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Exempt Research
Published on Jun 15, 2022 · Last Updated 1 year 2 months ago
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IRB SOP 302: Research Exempt from IRB Review contains the complete policy regarding exempt research.
See also, the IRB's webpage on What must be reviewed by the IRB? and the page on Submission Requirements for additional information on determining when research involves human subjects and when it could be exempt.
Some minimal risk human subjects research may be exempt. 'Exempt' does not always mean a submission is exempt from all the requirements of 45 CFR 46. The research is still considered human subjects research, but must fit the description of the exempt category and not include nonexempt research activities. Some exempt categories (e.g. categories 7 and 8) identify specific criteria that must be met (e.g. limited IRB review, broad consent) as a condition of being exempt from other regulatory requirements. The CHOP Office of Research Compliance may still review exempt studies.
Who decides if the research is exempt?
The Office of Human Research Protections (OHRP) does not permit the investigator to make the determination that their research qualifies for exemption. At CHOP, the IRB is the sole regulatory body empowered to make this determination. The investigator must complete and submit an application in the eIRB system in order for the IRB to make its determination. For certain exempt categories,, a limited IRB review is required to determine that adequate provisions are in place to protect the privacy of subjects and the confidentiality of data.
Additional Flexibility for Exempt Research at CHOP
The CHOP IRB does not apply all of the criteria of 45 CFR 46 to research that is not federally funded or subject to FDA regulations. For exempt research, the CHOP IRB has developed an expanded list of categories of research that is eligible for an exempt research determination. The expanded list only applies to research that is not federally funded and not subject to the FDA regulations.
Categories of Federally Funded Research Eligible for a Determination of Exemption
45 CFR 46.104(a) Unless otherwise required by law or by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories…are exempt from the requirements of this policy, except that such activities must comply with the requirements of this section and as specified in each category:
| Categories of Research | Comments and Explanations |
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(1) Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods, so long as the research is not likely to adversely affect students’ opportunity to learn required educational content or the assessment of educators who provide instruction. |
The University of Pennsylvania and CHOP are established educational institutions for medical, nursing and other allied health professional students, residents, fellows, and post-doctoral fellows. Quite a few investigators at CHOP are engaged in research that is limited to the requirements of this category. |
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(2) Research that only includes interactions involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, 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 §_.111(a)(7). |
This category does not apply to children unless the research involves educational tests or observations of public behavior and the investigator does not participate in the activities being observed. The research cannot include interventions in addition to the educational tests, survey or interview procedures, or observation of public behavior. Example: If a research study were to randomly assign students to take an educational test in a quiet room or in a room with moderate level of noise, or to consume a snack (or not) before taking the test, this research would not be exempt under this category. Subjects may be audio or video recorded, but note that CHOP policy No. RI-2-03 “Recording or Filming of Patients” will apply to any subjects who are also CHOP patients. Criterion (2)(iii) requires a limited IRB review to determine that adequate provisions are in place to protect the privacy of subjects and the confidentiality of data. It may not be applied to research involving children under subpart D.
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(3) (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 indirectly 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 §_.111(a)(7). (ii) For the purposes 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. |
Subjects must be adults. Subjects may be audio or video recorded, but note that CHOP policy No. RI-2-03 “Recording or Filming of Patients”will apply to any subjects who are also CHOP patients. |
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(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 in such a manner that the identity of subjects cannot readily be ascertained directly or through identifiers linked to the subjects, and 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 investigators’ use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164 (the HIPAA Privacy Rule), subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined in 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 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. |
This category covers the re-using of identifiable data that are collected for some other “primary” or “initial” activity. Those covered by this would generally be found in medical or research records or a registry. It does not cover any primary collections of data or specimen. |
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(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. |
This category is limited to programs designated by a federal department head, such as the Secretary of Health and Human Services. |
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(6) 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. |
This category also qualifies for exemption under the FDA regulations at 21 CFR 56.104(d). |
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(7) Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable specimens for potential secondary research use if an IRB conducts a limited IRB and makes the determinations required by §_.111(a)(8). |
A limited IRB review is required to determine that broad consent for storage, maintenance, and secondary research use of identifiable private information or bio-specimens is or will be obtained in accordance with the requirements of §_.116(a)(1)-(4), (a)(6), and (d), that the elements of broad consent were or will be included in the consent form, and that consent is appropriately documented (or a waiver of documentation of consent was appropriate), and that if there is a change made for research purposes in the way identifiable data or bio-specimens are stored or maintained, that adequate provisions are in place to protect the privacy of subjects and the confidentiality of data. Relevant changes that require amendments include (but are not limited to) any change for research purposes that introduces or alters risks to the privacy or security of the stored information or bio-specimens, including giving access to or transferring information or bio-specimens for research purposes to someone who otherwise would not have access. |
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(8) Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable bio-specimens 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 the identifiable bio-specimens was obtained in accordance with §_.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 §_.117; (iii) An IRB conducts a limited review and makes the determination required by §_.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 results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by an legal requirements to return individual research results. |
A limited IRB review is required to determine that, when appropriate, adequate provisions are in place to protect the privacy of subjects and the confidentiality of data, and that the research is within the scope of what was described in the broad consent form. |
Expanded Exempt Categories for Non-Federally Funded Research
| Categories of Research | Comments and Explanations |
|---|---|
| (1) In addition to research exempt under Category 2 (see above), research that involves interviews or questionnaires of adults is exempt even when the subject of the research is a child. | The rationale for the expansion of Category 2 is that the risks of the research are equivalent when an adult is interviewed about themselves or about their child. |
| (2) Interviews with adolescents where the IRB would otherwise waive the requirement for parental permission. | Interviews and questionnaires that are limited to adolescents and which would be eligible for a waiver of parental permission is very low-risk research. |
| (3) Benign behavioral interventions (exempt under Category 3(i)(A) or (i)(B) with adolescents where the IRB would otherwise waive the requirement for parental permission.. | Benign behavioral interventions that are limited to adolescents and which would be eligible for a waiver of parental permission is very low-risk research. |
Frequently Asked Questions
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Who makes the determination that the research is exempt?
At CHOP, the IRB's SOPs place the responsibility on the IRB for making the determination. At other institutions, others may be responsible or share the responsibility with the IRB.
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Is a protocol needed to submit for a determination of exemption?
No. The CHOP IRB does not require a full protocol. A description of the study should be entered into eIRB Question 3.01 (1.0). The question reads "Provide a summary of the proposed study including: 1) the age range of subjects; 2) projected enrollment at CHOP and total enrollment study-wide; and 3) description of study procedures. If the study will enroll children, provide the justification for involving children in this research. The information provided should include enough details so that the IRB can determine that the research qualifies as exempt. For studies which require a limited IRB review, additional information regarding the privacy of subjects and confidentiality of the data must be included. The eIRB application will ask the investigator to provide information regarding how the data is stored, how confidentiality of the data will be ensured, etc.
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Does Category 2 apply to research involving children?
Surveys and observations of behavior require IRB approval, usually through expedited review. The lone exceptions are observations of public behavior or educational tests where the investigator does not participate in the activities being observed, for example, watching children play on a playground.
When research is not federally funded, the CHOP IRB's SOPs permit an expansion of Category 2 (1) to include adolescents for whom the IRB would otherwise waive the requirement for parental permission, and (2) for research that involves interviews or questionnaires with adults even when the subject of the research is a child.
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When would a record review study not qualify for exemption under category (4)(iii)?
Exempt category 4(iii) includes the secondary use of data (not including specimens) if all of the abstracted data is regulated by HIPAA (meaning that subjects’ personal health information is being used or disclosed). The data can be recorded in an individually identifiable manner (e.g. a master list can be maintained, etc.), and both prospective and retrospective data can be used. For this exempt category to apply, HIPAA must apply to ALL individuals whose individually identifiable or coded data is recorded.
If, for example, an investigator reviews medical records to obtain individually identifiable patient data on complications of tracheostomy for research purposes, HIPAA would apply to the use of patient data (personal health information about the patient is being collected). If the investigator also records which clinician performed the procedure to determine how years of experience impact complication rates, HIPAA would NOT apply to the use of clinician data (no personal health information is being collected about the clinician). The study would therefore NOT qualify under category 4(iii).
In order for the study to qualify for exemption, the data about the clinicians would need to be recorded without identifiers and without a way to re-identify these individuals (i.e. no master list). The study would then qualify for exemption under category 4(ii) for the clinician data and 4(iii) for the patient data.
Please note: Category 4(iii) only applies to the use of data (when HIPAA applies) and not biospecimens.
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Do I need to obtain HIPAA authorization for exempt research?
It depends. If the exempt research involves the use or disclosure of PHI, HIPAA applies. Investigators would either have to obtain HIPAA authorization or justify why the criteria for a waiver or alteration of HIPAA are met.
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When do I need to submit an amendment for exempt research?
In general, amendments are only required for exempt studies if the changes made to the research could affect the determination of exemption. Please note that staff changes are never required for exempt studies. Examples of the need for such amendments include:
- For studies determined to be exempt under category 7, additional changes to the research must be reported to the IRB through an amendment. An amendment should be submitted whenever changes include moving information or specimens from the original location where they are maintained, storing information or specimens for longer than they otherwise would have been, granting other investigators (e.g. external to CHOP) access to the information or specimens, and any other change that introduces or alters risks to the privacy or security of the information or the specimens. As noted above, staff changes are not required for exempt studies.
- An investigator conducting a chart review now wants to include mental health records (as defined by CHOP policy (IM-2-04)). Written consent will now have to be obtained. As the study now requires consent, it no longer meets the exemption criteria under category 4 (iii).
- A study includes surveys with adults and was determined to be exempt under category 2(i). If the investigator now wishes to survey children, the study may no longer meet the criteria for exemption.
- An investigator obtains new NIH funding. If the study was previously determined to be exempt under the expanded exempt criteria (which only apply to non-federally funded, non-FDA regulated studies; see IRB SOP 302;), in light of the newly obtained federal funding, the expanded exempt categories may no longer apply.