Is it Really All about the Money? Reconsidering Non-Financial Interests in Medical Research

2012 ◽  
Vol 40 (3) ◽  
pp. 467-481 ◽  
Author(s):  
Richard S. Saver
Keyword(s):  
Medical Research ◽  
Conflicts Of Interest ◽  
Major Change ◽  
Academic Medical Centers ◽  
Department Of Health ◽  
Medical Centers ◽  
Institutional Review ◽  
Academic Medical ◽  
Financial Interests ◽  
Do So

Conflicts of interest have been reduced to financial conflicts. The National Institutes of Health’s (NIH) new rules for managing conflicts of interest in medical research, the first major change to the regulations in over 15 years, address only financial ties. Although several commentators urged that the regulations also cover non-financial interests, the Department of Health and Human Services declined to do so. Similarly, the Institute of Medicine’s (IOM) influential 2009 Conflict of Interest Report focuses almost exclusively on financial conflicts. Institutional policies at academic medical centers and guidance from professional bodies and medical journals also primarily emphasize financial ties. Even broadly worded rules are applied more readily to financial ties than non-financial interests, such as the regulations that restrict institutional review board (IRB) members with conflicting interests from participating in protocol reviews.

Academic Medical Centers and Conflicts of Interest—Reply

JAMA ◽  
2006 ◽  
Vol 295 (24) ◽  
pp. 2845
Author(s):  
Troyen A. Brennan ◽  
David J. Rothman ◽  
Susan Chimonas ◽  
James Naughton ◽  
Jordan Cohen ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
Academic Medical Centers ◽  
Medical Centers ◽  
Academic Medical

Toward Evidence-Based Conflicts of Interest Training for Physician-Investigators

2012 ◽  
Vol 40 (3) ◽  
pp. 500-510 ◽  
Author(s):  
Kate Greenwood ◽  
Carl H. Coleman ◽  
Kathleen M. Boozang
Keyword(s):  
Conflicts Of Interest ◽  
The United States ◽  
Private Industry ◽  
High Quality Research ◽  
Advocacy Organizations ◽  
Medical Centers ◽  
Number Of Factors ◽  
Academic Medical ◽  
Financial Interests ◽  
The Government

In recent years, the government, advocacy organizations, the press, and the public have pressured universities, academic medical centers, and physicianinvestigators to do more to ensure that their financial interests and relationships do not conflict with their duties to conduct high-quality research and protect the safety and welfare of clinical trial participants. A number of factors underlie the increased focus. First, private sector funding of clinical research has grown both in absolute terms and as a proportion of overall funding. In 2008, the pharmaceutical, medical device, and biotechnology industries’ domestic research and development expenditures constituted approximately 60.9% of funding for biomedical research in the United States; the next largest funder, the National Institutes of Health, funded 27.9%. Private industry spent $58.6 billion on research in 2007, up from $40 billion in 2003, an increase of 25% after adjusting for inflation.

Policies of Academic Medical Centers for Disclosing Financial Conflicts of Interest to Potential Research Participants

2006 ◽  
Vol 81 (2) ◽  
pp. 113-118 ◽  
Author(s):  
Kevin P. Weinfurt ◽  
Michaela A. Dinan ◽  
Jennifer S. Allsbrook ◽  
Jo??lle Y. Friedman ◽  
Mark A. Hall ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
Academic Medical Centers ◽  
Research Participants ◽  
Medical Centers ◽  
Academic Medical ◽  
Financial Conflicts Of Interest

The Cost of Institutional Review Boards in Academic Medical Centers

2005 ◽  
Vol 352 (17) ◽  
pp. 1825-1827 ◽  
Author(s):  
Jeremy Sugarman ◽  
Kenneth Getz ◽  
Jeanne L. Speckman ◽  
Margaret M. Byrne ◽  
Jason Gerson ◽  
...  
Keyword(s):  
Academic Medical Centers ◽  
Institutional Review Boards ◽  
Medical Centers ◽  
Institutional Review ◽  
Academic Medical ◽  
The Cost ◽  
Review Boards

Academic Medical Centers and Conflicts of Interest

JAMA ◽  
2006 ◽  
Vol 295 (24) ◽  
pp. 2845 ◽  
Author(s):  
Orin M. Goldblum ◽  
Michael J. Franzblau
Keyword(s):  
Conflicts Of Interest ◽  
Academic Medical Centers ◽  
Medical Centers ◽  
Academic Medical

Confronting Conflict: Addressing Institutional Conflicts of Interest in Academic Medical Centers

2010 ◽  
Vol 36 (1) ◽  
pp. 136-187 ◽  
Author(s):  
Bryan A. Liang ◽  
Tim MacKey
Keyword(s):  
Conflicts Of Interest ◽  
Clinical Care ◽  
Study Participant ◽  
Academic Medical Centers ◽  
Public Healthcare ◽  
Federal Grant ◽  
Medical Centers ◽  
Academic Medical ◽  
Commercial Enterprise ◽  
Education Academic

Individual conflicts of interest are rife in healthcare, and substantial attention has been given to address them. Yet a more substantive concern-institutional conflicts of interest (“ICOIs”) in academic medical centers (“AMCs”) engaged in research and clinical care—have yet to garner sufficient attention, despite their higher stakes for patient safety and welfare. ICOIs are standard in AMCs, are virtually unregulated, and have led to patient deaths. Upon review of ICOIs, we find a clear absence of substantive efforts to confront these conflicts. We also assess the Jesse Gelsinger case, which resulted in the death of a study participant exemplifying a deep-seated culture of institutional indifference and complicity in unmanaged conflicts. Federal policy, particularly the Bayh-Dole Act, also creates and promotes ICOIs. Efforts to address ICOIs are narrow or abstract, and do not provide for a systemic infrastructure with effective enforcement mechanisms. Hence, in this paper, we provide a comprehensive proposal to address ICOIs utilizing a “Centralized System” model that would proactively review, manage, approve, and conduct assessments of conflicts, and would have independent power to evaluate and enforce any violations via sanctions. It would also manage any industry funds and pharmaceutical samples and be a condition of participation in public healthcare reimbursement and federal grant funding.The ICOI policy itself would provide for disclosure requirements, separate management of commercial enterprise units from academic units, voluntary remediation of conflicts, and education on ICOIs. Finally, we propose a new model of medical education—academic detailing—in place of current marketing-focused “education.” Using such a system, AMCs can wean themselves from industry reliance and promote a culture of accountability and independence from industry influence. By doing so, clinical research and treatment can return to a focus on patient care, not profits.

scholarly journals Patient Engagement and Attitudes Toward Using the Electronic Medical Record for Medical Research: The 2015 Greater Plains Collaborative Health and Medical Research Family Survey (Preprint)

2018 ◽  
Author(s):  
Ann M Davis ◽  
Lawrence P Hanrahan ◽  
Alex F Bokov ◽  
Sarah Schlachter ◽  
Helena H Laroche ◽  
...  
Keyword(s):  
Medical Research ◽  
Geographic Location ◽  
Academic Medical Centers ◽  
Child Rearing ◽  
Research Network ◽  
Willingness To Participate ◽  
Patient Centered ◽  
Medical Centers ◽  
Academic Medical ◽  
National Patient

BACKGROUND Electronic health records (EHRs) are ubiquitous. Yet little is known about the use of EHRs for prospective research purposes, and even less is known about patient perspectives regarding the use of their EHR for research. OBJECTIVE This paper reports results from the initial obesity project from the Greater Plains Collaborative that is part of the Patient-Centered Outcomes Research Institute’s National Patient-Centered Clinical Research Network (PCORNet). The purpose of the project was to (1) assess the ability to recruit samples of adults of child-rearing age using the EHR; (2) prospectively assess the willingness of adults of child-rearing age to participate in research, and their willingness (if parents) to have their children participate in medical research; and (3) to assess their views regarding the use of their EHRs for research. METHODS The EHRs of 10 Midwestern academic medical centers were used to select patients. Patients completed a survey that was designed to assess patient willingness to participate in research and their thoughts about the use of their EHR data for research. The survey included questions regarding interest in medical research, as well as basic demographic and health information. A variety of contact methods were used. RESULTS A cohort of 54,269 patients was created, and 3139 (5.78%) patients responded. Completers were more likely to be female (53.84%) and white (85.84%). These and other factors differed significantly by site. Respondents were overwhelmingly positive (83.9%) about using EHRs for research. CONCLUSIONS EHRs are an important resource for engaging patients in research, and our respondents concurred. The primary limitation of this work was a very low response rate, which varied by the method of contact, geographic location, and respondent characteristics. The primary strength of this work was the ability to ascertain the clinically observed characteristics of nonrespondents and respondents to determine factors that may contribute to participation, and to allow for the derivation of reliable study estimates for weighting responses and oversampling of difficult-to-reach subpopulations. These data suggest that EHRs are a promising new and effective tool for patient-engaged health research. INTERNATIONAL REGISTERED REPOR NA

Sign in / Sign up

Export Citation Format

Share Document