Existing Research Submissions

IRB Approval Expiration

Continuing Reviews

While the IRB Office makes every effort to notify the Principal Investigator (PI) of the need to renew the approval of existing research studies, ultimate responsibility lies with the PI to make sure his/her study approvals do not expire or lapse.

The forms for continuing reviews are located in the Forms section of this page.

• Approval will be granted for up to one year. However, studies involving more than minimal risk may require continuing review at a shorter interval.
• Studies that initially received full board review will continue to receive full board review for the duration of the project, unless the scope of the study changes such that it would qualify for a lower level of review.
• Investigators of exempt research projects are required to notify the IRB Office when they want to make changes to their project or when their project is completed.

Timeframe for Continuing Reviews

The timeframe varies based on the level of review required and when the project is submitted; generally, it takes approximately one month for a continuing review to be reviewed by the full board and two weeks for expedited review.

Failure to Review

If a study does not receive approval from the IRB to continue the research prior to the expiration date, the investigator will receive notification. Once a study expires, all research activities must stop, including enrollment of new participants, interaction with current participants and analysis of identifiable data.

Changes and Amendments to Existing Study

Investigators must report any changes whatsoever, regardless of the level of the original review and regardless of their assessment of the importance of the change.

The IRB requires that any proposed changes in approved research be reviewed and approved prior to implementing these changes to determine whether the modified research continues to fulfill the criteria for approval.

Investigators may request approval of proposed changes by the completion and submission of the Amendment/Modification Form located in the Forms section of this page.

Investigators are reminded that changes may not be implemented until final written approval is received from the Committee.

Guidelines for Determining Amendment Type

The IRB requires that any proposed changes in approved research, during the period for which IRB approval has already been given, be reviewed and approved prior to implementing these changes to determine whether the modified research continues to fulfill the criteria for approval, except where necessary to eliminate apparent immediate hazards to the human participants. Investigators may request approval of proposed changes by the completion and submission of an Amendment/Modification Form located in the Forms section of this page.

This guidance document provides additional information for determining whether an Amendment may be reviewed and approved using expedited review procedures or if the Amendment must be reviewed at a convened IRB meeting. Please note that it is ultimately the IRB who makes the review level determination.

Minor Changes in Approved Research

Minor amendments are reviewed using the expedited review procedure. Proposed change(s) are considered minor when the research meets all of the following criteria:

• the proposed change(s) do not significantly alter the risk to benefit assessment;
• the proposed change(s) do not significantly affect the safety of the subjects;
• the proposed change(s) do not involve the addition of invasive procedures (procedures not otherwise eligible for expedited review, e.g. collection blood samples in limited amounts;
• the proposed change(s) do not involve the addition of procedures, interactions or interventions that add significant medical, social, or psychological risks;
• the proposed change(s) do not involve addition of a vulnerable population in research not otherwise eligible for expedited review; and
• the proposed change(s) do not significantly alter the study design, the scientific question or the scientific quality of the study.

Examples of minor amendments may include

• Decrease in the amount of blood drawn
• Title change
• Study personnel change
• Clarification of minor issues or statements
• Additional risks due to adverse event (e.g. IRB requested addition)
• Extended accrual period
• Addition of urine pregnancy test
• Addition of audio taping
• Advertisements or minor changes in recruitment when changes are easily compared to the informed consent document
• Final taped message prepared from IRB-approved text
• Addition of subjects
• Addition or deletion of study sites
• Other minor changes to the informed consent document or study protocol

Major Changes in Approved Research

Major Amendments are reviewed at a convened IRB meeting. Proposed changes potentially involve increased risks or discomforts or decreased potential benefit.

Examples of major amendments may include

• Increase in the amount of blood drawn
• Safety issues
• Extension of the study duration
• Multiple or major changes in the study design
• New software in devices
• Additional arm added to the study
• Additional population
• Increase in the medication dose
• Increase in infusion rate
• Additional radiation exposure
• Addition of videotaping of subjects
• Any change that affects the risk/benefit to the subject

​ What Issues & Events Do I Need to Report to the IRB?

Unanticipated Problems & Noncompliance

Certain problems that occur during the conduct of the research must be promptly reported to the IRB. In general, any event that is unexpected, related or possibly related to participation in the research, and suggests that the research places subjects or others at greater risk, including physical, psychological, economic or social harm, must be promptly reported to the IRB.

Any unanticipated problem associated with a study must be reported to the IRB Office within 5 working days of notification.

To report an unanticipated problem to the IRB, use the Unanticipated Problem Involving Risk to Subjects or Others (UPIRSO) Form located in the Forms section of this page.

Noncompliance

All noncompliance must be promptly reported to the IRB. Noncompliance is any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with federal or state regulations, or institutional policies governing human subjects research or the requirements or determinations of the IRB.

Any noncompliance associated with a study must be reported to the IRB Office within 5 working days of notification of the event.

To report Noncompliance to the IRB, use the Noncompliance Reporting Form located in the Forms section of this page.

Study Closure

A research study may be closed under the following circumstances and conditions:

1. There is no further interaction or intervention with subjects, including follow-up or access to personally identifiable information AND
2. Either of the following are true:
   1. Data analysis is complete OR
   2. Data has been de-identified, with no codes or keys that would allow for the potential of identifying individuals in the future.

Investigators may close their study with completion and submission of the Closeout Report located in the Forms section of the page.