Right to Try – Unapproved Drugs or Biologics In May 2018, the Federal Right to Try (RTT) Act was signed into law, creating a federal framework for patients to access investigational new drugs and biologics outside of clinical trials and outside of the U.S. Food and Drug Administration’s (FDA) expanded access program. The federal law…

Humanitarian Use Devices A Humanitarian Use Device (HUD) is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year. Microsoft Word Icon Humanitarian Use Device Consent Form Download the Form Overview…

Human Gene Transfer Research The following explanations are provided to assist investigators in determining whether their proposed research may constitute human gene transfer and, therefore, require additional oversight. What is DNA? Deoxyribonucleic acid (DNA) is the building block of life. This molecule encodes different characteristics in all living things. With the exception of identical twins,…

Research Involving the Department of Defense (DoD) Background Post-Approval Instructions Additional Information Background The Department of Defense (DOD) IS a signatory to the Revised Common Rule, which took effect January 21, 2019.   To determine additional applicability and requirements when conducting DoD supported research, view the DoD Instruction 3216.02. The IRB Application in Kuali Research Protocols…

Single IRB (sIRB) Process A Single IRB means one IRB of record (or Reviewing IRB), selected on a study-by-study basis, provides the regulatory and ethical review for all sites participating in a specific multisite study. Questions the sIRB Process? Contact the HRP Reliance Team: IRBReliance@uci.edu sIRB Requirement At UCI, a single IRB will be required…

Expanded Access to Unapproved Drugs or Biologics The Food and Drug Administration (FDA) allows for two options for treating patients with an unapproved drug, biologic or test article outside of a clinical trial. One option is Expanded Access. The other option is Right to Try. wrench and screwdriver icon (Decorative) FDA Expanded Access eRequestA web-based…

Medical Devices Used in Clinical Investigations FDA Requirements for New Medical Devices A  medical device is defined, in part, as any health care product that does not achieve its primary intended purposes by chemical action or by being metabolized. Medical devices include, among other things, surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and…

Placebo-Controlled Studies The use of a placebo in clinical research continues to be a topic of debate in the medical community. Some argue that use of placebos is often unethical because alternative study designs would produce similar results with less risk to individual research participants. Others argue that the use of placebos is essential to…

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Data and Safety Monitoring for Clinical Research All clinical investigations involving greater than minimal risk to participants are, at a minimum, required to develop a data and safety monitoring plan to assure the safety and welfare of the research subjects. In addition, the IRB Chair retains the right to require a monitoring plan for a…