For individual investigators, the CARAS HRPP provides formal regulatory determinations to document the status of research that does not require IRB review, such as exempt research. If IRB review is required, the CARAS IRB can provide review and oversight of the project that is fully compliant with federal regulatory and other requirements, including GDPR.
For organizations that wish to sponsor or conduct research CARAS can serve as the IRB of Record for your organization.
Particular services provided by the CARAS HRPP include:
Discuss human subjects issues relevant to your research such as risks and benefits, informed consent, subject selection and recruitment, advertising, privacy and confidentiality
Pre-review your research protocol and consent form to identify potential regulatory issues and suggest ways to address them prior to official review
Provide educational information on the protection of human research subjects
Provide guidelines, interpretation of regulatory requirements, and research protocol templates
Assist in preparing needed documents, including protocol documents and required reports.
Assist in creating an IRB Authorization Agreement (IAA)
This is an agreement in which an Institution with a Federal Wide Assurance (FWA) will rely on the IRB of another institution. This is also referred to as using an “external IRB,” a very common configuration for IRB review in research today.
If you need more information or would like to discuss specific aspects of your research, please email the CARAS Human Research Protections Program (hrpp@carasresearch.org).