(This section applies to research outside of the United States and Canada. For Canadian research, please read about our Canadian review services.)
International research can provide crucial scientific insights, but myriad ethical review standards complicate any human research overseas. 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 review committees
- 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 ICFs and other study documents into the appropriate languages. Advarra is also available to provide consulting services to help you prepare for your research abroad and assess local regulatory requirements.
*Note: Advarra does not review research conducted in India.
Adaptive Trial Design
Adaptive trials present unique challenges for investigators and regulators alike. Adaptive trial design accommodates rapid adjustments to events in the study, but understanding the overall design and applying incremental changes can complicate an IRB’s oversight.
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.
As important as it is to find better treatments for children, or to confirm that a product for adults also works for children, researchers must take special considerations when evaluating the risks and benefits of a pediatric study. 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 and ensure they are equipped to conduct a pediatric protocol, administer consent and assent forms, 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.
Biologics – Vaccines
Vaccine trials can be large, and they often need to be fast. Advarra has a long history of reviewing vaccine trials. From our experience with vaccine trials, we know how to support them: rapid delivery of approval documents, daily review of every type of submission, and an international reach.
Minimal Risk Studies and Exemptions
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 review and approval timelines that are substantially faster 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. Advarra 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 — the careful review by a proven IRB. With a wealth of research industry experience, Advarra offers a customized approach to handling the ethical and regulatory implications of these studies.