Requirements of the Federal Government
In 1995, the National Science Foundation(NSF) issued a policy and the Public Health Service (PHS) promulgated a regulation, and in 1998 the Food and Drug Administration published a regulation addressing contractor and grantee responsibilities concerning conflicts of interest. Universities and other institutions had been concerned about this subject prior to the federal initiatives. The federal efforts, however, led most institutions to review their policies or create new ones.
National Science Foundation (NSF) Policy – See Section 510
Public Health Service (PHS/DHHS) Regulation – See Sections 601–607
An Excerpt from the PHS regulation (42 CFR 50.601):
This subpart promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting financial interest of an Investigator.
While worded differently, the scope of the PHS regulation and NSF policy are similar in content and identical in purpose, i.e. to eliminate, or mitigate through disclosure and effective management, the negative effects of conflicts of interest.
The FDA regulation is directed toward clinical trialsClinical Trials
A scientifically designed and executed investigation of the effects of a drug (or vaccine) administered to human volunteers. The goal is to define the safety, clinical efficacy, and pharmacological effects (including toxicity, side effects, incompatibilities, or interactions) of the drug. The US government, through the FDA, requires strict testing of all new drugs and vaccines prior to their approval for use as therapeutic agents. (Source: amFAR, the Foundation for AIDS Research) and is significantly different from the PHS and NSF issuances.
Requirements of the PHS Regulation/NSF Policy:
Contractors/grantees must have adequate policies. This means that a institution's policy must, at a minimum, address the points below.
- Disclosures of the financial interests of faculty
and their immediate family must be made by Principal Investigators and
others having decision-making authority over the conduct of the sponsored
work. There are two important
points to be made here. First, the institution must require disclosures from
all those having decision-making authority on all PHS and NSF sponsored projects.
Many, if not most, institutions have expanded this requirement such that
disclosures are required to accompany all sponsored project proposals irrespective
of sponsor. Second, we must be concerned with conflicts involving anyone
having decision-making authority, not just the Principal Investigator.
Often, projects employ co-investigatorsCo-Investigators
An individual collaborating with the Principal Investigator in the conduct of a sponsored project. A co-investigator usually works under the supervision and direction of the Principal Investigator. or other researchers who may have certain responsibilities that involve making decisions over the conduct or reporting of the work. Those individuals are subject to the same requirements as the Principal InvestigatorPrincipal Investigator
An individual designated by the institution to direct the project or activity being supported by external funding. He or she is responsible and accountable to the institution and sponsor for the proper conduct of the project or activity..
- A Significant Financial interest defined as $10,000 annual income or 5% equity in a company whichever is less, or a combination thereof.
- Contractors/grantees have discretion over who reviews disclosures. Institutions are given a great deal of latitude in this requirement. Some institutions have department chairs perform this function, while others have the responsibility residing in the dean's office. At most institutions, the Conflict of Interest Committee has responsibility for deciding how to eliminate or mitigate the conflict. In simple situations, this can be done by issuing instructions to the researcher. In more complicated cases, the Conflict of Interest Committee may create a Management Plan that will be written to eliminate or mitigate the conflict.
- Specific criteria for review will be at the institution's discretion. This means that each institution can decide for itself whether it will adopt the criteria in item 3 above or adopt more restrictive requirements, e.g., whether full disclosures or updates will be required annually, or whether it will impose other criteria for review.
- Management of conflicting financial interests must be undertaken. This means that if disclosures are submitted indicating that a real or potential conflict exists, the institution must develop a plan to eliminate or mitigate the conflict. For example, this could be done by requiring that financial holdings be placed in a blind trust, or that the individual give up certain roles within a company, or other similar steps. The plan must also contain monitoring provisions so that the institution can be assured that the plan is successfully implemented.
- Applications must contain certifications. PHS and NSF have made certifications a part of their application processes. In signing and submitting proposals, the institution certifies that it will abide by the agency's policy, and assures the agency that conflicts will be eliminated or mitigated prior to funds being expended under the award in question.
- Institutional records are subject to federal review. This is a standard federal requirement. The institution must maintain the disclosures and all records of decisions made in reviewing the disclosures as well as implemented in managing conflicts. The government retains the right to review the records to ensure that the institution is acting in compliance with federal and its own policies.