Exemptions

The revised requirements modify and add new categories of exemptions, including some that require a limited IRB review.

Research Conducted in Established or Commonly Accepted Educational Settings (Exemption 1)

• Exemption 1 Criteria

  "Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy:

  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 46.104(d)(1)(2018 requirements)

• Summary of Changes

  This exemption is revised to add a new condition that the research is not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. 

  This criteria was added because of concerns about whether the conduct of some research projects of this type might draw enough time and attention away from the delivery of the regular educational curriculum that they could have a detrimental effect on student achievement.

Research That Only Includes Interactions Involving Educational Tests, Survey Procedures, Interview Procedures, or Observation of Public Behavior (Exemption 2)

• Exemption 2 Criteria

  "Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy:

  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

  (iii) 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)." 45 CFR 46.104(d)(2)(2018 requirements)

• Summary of Changes
  Revised to Clarify that this Exemption Cannot Include Interventions
  

  • This exemption is revised to clarify (consistent with pre-2018 interpretation) that the research cannot include interventions in addition to the educational tests, survey or interview procedures, or observation of public behavior.
  • Research involving interventions that are distinct from those information collection methods allowable under this exemption do not satisfy the conditions of this exemption. For example, if a research study were to randomly assign students to take an educational test in a quiet room or in a room with a moderate level of noise, or to consume a snack (or not) before taking the test, this research would not be exempt under this exemption.
  • However, educational tests may include exposing test takers to certain materials as part of the test, and that such materials do not constitute interventions distinct from the test. For example, reading comprehension tests may direct test takers to read a passage, and a geography test may present test takers with a map, and ask them to draw information from that map.
  • Likewise, survey procedures may contain some information that respondents are asked questions about, which would not be considered distinct interventions. However, research in which the purpose of the research is to see whether respondents answer survey questions differently depending on the gender of the interviewer would not satisfy the conditions of the exemption, because the manipulation of the interviewer would be a distinct intervention.
  • An activity that includes the collection of a biospecimen (e.g., a cheek swab), in addition to collecting verbal or written responses to questions, could NOT qualify for this exemption.
  • Research involving observation of public behavior does not qualify for this exemption if the investigator intervenes with subjects, for example, by offering them an ostensibly lost wallet to see if they will accept it.

   

  Added a New Harm to Be Considered 

  • This exemption provides a list of specific harms that must be considered, with the addition of the specific harm of potential damage to the subjects’ educational advancement. 

   

  Added a New Criteria that Requires Limited IRB Review

  • This is a new criteria that permits research that records identifiable information that may place subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation to be exempt, when a limited IRB review is conducted. See the following section for more information.
• More Information About Limited IRB Review

  Regulatory Text

  "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:

  (iii) 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)." 45 CFR 46.104(d)(2)(2018 requirements)

  More Information

  • This is a new exemption criteria.
  • Exemption expanded to include research using the same methods involving identifiable private information that might be sensitive or potentially harmful if disclosed, so long as the investigators adhere to the limited IRB requirements [privacy and confidentiality], and the research does not involve children. 
  • The limited IRB review requires an IRB determination that, when appropriate, adequate provisions are in place to protect the privacy of subjects and the confidentiality of data. This is the same IRB approval criteria related to privacy and confidentiality that is required for nonexempt human subjects research.
  • The IRB may use the expedited review process when conducting limited IRB.
  • Modifications are REQUIRED for this exemption when the change may impact the privacy of subjects or the confidentiality of data.

Research Involving Benign Behavioral Interventions In Conjunction With the Collection of Information From an Adult Subject (Exemption 3)

• Exemption 3 Criteria

  "Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy:

  (i) 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; or

  (C) 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).

  (ii) 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.

  (iii) 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." 45 CFR 46.104(d)(3)(2018 requirements)

• Summary of Changes
  MSU Flexibility Intiative
  

  • While MSU has used a similar exemption criteria as a flexibilty initiative when specific criteria have been met, this category is new for Common Rule departments and agencies.

   

  Benign Behavioral Interventions

  • The exemption is specifically for 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 criteria is met.
  • This category excludes the use of medical interventions (including medical tests, procedures and devices).
  • Allows for the intervention to be distinct from the data collection method; for example, a research study comparing test performance of test takers in quiet or noisy surroundings could qualify for this exemption.
  • Subjects could also be asked to perform cognitive tasks, and audiovisual recording could be used to collect the data, without any educational test, survey or interview procedure occurring, and this research could qualify for this exemption.

   

  Adult Subjects

  • Subjects must be adults, but the provision does not specify that they must be competent, and therefore tests of competency are not necessary. However, the presumption is that, in keeping with the principle of respect for persons, such subjects will not be exploited.

   

  Deception

  • Allows deception to occur without the requirements of informed consent because the intervention is not likely to result in harm or offense to the subject, and the subject must prospectively agree to the intervention and the data collection.
  • ‘‘Deception’’ is used to include withholding the purpose of the research, which is consistent with how the term is often used in this context.

   

  Limited IRB Review

  • Exemption expanded to include research using the same methods involving identifiable private information that might be sensitive or potentially harmful if disclosed, so long as the investigators adhere to the limited IRB requirements [privacy and confidentiality], and the research does not involve children. Limited IRB review requirements are designed to provide privacy safeguards to reduce the chances that the disclosure of identifiable private information will occur and lead to harm.
  • The limited IRB review requires an IRB determination that, when appropriate, adequate provisions are in place to protect the privacy of subjects and the confidentiality of data. This is the same IRB approval criteria related to privacy and confidentiality that is required for nonexempt human subjects research.
  • IRB may use the expedited review process when conducting limited IRB.
  • Modifications are REQUIRED for this exemption when the change may impact the privacy of subjects or the confidentiality of data.

Secondary Research Uses of Identifiable Private Information or Identifiable Biospecimens (Exemption 4)

• Exemption 4 Criteria

  "Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy:

  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 46.104(d)(4)(2018 requirements)

• Summary of Changes

  Overview

  • The first two provisions are a modified version of the fourth exemption under the pre-2018 rule. The third and fourth provisions are NEW.

   

  Future Collection

  • The modified provisions allow the exemption to include research with information and biospecimens that do not yet exist when the research study is proposed for exemption (i.e., that could be collected, for purposes not related to the proposed research study, in the future).

   

  Identifiable Private Information

  • Some of the provisions allow investigators to see identifiable private information, and also allow them to retain and record that information (including the identifiers) as part of their research records.

   

  See the following sections for more information.

• More Information about Criteria for Identifiable Private Information or Identifiable Biospecimens are Publicly Available

  Regulatory Text

  "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;" 45 CFR 46.104(d)(4)(2018 requirements)

  More Information

   May apply to secondary research use of:

  • Archives in a public library.
  • Government or other institutional records where public access is provided on request.
  • From a commercial entity if the information is provided to members of the public on request or if the only requirement for obtaining the information is paying a user fee, registering or signing in as a visitor to an archive.
  • If a commercial entity made identifiable biospecimens publicly available to anyone on request or for a fee.
• More Information for Criteria for 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

  Regulatory Text

  "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:

  (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;" 45 CFR 46.104(d)(4)(2018 requirements)

  More Information

  • The prior exemption is being extended to now also cover research with information for which identifiers have been removed when the original collection of information or biospecimens occurs in the future.
  • Adds the criteria that investigator does not contact the subjects and the investigator will not re-identify subjects.
• More Information About Research that Involves Identifiable Health Information Regulated by HIPAA

  Regulatory Text

  "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:

  (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);" 45 CFR 46.104(d)(4)(2018 requirements)

  More Information

  • This exemption criteria is new. 
  • HIPAA also provides protections in the research context for the information that would be subject to this exemption (e.g., clinical records). Under HIPAA, these protections include, where appropriate, requirements to obtain the individual’s authorization for future, secondary research uses of protected health information, or waiver of that authorization by an IRB or HIPAA Privacy Board.
  • Introduces a clearer distinction between when the Common Rule and the HIPAA Privacy Rule application to research in order to avoid duplication of regulatory burden.
• More Information About Research Conducted by, or on Behalf of, a Federal Department or Agency Using Government-Generated or Government-Collected Information Obtained for Nonresearch Activities

  Regulatory Text

  "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:

  (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 46.104(d)(4)(2018 requirements)

  More Information

  • This is a new exemption.
  • Federal privacy protections apply to this type of research, and applies the federal statutory privacy safeguards identified in the exemption provision to both the original collection of the information, and to the secondary research use of the information to which the exemption applies.

Research and Demonstration Projects that are Conducted or Supported by a Federal Department or Agency Designed to Study, Evaluate, Improve, or Otherwise Examine Public Benefit or Service Programs (Exemption 5)

• Exemption 5 Criteria

  "Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy:

  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.

  (i) 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.

  (ii) [Reserved]" 45 CFR 46.104(d)(2018 requirements)

• Summary of Changes
  • This exemption criteria has been revised. 
  • Added ‘‘improve’’ to the purposes of these activities, to make more explicit the idea that the Federal Government conducts these activities in order to enable them to make the public benefit and service programs better, and not just to gauge their current quality.
  • Clarified the language to conform to OHRP’s previous interpretation of public benefit and service programs that are being evaluated as part of the research. This interpretation includes public benefit or service programs that a Common Rule department or agency does not itself administer or conduct through its own employees or agents, but rather supports through a grant or contract program. Applies to research and demonstration projects supported through, for example, federal grants or cooperative agreements.
  • Clarified to specifically include projects involving waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act.
  • Adds a requirement for making a list of research and demonstration projects under this exemption publicly available. The research or demonstration project must be published on this public website list before beginning the research involving human subjects.

Taste and Food Quality Evaluation and Consumer Acceptance Studies (Exemption 6)

• Exemption 6 Criteria

  "Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy:

  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." 45 CFR 46.104(d)(6)(2018 requirements)

• Summary of Changes
  This exemption criteria is not revised.

Storage or Maintenance of Identifiable Private Information or Identifiable Biospecimens for Potential Secondary Research (Exemption 7)

• Exemption 7 Criteria

  "Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy:

  Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8)." 45 CFR 46.104(d)(7)(2018 requirements)

• Summary of Changes
  This is a new exemption criteria that requires broad consent and a limited IRB review. This exemption is still being evaluated by MSU.

Research Involving the Use of Identifiable Private Information or Identifiable Biospecimens for Secondary Research Use (Exemption 8)

• Exemption 8 Criteria

  "Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy:

  Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:

  (i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d);

  (ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;

  (iii) An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results." 45 CFR 46.104(d)(8)(2018 requirements)
• Summary of Changes
  This is a new exemption criteria that requires broad consent and a limited IRB review. This exemption is still being evaluated by MSU.

Research Involving Pregnant Women, Neonates, Fetuses, Children, or Prisoners and Exemptions

• Exemption Criteria

  "Use of the exemption categories for research subject to the requirements of subparts B, C, and D: Application of the exemption categories to research subject to the requirements of 45 CFR part 46, subparts B, C, and D, is as follows:

  [Pregnant Women, Neonates, and Fetuses] (1) Subpart B. Each of the exemptions at this section may be applied to research subject to subpart B if the conditions of the exemption are met. 

  [Prisoners] (2) Subpart C. The exemptions at this section do not apply to research subject to subpart C, except for research aimed at involving a broader subject population that only incidentally includes prisoners.

  [Children] (3) Subpart D. The exemptions at paragraphs (d)(1), (4), (5), (6), (7), and (8) of this section may be applied to research subject to subpart D if the conditions of the exemption are met. Paragraphs (d)(2)(i) and (ii) of this section only may apply to research subject to subpart D involving educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed. Paragraph (d)(2)(iii) of this section may not be applied to research subject to subpart D." 45 CFR 46.104(b)(2018 requirements)

• Summary of Changes

  Pregnant Women, Neonates, and Fetuses

  • This requirement has not changed.

  Prisoners

  • This requirement has been revised.
  • Now permits the inclusion of prisoners when research is aimed at involving a broader subject population that only incidentally includes prisoners.

  Children

  • Modified to reflect the revised structure of the final rule
  • Exemption (1), and (4)–(8) may be applied to research that is subject to subpart D if the conditions of the exemption are met.
  • Exemption (2)(i) and (ii) may apply only to research activities that are subject to subpart D involving educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed.