Why use a Central IRB

Institution Cooperative Agreement

Objective

To form a cooperative agreement for the review of all clinical research to be conducted within the institution.

  • Research review initiated by drug or device sponsors will be provided at no cost to the institution, but will rather be financed through individual fees to be paid by the drug or device sponsors of the research.
  • Research conducted within the institution by personnel (e.g. residents, nurses) or through grants will be reviewed at a reduced rate.
  • Liberty IRB will in turn supply the institution with comprehensive monthly reports detailing the research currently being conducted within the facility.

Federal Requirements

The FDA requires that all research to be conducted on humans be approved or declared exempt by an institutional review board (IRB). Many institutions have established their own IRBs to review the research being conducted within their own facility. The FDA holds the individual institution responsible for meeting all federal regulations applicable to the functioning of the IRB. Additionally, the FDA has established a Biomedical Research Monitoring Program (BI-MO) to audit IRBs for compliance with current regulations. Hospitals may find it difficult to maintain compliance with these regulations due to many reasons which may include:

  • Lack of personnel trained in the federal regulations protecting human subjects
  • Lack of time, personnel, and available resources
  • Inability to obtain physician presence at IRB meetings (required for FDA regulated items)
  • Poor record keeping
  • Inadequate reviews due to lack of available expertise

Failure to meet the requirements established by the FDA may result in punitive action against the institution responsible for the IRB itself. Some of these sanctions may include:

  • Issuance of form 483 (Notice of Non-Compliance). This 483 is published online and is available for review by all parties. Receipt of a 483 may result in negative publicity to the local institution.
  • Suspension of all ongoing research until compliance with the regulation is achieved to the satisfaction of the FDA.
  • Disqualification of all obtained research data. This will result in negative consequences for the physicians and negative publicity for the institution itself.

Meeting the Needs

In response to the growing need for compliance with the federal regulations, independent institutional review boards specializing in the protection of human subject rights have developed across the United States. Liberty IRB is an independent IRB located in DeLand, Florida. It maintains the ability to review all types of research and is FDA compliant.

Liberty IRB can assist the institution in meeting its responsibilities regarding clinical research in the following ways:
  • All review of institution based research will be conducted by Liberty IRB, thus releasing the institution from the responsibility of maintaining FDA compliance (the institution will not receive an IRB audit from the FDA).
  • The institution will be protected and secure in the fact that all research will be adequately reviewed by a highly specialized group of professionals trained in the protection of human subject rights.
  • The institution may reallocate personnel, as they no longer will be required to maintain and run an IRB.
  • Liberty IRB will provide the institution with detailed reports outlining all research activities approved for the institution.

The FDA does not permit studies to be "transferred" to another IRB, but require each study is reviewed by the new IRB. Although this process may seem cumbersome, it protects the institution and quickly establishes compliance for any study which may have inadvertently been approved without following the regulatory guidelines. This "transfer" of studies is generally completed quickly, and does not interfere with any ongoing research studies.

Following this transition, the institution will request all physicians involved in the research to submit their new studies to Liberty IRB. Ongoing reports will be sent to the institution detailing all activity.

Summary of Key Benefits

Liberty IRB provides timely, ethical and comprehensive reviews of clinical research while diligently maintaining compliance with all established federal, state and local laws governing the conduct of clinical research.

Key benefits include:

  • Diverse IRB membership who collectively represent scientific, ethical, administrative and community attitudes that affect the review of clinical research. Each member receives initial and ongoing education on the protection of human subjects involved in clinical research. In addition to regular members, the board is complemented by specialized physician consultants in all areas of expertise.
  • Compliance with federal regulations is maintained by Liberty IRB; therefore the institution will not be audited for IRB compliance.
  • Use of Liberty IRB relieves the institution of the burden of allocating personnel and resources towards the maintenance of an IRB.
  • Investigators are provided with timely reviews of their research.
  • Institution will receive comprehensive reports detailing all research activity.

Liberty IRB serves as the local IRB for several institutions. We can do this if there is no local IRB with jurisdiction or when a local IRB defers to Liberty IRB in writing.

The forms found below will help you make the transition. Please take a look!

If you need any additional information please contact us.