The type of research known as cluster randomized trials raises ethical questions not readily answered within the standard understanding of research ethics. What distinguishes a CRT is that it randomizes at the level of social groups rather than at the level of individual research participants: in a CRT, the regimen under study might be assigned to a village, hospital, or school. The organizational schemes of CRTs raise an assortment of fundamental ethical problems. In certain CRTs, the question of (...) whether it is possible to obtain individual informed consent is central. Also, if the intervention is offered at the level of a sizable social group, there is usually no realistic possibility for individuals to opt out of the trial. Other ethical questions raised by CRTs have to do with identifying the subjects of research, and indeed with whether “research” is occurring at all. (shrink)

_BMC Medical Ethics_ is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies. _BMC __Medical Ethics _is part of the _BMC_ series which publishes subject-specific journals focused on the needs of individual research communities across all areas of biology and medicine. We do not make editorial decisions on the basis of the interest of a study or (...) its likely impact. Studies must be scientifically valid; for research articles this includes a scientifically sound research question, the use of suitable methods and analysis, and following community-agreed standards relevant to the research field. Specific criteria for other article types can be found in the submission guidelines. _BMC series - open, inclusive and trusted_. (shrink)

Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted with key stakeholders experienced in designing and conducting two selected CRTs in Malawi. The 18 interviewed stakeholders included investigators, clinicians, nurses, data management personnel and community workers who were (...) invited to share their experiences related to implementation of CRTs. Data analysis revealed five major themes with ethical implications: (1) The moral obligation for health care providers to participate in health research and its compensation; (2) Suboptimal care services compromising the integrity of CRT; (3) Ensuring scientific validity and withholding care service; (4) Obtaining valid consent and permission for waiver of consent; and (5) Inadequate risk assessment for trial participation. Understanding key ethical issues posed by CRTs in Malawi could improve ethical review and research oversight of this particular study design. (shrink)

"Cluster randomized trials," in which groups of patients are randomly assigned to different therapeutic interventions, provide a powerful way of evaluating drugs. CRTs have not been widely used, in good part because of concerns about whether patients must give informed consent to participate in them. A better understanding of how CRTs fit into clinical practice resolves the concerns.

Owing to unique features of their design, cluster randomized trials complicate the interpretation of standard ethics guidelines. The recently published Ottawa statement on the ethical design and conduct of cluster randomized trials provides researchers and research ethics committees with detailed guidance on the design, conduct and review of cluster trials. The Ottawa statement sets out 15 recommendations, including guidance on the justification of study design, the need for research ethics committee review, the identification of research (...) participants, obtaining informed consent, the role of gatekeepers in protecting cluster interests, the assessment of benefits and harms, and the protection of vulnerable participants. (shrink)

Children who live on the margins of society are disadvantaged in achieving their developmental potential because of the lack of a necessary stable environment and nurturing care. Many early prevention programs aim at mitigating such effects, but often the evaluation of their long-term effect is missing. The aim of the study presented here was to evaluate such long-term effects in two prevention programs for children-at-risk growing up in deprived social environments focusing on child attachment representation as the primary outcome as (...) well as on self-reflective capacities of teachers taking care of these children. The latter was a key component for promoting resilient behavior in children. Five hundred and twenty-six children aged 36 to 60 months at risk due to immigration status, low family socio-economic status and child behavior were examined in a cluster-randomized study comparing two preventions, the psychodynamic, attachment-based holistic approach EARLY STEPS (ES) with the classroom based FAUSTLOS (FA) for their efficacy. Primary outcome was the child attachment representation measured by the Manchester Child Attachment Story Task (MCAST). Secondary outcomes were derived from (a) the Caregiver-Teacher Report Form (C-TRF: problem behaviors, including anxiety/depressive symptoms, emotional-reactive and somatic problems, social withdrawal, aggressive behavior, and attention deficit), from (b) the Strength and Difficulties Questionnaire (SDQ, parent version: resilience and wellbeing) and (c) Self-Reflective Scales for teachers (SRS: self-reflective capacities of teachers). Compared to baseline, attachment and behavioral problems improved in both programs. ES led to more secure and more organized attachment representations (medium effect sizes). Aggressive behavior and externalizing problems were reduced in the FA group compared with ES, particularly in boys (medium effect sizes). Self-reflective capacities of the teachers increased only in the ES group. High correlation between children’s attachment type with the number of social risk factors and the increase of problematic social behavior strongly indicate that an increase in teachers’ self-reflective capacities helps to change children’s attachment patterns which thus strengthens the resilience of these children-at-risk [An ethical vote from LPPKJP 2009-02-25 was obtained and the trial registered; Clinical trial registration information: The trial was registered 14.02.2012 (DRKS00003500;https://www.drks.de)]. (shrink)

Background Informed consent is a universally accepted precondition for scientific researches involving human participants. However, various factors influence the process of obtaining authentic informed consent, and researchers particularly working in resource-poor countries often face considerable difficulties in implementing the universally recommended procedures for obtaining informed consent. We have conducted this Rapid Ethical Assessment to accommodate the local cultural norms and to understand the relevant ethical issues in the Silti community before the conduct of a cluster-randomized controlled trial. (...) Methods This REA was conducted in two purposively selected Woredas/Districts and Worabe Town administration of Silti Zone. Data were collected using in-depth interviews and focus group discussions. Purposive and convenient sampling techniques were used to select respondents. Five in-depth interviews and 15 Focus Group Discussions were conducted in the Amharic language. The collected data was transcribed, translated, and analyzed using a thematic approach. Result Most of the community members never heard about research and therapeutic misconception was common. In the area, the permission of people working in the formal and informal community administration is essential before approaching individuals. The male head of the household should also be involved in the decision before individual household members participate in research. Furthermore, sensitizing the community using public and religious gatherings was suggested before individual recruitment. In the consent process, delivering selected information particularly the purpose and benefits of the research was emphasized and the tendency of preferring verbal consent was documented despite the willingness of the individuals to sign on the consent form. Local health workers were identified as appropriate personnel to communicate information and the procedures of the research were found to be acceptable. However, the value of small incentives was suggested to motivate potential participants. Finally, involving all concerned stakeholders and respecting the cultural norm of the community was emphasized. Conclusion Through REA, we understand the research awareness of the community, their expectation, and the cultural norms relevant to the ethical conduct of research. It enabled us to devise culturally sensitive and scientifically sound strategies to secure authentic informed consent. The process of conducting REA was found to be feasible, quick, and efficient. (shrink)

This thesis addresses the tension in pragmatic cluster-randomized trials between their social value and the requirement to respect the autonomy of research participants. Pragmatic trials are designed to evaluate the effectiveness of treatments in real-world settings to inform clinical decision-making and promote cost-efficient care. These trials are often embedded into clinical settings and ideally include all patients who would receive the treatments under investigation as a part of routine care. Trialists increasingly adopt cluster-randomized designs—in which intact (...) groups, such as hospitals or clinics, are allocated randomly to study interventions—to simplify the inclusion of all patients. But including all-comers conflicts with the requirement to obtain written informed consent from research participants. Since informed consent is central to respecting patient autonomy, the question arises: how can the ends of autonomy and pragmatism be served simultaneously? Some philosophers argue that patients have an obligation to participate in clinical research and that this may negate consent requirements. I argue that while there may be grounds for a prima facie obligation for patients to participate in clinical research, no compelling argument has demonstrated that the obligation is enforceable. Others assert that broad application of a waiver of consent will facilitate the conduct of pragmatic cluster-randomized trials. I demonstrate that this proposal sharply conflicts with the historical origins of the waiver. I articulate a novel moral foundation for the use of a waiver of consent and show that when trials evaluate treatments delivered directly to patients, the autonomy interests at stake for participants are too substantial to permit its use. My solution draws a distinction between consent requirements in existing policy and consent as an autonomous authorization. As many pragmatic cluster-randomized trials are conducted in primary care settings with no research staff, I argue that patient autonomy can be promoted and protected using clinical-style consent, in which health providers seek verbal informed consent from patients and document it in the electronic health record. This approach has been associated with high rates of recruitment and, thus, may satisfy both requirements for social value and respect for autonomy. (shrink)

Volume 19, Issue 10, October 2019, Page 101-103.

Volume 19, Issue 10, October 2019, Page 110-111.

The purpose of the present two studies was to investigate whether in framing messages that target salient beliefs of youth, the type of goal framed matter to promote physical activity participation among low-active adolescents. More specifically, the main trial compared the effect of intrinsic and extrinsic-goal framing messages alongside planning to a control condition on low-active adolescents’ physical activity, intention, attitude, and exercise goals, and examined the potential meditational effect of these variables between condition and PA. Low-active students from (...) fifteen classes were assigned to one of these three conditions. PA was assessed using an accelerometer, and the socio-cognitive mediators were measured at baseline and post-test, and the intention was measured again at follow-up. Results showed that compared to adolescents in the CC group, those in the experimental conditions did not do more moderate PA, but carried out more light PA, and yielded an increase in attitude and intention. Mediational analysis revealed no significant effect of the potential mediators. (shrink)

This paper discusses the issue of overriding the right of individual consent to participation in cluster randomised trials (CRTs). We focus on CRTs testing the efficacy of non-pharmaceutical interventions. As an example, we consider school closures during the COVID-19 pandemic. In Norway, a CRT was promoted as necessary for providing the best evidence to inform pandemic management policy. However, the proposal was rejected by the Norwegian Research Ethics Committee since it would violate the requirement for individual informed consent. This (...) sparked debate about whether ethics stand in the way of evidence-based health policy, since the Norwegian Research Ethics law’s strict requirements for individual consent make it practically impossible to carry out CRTs of public health interventions. We argue that, in the case of the school closure trial, the suggested CRT would not have eliminated an epistemic gap and thus would not have justified the violation of consent rights. First, we focus on the methodological challenges to estimating quantifiable effects of school closures in the specific case of an airborne infectious disease. Second, in line with Evidential Pluralism, we highlight the value of alternative lines of evidence for informing school closure policy in a pandemic. In general, we propose that a trial requiring the waiver of participants’ consent rights must be highly likely to eliminate an epistemic gap. We elaborate on the practical aspects of this criterion and discuss the potential advantages of adding it to the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. (shrink)

Schools have been the main context for physical activity and sedentary behavior interventions among adolescents, but there is inconsistent evidence on whether they also improve dimensions of the health−related quality of life. The aim of this study was to evaluate the effects of a school-based active lifestyle intervention on dimensions of HRQoL. A secondary aim was to verify whether sex, age, and HRQoL at baseline were moderators of the intervention effect. A cluster-randomized controlled trial was conducted at (...) three control and three intervention schools in Florianopolis, Brazil. All students from 7th to 9th grade were invited to participate. A school year intervention, designed primarily to increase PA and reduce SB, included strategies focused on teacher training on PA, SB, and nutrition, and availability of teaching materials related to these contents; environmental improvements ; and education strategies, with the availability of folders and posters regarding PA, SB, and nutrition. Participants and the research staffs were not blinded to group assignment, but a standardized evaluation protocol was applied at baseline and after the intervention using the KIDSCREEN−27 to assess HRQoL across five dimensions. Mixed linear models were performed to evaluate the effect of the Movimente intervention on the five HRQoL dimensions. Of the 921 students who answered the questionnaire at baseline, 300 and 434 completed the study in control and intervention groups, respectively. The results revealed no significant effects of the intervention on any HRQoL dimensions. A reduction of the school environment dimension was observed in both the control and intervention groups. Sensitivity analyses showed that students in the highest baseline tertiles of HRQoL in any dimension had a reduction in their respective scores from pre- to post-intervention in both school groups. In conclusion, our results demonstrated no intervention effect on HRQoL dimensions and those students with the highest levels of HRQoL at baseline on all dimensions reduced from pre to post-intervention.Clinical Trial RegistrationThe trial is registered at the Clinical Trial Registry. (shrink)

Business and Society Review, Volume 127, Issue 1, Page 69-96, Spring 2022.

Background There is a need for interdisciplinary research to better understand how pedagogical approaches in primary physical education (PE) can support the linked development of physical, cognitive and affective aspects of physical literacy and physical activity behaviors in young children living in deprived areas. The Skill Acquisition Methods fostering Physical Literacy in Early-Physical Education (SAMPLE-PE) study aims to examine the efficacy of two different pedagogies for PE, underpinned by theories of motor learning, to foster physical literacy. Methods SAMPLE-PE will be (...) evaluated through a cluster-randomized controlled trial targeting 5–6 year old children from schools located in areas of high deprivation in Merseyside, North-West England. Schools will be randomly allocated to one of three conditions: Linear Pedagogy, Non-linear Pedagogy, or Control. Non-linear and Linear Pedagogy intervention primary schools will receive a PE curriculum delivered by trained coaches over 15 weeks, while control schools will follow their usual practice. Data will be collected at baseline (T0), immediately post-intervention (T1), and 6 months after the intervention has finished (T2). Children’s movement competence is the primary outcome in this trial. Secondary outcomes include physical activity, perceived competence, motivation, executive functions, and self-regulation. An extensive process evaluation will also examine implementation factors such as intervention context, reach, dose, fidelity and acceptability. Discussion The SAMPLE-PE project will enable better understanding surrounding how to operationalise physical literacy through enrichment of PE practices in early PE. The study will provide robust scientific evidence regarding the efficacy of underpinning PE pedagogy with theories of motor learning to promote the development of physical literacy. Trial Registration Retrospectively registered on 5th September 2018 at ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (Identifier: NCT03551366). (shrink)

BackgroundIn their research reports, scientists are expected to discuss limitations that their studies have. Previous research showed that often, such discussion is absent. Also, many journals emphasize the importance of avoiding overstatement of claims. We wanted to see to what extent editorial handling and peer review affects self-acknowledgment of limitations and hedging of claims.MethodsUsing software that automatically detects limitation-acknowledging sentences and calculates the level of hedging in sentences, we compared the submitted manuscripts and their ultimate publications of all randomized (...) trials published in 2015 in 27 BioMed Central (BMC) journals and BMJ Open. We used mixed linear and logistic regression models, accounting for clustering of manuscript-publication pairs within journals, to quantify before-after changes in the mean numbers of limitation-acknowledging sentences, in the probability that a manuscript with zero self-acknowledged limitations ended up as a publication with at least one and in hedging scores.ResultsFour hundred forty-six manuscript-publication pairs were analyzed. The median number of manuscripts per journal was 10.5 (interquartile range 6–18). The average number of distinct limitation sentences increased by 1.39 (95% CI 1.09–1.76), from 2.48 in manuscripts to 3.87 in publications. Two hundred two manuscripts (45.3%) did not mention any limitations. Sixty-three (31%, 95% CI 25–38) of these mentioned at least one after peer review. Changes in mean hedging scores were negligible.ConclusionsOur findings support the idea that editorial handling and peer review lead to more self-acknowledgment of study limitations, but not to changes in linguistic nuance. (shrink)

The ethics of the Flexibility In duty hour Requirements for Surgical Trainees trial have been vehemently debated. Views on the ethics of the FIRST trial range from it being completely unethical to wholly unproblematic. The FIRST trial illustrates the complex ethical challenges posed by cluster randomised trials of policy interventions involving healthcare professionals. In what follows, we have three objectives. First, we critically review the FIRST trial controversy, finding that commentators have failed to sufficiently identify (...) and address many of the relevant ethical issues. The 2012 Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials provides researchers and research ethics committees with specific guidance for the ethical design and conduct of CRTs. Second, we aim to demonstrate how the Ottawa Statement provides much-needed clarity to the ethical issues in the FIRST trial, including: research participant identification; consent requirements; gatekeeper roles; benefit-harm analysis and identification of vulnerable participants. We nonetheless also find that the FIRST trial raises ethical issues not adequately addressed by the Ottawa Statement. Hence, third and finally, we raise important questions requiring further ethical analysis and guidance, including: Does clinical equipoise apply to policy interventions with little or no evidence-base? Do healthcare providers have an obligation to participate in research? Does the power-differential in certain healthcare settings render healthcare providers vulnerable to duress and coercion to participant in research? If so, what safeguards might be implemented to protect providers, while allowing important research to proceed? (shrink)

Cluster randomized controlled trials (cluster RCTs) randomize whole clusters of individuals in testing two or more competing interventions. Here we will present the ethical problems raised by cluster RCTs concerning their effect on inequality. We argue that some inequalities generated by cluster RCTs are larger in scope than those generated from individual RCTs. We also argue that any cluster RCT-generated inequalities, which divide groups rather than individuals, are more problematic in type than the inequalities (...) created in individual RCTs. These concerns should be taken into consideration when designing research at the cluster level, and those conducting the research should consider modified research design strategies in cases where they believe the risk of generating inequalities is large. (shrink)

The aim of the present study is to examine the effect of group-play intervention on executive function in preschoolers. This group-play intervention was integrated as moderate to vigorous physical activity and cognitively loaded exercise to promote EF in preschoolers. An 8-week group-play MVPA intervention program, consisting of a series of outdoor physical and cognitively loaded games, was designed to improve preschoolers’ EF. This intervention program was implemented in group-play form, and conducted by teachers who received standardized training before the intervention. (...) Two classes of second grade preschoolers were randomly allocated to experimental and control groups. The intervention group received the intervention three times a week, while the control group exercised as usual in preschool. Before, in the middle of, and after the intervention, 10-m running, standing broad jump, throwing, body flexion, balance beam, and skip jump were assessed as tests of motor skills. In addition, three components of EF were measured separately before, in the middle of, and after the intervention: inhibitory control was assessed by using the silly sound Stroop task, working memory was tested using the empty house task, and shifting was assessed using the dimensional change card sorting task. Although both groups showed an increasing trend in terms of motor skills and EF during the intervention, the increasing amounts of the intervention group were significantly higher than the control group. The findings of the present study suggested that group-play intervention has positive effects on aspects of EF in addition to motor skills in preschoolers. (shrink)

Statistical power is often a concern for clustered randomized control trials (RCTs) due to variance inflation from design effects and the high cost of adding study clusters (such as hospitals, schools, or communities). While covariate pre-specification can improve power for estimating regression-adjusted average treatment effects (ATEs), further precision gains can be achieved through covariate selection once primary outcomes have been collected. This article uses design-based methods underlying clustered RCTs to develop Lasso methods for the post-hoc selection of covariates for (...) ATE estimation that avoids a lack of transparency and model overfitting. Our focus is on two-stage estimators: in the first stage, Lasso estimation is conducted using data on cluster-level averages or sums, and in the second stage, standard ATE estimators are adjusted for covariates using the first-stage Lasso results. We discuss l 1 {l}_{1} consistency of the estimated Lasso coefficients, asymptotic normality of the ATE estimators, and design-based variance estimation. The nonparametric approach applies to continuous, binary, and discrete outcomes. We present simulation results and demonstrate the method using data from a federally funded clustered RCT testing the effects of school-based programs promoting behavioral health. (shrink)

_Background:_ Literature has documented the role of family in the outcome of chronic schizophrenia. In the light of this, family interventions (FIs) are becoming an integral component of treatment for psychosis. The First Episode of Psychosis (FEP) is the period when most of the changes in family atmosphere are observed; unfortunately, few studies on the relatives are available. _Objective:_ To explore burden of care and emotional distress at baseline and at 9-month follow-up and the levels of service satisfaction at follow-up (...) in the two groups of relatives (experimental treatment EXP vs. treatment as usual TAU) recruited in the cluster-randomized controlled GET UP PIANO trial. _Methods:_ The experimental treatment was provided by routine public Community Mental Health Centers (Italian National Health Service) and consisted of Treatment as Usual plus evidence-based additional treatment (Cognitive Behavioral Therapy for psychosis for patients, Family Intervention for psychosis, and Case Management). TAU consisted of personalized outpatient psychopharmacological treatment, combined with non-specific supportive clinical management and informal support/educational sessions for families. The outcomes on relatives were assessed by the Involvement Evaluation Questionnaire (IEQ-EU), the General Health Questionnaire (GHQ-12), and the Verona Service Satisfaction Scale (VSSS-EU). Differences within and between groups were evaluated. _Results:_ At baseline, 75 TAU and 185 EXP caregivers were assessed. In the experimental group 92% of relatives participated in at least 1 family session. At follow-up both groups experienced improvement in all IEQ and GHQ items, but caregivers belonging to the EXP arm experienced a significantly greater change in 10 IEQ items (mainly pertaining to the “Tension” dimension) and in GHQ items. Due to the low sample size, a significant effectiveness was only observed for 2 IEQ items and 1 GHQ-12 item. With respect to VSSS data at follow-up, caregivers in the EXP arm experienced significantly greater satisfaction in 8 items, almost all pertaining to the dimensions “Relatives' Involvement” and “Professionals' Skills and Behavior.” _Conclusions:_ The Family intervention for psychosis delivered in the GET UP PIANO trial reduced family burden of illness and improved emotional distress and satisfaction with services. These results should encourage to promote FIs on caregivers of first-episode psychosis patients. (shrink)

In this book, scholars with different disciplinary and national backgrounds argue for possible answers and analyse case studies on current issues of governance in biomedical research. These issues comprise among others the research-care distinction, risk evaluation in early human trials, handling of incidental findings, nocebo effects, cluster randomized trials, publication bias, or consent in biobank research. This book demonstrates how new technologies and research possibilities multiply or intensify already known governance challenges, leaving room for ethical analysis and complex (...) moral choices. Clinical researchers, research ethics committee members and research ethicists have all to deal with such challenges on a daily basis. While general reflection on core concepts of research ethics is seldom pointless, those confronted with hard moral choices do need more practical and contextualized reflection on the said issues. This book particularly provides such contextualized reflections and aims to inform all those who study, conduct, regulate, fund, or participate in biomedical research. (shrink)

The recent Ebola virus disease outbreak in Western African countries has raised questions regarding the feasibility of adopting conventional trial designs such as randomized controlled trials for conducting experimental trials in the midst of a fatal epidemic. In the context of Ebola ça Suffit trial conducted in Guinea for testing the efficacy and effectiveness of rVSV–ZEBOV, a candidate vaccine, I argue that the trial design and the methodologies adopted for the trial have been rightly chosen (...) for their ethical appropriateness and social utilities rather than only epistemic advantages. In this paper, I propose and defend the view that in varying scientific research contexts, it is entirely legitimate that non-epistemic values may be prioritized over epistemic considerations. Two vital methodological choices scientists should make while designing a clinical trial are: the choice of appropriate control group and the choice of appropriate randomization. Given this background, I show that the choice of delayed vaccination arm as the control group over placebo control group and the choice of cluster randomization over individually controlled randomization for conducting Ebola ça Suffit trial are perfect instances of such a scenario where addressing social and ethical issues have been justifiably prioritized over epistemic values so that the research in a specific scientific context could be conducted in a socially relevant manner. (shrink)

Randomized controlled trials sometimes test interventions that aim to improve existing services targeted to a subset of individuals identified after randomization. Accordingly, the treatment could affect the composition of service recipients and the offered services. With such bias, intention-to-treat estimates using data on service recipients and nonrecipients may be difficult to interpret. This article develops causal estimands and inverse probability weighting estimators for complier populations in these settings, using a generalized estimating equation approach that adjusts the standard errors for (...) estimation error in the IPW weights. While our focus is on more general clustered RCTs, the methods also apply to nonclustered RCTs. Simulations show that the estimators achieve nominal confidence interval coverage under the assumed identification conditions. An empirical application demonstrates the methods using data from a large-scale RCT testing the effects of early childhood services on children’s cognitive development scores. An R program for estimation is available for download. (shrink)

Implementation research is increasingly common in developing countries as a way of studying the introduction to the population of health interventions that have been proven to be effective elsewhere. Implementation studies are often conducted as cluster randomized trials, a design that raises ethical and conceptual questions different from those in conventional randomized controlled trials. It is often unclear who the subjects of the research are, informed consent may be difficult or impossible to obtain and controversy surrounds the (...) use of comparison clusters that provide substandard care to the population where the research is carried out. An examination of protocols for this type of research reveals uncertainty on the part of researchers themselves about whom or what they are studying and from whom (if anyone) informed consent is required. (shrink)

Context Physicians are regularly confronted with research that is funded or presented by industry. Objective To assess whether physicians discount for conflicts of interest when weighing evidence for prescribing a new drug. Design and setting Participants were presented with an abstract from a single clinical trial finding positive results for a fictitious new drug. Physicians were randomly assigned one version of a hypothetical scenario, which varied on conflict of interest: ‘presenter conflict’, ‘researcher conflict’ and ‘no conflict’. Participants 515 randomly (...) selected Fellows in the American College of Obstetricians and Gynecologists' Collaborative Ambulatory Research Network; 253 surveys (49%) were returned. Main object measures The self-reported likelihood that physicians would prescribe the new drug as a first-line therapy. Results Physicians do not significantly discount for conflicts of interest in their self-reported likelihood of prescribing the new drug after reading the single abstract and scenario. However, when asked explicitly to compare conflict and no conflict, 69% report that they would discount for researcher conflict and 57% report that they would discount for presenter conflict. When asked to guess how favourable the results of this study were towards the new drug, compared with the other trials published so far, their perceptions were not significantly influenced by conflict of interest information. Conclusion While physicians believe that they should discount the value of information from conflicted sources, they did not do so in the absence of a direct comparison between two studies. This brings into question the effectiveness of merely disclosing the funding sources of published studies. (shrink)