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Exempt determinations do not expire; this process does not apply to Exempt research. 

Non-exempt research is approved for one year or less, depending on the level of risk. To maintain IRB Approval, investigators will submit an annual review to the IRB. Minimal risk research usually requires a Check-in (with a few exceptions) and more than minimal risk research requires a Continuing Review. eRA automatically generates the appropriate form for your research.

IRB Approval letters include the IRB Approval dates and the date in which the Continuing Review or Check-in should be submitted to the IRB. This is 90 days prior to the expiration date for Continuing Reviews and 30 days prior to the expiration date for Check-ins.

CU ��«����Ƶ's IRB Office will send out a reminder email before the protocol’s expiration date; however, it is the investigator’s responsibility to monitor approval/expiration dates to ensure the IRB approval does not expire.

STOP RESEARCH ACTIVITIES

There is no grace period extending the conduct of the research past the expiration date of an IRB approved protocol. Extensions will not be granted. All study research activities must stop after the expiration date. IRB approval must be obtained before the research activities can resume.

If a protocol is expired for more than 90 days, the protocol will be administratively closed by the IRB Office. A new application may be submitted for the continuation of the research, which will go through IRB review.

Continuing Review

Gather Relevant Documentation

• A copy of the most recent monitoring report, if the study is overseen by an independent monitoring body (e.g., Data Safety Monitoring Board report, Data Monitoring Committee report)
• Any relevant recent literature
• Any relevant multi-center trial reports
• IND reports

Note: DO NOT submit updated or revised research documents (Protocol, Consent Forms, etc.) in your Continuing Review. These documents must be submitted in a separate Amendment Submission. See Step 4 below.

Submit the Continuing Review via eRA

• Continuing Reviews are submitted to the IRB via . For step-by-step instructions, refer to “Continuing Review” in the eRA Submission Guides.

Check-in

No additional materials are required for Check-in submissions. Submit to the IRB using the same instructions as the Continuing Review. 

All changes related to IRB approved research must be reviewed and approved by the IRB before the changes may be implemented. This includes, but is not limited to, changes in study staff, recruitment, procedures and funding.

Amendments that may be reviewed using the expedited procedure may include:

• The addition or removal of key personnel
• Revisions to improve the clarity of statements or to correct typographical errors, provided that such a change does not alter the content or intent of the statement
• Changes in participant payment
• Adding or revising recruitment materials

Amendments that must be reviewed at a convened IRB meeting may include:

• The addition of a description of serious unexpected adverse events or other risks
• Substantial alteration to the research design or methodology
• Personnel or site changes that affect the qualifications of the research team or facilities available to support the safe conduct of research.

Submit the Amendment via eRA

Amendments are submitted to the IRB via . For step-by-step instructions, refer to “A����Ի峾��Գ�” in the eRA Submission Guides.

Events that fall into one or more of the categories listed below are reportable events that should be submitted to the IRB within 5 business days of the date when the Principal Investigator became aware of the event/information.

• New or Increased Risk/Safety Issue
  • New information (e.g., an interim analysis, safety monitoring report, publication in the literature, sponsor report, or investigator finding) indicates an increase in the frequency or magnitude of a previously known risk or uncovers a new risk
  • Protocol violation that harmed subjects or others or that indicates subjects or others might be at increased risk of harm
  • Complaint of a subject that indicates subjects or others might be at increased risk of harm or at risk of a new harm
  • An investigator brochure, package insert, or device labeling is revised to indicate an increase in the frequency or magnitude of a previously known risk, or describe a new risk
  • Withdrawal, restriction, or modification of a marketed approval of a drug, device, or biologic used in a research protocol
  • Changes significantly affecting the conduct of the clinical trial or increasing the risk to participants
• Harm experienced by a subject or other individual (e.g., adverse event), which in the opinion of the investigator are unexpected and probably related to the research procedures.
  • A harm is “unexpected” when its specificity or severity are inconsistent with risk information previously reviewed and approved by the IRB in terms of nature, severity, frequency, and characteristics of the study population.
  • A harm is “probably related” to the research procedures if in the opinion of the investigator, the research procedures more likely than not caused the harm.
• Non-compliance with the federal regulations governing human research or with the requirements or determinations of the IRB, or an allegation of such non-compliance
• Failure to follow the protocol due to the action or inaction of the investigator or research staff
• Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a subject.
• Breach of confidentiality
• Complaint of a subject that cannot be resolved by the research team
• Premature suspension or termination by the sponsor, investigator, or institution
• Incarceration of a subject in a study not approved by the IRB to involve prisoners
• Audit, inspection, or inquiry by a federal agency and any resulting reports (e.g., FDA Form 483)
• Written reports of study monitors
• Unanticipated adverse device effect (any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application [including a supplementary plan or application] or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects)

Any other protocol-related events or information that do not fall into these categories should be included in Continuing Review/Check-in submissions. 

Use to submit events (new information) to the IRB within 5 business days of the date when the Principal Investigator became aware of the event/information.

Submit the Event/New Information via eRA

Events (new information) are submitted to the IRB via . Follow steps 1-3 for the "Amendments" instructions in eRA Submission Guides but select "Reportable event" from the "Create New" menu.

A study is ready to be closed when the criteria below are met:

• The study is permanently closed to enrollment, AND
• All subjects have completed research-related interventions or interactions, AND
• All long-term subject follow-up activities are complete, AND
• Identifiable data are no longer needed and all data has been de-identified

Once a study is closed, no further human research, follow-up, or analysis of identifiable data can be performed.

Letting a study expire is not the same as closing a study. IRB approval must be maintained until the criteria above are met, then investigators should close the study.

To close a study, submit a Final Review submission in eRA. The information requested is the same for a Continuing Review as for a Final Review. Your responses in the Study Details - Current Protocol Status section will determine whether the study meets the criteria for closure and additional information will be requested.

Final Reviews are submitted to the IRB via . For step-by-step instructions, refer to “Final Review” in the eRA Submission Guides.