Statement of Compliance

WIRB Statement of Compliance

Western Institutional Review Board (WIRB) is duly constituted, has written procedures for initial and continuing review of clinical trials; prepares written minutes of convened meetings, and retains records pertaining to the review and approval process; all in compliance with requirements of FDA regulations 21 CFR Parts 50 and 56, HHS regulations 45 CFR 46, and International Conference on Harmonisation (ICH) E6, Good Clinical Practice (GCP), as applicable. WIRB is registered with OHRP/FDA; our IRB registration number is IRB00000533, parent organization number is IORG0000432.

WIRB also reviews in compliance with other applicable federal and state laws and regulations governing IRBs and research with human beings. Where appropriate, WIRB complies with additional regulations and guidelines (such as the Canadian Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans) as required in specific research jurisdictions.

Since 2003, WIRB has been fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

Clarification regarding the requirement in section five of FDA Form 1572 that the site / investigator provide the name and address of the institutional review board that is responsible for review and approval of the study:

Panel 18 is shared by Western IRB (WIRB) and Copernicus Group IRB (CGIRB), working in a single electronic system. The electronic system that is used to manage Panel 18 is fully validated and compliant with 21 CFR Part 11.

All actions by Panel 18 are applicable at both WIRB and CGIRB. Therefore, either WIRB or CGIRB may be listed on a 1572 for a site / investigator approved by Panel 18 and this will be compliant with FDA requirements.

Addresses for section 5 of FDA Form 1572:

Copernicus Group IRB                                                                 Western Institutional Review Board
5000 Centregreen Way, Suite 200                                             1019 39th Avenue SE Suite 120
Cary, NC 27513                                                                              Puyallup, WA 98374

If you have questions or need further information, please do not hesitate to contact us.

You may download a copy of this information on IRB letterhead below:

Statement of compliancee: PDF Version           Panel 18 1572 information: Panel 18 1572 memo 

Use of electronic signatures

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

Electronic signatures are available for use in the signature module of the Western Institutional Review Board (WIRB) electronic workflow system. Security rights to access this module are given only to those with signature authority, as listed on the Panel 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.

WIRB Quality Policy

WIRB is an independent institutional review board providing ethical review for research studies involving human subjects.

WIRB recognizes 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 continually monitored.

It is WIRB’s policy to meet these goals through continual process improvement.

Management will communicate this quality policy to members of the organization and support understanding in part through the quality motto:

“Protect, Comply, Accomplish, Improve.”