A. Reasons for Continuing Review
IRB review is a continuing process. Research projects that were approved by expedited or full board review are re-evaluated on a regularly scheduled interval, at least once per year, as required by the federal government. The level of risk of a study determines the schedule of review; studies presenting higher levels of risk for participants can be reviewed on a more frequent basis. Studies utilizing investigative devices that pose significant risk can be reviewed on a more frequent basis. Reasons for continuing review include:
- To ensure that the risk/benefit relationship is still acceptable;
- To ensure that participants remain protected from inappropriate risks;
- To determine whether new information that may be important to the subject has surfaced;
- To determine if unanticipated risks were discovered;
- To ensure the protocol that was previously approved is being followed; and
- To ensure that the project adheres to regulations and guidelines, which may have been altered since the project was previously approved.
Unless otherwise specified, the approval period for research approved is one year from the date of the approval letter sent by the IRB. In specific cases, the IRB may specify a shorter approval period. Such instances might include complex studies, studies that include vulnerable participants, studies with high risk to participants, and studies conducted at multiple sites. The IRB may also consider the qualifications of the principal investigator and other members of the research team and the specific experiences of the PI and other members of the research team in determining the frequency for continuing review.
The interval for continuing review (the submission of a progress report) is made at the time of initial IRB approval but may be changed upon subsequent IRB review. The IRB has the authority to suspend, terminate, or place restrictions on a study that has previously been approved for reasons of noncompliance or if deemed necessary to ensure protection of human research participants.
B. Documentation Required for Continuing Review
The following information is required for the submittal of continuing review reports:
- A copy of the current complete research protocol, with the text revised to include all previously approved amendments, and a copy of the recruitment documents, consent documents, and instruments if these documents have been amended.
- Research Study Progress Report that includes the following information:
- The number of participants entered in the study indicating active or completed;
- The number of participants still pending and the time frame of subject participation;
- Details of any adverse or unexpected reactions or side effects that have occurred or are expected (if none then state none); and
- A brief summary of the results of the research project to date.
- If the PI wishes to amend the protocol at the time of the extension, the following documents should be submitted:
- A summary of any changes requested at this renewal.
- A copy of any new or revised instruments, informed consent documentation, and recruitment materials.
Submit one electronic copy of all materials.
C. Submission Timeline - Continuing Review (Progress Reports)
Continuing review reports are always due no later than one month before the expiration date for approval of the protocol. The due date of the next continuing review report is always stated in the previous approval letter. A reminder that a continuing review report is due will be sent to the principal investigator before the study will expire. This is to allow adequate time for submission and review. It is the responsibility of the principal investigator to submit the continuing review packet before the deadline. It is recommended that investigators, especially those submitting large numbers of protocols, develop their own tracking mechanism for the submission of continuing review reports. Note: Studies that are closed to subject entry but continue to follow participants are still considered to be active studies and must remain in the continuing review process.
D. Consequences of Late Progress Reports for Continuing Review
The IRB has the authority to suspend or terminate approval of research for noncompliance with federal regulations and guidelines and institutional directives regarding continued approval. The submission of progress reports is the responsibility of the investigator.
If continuing review does not take place before the expiration date of previous approval, the protocol will expire. If a protocol expires, the IRB may formally terminate the protocol and require a new submission to the Board to reestablish approval. Investigators who have had a study terminated due to failure to report continuing review may not be allowed to submit any new protocols until the terminated protocol is either re-established or closed out. When a protocol has expired, no participants shall be treated or recruited and all study-related activities including data analysis shall cease. An exception may be made if the cessation of treatment poses a threat to the life or welfare of a subject. Recruitment of participants under such a status constitutes non-compliance and may jeopardize the investigator’s ability to submit further protocols to the IRB and, in the worst case, may result in termination of protocols in the midst of data collection.
The administrative termination of approval will be provided in writing and shall include a statement of the reason(s) for the IRB's action. This action will be reported promptly to the investigator, the appropriate department chair and dean, and any appropriate sponsoring agency.
E. Evaluation of Continuing Review Packets (Progress Reports)
1. Determing the Type of Review
1.1. Expedited Studies
The review of studies that were originally approved on an expedited basis are screened by the IRB administrators to ensure that risks to participants remain minimal and can be approved on an expedited basis by the IRB chair or designated IRB member.
1.2. Full Board Studies
The review of studies that were originally approved on a full Board basis are screened by the IRB administrators to ensure that the project poses more than minimal risks to participants, therefore requiring full Board review. Some studies originally approved on a full Board basis may qualify for expedited review as a result of the minimal risk associated with remaining study activities. Such studies can be approved on an expedited basis by the IRB Chair or designated IRB member.
2. Criteria for Continuing Review
The criteria for the continuing review of projects are the same as those for initial review.
- Risks to subjects are minimized.
- Risks to subjects are reasonable in relation to anticipated benefits to subjects and to research in this area.
- Selection of subjects is equitable.
- Informed consent will be sought from each prospective subject or the subject’s legally authorized representative in accordance with 45 CFR 46.116.
- Informed consent will be appropriately documented in accordance with 45 CFR 46.117.
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- When appropriate, adequate provisions are made to protect the privacy of subjects and to maintain the confidentiality of data.
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence (such as children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons), additional safeguards have been included to protect the rights and welfare of these participants (45 CFR 46.111).
3. Outcomes of Continuing Review
The continuing review of studies by the full Board will result in one of the following actions:
- Approval without changes;
- Approval with modifications; or
- Not approved (a decision that can be made only by the full board).
After a study is approved, a notice is sent to the principal investigator informing of the continued approval of the study by the IRB and the institution is notified via the IRB Minutes. Each approval notice includes the following stamped and dated documents:
- An approval memorandum containing the investigator’s name; the UNF IRB number; the study title; the method of review; the effective date of the continuation; the period for which the study is approved; and the date the next progress report is due.
- Any new study documents approved such as a revised research protocol, revised consent and assent forms, revised instruments, and revised recruitment materials.
If modifications are requested, the notice should identify changes to be made to appropriate study documents.
When the IRB disapproves or requires modifications to continuing research, PIs may appeal the IRB decision in writing to the IRB. All appeals of full board decisions will be reviewed by the full board. Only the IRB may change or overturn a decision not to approve a study. The Board is willing to meet with the investigator and discuss alternatives that might allow eventual approval of a rejected study. Written notification is also promptly provided to the institution when a study is not approved by the IRB. Investigators may have the opportunity to resubmit their study and appear before the Board to answer questions or discuss any concerns the Board has with the study.