In clinical research, the purpose of institutional review board (IRB) review is to ensure the rights and welfare of human subjects are protected. Unnecessary delays in the IRB review process can prevent treatments from getting to patients and slow the improvement of public health outcomes. Reducing IRB turnaround time has been identified as an essential objective by industry groups such as the National Institutes of Health (NIH) and the Clinical and Translational Science Awards program (CTSA). This blog examines the importance of selecting an IRB partner with quick turnaround times and offers tips on setting yourself up to help optimize your chances for timely IRB approval success.

The Purpose and Function of IRBs

Participation in medical research can range from answering a simple survey or participating in a focus group, to providing blood and tissue samples or receiving a new drug. Thus, government regulation exists to protect research participants. Per FDA regulations, an IRB is a formally designated group with the authority to review and monitor biomedical research involving human participants. In addition to approving or disapproving research, IRBs have the authority to stipulate specific modifications required for approval.

The purpose of IRB review is to assure appropriate steps are taken to protect the rights and welfare of persons participating as research subjects. To accomplish this, IRBs use a group process to review research protocols and related materials such as informed consent documents and investigator brochures. IRBs monitor trial recruitment, making sure the process is equitable and non-coercive, and monitor research protocols, compliance, safety, and evaluations. An IRB will conduct continuing reviews at least once a year for certain non-exempt studies, and perhaps more often if there’s a higher degree of risk to the subjects.

IRB Turnaround Time and Industry Benchmarks

When gauging turnaround time, a key consideration is the type of review required. Studies with minimal risk may be eligible for exemption or expedited review. Otherwise, a full board review is required.

The IRB process of universities, hospitals, and other large organizations is often layered and cumbersome, and some researchers have expressed concern that timeliness issues within the review process can prevent treatments from reaching patients quickly enough to improve public health outcomes.

As more and more research moves beyond academic settings, independent IRBs have grown to accommodate this need. Speed is principal among the advantages to working with independent boards or CROs that offer IRB services. As in any industry, a smaller company can anticipate and more quickly respond to the individual needs of its customer or researcher.

Academic institutional IRBs (e.g., Penn State, Johns Hopkins, etc.) report their average turnaround times to be 10 to 25 days for an exempt or expedited review and 25 to 35 days for a full board review. The process can be far more expedient with independent organizations— for example, Pearl IRB’s average turnaround time is under 3 and 10 days for an exempt or expedited and a full board review, respectively.

Collaboration is Key

Reducing turnaround time is a goal across medical research industry groups. The National Center for Advancing Translational Sciences created the Clinical and Translational Science Awards program (CTSA). This network of researchers collaborates in training, research, and processes to get a greater number of treatments to more patients in less time.

The CTSA program includes a Common Metrics Initiative in order to accelerate and improve clinical research. One way it does so is by fostering community with the reuse of data, making it findable, accessible, interoperable, and reusable (known as the FAIR principles).

The CTSA also includes the Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Platform to encourage multisite clinical studies to rely on a single IRB.

Other Strategies for Minimizing IRB Turnaround Time

As the initiatives above make clear, collaboration is an important tool to improve turnaround time in the IRB review process. It should be a goal to find an IRB capable of managing and connecting multisite testing.

Other ways to reduce IRB delays include:

• Before submitting an application:
  • Thoroughly review and comply with the submission instructions
  • Check the submission to ensure completeness
  • Determine the level of review appropriate for the research
• Ensure committee members have the appropriate background and experience for the type of research being conducted
• Avoid collecting extra data—delays can result when researchers stray from the board’s guidance
• Quickly respond to the board’s queries and/or document requests

Partnering with a CRO like Pearl

Pearl’s nimble and experienced IRB is part of the SMART platform, capable of managing multisite research, and one of only 19 IRBs accredited by Association for the Accreditation of Human Research Protection Programs.

Contact us to learn more about Pearl IRB’s timely review process or to discuss submitting an application for research review.