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Journal of Long-Term Effects of Medical Implants
Abstract of "Ethical Safeguards for Industry-Funded Research in an Academic Setting
Fred R. T Nelson
Osteoarthritis Center, Department of Orthopaedics, Henry Ford Hospital, Dearborn, MI 48202
Investigators are increasingly faced with public scrutiny on the manner in which they fund and report their research into new materials and appliances for patient care. This is particularly important in academic centers where there are four stakeholders, namely, the investigator, the institution, patients, and industry. This is a report on the elements of how one institution provides support to an investigator. This process makes it possible for the investigator to concentrate on research methodology and be secure about the ethical nature of their research. At Henry Ford, all industrial-funded research is arranged on an institution-to-sponsor basis. Although investigators are the most common resource for initial contact from industry, the investigator can immediately hand over to the institution materials for the formulation of contracts and IRB proposals. The following steps occur in parallel. Contract language is generated by the institution, not the investigator. This protects the investigator (utilization of data for research purposes, freedom to publish regardless of the results, and intellectual property), patient protection (HIPAA privacy laws, subject injury coverage, and IRB approval) and the institution (intellectual property, compliance with the federal/state guidelines, and indemnification). Concurrently, IRB proposals are prepared and submitted. To insure that all steps meet ethical standards, investigators and their departmental chairs are required to complete and sign a document called the preaward and postaward authorization form. This form has multiple purposes. It insures that there are no conflicts of interest, cost sharing is defined if applicable, IRB approval is obtained, and that the departmental chair supports the proposal. The document also collects information that is entered into a database that tracks institutional, investigator, and sponsor project data and captures research funding. The investigator, with the knowledge of the conduct of the study, formulates the budget to ensure that the actual costs for equipment, supplies, and personnel effort are captured. All contractual negations take place in the central Research Administration office, and do not involve the investigator. This frees the investigator for other details of the proposal and research methodology. This process provides a transparency acceptable to all stakeholders.
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