A. Must occur within 12 months of the approval date.
B. Must occur within 11 months of the approval date.
C. Must occur within 10 months of the approval date.
D. Must occur within 9 months of the approval date.
The answer is A. Must occur within 12 months of the approval date. The explanation on Continuing Review is given below.
Continuing review & why is it needed?
A continuing review is a process through which the IRB re-evaluates whether a protocol is being conducted in compliance with the criteria for approval that are applied during the initial review. Except for studies that are exempt from IRB oversight, all studies relating to human subjects come under continuing review.
The IRB reviews all non-exempt research projects at appropriate intervals, but not less than a year and this is known as a continuing review.
Exempt research is initially reviewed by the IRB but is exempt from further review. Exempt research will meet the specified federal criterion and fall in one of the six categories.
The continuing review keeps taking place as long as the research remains active for the long-term follow-up of the research subject:
- Even if the research is permanently closed for enrollment of new subjects and all subjects have cleared research-related interventions.
- Even when the remaining research activities are limited to the collection of identifiable private intervention.
The IRB reviews the continuing application submission form along with the research project and applicable attachments thoroughly.
Criteria for approving research during continuing review
The criteria for IRB approval of research (21 CFR 6.111) apply to both initial as well as continuing review. To approve research, the IRB must determine that all of the following requirements are met:
- Selection of subjects is equitable.
- The risk to subjects are minimized.
- The risk to subjects are reasonable in relation to anticipated benefits to the human subjects and the importance of the available knowledge that may be expected to result.
- Informed consent is sought from each prospective subject or the subject’s legally authorized representative and adequately documented.
- The research plan adequately provides for monitoring the data collected to ensure the safety of subjects, wherever appropriate.
- There are proper provisions to preserve the confidentiality of data and to protect the privacy of subjects, where appropriate.
- Additional safeguards must be included to protect vulnerable subjects, wherever applicable.
- If the study involves children, then the research must comply with 21 CFR part 50, Subpart D.
The IRB makes a continuing review decision if any new information is available, that would affect the IRB’s prior finding that the research meets the criteria in 21 CFR 56.111.
IRB’s can disapprove or require modifications in a research activity that does not meet the above criteria but needs to secure a pre-approval.
Process for conducting continuing review
Continuing review by IRB takes place at a convened meeting unless the research meets the criteria for an expedited review. The IRB reviews the research and must maintain records of its continuing review activities and the minutes of meetings at which such analysis is done.
The minutes must contain the actions taken by IRB, the vote on these actions and a summary of the complete discussion of discussed issues and their resolution. The majority of the IRB members must be present at a meeting to approve research.
If the IRB members have a conflicting interest in a project that is being continually reviewed, then the IRB must ensure that he does not participate in the review, except to provide the information requested from IRB.
The meeting minutes must also confirm that the conflicted members did not participate in the continuing review of the studies.
The IRB must maintain written records and can consider the use of templates, checklists or other tools to standardize the requested information.
Investigators must follow IRB policies, and the studies must be conducted as per regulatory requirements. The IRB’s written procedures in a continuing review may call for certain written documents.
The annual report for drug studies is one way of providing the required information to the IRB during a continuing review. The report will contain most of the information that is required in the written document.
At the IRB meeting, relevant reports, minutes of the prior relevant meeting must be available to members.
Federal requirements for continuing review
The IRB is required to review the ongoing research for human studies at regular intervals, except for exempt research.
While the initial review of IRB is based on the researcher’s best assessment of the anticipated risks, benefits and procedures, the continuing review is based on the conduct of the study, wherein actual risk can be analyzed and evaluated, and preliminary results can be used to assess the risk/benefit ratio.
The risks/benefit ratio may change not only because of unexpected results but also due to the new knowledge resulting from the related research.
The criteria to get initial approval is the same as the one for continuing IRB approval as mentioned in the preceding paragraphs.
As per FDA and OHRP, the IRB must be provided with the following information when conducting continuing research.
- The number of participants that have enrolled.
- A summary of all the important events and unanticipated problems that may involve risk for participants.
- The number of participants that have withdrawn, if any, and the reasons for withdrawal.
- A summary of complaints about the research.
- A summary of relevant interim findings, recent literature and modifications to the research since the last review. A current risk/benefit analysis based on the existing study results.
- Any other relevant information, like information about risks associated with research.
- A copy of the latest informed consent form.
Post reassessment of research at the continuing review, the IRB can suspend, require modifications, approve or terminate approval of research that isn’t being conducted in accordance with the IRB requirements or is associated with unexpected but severe harm to participants.
Key topics to consider during continuing review
The risks to subjects should be minimized, and the risks are reasonable in relation to anticipated benefits.
Local concerns like complaints, reports from 3rd party observers, Investigator concerns and qualifications or changes in acceptability of proposed research is considered by IRB.
IRB also reviews the trial progress in terms of the number of enrollments and dropouts or subject withdrawals.
Adequacy of informed consent
The informed consent form must be the most recently approved version and must contain the most up-to-date information.
The IRB performs the continuing review on the basis of specific federal criteria. It must also be completed within the year at least once.
- Continuing Review: Taken from hso.research.uiowa.edu
- Criteria for Approving the Research & Key Topics: Taken from fda.gov
- Federal Requirements for Continuing Review: Taken from research.uci.edu