Institutional Review Board (IRB) Services
Solutions to Safeguard Trial Participants
Regardless of your project’s scope, therapeutic niche, or number of investigators, Advarra is your partner in the conduct of efficient, responsible research. Objectivity and concern for participant well-being drive all review decisions.
As the research community’s preferred independent IRB, Advarra is advancing clinical research: safer, smarter, faster™.
Our processes ensure efficient delivery of quality documentation, and our people provide dedicated, attentive service and expertise to support your research. Using technology, we create smarter and faster workflows while maintaining the highest standards of transparency and quality.
- Speed: Reviews of all types of submissions every day for faster decisions
- Flexibility: Convenient electronic tools and dedicated staff for easy, efficient study administration
- Accountability: A dedicated point of contact throughout your study
- Expertise: Experienced IRB members and administrative staff ensure high-caliber reviews
- Savings: Early engagement proven to save time and resources in later phase trials
Sponsors and CROs
Biopharmaceutical, biotech, medical device, and diagnostic product developers trust Advarra’s expert guidance across every phase of research and all major therapeutic areas.
Institutions, Health Systems, and Research Consortia
Advarra has relationships with over 3,500 institutions, hospitals, health systems, and academic medical centers (AMCs), supporting everything from single investigational sites to multiple site research consortia and therapeutic networks.
Private Research Sites and Site Networks
Dedicated coordinators, real-time reporting, and web-enabled technologies support transparent and efficient reviews to simplify collaboration.
Based in Ontario, Advarra has the largest central REB/IRB in Canada that is AAHRPP accredited to support research conducted exclusively in Canada and cross-border studies.
Advarra understands early phase research is unique, and we have developed specialized services to support early phase trials and dedicated Phase I sites. Given the timelines in Phase I/healthy, a study can start within days of an initial IRB application.
Advarra has reviewed all device study categories, with IRB review experience including implantable and portable devices, diagnostic tools, mobile medical devices and apps, human factors testing, and HUD/HDE studies. Our regulatory team can help determine the appropriate classifications for your product and has experience reviewing the latest in healthcare technology.
Leading Intelligence for Every Research Program
Vaccine trials can be large, and they often need to be fast. Advarra’s IRB and IBC have a long history of reviewing vaccine trials, including supporting 100% of Operation Warp Speed vaccine trials for COVID-19. From our experience with vaccine trials, we know how to support them: early engagement to meet critical enrollment milestones, and scientific expertise for robust and insightful reviews.
Adaptive Trial Design
Adaptive trials present unique challenges for investigators and regulators alike, accommodating rapid adjustments to study events. With researchers pursuing the flexibility of stopping dosing arms, changing randomization proportions, or combining multiple phases into a single trial, finding an IRB with the proper knowledge and understanding is crucial. Advarra has the right experience to oversee a study with an adaptive trial design.
Researchers must take special considerations when evaluating the risks and benefits of a clinical trial involving children. Protocols for this vulnerable population require extensive safeguards, and researchers must approach the consent of the parents as well as the assent of the minor with care.
Advarra has pediatricians as IRB members and as consultants. We can engage pediatric researchers early to ensure they are equipped to conduct a pediatric protocol and protect young study participants.
The study of biologics — medical treatments manufactured from living cells — represents one of the most exciting areas of clinical research today. When a study has to start or change quickly, Advarra can help. Our experienced IRB members, service-oriented staff, and knowledgeable regulatory teams appreciate the unique needs of biologic research.
This section applies to research outside of the United States and Canada. For Canadian research, please read about our Canadian review services.
Advarra has experience reviewing international studies and can support it in the following ways:
- Review to ensure compliance with US standards (with local ethics committee review)
- Collaborate with local ethics committee review
- Serve as the sole IRB of record for online research not targeted at a specific country and certain other minimal risk research
Advarra can translate informed consent forms (ICFs) and other study documents into the appropriate languages. We can also provide consulting services to help you prepare for research abroad and assess local regulatory requirements.
*Note: Advarra does not review research conducted in India.
Minimal Risk Studies
Not every study protocol needs to be reviewed by a fully convened IRB. Advarra has fully compliant, AAHRPP accredited criteria for appropriately referring research to expedited reviewers instead of a full board meeting. Qualifying minimal risk studies — such as retrospective chart reviews or some Phase IV observational studies — have substantially faster review and approval timelines than other reviews. We can respond to qualifying submissions as soon as the next business day.
Not all research is subject to IRB oversight. Some projects do not meet the criteria for research. Some meet the criteria for research but do not involve human subjects, and others involve human subjects but qualify for exemption from IRB review. The determination can be complex, but Advarra’s regulatory and IRB experts can assess and confirm whether your project requires IRB oversight. This type of assessment can provide these determinations for research conducted in the US or in Canada.
Retrospective Chart Review
By examining and assessing existing medical data, retrospective chart reviews can reveal unexpected insights. But this type of research requires an understanding of the regulations around accessing medical information and — if applicable — a proven IRB’s careful review. With a wealth of research industry experience, Advarra offers a customized approach to handling the ethical and regulatory implications of these studies.
How often does your IRB meet?
Our US-based IRB meets daily (Monday through Friday). Our Canadian-based IRB meets three times each week (Tuesday, Wednesday, Friday).
Do I have a point of contact for my study?
Yes. Advarra has a dedicated point of contact assigned to all your studies to ensure any questions you have are rapidly addressed.
What items can an IRB review by expedited review?
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.
Is Advarra a central or local IRB?
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.
Does Advarra provide translation services?
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.
What are the IRB’s possible 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. 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 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.
If an IRB doesn't approve the study, can the sponsor/CRO or principal investigator submit the study to a second IRB?
Yes. However, the FDA states the sponsor/CRO or investigator should inform the second IRB of the other IRB previously disapproving the study.
Can Advarra provide retroactive IRB approval for research already conducted?
No, the federal regulations do not provide for IRB approval for research already conducted; IRB 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.
What could slow the approval process for my study or site?
- Incomplete submission documents: Please refer to the submission form to ensure you are submitting all required documents for the review of new studies and additional sites.
- 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.
- 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.
How do I submit information to Advarra?
Advarra is a paperless IRB. All submissions, from beginning to termination, needs to occur through the Advarra CIRBI Platform.
What is the IRB’s 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’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.
Where can I find the IRB’s compliance statement?
You can access Advarra’s statement of compliance in the Reference Materials section of CIRBI (login required).
Is Advarra registered with FDA and OHRP?
Yes. Advarra’s IRB Organization (IORG) Number is 0000635 and IRB Registration number is 00000971.
Does Advarra have a Federalwide Assurance (FWA) number?
Yes, Advarra’s FWA number is 00023875.
Where can I find more information about working with Advarra’s IRB?
Login to the Advarra CIRBI Platform and click the “Resources” tab to access the IRB Handbook and other guidance.
Leveraging a Central IRB Office to Improve Turnaround Times and Consistency
Evaluating Payment to Participate in Research: Ethical and Regulatory Issues
In this webinar, Luke Gelinas, IRB Chairperson at Advarra, proposes a practical framework for evaluating offers of payment and applies it to case studies to yield guidance on challenging ethical and regulatory issues involved in paying research subjects.
Global CRO Drives Study Startup Efficiency by Converting Local IRB Sites to Central IRB Review
Research sites that rely on a local IRB typically take at least twice as long to activate than sites that rely on the study’s single central IRB. Utilizing the central ...