Research studies have the potential to improve patient care and advance medical knowledge. However, conducting a study involves risks that may compromise the safety and well-being of study participants. That is why researchers and institutions are required to follow a rigorous protocol to ensure the safety and protection of study participants. One key element of this protocol is the continuing review of an approved and ongoing study.
Importance of Continuing Review of an Approved and Ongoing Study
Continuing review is the process of evaluating an approved and ongoing study to ensure that its risks and benefits are still appropriate and that the study is making progress towards its goals. The review is typically conducted by an Institutional Review Board (IRB), an independent committee that oversees the conduct of research studies involving human subjects.
Ensuring Participant Safety
The primary goal of continuing review is to ensure the safety and well-being of study participants. The IRB evaluates the study’s risks and benefits to ensure that they are still appropriate given the current state of knowledge and any new information that has emerged since the study’s initiation. If the IRB determines that the risks of a study outweigh its potential benefits, the study may be suspended or terminated to protect participant safety.
Monitoring Study Progress
Continuing review also involves monitoring the study’s progress towards its objectives. The IRB evaluates the study’s data and any adverse events to determine whether the study is making progress towards its goals. If the study is not making progress or is not meeting its objectives, the IRB may require modifications to the study protocol or terminate the study.
Continuing review is essential for ensuring that research studies involving human subjects are conducted safely and ethically. By evaluating risks and benefits and monitoring study progress, the IRB can ensure that the study is ethical, scientifically sound, and is making progress towards its objectives.
Timeline for Continuing Review of an Approved and Ongoing Study
Continuing review is an ongoing process that occurs at regular intervals throughout the study’s duration. The frequency of review depends on the level of risk involved in the study and the requirements of the IRB. Typically, studies that involve higher levels of risk are reviewed more frequently than studies with lower levels of risk.
Documentation requirements vary depending on the institution and the study’s funding source. However, researchers should maintain accurate and up-to-date records of study progress, adverse events, and any modifications to the study protocol to ensure compliance with regulations and to facilitate the continuing review process.
In the next section, we will discuss the process of continuing review and the role of the IRB in ensuring the safety and validity of research studies.
Timeline for Continuing Review of an Approved and Ongoing Study
Continuing review is an ongoing process that occurs at regular intervals throughout the study’s duration. The frequency of review depends on the level of risk involved in the study and the requirements of the IRB. Typically, studies that involve higher levels of risk are reviewed more frequently than studies with lower levels of risk.
For example, clinical trials that involve investigational drugs or medical devices may require more frequent review than observational studies that involve minimal risk to participants. The IRB may require annual reviews, or reviews at more frequent intervals such as every six months, three months, or even monthly depending on the level of risk involved.
Documentation requirements vary depending on the institution and the study’s funding source. However, researchers should maintain accurate and up-to-date records of study progress, adverse events, and any modifications to the study protocol to ensure compliance with regulations and to facilitate the continuing review process. Timely and accurate documentation is also important for ensuring that the study’s progress can be adequately communicated to the IRB and other stakeholders.
Process of Continuing Review of an Approved and Ongoing Study
The process of continuing review involves several key steps to ensure that the study remains ethical, scientifically sound, and is making progress towards its objectives. The following are the key steps involved in the process of continuing review:
Role of the Institutional Review Board (IRB)
The IRB is an independent committee that oversees the conduct of research studies involving human subjects. The IRB is responsible for evaluating the study’s risks and benefits, monitoring study progress, and ensuring that the study is conducted in compliance with regulations and ethical standards. The IRB also has the authority to approve, require modifications to, or suspend/terminate the study if necessary.
Review of Study Progress
Continuing review involves a comprehensive evaluation of the study’s progress towards its objectives. The IRB reviews the study’s data and any adverse events to determine whether the study is making progress towards its goals. The IRB may also review any modifications to the study protocol to ensure that they are appropriate and do not increase risks to participants.
Evaluation of Adverse Events
Adverse events are any untoward medical occurrences that happen to participants during the course of the study. The IRB reviews any adverse events that occur during the study to determine whether they are related to the study and whether they pose a risk to participants. The IRB may require modifications to the study protocol or terminate the study to protect participant safety.
Re-evaluation of Risks and Benefits
The IRB re-evaluates the study’s risks and benefits at each continuing review to ensure that they are still appropriate. The IRB considers any new information that has emerged since the study’s initiation to determine whether the risks of the study have changed. If the IRB determines that the risks of the study outweigh its potential benefits, the study may be suspended or terminated to protect participant safety.
Continuing review is a critical component of the research study process. By evaluating study progress, adverse events, and risks and benefits, the IRB can ensure that research studies involving human subjects are conducted safely, ethically, and are making progress towards their objectives.
Potential Outcomes of Continuing Review of an Approved and Ongoing Study
Continuing review may result in several possible outcomes, depending on the study’s progress and the IRB’s evaluation of risks and benefits.
Approval
If the IRB determines that the study continues to meet ethical and scientific standards and is making progress towards its objectives, the study will be approved to continue with no modifications. Researchers can continue to enroll participants and collect data as outlined in the study protocol.
Approval with Modifications
If the IRB determines that modifications to the study protocol or informed consent are necessary to ensure participant safety or scientific validity, the study may be approved with modifications. Researchers must address the IRB’s concerns and make the necessary modifications before continuing the study.
Suspension or Termination
If the IRB determines that the risks of a study outweigh its potential benefits or that the study is not making progress towards its objectives, the study may be suspended or terminated. Researchers must immediately cease any further enrollment of participants and data collection and address the IRB’s concerns before continuing the study.
It is essential to note that the outcome of continuing review is not a reflection of the quality or integrity of the study or the researchers. Instead, it reflects the IRB’s ongoing evaluation of the study’s risks, benefits, and progress towards its objectives.
Conclusion
Continuing review is a critical component of the protocol for conducting research studies involving human subjects. It ensures that studies are conducted safely, ethically, and are making progress towards their objectives.
Researchers must prioritize continuing review and maintain accurate and up-to-date records to facilitate the review process. IRBs must also prioritize continuing review to ensure the safety and protection of study participants, compliance with regulations, and the scientific validity of research studies.
In conclusion, continuing review is essential for the success of research studies involving human subjects. It is the responsibility of researchers and IRBs to work together to ensure the safety, validity, and success of research studies.