Project Grant ORIIR240081

CULTIVATING RESEARCH INTEGRITY: ESSENTIAL FOR TRANSITIONING FROM A COMMUNITY HOSPITAL INTO AN ACADEMIC MEDICAL CENTER - A. PROJECT DESCRIPTION: READING HOSPITAL, THE FLAGSHIP HOSPITAL OF TOWER HEALTH, IS SUBMITTING THIS APPLICATION IN RESPONSE TO THE NOTICE OF FUNDING OPPORTUNITY (IR-OR-24-001): ENSURING RESEARCH INTEGRITY - CONFERENCES. OUR PROPOSED CONFERENCE AIMS TO PROVIDE A FORUM FOR EDUCATION ON RESEARCH INTEGRITY, EXCHANGE OF BEST PRACTICES, NETWORKING, AND PRODUCING TANGIBLE OUTCOMES PRIMARILY RELATED TO THE FIRST TWO THEMES LISTED IN THE NOFO - 1) FOSTERING AN ENVIRONMENT THAT PROMOTES RESEARCH INTEGRITY AND THE RESPONSIBLE CONDUCT OF RESEARCH, AND 2) PREVENTION OF RESEARCH MISCONDUCT. SPECIFICALLY, THIS CONFERENCE PROPOSES TO EMPHASIZE THE IMPORTANCE AND IMPACT OF CULTIVATING RESEARCH INTEGRITY CULTURE IN A COMMUNITY HOSPITAL AS IT IS TRANSITIONING INTO AN ACADEMIC MEDICAL CENTER, THEREFORE ADDRESSING AN UNMET NEED IN THE RESEARCH INTEGRITY SPACE. THIS CONFERENCE ALSO INTENDS TO SHARE THE INSTITUTION'S EXPERIENCES AND LESSONS LEARNED DURING THEIR OWN TRANSITIONS AND DISSEMINATE BEST PRACTICES IN RESEARCH INTEGRITY TO THE CONFERENCE PARTICIPANTS. OUR APPROACH IS CONSISTENT WITH THE RECOMMENDATION FROM NATIONAL ACADEMIES OF SCIENCES ENGINEERS MEDICINE (2017): "RESEARCHERS, RESEARCH SPONSORS, AND RESEARCH INSTITUTIONS SHOULD CONTINUE TO DEVELOP AND ASSESS MORE EFFECTIVE EDUCATION AND OTHER PROGRAMS THAT SUPPORT THE INTEGRITY OF RESEARCH. THESE IMPROVED PROGRAMS SHOULD BE WIDELY ADOPTED ACROSS DISCIPLINES AND ACROSS NATIONAL BORDERS". 1. RATIONALE AND BACKGROUND: INTEGRITY IN RESEARCH IS A FUNDAMENTAL PILLAR OF RESEARCH EXCELLENCE AND PUBLIC TRUST OF SCIENTIFIC ADVANCEMENT THROUGH RESEARCH. IT ENCOMPASSES OBJECTIVITY, HONESTY, OPENNESS, FAIRNESS, ACCOUNTABILITY, AND STEWARDSHIP (NATIONAL ACADEMIES OF SCIENCES ENGINEERING AND MEDICINE (U.S.). COMMITTEE ON RESPONSIBLE SCIENCE. & COMMITTEE ON SCIENCE ENGINEERING MEDICINE AND PUBLIC POLICY (U.S.), 2017). DESPITE SIGNIFICANT PROGRESS IN RESEARCH ON INTEGRITY RESEARCH AND ENHANCED OVERSIGHT AT FEDERAL, LOCAL, AND INSTITUTIONAL LEVELS, EROSIONS OF RESEARCH INTEGRITY AND MISCONDUCT CONTINUE TO RISE. IN 2022, OFFICE OF RESEARCH INTEGRITY (ORI) RECEIVED 269 ALLEGATIONS (THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, 2022). RESEARCH MISCONDUCT IS DEFINED IN 42 CFR PART 93 AS FABRICATION, FALSIFICATION, OR PLAGIARISM IN PROPOSING, PERFORMING, OR REVIEWING RESEARCH, OR IN REPORTING RESEARCH RESULTS. EVEN THOUGH IT IS DIFFICULT TO ACCURATELY ASSESS THE "EPIDEMIOLOGY" OF RESEARCH MISCONDUCT, A RECENT META-ANALYSIS (PHOGAT ET AL., 2023) REPORTED THE PREVALENCE RATE (SELF-REPORT VS OBSERVED) OF 4.2% VS 27.9% FOR PLAGIARISM, 4.5% VS 21.7% FOR DATA FABRICATION, AND 9.7% VS 33.4% FOR DATA FALSIFICATION. IN CLINICAL RESEARCH INCLUDING CLINICAL TRIALS, RESEARCH MISCONDUCT MAY INVOLVE BROADER PRACTICES THAT CAN BE DEEMED QUESTIONABLE AND EVEN DETRIMENTAL TO THE WELLBEING OF STUDY SUBJECTS. EXAMPLES OF COMMON MISCONDUCT FINDINGS IN CLINICAL TRIALS INCLUDE FAILURE TO ADHERE TO RESEARCH PROTOCOLS; FAILURE TO REPORT SERIOUS ADVERSE EVENTS; REPEATED OR DELIBERATE FAILURE TO OBTAIN ADEQUATE INFORMED CONSENT; FAILURE TO OBTAIN INSTITUTIONAL REVIEW BOARD (IRB) REVIEW AND APPROVAL OF STUDY PROTOCOL OR CHANGES; FAILURE TO ADEQUATELY SUPERVISE THE CLINICAL TRIAL (GUPTA, 2013). THREE KEY CONTRIBUTING FACTORS TO RESEARCH MISCONDUCT INCLUDE INDIVIDUAL BEHAVIORS, INSTITUTIONAL ISSUES, AND STRUCTURAL ISSUES IN RESEARCH IN GENERAL (GUPTA, 2013). RESEARCH INTEGRITY RISK OR MISCONDUCT ESPECIALLY ASSOCIATED WITH INDIVIDUAL AND INSTITUTIONAL RISK FACTORS CAN BE FURTHER EXPOSED OR ELEVATED IN AN INSTITUTION THAT IS LESS EXPERIENCED IN CLINICAL RESEARCH AND LACK OF EFFECTIVE RESEARCH COMPLIANCE MECHANISMS, PROGRAMS, OR INFRASTRUCTURE. WE BELIEVE THAT A COMMUNITY HOSPITAL THAT IS SEEKING STRATEGIC TRANSITION INTO AN ACADEMIC CENTER BY ENGAGING MORE MEDICAL STUDENT EDUCATION OPPORTUNITIES, ESTABLISHING RESIDENCY AND FELLOWSHIP PROGRAMS, AND PROMOTING CLINICAL RESEARCH MAY REPRESENT SUCH CHALLENGES. THERE ARE SIGNIFICANT NEEDS TO INC