Institution FAQs

Is Liberty IRB registered with the Office for Human Research Protections (OHRP)?

Yes, Liberty IRB is registered with OHRP as IRB00003411 and is in compliance with all federal regulations.

Can our institution use Liberty IRB to review some of our clinical research studies and still maintain local oversight for other studies?

Yes you can. We can form a cooperative agreement to meet your specific needs for your institution.

If our institution, conducting clinical research under a Federal Wide Assurance (FWA), wants to change to Liberty IRB, what must we do?

If Liberty is not on your institutions FWA, you must add Liberty to it and submit the FWA to OHRP. In addition, you must sign an IRB Authorization Agreement with Liberty IRB.

What type clinical research does Liberty IRB have experience reviewing?

  • Phase I-IV Drug Studies
  • Device Studies
  • Biological Studies
  • FDA and OHRP Regulated Studies
  • Registry Studies
  • Social-Behavioral Studies

We are always updating our education to stay current in clinical research.

We have concerns about local review when using a central IRB located elsewhere in the country. How do you handle this?

Liberty IRB feels that it is important to meet the concerns of the local subject population for every study. Typically, we visit the site and consult with your institutional officials. We also obtain periodic reports of community attitudes towards research.

How long would the process take to set up a cooperative partnership with Liberty IRB and our institution?

You should conservatively allow 2-5 months from initial discussions to the first review conducted by Liberty. This time depends on the education of investigators on the new submission process, as well as, the acceptance of the transfer to Liberty IRB by your current IRB members and institution officials. A facilitator from your institution should be available to work with Liberty IRB for this transfer.

What are some of the reasons our institution should partner with Liberty IRB?

The FDA holds the individual institution responsible for meeting all federal regulations applicable to the functioning of an IRB. Institutions may find it difficult to maintain compliance for 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.

What are some of the benefits we could expect from partnering with Liberty IRB?

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 reports outlining all research activities approved for the institution.

What have been the most common findings by FDA in warning letters that have been issued to institutional review boards?

* Warning letters have been issued by the FDA for approval of studies without a quorum; conflict of interest of members on the board; approving new protocols and full board amendments by expedited review; and not having proper standard operating procedures in place for continuing review.


Are all IRBs required to have Federal- Wide Assurances?

No. Only institutions receiving federal funding for research are required to have Federal Wide Assurances on file with OHRP.

With questions regarding the information found above, please contact: Liberty IRB at info@libertyirb.com or by phone (386)740-9278