From: Julie Gottlieb [jgottlie@jhmi.edu]
Sent: Friday, May 30, 2003 4:13 PM
To: fdadockets@oc.fda.gov
Cc: Julie Gottlieb; tfournie@pobox.upenn.edu
Subject: Re: Docket No. 02M-0475: Draft *Financial Relationships and Interest in Research Involving Human Subjects: Guidance for Human Subject Protection*

May 30, 2003

 

Tommy Thompson, Secretary

Department of Health and Human Services

Dockets Management Branch (HFA-305)

Docket Number 02N-0475

Food and Drug Administration

5630 Fishers Lance

Room 1061

Rockville, MD  20852

 

Re:  Docket No. 02M-0475:  Draft Financial Relationships and Interest in Research Involving Human Subjects:  Guidance for Human Subject Protection

 

Dear Secretary Thompson:

 

Thank you for the opportunity to submit comments on the draft document titled Financial Relationships and Interests in Research Involving Human Subjects:  Guidance for Human Subject Protection.   We are submitting these comments as individuals whose professional responsibilities include implementation of institutional and regulatory policies on conflict of interest as well as management of compliance with these policies.  While our institutional affiliations are included below for identification purposes, our comments reflect our views as professionals working at the nexus of policy making and policy implementation in the field of conflict of interest management and not necessarily those of our institutions. 

 

Given our responsibilities, we believe that a robust process for identifying and reviewing potential conflicts of interest is central to the protection of human research subjects.  

We recognize that careful management of potential conflicts of interest is critical for maintaining public trust and confidence, protecting research subjects, and preserving the objectivity of research.  

 

We commend the Department for recognizing the complexity of conflict of interest management by issuing guidelines, rather than proscriptive rules.  Experience in administering conflict of interest policies has taught us that each arrangement involving a financial interest poses unique concerns.  In taking the approach represented by the proposed Guidance, the Department appropriately acknowledges that some arrangements among government, academia, and industry involve legitimate financial relationships that create neither the potential for harm to human subjects nor risks to objectivity in research.  Likewise, there are arrangements that give rise to such risks and must be managed.  Accordingly, we support guidance that allows institutions to adopt policies involving case-by-case review.  

 

We applaud DHHS for issuing Guidance that, within a framework of case-by-case review, advises investigators, institutions, and IRBs to ask key questions not only about the magnitude and nature of financial interests, but also about how particular interests will impact the subjects in specific research projects.  In particular, the Guidance allows institutions themselves to develop a system for assessing the impact of financial interests in specific situations and determining which conflict of interest management tools will be most effective given the circumstances of each case and the governance structures of their institutions.  

 

The Guidance provides a useful framework for the consideration of institutional financial interests and their potential impact on human research subjects.  This issue is particularly complex.  Here, as in other areas, the Guidance sets forth important points for consideration in establishing and implementing policies on institutional conflicts of interest.  We are pursuing active dialog with one another in an effort to identify best practices.   

 

Along with recent contributions from the research community itself, the draft Guidance represents a valuable tool for evaluating and enhancing our institutions conflict of interest management programs.  Our work will benefit from the framework set forth in the document. We strongly urge the Department to maintain this programmatic approach and flexibility in the final Guidance document, as well as in related future initiatives. 

 

Finally, as the Guidance acknowledges, conflict of interest policies differ from institution to institution.  Yet institutions and investigators around the country confront similar issues.  We strive to learn from one another and are participating in informal networks of professionals in the fields of conflict of interest and compliance.   We appreciate the opportunity to partner in the development of HHS policy on conflicts of interest and urge the Department to actively continue this dialog with us. 

 

Sincerely,

 

Salim Alani 

Director of University Audit 

University of Rochester 

 

Barbara Flynn

Manager, Conflict of Interest Review Program

Stanford University School of Medicine

 

Timothy Fournier

Institutional Compliance Officer
University of Pennsylvania

 

Julie Gottlieb

Assistant Dean, Policy Coordination

Johns Hopkins University School of Medicine

 

Steve Jung 

Director, Internal Audit & Institutional Compliance Officer 

Stanford University

 

Ann Pollack

Assistant Vice Chancellor - Research

University of California at Los Angeles

 

Thomas Schumacher

Director of Institutional Compliance

University of Minnesota

 

Delia Talamantez

Director, Conflict of Interest Office

University of California at San Diego