IRB Review Continuation Review (CR)/Annual Administrative Review (AAR)

Continuation/Annual Administrative Review SOP [C2.0250]

To initiate a Continuation Review (CR)/Annual Administrative Review (AAR), or Final Review (FR) for closure, find your application under the Approved folder.  Open your application by clicking on the IRB # and selecting the "Continuation Review (CR) or Study Closure" menu option under the “Create” bar.  Then follow the prompts for completing the CR/AAR/Closure.  If you (or someone else on your research team) have already performed this step, but have not submitted yet, you will find the incomplete CR/AAR/FR in your Draft folder.

• Food and Drug Administration (FDA) Continuing Review After Study Approval
  Guidelines from the Food and Drug Administration (FDA) Information Sheets.
• Office for Human Research Protections (OHRP) Compliance & Reporting
  This web page provides information regarding types of determinations, the determination of noncompliance issued over several years, etc.
• Office for Human Research Protections (OHRP) Guidance on Continuing Review  - November 2010
  This document describes the requirements of Department of Health and Human Services (HHS) regulations at 45 CFR 46.109(e) for the continuing review of human subjects research by an Institutional Review Board (IRB).
• UK ORI Requested Revisions from a Full Review - Major versus Minor Determination
  Guidance on whether a convened IRB request should be designated as minor (vote #2) or major (vote # 3 or 4)

Tips developed to help researchers with the submission of Continuation Review materials.

For full-review, pre-2019 expedited and FDA-regulated protocols, the IRB approval period can extend no longer than one year after the start of the approval period. In accord with federal regulations, the IRB conducts a Continuing Review (CR) prior to continuing the IRB approval. 

It is critical to complete the CR in a timely manner to allow time for IRB review and IRB-requested revisions, if any, and to prevent a lapse of IRB approval.  If a lapse of approval occurs, no research activities may be conducted, and a new application would need to be submitted to continue the research.

The following are tips or explanations to guide investigators in completing the CR report.

• Advance awareness: When you receive your initial IRB approval, take a quick look at the sample Continuation Review (CR) Report to develop a systematic plan for collecting the requested information as the study progresses.
• CR Reminders: You will begin receiving prompts to complete the CR approximately three months in advance of the expiration date. Respond to the first notice.  Submission of the CR close to the end of the current approval period may result in a lapse of approval, as the IRB may not have adequate time to review the CR materials.
• On your dashboard in E-IRB, click Create New… Continuation Review (CR): You will see a list of protocols eligible for Continuing Review.
• CR involves TWO processes:
  1. Complete the CR report page.
  2. Update all applicable sections of the application (e.g., subject demographics, research description, etc.)
• SAVE the CR Report each time you leave the page to update sections of the application. Click SAVE at the bottom of each section of the application you edit or change.
• At CR, remove all old attachments that are no longer in use or not applicable.  Removed attachments are always available for review under Protocol History.
• Item 2, Signed consent/assent forms: Before attaching copies of the signed consent forms, check the signature on the ‘name of [authorized] person obtaining informed consent’ signature line to make sure it is legible. If it is not, print the name underneath the signature.  This also applies to the ‘signature of investigator’ line.
• Item 3, Informed Consent: If requesting changes to the consent/assent/cover letter, submit one copy with the changes highlighted (and designate Document Type as "Highlighted"), and one clean copy in PDF (without the changes highlighted) for stamping. After this step, please delete any outdated consent/assent/cover letter you have replaced, as the outdated copy will no longer be relevant to the application moving forward.
• Item 5, Enrolled subjects: The CR Report asks for the number of subjects enrolled. The IRB considers a subject “enrolled” when the subject signs a consent document.  In cases where the IRB approves a waiver for the informed consent requirement or a waiver of documentation of informed consent, any individual on whom data has been collected should be counted as an “enrolled” subject. 
• Item 6, Data Safety and Monitoring: If a data safety monitoring plan or board are applicable to the study, include any reports, literature, meeting minutes, or assessments related to safety monitoring activities, even if no safety issues have been identified and the recommendation is for the research to continue.
• Item 11, Study personnel: Ensure personnel are up to date on their human subjects protection training.
• Item 12, Progress of Research:  Update applicable sections of the research description, including changes based on revised versions of sponsor protocols. The IRB expectation is that the Research Description is current and up-to-date. For reference, when summarizing modifications approved since the initial or last continuing review, refer to the Protocol History.
• Item 14, Subject demographics: The CR Report includes a demographic table that requests a breakdown of the total number of subjects enrolled by ethnic /racial category and gender. The sum total number of subjects listed in the demographic table (#14) should equal the number in the fourth box under #5, total number of subjects enrolled (or records/specimens reviewed) since activation of the study. When the numbers do not match, provide a brief explanation.
• After saving the completed CR report, go to the Submission Section and click Submit to send the report to ORI. 

Please note that the SAMPLE CR or AAR report does not contain protocol-specific data, and you should not complete and submit this form to meet the requirements for Continuation Review or Annual Administrative Review. 

In accordance with federal regulations and/or local policies, the IRB conducts periodic review of all currently approved projects. If you need your IRB approval to continue and you do not complete and submit the required materials in a timely manner, IRB approval will expire at the end of your current approval period. 

If you have any questions, please contact the Office of Research Integrity at 859-257-9428 or via email. 

To initiate your continuation review (CR)/annual administrative review (AAR), or properly close your study, complete this section and update/correct all other sections of your IRB application as applicable. 

***IMPORTANT*** Before leaving this page to update other sections of your application, be sure to SAVE this section first.

1. Status of the Research

Check the statement(s) that best describe(s) the current status of your research: 

• No subjects have enrolled to date. 
• Recruitment and/or enrollment of new subjects or review of records/specimens continue. 
• Study is closed to enrollment, but subjects still receive research-related interventions (e.g., treatment, blood draws). 
• Study enrollment is permanently closed; subjects have completed all research-related interventions; and the study remains active only for long-term follow-up of subjects (see Tool Tip above for info on long-term follow-up of subjects).* 
• Research has progressed to the point that it involves 1) Data analysis, including analysis of identifiable private information or identifiable biospecimens; and/or 2) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.* 
• The remaining research activities are limited only to data analysis. There is access to records or specimens either directly or through codes or links to the data.* 
• The remaining research activities are limited only to data analysis. There is no subject/record/specimen identifying codes or links to the data; the researcher or research team cannot readily ascertain the subject's identity.* 
• All study activities are complete. IRB approval can be inactivated. 
• *Possibility that review will move from Full to Expedited.

2. If subjects have been enrolled within the last year, and the IRB approved a consent/assent form for your study: 

Please attach a complete, signed copy of the last two subjects enrolled with each consent/assent form/HIPAA form since the last annual review. 

(Example: If 3 different approved consent forms were used since the last annual review, please provide the two most recent signed copies of each version for a total of six.) 

3. Informed Consent 

If the study is open to subject enrollment, please go to the Informed Consent section of the E-IRB Application and verify attachment(s) include: 

• One clean copy in PDF (without the IRB Approval stamp) of the currently approved consent/assent document(s), or, 
• If requesting changes to the consent/assent document(s), submit one copy with the changes highlighted (and designate Document Type as "Highlighted"), and one clean copy in PDF (without the changes highlighted). 

If the study is open to subject enrollment and the IRB has waived the requirement to document informed consent, please go to the Informed Consent section of the E-IRB Application and verify attachment(s) include: 

• One clean copy in PDF of the currently approved document used for the informed consent process (e.g., cover letter, phone script), or, 
• If requesting changes to the consent/assent document(s), submit one copy with the changes highlighted (and designate Document Type as "Highlighted"), and one clean copy in PDF (without the changes highlighted).

If the study is closed to subject enrollment, please go to the Informed Consent section of the E-IRB Application and remove Informed Consent Documents designated to get an IRB approval stamp to avoid having them appear valid for enrollment.

4. Unanticipated Problems Involving Risk to Subjects or Others/Adverse Events Summary & Assessment 

Did any problems/adverse events occur during the last 12 months? 

• Yes 
• No 

In the space below, provide a written summary of both unanticipated problems* and available information regarding adverse events since the last review (e.g., initial review or annual/continuing review). The amount of detail provided in such a summary will vary depending on the type of research being conducted; in many cases, such a summary could be a brief statement that there have been no unanticipated problems and that adverse events have occurred at the expected frequency and level of severity as documented in the research protocol, the informed consent document, and investigator’s brochure (if applicable). The summary must include the PI’s assessment of whether the problems/adverse events warrant changes to the protocol, consent process, or risk/benefit ratio. 

Note: It is the IRB's expectation that all unanticipated problems involving risk to subjects or others or related deaths requiring prompt reporting are submitted in the appropriate time frame (See Policy). Your response to this Annual/Continuing Review is considered assurance that all prompt reportable problems/adverse events have been submitted for IRB review.

Enter information

*For multisite studies, the written summary should describe external events determined to be unanticipated problems involving risk to subjects or others.

5. Subject Info To-Date 

Our records for the previously approved IRB application indicate the IRB-approved estimate of subjects to be enrolled (or records/specimens reviewed) is: 

Enter the number of enrolled subjects (or records/specimens reviewed) that have not been previously reported to the IRB.

Please refer to the Project Information section of the last approved application for this information.

Our records for the previously approved IRB application indicate the previous total # of subjects enrolled (or records/specimens reviewed) since activation of the study is: 

Please refer to the last approved Continuation Review for this information.

The new total number of subjects enrolled (or records/specimens reviewed) since activation of the study: 

Please provide the calculation.

Please review the Project Info section for the IRB-approved estimate of subjects to be enrolled (or records/specimens reviewed). If this new total exceeds your approved estimate of subjects to be enrolled (or records/specimens reviewed), please update the number in the field for Number of Human Subjects in the Project Info section.

6. Data and Safety Monitoring Board (DSMB)/Plan (DSMP) 

If your study is monitored by a DSMB or under a DSMP, attach all documentation (i.e., summary report; meeting minutes) representing Data and Safety Monitoring activities that have not been previously reported to the IRB.

(Attachment)

7. Since the most recent IRB Initial/Continuation Review Approval: 

Have there been any participant complaints regarding the research? 

• Yes 
• No 

If yes, in the field below, provide a summary describing the complaints.

Enter information.

Have any subjects withdrawn from the research voluntarily or by you as the PI for reasons related to safety, welfare, or problems related to the conduct of the research? If a participant does not meet the screening criteria for a study, even if they signed a screening consent, it is NOT considered a withdrawal. 

• Yes 
• No 

If yes, in the field below, provide a detailed explanation of the withdrawal(s), including if participants were lost to contact.

Enter information.

Has any new and relevant literature been published since the last IRB review, especially literature relating to risks associated with the research? 

• Yes 
• No 

If yes, attach a copy of the literature as well as a brief summary of the literature, including, if pertinent, the impact of the findings on the protection of human subjects.

(Attachments)

Have there been any interim findings? 

• Yes 
• No 

If yes, attach a copy of Interim Findings.

(Attachments)

Have subjects experienced any benefits? 

• Yes 
• No 

If yes, in the field below, provide a description of the benefits subjects have experienced.

Enter information.

Have there been any inspections/audits/quality improvement reviews of your research protocol resulting in the need for corrective action in order to protect the safety and welfare of subjects? 

• Yes 
• No 

If yes, please attach documentation evidencing the outcome(s) and any corrective action(s) taken as a result. 

(Attachments)

Was an FDA 483 issued as a result of any inspections/audits? 

• Yes 
• No 

If yes, submit documentation using the attachment button above.

8. Risk Level: 

Our records for the previously approved IRB application show your research is: 

Risk Level: Please refer to the Risk Level section of the last approved application for this information.

Has something during the course of your research changed the level of risk? 

• Yes 
• No 

If yes, go to the Risk Level section, mark the appropriate risk level, and in the field below, describe why the risk level has changed:

Enter information.

9. Funding/Support: 

Our records for the previously approved IRB application indicate your research is being submitted to, supported by, or conducted in cooperation with the following external or internal agency or funding program(s):

• Grant application pending 
• (HHS) Dept. of Health & Human Services 
  • (NIH) National Institutes of Health 
  • (CDC)Centers for Disease Control & Prevention 
  • (HRSA) Health Resources and Services Administration 
  • (SAMHSA) Substance Abuse and Mental Health Services Administration 
• (DoJ) Department of Justice or Bureau of Prisons 
• (DoE) Department of Energy 
• (EPA) Environmental Protection Agency 
• Federal Agencies Other Than Those Listed Here 
• Industry (Other than Pharmaceutical Companies) 
• Internal Grant Program w/ proposal 
• Internal Grant Program w/o proposal 
• National Science Foundation 
• Other Institutions of Higher Education 
• Pharmaceutical Company 
• Private Foundation/Association
• U.S. Department of Education 
• State 
• Other: Enter information.

Please update the Funding/Support section of your IRB application if needed, including the following attachments if they contain changes not previously reported to the IRB: 

• A current copy of your protocol if you are conducting industry/pharmaceutical research; 
• A current Investigator Brochure (submit a copy with all changes underlined). 
• A new or revised grant application for this project. 

Did your project receive extramural funding? 

• Yes 
• No 

If yes, please review and correct if necessary, the OSPA Account # information under the Funding/Support section of your IRB application. 

If the project is externally funded, has the sponsor offered any of the research team enrollment incentives or other personal benefit bonuses? (e.g., cash/check, travel reimbursements, gift checks, etc.) 

• Yes 
• No 
• N/A 

Note: It is University of Kentucky policy that personal benefit bonuses are not allowed. If these conditions change during the course of the study, please notify the IRB.

10. Project Information 

Our records for the previously approved IRB application indicate your estimated project end date is: 

Please refer to the Project Information section of the last approved application for this information.

If you have a new estimated project end date, please go to the Project Info section and change the date in the field for Anticipated Ending Date of Research Project.

11. Study Personnel 

Our records for the previously approved IRB application indicate the following individuals are study personnel on this project (if applicable): 

Refer to the Study Personnel section in your last approved application.

Please review the individuals listed above and update your records as needed in the Study Personnel section of the E-IRB application, being sure that each individual listed has completed or is up-to-date on the mandatory human research protection training [see the policy on Mandatory Human Subject Protection Training FAQs (required every three years)].

12. Progress of the Research

To meet federal requirements, the IRB is relying on your RESEARCH DESCRIPTION as a protocol summary, and their expectation is that it is up-to-date. If the currently approved protocol (or research description) in your E-IRB application is outdated, please make applicable changes, and describe in the field below any substantive changes and explain why they are essential. If none, insert "N/A" in the text field below. If you are closing your study, you may use the space below to summarize the final status of the research.

Enter information.

Note: No changes in the research procedures should have occurred without previous IRB review. Approval from the IRB must be obtained before implementing any changes. 

Provide a brief summary of any modifications that affect subject safety and/or welfare approved by the IRB since the last initial or continuation review (If none, insert "N/A" in the text field below.):

Enter information.

Attach one copy of the most recent progress report sent to the FDA, if available. All PI-sponsored IND/IDE studies are required to submit a copy of the FDA progress report.

(Attachments)

13. Confidentiality/Security 

Review your Research Description section and update the Confidentiality portion, if necessary, to describe measures for security of electronic and physical research records (e.g., informed consent document(s), HIPAA Authorization forms, sensitive or private data).

14. Subject Demographics 

Our records for the previously approved IRB application indicate the following categories of subjects and controls are included in your research: 

• Children (individuals under age 18) 
• Wards of the State (Children) 
• Emancipated Minors 
• Students 
• College of Medicine Students 
• UK Medical Center Residents or House Officers 
• Impaired Consent Capacity Adults
• Pregnant Women/Neonates/Fetal Material 
• Prisoners 
• Non-English Speaking 
• International Citizens 
• Normal Volunteers 
• Military Personnel and/or DoD Civilian Employees 
• Patients 
• Appalachian Population

Please refer to the Subject Demographics section of the last approved application for this information.

Please review the Subject Demographics section of your IRB application for accuracy, and note the following: 

If during the course of your research 1) any prisoners have been enrolled, OR 2) subjects have been enrolled that became involuntarily confined/detained in a penal institution that have not been previously reported to the IRB, go to Subject Demographic section in your EIRB application and mark “prisoners” in the categories of subjects to be included in the study, if it is not already marked. 

Note: If either 1 or 2 above apply, and you have received funding from the Department of Health and Human Services (HHS), a Certification Letter should have been submitted to the Office for Human Research Protections (OHRP); prisoners and individuals who have become involuntarily confined/detained in a penal institution cannot continue participation in the research until OHRP issues approval. If the Certification has not been submitted, contact the Office of Research Integrity. 

Based on the total # of subjects who have enrolled, complete the subject demographic section below:

Participant Demographics

If unknown, please explain why:

Enter information.

15. Research Sites 

Our records for the previously approved IRB application indicate that you are conducting research at the following sites: 

Please refer to the Research Sites section of the last approved application for this information.

UK Sites

• UK Classroom(s)/Lab(s) 
• UK Clinics in Lexington 
• UK Clinics outside of Lexington 
• UK Healthcare 
• Good Samaritan Hospital 
• UK Hospital

Schools/Educational Institutions

• Fayette Co. School Systems* 
• Other State/Regional School Systems 
• Institutions of Higher Education (other than UK)

Other Medical Facilities

• Bluegrass Regional Mental Health Retardation Board 
• Cardinal Hill Hospital 
• Eastern State Hospital 
• Nursing Homes 
• Shriner’s Children’s Hospital 
• Other Hospitals and Med. Centers

Other

• Correctional Facilities 
• Home Health Agencies 
• International Sites 
• Other: Enter information.

If the above-listed sites are not accurate, go to the Research Sites section of the E-IRB application to update the facilities at which research procedures have been or will be conducted. 

If you are adding a new off-site facility, you may also need to update your E-IRB application's Research Description, Research Sites, Informed Consent, and other affected sections, as well as any documents that will list the off-site facility. Documents needing updating may include, but are not limited to: 

• Consent forms (attachment under Informed Consent section) 
• Brochures (attachment under the Additional Info section) 
• Advertisements (attachment under Research Description section); 
• Letter of support (attachment under Research Sites section). Please revise applicable sections and attachments as necessary.

16. Disclosure of Significant Financial Interest

Our records for the previously approved IRB application indicate that you, your investigators, and/or key personnel (KP) have a significant financial interest (SFI) related to your/their responsibilities at the University of Kentucky (that requires disclosure per the UK administrative regulation 7:2): 

• Yes 
• No 

If you need to update your records, please go to the PI Contact Information section and/or Details for individuals listed in the Study Personnel section to change your response to the applicable question(s).

17. Supplementals 

To ensure the IRB has the most accurate information for your protocol, you are expected to revisit the E-IRB application sections and make corrections or updates as needed. At a minimum, you are being asked to review the following sections for accuracy: 

STUDY DRUG INFORMATION—Please review for accuracy. 

STUDY DEVICE INFORMATION—Please review for accuracy. 

RESEARCH ATTRIBUTES—Please review for accuracy. 

OTHER REVIEW COMMITTEES -- Please review for accuracy. 

If applicable, submit one copy of the entire signed HIPAA Authorization form for the same last TWO subjects enrolled.

(Attachments)

Please note that the SAMPLE CR or AAR report does not contain protocol-specific data, and you should not complete and submit this form to meet the requirements for Continuation Review or Annual Administrative Review. 

In accordance with federal regulations and/or local policies, the IRB conducts periodic review of all currently approved projects. If you need your IRB approval to continue and you do not complete and submit the required materials in a timely manner, IRB approval will expire at the end of your current approval period. 

If you have any questions, please contact the Office of Research Integrity at 859-257-9428 or via email. 

To initiate your continuation review (CR)/annual administrative review (AAR), or properly close your study, complete this section and update/correct all other sections of your IRB application as applicable. 

***IMPORTANT*** Before leaving this page to update other sections of your application, be sure to SAVE this section first.

1. Status of the Research

Check the statement(s) that best describe(s) the current status of your research: 

• No subjects have enrolled to date. 
• Recruitment and/or enrollment of new subjects or review of records/specimens continue. 
• Study is closed to enrollment, but subjects still receive research-related interventions (e.g., treatment, blood draws). 
• Study enrollment is permanently closed; subjects have completed all research-related interventions; and the study remains active only for long-term follow-up of subjects (see Tool Tip above for info on long-term follow-up of subjects).* 
• Research has progressed to the point that it involves 1) Data analysis, including analysis of identifiable private information or identifiable biospecimens; and/or 2) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.* 
• The remaining research activities are limited only to data analysis. There is access to records or specimens either directly or through codes or links to the data.* 
• The remaining research activities are limited only to data analysis. There is no subject/record/specimen identifying codes or links to the data; the researcher or research team cannot readily ascertain the subject's identity.* 
• All study activities are complete. IRB approval can be inactivated. 

*Possibility that review will move from Full to Expedited.

2. If subjects have been enrolled within the last year, and the IRB approved a consent/assent form for your study: 

Please attach a complete, signed copy of the last two subjects enrolled with each consent/assent form/HIPAA form since the last annual review. 

(Example: If 3 different approved consent forms were used since the last annual review, please provide the two most recent signed copies of each version for a total of six.)

(Attachments)

3. Informed Consent 

If the study is open to subject enrollment, please go to the Informed Consent section of the E-IRB Application and verify that attachment(s) include: 

• One clean copy in PDF (without the IRB Approval stamp) of the currently approved consent/assent document(s), or, 
• If requesting changes to the consent/assent document(s), submit one copy with the changes highlighted (and designate Document Type as "Highlighted"), and one clean copy in PDF (without the changes highlighted). 

If the study is closed to subject enrollment, please go to the Informed Consent section of the E-IRB Application and remove Informed Consent Documents designated to get an IRB approval stamp to avoid having them appear valid for enrollment.

4. Unanticipated Problems Involving Risk to Subjects or Others/Adverse Events Summary & Assessment 

Did any problems/adverse events occur during the last 12 months? 

• Yes 
• No 

In the space below, provide a written summary of both unanticipated problems* and available information regarding adverse events since the last review (e.g., initial review or annual/continuing review). The amount of detail provided in such a summary will vary depending on the type of research being conducted; in many cases, such a summary could be a brief statement that there have been no unanticipated problems and that adverse events have occurred at the expected frequency and level of severity as documented in the research protocol, the informed consent document, and investigator’s brochure (if applicable). The summary must include the PI’s assessment of whether the problems/adverse events warrant changes to the protocol, consent process, or risk/benefit ratio. 

Note: It is the IRB's expectation that all unanticipated problems involving risk to subjects or others or related deaths requiring prompt reporting are submitted in the appropriate time frame (See Policy). Your response to this Annual/Continuing Review is considered assurance that all prompt reportable problems/adverse events have been submitted for IRB review. 

Enter information.

*For multisite studies, the written summary should describe external events determined to be unanticipated problems involving risk to subjects or others.