What is Central IRB

Tags

Central IRB, IRB, Local IRB

In simple term a central Institutional Review Board (IRB) as a single IRB of record for all clinical trial sites in a multi-center trial.

To understand what is central IRB we have to first know what is IRB In clinical research. An institutional review board (IRB) is the group or committee responsible for ensuring the safety and protection of human subjects participating in a study.

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

The IRB’s responsibilities are broad, including review of study documentation such as protocol and informed consent to confirm that there is no conflict of interest for researchers. Whether the research study includes 1 participant or 1,000, the investigators must receive approval from an IRB before they can begin their research.

An IRB committee is made up of :- at least five members of varying backgrounds, at least one non-scientific member, and at least one member not affiliated with the institution, and a gender balance must exist. Additionally, both local and central IRBs must register with the U.S. Department of Health and Human Services (HHS) 21 CRF 56.106, hold a Federalwide Assurance (FWA), and be 21 CRF Part 56 compliant. They must also document training of IRB personnel on human subjects protection and notify all local institutions if their IRB accreditation status changes. Several IRB models currently exist, though the emphasis on responsible stewardship to protect human subjects is the same:

Types of IRB:-

• Local IRB—a group designated to monitor research involving human subjects at a single academic or hospital site. This group provides approval for investigators to conduct research under its auspices, grant admitting privileges and use facilities.
• Central IRB—a group designated to monitor research involving human subjects for all sites involved in a research study (IRB of record). This group could be an institution’s IRB; a federal IRB; or a private, independent IRB.

Name of Different IRBs:-

• Chesapeake IRB 
  Chesapeake IRB (Chesapeake) is an independent (commercial) IRB located in Columbia Maryland.
  Web: http://chesapeakeirb.com/
  Telephone: (410) 884-2900 (Main Reception)
  Fax: (410) 884-9190 (Main Fax)
  Email: info@chesapeakeirb.com

• NCI CIRB (CIRB)  

CIRB is a central IRB that conducts all IRB reviews of selected NCI-sponsored trials.              Telephone 888-657-3711 Fax: 301-560-6538

Email: ncicirbcontact@emmes.com
Web: http://www.ncicirb.org

• Quorum Review IRB
  • www.quorumreview.com. 
• Schulman Associates IRB

Schulman Review (Schulman) is an independent (commercial) IRB with locations in Cincinnati, Ohio and Ft. Lauderdale, Fl.
Office Telephone (513)794-5743
Mobile Telephone: (859) 760-6772
Fax: 513.761.1460
Email: mstivers@sairb.com
Web: http://www.sairb.com/

• Western IRB (WIRB)

Western Institutional Review Board (WIRB) is an independent (commercial) IRB located in Washington State. WIRB also works with several Affiliate IRBS to provide access to studies.

Affiliate IRBs include:

Copernicus Group, Inc. ; Aspire IRB; New England IRB; and Midlands IRB.

Main Contact: Telephone: (360)252-2460
Fax: (360) 252-2498 Email: cgennai@wirb.com

https://www.wirb.com/Pages/default.aspx

In the past decade, a number of agencies have endorsed the use of a central IRB for multicenter studies to increase the efficiency and to reduce the duplication of effort when reviewing clinical research. The U.S. Food and Drug Administration marked the initiation of this guidance in 2006, releasing a document to assist entities involved in multicenter research to consider use of a centralized IRB review process.¹ Since the release of this guidance, the U.S. Office of Human Research Protections, the National Institutes of Health, and other organizations such as the Clinical Trials Transformation Initiative have provided recommendations on the use of a single central IRB to reduce time, burden, and costs associated with conducting a research study.^2-4 Most recently, the Common Rule, which is the rule of ethics governing biomedical and behavioral research, released a Notice of Proposed Rulemaking (NPRM), where they are considering a change to the existing rule about the IRB review process. Specifically, it is being considered that for all U.S. sites in a multicenter study a single IRB of record be utilized.⁵

While overarching functions of a local and central IRB are the same, there are some distinctions in what a central IRB must consider as the single group overseeing the research across multiple sites. Central IRBs must understand and adhere to the local requirements at each site, which, in some cases, can be in direct conflict with one another. They must provide an informed consent form template and review each site-specific form for accuracy. This group is also solely responsible for keeping all investigative sites informed of IRB decisions; informing sites of potential risks to study participants; and notifying the sites of any serious misconduct or complaints, including termination or suspension of research. While there are inherent complexities in a single IRB being responsible for the oversight of all sites, little evidence supports that having multiple IRBs review the same study enhances protections for human subjects.⁵

There are both benefits and limitations to consider when using a central IRB.

Benefits

• Reduction in IRB burden and study costs: Protocols are often amended multiple times during the course of a study. Rather than submitting these amendments to each site’s IRB every time that they occur, the central IRB would be responsible for reviewing and approving these changes to all sites. This streamlined review of changes to a protocol may significantly reduce the level of effort by study staff and the IRB.
• Understanding local laws: IRBs accustomed to serving as the single IRB have an understanding of the local laws that affect the sites with which they interact on a research study. This universal view of the local requirements will allow the IRB to provide feedback to the investigators about potential barriers to implementing their research earlier on in the process.
• Quicker startup: During the study startup phase, a site is often temporarily prohibited from initiating recruitment due to the frequency of the IRBs review schedule. For example, if a protocol requires full board review, some local IRBs meet once a month, and the application must be submitted at least 1–2 months before the meeting date. Typically, private IRBs meet daily or weekly, which may allow for a more coordinated effort across sites in submitting the materials and getting a more rapid response.

Limitations

• Trust: Despite some of the delays associated with a local IRB, investigators are comfortable with their institution’s IRB and its requirements. Utilizing a private central IRB or another institution’s IRB may act as a barrier to the adoption of a central IRB review process. Researchers considering use of a central IRB should survey a few central IRB options and get to know them before selecting which group to use.

• Administrative concerns: While this option offers a centralized approach to the review of protocols involving human subjects, the amount of coordination in collecting all necessary documents across sites remains the same. When using a central IRB, the study staff still must carefully plan how to obtain the necessary documents and must ensure that the central IRB has the processes, staff, and tools in place to handle multiple sites-specific materials.
• Acceptance of private IRBs by academic institutions: Historically, local IRBs would not accept private, independent IRBs overseeing research conducted at their academic or medical institution. However, strides have been made to establish relationships between private IRBs and these institutions. These institutions have included the private IRBs on their FWAs or given the private IRBs permission to include their institutions on their lists.

Clinical research is moving away from the single-site model and increasingly considering how to design studies that will produce generalizable findings. A way to achieve this goal is to include multiple centers in the conduct of these studies. As complex, innovative, multicenter studies continue to be implemented, it will be important to consider ways to improve the efficiency of these studies. One approach is to implement a single IRB to conduct the ethics review to approve a study. Multiple agencies have provided guidance on utilizing the central IRB model for multicenter research, but additional requirements and practical applications of this approach are needed to increase adoption.

References

1. Food and Drug Administration. (2015). Using a centralized IRB review process in multicenter clinical trials. Retrieved from http://www.fda.gov/RegulatoryInformation/Guidances/ucm127004.htm.
2. Guidance for Institutional Review Boards and Clinical https://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm
3. Department of Health and Human Services. (2015). Use of a centralized institutional review board (IRB) (April 30, 2010). Retrieved from http://www.hhs.gov/ohrp/policy/protocol/cirb20100430.html. https://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm
4. Guidance for Institutional Review Boards (IRBs) https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM171256.pdf
5. National Institutes of Health. (2015). Request for comments on the draft NIH policy on the use of a single institutional review board for multi-site research. Retrieved from https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-026.html.
6. Clinical Trials Transformation Initiative. (2015). Central IRB. Retrieved from http://www.ctti-clinicaltrials.org/what-we-do/study-start/central-irb.
7. Department of Health and Human Services. (2015). Regulatory changes in ANPRM. Retrieved from http://www.hhs.gov/ohrp/humansubjects/anprmchangetable.html.