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Data Collection for Implementation of PHS/NIH Financial Conflicts of Interest Regulations

We know that you have been busy this summer preparing for the implementation of the Public Health Service/National Institutes of Health (PHS/NIH) regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors [42CFR Part 50; 45CFR Part 94] a.k.a. the financial conflicts of interest regulations (FCOI). The disclosure forms are done; the training is complete; the review processes have been outlined; you survived August 24, 2012; and you are ready for a break.

We are asking you to look back and plan for the future and engage in some data collection and preservation. As we proposed early in the year, the Council on Governmental Relations (COGR) would like to prepare for the planned evaluation of the regulations promised by PHS/NIH in its notice of the final rule (published August 25, 2011, 76FR53256).

We have posted here the detailed descriptions of data elements we propose to request in August 2013. At this time, we are asking you to help prepare a response to any future request for comments by preserving and collecting data on your implementation of the new regulations with the addition of some baseline FY 2011-12 data collection as well. Early in 2013, we will ask you to submit data for the 2011/12 baseline year; in September, 2013, we’ll ask you to submit the data elements for the 2012/13. We plan on using a web-based form/format that will ask for some broad institutional data, e.g., total external funding, public or private, medical school, etc., and then data specifically linked to your implementation of the PHS/NIH FCOI regulations.

We hope you will be willing to engage in this data collection and preservation effort. We are always challenged by Federal agencies to document the time and costs associated with a specific regulation when we argue for changes, reductions or elimination of regulations to manage the costs and burden of compliance. We want to be prepared for the evaluation of these regulations with data that demonstrates those costs and burdens. We are aware of the Association of American Medical Colleges (AAMC) COI Metrics Project and believe the data elements are sufficiently similar that these two approach will not increase the burden on institutions.

Take a look at the data elements. The first set is for the baseline year, 2011/12; the second set (asking similar questions) is for the implementation year 2012/13. We welcome your comments and suggestions NOW to ensure that the collection of the data minimizes the burden to you. (cblum@cogr.edu) As we develop the web-based survey, we will ask for volunteers to help us get it right but we need you to be preserving information now for the future.

Financial Conflicts of Interest Self-Assessment

This self-assessment tool is intended to help an institution evaluate the operation of its individual financial conflict of interest policies and procedures. It includes a very basic set of questions or statements concerning institutional policies and procedures that may be useful in assisting an institution to look carefully at how it operates rather than to assume that tasks, processes and documentation are being managed according to its policies and procedures.

Click here to view Self-Assessment Document

Approaches to Developing an Institutional Conflict of Interest Policy

As a companion to COGR's Recognizing and Managing Personal Financial Conflicts of Interest (Winter 2002), this site is designed to consider financial conflicts of interest at an institutional level. As more universities consider the development of new policies and procedures a general framework is beginning to emerge. This web-based discussion is intended to assist universities in the policy development process. In a series of short sections that will be updated as needed COGR hopes to assist its members in building an effective approach for identifying and managing institutional conflicts of interest.

We encourage you to help build this site by making contributions of references or information that will help build a consensus on guiding principles and best practices for addressing our shared goal - preserving the integrity and objectivity of the research enterprise at our universities.

Recognizing and Managing Personal Conflicts of Interest, October 2002

Click here to view