An IRB reviews study materials and investigator credentials to ensure the rights and welfare of human research participants are protected. For more information on the participant’s role in research, you can find additional resources here.

Advarra’s U.S.-based IRB meets daily, Monday through Friday. The Canadian-based IRB meets three times each week on Tuesday, Wednesday, and Friday.

Yes, Advarra is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). This certification demonstrates Advarra’s commitment to high standards in research ethics and participant protection.
You can view a copy of the certification here.

Yes, Advarra assigns a dedicated point of contact to all your studies, ensuring any questions are addressed promptly.

Advarra’s IRB follows expedited review procedures for research presenting no more than minimal risk, as defined in OHRP guidance. Additionally, minor changes to previously approved research during the approval period (one year or less) can be reviewed in an expedited manner. Advarra uses expedited review procedures for most new research site submissions, recruitment materials, study-related materials, and certain amendments.

Advarra can serve as both a central IRB (single IRB) for multisite studies and a local IRB for individual sites. If a site does not have a local IRB or prefers to defer oversight to Advarra, we can serve as that site’s local IRB.

Yes, Advarra offers certified translation services through an approved vendor. We also accept a valid certificate of translation from external sources. Please contact us for more details regarding translation services.

The IRB can make several determinations for each study, including approval, approval with modifications (conditional approval), deferral for additional information, or disapproval. Approved studies are approved for up to one year, unless continuing review is not required under the revised Common Rule. The IRB may also approve research with modifications, requiring specific changes to be made to study elements. Deferred studies are held until the principal investigator (PI), sponsor, or CRO provides additional requested information. If a study is disapproved, the IRB will issue a formal disapproval letter explaining the reasons behind the decision.

In cases of approval, approval with modifications, or deferral, the submitting party will be notified. Advarra’s IRB has the authority to determine the adequacy of all consent form wording, in accordance with 21 CFR 56.109 and FDA’s informed consent guidance. The approved consent will be included with the initial approval documents.

Yes, the sponsor or PI may submit the study to another IRB. However, the FDA recommends the second IRB be informed the study was previously disapproved by another IRB.

No, federal regulations do not allow IRBs to retroactively approve research that has already been conducted. IRB approval must be obtained before research begins. If you anticipate publishing research potentially exempt from IRB review or qualifies as non-human subject research (NHSR), we recommend obtaining an official exemption or NHSR determination from an IRB before starting the study.

The IRB approval process may be delayed due to incomplete submissions, missing documents, or issues identified during review. Delays can result from missing submission documents, protocols lacking key information, or complications in finalizing the informed consent form (ICF). Additional delays may occur if site-specific issues are identified, such as incomplete site submission forms, missing curriculum vitae (CVs), unresolved investigator conflicts of interest, or compensation issues for study participants. The IRB will not provide site approval until the study is approved and the ICF is finalized.

All submissions to Advarra are managed through our paperless CIRBI Platform. From the start of the study through to termination, all required documents must be submitted electronically via CIRBI.

The IRB’s mission is to protect the rights and welfare of human subjects participating in research. The IRB operates as an independent body, and its decisions can only be made by IRB board members through exempt, expedited, or full board procedures. The IRB reviews all research activities following Advarra’s IRB Policy Manual and IRB Handbook.

Advarra’s IRB members come from a wide range of backgrounds, ensuring diverse ethical perspectives. Our network includes scientists and consultants who have expertise in vulnerable populations, such as pediatrics, critically ill patients, and cognitively impaired participants. We also have experts who have pioneered techniques and methodologies in various scientific fields.

Advarra’s IRB services were established in 1983 through the merger of several legacy IRB organizations. Since then, Advarra has been providing high-quality IRB review services.

You can find Advarra’s compliance statement in the “Reference Materials” section of the CIRBI Platform (login required).

Yes, Advarra is registered with both the FDA and OHRP. Our IRB Organization (IORG) number is 0000635, and our IRB Registration number is 00000971.

Yes, Advarra’s FWA number is 00023875.

When registering a study on ClinicalTrials.gov, enter the following details for Advarra:

Board Approval: Select the applicable option (e.g., request not yet submitted, submitted pending, submitted approved, etc.).

Approval Number: Enter the Advarra approval date (mm/dd/yyyy).

Board Name: Advarra

Board Affiliation: Independent

Board Contact: 410.884.2900

More information, including the IRB Handbook and guidelines, can be accessed through the “Reference Materials” section of the CIRBI Platform (login required).