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.
For organizations that wish to sponsor or conduct research, and/or meet requirements to apply for federal funding for research, the CARAS HRPP can work with your organization to establish a compliant institutional HRPP, including necessary policy, procedures, and training. 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 organization/institutions that wish to apply for federal research funding, and/or conduct or support research that is legally required to comply with federal requirements applicable to human subjects research or clinical investigations, to obtain a Federalwide Assurance (FWA).
Institutions that are engaged in federally supported human subjects research must obtain a Federalwide Assurance (“Assurance”). An Assurance is a formal declaration in which the institution promises to comply with federal requirements for the protection of human subjects. FWA registration is managed by the Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP).
Assist in creating an IRB Authorization Agreement (IAA)
This is an agreement in which an Institution with a FWA will rely on the IRB of another institution. This is also referred to as using an “external IRB,” a very common practice in research today.
Assist in creating an Individual Investigator Agreement (IIA)
The IIA is used by an assured institution to extend – for one or more research protocols – the applicability of its FWA to cover either independent investigators or collaborating institutional investigators.
If you need more information or would like to discuss specific aspects of your research, please call (858) 480-7712 or email the CARAS Human Research Protections Program (email@example.com).