Exempt Research

Other Resources:

IRB SOP 302: Research Exempt from IRB Review contains the complete policy regarding exempt research.

See also, the IRB's intranet page 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 is exempt from the regulations at 45 CFR 46. When research is exempt, that means that the federal regulations do not apply. The research is still considered human subjects research but the IRB does not provide oversight. The CHOP Office of Research Compliance may still review exempt studies.

Who decides if the research is exempt?

While the research is considered exempt, the Office of Human Research Protections (OHRP) does not permit the investigator to make the determination that their own 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.

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 46.101(2)(b) Unless otherwise required 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 this policy:

Categories of Research Comments and Explanations

(1) Research conducted in established or commonly accepted educational settings, involving 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.

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.

(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:(i.) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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.

This category does not apply to children unless the investigator does not interact with the subjects (observations of public behavior). Frequently forgotten is the inclusion of an and between the requirement that subjects not be identifiable and the requirement that the disclosure of the subject's responses impose risk. Both conditions must apply and therefore, under some conditions investigators may collect identifiers with surveys.

(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i.) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

This category has not been used by an investigator at CHOP within recent memory.

(4) 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.

Research in this category is confined to existing data and specimens, where existing means present, as of the date of submission to the IRB. Data collected after the date of IRB submission is, by definition, prospective. The data/specimens may contain individual identifiers - for example, names and dates - provided that the research database and research samples cannot be linked.

Example: An investigator could develop a list of potential subjects. Data could then be abstracted from each eligible subject's medical chart and recorded on a paper case report form or into an electronic record, provided, that there was no link to the master list. If this method is selected, then the investigator will not be able to go back to the medical record to recheck any data elements.

(5) 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:
(i.) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
This category is limited to programs designated by a federal department head, such as the Secretary of Health and Human Services.
(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).

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 extremely low-risk research.
(3) In addition to research that is exempt under Category 4 (see above), research that involves the use of existing data, documents, records, pathological specimens, or diagnostic specimens collected during a previously approved research study may be eligible for a determination of exemption, provided that the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. The regulations only includes data collected for clinical purposes. This category allows investigators to obtain a determination of exemption for use of data collected for research purposes.
  1. 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.

  2. 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 should include enough information so that the IRB can determine that the research qualifies as exempt.

  3. Does Category 2 apply to research involving children?

    Surveys and observations of behavior require IRB approval this is usually through expedited review. The lone exceptions are observations of public behavior where the investigator has no interactions with the subjects, 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 to include adolescents for whom the IRB would otherwise waive the requirement for parental permission.

  4. Does the IRB approve the consent form for exempt research?

    When the research is exempt, that means that none of the requirements of 45 CFR 46 apply. This means that the IRB has no role in the review and approval of the consent documents. The eIRB application Question 3.02 (3.0) requests that the investigator provide a description of the plan for obtaining the informed consent of the participants (if applicable). A copy of the consent form is not required. This request is not due to the regulatory requirements of 45 CFR 46 but rather is due to the additional standards set by CHOP's Human Subjects Protection program. As a service to investigators, the IRB provides an consent form template (on the Consent Form Templates page) that can be used/modified for exempt research.

  5. When is an amendment necessary for research determined to be exempt?

    When the IRB determines that the research qualifies for exemption from the federal regulations it means that the IRB has no oversight over the ongoing research. Changes to the exempt research do not need to be submitted to the IRB for approval unless the changes affect the original determination of exemption. For example, if research was originally limited to review of existing records will now involve prospective medical records, that research is no longer exempt and would require IRB approval.