Health care professionals rely on their education, training, judgment and the body of evidence reported in the literature to guide decision-making. However, there are gaps in currently available medical knowledge and areas lacking clear evidence to guide patient care. Investigator-Initiated Trials (IIT) seek to address these gaps and contribute information to benefit future clinical care.
Mercy Research supports physicians, pharmacists, nurses, therapists and other clinical professionals in developing and conducting their own research studies at Mercy. In addition, we support students and trainees who meet research and scholarly activity program requirements. Students and trainees represent a variety of programs including Graduate Medical Education, Pharmacy Residency Programs, nurses seeking master’s or doctoral degrees and other graduate or health professional programs.
Mercy investigators contribute to a culture of continual growth and development to improve the Mercy patient experience. By seeking answers to clinical questions in routine patient care settings, Mercy investigator-initiated studies expand medical knowledge, inform clinical decision-making and enable current and future clinicians to provide excellent health care.
Mercy Research support for investigator-initiated studies includes study development assistance, budget preparation and navigation of funding applications, facilitating necessary Mercy approvals, obtaining required Mercy Institutional Review Board approval and meeting other regulatory requirements.
Mercy Research also helps Mercy physicians understand their responsibilities and meet regulatory requirements for clinical use of a Humanitarian Use Device or Expanded Access of an investigational or experimental product (drug, device or biologic) for diagnosis or treatment of a patient. This is not considered research.
A Humanitarian Use Device (HUD) is defined by the Food and Drug Administration as a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is seen in less than 8,000 people in the United States per year (Section 3052 of the 21st Century Cures Act (Pub. L. No. 114-255).
Expanded Access, also sometimes called “compassionate use,” is a way for patients who have a serious or life-threatening disease or condition to gain access to an investigational product, outside of a research study, when there are no equally similar or satisfactory treatment options available.
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