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.     

Parents' perspectives on research involving children

Children's participation in research is essential for the development of safe and age-appropriate treatments. However, children's participation is limited. The aim of this study was to determine (1) mothers' and fathers' views on which agencies/persons should evaluate the level of acceptable risk for children and (2) parents' willingness to allow children to participate in research. Medical factors, sociodemographics, and research attitudes were related to willingness. The study used a cross-sectional and longitudinal design with 863 expectant parents (435 women; 428 men) consecutively recruited at gestational week 19 during routine ultrasound examination at 2 hospitals in Uppsala County, Sweden. 123 women at gestational week 34 were followed-up. Parental ratings of agencies/persons' degree of involvement in risk-evaluation for. child research participants and parents' willingness to allow children to participate in research were the main outcome measures. Most parents believed that more pediatric research was needed. Attitudes played a major role in willingness, indicating a potential for information that could modify willingness. Over 80% of mothers and fathers rated the attending physician as needing to be "fully involved" in risk evaluation for research participants. Parents' views contradict current trends in research ethics which place evaluation of risk in the hands of regional agencies. Instead, the majority of parents would like the decision to be individually based on the attending physicians advise. We conclude that children's participation in research could be improved by actively incorporating the attending physician and by educating the public so that research attitudes can be based on accurate information.     

Are self-regulation and declaration of conflict of interest still the benchmark for relationships between physicians and industry?

Potential conflicts of interest do not imply wrongdoing, but can create bias, distort decision making, and create a perception that practitioners are being "bought "or "bribed" by industry. Transparency alone may not be sufficient to erase the doubts created when authors of clinical practice guidelines or editorials declare potential conflicts of interest. Can the subconscious obligation for reciprocation that exists when gifts are offered and accepted be fully negated? Analyses of published clinical cancer research studies have found a positive association between pharmaceutical industry sponsorship and reporting of positive outcomes, manipulation of clinical trials, and hiding of "preliminary data sets". More problematic is the issue of clinical researchers leaking preliminary results to the investment industry. Influential literature reviews and treatment guidelines have been associated with widespread declarations of conflict of interest. Some potential solutions are: regulating pharmaceutical companies to declare all gifts to clinicians, or ban such gifts; for clinicians to carefully declare potential conflicts of interest or to provide pro bono advice without accepting industry sponsorship; and for all gifts and payments from industry to academic physicians to be coordinated by an independent review committee. Journals should only allow reviews, editorials, guidelines and opinion pieces to be written by those without significant conflicts of interest.     

Assessing faculty financial relationships with industry: A case study

CONTEXT: A growing number of academic researchers receive industry funding for clinical and basic research, but little is known about the personal financial relationships of researchers with their industry sponsors. OBJECTIVES: To assess the extent to which faculty researchers have personal financial relationships with the sponsors of their research, the nature of those financial relationships, and efforts made at the institutional level to address disclosed financial relationships and perceived conflicts of interest. DESIGN AND SETTING: Case study of the University of California, San Francisco (UCSF). Data sources included disclosure forms and official documents maintained by the UCSF Office of Research Administration from December 1980 to October 1999, including decisions made by the UCSF Chancellor's Advisory Panel on Relations with Industry. MAIN OUTCOME MEASURES: Number and types of personal financial relationships with external sponsors (positive financial disclosures from all clinical, basic, or social science faculty who were principal investigators), amount of annual income received from sponsors, and decisions and management strategies used by the advisory panel. RESULTS: By 1999, almost 7.6% of faculty investigators reported personal financial ties with sponsors of their research. Throughout the study period, 34% of disclosed relationships involved paid speaking engagements (range, $250-$20, 000 per year), 33% involved consulting agreements between researcher and sponsor (range, <$1000-$120,000 per year), and 32% involved the investigator holding a position on a scientific advisory board or board of directors. Fourteen percent involved equity ownership, and 12% involved multiple relationships. The advisory panel recommended managing perceived conflicts of interest in 26% of the cases, including recommending the sale of stock, refusing additional payment for talks, resigning from a management position, or naming a new principal investigator for a project. CONCLUSIONS: Faculty researchers are increasingly involved in financial relationships with their research sponsors. Guidelines for what constitutes a conflict and how the conflict should be managed are needed if researchers are to have consistent standards of behavior among institutions. JAMA. 2000;284:2209-2214.     

生物医学研究者的利益冲突及控制

随着医学研究与产业界的密切合作,生物医学研究者面临着更多的科学道德规范与商业价值追求之间的冲突,这些冲突潜在或现实地影响到研究的客观性以及研究者“无私利性”的专业判断。本文探讨了生物医学研究者利益冲突产生的背景、影响因素及其危害,并提出利益冲突的治理对策,以期促进公众对该问题的认识,并为制定有关政策提供帮助。     

Financial disclosure and clinical research: what is important to participants?

OBJECTIVE: To assess what participants in company-sponsored clinical trials wish to know about financial aspects of the study. DESIGN, SETTING AND PARTICIPANTS: Cross-sectional questionnaire administered to 324 participants in six clinical trials conducted at the Royal Melbourne Hospital in 1999-2000 and 2006 for non-acute conditions (asthma, chronic obstructive pulmonary disease, osteoporosis, rheumatoid arthritis, diabetes and influenza vaccine efficacy). MAIN OUTCOME MEASURES: Participants' desire for information on study funding, investigators' conflicts of interest, and use of accrued funds. RESULTS: 259 participants (80%) completed the survey. Participants wanted to be informed about the identity of the project sponsor (148 participants; 57%), whether the investigators owned shares in the company (105; 41%) or received travel grants (83; 32%), how much funding was accrued at study completion (88; 34%), how accrued funds were used (98; 38%), and who approved their use (91; 35%). After adjusting for year of survey and level of education, younger subjects (aged 相似文献   

如何处理临床研究中研究者的经济利益冲突?--主体、原则与方法

临床研究中研究者的经济利益冲突可能会影响到受试者的安康和研究的客观性、可靠性.我们是否应该处理这种利益冲突?应该由谁处理?根据哪些伦理原则处理?具体采取哪些措施处理?围绕这些问题,本文批判地分析了反对处理利益冲突的观点,主张研究者、研究机构、行业组织、政府部门和学术期刊多方共同努力,根据公正、有利/不伤害、尊重三个伦理原则,采取公开、管理和禁止等措施,处理研究者的经济利益冲突,以保护受试者的安康和研究的客观性.     

医学专业临床实习相关参与者权利维护的辩证思考

医学生进行临床实习的需要常会与患者追求高质量医疗服务的需求产生冲突。从分析患者、医学生、带教教师等临床实习相关参与者的权利出发,探讨他们之间的权利维护矛盾,并在统筹兼顾临床实习相关参与各方,尤其是医学生和患者各自当前与长远、社会与个体利益的前提下,针对性的找到缓解这种利益冲突的对策。     

The influence of risk and monetary payment on the research participation decision making process

OBJECTIVES: To determine the effects of risk and payment on subjects' willingness to participate, and to examine how payment influences subjects' potential behaviours and risk evaluations. METHODS: A 3 (level of risk) x 3 (level of monetary payment), between subjects, completely randomised factorial design was used. Students enrolled at one of five US pharmacy schools read a recruitment notice and informed consent form for a hypothetical study, and completed a questionnaire. Risk level was manipulated using recruitment notices and informed consent documents from hypothetical biomedical research projects. Payment levels were determined using the payment models evaluated by Dickert and Grady as a guide. Five dependent variables were assessed in the questionnaire: willingness to participate, willingness to participate with no payment, propensity to neglect to tell about restricted activities, propensity to neglect to tell about negative effects, and risk rating. RESULTS: Monetary payment had positive effects on respondents' willingness to participate in research, regardless of the level of risk. However, higher monetary payments did not appear to blind respondents to the risks of a study. Payment had some influence on respondents' potential behaviours regarding concealing information about restricted activities. However, payment did not appear to have a significant effect on respondents' propensity to neglect to tell researchers about negative effects. CONCLUSIONS: Monetary payments appear to do what they are intended to do: make subjects more willing to participate in research. Concerns about payments blinding subjects to risks could not be substantiated in the present study. However, the findings do raise other concerns--notably the potential for payments to diminish the integrity of a study's findings. Future research is critical to make sound decisions about the payment of research subjects.     

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.     

Financial Interest and Its Disclosure in Scientific Publications

Journal policies and requirements of funding agencies on financial disclosure of authors and grant applicants have divided editors and scientists who disagree on whether such policies can improve the integrity of science or manage conflicts of interest. Those opposed to such disclosure policies argue that financial interest is one of many interests held by scientists, is the least scientifically dangerous, and should not be singled out. Those who favor open reporting of financial interests argue that full disclosure removes the suspicion that something of relevance to objectivity is being hidden and allows readers to form their own opinions on whether a conflict of interest exists and what relevance that has to the study. The authors believe that the scientific community and the public will be best served by open publication of financial disclosures for readers and reviewers to evaluate.      

Mammon and medicine. The rewards of clinical trials

The author raises the question of whether physicians should disclose the stakes they have as researchers in persuading their patients to participate in clinical trials. In the course of giving informed consent, patients are rarely told that their doctors may have strong financial and professional interests in recruiting them as subjects, that pharmaceutical companies and the National Institutes of Health pay research centers and physicians well for completed patient studies, and that professional advancement and distinction depend on the amount of research done. Spiro believes controlled clinical trials are valuable, but argues that full disclosure of the benefits that physicians expect to achieve from their patients' willingness to serve as subjects will enhance the latters' freedom to decide on participation.     

如何在医院管理中发展建设性冲突

发展建设性冲突有助于查找不足、推动创新、激发潜能、形成共识、增进关系.结合十堰市太和医院院、科两级“一把手”在管理冲突方面思想认识上存在偏差、消极回避冲突、严加防控所有冲突等问题,提出了通过发展建设性冲突来提高管理绩效的具体措施:营造民主和谐的氛围;鼓励良性竞争;扩大沟通交流渠道;有意识地树立“对立面”;敢于坚持正确意见;预防和避免破坏性冲突.     

Why mothers choose to enrol their children in malaria clinical studies and the involvement of relatives in decision making: Evidence from Malawi

This study was aimed at researching the reasons why mothers enrol their children in malaria clinical research and how family members or relatives are involved in the decision-making process. Issues related to informed consent were also a particular focus of this study. A total of 81 participants took part in 8 focus group discussions. Thirty-nine participants were recruited from Blantyre, an urban setting, and forty-two participants were from Chikwawa, a rural setting. All the participants were mothers whose children had participated or were participating in the Intermittent Prevention Therapy post-discharge (IPTpd) Malaria Research. A majority of the participants reported that they chose to participate in the IPTpd research as a way of accessing better quality medical care. They also decided to enrol their children in order to benefit from the material and monetary incentives that were being given to participants for their participation. Most participants reported that they made the enrollment decisions on their own. They informed their family members/marital partners about their enrollment decisions after they had given their consent. A few made their enrollment decisions after consulting their family members. There was also a sense of trust in health workers who asked the potential participants to join the IPTpd research. Most participants decide to take part in malaria research because of better medical treatment. Partners and relatives play a very small role in the decision-making process of participants in malaria clinical research. Research participants have a sense of trust in health workers who enrol them in clinical research.     

Bioethics for clinicians: 17. Conflict of interest in research, education and patient care

A conflict of interest occurs in a situation in which professional judgement regarding a primary interest, such as research, education or patient care, may be unduly influenced by a secondary interest, such as financial gain or personal prestige. Conflicts of interest exist in every walk of life, including medicine and science. There is nothing inherently unethical in finding oneself in a conflict of interest. Rather, the key questions are whether one recognizes the conflict and how one deals with it. Strategies include disclosing the conflict, establishing a system of review and authorization, and prohibiting the activities that lead to the conflict.     

Clinical practice guidelines: the need for greater transparency in formulating recommendations

A recently published critique of a set of Australian clinical practice guidelines (CPG) highlighted problematic issues in guideline development concerning conflicts of interest of guideline panellists, validity and strength of recommendations, and involvement of end users and external stakeholders. Management of financial or intellectual conflicts of interest requires: full disclosure; limitations on industry or agency financial support during guideline development; a representative panel that includes conflict-free members; and only conflict-free panellists to be involved in drafting guideline recommendations. Guideline panels should consider adopting the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system to assist in determining the validity and strength of recommendations. Guideline panels should seek formal feedback from external stakeholders and end users. Enacting such policies aims to lend greater transparency and credibility to CPG, limit protracted and unhelpful interpretive debates, and promote wider use of CPG.     

HIV男性感染者的阴性配偶参与杀微生物剂试验的意愿调查

目的调查HIV男性感染者的阴性配偶对杀微生物剂临床试验参与意愿及其影响因素。方法采用横断面的研究设计,于2009年5月～7月,在云南省德宏州潞西市和盈江县,采用方便抽样对212名HIV男性感染者的阴性配偶进行问卷调查。结果共有191名调查对象符合研究标准,30.9%的调查对象表示愿意参加杀微生物剂临床试验,56.5%的调查对象表示不愿意,12.6%不置可否。影响调查对象临床试验参与意愿的因素有:调查地点(OR=5.98,95%CI:2.33～15.33)、民族(OR=3.25,95%CI:1.35～7.81)、参加过HIV相关防治和调查项目(OR=9.37,95%CI:2.49～35.28)、避孕方式(OR=0.20,95%CI:0.06～0.61)。结论调查对象对杀微生物剂临床试验参与意愿较低,需加强对杀微生物剂临床试验的健康宣导,为将来进行的杀微生物剂临床试验做准备。     

Resolving disagreements in the patient-physician relationship: tools for improving communication in managed care.

Managed care uses financial incentives and restrictions on tests and procedures to attempt to influence physician decision making and limit costs. Increasingly, the public is questioning whether physicians are truly making decisions based on the patient's best interest or are unduly influenced by economic incentives. These circumstances lead to the potential for disagreements and conflict in the patient-physician relationship. We convened a group of individuals in October 1998, including patient representatives, leaders from health care organizations, practicing physicians, communication experts, and medical ethicists, to articulate the types of disagreements emerging in the patient-physician relationship as a result of managed care. We addressed 3 specific scenarios physicians may encounter, including allocation, illustrated by a patient who is referred to a different ophthalmologist based on a new arrangement in the physician's group; access, illustrated by a patient who wishes to see his own physician for a same-day visit rather than a nurse specialist; and financial incentives, illustrated by a patient who expects to have a test performed and a physician who does not believe the test is necessary but is afraid the patient will think the physician is not ordering the test because of financial incentives. Using these scenarios, we suggest communication strategies that physicians can use to decrease the potential for disagreements. In addition, we propose strategies that health plans or physician groups can use to alleviate or resolve these disagreements.     

12th Annual College of Medicine Research Dissemination Meeting,November 29th, 2008

Objectives

This study was aimed at understanding cultural attitudes, beliefs and perceptions to biomedical research, community consultation and informed consent process in peri-urban and rural settings in Malawi. It attempted to provide a base for informing, reforming and improving informed consent policy and practice by describing the local cultural attitudes and perceptions to research, autonomy, informed consent process and community consultation. It also assessed the validity of the Western concepts of informed consent and autonomy in a Malawian (African) setting.

Methods

The study employed both qualitative and quantitative research methods. Data were obtained from research participants during focus groups and individual interviews. 50 FGDs were conducted with 494 research participants. Individual interviews were conducted with 319 participants drawn from 5 different clinical trials in Lilongwe and Blantyre. The data were analyzed both manually and electronically.

Results

A majority of research participants described biomedical research as activities associated with preventive health measures such as community assessment and health education. This was common among the refusers and non-participants. Most research participants could differentiate between biomedical research and standard health care; but the difference was seen in the quality of care, rather than procedures involved. Among the category of participants, the need to receive better medical treatment was said to be their motivating factor to participate in biomedical research. 94.6% (298) of clinical research participants said they understood the study objectives, but only 21.8% (65) were able to state them correctly. 92% (294) of participants understood the informed consent procedure and its meaning. 33% (97) of those who perceived benefits of participation mentioned the care provided to them in clinical research as one of the benefits. 16.6% (52) acknowledged existence of risks to their participation in the clinical research; and were able to name the risks involved While 98% (313) said they joined clinical research freely, only 92% (294) understood the informed consent procedures. 90.9% (290) informed their partners/relatives about study participation; rather than seeking permission, 64.4% (187) said they did so “to let them know what was happening.” 84.6% (270) had no problem with allowing their samples to be stored for future research.

Conclusion

People who refuse to take part in biomedical research do so with an impaired understanding of its meaning and objectives due to rumors associated with biomedical research. There is a knowledge gap between real and perceived objectives among those who participated or were participating in biomedical research. People are motivated to take part in biomedical research by the “quality of care” provided to research participants. Participants understand their voluntary participation in research and understand the informed consent procedures; with community consultation seen as customary and preceding individual consent. People accept to participate in clinical research with knowledge of the existence of risks to their participation. Preference of signing or thumb printing is contrary to the Western concepts which allude to oral consent to be sought in illiterate communities. Communities have a good attitude towards biomedical research but are put off by researchers who

• do not follow customary procedures like community consultation and
• do not give feedback of results after the research is over.

Recommendations

Researchers should state objectives in simple terms and should remind participants about the objectives throughout the study. Researchers should clearly explain why each procedure is being done or why materials are being given to participants in biomedical research. Researchers have social obligations to provide services to communities where they recruit participants. Researchers have to engage communities before initiating biomedical research in communities or health centres; community engagement would help to dispel rumors associated with clinical research and would encourage community members to participate.

• Malawi Med J. 2009 Mar; 21(1): 34–43.
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• Rotavirus gastroenteritis in children in Blantyre, Malawi

Malawi Med J. 2009 Mar; 21(1): 34–43.

Rotavirus gastroenteritis in children in Blantyre, Malawi

NA CunliffeAuthor information Copyright and License information DisclaimerDepartment of Medical Microbiology, University of Liverpool, UKCopyright © Malawi Medical Journal