IRB FAQ

Our US-based IRB meets daily (Monday through Friday). Our Canadian-based IRB meets three times each week (Tuesday, Wednesday, Friday).

Yes. Advarra has a dedicated point of contact assigned to all your studies to ensure any questions you have are rapidly addressed.

Per regulations, Advarra’s IRB can follow expedited review procedures for:

• Research presenting no more than minimal risk. These categories are listed in OHRP Guidance; and
• “Minor changes” to previously approved research during the period (one year or less) for which approval is granted.

Advarra reviews most new research site submissions, recruitment, and study-related materials, as well as some amendments and new study submissions using expedited review procedures.

Advarra can serve as both. For multisite studies, Advarra can serve as the central or single IRB for all participating sites. For a site who does not have a local IRB or who would like to defer oversight to Advarra, Advarra can serve as that site’s local IRB.

Yes. Advarra can assist with certified translation using our approved vendor, or we can accept a valid certificate of translation. Please contact us for additional information.

Each study will be given one of the following designations:

• Approved: The IRB approves the study as submitted for up to 1 year. This is 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 Informed Consent Guidance 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.

Yes. However, the FDA states the sponsor/CRO or investigator should inform the second IRB of the other IRB previously disapproving the study.

No, the federal regulations do not provide for IRB approval for research already conducted; IRBs can only grant approval prior to research initiation. If you anticipate publishing research that may be considered exempt from IRB review or non-human subject research (NHSR), we recommend obtaining an official exemption or NHSR determination from an IRB prior to beginning the study.

IRB standard turnaround times apply only when a submission is complete and follow-up activities resolved as appropriate. Turnaround time is dependent upon complete and accurate submission of study documents, and may be extended if the IRB, upon review, requires further information.

Additionally, site approval will not be provided until the study has been approved and the informed consent finalized.

The following list reflects common reasons for delays in the IRB review process:

• Incomplete submission documents: Please refer to the submission form to ensure you are submitting all required documents for review. The IRB must have all necessary information relevant to the submission to conduct its review.
• Study protocol missing key information: The IRB may identify areas of concern with the protocol and defer study approval or require modifications as part of the approval.
• Delays in ICF finalization: After formal IRB review, additional Advarra-internal or sponsor/CRO/institution review of the ICF may be required prior to finalization. Approval documents will not be sent to sites until the ICF is finalized.
• IRB concerns with site submission information: Upon review of additional sites conducting a previously approved protocol, the IRB may note an area of concern with the site’s responses on the submission documents. If concerns are noted or the compensation for participation information is unclear, an Advarra representative will contact the site. The site must provide satisfactory resolution of the identified issues before approval process completion. Common causes for site review delays include:
  •  Missing curriculum vitae (CV)
  • Incomplete research site submission form
  • Site’s failure to include FDA audit findings
  • Site’s failure to include documentation of disciplinary actions against investigators (e.g., state medical board)
  • Subject compensation issues
  • Principal investigator conflict of interest
• Site-specific ICF revisions: If a site submits a request for additional site-specific revisions, an IRB member must review the requested revisions to determine their appropriateness. In some instances, the sponsor/CRO may also require approval.

Advarra is a paperless IRB. All submissions, from beginning to termination, need to occur through the Advarra CIRBI Platform (login required).

Yes, the References section of the Advarra CIRBI Platform (login required) provides additional guidance materials and templates.

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’s 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. IRB members 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 was formed through the merger of several legacy IRB organizations and has been providing IRB review services since 1983, making it the second oldest independent IRB organization in the US.

You can access Advarra’s statement of compliance in the Reference Materials section of CIRBI (login required).

Yes. Advarra’s IRB Organization (IORG) Number is 0000635 and IRB Registration number is 00000971.

Yes, Advarra’s FWA number is 00023875.

When registering a study at ClinicalTrials.gov, Advarra suggests the following responses:

• Board Approval – select one of the following as applicable:
  • Request not yet submitted
  • Submitted, pending
  • Submitted, approved
  • Submitted, exempt
  • Submitted, denied
  • Submission not required
• Approval Number – Enter the Advarra approval date (mm/dd/yyyy)
• Board Name – Advarra
• Board Affiliation – Independent
• Board Contact – 410.884.2900

Login to the Advarra CIRBI Platform and click the Reference Materials tab to access the IRB Handbook and other guidance.