Animal and Human Subject Research Compliance
CARB-X is committed to high ethical standards in all research and business operations. To qualify for CARB-X funding, a research project must adhere to Animal and Human Subject Research standards and requirements. Specifically, CARB-X funded companies must comply with the US Office of Human Research Protections (OHRP) requirements for human subjects research and the US Office of Laboratory Animal Welfare (OLAW) requirements for studies involving any vertebrate species. Certain vertebrate species also trigger NC3R and United States Department of Agriculture (USDA) requirements.
Useful forms (for information only)
Attachment A Form
All product developers whose applications enter the negotiations stage of the CARB-X application process are required to complete a questionnaire providing information about Animal and Human Subjects Research
Attachment A-1 Form
All product developers whose applications enter the negotiations stage of the CARB-X application process are required to complete Attachment A-1, as applicable, to support information for Attachment A
Resources
Assured Performance Sites that may meet NC3Rs guidelines
Human Study Prerequisites
Study start prerequisites include the approved study protocol, investigator brochure, IRB or IEC approved informed consent document, OHRP FWA number, and IRB or IEC approval letter, among other prerequisites.
Human Monitoring Requirements
Bi-weekly clinical teleconferences are required, and independent monitoring is strongly recommended.
Human Reporting Requirements
Monthly, annual, and ad hoc reporting is required.