IRB Compliance & Registration

As a trusted partner to the industry’s top sponsors and leading research institutions, our highest priority is ensuring that our client’s trials and studies comply with all regulations: ensuring the protection of the rights and welfare of human research participants.

About Federal Wide Assurance (FWA)

An FWA is documentation stating that your institution will comply with federal regulations, maintain ethical research policies, and follow procedures to protect your research participants. 

WCG Registration

WCG IRB is registered with the Office for Human Research Protections (OHRP and FDA) as IRB00000533. 

This registration enables us to be the IRB of record for HHS-supported or conducted research involving human participants under the FWA of a submitting organization. 

Our Canadian board’s registration number is IRB00002354.

FDA Compliance

Our organization is routinely inspected by the Food and Drug Administration (FDA) – and found to be in good standing and compliant with federal regulations. This underscores WCG IRB’s commitment to championing scientifically and ethically sound research, safeguarding clinical trial participants, and demonstrating continuous improvement.

Use of Electronic Signatures

WCG IRB’s electronically signed regulatory documents are generated in compliance with 21 CFR Part 11 regulations covering electronic records and electronic signatures.

Electronic signatures are available for use in the signature module of the WCG IRB electronic workflow system. Security rights to access this module are given only to those with signature authority, as listed on the board membership rosters. All signers must attest to an understanding that electronic signatures are the legal equivalent of handwritten signatures prior to attaining signature security rights. A signer must enter a unique user name and password to access the electronic workflow system. The signer must re-enter his or her own unique password to access the signature module and affix the electronic signature. An electronic signature can only be applied by the user named in the signature. Proxy signatures—i.e., Dr. X signing for Dr. Y—are clearly indicated on the signed document. Sharing of passwords is prohibited.

Changes to records in the system, including all document signings, are recorded in a secure, electronically generated audit trail. 

AAHRPP Accreditation

In 2003, our flagship IRB was the first central IRB to receive accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP®), an organization that endeavors to improve safeguards for clinical research participants. As per AAHRPP requirements, WCG IRB undergoes the organization’s rigorous reaccreditation process every five years. Most recently, we were awarded reaccreditation status by AAHRPP in September 2019.

SMART IRB Participating Institution

WCG’s IRB has joined SMART IRB and may use the SMART IRB Agreement to enable IRB reliance (
WCG’s IRB does not utilize the online reliance system available through SMART IRB. To coordinate a reliance arrangement for a study, please utilize the template available here to document oversight.

WCG’s Quality Policy

WCG’s IRB and IBC are both ISO 9001 certified because we recognize the need to deliver the highest quality performance possible, throughout the organization, by complying with all applicable client, regulatory, and operational requirements. Our commitment to quality is based on effective and consistent operational systems, which are ISO 9001 certified and are continually monitored. It is WCG’s policy to meet these goals through continual process improvement. Details

If you will be registering research overseen by WCG IRB on, use the following information:

Additional Compliance

In addition to IRB registration, WCG IRB complies with: