E-IRB Guidance IRB Reviewer Determinations

1. Approved: The research proposal meets all of the applicable criteria for approval (refer to Criteria for IRB Approval Reviewer Checklist).
2. Minor Revision: Approval pending receipt of non-substantive revisions. Subsequent review by Primary Reviewer/Expedited Review.
3. Major Revision: Approval Deferred – substantive clarifications or revisions regarding the protocol or informed consent document(s) required. Subsequent review at a convened meeting. PI not required to attend.
4. Major Revision: Approval Deferred – substantive clarifications or revisions regarding the protocol or informed consent document(s) required. Subsequent review at a convened meeting. PI attendance is required.
5. Disapproved: Determination made at a convened meeting.
6. Eligible for Expedited Process: application does not need review at a convened meeting, and consideration for approval can be made by a Primary Reviewer from this point forward.
7. Withdrawn: Application will be cancelled & the research proposal will no longer be available for review or approval.

Serious or Continuing Noncompliance or Suspension/Termination: Determination made at a convened meeting.

1. Approved: The research meets the criteria for IRB approval (refer to the Criteria for IRB Approval Reviewer Checklist, if necessary).
2. Minor Revision: Approval withheld pending receipt of non-substantive revisions. Subsequent review by Primary Reviewer/Expedited Review.
3. Full review required: Application is not eligible for expedited review, or Primary Reviewer needs additional expertise/discussion about the research at a convened meeting. Please specify whether the PI should attend the meeting.
4. Not Human Research: Proposed activities do not meet the definition of human research.
5. Withdrawn: Application will be cancelled & the research proposal will no longer be available for review or approval. 
6. Disapproved: Primary Reviewer alone cannot make this determination. The decision needs to be made at a convened meeting.

Serious or Continuing Noncompliance or Suspension/Termination: Determination made at a convened meeting. 

1. Approved Exempt Status: Meets 45 CFR 46.104(d) Exemption Category: {insert category}
2. Minor Revision: Additional Information Needed to Determine Exempt Status.
3. Not Exempt: The researcher will be sent a letter with reasons for disapproval of the Exemption Request.
4. Not Human Research: The proposed activities do not meet the definition of human research.
5. Withdrawn: The application will be cancelled and will no longer be available for review or approval.

Serious or Continuing Noncompliance or Suspension/Termination: Determination made at a convened meeting. 

1. Approved: The criteria for approval are met (refer to Criteria for IRB Approval Reviewer Checklist), and any previously approved research categories requiring documented determinations are not affected (or if any new research categories apply, specific findings have been met and are appropriately documented).
2. Minor Revision: Approval withheld pending receipt of non-substantive revisions; subsequent expedited review of PI response.
3. Major Revision: Approval Deferred, e.g., substantive clarifications or revisions regarding the protocol or informed consent document(s) required, or Primary Reviewer needs additional expertise/discussion about the research at a convened meeting. PI not invited to the meeting.
4. Major Revision: Approval Deferred, e.g., substantive clarifications or revisions regarding the protocol or informed consent document(s) required, or Primary Reviewer needs additional expertise/discussion about the research at a convened meeting. PI is invited to the meeting.
5. Disapproved: The application for the MR will be cancelled & no longer available for review or approval. The PI will be sent a letter with an explanation. The last approved application will be reinstated as the most current protocol.
6. Withdrawn: Typically, the PI requested. The application for the MR will be cancelled & no longer available for review or approval. The last approved application will be reinstated as the most current protocol.

Serious or Continuing Noncompliance or Suspension/Termination: Determination made at a convened meeting. 

1. Approved: The criteria for approval are met (refer to Criteria for IRB Approval Reviewer Checklist), and any previously approved research categories requiring documented determinations are not affected (or if any new research categories apply, specific findings have been met and are appropriately documented).
2. Minor Revision: Approval withheld pending receipt of non-substantive revisions; subsequent expedited review of PI response.
3. Full Review Required: Approval Deferred, e.g., substantive clarifications or revisions regarding the protocol or informed consent document(s) required, or Primary Reviewer needs additional expertise/discussion about the research at a convened meeting. Please specify whether the PI should attend the meeting.
4. Disapproved: This determination must be made at a convened meeting. The application for the MR will be cancelled & no longer available for review or approval. The PI will be sent a letter with an explanation. The last approved application will be reinstated as the most current protocol.
5. Withdrawn: Typically, the PI requested. The application for the MR will be cancelled & no longer available for review or approval. The last approved application will be reinstated as the most current protocol.

Serious or Continuing Noncompliance or Suspension/Termination: Determination made at a convened meeting.

1. Approved: The change(s) to the activities do not exclude it from meeting 45 CFR 46.104(d) Exemption Category: {insert category} 
2. Not Exempt: The change(s) to the activities exclude it from meeting 45 CFR 46.104(d) Exemption Category: {insert category}
3. Not Human Research: The change(s) make the activities not meet the definition of human research. 
4. Minor Revision: Additional information needed to determine whether the activities are approvable. 
5. Disapproved: Determination made at a convened meeting. The MR will be cancelled & no longer available for review or approval; PI will be sent letter with explanation. The last approved application is re-instated as the most current protocol. 

Serious or Continuing Noncompliance or Suspension/Termination: Determination made at a convened meeting.

1. Approve: The research meets the criteria for IRB approval (refer to Criteria for IRB Approval Reviewer Checklist, if necessary).
2. Minor Revision: Approval pending receipt of non-substantive revisions/additional information; subsequent expedited review of PI response.
3. Full Review Required: N/A unless application was routed incorrectly – already being reviewed at convened meeting.
4. Major Revision and invite PI to meeting: Approval Deferred – e.g., substantive clarifications or revisions regarding the protocol or informed consent document(s) required, or Primary Reviewer needs additional expertise/discussion about the research at a convened meeting with PI attending.
5. Disapproved: Determination made at a convened meeting. The application will be closed and no longer under IRB approval; PI will be sent letter with explanation.
6. Withdrawn: Typically PI requested. Application for CR will be cancelled & no longer available for review or approval; the last approved application is re-instated as the most current protocol. 

Serious or Continuing Noncompliance or Suspension/Termination: Determination made at a convened meeting.

1. Approve: The research meets the criteria for IRB approval (refer to Criteria for IRB Approval Reviewer Checklist, if necessary).
2. Minor Revision: Approval pending receipt of non-substantive revisions/additional information; subsequent expedited review of PI response.
3. Full Review Required: Please specify Option A or Option B in IRB Reviewer Comments & whether PI should be invited to the convened meeting: 
   1. Approval Deferred (e.g., substantive clarifications or revisions are necessary, or Primary Reviewer needs additional expertise/discussion about the research at a convened meeting).
   2. Approval Deferred because the activities described exclude the research from expedited eligibility. This CR and all future CR’s may need to undergo review at a convened meeting until further notice.
4. Major Revision and invite PI to meeting: Approval Deferred – e.g., substantive clarifications or revisions regarding the protocol or informed consent document(s) required, or Primary Reviewer needs additional expertise/discussion about the research at a convened meeting.
5. FOR AAR ONLY: Investigator to submit a “long-form” CR – Please provide specific justification for recommending that the PI submit the “long-form” CR (Documentation required per .115(a)(3) as to why the determination differs from regulatory baseline. This could be based on an overriding safety concern, ethical, or regulatory issue that warrants submission of the “long-form” CR and/or review by the convened board.). Subsequent expedited review of PI’s response unless you specify otherwise.
6. Disapproved: Determination must be made at a convened meeting. The application will be closed and no longer under IRB approval; PI will be sent letter with explanation.
7. Withdrawn: Typically PI requested. Application for CR will be cancelled & no longer available for review or approval; the last approved application is re-instated as the most current protocol.

Serious or Continuing Noncompliance or Suspension/Termination: Determination made at a convened meeting.

1. Approve: The research meets the criteria for IRB approval (refer to Criteria for IRB Approval Reviewer Checklist, if necessary).
2. Minor Revision: Approval pending receipt of non-substantive revisions/additional information; subsequent expedited review of PI response.
3. Full Review Required: Please specify Option A or Option B in IRB Reviewer Comments & whether PI should be invited to the convened meeting: 
   1. Approval Deferred (e.g., substantive clarifications or revisions are necessary, or Primary Reviewer needs additional expertise/discussion about the research at a convened meeting).
   2. Approval Deferred because the activities described exclude the research from expedited eligibility. This CR and all future CR’s may need to undergo review at a convened meeting until further notice.
4. FOR AAR ONLY: Investigator to submit a “long-form” CR – Please provide specific justification for recommending that the PI submit the “long-form” CR (Documentation required per .115(a)(3) as to why the determination differs from regulatory baseline. This could be based on an overriding safety concern, ethical, or regulatory issue that warrants submission of the “long-form” CR and/or review by the convened board.). Subsequent expedited review of PI’s response unless you specify otherwise.
5. Withdrawn: Typically PI requested. Application for CR will be cancelled & no longer available for review or approval; the last approved application is re-instated as the most current protocol.

Serious or Continuing Noncompliance or Suspension/Termination: Determination made at a convened meeting.

1. Approve: Closure is acceptable as there are no ethical, safety, or welfare concerns for the participants as a result of IRB oversight ceasing.
2. Approve for Continuation Review: The application should remain under IRB approval for additional human research activity or concerns; please provide justification for why closure is not suitable.
3. Minor Revision: Approval pending receipt of non-substantive revisions/additional information; subsequent expedited review of PI response.
4. Full Review Required: N/A for application already slated for Full Review unless application was routed incorrectly. For application slated for Expedited Review, this option means Approval Deferred – e.g., substantive clarifications or revisions are necessary, or Primary Reviewer needs additional expertise/discussion about the research at a convened meeting. Specify whether the PI is invited to the meeting.
5. FOR AAR ONLY: Investigator to submit a “long-form” CR – Please provide specific justification for recommending that the PI submit the “long-form” CR (Documentation required per .115(a)(3) as to why the determination differs from regulatory baseline. This could be based on an overriding safety concern, ethical, or regulatory issue that warrants submission of the “long-form” CR and/or review by the convened board.). Subsequent expedited review of PI’s response unless you specify otherwise.
6. Withdrawn: Typically PI requested. Application for CR will be cancelled & no longer available for review or approval; the last approved application is re-instated as the most current protocol.

Serious or Continuing Noncompliance or Suspension/Termination: Determination made at a convened meeting.

• Minor Violation reviewed or Major Violation reviewed by convened IRB: No further action requested.
• Additional information/revisions required: Return the PV to the PI.
• Major Violation/Protocol requires full review for determination whether the violation constitutes serious noncompliance, termination or suspension, or an unanticipated problem involving risk to subjects or others.
  • Subsequent to full review, this determination is available for selection: Convened IRB determined the violation constituted an unanticipated problem involving risk to subjects or others, serious or continuing noncompliance or resulted in termination or suspension of research.

1. Report Acknowledged/accepted without recommendation: No further action requested.
2. Additional information/revisions required: Return the UP report to the PI; subsequent expedited review.
3. Requires Full review: N/A for UP already slated for Full Review unless application was routed incorrectly. For UP slated for Expedited Review, this option means acknowledgment/acceptance deferred – e.g., substantive clarifications or revisions are necessary or Primary Reviewer needs additional expertise/discussion about the UP at a convened meeting. Please specify whether the PI is invited to the meeting.

Serious or Continuing Noncompliance or Suspension/Termination: Determination made at a convened meeting

1. Approved: The request for a one-time deviation or exception to the approved protocol is accepted.
2. Approval pending minor revisions: Approval for the one-time deviation or exception is being withheld pending receipt of non-substantive revisions; subsequent expedited review of PI response.
3. Full Review required: N/A for DEV/EXC already slated for Full Review unless application was routed incorrectly. For DEV/EXC slated for Expedited Review, this option means approval deferred – e.g., substantive clarifications or revisions are necessary, or Primary Reviewer needs additional expertise/discussion about the research at a convened meeting. Please specify whether the PI is to attend the meeting or not.
4. Disapproved: Determination must be made at a convened meeting. The Deviation or Exception request will be cancelled & no longer available for review or approval; PI will be sent letter with explanation. The last approved application is re-instated as the most current protocol.

Serious or Continuing Noncompliance or Suspension/Termination: Determination made at a convened meeting.

1. Return to PI: Additional information is required to determine eligibility for closure.
2. Confirm protocol/withdrawal/closure: Application deemed appropriate for closure.
3. Not eligible for withdrawal/closure: Cancels the closure request and re-instates the last approved application as the most current protocol.

Examples:

• Eligibility for expedited review: See Expedited Categories
• Waiver of Informed Consent: See the Informed Consent section of the corresponding E-IRB application to review the researcher's request and justification to waive informed consent per 45 CFR 46.116(c)(d).
• Waiver of Documentation of Informed Consent: See the Informed Consent section of the corresponding E-IRB application to review the researcher's request and justification to waive documentation of informed consent per 45 CFR 46.117.
• FDA-regulated Medical Device: see the Study Device Information section of the corresponding E-IRB application and Study Device Form attachment, to review the researcher's request and justification for use of a device per 21 CFR 812.
• FDA-regulated Drug or Biologic: See the Study Drug Information section of the corresponding E-IRB application and Study Drug Form attachment, to review the researcher's request and justification for use of study drug per 21 CFR 312.
• Decisionally Impaired/Challenged: See the "Impaired Consent"/"Form T" attachment of the corresponding E-IRB application to review the researcher's request and justification for recruitment of adults with impaired consent capacity per UK IRB Policy.
• Pregnant Women: See the Pregnant Women/Fetuses/Neonates subsection of the corresponding E-IRB application to review the researcher's request and justification for recruitment of individuals within this vulnerable population per Subpart B.
• Fetuses &/or Neonates: See the Pregnant Women/Fetuses/Neonates subsection of the corresponding E-IRB application to review the researcher's request and justification for recruitment of individuals within this vulnerable population per Subpart B.
• Prisoners: See the Prisoners subsection of the corresponding E-IRB application to review the researcher's request and justification for recruitment of individuals within this vulnerable population per Subpart C.
• Children: See the Children subsection of the corresponding E-IRB application to review the researcher's request and justification for recruitment of individuals within this vulnerable population per Subpart D.

45 CFR 46.110 and 21 CFR 56.110

Applicability

(A) Research activities that (1) present no more than minimal risk to human subjects*, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

(B) The categories in this list apply regardless of the age of subjects, except as noted.

(C) The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

(D) The expedited review procedure may not be used for classified research involving human subjects.

(E) IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review—expedited or convened—utilized by the IRB.

(F) Categories one (1) through seven (7) pertain to both initial and continuing IRB review.

*“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests. 45 CFR 46.102(i)

The following categories allow expedited review of your research proposal:

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
   1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
   2. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
   1. From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
   2. From other adults and children¹ considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
      
      NOTE: Intravenous (IV), Port, Central, or any other lines are NOT eligible under this category even if the research involves “minimal risk”.
3. Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) Hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: (a) Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
5. Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
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: Some research in this category may be exempt from the HHS regulations for the protection of human subjects 45 CFR 46.101 (b)(2) and (b)(3). This listing refers only to research that is not exempt.)
8. Continuing review of research previously approved by the convened IRB as follows:
   1. Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
   2. Where no subjects have been enrolled and no additional risks have been identified; or
   3. Where the remaining research activities are limited to data analysis.
9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

*THE CATEGORIES OF RESEARCH THAT MAY BE REVIEWED BY THE INSTITUTIONAL REVIEW BOARD (IRB) THROUGH AN EXPEDITED REVIEW PROCEDURE BECAME EFFECTIVE NOVEMBER 9, 1998.
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¹ In Kentucky, “child/children” refers to all individuals less than 18 years of age unless the individual(s) is/are legally emancipated. (See Informed Consent SOP for discussion of “Emancipated Individuals” under Kentucky state law.) Individuals less than 18 years of age who are not emancipated meet the federal definition for “child” (e.g., DHHS, FDA, and U.S. Department of Education). Children are defined in the HHS regulations as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” 45 CFR 46.402(a) If conducting research outside the state of Kentucky, you are responsible for complying with applicable state law.