Essentia Health patients have access to only those studies that have met rigorous standards for safety. All studies are conducted according to U.S. Food and Drug Administration (FDA) guidelines and good clinical practice.
- Conflict of interest
Essentia Institute of Rural Health has an obligation to assure that its scientific and clinical research is conducted to the highest standards of ethical conduct and free from any improper external bias. While we encourage and support research geared toward developing new and improved medications, therapies and devices, we understand that these economic relationships with industry have the potential to directly and significantly affect the conduct of research. To safeguard the integrity of Essentia Institute of Rural Health, we have adopted a rigorous conflict of interest policy. The policy sets forth the requirements of disclosing potential conflicts of interest in research and specifies the procedures for reviewing such disclosures and determining what corrective measures, if any, should be implemented. The policy subjects all studies in which the researchers, institution, research teams or review boards (Essentia Institute of Rural Health Scientific Review Board and Essentia Health Institutional Review Board) has an ongoing financial interest to thorough review.
- Administrative and financial oversight
Essentia Institute of Rural Health provides administrative, financial, scientific, ethical and clinical oversight for research. Services include completion of regulatory documents, budget and contract negotiation, and the Essentia Health Institutional Review Board application and submission. Studies are conducted in accordance with federal regulations and current guidelines for clinical practice.
Essentia Health has a Federalwide Assurance (FWA) on file with the Office for Human Research Protections (OHRP). The FWA contains the guidelines that govern Essentia Health in protecting the rights and welfare of research participants.
Essentia Institute of Rural Health Scientific Review Board
The Essentia Institute of Rural Health Scientific Review Board (SRB) is a group of scientists, physicians, PhDs and nurses who review proposed research for scientific merit prior to the Essentia Health Institutional Review Board's evaluation.
Essentia Health Institutional Review Board
The Essentia Health Institutional Review Board (IRB) examines each potential research study and evaluates all components to ensure the protection of human subjects. The IRB safeguards the rights and welfare of anyone participating in research projects by making sure each study is ethically sound.
Guided by federal rules and regulations, the IRB tracks every study's progress. The IRB must review and approve any changes made to studies, and reapprove each study on, at minimum, an annual basis.
As a further assurance of quality, Essentia Health is accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).