A national survey of policies on disclosure of conflicts of interest in biomedical research

被引:119
作者
McCrary, SV
Anderson, CB
Jakovljevic, J
Khan, T
McCullough, LB
Wray, NP
Brody, BA
机构
[1] Baylor Coll Med, Ctr Med Eth & Hlth Policy, Houston, TX 77030 USA
[2] Baylor Coll Med, Dept Med, Houston, TX 77030 USA
[3] Vet Affairs Med Ctr, Houston Ctr Qual Care & Utilizat Studies, Houston, TX 77030 USA
关键词
D O I
10.1056/NEJM200011303432207
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background: Conflicts of interest pose a threat to the integrity of scientific research. The current regulations of the U.S. Public Health Service and the National Science Foundation require that medical schools and other research institutions report the existence of conflicts of interest to the funding agency but allow the institutions to manage conflicts internally. The regulations do not specify how to do so. Methods: We surveyed all medical schools (127) and other research institutions (170) that received more than $5 million in total grants annually from the National Institutes of Health or the National Science Foundation; 48 journals in basic science and clinical medicine; and 17 federal agencies in order to analyze their policies on conflicts of interest. Results: Of the 297 institutions, 250 (84 percent) responded by March 2000, as did 47 of the 48 journals and 16 of the 17 federal agencies. Fifteen of the 250 institutions (6 percent) -- 5 medical schools and 10 other research institutions -- reported that they had no policy on conflicts of interest. Among the institutions that had policies, there was marked variation in the definition and management of conflicts. Ninety-one percent had policies that adhered to the federal threshold for disclosure ($10,000 in annual income or equity in a relevant company or 5 percent ownership), and 9 percent had policies that exceeded the federal guidelines. Only 8 percent had policies requiring disclosure to funding agencies, only 7 percent had such policies regarding journals, and only 1 percent had policies requiring the disclosure of information to the relevant institutional review boards or to research subjects. Twenty journals (43 percent) reported that they had policies requiring disclosure of conflicts of interest. Only four federal agencies had policies that explicitly addressed conflicts of interest in extramural research, and all but one of the agencies relied primarily on institutional discretion. Conclusions: There is substantial variation among policies on conflicts of interest at medical schools and other research institutions. This variation, combined with the fact that many scientific journals and funding agencies do not require disclosure of conflicts of interest, suggests that the current standards may not be adequate to maintain a high level of scientific integrity. (N Engl J Med 2000;343:1621-6.) (C) 2000, Massachusetts Medical Society.
引用
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页码:1621 / 1626
页数:6
相关论文
共 29 条
[1]  
ANDERSON C, 1994, SCIENCE, V265, P179, DOI 10.1126/science.8023137
[2]   Is academic medicine for sale? [J].
Angell, M .
NEW ENGLAND JOURNAL OF MEDICINE, 2000, 342 (20) :1516-1518
[3]   Disclosure of authors' conflicts of interest: A follow-up. [J].
Angell, M ;
Utiger, RD ;
Wood, AJJ .
NEW ENGLAND JOURNAL OF MEDICINE, 2000, 342 (08) :586-587
[4]  
[Anonymous], 1991, FED REG
[5]  
*ASS AM MED COLL, 1999, MED SCH US CAN GEOGR
[6]  
Babbie E., 2015, PRACTICE SOCIAL RES
[7]   Uneasy alliance - Clinical investigators and the pharmaceutical industry [J].
Bodenheimer, T .
NEW ENGLAND JOURNAL OF MEDICINE, 2000, 342 (20) :1539-1544
[8]  
BRODY BA, 1996, CONFLICTS INTEREST C, P407
[9]   Uniform requirements for manuscripts submitted to biomedical journals [J].
Clever, LH ;
Colaianni, LA ;
Davidoff, F ;
Glas, R ;
Horton, R ;
Lundberg, G ;
Nylenna, M ;
Robinson, RG ;
Smith, R ;
Squires, BP ;
Utiger, R ;
VanderWeyden, M ;
Woolf, P .
ANNALS OF INTERNAL MEDICINE, 1997, 126 (01) :36-47
[10]  
DEPALMA A, 1993, NY TIMES 0317, pB12