• Clinical trials overview
• Cancer studies
  • Cancer studies overview
  • Current clinical trials
  • Benefits of CCOP research trials
• Heart/vascular studies
  • Heart/vascular studies overview
  • Current clinical trials
• Other studies
• Participating in a clinical trial
• Research oversight
• For sponsors
• National program affiliations
• Other resources

Oversight for the Conduct of Research

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.

Full review process for studies

• 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 conducting a research study. To safeguard the integrity of Essentia Institute of Rural Health, we have adopted a rigorous conflict of interest policy. The policy sets out 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 investigator, institution, study staff or 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 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.
• Peer review
  Investigators who are the professional equals of the people who have conducted the research evaluate studies to ensure the research was conducted correctly, and is of a high quality.

Scientific Review Board

The Scientific Review Board is a group of scientists, physicians, PhDs and nurses who review proposed research for scientific merit prior to the Institutional Review Board's evaluation.

As a further assurance of quality, SMDC Health System, now a part of Essentia Health, is accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

Essentia Health Institutional Review Board

The Essentia Health Institutional Review Board (IRB) examines each potential research study and evaluates all components to ensure quality and patient safety. 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 an annual basis.

The IRB 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.