” and “research”. 

Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

  • Intervention  includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.  
  • Interaction includes communication or interpersonal contact between investigator and subject.
  • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record).
  • Identifiable Private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information..

Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.