Regulatory Environment

As an institution that receives federal research funding, Icahn School of Medicine at Mount Sinai is obligated to comply with all relevant conflict of interest in research requirements issued by the Public Health Service, the National Institutes of Health, the National Science Foundation and other agencies. The academic community as a whole - with particular leadership from the Association of American Medical Colleges (AAMC) -- has responded to the Federal call for tighter controls by developing strategies and mechanisms for the identification, elimination or management of conflicts of interest.

The MSSM Financial Conflict in Interest in Research policy reflects both Federal regulatory requirements and AAMC guidelines. Excerpted descriptions of some key regulations and recommendations are provided below, along with internet links to enable you to learn about them in more detail.

Public Health Service excerpt: "Responsibility of Applicants for Promoting Objectivity in Research...regulations establishing standards and procedures to be followed by institutions that apply for research funding from the PHS to ensure that the design, conduct, or reporting of research funded under PHS grants, cooperative agreements or contracts will not be biased by any conflicting financial interest of those investigators responsible for the research...investigators are required to disclose...institutional official(s) will review those disclosures and determine whether any of the reported financial interests could directly and significantly affect the design, conduct, or reporting of the research and, if so, the institution must, prior to any expenditure of awarded funds, report the existence of such conflicting interests to the PHS Awarding Component and act to protect PHS-funded research from bias due to the conflict of interest..."

National Institutes of Health excerpt: "Objectivity of researchers is an essential value in scientific research and the basis for public trust. Researchers should be led by their data, not by other interests that might undermine the scientific integrity of their work...Concerns are raised when financial considerations may compromise or have the appearance of compromising an investigator's professional judgment and independence in the design, conduct, or publication of research...Institutions are required, therefore, to know what conflicts might exist; to manage, reduce, or eliminate those conflicts; and to report that information to the NIH..."

Food and Drug Administration excerpt: "FDA may consider clinical studies inadequate and the data inadequate if, among other things, appropriate step have not been taken in the design, conduct, reporting, and analysis of the studies to minimize bias. One potential source of bias in clinical studies is a financial interest of the clinical investigator in the outcome of the study because of the way payment is arranged (e.g., a royalty) or because the investigator has a proprietary interest in the product (e.g., a patent) or because the investigator has an equity interest in the sponsor of the covered study...require an applicant whose submission relies in part on clinical data to disclose certain financial arrangements between sponsor(s) of the covered studies and the clinical investigators and certain interests of the clinical investigators in the product under study or in the sponsor of the covered studies. FDA will use this information, in conjunction with information about the design and purpose of the study, as well as information obtained through on-site inspections, in the agency's assessment of the reliability of the data."

National Science Foundation excerpt: "...institutional policy must ensure that investigators have provided all required financial disclosures at the time the proposal is submitted to NSF. It must also require that those financial disclosures are updated during the period of the award...institutional policy must designate one or more persons to review financial disclosures, determine whether a conflict of interest exists, and determine what conditions or restrictions, if any, should be imposed by the institution to manage, reduce or eliminate such conflict of interest..."

Association of American Medical Schools (AAMC) has issued a number of reports to guide medical schools on conflict of interest in research. 

"Protecting Patients, Preserving Integrity, Advancing Health", released jointly by the AAMC and the Association of American Universities (AAU) in February 2008, is their latest call for enhanced vigilance in identifying and managing conflicts of interest in research involving human subjects.