IRB FAQs

The IRB reviews research studies involving human subjects. The IRB is federally mandated to ensure that proper safeguards are in place to protect human subjects enrolled in research studies.

Research (DHHS): “A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.  Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes.  For example, some demonstration and service programs may include research activities”. [45 CFR 46.102(l)]

Human Subject (HHS):  “A living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or Obtains uses studies, analyzes, or generates identifiable private information or identifiable biospecimens.” [45 CFR 46.102(e)]

• Getting Started [HTML]
• New Researcher Frequently Asked Questions (FAQs) [HTML Interactive Tool] [PDF]

See the Getting Started webpage [HTML] for guidance and resources to navigate the IRB submission and review process. See the IRB Survival Handbook [HTML] for topical guidance documents and more. Announcements, events, and newsletters will be distributed on the IRB listserv and posted on the News & Announcements webpage [HTML]. Also see the Training & Education webpage [HTML] for information on mandatory training, workshops and conferences. To be added to ORI/IRB email distribution list, complete the subscription form.

Common IRB Acronyms & Abbreviations [HTML Interactive Tool]

The IRB considers a subject enrolled in a study when the subject signs a consent document.  Any screening or testing done for research purposes to determine subject eligibility should not be conducted prior to the subject agreeing and documenting their consent to participate in the research (except where waiver approved).

In cases where the IRB approves a waiver from the requirement for obtaining informed consent and/or a waiver from the requirement for documentation of informed consent, any individual on whom data has been collected should be counted as an enrolled subject.

*Reminder: Ensure compliance with clinicaltrials.gov registration requirements for applicable clinical trials

Clinical Research. NIH defines human clinical research as research with human subjects that is: (1) Patient-Oriented Research. Research Conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical studies, or (d) development of new technologies. (2) Epidemiologic and Behavioral Studies. (3) Outcomes Research and Health Services Research. Note: Studies falling under Exemption 4 for human subjects research are not considered clinical research by this definition. 

Clinical Trial. The NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. 

• The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of the clinical trial. 
• An intervention is defined as a manipulation of the subject or subject's environment for the purpose of modifying one or more health-related processes and/or endpoints. Examples include, but are not limited, to: drugs/small molecules/compounds, biologics, devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); and, treatment, prevention, and diagnostic strategies. 
• A health-related biomedical or behavioral outcome is defined as the pre-specified effect of an intervention on the study subjects. Examples include positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and/or information retention); disease processes; health-related behavior; and, well-being or quality of life. 
• Biomedical clinical trials of an experimental drug, treatment, device, or behavioral intervention may proceed through four phases: 
  Phase I. Tests a new biomedical intervention in a small group of people (e.g. 20-80) for the first time to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects). 
  Phase II. Study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and further evaluate safety. 
  Phase III. Study to determine efficacy of the biomedical or behavioral intervention in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the interventions to be used safely.
  Phase IV. Studies conducted after the intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.
  NIH-Defined Phase III Clinical Trial. For the purpose of the Guidelines an NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.

Faculty, staff or students from the Colleges of Medicine (UK Medical Center's Basic and Clinical Sciences Departments), Dentistry, Health Sciences, Public Health, Nursing, and Pharmacy, should present any research involving use of human subjects to the Medical Institutional Review Board (IRB) for review and approval prior to initiation of the project.

Faculty, staff, or students from the Colleges of Agriculture, Arts & Sciences, Business & Economics, Communication & Information, Design, Education, Engineering, Fine Arts, Law, Social Work or other Lexington Campus department should present any research involving the use of human subjects to the Nonmedical Institutional Review Board (IRB) for review and approval prior to initiation of the project. Please note the Nonmedical IRB does not review studies that involve administration of drugs or studies that involves invasive medical procedures.

The IRB conducts the following types of reviews [HTML]:

• Initial IRB Review for new protocols. Review types include Exemption Certification, Expedited or Full.
• Modification Review for changes made to IRB approved studies.
• Continuation Review is usually an annual review conducted by the IRB for ongoing approved studies.
• Review of Unanticipated/Anticipated Problems/Adverse Events associated with the study.
  
  Additional information is available through the Human Research Forms web page [HTML]. Please call ORI at 257-9428 if you have questions.

The document below includes information on submitting new or updating existing research which focuses on COVID-19.

Conduct and Submission of COVID-19 Research in Human Subjects [PDF]

Community-Engaged and Community-Based Participatory Research FAQs [PDF]

E-IRB web page [HTML]

E-IRB Frequently Asked Questions [FAQs] [HTML Interactive Tool]

The University of Kentucky (UK) uses a web-based IRB application system called E-IRB for review and approval of proposed research. E-IRB automatically generates an application specific to the researcher’s selections in the Protocol Type section (Medical IRB vs. Nonmedical IRB; Full Review vs. Expedited Review vs. Exemption Review). Additional sections within the E-IRB application prompt the researcher to answer required questions and provide pertinent information for the IRB to consider for approval. Materials the researcher may be required to attach to the application, if applicable, include (but not limited to):

• Informed Consent Documents (For additional information, see Instructions for Informed Consent Documents. [HTML])
• HIPAA forms to obtain protected health information (For additional information, see the HIPAA in Research. [HTML])
• Forms for study materials such as data collection instruments, recruitment materials (e.g., advertisements), off-site letters of support, etc. (Links for additional information pertaining to these materials are contained in the corresponding section of the E-IRB application.)
• A form for adults with impaired consent capacity (For additional information, see “Research Involving Adults with Impaired Consent Capacity" [HTML]). 
• Copy of grant(s), product related documents, other required committee reviews/approvals such as IBC, RDRC, etc.

For frequently asked questions (FAQs) regarding system, navigation, and procedural topics, see E-IRB Frequently Asked Questions [HTML Interactive Tool] and/or review applicable video tutorials in the secure online Video Tutorial Library. 

When you submit your IRB application to the Office of Research Integrity (ORI), your protocol materials will be assigned to an IRB meeting date. When the agenda for that meeting date is processed by ORI staff (approximately 10 days prior to the meeting date), your materials will be listed on the agenda.  Information about meeting dates is available on the Medical IRB meeting calendar or the Nonmedical IRB meeting calendar. [HTML, under IRB Meeting Dates]

Full reviews generally take longer to approve because the IRB must conduct the initial review (and sometimes subsequent reviews) at a convened meeting. A typical turnaround time for full review submissions includes:

• Protocol Submission: When an investigator submits a full review protocol, the E-IRB system schedules the application on the agenda for the next available IRB meeting. Medical IRBs meet every three weeks, and the Nonmedical IRB meets once a month. Protocols are scheduled “first-come, first-served” with a limited number of full reviews allocated per IRB meeting to ensure adequate time for discussion and deliberation.
• Initial IRB full review: IRB members receive the agenda for a convened meeting 7 working days in advance. Determinations for scheduled protocol reviews are made during the convened meeting.
• If the IRB committee requests revisions, ORI staff can take up to 3 working days to convey the IRB’s request. If the protocol is approved during the initial convened meeting, ORI staff may take up to 2 working days to communicate the determination.
• Additional IRB full review: If the IRB makes a ruling of minor revisions (directive or non-substantive changes), the IRB Chair is given the authority to approve the revisions through an expedited review procedure when they are submitted. In this instance, ORI staff can take up to 3 working days to screen revisions after the protocol has been resubmitted. The Chair reviewing the revisions can then take 10 working days to complete the review.
  
  If the IRB requests major (substantive) clarification or revisions, the revisions cannot be approved through the expedited review procedure (i.e., only by the IRB Chair). An entire convened board will review the major revisions at the next available convened meeting. In this instance, the revisions should be submitted before the close of the meeting agenda.

Factors That Can Impact the Review and Approval Process

• Screening and reviewing timelines are working days and do not include weekends or holidays.
• The amount of time it takes an investigator to respond to a request for revisions from the IRB reviewer. The longer the investigator needs or takes to resubmit the application, the longer the overall review and approval time.
• An IRB-requested consultant review of the application (e.g., due to subject population and/or non-English consent documents).
• Limited ORI staff or high volumes of protocol application submissions.

Generally, IRB approval can take between 4-6 weeks. However, not all submissions will take that long, and some approvals may take longer. General turnaround for an exempt or an expedited approval includes:

• Initial Screening: Once a protocol application is submitted, ORI staff may take up to 3 working days to either contact the investigator for further information or send for IRB review. This is the same for Initial Reviews (IR), Modification Requests (MR), Annual Administrative Reviews (AAR), Continuation Reviews (CR), or Other Reviews (OR).
• Additional Screening: If a protocol application is returned to the investigator with screening comments from ORI staff or request for revisions from the IRB reviewer, ORI staff may take up to 3 working days for an additional screening after the protocol is resubmitted by the investigator.
• Initial IRB review: Once a protocol application has been assigned an IRB reviewer, the IRB reviewer is asked to complete their review for an IR, MR, AAR/CR, or an OR within 10 working days.
• Additional IRB review: If the IRB reviewer requests revisions be made to the protocol application, ORI staff may take up to 3 working days to communicate the IRB request for revisions to the investigator. When the investigator resubmits the revised protocol application, the IRB reviewer is asked to complete review of the revisions within 10 working days.

Factors That Can Impact the Review and Approval Process

• Screening and reviewing timelines are working days and do not include weekends or holidays.
• The amount of time it takes an investigator to respond to screening comments from ORI staff or request for revisions from the IRB. The longer the investigator needs or takes to resubmit the application, the longer the overall review and approval time.
• An IRB-requested consultant review of the application (e.g., due to subject population and/or non-English consent documents).
• Limited ORI staff or high volumes of protocol application submissions.
• IRB reviewers who volunteer their time can sometimes experience unforeseen circumstances that require reassigning the protocol to another reviewer.

Send protocol questions to IRBSubmission@uky.edu with the IRB protocol number and your email will be routed to the appropriate staff member. You may also call the department at 859-257-9428, or reference the ORI staff directory [HTML] for individual contact information.

Yes. All investigators, and study personnel who interact and/or intervene with human subjects or handle personally identifiable data of a human subject must be trained in the protection of human subjects before IRB approval will be issued. Additional information is available on ORI's Human Subject Protection (HSP) Training FAQs web page. [HTML]

In July 2020, the University issued a Responsible Conduct of Research (RCR) training mandate for active faculty, graduate students, and UK personnel/students engaged in research at UK (i.e., listed on a grant, sponsored project, or research protocol). Additional information is available on the Responsible Conduct of Research & Scholarly Activity website. [HTML]

NOTE: For high school students who want to work with UK researchers, a process has been established  to verify that these students adhere to institutional guidelines. Please see the VPR COVID-19 FAQs for Researchers, "Can I host high school students in my research laboratory?", to review this process.

Review the University of Kentucky's Administrative Regulation on "Minors Involved in University-Sponsored Programs or Programs Held at the University" [PDF] and UK Risk Management Instructions for UK requirements [HTML]. At a minimum for the IRB, you should:

• add non-UK individuals to E-IRB [instructional video, login may be required] and submit a modification request [HTML] to add them as study personnel to applicable protocols;
• have the individual complete mandatory human subject protection (HSP) training [HTML] as well as any protocol-specific procedural training; and
• contact the ORI Reliance Team at IRBReliance@uky.edu to complete an Individual Investigator Agreement (IIA).

University of Kentucky researcher responsibilities are outlined in the guidance/policy document entitled "A Principal Investigator's Guide to Responsibilities, Qualifications, Records and Documentation of Human Subjects Research" [PDF].  See also ORI's IRB Survival Handbook web page. [HTML]

A student investigator (undergraduate, graduate, and postdoctoral students) must add a faculty advisor as study personnel to their protocol to meet the requirement of a University of Kentucky academic program. Additionally, faculty advisors must sign the Assurance Statement on the protocol to certify the scientific merit of the study, the qualifications of investigators, and the adequacy of the facility and resources needed to conduct the research. 

As a student’s faculty advisor, you accept a supervisory role in guiding the student in conducting regulatory compliant research. You must be certified in HSP and RCR training. You will sign the protocol assurance statement certifying that you have reviewed the research and attest to the scientific merit of the study, qualifications of the personnel, and adequacy of the facility and resources needed to conduct the research. For full review protocols, you are encouraged to accompany the student to the IRB meeting. Keeping an eye on requested revisions can enhance your IRB knowledge for the benefit of current and future students. See the ORI video training “Faculty Advisor Responsibilities” [HTML Video] which includes ORI tools to help your students succeed with human subject research.

Studies are regulated by the UK HIPAA Privacy Rule if the investigator obtains protected health information from a UK covered entity department.  A detailed explanation is available at the HIPAA in Human Research web page. [HTML]

The IRB Drug and Device section of the IRB application and the IRB Survival Handbook [HTML] provide guidance for a variety of FDA-regulated research. The ORI Interactive Medical Device Trials [HTML] and Drugs/Biologics Trials [HTML] Flow Charts can help in determining if and which regulations apply. For assistance contact the ORI Research Education Specialist Belinda Smith at 859-323-2446 or belinda.smith@uky.edu.

Yes. All changes (including study personnel changes) to a study must be approved by the IRB. Please use ORI's modification form when submitting changes to the IRB. The modification form is available on the Modification Requests web page. [HTML]

Universities are now charging a fee to commercial/industry sponsors of clinical trials for IRB-related expenses. This is either a single flat fee, or a fee for initial review. The funds generated by this fee are used to support the IRB and related expenses (e.g. educational initiatives). The industry sponsors are accustomed to this as an expected fee for clinical trial research projects.

University policy specified that budgets for commercially funded clinical projects should include a one-time fee of $3,000 (amount effective 2/1/17), listed as "IRB Review Fee". ORI sends a separate invoice to the company for this fee and the income will be deposited in an account other than the grant account.

This fee is separate from any start-up costs that the department may apply or any costs incurred through the UK Center for Clinical and Translational Science (CCTS). [HTML]

As we seek to accelerate UK's clinical research activities it is important that we have strong, well-supported systems for the protection of the individuals who participate in that research. By applying this fee we help support these vital activities and place UK in the mainstream of how such systems function and are supported.

The IRB Policy on Unanticipated Problem and Safety Reporting (Policy Effective 6/15/06; Revised 7/18/18) [PDF] outlines prompt internal and external reporting requirements.  To help understand how to differentiate between what needs to be reported as prompt vs. non-prompt, see the Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs) - Prompt/Non-Prompt Reporting. [PDF]

The reporting forms and instructions are available here [HTML].

University of Kentucky Investigator Quick Guide to IRB Reporting Requirements [D109.0000] [PDF]

Please see UK ORI's IRB Review Types webpage [HTML]

IRB policy requires investigators to maintain their research records (signed documents and IRB records) for six years after completion of the study.  For research which falls under authority of other agencies or statutes with longer research record retention requirements, the longer retention period applies.  For more details on Investigator recordkeeping responsibilities, see the Investigator Records and Documentation section in "A Principal Investigator’s Guide to Responsibilities, Qualifications, Records and Documentation of Human Subjects Research" [PDF].

When transferring IRB review and oversight of human research protocols from one IRB to another IRB, Federal Guidance [HTML] recommends that a plan for the transfer process be documented.  A written agreement between the original and receiving IRB should address how each will handle, and document as appropriate, the following eight steps: 

1. Identifying those studies for which IRB oversight is being transferred;
2. Ensuring the availability and retention of pertinent records;
3. Establishing an effective date for transfer of oversight, including records, for the protocol(s);
4. Conducting a review of the study(ies) by the receiving IRB, where appropriate, before it accepts responsibility for the study(ies); 
5. Confirming or establishing the date for the next continuing review;
6. Determining whether the consent form or other participant resources need to be revised (notification may be adequate for enrolled participants); 
7. Notifying the key parties, (investigators, sponsors, IRBs); and
8. IRB update to IRB registration [HTML] if applicable, (e.g., accepts FDA-regulated study and not registered to review FDA research).

Additional protocol specific actions may be necessary on a case-by-case basis. 

Data Transfer:

Consult the University’s Data Retention and Ownership Policy [HTML] for restrictions and requirements regarding data transfer.           

For additional details regarding Study Closure, see the ORI/IRB Study Closure SOP [PDF].

When a Principal Investigator (PI) leaves the University of Kentucky (UK), he/she should close his/her protocol(s) in E-IRB, or submit an E-IRB Modification Request (MR) [HTML] to transfer the protocol to another UK researcher. Transfer of a study to a different PI is considered a modification to the study and will require IRB review and approval.  The PI or researcher designated as an editor (DP)* on the E-IRB application can create a new MR and edit the "PI Contact Information" section of the application to reflect the new PI's contact information. When a PI or designee transfers a protocol, wherever applicable, the new PI or designee submits appropriate changes to consent forms, advertisements, etc. to the IRB for review. Additionally, the new PI and his/her Department Chair (or equivalent) completes a new Signature Assurance Statement in the “Signatures (Assurances)” section of the E-IRB application. An investigator assuming the role as PI should have applicable training and credentials to assume responsibility [PDF] for the study.

*It is recommended to have at least one study personnel designated as editor (DP) in case the current PI is not available. If the PI fails to transfer the protocol to another PI, no study personnel have access to perform a study closure, or extenuating circumstances warrant closure, ORI staff may administratively close the protocol before the end of the approval period in response to the request of or approval by the department chairperson or equivalent.

Data Transfer:

Consult the University’s Data Retention and Ownership Policy [HTML] for restrictions and requirements regarding data transfer.

For additional details regarding Study Closure, see the ORI/IRB Study Closure SOP [PDF].

For IRB determination issues, contact the applicable IRB Committee. Go to the Contact Us webpage [HTML] to contact a specific staff member or submit feedback anonymously on our customer service form. If the issue is regarding ORI or administrative procedures, contact ORI Director, Dr. Helene Lake-Bullock.

You can also request a consultation if you aren’t sure who to ask. Consultations are offered for studies in development as well as approved research projects. Provide the E-IRB protocol number for approved or submitted studies. Click here to submit a request for consult.

We host Office Hours events as well, for your convenience. You’re welcome to drop in with any questions about current research, developing projects, the E-IRB system, and more! A variety of staff will be available to answer questions and provide support in real time. View upcoming dates here.

Any activity that meets the federal definition of both "Research" and "Human Subjects" or the Food and Drug Administration (FDA) definition of "Clinical Investigation" requires review and approval by the University of Kentucky (UK) IRB. Additional information on this topic is available at the What Needs IRB Review webpage [HTML] and in ORI's Guidance/Policy Document: When do activities involving human subjects need Institutional Review Board (IRB) review and approval? [PDF]

Research (DHHS): “A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.  Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes.  For example, some demonstration and service programs may include research activities”. [45 CFR 46.102(l)]

Human Subjects (Department of Health & Human Services definition) - Human Subject (HHS):  “A living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or Obtains uses studies, analyzes, or generates identifiable private information or identifiable biospecimens.” [45 CFR 46.102(e)]

Human Subjects (FDA definition) - "An individual who is or becomes a participant in research either as a recipient of a test article or as a control. A subject may be either a healthy human or a patient". [21 CFR 56.102(e)] (Drug, Food, Biologic)

Human Subjects (FDA for medical devices definition) - "A human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or who participates as a control. A subject may be in normal health or may have a medical condition or disease" [21 CFR 812.3(p)] (Device).

Additional information on this topic is available in ORI's Guidance/Policy Document: When do activities involving human subjects need Institutional Review Board (IRB) review and approval? [PDF]

If the study meets the definition of "research" and "human subjects", the study requires IRB review. See the Guide for Determining When Protocols Involving Coded Private Information or Biological Specimens Meet the Federal Definition of "Human Research" [PDF]. Please note that all studies involving fetal tissue require IRB review even if they don't meet the definition of "research" and "human subjects".

If the drug, device or biologic is investigational, then the IRB must confirm the FDA criteria for emergency use are met.

If the drug, device or biologic is:

1. approved, and
2. does not need an IND or IDE, and
3. is being used off label or as marketed for clinical care,

then the IRB does not need to confirm FDA criteria for emergency use are met.

Please call ORI at 859-257-9428 if you have questions.

If you are completing the study as a UK student or UK faculty member, your research should receive review by UK's IRB.

Graduate work (thesis or dissertation) which involves research on human subjects requires IRB Review.

Class project or assignments involving collection of data from human subjects may or may not meet the definition of research. Course instructors are responsible for making the decision whether the activities meet the definition of research. Course instructors are encouraged to call ORI if they have any questions.

Basically a consent form is a written document that explains the research study to potential subjects. This document is signed by the subjects and must contain information/statements to ensure that subjects are fully informed about the study. ORI's Informed Consent/Assent web page [HTML] contains consent templates. The Investigator should use the templates when developing a consent form. 

Please note that the IRB may waive consent procedures for some research proposals.

Upon approval, the E-IRB system stamps Informed Consent documents with an Approved Stamp indicating the Approval Date. Each time you receive a newly approved consent/assent document, all previously approved consent/assent documents are then considered invalid for enrollment of subjects. 

The system does not add an Expiration Date to the stamp.  Generally, researchers are not permitted to make changes in consent/assent form(s) without prior IRB review and approval.  However, the IRB does allow researchers to add text that serves as an internal tracking mechanism as long as it does not affect the information in the consent document, or confuse potential research participants.  For example, researchers may add version numbers or consent form expiration dates in the footer of the document for tracking purposes or to facilitate compliance.

See the brief video, "Waiver of Consent vs. Waiver of Documentation of Consent" [HTML Video, 04:15 minutes], or call ORI at 859-257-9428 for guidance.

Guidance for using informed consent templates based on the revised Common Rule regulations 1/2/18 [PDF]

If the IRB has not reviewed and approved a research study by the end of the approval period specified by the IRB, all research activities must cease, including recruitment and enrollment of subjects, consent, interventions, interactions and data collection, unless the IRB concludes it is in the best interests of individual subjects to continue participation in the research interventions or interactions. The protocol may expire even if the investigator has provided the continuing information before the expiration date, if the IRB was unable to review the materials due to the time of receipt, non-inclusion of required information or other delays ensue.

Full-Board and FDA-Regulated studies may be approved by the IRB for up to one year.  Continuing review (CR) must be conducted to prevent a protocol approval from expiring. If a protocol expires, the investigator must cease all research activities and may not enroll new subjects in the study. Approximately 90 days before the approval period expires, the principal investigator will receive a reminder notice which will recur monthly until the project is submitted or expires. to give investigators ample time to submit and disperse submissions so that the IRB can accommodate the volume. 

How the CR approval date works:

So, while a study is approved for up to a year, some of that time must be used to obtain CR approval. The next cycle starts on the date of the convened meeting in which the study was approved or approved pending minor revisions. Therefore, the next annual cycle will not have identical dates to the first cycle. However, this should not be a concern, as the investigator can continue to conduct research while the CR is pending. 

Why submitting your CR submission early is best practice? 

1. The boards meet every three weeks, but submitting early provides time for the IRB to conduct its review at a convened meeting.
2. If the investigator makes or IRB requests revisions, adequate time is needed for screening and placing the CR on a full-board meeting agenda.
3. Investigators can not submit a modification request (MR) while a CR is pending. 
4. To reactivate an expired protocol, the investigator must complete the CR and resubmit an initial review application.  It is much less work to complete the CR on time. 

To save time, download a sample CR form in advance to begin collecting the information that will be requested with the CR. 

Non-FDA regulated Expedited protocols approved after January 21, 2019, qualify for an Annual Administrative Review.  The review consists of four items:

1. Status of the research;
2. If subjects were enrolled in the last year, consent forms from the last 2 subjects;
3. If still enrolling subjects, a clean consent form(s) for stamping;
4. If an Unanticipated Problem/Adverse Event occurred in last 12 months (IRB expectation is that any events meeting prompt criteria have been reported), a summary of unanticipated problems/adverse events since the last review with assessment of whether events warrant changes to the protocol, consent process, or alter risk/benefit ratio.

The IRB reviewer may request additional information or request a complete continuation review submission.  

The principal investigator (PI) is responsible for promptly submitting a closure request of an IRB-approved study to the Office of Research Integrity if any of the following conditions exist:

1. All research/clinical investigation activities including data analysis and reporting are complete;
2. The PI never initiated the study;
3. Accrual for the study is finished, all data collection is complete and the only remaining activity is analysis of the data and:
   i. Data are de-identified; or
   ii. Data with identifiers for studies subject to the Revised Common Rule (approved on or after January 21, 2019) are encrypted; or
   iii. For FDA-regulated studies, there are no outstanding data queries or other investigator/site responsibilities in the trial (confirm with external study sponsor);

4. The PI plans to leave the University and intends to continue the research activities at another institution;

5. The study has been open for a period of three (3) or more years and the PI has enrolled no subjects in the study, collected no data from records, and/or collected/received no specimens.

• Study Closure SOP [C4.0200] [PDF]
• Two circumstances when IRB approved active protocols may be closed by the PI and/or the IRB [D76.0000] [PDF]

A PI cannot close an active IRB approval if:

1. 1. Interaction or intervention with currently enrolled subjects is still occurring
   2. Data is being collected from currently enrolled subject and or samples

To submit a study closure, log into E-IRB.  Click “Continuation (CR) or Study Closure” and complete the application process.