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.
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Vaccine trials can be large, and they often need to be fast. Advarra’s IRB and institutional biosafety committee (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: through 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.
Federally Funded Research
Ensure expert oversight and experienced guidance when you select Advarra as your IRB of record in your federal grant proposal. Advarra has overseen more than 1,000 federally funded studies, both as a local IRB for a single investigator and as a designated single IRB (sIRB) for multisite studies. We can provide a budget estimate for IRB and more, as well as documentation for your National Institutes of Health (NIH) grant application to identify your project’s sIRB and outline responsibilities and communication tactics.
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.
Go Direct with Advarra Connect
- No manual loading or document manipulation of documents before export
- Map files, indexing information, and metadata to the correct filing structure
- Ensure your IRB documents are always in-sync
Replace manual, error-prone processes by automating the secure transfer of IRB-related documents directly to your electronic trial master file (eTMF).
Are you a research participant?
Find out how the IRB helps protect your rights and welfare.
Beginner’s Guide to Institutional Review Boards (IRBs)
In the U.S., there is an independent group overseeing clinical research, ensuring participants’ rights and welfare are protected.
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.