11 No. 5
The New Reality
Emory faculty respond to a transformed economic world
Schools adjust to hard times
“To suddenly have to do a complete, 180-degree about-face and think about where we can slow down, where we can cut, and constricting ourselves while trying to maintain some of our momentum and simultaneously go in the opposite direction—that's quite disconcerting.”
“We are very stretched in a number of important areas. Our challenge is to find the right balance between reductions in staffing versus reductions in the collections.”
Conflict of Interest and Ensuring the Public Trust
Historical perspectives and current concerns
Hearing the Music
A composer considers audience response
Making Love to the World
The practices that sustain research
In Fall 2008, Emory University became embroiled in the national debate regarding conflict of interest in research as members of Congress publicized allegations that faculty at academic medical centers, including Emory, received undisclosed income from pharmaceutical companies that manufacture drugs used in federally funded research. While the conversation across campus (and on other campuses across the country) has been heightened in recent months, the issue has been considered, discussed, and ultimately regulated.
Although issues surrounding faculty relationships with industry drew the spotlight of the US Senate, press, and public in 2008, the topic has a long history. In 1964, the American Association of University Professors and the American Council on Education published a statement titled “On Preventing Conflicts of Interest in Government-Sponsored Research at Universities.” This document observed that “when a university staff member (administrator, faculty member, professional staff member, or employee) undertaking or engaging in Government-sponsored work has a significant financial interest in, or a consulting arrangement with, a private business concern, it is important to avoid actual or apparent conflicts of interest between his Government sponsored university research obligations and his outside interests and other obligations.”
Nearly three decades ago, the passage of the Bayh-Dole Act
(1980) stimulated further discussion around the proper relationships between the private sector and university researchers. Before this pivotal moment, the federal government owned title to inventions made using federal funds. The Bayh-Dole Act transferred ownership of technologies developed with government funding to the institutions receiving the funding. The Act also obligated institutions to license these technologies for purposes of reaching the marketplace.
The success of Bayh-Dole on technology transfer is documented by universities responding to the 2007 survey by the Association of University Technology Managers, which reported licensing new technologies to 555 startup companies and a total of 5,109 licenses and options signed. In fact, the concept of taking new technologies from bench to bedside is a driving force in biomedical research (as well as many other disciplines), and Emory has been very successful in this transfer of knowledge. Just one example: more than 94 percent of HIV patients in the US receiving antiviral therapy receive a drug developed at Emory.
By the late 1980s, the increase in industry–academic relationships as well as the growing role of biotechnology in health care fueled concerns that the prospect of financial gain might influence objectivity in research. This was of particular concern in research involving human subjects, specifically in clinical trials. The national dialogue led to the passage of regulations in 1995 by the Public Health Service (which includes the National Institutes of Health and the Centers for Disease Control and Prevention) and the National Science Foundation, followed by the Food and Drug Administration in 1998.
The regulations are largely performance-based. That is, they do not prescribe any set prohibitions or management strategies for outside financial interests. Instead, they identify the types of financial activities that must be reviewed and then set the expectation that the investigator’s institution will properly manage activities in a way that ensures objectivity in the research. The guiding principle embodied in these regulations is that the public has a right to expect research supported with its tax dollars and clinical trial data for any drug or device submitted to the FDA be free of bias or the perception of bias.
While the regulations focus on ensuring the objectivity and
integrity of research, the core of the national dialogue has
concentrated on the investigator’s financial interests and human
subject research. The federal regulations do not distinguish between research with or without human subjects, but ethicists, institutional conflict of interest committees, and the public agree that the welfare and rights of human subjects necessitate special consideration when developing management strategies.
The Association of American Medical Colleges (AAMC) and Association of American Universities (AAU) published Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research in February 2008 to assist investigators and institutions in evaluating and managing conflicts of interest. This report includes the observation that “Integrity of research, the protection of human research subjects, and the preservation of public trust are paramount values of academic culture.”
Emory is committed to the principle of preserving the public trust. The university has had a strong policy on disclosure and management of investigator financial interest for more than a decade. In recent months, this and related policies have been re-evaluated to ensure continued trust in the quality and objectivity of our research. While our principles and standards have not changed, the university has reorganized administrative processes to clarify reporting procedures for investigators and to ensure that required reports are filed with federal agencies and other research sponsors. Through close coordination between a central Conflict of Interest Office with other units such as the Institutional Review Board and the Office of Sponsored Programs, we are working to ensure the continuation of the public trust regarding research conducted at Emory.
At the same time, discussions are proceeding with all schools to ensure that mechanisms by which faculty report external
compensated activities are clear, well communicated, and user-friendly. Administrators are working with Emory’s Information Technology professionals to develop electronic reporting systems that will integrate the reporting systems for all outside activities, including those related to research.
In the coming year, faculty, staff, and students will be kept abreast of these changes as they are developed and implemented. Meanwhile, anyone with questions related to the need to report their outside compensated professional activities should contact their dean’s office or the Conflict of Interest Office in the Vice President for Research Administration’s Office.
To read the AE’s coverage of ethical issues surrounding drug companies and academic medicine, see the February-March 2007 issue cover story, “Drugs and Money: Pharmaceutical Companies, academic medicine, and the flow of funds and favors.” The issue is available online at www.emory.edu/ACAD_EXCHANGE/2007/febmar/lead.html.