A compilation of information, announcements, & updates for UK Institutional Review Board (IRB) members, research investigators, & others involved with human subject research.
Expedited IRB Review for Individual Patient Compassionate Use
Sometimes called “compassionate use”, FDA’s expanded access program (EAP) provides a pathway for a patient with an life-threatening condition or serious diseaseto gain access to an investigational product. In April, FDA released a new FDA Form 3926, physicians may use to request Individual Patient Access to investigational drugs. The new form includes a checkbox for requesting a “waiver from Full IRB review”. Checking the box permits the IRB to use Expedited Review, which is review by one IRB member as opposed to the convened board.
FDA’s recent guidance on individual expanded access during the COVID-19 public health emergency, emphasized provision of sufficient information for the IRB reviewer to determine if expanded access criteria are met. ORI encourages physicians to use Form 3926 when submitting individual patient access requests to the FDA, as it addresses each criterion.
To submit individual patient EAP for Expedited IRB review, check Individual Patient Expanded Access IND on the Drug Section of the IRB application and choose Expedited Category 1.
COVID-19 Human Research Protocols
The number of COVID-19 human research protocols has reached 162 submitted or approved projects. The research projects span diverse aspects of the novel coronavirus, from potential treatments to impact on daily life. Click here for guidance on conducting or submitting COVID-19 research for IRB review.
Please note: Individuals conducting human subjects research must review and comply with the requirements of the VPR’s Resumption of Research Phased Planbefore initiating or resuming any in-person research.