IRB Reviewer Checklists and Forms

1. Risks to subjects are minimized*:
   • Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result (achieved from research interventions).
   • Risks to subjects are minimized by using procedures that are consistent with sound research design and which do not unnecessarily expose subjects to risk. 
   • When possible, risks to subjects are minimized by using procedures already being performed on the participants for diagnostic or treatment purposes. 
   • The research proposal addresses the likelihood of harm and magnitude of harm (encompassing potential physical, psychological, social, and/or economic risks to the subjects). 
   • The research is likely to achieve its proposed aims. 
   • The importance of the knowledge expected to result is clear. 
2. Subject selection is impartial and just, in relation to*:
   • Objectives of the research;
   • The setting in which the research is to take place;
   • The special problems of research involving special populations;
   • Recruitment methods;
   • Enrollment criteria.
3. Informed consent*:
   • Adequate provisions are in place for seeking informed consent from each prospective subject (“subject), or the prospective subject’s legally authorized representative (“subject’s LAR”). 
   • The proposed consent process provides the subject/subject’s LAR with sufficient opportunity to consider whether to participate. 
   • The proposed consent process minimizes the possibility of coercion or undue influence. 
   • The information to be relayed during the consent process is in a language understandable to the subject/subject’s LAR. 
   • The information being communicated during the consent process does not include exculpatory language through which the subject/subject’s LAR waives or appears to waive any of the subject’s legal rights. 
   • The information being communicated during the consent process does not include exculpatory language through which the subject/subject’s LAR releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. 
4. The provisions for documenting informed consent/assent are appropriate.*

If N/A for any of #3 or #4 above, a request for waiver/alteration of the informed consent process must be completed by the PI, and the criteria must be met.  

5. The research proposal describes adequate provisions for protecting the privacy of subjects.*
6. The research proposal describes adequate provisions for maintaining the confidentiality of the data.*
7. The credentials and/or described qualifications of the research staff/ investigators are representative of the appropriate expertise needed to perform their responsibilities in the study. 
8. The research setting (e.g., location of research, facilities, drug/device controls & accounting) supports adequate safeguards for protection of human subjects. 
9. Additional safeguards have been included in the study to protect the rights and welfare of subjects vulnerable to coercion or undue influence (e.g., children, prisoners, adults with impaired consent capacity, economically or educationally disadvantaged persons, etc.).*
10. For greater than minimal risk research or NIH-funded/FDA-regulated clinical investigations, adequate provisions are in place for monitoring the data collected to ensure the safety of subjects.* Where applicable, the following may be considered in evaluating whether the data and safety monitoring are adequate:
    • Is the proposed plan commensurate with the nature, size, and complexity of the research as well as the degree of risk involved?
    • Does the proposal include procedures for promptly detecting harm and mitigating potential injuries?
    • What safety information will be collected? How will safety information be collected (e.g., at study visits, by monthly telephone calls, etc.)?
    • What data will be monitored and who will monitor the data?
    • What is the frequency of review or analysis of cumulative safety data to determine whether harm is occurring?
    • Are there procedures for ensuring appropriate reporting of findings to the IRB?
    • Are there any conditions or criteria that could trigger an immediate suspension/ termination of the research, and if so, are there procedures for reporting the suspension/ termination to the appropriate entities?
    • Is the establishment of an independent individual or data and safety monitoring board (DSMB) warranted? If so, is there a plan for providing DSMB reports (routine and urgent) to the IRB? 
11. If the proposal is a multicenter study in which the lead PI or UK is the coordinating institution, the plans for communication among sites are adequate to protect the participant (e.g., consider communication of protocol modifications, data, and safety monitoring reports, and unanticipated problems). 
12. Proposed payment to participants and/or cost to subjects for participation is appropriate.
13. If PI/research staff conflict of interest is identified, the conflict of interest in relation to human research protections is appropriately minimized or managed (e.g., limit who obtains informed consent; add disclosure(s) in informed consent process; University COI management plan appropriate, etc.).
14. Review and approval by other committees/units, as applicable for medical research (e.g., RDRC, IBC, RSC, MCC PRC), has been conducted. 
15. Approval from external institutions has been obtained from an authorized official.
16. A signature assurance statement signed by the Principal Investigator and their Department Chairperson (or appropriate equivalent) is on file.

*Regulatory Criteria

Unless use was required to preserve the life of a patient, IRB policy requires the IRB Chair, Vice Chair, or Physician Member to concur with the Emergency Use determination based on review of: 

• Written memorandum, email, or telephone call of explanation which justifies the administration of the test article; and 
• Copy of the informed consent form. 

The following conditions must be met to confirm that use of a test article in a single subject meets FDA requirements for administration without prior IRB review and, if applicable, without Informed Consent. Please check the required conditions for use, either with or without informed consent:

WITH INFORMED CONSENT

• Not Applicable 
• A human subject is confronted by a life-threatening situation necessitating the use of the test article; 
• There is no available alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the subject’s life; AND 
• In which there is not sufficient time to obtain IRB approval.

WITHOUT INFORMED CONSENT

• Not applicable 
• A human subject is confronted by a life-threatening situation necessitating the use of the test article; 
• There is no available alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the subject’s life; 
• In which there is not sufficient time to obtain IRB approval; 
• Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject*; AND 
• Time is not sufficient to obtain consent from the subject’s legal representative.*

*Requires an independent evaluation by a nonparticipating physician (in advance if available, or with a 5-day report if insufficient time). 

Add Reviewer Comments

ORI E-IRB Instruction: Physician researchers may initially submit emergency use requests external to E-IRB or via E-IRB submission. The following outlines the ORI E-IRB Process when the request is initially submitted in E-IRB: 

If the application is a FULL (FL) Protocol Process Type, to avoid returning the application to the researcher after Primary Reviewer (PR) concurrence: 

• Take measures to ensure the Primary Reviewer (PR) does not complete his/her IRB Review task* (e.g., make yourself the required reviewer); 
• In the Select Reviewer task window, assign the Emergency Use Checklist to the Primary Reviewer; 
• Inform the PR in advance (e.g., application comment; email; whatever works best to get their attention) that they should NOT click the “Complete Review” button in the IRB Review task window, only complete the Emergency Use Reviewer Checklist, and write applicable review notes about concurrence (or not) in their IRB Review task window, date them, and click Save. 
  Note: To view the PR's "determination," in the ORI Dashboard select "IRB TASKS AND MAINTENANCE-->Tasks in Progress," and click on the Primary Reviewer's IRB Review task button (you might need to ask for the task to be released first). 
• Use the Re-select Reviewer tool to add all the other committee members to review the application (removing ‘required reviewer’ in the process); 
• Manually add the application to an agenda. 

*If the PR completes their IRB Review task, getting the application fully reviewed without returning to the PI first is no longer an option. 

Note: If the study comes in as XP Protocol Process Type, the reviewer can complete their task with determination of “Full Review Required,” and the application does not get returned to the PI, ORI immediately has the option to schedule a meeting via the “Screen Revision” task button.

HIPAA Authorization Tab

Below are the required elements for an Authorization under HIPAA to be approved for this application. 

Mark the box by the elements NOT COMPLETED and which still need to be addressed by the researcher (if you determine all elements are included, no boxes should be checked).

• The name of the researcher(s) authorized to make the use or disclosure of the PHI. 
• A description that identifies PHI to be used/disclosed in a specific and meaningful fashion. 
• An explanation that information disclosed pursuant to the authorization may no longer be protected when re-disclosed by the recipient. 
• A statement that a subject’s treatment, payment, or enrollment in any health plan or their eligibility for benefits will NOT be affected if they refuse to sign the authorization. 
• A statement that the subject may not participate in a research study if they refuse to sign the authorization. 
• A description of how the individual may revoke the authorization in writing and the exceptions to the revocation (researcher may use data already collected, PHI may be used/disclosed if adverse event occurs, subject may not be able to participate in the study);. 
• An expiration date or an expiration event that relates to the use or disclosure (“end of the research study,” “none,” or similar language is sufficient if the authorization is research). 
• A space for the signature of the individual and date. If a personal representative signs the authorization, a description of the representative’s authority must be provided. 
• The authorization written in plain language AND the statement that the subject will be given a copy of the signed authorization. 
• Optional statement that review of PHI is not permitted by the subject until the study is completed.

IRB Decision (choose determination):

• The authorization form is APPROVED by the IRB based on the information related to the IRB by the researcher in this application. 
• The authorization form is NOT APPROVED by the IRB based on the information related to the IRB by the researcher in this application.

Comments about elements and/or an explanation for not approving. (Provide details)

HIPAA Waiver of Authorization Tab

Below is a list of required elements for Waiver of Authorization under HIPAA to help you ensure that all of the elements required for a waiver of authorization under HIPAA are included in this application. 

We suggest that if you are not sure if a statement qualifies for a certain category, put a note in the explanation text box below.

• An explanation of WHY the use or disclosure of Protected Health Information (PHI) involves no more than a minimal risk to the privacy of individuals. 
• A detailed list of the PHI to be collected is included in addition to a list of the SOURCE(S) of the PHI. 
• A plan to describe HOW to protect the PHI and an indication WHERE the PHI will be stored and WHO will have access is provided. 
• An explanation of WHEN the identifiers collected during the study will be destroyed. 
• An explanation of HOW all the data collected during the study will be destroyed (electronically, paper, audio/video, photography, or other) OR an explanation WHY the PHI collected during the study will NOT be destroyed. 
• An explanation of WHY the research could not practicably be conducted without the waiver. 
• An explanation of WHY the research could not practicably be conducted without access to and use of the PHI. 
• An explanation of WHY the PHI obtained for this study is the minimum information necessary to meet the research objectives.

IRB Decision (choose determination):

• The waiver application is APPROVED by the IRB based on the information in this application. 
• The waiver application is NOT APPROVED by the IRB based on the information in this application.

Comments about elements and/or an explanation for not approving. (Provide details)

CR Primary Reviewer Tab

The research meets the criteria for IRB approval. (Refer to the Criteria for IRB Approval Checklist as needed)

• Yes
• No

The risk/benefit ratio or review category has changed since the last approved protocol? (Refer to Assessing Research Risk)

• Yes
• No

If YES to the risk/benefit ratio or review category changing, select the single option below that describes the protocol now:

• Expedited Category 8: The IRB agreed that this research, previously reviewed by the convened IRB, meets the Expedited criteria set forth in 45 CFR 46.110(a)(8); therefore, an Expedited review was conducted. 
• Expedited Category 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. 
• Risk Level 1: Not greater than minimal risk 
• Risk Level 2: Greater than minimal risk, but presenting the prospect of direct benefit to individual subjects 
• Risk Level 3: Greater than minimal risk, no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition; 
• Risk Level 4: Research not otherwise approvable, which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of subjects.

Please describe in the space below why the risk/benefit ratio or review category has changed:

Significant new findings that might relate to the subject’s willingness to continue participation need to be relayed to the subject. (e.g., From scientific literature; a procedural change, PI disclosure of financial interest, privacy/ confidentiality issues, etc.)

• Yes
• No

If YES to significant new findings, describe what should be relayed to the subjects and how the subjects should be informed: (e.g., revise consent document and re-consent subjects; send letter to subjects)

The consent documents are complete and accurately describe the research. [The consent form(s) include the required elements of informed consent (see Required Elements of Informed Consent), which applies to, for example, consent form, cover letter, and/or phone script when used alone or in combination with a debriefing and permission to use data form when applicable.]

If NO, provide related comments:

Recommended interval for Continuation Review:

• 12 months
• Other - specify below

If the recommended interval for Continuation Review or AAR is other than 12 months, please describe the other recommendation:

Some of the following may or may not apply to the research. You only need to provide in the text boxes provided for the applicable topic your comments, requests, and/or recommendations for items deemed to involve controverted issues.

[MINOR concerns include, but are not limited to: typographical errors, grammar, pagination, headers/footers, template language, signatures;
MAJOR concerns include, but are not limited to: risk/benefit ratio, ethical concerns, cognitive ability, failure to obtain consent, waiver of consent, etc.]

For Minor concerns regarding the consent document submitted for approval, you may write the corrections on your copy of the consent document(s) and return it to the ORI staff person OR provide comments in E-IRB. 

For other minor or major concerns about the consent document(s)/process, please describe in the space below, providing specific page numbers: Consent Document(s)/Process

Human subjects training for each new or existing study personnel has NOT been completed.

If there are other issues related to study personnel (expertise not appropriate, etc.), please describe below:

Unanticipated problem(s)/Adverse Event(s) or other New Safety Information (e.g., data and safety monitoring report, new relative literature, etc.):

Subject withdrawals:

Deviations/Exceptions/Violations:

Other (e.g., unanswered questions, form missing, etc.):

IRB Decision (choose determination):

• Approve
• Minor Revision
• Approved CR - Eligible for Expedited Process
• Full Review Required
• Major Revision and ask ORI to invite PI to meeting
• Disapproved
• Withdrawn

Comments/Requested Revisions:

AAR Primary Reviewer Tab

The research meets the criteria for IRB approval. (Refer to the Criteria for IRB Approval Checklist as needed)

• Yes
• No

The risk/benefit ratio or review category has changed since the last approved protocol? (Refer to Assessing Research Risk)

• Yes
• No

If YES to the risk/benefit ratio or review category changing, select the single option below that describes the protocol now:

• Expedited Category 8: The IRB agreed that this research, previously reviewed by the convened IRB, meets the Expedited criteria set forth in 45 CFR 46.110(a)(8); therefore, an Expedited review was conducted. 
• Expedited Category 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. 
• Risk Level 1: Not greater than minimal risk 
• Risk Level 2: Greater than minimal risk, but presenting the prospect of direct benefit to individual subjects 
• Risk Level 3: Greater than minimal risk, no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition; 
• Risk Level 4: Research not otherwise approvable, which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of subjects.

Please describe in the space below why the risk/benefit ratio or review category has changed:

Significant new findings that might relate to the subject’s willingness to continue participation need to be relayed to the subject. (e.g., From scientific literature; a procedural change, PI disclosure of financial interest, privacy/ confidentiality issues, etc.)

• Yes
• No

If YES to significant new findings, describe what should be relayed to the subjects and how the subjects should be informed: (e.g., revise consent document and re-consent subjects; send letter to subjects)

The consent documents are complete and accurately describe the research. [The consent form(s) include the required elements of informed consent (see Required Elements of Informed Consent), which applies to, for example, consent form, cover letter, and/or phone script when used alone or in combination with a debriefing and permission to use data form when applicable.]

If NO, provide related comments:

Recommended interval for Continuation Review:

• 12 months
• Other - specify below

If the recommended interval for Continuation Review or AAR is other than 12 months, please describe the other recommendation:

Some of the following may or may not apply to the research. You only need to provide in the text boxes provided for the applicable topic your comments, requests, and/or recommendations for items deemed to involve controverted issues.

[MINOR concerns include, but are not limited to: typographical errors, grammar, pagination, headers/footers, template language, signatures;
MAJOR concerns include, but are not limited to: risk/benefit ratio, ethical concerns, cognitive ability, failure to obtain consent, waiver of consent, etc.]

For Minor concerns regarding the consent document submitted for approval, you may write the corrections on your copy of the consent document(s) and return it to the ORI staff person OR provide comments in E-IRB. 

For other minor or major concerns about the consent document(s)/process, please describe in the space below, providing specific page numbers: Consent Document(s)/Process

Human subjects training for each new or existing study personnel has NOT been completed.

If there are other issues related to study personnel (expertise not appropriate, etc.), please describe below:

Unanticipated problem(s)/Adverse Event(s) or other New Safety Information (e.g., data and safety monitoring report, new relative literature, etc.):

Subject withdrawals:

Deviations/Exceptions/Violations:

Other (e.g., unanswered questions, form missing, etc.):

IRB Decision (choose determination):

• Approve
• Minor Revision
• Full Review Required
• FOR AAR ONLY: Investigator to submit Continuation Review (CR): In the text box below, provide specific justification for recommending that the PI submit a CR
• Disapproved
• Withdrawn

Comments/Requested Revisions:

Checklist of requirements for ORI/IRB use to facilitate review of human subject research supported by the DoD. 

Instructions: Review and check to indicate criteria have been considered and/or are met for items applicable to the proposed research.

SCIENTIFIC REVIEW

• Scientific review completed by Department Chairperson, Faculty Advisor, or equivalent, as documented by Signed Signature Assurance Sheet
• Consider the scientific integrity of the study within the scope of human research protections and ethical principles.

RISK DETERMINATION

• When making the minimal risk determination, the risks imposed in research involving human subjects focused on a special population should not be evaluated against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat zone) or having a medical condition (e.g., frequent medical tests or constant pain).

VULNERABLE POPULATIONS

Limitations or Modifications to standard Vulnerable Subject Subpart B, C, & D regulatory requirements provided by the supporting Component are met.

• Yes
• No
• N/A

Prisoner research is reviewed by a convened IRB.

• Yes
• No
• N/A

If the study includes active duty or reserve members under the age of 18, the IRB considers whether such members are necessary or appropriate to include in the proposed research.

• Yes
• No
• N/A

INTERNATIONAL POPULATIONS

Knowledge of local context is met by a standing or ad hoc IRB member or cultural consultant.

• Yes
• No
• N/A

Research is compliant with any local applicable laws, regulations, customs, and required local ethics review as identified by the investigator or DoD Component.

• Yes
• No
• N/A

DETAINEES

• Detainees are not included as potential subjects, except in cases of investigational drugs per FDA regulations. 

HUMANS AS EXPERIMENTAL SUBJECTS [research conducted for the purpose of obtaining data regarding the effect of an intervention or interaction (includes planned emergency research)]

• Not Applicable
• 1) Informed Consent is obtained.
• 2) If consent is likely to be obtained from a Legally Authorized Representative, research must offer potential benefit to the study subject.

ARMED SERVICES PERSONNEL, MILITARY OR CIVILIAN DoD EMPLOYEES

1. If the study is a clinical investigation, including Armed Services personnel, women, and minorities as subjects.
   • Yes
   • No
   • N/A
2. Research with DoD personnel (military or civilian DoD employees) includes a recruitment plan that ensures no undue influence from superiors in the chain of command.
   • Yes
   • No
   • N/A
3. When required by DoD Component, PI has obtained local command permission for subjects to participate on and/or off duty in research that could impact their military duties.
   • Yes
   • No
   • N/A
4. Recruitment of DoD/military personnel (and/or informed consent) occurring in a group setting for a greater than minimal risks study will be monitored to ensure voluntariness, which cannot include the participant’s supervisor.
   • Yes
   • No
   • N/A
5. If civilian DoD employees will be recruited (and/or consented) in a group setting for a greater than minimal risks study, the IRB assigns an ombudsperson to ensure voluntariness and address participant concerns. The ombudsperson is unaffiliated with the research.
   • Yes
   • No
   • N/A

COMPENSATION FOR DoD PERSONNEL [active duty military or civilian DoD employees]

On Duty: Compensation limited to blood draws

• May participate in research during work or duty hours with supervisor approval and no compensation other than $50 per blood draw
• Compensation can be from a Federal or non-Federal source
  • Yes
  • No
  • N/A

Off Duty:

• No restrictions as long as the source of compensation is not Federal dollars, but compensation for up to $50 per blood draw can be from a Federal source
  • Yes
  • No
  • N/A

WAIVER OF INFORMED CONSENT CONSIDERATIONS/LIMITATIONS

* Research Involving Humans as Experimental Subjects is defined as research involving intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction [NIH Glossary].

1. Unless granted by the Secretary of Defense, waiver of informed consent is prohibited in Research involving Humans as Experimental Subjects.
   • Yes
   • No
   • N/A
2. Waiver of informed consent is also prohibited in “Classified Research."
   • Yes
   • No
   • N/A
3. Exception from informed consent in Planned Emergency Research is prohibited unless the DoD has 
   issued a waiver.
   • Yes
   • No
   • N/A
4. Waiver of informed consent may be considered if research is exempt, or research is minimal risk, and does NOT involve Research with Humans as Experimental Subjects. For example, the IRB may consider a request for waiving informed consent for a retrospective study of existing data, documents, or records. The IRB applies standard waiver criteria. 
   • Yes
   • No
   • N/A

CLASSIFIED RESEARCH [Research involving classified information requires prior approval from the Secretary of Defense]

• Not Applicable
• 1) Research involving classified information includes a description of the information and implications in informed consent.
• 2) Classified research is reviewed by a convened IRB.

Note: DoD Component (Air Force, Army, Navy, etc.) may have additional requirements [It is the Principal Investigator’s responsibility to share any Component requirements with ORI/IRB]

• Not Applicable

_{Source: Department of Defense Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Conducted and -Supported Research, April 15, 2020}

Instructions: Review and check to indicate criteria have been considered and/or are met for items applicable to the proposed research.

FOR STUDIES SPONSORED BY NIJ:

• Not Applicable (skip answering the NIJ questions below)

NIJ-funded research requires a Privacy Certificate, which documents the investigator’s obligations under the DOJ confidentiality. As such, researchers and research staff are not required to report current or past abuse. Since this is in conflict with Kentucky child and elder abuse reporting laws, a separate consent form (addendum) allowing the mandatory reporting should be available for use in the event that a subject discloses abuse.

The following is a checklist of requirements for ORI/IRB use to facilitate review of human subject research supported by the EPA and research in which the intent is the submission of data to the EPA.

PROTOCOL INVOLVES INTENTIONAL EXPOSURE RESEARCH

(A study where the exposure experienced by the subject would not have occurred but for the human subject's participation in the study. This includes any research in which the subject's exposure is artificially manipulated or controlled.)

• Not Applicable (skip answering "intentional exposure" questions; proceed to "observational research" section)
   

1. EPA Subpart B prohibits intentional exposure research, under all circumstances, in children and women who are pregnant or nursing. All circumstances include studies involving controlled exposures to neutral substances (such as clean, filtered air), foods, pesticides, or therapeutic drugs. This prohibition is absolute and does not incorporate reference to either risk level or potential benefit.
   • Not Applicable (Intentional Exposure Research Protocol does not include children or women who are pregnant or nursing.)
2. EPA 2013 Subpart K Final Rule involving Intentional Exposure to Pesticides - Applies to all other adults (non-pregnant, non-nursing) and includes no provision of consent by a legally authorized representative in research involving intentional exposure to a pesticide.
   • Not Applicable (does not involve intentional exposure to pesticides)

For research involving intentional exposure to pesticides:

• Protocol includes no plans for enrolling subjects who cannot consent on their own behalf, and consent form does not include a signature line for a subject's legally authorised representative; AND
• Consent identifies the pesticide and the nature of pesticidal function. Consent includes unforeseeable risks, such as risk to the embryo or fetus should the subject become pregnant.

PROTOCOL INVOLVES OBSERVATIONAL RESEARCH

(Any research that does not involve intentional exposure. Studies that involve naturally occurring environmental exposures may meet the regulatory definition of observational research.)

• Not Applicable (skip answering for populations listed below)
   

1. Observational Research with Pregnant Women/Fetuses:
   • Not Applicable

For Observational Research Involving Pregnant Women or Fetuses:

• There is direct benefit to the woman or the fetus, OR
• In the absence of direct benefit, the risk is no greater than minimal to the fetus, and the research is important for biomedical knowledge that cannot be obtained in any other manner.
   

2. Observational Research with Children:
   EPA does not permit observational research that is greater than minimal risk when there is no direct benefit to the child. Also, EPA does not recognize the “minor increase over minimal risk”.
   • Not Applicable (research is not greater than minimal risk or does not involve children)

For observational research involving children that does involve greater than minimal risk but presents the prospect of direct benefit to the individual participants, the following must be met and documented:

• The intervention or procedure holds out the prospect of direct benefit to the individual participant or is likely to contribute to the participant's well-being.
• The risk is justified by the anticipated benefit to the participants.
• The relation of the anticipated benefit to the risk is at least as favorable to the participants as that presented by available alternative approaches; AND
• Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians.

PRE-2019 Common Rule Policy

Exempt Status: 

This protocol meets a 45 CFR 46.101(b) Exemption Category. 

(If this study does not meet an exemption category and/or requires additional information or revisions, please insert comments in pertinent sections of the E-IRB application and select the appropriate determination with applicable notations about your determination on the “IRB Review” task page.)

General Comments that Do Not Influence Approval:

Children/Minors (if applicable) 

The IRB agreed with the PI’s assessment provided in the IRB application that this protocol meets the requirements for the involvement of children/minors set forth in 45 CFR 46.404 and 45 CFR 46.408: 

• The study meets the federal definition of minimal risk; 
• Adequate provisions have been made for soliciting the assent of the child; and 
• Adequate provisions have been made for soliciting the permission of their parents or guardians. If one parent can give permission, please document this approval.

2019 Common Rule Policy

1. On the IRB Review task window (under “Finish” tab), select the applicable determination, and per 45 CFR 46.104(d), specify here which Exemption Categories this protocol meets:
   
   (If this study does not meet an exemption category and/or requires additional information or revisions, please insert comments in the pertinent sections of the E-IRB application and on the IRB Review task window (under “Finish” tab) select the appropriate determination with applicable notations about your determination.)
   
   General Comments that Do Not Influence Approval:
2. (If Applicable) Limited IRB Review Section List Exempt Research Categories for Limited Review:

If Limited IRB Review applies, in the box below, explain what adequate provisions have been made for protecting the privacy of subjects and maintaining the confidentiality of data. To help make the "Limited IRB Review" determination, consider: 

• The extent to which identifiable private information is or has been de-identified and the risk that such de-identified information can be re-identified; 
• Use of the information; 
• Extent to which the information will be shared, transferred, or otherwise disclosed or released; 
• Likely retention period or life of the information; 
• Security controls that are in place to protect the confidentiality and integrity of the information; and 
• Potential risk of harm to individuals should the information be lost, stolen, compromised, or otherwise used in a way contrary to the contours of the research under the exemption.

IRB Decision (choose determination):

• Approve
• Minor Revision
• Not Exempt
• Not Human Research
• Withdrawn

Comments/Requested Revisions:

Indicate if the proposed research is eligible for expedited review: 

[Research activities are eligible for expedited review when they meet all the expedited applicability criteria, including no more than minimal risk, and fall under at least one of the expedited categories: see Expedited Categories] 

(If no, proceed to the Comment Field in the Finish tab to enter justification for why the study is not eligible for Expedited Review (e.g., greater than minimal risk).

• Yes
• No

Identify the expedited category number(s) that apply to this research proposal (e.g., 4, 5): [see Expedited Categories]

Enter the category number(s)

The IRB agreed with the PI's written informed consent document and confirms that the form meets general regulatory requirements and includes required elements and applicable additional elements of informed consent (select “N/A” if waiver of informed consent is requested). [See "Federally Required Elements of Informed Consent" to review the required and additional elements of informed consent that apply to, for example, consent form, cover letter, and/or phone script when used alone or in combination with a debriefing and permission to use data form when applicable.]

• Yes
• No
• N/A

The requirements for Waiver of Informed Consent are met, and are appropriately documented (select "N/A" if waiver not requested). 

[To help make this determination, if applicable, see the Informed Consent section to review the researcher's request and justification to waive informed consent per 45 CFR 46.116(c)(d).]

• Yes
• No
• N/A

The requirements for Waiver of Signatures on Informed Consent Forms are met, and are appropriately documented (select “N/A” if waiver of doc not requested).

• Yes
• No
• N/A

• Yes
• No
• N/A
   

• Yes
• No
• N/A

• Yes
• No
• N/A

• Yes
• No
• N/A

• Yes
• No
• N/A

• Yes
• No
• N/A

• Yes
• No
• N/A

IRB Decision (choose determination):

• Approve
• Minor Revision
• Full Review Required
• Not Human Research
• Withdrawn
• Disapproved

Comments/Requested Revisions:

Instructions: Complete Sections I and II below, and make the applicable selection and comments for your determination under the "Finish” tab of your IRB Review task window.

If “Approve” is your determination for this modification request and you record such under the "Finish" tab, you are attesting the criteria for approval are met [refer to Criteria for IRB Approval, noting you may also wish to see “Guidance on Expedited Review of Minor Changes in Previously Approved Research” for what constitutes a minor change], and your responses in Section I and II below indicate: 

Click "Prisoners are not the targeted population," if prisoners are not the specific targeted population.

Instructions

• Category 1 (45 CFR 46.306(a)(2)(i)) - This research involves the study of possible causes, effects, processes of incarceration, and of criminal behavior.
• Category 2 (45 CFR 46.306(a)(2)(ii)) - This research involves the study of prisons as institutional structures, or of prisoners as incarcerated persons.
• Category 3 (45 CFR 46.306(a)(2)(iii)) - This research involves the study of conditions particularly affecting prisoners as a class.
• Category 4 (45 CFR 46.306(a)(2)(iv)) - This research involves the study of practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject.

• Advantages acquired through participation in the research, when compared to the prisoners' current situation, are not so great that they impair their ability to weigh risks.
• Risks are the same as those that would be accepted by non-prisoners.
• Procedures for selection are fair to all prisoners and are immune from intervention by prison authorities in prisons; control subjects are randomly selected.
• Parole Boards cannot take into consideration a prisoner's participation in research. Informed consent states that participation will not impact parole.
• For studies that require follow-up, provisions are made, including consideration for the length of individual sentences; informed consent must reflect provisions for follow-up.
• Information about the study is presented in a language understandable to prisoners.

• The PI has requested a waiver for meeting the category conditions under Section 1 of this form.
• This research involves epidemiologic research intended to describe the prevalence/incidence of a disease by identifying all cases, or to study potential risk factor associations for a disease; and
• Prisoners are not the sole focus of the research.

Note: You are evaluating this protocol specific to your area of expertise; you are not the Primary Reviewer. Please note: you are being asked to voluntarily donate your services; you will not be compensated for your time, however, your services are appreciated.

THIS CONFIDENTIALITY AGREEMENT is made this {insert day, ex. 5^th} day of {insert month}, {insert year} (“Effective Date”) by                  {insert printed name} (hereinafter “IRB MEMBER”) and the University of Kentucky (hereinafter “UK”). 

W I T N E S S E T H: 

WHEREAS, IRB MEMBER will attend meetings of UK’s Institutional Review Board ("IRB") and have access to UK's electronic IRB submission system (“E-IRB”); and

WHEREAS, IRB MEMBER will be exposed to certain confidential and possibly proprietary information during the meetings and within the E-IRB (hereinafter the “Confidential Information”); and

WHEREAS, IRB MEMBER is allowed to participate in the meetings and have access to the E-IRB so long as IRB MEMBER agrees to maintain the Confidential Information in confidence.

NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth, IRB MEMBER agrees as follows:

1. IRB MEMBER shall maintain the confidentiality of all Confidential Information received or discussed at the meetings or viewed in the E-IRB. This obligation of confidentiality extends to all Confidential Information in whatever form disclosed, including, without limitation, oral and written disclosures, and it includes the identities of participants, researchers, sponsors, and any information of any other type or nature revealed at the meetings or in the E-IRB.
2. IRB MEMBER shall maintain the Confidential Information as secret and confidential and, with the sole exception of discussions with other IRB MEMBERS as a part of the review process, ORI staff, IRB ad hoc consultants as needed, legal counsel and any institutional official with legitimate job duties, and IRB MEMBER shall not discuss it with or disclose it to third parties for any reason without prior written permission from UK.  All publications and writings of any nature relating to IRB review materials, including publications and writings prepared for class, are subject to this nondisclosure requirement and must be submitted to UK for its review and approval.
3. IRB MEMBER agrees to only access and review Confidential Information within the E-IRB that is related to the matters and duties assigned to the IRB Member.
4. The restrictions and obligations upon IRB MEMBER under this Agreement concerning confidentiality shall begin on the date on which the Confidential Information is first received by IRB MEMBER and shall not apply to any portion of the Confidential Information which: 
   1. is known to IRB MEMBER prior to receipt thereof under this Agreement, as evidenced by competent proof;
   2. is disclosed to IRB MEMBER in good faith by a third party who is in lawful possession of the Confidential Information and who has the right to make such a disclosure; or
   3. is or shall have become part of the public domain, by publication or otherwise through no fault of IRB MEMBER;
   4. is independently developed by or for IRB MEMBER by persons who did not have access to the Confidential Information; or
   5. IRB MEMBER is required by law to disclose, provided that IRB MEMBER gives UK reasonable notice of its intent to disclose such Confidential Information.
5. This Agreement shall begin on the Effective Date and does not expire.

IN WITNESS WHEREOF, IRB MEMBER has duly executed this Agreement as of the Effective Date.

IRB MEMBER

{Insert signature}

{Insert printed name}

Date: {insert date}
Name of Person giving Statement: {insert name of person giving statement}

Position of the person giving the statement: 

• IRB Chair
• IRB Member
• UK administrator (specify position): {specify administrator position}
• Other (specify position): {specify position}

Federal regulations require that IRB members abstain from participating in an initial or continuing IRB review for a project in which the member has a conflicting interest (45 CFR 46.107e) except to provide information as requested.  IRB members who have a conflicting interest regarding a project, which is scheduled to undergo IRB review, should disclose the conflicting interest to the IRB.

To maintain the University of Kentucky IRB’s independence from researchers and sponsors and to avoid a conflict of interest, IRB members (including the spouse and dependent children of the IRB member) either do NOT have or will disclose a conflicting interest.

A conflict of interest involves any situation where an IRB member has any significant personal or financial interest.

Examples of a conflicting interest would be if the IRB member is: 

• Principal Investigator (PI);
• Co-Principal Investigator;
• Investigator receiving funding from the study, as listed in the study budget;
• In a supervisory role over the PI of the study, or
• Family member of PI.

A conflict of interest also occurs whenever an IRB member has a significant financial interest in the research proposal. A financial interest is defined as anything of monetary value, including, but not limited to:

• salary or other payments for services (e.g., consulting fees or honoraria);
• financial interests (e.g., stocks, stock options, or other ownership interests, excluding any interest arising solely by reason of investment in a business by a mutual, pension, or other institutional investment fund over which the IRB member or his/her immediate family does not exercise control);
• intellectual property rights (e.g., patents, copyrights, and royalties from such rights).

The term does NOT include: 

• Salary, royalties, or other remuneration from the University;
• Income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;
• Income from service on advisory committees or review panels for public or non-profit entities; or
• A financial interest that, when aggregated for the IRB member and the IRB member’s spouse and dependent children, meets both of the following tests: Does not exceed $5,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a 5% ownership interest in any single entity; or,
• Salary, royalties, or other payments that, when aggregated for the IRB member and the IRB member’s and dependent children over the next 12 months, are not expected to exceed $5,000.

I also recognize that the protection of human subjects requires objectivity in communicating risks, selecting subjects, promoting informed consent, and gathering, analyzing, and reporting data. Therefore, I will consider conflict of interest issues in my deliberation of applications, and when appropriate, will recommend that researchers include suitable disclosure statements and relevant information related to conflicting interests in informed consent documents.

By signing this document, I acknowledge that I have read the statement on conflict of interest and that I will notify the IRB of any potential conflicts of interest I may have on a protocol-by-protocol basis. 

Signature of IRB Member: {insert signature of IRB member} 

Date: {insert date signature is acquired} 

The IRB Chair and each IRB member should complete this form annually.   
A copy of the signed statement should be given to the person giving the affidavit.  

Date: {insert date} 

Name of Consultant receiving document: {insert date of consultant receiving document}

IRB Protocol Number: {insert IRB protocol number} 

U.S. Department of Health and Human Services (HHS) regulations [45 CFR 46.107(e)] stipulate that no IRB member may participate in the IRB’s initial or continuing review of a project in which the member has a conflicting interest, except to provide information requested by the IRB. The University of Kentucky has the same requirement for IRB consultants.

To maintain the University of Kentucky IRB’s independence from researchers and sponsors and to avoid a conflict of interest, IRB consultants either do NOT have or will disclose a conflicting interest.

A conflict of interest involves any situation where an IRB consultant has any significant personal or financial interest.

Examples of a conflicting interest would be if the IRB consultant is:

• Principal Investigator (PI);
• Co-Principal Investigator;
• Investigator receiving funding from the study, as listed in the study budget;
• In a supervisory role over the PI of the study; or
• Family member of PI.

A conflict of interest also occurs whenever an IRB consultant has a significant financial interest in the research proposal.  A financial interest is defined as anything of monetary value, including, but not limited to:

• salary or other payments for services (e.g., consulting fees or honoraria);
• financial interests (e.g., stocks, stock options, or other ownership interests, excluding any interest arising solely by reason of investment in a business by a mutual, pension, or other institutional investment fund over which the IRB member or their immediate family does not exercise control);
• intellectual property rights (e.g., patents, copyrights, and royalties from such rights).

The term does NOT include:

• Salary, royalties, or other remuneration from the University;
• Income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;
• Income from service on advisory committees or review panels for public or non-profit entities; or
• A financial interest that, when aggregated for the IRB consultant and the IRB consultant’s spouse and dependent children, meets both of the following tests: Does not exceed $5,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a 5% ownership interest in any single entity; or,
• Salary, royalties, or other payments that, when aggregated for the IRB consultant and the IRB consultant’s and dependent children over the next 12 months, are not expected to exceed $5,000.

Consultant recognizes that the protection of human subjects requires objectivity in communicating risks, selecting subjects, promoting informed consent, and gathering, analyzing, and reporting data. Therefore, the consultant must consider conflict of interest issues in his/her deliberation of applications, and when appropriate, will recommend that researchers include suitable disclosure statements and relevant information related to conflicting interests in informed consent documents.

Consultant is obligated to notify the IRB of any potential conflicts of interest the consultant may have prior to any review on a protocol-by-protocol basis. 

CONFIDENTIALITY AGREEMENT 

THIS CONFIDENTIALITY AGREEMENT is made this {insert day, ex. 5^th} day of {insert month}, {insert year} by {insert printed name} (hereinafter “CONSULTANT”) and the University of Kentucky (hereinafter “UK”).

WHEREAS, CONSULTANT may attend and/or review the UK Institutional Review Board (IRB) and/or Institutional Animal Care and Use Committee (IACUC) protocol(s) to assist in the review of applicable protocols and

WHEREAS, CONSULTANT will be exposed to certain confidential and possibly proprietary information during the review (hereinafter the “Confidential Information”); and

WHEREAS, UK is willing to allow the CONSULTANT to participate in the review so long as the CONSULTANT agrees to maintain the Confidential Information in confidence.

NOW, THEREFORE, in consideration of the mutual agreement set forth, CONSULTANT is obligated by the following:

1. CONSULTANT shall receive all Confidential Information received or discussed in the review as confidential information. This obligation of confidentiality extends to all information in whatever form, in whatever form disclosed, including, without limitation, oral and written disclosures, identities of participants, researchers, sponsors, and any information of any other type or nature revealed at the meetings.
2. CONSULTANT shall maintain the Information secret and confidential and, with the sole exception of discussions with the IRB and/or ORI staff as a part of the assessment process, shall not discuss it with or disclose it to third parties for any reason without prior written permission from UK.
3. The restrictions and obligations upon CONSULTANT under this Agreement concerning confidentiality shall expire five (5) years from the date on which the Information is first received by CONSULTANT and shall not apply to any portion of the Information which:
   1. is known to CONSULTANT prior to receipt thereof under this Agreement, as evidenced by competent proof;
   2. is disclosed to CONSULTANT in good faith by a third party who is in lawful possession of the Information and who has the right to make such a disclosure; or
   3. is or shall have become part of the public domain, by publication or otherwise through no fault of CONSULTANT;
   4. is independently developed by or for CONSULTANT by persons who did not have access to the information; or
   5. CONSULTANT is required by law to disclose, provided that CONSULTANT gives UK reasonable notice of its intent to disclose, such information.