The levels of review (exempt, expedited, and full) are defined by the U.S. Department of Health and Human Services and published in the Code of Federal Regulations (CFR) Title 45, Part 46 (45CFR46) regarding the protection of human research subjects. The following abbreviated definitions of the levels of review provide links that will help you access the original CFR source, however you may have to scroll to find the exact section of interest. Note: The “exempt level of review” does not mean the research is exempt from review from IRB.

Applications submitted to the Kenyon College IRB that qualify for either the exempt or expedited level of review are examined by a subset of the Board for approval. Research that does not qualify for these two lower levels of review must undergo the full level of review.  The full review requires a convened meeting of the IRB with a quorum present and for the research to be authorized, it must be approved by the majority of the voting members present. 

IRB Application Form

The same IRB application is used for all levels of review and is found on the IRB Forms page.

Timeline

Regardless of level of review, typically there is at least one round of revisions and/or clarifications required between the submission and approval. For Exempt or Expedited Level of Review the IRB request for revision and/or clarification will typically come a week or two after the application has been received. Approval is only made after the IRB is satisfied that there is adequate evidence that the research process will follow procedures that adhere to the HHS requirements for the protection of human research subjects (45CFR46).

If your study is not approved, the IRB offers reasoning for the denial. If requested, a reviewing IRB member may be able to offer suggestions on alterations that would allow for approval.

Determination of Minimal Risk and Level of Review

If you are not familiar with the definition of minimal risk and/or the levels of review, the following steps may be helpful.

A.Read the following Health and Human Services (HHS) definition of minimal risk.  Determine if your study qualifies as posing no greater than minimal risk to participants:

a. If no greater than minimal risk, continue to step B.

b. If greater than minimal risk, your study likely falls under the Full Level of review 

B. Read through the description of “Exempt Level of Review & Categories of Work.”

C. Record which exempt categories that underlie your research project

D. Determine if your study violates any of the exempt categories that do not underlie your research. 

a. If no violation of exempt categories and your study does not pose more than minimal risk to participants, your application is likely to follow the exempt level of review.  

b. If there is a violation of any of the exempt categories of work, continue to the next step

E. Read through the description of “Expedited Level of Review & Categories of Work” below.

F. Record which expedited categories that underlie your research project

a.vIf no violation of the expedited categories and your study does not pose more than minimal risk to participants, your application is likely to follow the expedited level of review.  

b. If there is a violation of any of the expedited categories of work, continue to the next step.

G. Read through the description of “Full Level of Review & Categories of Work” below and record the categories of work that apply to your research project. if you didn't select any categories in this level of review but your application doesn't fit with exempt or expedited, it is likely that the study will still fall under the full level of review. However, as with all applications the IRB will make that final  determination.

Definition of Minimal Risk and Descriptions of Levels of Review

Minimal Risk: The Code of Federal Regulations (45CFR46.102(j)), defines minimal risk as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than the harm or discomfort ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

The Exempt and Expedited Level of Review may not be used if risks are greater than minimal risk. For example, where identification of participants and/or their responses would reasonably place them at risk of criminal or civil liability, be damaging to the participants with respect to financial standing, employability, insurability, reputation, or be stigmatizing, the level of review will be Full.

Exempt Level of Review & Categories of Work

Note: The “exempt level of review” does not mean the research is exempt from review from IRB.   

A study may qualify for the exempt level of review if the proposed research involves no greater than minimal risk to the participants and does not violate any of the categories of research defined in the “Common Rule”, the 45CFR46.104 (d) section of the Health and Human Services (HHS) Code of Federal Regulations (CFR). (Effective January 21, 2019).  The following provides an overview of the categories of research described in 45CFR46.104(d), the Common Rule.

Select any exempt categories of work associated with your research study. 

Note: Exempt review may not be used for research involving deception, research using prisoners as participants, or for some research using children as participants. In addition, to proceed with an exempt level of review, the unchecked categories must not be violated.

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. (subjects may be under 18)

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: (check the appropriate criterion.) 

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; (subjects may be under 18 if PIs not involved in observation/activity) 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 45CFR46.111(a)(7).  (participants must be adults)

3. Benign behavioral research with adults that does not violate any of the following: 

i. The research involves 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 and if the subject prospectively agrees to the intervention and information collection and at least one of the criteria listed in the Code of Federal Regulations, 45CFR46.104 (d) 3 (i)-(iii) on the Health and Human Services (HHS) website, is met.

ii. The 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. Examples are found at 45CFR46.104 (d) 3 (i)-(iii) on the Health and Human Services (HHS) website.

iii. The research involves deceiving the subjects regarding the nature or purposes of the research and 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.

4. Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, and at least one of the criteria listed in the Code of Federal Regulations, 45CFR46.104 (d) 4 (i)-(iv) on the Health and Human Services (HHS) website, is met.

5. Research and demonstration projects that are conducted or supported by a Federal department or agency…  (For the full statement, see the Code of Federal Regulations, 45CFR46.104 (d) 5 on the Health and Human Services (HHS) website.)

6. Taste and food quality evaluation and consumer acceptance studies…  (For the full statement, see the Code of Federal Regulations, 45CFR46.104 (d) 5 on the Health and Human Services (HHS) website.)

7. Storage or maintenance for secondary research for which broad consent is required...  (For the full statement, see the Code of Federal Regulations, 45CFR46.104 (d) 5 on the Health and Human Services (HHS) website.)

8. Secondary research for which broad consent is required… (For the full statement, see the Code of Federal Regulations, 45CFR46.104 (d) 5 on the Health and Human Services (HHS) website.)   

Expedited Level of Review 

A study may qualify for the expedited level of review if the proposed research involves no greater than “minimal risk” to the participants and involves the categories of research defined through 45CFR46.110. A full statement of the categories of research that may be reviewed through an expedited procedure is found on the Health and Human Services (HHS) website, and an abbreviation is found below.  

 If the expedited level of review is selected, record any expedited categories of work associated with your research study. 

  1. Clinical studies of drugs and medical devices when conditions found in the HHS full statement of expedited review categories are met.
  2. Collection of blood samples by finger stick, etc. as noted in the HHS full statement of expedited review categories
  3. Prospective collection of biological specimens for research purposes by noninvasive means. Examples found in the HHS full statement of expedited review categories
  4. Collection of data through noninvasive procedures routinely employed in clinical practice, excluding procedures involving general anesthesia, sedation, x-rays, microwaves. Details and examples found in the HHS full statement of expedited review categories
  5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
  6. Collection of data from voice, video, digital, or image recordings made for research purposes.
  7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (Note: oral histories not used for generalizable research do not require IRB approval.)

Full Level of Review

If the proposed research does not qualify for exempt or expedited review it will be reviewed at the full level of review. If you believe your research falls under this category of review, check the box(es) that help describe why the study should be reviewed at the full level. 

If the full level of review is selected, record any of the following categories of work associated with your research study. 

  • more than minimal risk
  • children under the age of 18
  • prisoners
  • pregnant women, human fetuses, neonates
  • individuals with impaired decision-making capacity
  • economically or educationally disadvantaged persons
  • collection of information about highly sensitive topics.
  • collection of information about illegal behavior.collection of information that could seriously harm the participant legally, socially, financially etc. if other people could identify them.
  • procedures that might cause physical harm.
  • procedures that might cause significant psychological/emotional distress.
  • procedures that involve deception