NIH Proposes New Conflict of Interest Regulations

The original NIH regulations went into effect in 1995. At that time we were fairly early into the avalanche of allegations that financial “conflicts of interest” promoted research corruption and were just emerging from a spate of high-profile scientific misconduct incidents. Therefore, one might cut the NIH some slack for some of the disingenuous aspects of its policy.


First, I put “COI” in quotes, because it is a meaningless framing bias that ignores the fact that interests are only perfectly aligned in anthills and that the pejorative use of “conflicts” emphasizes potential risks over potential benefits (otherwise there would be no need to disclose, manage or eliminate them). If you accept the frame, it puts you in the impossible position of disproving a negative (“I am not a crook”). It gets worse when you stretch the rules to cover “appearance” of conflict, because appearance is reality in politics, not science and because it is totally subjective. “Appearance” is invoked frequently in the proposal (I assume it was in the original as well).


What is striking and focuses the discussion is the title of the document: “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors.” The assumption is that COI detracts from “objectivity in research.”


There was no evidence in 1995 that this assumption is true, and no evidence has emerged in the intervening 15 years. In fact the totality of evidence of “corruption” due to FCOI has shifted almost totally to marketing, not research – and that evidence is vanishingly weak.


I am unaware of a single case of research misconduct that involved industry-related FCOI. The approach to research misconduct has been to maintain a narrow definition of misconduct, investigate allegations thoroughly, and punish the convicted. We do not “manage” (and we can’t eliminate) misconduct. It is therefore bizarre that we have allowed a prophylactic regime to permeate biomedical research – instead of ticketing speeders, we ban fast cars.


The ramping up of regulation in the absence of substantive evidence that we need it is, of course, the fallout from demagoguery exercised by certain politicians abetted by COI critics and the media – and by the failure of rank and file researchers to resist.


The proposed regulations represent a stimulus plan for COI bureaucracy and the “COI experts” who encourage it. The emphasis on appearance empowers the type II error


At a time when the NIH budget is flat and the investment pipeline is seized up due to the recession, why would we divert energy and scarce resources into the minute compilation of who is being paid how much and speculate on what constitutes a “significant” COI – even a FUTURE COI -- “that COULD effect the design, conduct or reporting of research?”


Prior to 1995, commercial influence permeated biomedicine exponentially, and only good things happened. Investigators were free to mingle with industry, and research superstars deservedly made a lot of money. Medical research is not immune to opportunity costs and the emerging compliance culture will hurt progress – and patients.