Exemption Categories: Revised Common Rule

"Exempt" human subjects research is a subset of research involving human subjects that does not typically require IRB review and approval because the only research activity involving human subjects falls into one or more specific exemption categories as defined by the Common Rule. While most exempt research does not require IRB review, Brown's HRPP must independently verify that the PI made the correct self-determination and that relevant safeguards and ethical education (CITI training) are in place. Once an exempt determination is made by the HRPP:

  • The exempt project is not subject to continuing review; and
  • The PI does not need to amend the exempt protocol; instead, the PI must contact the HRPP only if changes to the project
    could alter the exempt determination
  • Under the revised Common Rule with expanded Exemption categories and criteria, certain studies that once required Expedited review by the IRB now meet criteria for "Limited IRB Review," described in relevant Exemption categories below (exemptions 2, 3, 7 & 8).

Exemption #1: Educational Exemption

Exemption #4: Secondary Research (Identifiable Private Information / Biospecimens)

Exemption #7: Storage / Maintenance of Identifiable Biospecimens with Broad Consent (*NEW*)

Exemption #2: Surveys, Interviews, Educational Tests, & Observation of Public Behavior

Exemption #5: Public Benefit / Service Program Research (Federal Demonstration Projects)

Exemption #8: Use of Identifiable Data / Biospecimens Obtained with Broad Consent (*NEW*)

Exemption #3: Benign Behavioral Intervention (*NEW*)

Exemption #6: Taste/Food Quality Evaluation & Consumer Acceptance 

NIH Exempt Infographic and OHRP Q&As

Exemption #1: EDUCATIONAL EXEMPTION [45 CFR 46.104(d)(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.

What's New:  A new ineligibility criterion was 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.

Exemption #2: SURVEYS, INTERVIEWS, EDUCATIONAL TESTS, AND OBSERVATION OF PUBLIC BEHAVIOR [45 CFR 46.104(d)(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
(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).

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

“Limited IRB Review” is required when sensitive identifiable data are collected to ensure that adequate protections are in place to protect subject privacy and the confidentiality of data. This means that the IRB must review and approve procedures for data management and security where sensitive information is collected with direct identifiers (e.g., name, address, email, phone number, social security number, student ID, patient ID) OR indirect identifiers, such as a code that can link back to a subject, or data elements that could be combined to readily re-identify a subject (e.g., dates, employment history, etc.).  At Brown, exempt protocols that propose to use sensitive identifiable data will complete the new Exempt Application form as well as the Limited IRB Review Appendix.

Exemption #2 applies to studies that collect data using one or more of the following research methods ONLY:

Surveys • Interviews (including cognitive interviews) • Focus groups • Educational tests (e.g., cognitive, diagnostic, aptitude, achievement) • Observation of public behavior (i.e., behavior that occurs in a public place where there is no expectation of privacy and where no special permission is required to observe others such as a public venue)

Exemption #3: BENIGN BEHAVIORAL INTERVENTION (*NEW*) [45 CFR 46.104(d)(3)(i)]

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.

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:

(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.

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.  The following is not allowed:

Examples: Benign behavioral interventions could include having participants play an online game, having them solve puzzles under various environmental conditions, or having them decide how to allocate a nominal amount of cash between themselves and others.

Deception: If the research involves deceiving participants regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception. This must occur through a participant being informed that he/she/they will be unaware of or misled regarding the nature or purposes of the research. Debriefing participants is highly encouraged.

“Limited IRB Review” is required when sensitive identifiable data are collected to ensure that adequate protections are in place to protect subject privacy and the confidentiality of data. This means that the IRB must review and approve procedures for data management and security where sensitive information is collected with direct identifiers (e.g., name, address, email, phone number, social security number, student ID, patient ID) OR indirect identifiers, such as a code that can link back to a subject, or data elements that could be combined to readily re-identify a subject (e.g., dates, employment history, etc.).  At Brown, exempt protocols that propose to use sensitive identifiable data will complete the new Exempt Application form as well as the Limited IRB Review Appendix.

Exemption #4: SECONDARY RESEARCH (IDENTIFIABLE PRIVATE INFORMATION/BIOSPECIMENS) [45 CFR 46.104(d)(4)]

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 HIPAA 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). Note that HIPAA does not apply to biospecimens, so this provision applies only to the secondary use of identifiable private health information (which can include information obtained from biospecimens).

(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research 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.

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

  • Prospective data review - in other words, private information and biospecimens no longer have to be in existence prior to the start of the research.
  • 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

Exemption #5: Public Benefit / Service Program Research [45 CFR 46.104(d)(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.

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.

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

Consult with the HRPP: This category of exempt review is rarely used at Brown. Please contact the HRPP for consultation before submitting an exempt protocol application under this exemption.

Exemption #6: TASTE/FOOD QUALITY EVALUATION & CONSUMER ACCEPTANCE [45 CFR 46.104(d)(6)]

This category remains unchanged.  

Consult with the HRPP: This category of exempt review is rarely used at Brown. Please contact the HRPP for consultation before submitting an exempt protocol application under this exemption.

Exemption #7: STORAGE/MAINTENANCE OF IDENTIFIABLE BIOSPECIMENS WITH BROAD CONSENT (*NEW*) [45 CFR 46.104(d)(7)]

This is a new exemption in the revised Common Rule that covers the storage or maintenance of identifiable private information or identifiable biospecimens for secondary research. Secondary research refers to research with materials originally obtained for non-research purposes or for research other than the current research proposal. The exemption can only be used when there is broad consent from the subjects for the storage, maintenance, and secondary research use of their identifiable materials. [Refer to 45 CFR 46.104(d)(7), 46.111(a)(8), and 46.116(d) of the revised Common Rule.]

What's New:  This new exemption allows for the storage of data and/or specimens in a repository, with identifiers maintained, that were collected under an approved IRB protocol with "Broad Consent" for future secondary use research.  

Brown's position on this Exemption: Brown is effectively not implementing this exemption at this time except on an exceptions basis. If you have an existing study that employs "broad consent," please contact the HRPP for consultation.

Exemption #8: USE OF IDENTIFIABLE DATA / BIOSPECIMENS OBTAINED WITH BROAD CONSENT (*NEW*) [45 CFR 46.104(d)(8)]

This is a new exemption in the revised Common Rule that covers the secondary research use of identifiable private information or identifiable biospecimens originally obtained for non-research purposes or for research other than the current proposal. There are four requirements that must be satisfied to use Exemption #8:

1) Broad consent must be obtained from the subjects for the secondary research use of their identifiable materials; and

2) Documentation or waiver of documentation of informed consent must be obtained; and

3) An IRB must conduct a limited review to make certain determinations relating to privacy and confidentiality protections and broad consent; and

4) Investigators cannot include the return of individual research results to subjects in the study plan. Note that this requirement does not limit an investigator’s ability to abide by any other legal requirement to return individual research results.

What's New:  This new exemption allows for secondary research use/analysis of identifiable data/biospecimens that were collected under an approved IRB protocol with "Broad consent."

Brown's position on this Exemption:  Brown is effectively not implementing this exemption at this time except on an exceptions basis. If you have an existing study that employs "broad consent," please contact the HRPP for consultation.