Institution Bulletin vol 4, issue 1
Over the last decade, clinical researchers have expanded their use of study sites located outside of North America. While this shift has increased participant availability in the clinical trials pipeline, it has also exposed research protocols to redundancy and delays arising from multiple ethics review requirements and multiple service providers.
Quorum’s Commitment to International
In response, Quorum Review IRB has delivered on our strategic commitment to develop the expertise and processes needed to meet the research industry’s demand for international and domestic ethics reviews. As a result, sponsors, CROs, and institutions can now access Quorum’s industry leading ethics review or consulting services even when protocols employ study sites across the globe.
Quorum’s strategic investment in international capabilities builds on more than 20 years of experience conducting ethics reviews in North America. Already boasting one of the industry’s largest team of regulatory attorneys, Quorum has bolstered this expertise with extensive research on international laws and policies governing participant ethics reviews. In addition, Quorum has crafted submission requirements that ensure qualifying international protocol submissions can benefit from the same standard turnaround times available to North American studies.
What kinds of international ethics reviews are available to Quorum’s clients?
Quorum’s expertise gives us the flexibility to provide ethics reviews in one of three ways, depending on the client’s individual needs and requirements under local law:
- Ethics reviews based solely on United States standards.
- Hybrid ethics reviews in which both United States and country-specific standards are considered.
- Ethics reviews based solely on country-specific requirements. Typically, this form of review is only available when the country-specific standards are the same or more protective than U.S. Common Rule.