Continuing Review Of An Approved And Ongoing Study?
Continuing review is a process of periodically reviewing previously approved research to determine whether the research complies with the regulatory requirements that were in place when it was initially approved.
At the time of initial approval, IRBs generally specify a specific interval by which continuing review must occur (e.g., four months, six months, or one year) for research to continue.
Changes To The Study
A change to an ongoing study, including introducing new subjects or discontinuing a study, requires IRB approval. This includes changes in inclusion criteria, procedures, recruitment, advertisements, consent forms, and questionnaires.
Modifications are a common part of clinical research, especially as we move forward with our studies. Still, they can also be difficult to handle if not handled well. For example, changing study endpoints can be problematic because it may affect the statistical data analysis.
IDE supplements requesting these changes should include the following:
- A detailed description (cross-referenced to the appropriate sections of the original submission).
- An explanation of why the change is being requested.
- An assessment of the impact of the change on the study and documentation supporting the change.
This can include preclinical bench/animal testing, peer-reviewed published literature, risk analysis of the change, and statistical analysis of the impact on the study.
These changes may be minor or major, depending on the situation. A major change would include a change in the primary or secondary endpoint that affects sample size estimates and planned statistical analysis or may cause a loss of scientific soundness of the investigational plan.
Another example of a minor change might be modifying the informed consent form to provide participants with new information about risks they might face. This could be as simple as a few lines on the form about a specific medication or as extensive as a revised document with all of the new information about the study and the medications involved.
In either case, a CIR must be submitted with all the relevant information for the IRB to review. It is important to ensure that the IRB can follow the proposed change and understand its context and rationale. This will help them decide whether to proceed through an expedited review pathway or to conduct a full, convened IRB meeting.
If the proposed change is significant, it may require a complete study redesign to ensure that the new information is included. This can be a time-consuming and expensive process, so be careful to consider the costs before you make this decision.
Modifications To The Informed Consent Document
Informed consent is a cornerstone of ethical human subjects research. Therefore, the researcher must ensure that prospective participants receive information about the study sufficiently detailed to facilitate a truly informed choice and to offer them an opportunity to discuss that information with their legally authorized representatives.
To meet this requirement, the consent process should include a description of the procedures being conducted, including standard medical tests and interventions required by the protocol. It should also describe any reasonably foreseeable risks or discomforts to the subject. In addition, the consent process should explain any benefits to the subject that may be expected from participation in the study. Finally, it should also disclose any alternative procedures or courses of treatment that the subject may be eligible to receive outside of the research.
It should also include information on any new or previously described risks that are now occurring with greater frequency or severity. This should be documented in the study’s continuing review report. It should also describe how this information will be communicated to current subjects.
The consent document should also contain a statement that participation is voluntary and that the subject’s refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled. For example, suppose a subject declines to participate in a study. In that case, the consent document should indicate what will happen to the subject’s information and biospecimens and whether or not the subject can withdraw from the research at any time without penalty.
Another element of the consent process is the disclosure of any financial relationships and interests that may affect a subject’s decision to participate in the study. This may include any relationship between the subject and the sponsor or a third party, such as a caregiver or spouse. It should also describe the extent to which the institution intends to maintain the confidentiality of records identifying the subject and warn the subject that the FDA may inspect them.
The content of the consent document is primarily determined by the IRB, though institutional templates or samples are sometimes used. In addition, the IRB is responsible for ensuring that all consent documents follow federal law and agency requirements.
When the IRB re-approves an approved and ongoing study for continued use, it typically requires that the investigator add any new subjects to the research. This is to ensure that any potential risks to subjects are minimized and that the investigator fully understands all aspects of the study before they begin work with new subjects.
Suppose you are adding new subjects to the study. In that case, you must indicate this on the Continuing Review Form and include any documents (such as consent forms) that will be used in connection with the research. You may also choose to attach other materials related to the research that was not included in the original approval.
You should also describe why these new subjects are added and how you will communicate this information to current subjects. This information will help you and the IRB understand whether there is a need to modify the consent documents or notify existing subjects about the changes to the research.
In addition, you should also evaluate the enrollment rate for the study at the time of continuing review. This evaluation is important because a marked difference between the actual and expected enrollment rates may indicate a problem with the research project that requires further evaluation.
As part of its initial review, the IRB usually approves a protocol that includes the anticipated number of subjects to be enrolled by the investigator and the expected enrollment rate. The IRB can evaluate this information to determine whether the planned number of subjects and the enrollment rate are consistent. It can also evaluate whether the research project will likely provide sufficient data to answer the proposed scientific question(s).
The IRB will conduct continuing reviews of research that requires full board review at convened meetings unless the HSO deems that one or more of the members of the IRB will be unavailable for a meeting. For example, during holiday seasons or periods of high traffic, the HSO may move a meeting to another scheduled date.
Closure Of The Study
When the research activities involving human subjects are complete and there are no further studies, a closure form must be submitted to the IRB for approval. This form serves as a formal notification of the study’s closure, notifying the IRB that it no longer needs to review the study.
The closure of the study may be based on an assessment of unanticipated problems and/or concerns involving risk to participants or others. The IRB can review such issues under IRB policies and procedures, sponsor requirements, or appropriate Federal agencies as required.
In addition, the IRB may close a study if an investigator fails to properly comply with an IRB policy or requirement to submit a study closure form. For example, suppose repeated failure to properly close a study is discovered. In that case, the IRB can review this as a potential non-compliance with the Wright State IRB Human Subjects Non-Compliance Policy.
Closure of the study is important because it ensures that no further research involving human subjects will be conducted on the project. This includes not collecting, using, or analyzing any identifiable data (i.e., coded, linked to identifiers) or generating any biospecimens containing identifiable private information about the individual.
To determine whether your research project is eligible for closure, follow the following steps:
Upload the HRP-528 template from the SmartForms page in Cayuse. This template provides instructions for submitting a study closure request via Kuali Protocols, the study’s protocol management system.
You will receive a formal notification of the IRB’s decision to close the study by email from Kuali Protocols when the IRB has determined that the study is eligible for closure. You will want to retain a copy of this notification for your records.
A closure report should be submitted to the IRB within 30 days of study completion. This form will update the IRB on the conduct and outcomes of the study, any new risks, safety issues, or problems that have arisen since the last study renewal, and inform the IRB of the final disposition of research records and data. This is an important step for ensuring the IRB has all the information it needs to review and approve future research protocols involving human subjects.
Continuing Review Of An Approved And Ongoing Study? Guide To Know
Continuing review is a critical process that helps ensure that approved research studies meet ethical and regulatory requirements throughout their duration. It involves regularly evaluating the study’s progress, risks, and benefits and determining whether any changes need to be made to the study protocol, consent forms, or other study-related documents.
In the United States, the continuing review is required for all research studies that involve human subjects and are subject to oversight by an Institutional Review Board (IRB). The IRB reviews and approves research studies to ensure they meet federal and institutional ethical and regulatory standards for protecting human subjects. Once a study is approved, the IRB must conduct regular continuing reviews to ensure that the study continues to meet these standards.
The exact frequency of continuing review can vary depending on the level of risk posed by the study. For example, studies that involve minimal risk to participants may require only an annual review. In contrast, studies that involve greater risks may require more frequent reviews. However, most studies require continuing review at least once a year.
During The Continuing Review Process, The IRB Evaluates The Following:
- Study progress: The IRB evaluates whether the study is progressing as planned, whether the recruitment of participants is on track, and whether the research team is following the study protocol and other study-related documents.
- Risks and benefits: The IRB evaluates the risks and benefits of the study to determine whether they are still acceptable. If new risks or benefits have emerged, the IRB may require changes to the study protocol or other study-related documents.
- Informed consent: The IRB evaluates whether the informed consent process is still adequate and whether participants continue to understand the risks and benefits of the study.
- Data safety monitoring: The IRB evaluates whether the study has a data safety monitoring plan in place and whether it is being implemented effectively. This includes reviewing any adverse events or unanticipated problems during the study.
Suppose the IRB determines that the study no longer meets ethical or regulatory standards. In that case, it may require changes to the study protocol, consent forms, or other study-related documents. In some cases, the IRB may suspend or terminate the study.
Continuing review is a critical component of the research process that helps ensure research studies are conducted ethically and responsibly. It also helps ensure that the interests and welfare of research participants are protected throughout the study. By conducting regular continuing reviews, researchers and IRBs can identify and address any problems that may arise during the study and take appropriate action to ensure that the study complies with ethical and regulatory standards.
What is continuing review of an approved and ongoing study IRB?
What does Ongoing Review entail? You must submit a study to the IRB for continuing review permission if you want to keep working on it after its expiration date. The IRB conducts a fresh evaluation of the trial to decide whether it should proceed unaltered or with changes.
What is a continuation review?
Every person who gets disability benefits has their case reviewed by the Social Security Administration (SSA) on a regular basis as required by law. A continuing disability review, or CDR, is a procedure used to find recipients who would no longer be considered disabled.
How often does IRB review ongoing research studies?
All non-exempt research initiatives must be reviewed and approved by the IRB at intervals commensurate with the level of risk, but at least once a year [45 CFR 46.109(e) (DHHS) and 21 CFR 56.109(f) (FDA)].
How often will the IRB conduct a continuing review?
A continual review of research must be conducted by an IRB at intervals suitable to the level of risk, but not less frequently than once year.
What are the three types of IRB review?
Before any data is collected, all projects that fall within the definition of research and include human subjects must be reviewed by IRB in order to identify the proper level of scrutiny and, if necessary, to receive approval. Exempt, Expedited, and Full reviews are the three main categories.
What does it mean to be exempt from continuing IRB review?
If there is only a small risk associated with the research and all of the research procedures fall under one or more of the exemption categories listed in the federal IRB regulations, the research may be exempt. Before beginning a study that is exempt, the IRB must receive a submission for review.