Exempt Categories

To be classified as exempt, the research:

1. Must involve only procedures or be a type of research study listed in one or more of the exempt categories (see exempt categories sections below);
2. Cannot involve any of the exceptions for the exempt categories for research that involves children ;
3. For studies subject to pre-2018 Common Rule requirements:
   1. The study cannot involve prisoners as research subjects.
   2. Cannot be greater than minimal risk. “Minimal risk means that 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(i)(Pre-2018 Requirements).
4. For studies subject to the Revised Common Rule (2018 Requirements):
   1. The study cannot involve prisoners unless the research is aimed at involving a broader subject population that only incidentally includes prisoners.
   2. For exempt categories that require limited IRB review, the IRB must conducts a limited IRB review to make the determination required by the exemption.

Currently, MSU does not plan to use the Revised Common Rule (2018 Requirements) Exempt Category 7 or 8.

Submission to the MSU Human Research Protection Program for an exempt determination is required. See What & How to Submit: Exemptions and Review Process: Exemptions for submission help. Also see HRPP Manual 8-1, Exemptions.

Revised Common Rule (2018 Requirements) Exempt Categories

Unless otherwise required by federal department/agency, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt:

• Exempt 1. Research conducted in established or commonly accepted educational settings, involving normal educational practices.

  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.

• Exempt 2(i). Research involving the use of educational tests, survey procedures, interview procedures or observation of public behavior and information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained.

  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 the following criteria is met:

  • 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.

  Research Involving Children
  Research involving children cannot be classified as exempt under this category if the research involves survey, interview procedures, or observations of public behavior when the investigator participates in the activities being observed.
  
  Research involving children can be classified as exempt under this category if the research involves only educational tests and / or observation of public behavior where the investigator does not participate in the activities being observed and meets the other conditions of the exempt category.

• Exempt 2(ii). Research involving the use of educational tests, survey procedures, interview procedures or observation of public behavior and disclosure of subjects' responses outside research would not reasonably place the subjects at risk.

  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 the following criteria is met:

  • 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.

  Research Involving Children
  Research involving children cannot be classified as exempt under this category if the research involves survey, interview procedures, or observations of public behavior when the investigator participates in the activities being observed.
  
  Research involving children can be classified as exempt under this category if the research involves only educational tests and / or observation of public behavior where the investigator does not participate in the activities being observed and meets the other conditions of the exempt category.

• Exempt 2(iii). LIMITED IRB REVIEW REQUIRED. Research involving the use of educational tests, survey procedures, interview procedures or observation of public behavior and information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained and disclosure of the responses outside the research could reasonably place the subjects at risk.

  LIMITED IRB REVIEW REQUIRED

  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 the following criteria is met:

  • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

  Limited IRB Review Criteria
  The IRB must conduct a limited IRB review and make the determination that “[w]hen appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.” 45 CFR 46.111(a)(7)(2018 Requirements)

  Research Involving Children
  Research involving children cannot be classified as exempt under this exemption criteria.

• Exempt 3(i)(A). Research involving benign behavioral interventions in conjunction with the collection of information from adult subjects and information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained.

  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 the following criteria is met:

  • 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.

  Benign Behavioral Interventions
  For the purpose of this provision, benign behavioral interventions are brief in duration, 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.

  Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

  Deception Regarding the Nature or Purposes of the Research
  If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

  Research Involving Children
  Research involving children cannot be classified as exempt under this exemption category.

• Exempt 3(i)(B). Research involving benign behavioral interventions in conjunction with the collection of information from adult subjects and disclosure of subjects' responses outside research would not reasonably place the subjects at risk.

  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 the following criteria is met:

  • 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

  Benign Behavioral Interventions
  For the purpose of this provision, benign behavioral interventions are brief in duration, 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.

  Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

  Deception Regarding the Nature or Purposes of the Research
  If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

  Research Involving Children
  Research involving children cannot be classified as exempt under this exemption category.

• Exempt 3(i)(C). LIMITED IRB REVIEW REQUIRED. Research involving benign behavioral interventions in conjunction with the collection of information from adult subjects and information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained and disclosure of the responses outside the research could reasonably place the subjects at risk.

  LIMITED IRB REVIEW REQUIRED

  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 the following criteria is met:

  • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

  Benign Behavioral Interventions

  For the purpose of this provision, benign behavioral interventions are brief in duration, 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.

  Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

  Deception Regarding the Nature or Purposes of the Research

  If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

  Research Involving Children
  Research involving children cannot be classified as exempt under this exemption category.

  Limited IRB Review Criteria

  The IRB must conduct a limited IRB review and make the determination that “[w]hen appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.” 45 CFR 46.111(a)(7)(2018 Requirements)

• Exempt 4(i). Secondary research uses of identifiable private information or identifiable biospecimen - publicly available.

  Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if the following criteria is met:

  • The identifiable private information or identifiable biospecimens are publicly available.

• Exempt 4(ii). Secondary research uses of identifiable private information or identifiable biospecimen - information recorded by investigator in manner that identity of subjects cannot readily be ascertained.

  Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if the following criteria is met:

  • 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.

• Exempt 4(iii). Secondary research uses of identifiable private information or identifiable biospecimen - use of identifiable health information regulated under HIPAA.

  Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if the following criteria is met:

  • The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under HIPAA (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).

• Exempt 4(iv). Secondary research uses of identifiable private information or identifiable biospecimen - research conducted by or on behalf of a federal department or agency using government-generated or government collected information obtained for non-research purposes that will be maintained according to certain federal privacy standards.

  Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if the following criteria is met:

  • 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.

• Exempt 5. Federal demonstration projects.

  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.

  Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

• Exempt 6. Taste and food quality evaluation and consumer acceptance studies.

  Taste and food quality evaluation and consumer acceptance studies:

  • If 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.

• Research Involving Prisoners
  Please note that the study cannot qualify for an exemption if the study involve prisoners, unless the research is aimed at involving a broader subject population that only incidentally includes prisoners.

Pre-Common Rule Exempt Categories

Unless otherwise required by federal department/agency, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt:

• Exempt 1. Research conducted in established or commonly accepted educational settings, involving normal educational practices.

  Research conducted in established or commonly accepted educational settings, involving normal educational practices, 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.
• Exempt 2. Research involving the use of educational tests, survey procedures, interview procedures or observation of public behavior, with exclusions.

  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.

  Research Involving Children
  Research involving children cannot be classified as exempt under this category if the research involves survey, interview procedures, or observations of public behavior when the investigator participates in the activities being observed.
  
  Research involving children can be classified as exempt under this category if the research involves only educational tests and / or observation of public behavior where the investigator does not participate in the activities being observed and meets the other conditions of the exempt category.

   

• Exempt 3. Educational tests, survey procedures, interview procedures, or observation of public behavior not otherwise exempt that involves public officials or federal statute.

  Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt, if:

  • the human subjects are elected or appointed public officials or candidates for public office; or
  • Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
• Exempt 4. Collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens if publicly available or information is recorded by investigator in a manner that subjects cannot be identified.

  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.
• Exempt 5. Federal demonstration projects.

  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:

  • Public benefit or service programs;
  • 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.

  The Office for Protection from Research Risks (OPRR) has determined that the following criteria (see 48 FR 9266-9270, March 4, 1983) must be satisfied to invoke exemption 5:

  • The program under study 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 federal statutory authority.
  • There must be no statutory requirement that the project be reviewed by an Institutional Review Board (IRB).
  • The project must not involve significant physical invasions or intrusions upon the privacy of participants.
• Exempt 6. Taste and food quality evaluation and consumer acceptance studies.

  Taste and food quality evaluation and consumer acceptance studies:

  • if 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.
• Research Involving Prisoners
  Please note that the study cannot qualify for an exemption if the study involve prisoners.

Exempt Category Flexibility Initiatives

When certain criteria are met (e.g. project does not include use of federal funds), a research project that would not otherwise qualify for exempt review through the DHHS or FDA exempt categories may be granted exempt status through HRPP flexibility initiatives.

• Exempt 97. Research involving the study of previously collected identifiable data (ONLY applicable to research NOT FUNDED by a federal department or agency).

  Research involving the study of previously collected identifiable data.The data may include documents or records (but not identifiable biospecimens), unless:

  • disclosure of the data 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.

  This exemption allows the information to be recorded by the investigator in such a manner that subjects can be identified, directly or through identifiers linked to the subjects.

  Exclusions
  To qualify for exemption category 97, the research project must not include any of the following:

  • Federal funding or federal training grants
  • FDA regulated
  • Sponsor or other contractual restrictions
  • Clinical interventions (including clinical behavioral interventions)
  • Prisoners as subjects, unless the research is aimed at involving a broader subject population that only incidentally includes prisoners
  • Receipt of an NIH issued certificate of confidentiality to protect identifiable research data
  • Be a study for which MSU serves as the IRB of record

  If any of the above criteria become applicable to a project determined exempt under this flexibility initiative, the IRB office must be promptly notified prior to implementation of the criteria and the project must be reviewed and approved in accordance with the appropriate review level (e.g. expedited, full board).
• Exempt 98. Prospective data collection with adults through verbal or written responses involving a benign intervention (ONLY applicable to research NOT FUNDED by a federal department or agency).

  Research involving benign interventions in conjunction with the collection of data from an adult subject through verbal or written responses (including data entry) or video recording if:

  • the subject prospectively agrees to the intervention and data collection and
  • at least one of the following criteria is met:
    • The information obtained is recorded in such a manner that human subjects cannot be identified directly or through identifiers linked to the subjects; or
    • 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.

  For the purpose of this provision, benign interventions are:

  • brief in duration,
  • 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.

  If these criteria are met, such benign interventions might include research activities in which a subject is asked to read materials, review pictures or videos, play online games, solve puzzles, or perform cognitive tasks.

  If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception. Authorized deception is prospective agreement by the subject to participate in research where the subject is informed that  he or she will be unaware of or misled regarding the nature or purposes of the research.

  Exclusions

  To qualify for exemption category 98, the research project must not include any of the following:

  • Federal funding or federal training grants
  • FDA regulated
  • Sponsor or other contractual restrictions
  • Clinical interventions (including clinical behavioral interventions)
  • Prisoners as subjects, unless the research is aimed at involving a broader subject population that only incidentally includes prisoners
  • Receipt of an NIH issued certificate of confidentiality to protect identifiable research data
  • Be a study for which MSU serves as the IRB of record
  • Children as research subjects

  If any of the above criteria become applicable to a project determined exempt under this flexibility initiative, the IRB office must be promptly notified prior to implementation of the criteria and the project must be reviewed and approved in accordance with the appropriate review level (e.g. expedited, full board).

U.S. Food and Drug Administration (FDA) Exempt Categories

The following exempt categories apply to research subject to FDA regulations (i.e., clinical investigations). 21 CFR 56.104 sub-categories (a), (b), and (c) cannot be applied to activities that are regulated by the U.S. Department of Health and Human Services (DHHS).

• Exempt FDA Clinical Investigations

  21 CFR 56.104 Exemptions from IRB requirement. “The following categories of clinical investigations are exempt from the requirements of this part for IRB review:

  (a) Any investigation which commenced before July 27, 1981 and was subject to requirements for IRB review under FDA regulations before that date, provided that the investigation remains subject to review of an IRB which meets the FDA requirements in effect before July 27, 1981.

  (b) Any investigation commenced before July 27, 1981 and was not otherwise subject to requirements for IRB review under Food and Drug Administration regulations before that date.

  (c) Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject to IRB review.”

  (d) Taste and food quality evaluations and consumer acceptance studies, if 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.