Research, ethics and conflicts of interest.

In this paper, I have tried to develop a critique of committee procedures and conflict of interest within research advisory committees and ethical review committees (ERCs). There are specific features of conflict of interest in medical research. Scientists, communities and the subjects of research all have legitimate stakeholdings. The interests of medical scientists are particularly complex, since they are justified by the moral and physical welfare of their research subjects, while the reputations and incomes of scientists depend on the success of their science. Tensions of this kind must at times produce conflict of interest. It is important to recognise that conflicts of interest may unwittingly lead to manipulation of research subjects and their lay representatives on research committees. It is equally important to recognise distinctions between the legal and moral aspects of conflict of interest. Some practical suggestions are made which may go some way towards resolving these difficulties. They indicate what might be needed to ensure the validity of ethical discourse, and to reduce the risks associated with conflict of interest.     

Responses of medical schools to institutional conflicts of interest

Susan H. Ehringhaus, JD; Joel S. Weissman, PhD; Jacqueline L. Sears, MPH; Susan Dorr Goold, MD, MHSA, MA; Sandra Feibelmann, MPH; Eric G. Campbell, PhD

JAMA. 2008;299(6):665-671.

Context  Institutional financial conflicts of interest may affect research results. No national data exist on the extent to which US medical schools have formally responded to challenges associated with institutional conflicts of interest (ICOI).

Objective  To assess the current state of ICOI policies and practices in US medical schools using the recommendations issued by 2 national higher education and research organizations as the standard.

Design, Setting, and Participants  National survey of deans of all 125 accredited allopathic medical schools in the United States, administered between February 2006 and December 2006.

Main Outcome Measures  The extent to which medical schools have adopted ICOI policies applicable to their institution and to their institutional officials; the scope of these policies in terms of those covered entities, offices, and financial relationships; the existence of recommended organizational structures as means to address ICOI; and the institutions' linkages between ICOI and their institutional review boards (IRBs).

Results  Responses were received from a total of 86 (69%) of 125 US medical schools. Although only 30 (38%) respondents (not all overall respondents answered all questions) have adopted an ICOI policy applicable to financial interests held by the institutions, a much higher number have adopted ICOI policies applicable to the financial interests of the officials: 55 (71%) for senior officials, 55 (69%) for midlevel officials, 62 (81%) for IRB members, and 51 (66%) for governing board members. Most institutions treat as potential ICOI the financial interests held by an institutional research official for a research sponsor (43 [78%]) or for a product that is the subject of research (43 [78%]). The majority of institutions have adopted organizational structures that separate research responsibility from investment management and from technology transfer responsibility. Gaps exist in institutions informing their IRBs of potential ICOI in research projects under review.

Conclusions  This study provides the first national data on the existence and nature of policies and practices of US medical schools for addressing potential ICOI. The gaps identified suggest the need for continuing attention by the academic medical community to address the challenges presented by ICOI more consistently and comprehensively.

     

外科杂志封杀隐瞒利益冲突的作者

《胸心外科杂志》（The Journal of Thoracic and Cardiovascular）编辑，美国费城Drexel大学医学院心胸外科系主任，Andrew Wechsler近日宣布，故意隐瞒利益冲突的作者至少一年内不得在该杂志再次发表文章，以强调他们充分公开的重要性。     

Policies on faculty conflicts of interest at US universities

CONTEXT: Despite federal regulations on faculty conflicts of interest in federally funded research, academic-industry ties are common, and evidence exists that financial considerations bias the research record. Public scrutiny of these ties is increasing, especially in cases where researchers have financial interests in the corporate sponsors of their clinical research. OBJECTIVE: To review policies on conflict of interest at major biomedical research institutions in the United States. DESIGN: Cross-sectional survey and content analysis study conducted from August 1998 to February 2000. SETTING AND PARTICIPANTS: The 100 US institutions with the most funding from the National Institutes of Health in 1998 were initially sampled; policies from 89 institutions were available and included in the analysis. MAIN OUTCOME MEASURES: Process for disclosure, review, and management of conflicts of interest and specified management strategies or limitations, according to the institutions' faculty/staff conflict of interest policies. RESULTS: Content of the conflict of interest policies varied widely across institutions. Fifty-five percent of policies (n = 49) required disclosures from all faculty while 45% (n = 40) required them only from principal investigators or those conducting research. Nineteen percent of policies (n = 17) specified limits on faculty financial interests in corporate sponsors of research, 12% (n = 11) specified limits on permissible delays in publication, and 4% (n = 4) prohibited student involvement in work sponsored by a company in which the faculty mentor had a financial interest. CONCLUSIONS: Most policies on conflict of interest in our sample of major research institutions in the United States lack specificity about the kinds of relationships with industry that are permitted or prohibited. Wide variation in management of conflicts of interest among institutions may cause unnecessary confusion among potential industrial partners or competition among universities for corporate sponsorship that could erode academic standards. It is in the long-term interest of institutions to develop widely agreed-on, clear, specific, and credible policies on conflicts of interest. JAMA. 2000;284:2203-2208.     

Potential research participants' views regarding researcher and institutional financial conflicts of interest

BACKGROUND: Financial conflict of interest in clinical research is an area of active debate. While data exist on the perspectives and roles of academic institutions, investigators, industry sponsors, and scientific journals, little is known about the perspectives of potential research participants. METHODS: The authors surveyed potential research participants over the internet, using the Harris Interactive Chronic Illness Database. A potential research participant was defined by: (1) self report of diagnosis by a health care professional and (2) willingness to participate in clinical trials. Email invitations were sent to 20 205 persons with coronary artery disease, breast cancer, or depression; a total of 6363 persons were screened; of these, 86% or 5478 met inclusion criteria and completed the survey. The outcome measures were respondents' ratings on: importance of knowing conflict of interest information, whether its disclosure ought to be required, and its effect on willingness to participate-across seven widely discussed scenarios of financial conflicts of interest (ranging from commercial funding to equity ownership). RESULTS: Majority responded that knowing conflict of interest information was "extremely" or "very" important; a larger majority felt financial conflicts of interest should be disclosed as part of informed consent (64% to 87%). In all seven scenarios, a majority was still willing to participate but in some scenarios a sizable minority would be wary of participation. Respondents were more wary of individual than institutional conflicts of interest. Illness group and sociodemographic factors had modest effects and did not affect the main trends. CONCLUSIONS: The prevailing practice of non-disclosure of financial conflicts of interest in clinical research appears contrary to the values of potential research participants.