Advarra Institutional Review Board Mission

The mission of the Institutional Review Board is to protect the rights and welfare of human subjects enrolled in research. The IRB operates as an independent body. IRB decisions may only be made by IRB board members following the exempt, expedited or full board procedures.

The IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities submitted to Advarra for review. All research submitted to Advarra for review by the IRB follows the processes and procedures set forth in the Advarra IRB Policy Manual and IRB Handbook.

Advarra is organized and operates in compliance with the US federal regulations (including, but not limited to 21 CFR Parts 50 and 56, and 45 CFR Part 46), various guidelines as applicable (both domestic and international, including but not limited to OHRP, FDA, EPA, ICH GCP as specific to IRB review, Canadian Food and Drug Regulations, the Tri-Council Policy Statement 2, and CIOMS), and the ethical principles underlying the involvement of human subjects in research (including The Belmont Report, Nuremberg Code, Declaration of Helsinki).

Advarra’s IRB Organization (IORG) Number is 0000635 and IRB Registration number is 00000971. Advarra’s Federalwide Assurance (FWA) number is 00023875.

About Advarra IRB

Advarra’s institutional review board (IRB) members have extensive, varied backgrounds, including service on institutional, academic, and independent IRBs. This diverse membership ensures we hear the full range of ethical perspectives, and we maintain a network of consultants to provide additional insights when necessary. Members of the Advarra® IRBs are versed in examining research for its ethical implications, including research involving vulnerable populations such as pediatrics, critically ill, and cognitively impaired participants.

Review groups and service teams include scientists who have pioneered techniques, methodologies, and discoveries in their fields. Advarra synthesizes this deep expertise and commitment to review excellence across all therapeutic areas, and continues to set the standard for review services in areas such as oncology and neurology.

Advarra supports all phases of drug, device, and biologics development, as well as social, behavioral, and international research through:

  • Multiple daily IRB meetings to ensure timely review and response
  • Priority review meetings when needed
  • 24/7 access to the IRB submission management platform (the Advarra CIRBI® Platform)
  • Recruitment guidance for all media strategies and materials
  • On-call consultation on all aspects of the study submission and review process
  • Close collaboration with the Advarra operations team
  • Additional expert advice on protocol design through Advarra Consulting

Meeting Schedule

US review boards

Meetings daily (Monday through Friday)

Canadian review boards

Meetings 3x weekly (Tuesday, Wednesday, Friday)

IRB Review Determinations

Each study will be given one of the following designations:

Approved

The IRB approves the study as submitted for up to 1 year
(Not applicable for studies that do not require continuing review under the revised Common Rule)

Approved with Modifications

The IRB may approve research with modifications, also known as a “Conditional Approval,” with IRB-required restrictions or alterations of specific elements and/or documents

Deferred

The IRB defers a decision on the study to seek additional information from the PI, sponsor/CRO, or a consultant

Disapproved

The IRB cannot approve the study and will issue a formal letter of disapproval stating the basis for its decision

In the case of an approved, approved with modifications, or deferred decision, the submitting party will be notified. Advarra’s IRB has the responsibility and authority to determine the adequacy and appropriateness of all the wording in the informed consent form. (See 21 CFR 56.109 and FDA’s A Guide to Informed Consent.) Advarra will provide proposed consent revisions to the submitting party.

Approval for studies and sites will last for the period specified in the approval documentation but will not exceed 1 year (not applicable for studies that do not require continuing review under the revised Common Rule). Advarra will specify the expiration date in your approval letter. The Advarra-approved consent will be included with the initial approval documents.

The IRB will issue a formal letter if the study is disapproved. The recipient has the right to submit a written appeal to the IRB. If you submit the study to a second IRB after disapproval by Advarra, you must notify the other IRB of Advarra’s disapproval.