Conflicts of Interest
Guidelines for Vendor Relationships
Answers to Frequently Asked Questions
Commercially Sponsored Research
Q: Can investigators and research staff attend the initiation conference and investigator meetings for multi-centered clinical trials?
A: The Principal Investigator and the Study Coordinator can attend initiation conferences and update meetings for multi-center clinical trials, and the sponsor can pay for transportation, meals, etc. associated with attending. Such expenses should be part of the research budget.
Q: When a research representative from a sponsoring company comes to Mount Sinai for a monthly site visit for a multi-center clinical trial, can the sponsor pay for lunch for the research team?
A: Monthly site visits by the sponsor are required by the Food and Drug Administration to ensure the integrity of the research data. These visits tend to take all day. It is permissible for the study sponsor to pay for working lunches with the study coordinator when the meetings are mandated by the sponsor and/or the FDA.
Q: Is it ever appropriate to accept a research grant from the marketing arm of a corporation?
A: The marketing arm of a large pharmaceutical company sometimes supports product research after a product receives regulatory approval approved. The scientific research that is conducted after approval can be valuable and is often supported through investigator-initiated studies. All research proposals - whether for basic science or human subject research - should be for specific scientific studies, with a signed agreement that defines the scope or work that will be accomplished, and a budget that is commensurate with the project being proposed.