Trust In Medical Research Research Articles

An empirical assessment of the short-term impacts of a reading of Deborah Zoe Laufer's drama Informed Consent on attitudes and intentions to participate in genetic research

ABSTRACTObjective: This study assessed the short-term impact of the play “Informed Consent” by Deborah Zoe Laufer (a fictionalized look at the controversy over specimens collected from the Havasupai Tribe for diabetes research in 1989) on perceptions of trust, willingness to donate biospecimens, and attitudes toward harm and privacy among the medical and undergraduate students, faculty, and the public in the Intermountain West. Methods: Surveys were administered before and after a staged reading of the play by professional actors. Survey items included the short form Trust in Medical Researchers, and single-item questions about group identity, ethics of genetic testing in children, and willingness to donate biospecimens. In addition, respondents were given the option to answer open-ended questions through e-mail. Results: Out of the 481 who attended the play, 421 completed both the pre and post surveys, and 166 participants completed open-ended questions online approximately 1 week after the play. Across all participants, there were significant declines for trust in medical researchers and for the survey item “is it ethical for investigators to test children for adult onset diseases” (p < .001 for both) following the play. There was a significant increase in agreement to improve group identity protections (p < .001) and there were no differences on willingness to donate biospecimens to research (p = .777). Qualitative data provided extensive contextual data supporting these perspectives. Discussion: This is one of the first studies to document short-term impacts of a theatrical performance on both attitudes and behavioral intentions toward research ethics and clinical research participation. Future research should continue to explore the impact of theatrical performances among public and investigators on the ethical issues and complexities in clinical research.

When Trust Is Not Enough: A Serial Mediation Model Explaining the Effect of Race Identity, eHealth Information Efficacy, and Information Behavior on Intention to Participate in Clinical Research.

Black participants remain significantly underrepresented in clinical research. Mistrust in medical researchers has been named a key barrier to the successful enrollment of minority study participants. However, trust is a social-interactional construct, and its effects on behavior are complex. This study hypothesized that intention to participate in clinical research is mediated by trust in medical researchers, eHealth literacy, and information seeking behavior. The data were collected through an online survey ( N = 340) and analyzed to identify serial mediation. The model showed insignificant direct effect of race identity on behavioral intention, c' = -0.19, t(335) = -1.22, p = .22, but a significant total effect, c = -0.44, t(335) = -2.59, p < .01. The indirect effect of race identity on behavioral intention was also significant. The positive effect of trust in medical researchers on decisions to participate in clinical research can be amplified by stronger eHealth literacy and active information seeking, which can be supported through focused strategic health education and communication interventions. A focus on the development of information literacy that could provide prospective minority research volunteers with skills for informed decision making should be explored as an option for increasing mindful, informed participation in clinical research among currently underrepresented racial and ethnic groups.

Improving recruitment to clinical trials during pregnancy: A mixed methods investigation

ObjectiveTo identify reasons underlying women's refusal to participate in a pregnancy trial and to identify ways of increasing recruitment. DesignMixed methods study using a questionnaire and qualitative interviews. SampleA questionnaire asking them to indicate reasons for their decision was completed by 296 pregnant women who declined to participate in one of two trials of nutritional supplementation in a large teaching hospital in southern England. Qualitative interview data were collected from two samples of pregnant women: 1) 30 women who declined to participate in a trial but completed the questionnaire; and 2) 44 women who participated in a trial. ResultsQuestionnaire data from pregnant women who declined to participate suggested the major barriers to participation were study requirements, including taking study medication, having a bone scan or blood tests, or being too busy. Thematic analysis of interview data identified differences in self-efficacy and levels of trust in medical research between participants and decliners. Participants believed that the research would cause no harm, while decliners felt they or their unborn child would be at risk. When faced with potential obstacles, participants found ways around them while decliners felt they were insurmountable. ConclusionsRecruitment methods for pregnancy trials should focus on building women's trust in the trial, and on enhancing women's self-efficacy so they feel able to meet trial requirements. Suggestions for building trust include investing time in open, honest discussion of the risks and benefits of participation, improving visibility of the research team, testimonials from previous participants and advertising study safety and ethical conduct. Self-efficacy can be enhanced by training research staff in empowering styles of communication enabling women to feel heard and supported to problem-solve. These strategies could be implemented relatively easily into pregnancy trial protocols, and their effectiveness tested through their impact on recruitment rates.

A paradigm for understanding trust and mistrust in medical research: The Community VOICES study

ABSTRACTBackground: To promote justice in research practice and rectify health disparities, greater diversity in research participation is needed. Lack of trust in medical research is one of the most significant obstacles to research participation. Multiple variables have been identified as factors associated with research participant trust/mistrust. A conceptual model that provides meaningful insight into the interplay of factors impacting trust may promote more ethical research practice and provide an enhanced, actionable understanding of participant mistrust. Methods: A structured survey was developed to capture attitudes toward research conducted in emergency situations; this article focuses on items designed to assess respondents' level of trust or mistrust in medical research in general. Community-based interviews were conducted in English or Spanish with 355 New York City residents (white 42%, African American 29%, Latino 22%). Results: Generally favorable attitudes toward research were expressed by a majority (85.3%), but many respondents expressed mistrust. Factor analysis yielded four specific domains of trust/mistrust, each of which was associated with different demographic variables: general trustworthiness (older age, not disabled); perceptions of discrimination (African American, Latino, Spanish language preference); perceptions of deception (prior research experience, African American); and perceptions of exploitation (less education). Conclusions: The four domains identified in the analysis provide a framework for understanding specific areas of research trust/mistrust among disparate study populations. This model offers a conceptual basis for the design of tailored interventions that target specific groups to promote trust of individual researchers and research institutions as well as to facilitate broader research participation.

The Attitude of Patients from a Romanian Tertiary Cardiology Center as Regards Participation in Biomarker-Based Clinical Trials - Survey Methodology.

One of the challenges faced when conducting a clinical trial is the recruitment of the proposed number of participants. Accordingly, identifying barriers to patients’ enrollment and developing effective strategies to overcome them is mandatory. One of the main strategies employed to improve participation rate consists of designing the informed consent forms based on patients’ feedback. This survey aims to explore the attitude of patients admitted in a Romanian tertiary cardiology center to take part in biomarker-based clinical trials.This is a descriptive, prospective and longitudinal single-center study. Participants will be recruited until the planned sample size will be reached (n=333). The patients will be interviewed based on a semi-structured questionnaire which includes four sections: demographics (7 items), personal medical history (7 items), attitudes (9 items) and trust (4 items). Descriptive statistics will be used to illustrate patients’ demographics, medical history, attitudes toward biomarker-based clinical trials and trust in medical researchers. Logistic regression models will be employed to assess relations between patients’ attitudes, trust, and different socio-demographic variables.Data analysis will offer answers to key questions addressed by this survey: What amount of and in what form should information be disclosed? Who should make the invitation to participate?The information gained will facilitate tailoring informed consent forms to suit the needs of patients with various demographic, social and educational backgrounds.

Participant-Centric Initiatives and Medical Research: Scoping Review Protocol.

BackgroundSignificant advances in digital technologies have meant that health care data can be collected, stored, transferred, and analyzed for research purposes more easily than ever before. Participant-centric initiatives (PCI) are defined as “tools, programs, and projects that empower participants to engage in the research process” using digital technologies and have the potential to provide a number of benefits to both participants and researchers, including the promotion of public trust in medical research, improved quality of research, increased recruitment and retention, and improved health care delivery.ObjectiveThe main objective of this scoping review is to describe the extent and range of PCIs across the United Kingdom, United States, and Japan that are designed to facilitate medical research.MethodsThe methodological framework described by Levac et al will be applied to this scoping review. We will search electronic databases (MEDLINE, EMBASE, PsychINFO, Cumulative Index to Nursing, and Allied Health Literature and CiNii), grey literature sources, Internet search engines (Google and Bing), and hand search key journals and reference lists of relevant articles. All digital tools and programs will be eligible for inclusion if there is a description of key features and functions that fall within the parameters of a PCI. Only those that play a role in medical research will be included.ResultsPreliminary searches conducted in MEDLINE and EMBASE retrieved 1820 and 2322 results, respectively. The scoping review will be completed by January 2018.ConclusionsThe scoping review will be the first to map the extent and range of PCIs currently available across the United Kingdom, United States, and Japan, and will be the first review to contribute to a better understanding of what PCIs patients may benefit from. Researchers and practitioners will be able to use information in this review as a guide for patients and also as a guide for the development of future tools and programs. The results will be disseminated through a peer-reviewed publication and conference presentations.

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OBJECTIVES/SPECIFIC AIMS: Exposure to theatrical performances holds promise for addressing bioethical issues, but there has been little empirical examination of the impact of dramatic presentation on audiences’ attitudes. This study assessed the short-term impact of the play, Informed Consent, on perceptions of trust, willingness to donate biospecimens, attitudes toward harm and privacy among the general public and in faculty, medical and undergraduate students within an academic medical center in the intermountain west. METHODS/STUDY POPULATION: Surveys were administered before and after a staged reading of the play by professional actors. Pre and post survey responses were linked for each participant. Survey items included the short form Trust in Medical Researchers, and single item questions about group identity, of genetic testing in children, and willingness to donate biospecimens. In total, 3 additional questions about harm, consent, and ethical investigator behavior as represented in the play were asked in the post survey. In addition, respondents were given the option to answer open-ended questions through email. RESULTS/ANTICIPATED RESULTS: Out of the 481 who attended the play, 421 completed both the pre and post surveys, and 166 participants completed open-ended questions online ~1 week after the play. Across all participants, there were significant declines for Trust in Medical Researchers and for the survey item “is it ethical for genetic testing in children for adult onset conditions,” (p&lt;0.001 for both) following the play. There was a significant increase in agreement to improve group identity protections (p&lt;0.001) and no differences on willingness to donate biospecimens to research (p=0.777). When differences were analyzed by race of the participant, non-White participants (n=68) compared with White participants (n=344) were less willing to donate biospecimens in general (p&lt;0.001). Further, non-White participants’ willingness to donate biospecimens decreased (p=0.049) after viewing the play while the white participants’ willingness to donate was unchanged. Qualitative data provided extensive contextual data supporting these perspectives. DISCUSSION/SIGNIFICANCE OF IMPACT: This is one of the first studies to empirically examine the impact of a theatrical performance on both attitudes and behavioral intentions toward research and clinical research participation. Some attitudes changed following the play performance, but there were no significant differences on intention to donate biospecimens for research overall. Future research can further address the value and impact of theatrical performances and other creative arts as tools to engage the public and investigators in dialogue about the ethical issues and complexities in clinical research and further evaluation of the impact of performances on attitudes about research and ethics. Creative arts may be used to motivate investigators and study participants to confront fundamental questions about research participation and trust.

ARE MEMBERS OF UNDERREPRESENTED GROUPS REALLY LESS LIKELY TO PARTICIPATE IN BIOMARKER STUDIES REQUESTING BLOOD OR CSF ?

Information derived from biomarkers improves detection of AD pathology years before symptoms appear. Despite known contributions of biomarkers to AD research, a major drawback is the willingness of participants to undergo a lumbar puncture (LP). Data on factors affecting participation in LP studies are limited. We examined effects of socio-demographic variables and concerns related to trust in medical research on expressed likelihood to participate in research involving blood or CSF donation. Item responses to a comprehensive survey questionnaire from a diverse sample of 410 adults (mean age=44.7, SD=16.7) were used in the analysis. The sample included 25.6% African Americans, 24.4% Latinos, 24.4% American Indians, 24.6% Whites. The likelihood of providing blood or CSF samples was rated using a 5 pt scale ranging from “Very Likely “to “Very Unlikely”. Chi Square analyses evaluated associations of ethnic/racial background, trust in medical researchers, concerns about physical pain and infection, having a family member with AD, age, and gender on likelihood of providing blood or CSF samples. There was no significant association between ethnicity/race and likelihood to provide blood samples (p=0.027), 61 % of respondents were “very or somewhat likely” to provide blood. In contrast, only 17 % of the sample was “very or somewhat likely” to provide CSF and associations between ethnicity/race and likelihood to provide CSF approached significance (p=0.06). Concern about pain and trust (p=0.000) in medical researchers (p=0.000) decreased likelihood to provide CSF. Respondents more willing to provide blood were also more likely to provide CSF (p=0.00). Younger respondents were less willing to provide CSF than older respondents (p=0.030); Latinos expressed greater likelihood to participate in CSF studies than Whites (p=0.017). Respondents with higher educational levels were less likely to provide CSF samples than respondents with lower education (p=0.016). Having a family member with AD did not influence likelihood to provide blood or CSF. Although overall willingness to provide CSF was low, we found interesting and unexpected variations among racial/ethnic groups. Results suggest common and group specific barriers to LP studies. These issues that can inform tailored recruitment strategies designed to increase the propensity of CSF donation.

Biospecimen donors' views about biobank closure.

TPS6625 Background: The future of biobanks is often uncertain due to sporadic funding. A survey of 456 biobank administrators found that they consider the loss of funding to be either a "massive (40%)" or "moderate (31%)" concern. Only 26% of biobanks reported having a plan in the event of closure (Cadigan et al., Life Sciences, Society and Policy, 2013). Biospecimen donors’ views on how they want their tissue handled following biobank closure is unknown. Our study will be the first to determine how biospecimen donors want their data and biological materials handled if their biobanks were to close. We believe this report of 100 biospecimen donors’ views will be useful to researchers and tissue bank administrators in creating contingency tissue bank closure plans that incorporate biospecimen donors’ perspectives. Methods: We will complete accrual of 100 oncology biospecimen donors (current accrual is 65 patients) at one institution by interviewing them about their views of bank closure and preferences for the handling of their tissue post-closure. The interview asks participants if they have a preference for the handling of their tissue and information in the event of bank closure, and if so, if they prefer transfer of their materials to another tissue bank or destruction. Feelings about closure are captured in three categories: sad/disappointed, angry/frustrated, and other negative emotions. The effect of tissue bank closure upon trust in medical research is captured in three categories: decreases trust, does not decrease trust, and may decrease trust under certain circumstances. We ask the participants to rank the following options for transfer of their tissue and information: transfer to another local academic tissue bank, to a for-profit or pharmaceutical bank, to an international bank, or to a national bank. We also ask if any of these options are deemed absolutely unacceptable. Results: NA Conclusions: NA

Adolescent Participation in HPV Vaccine Clinical Trials: Are Parents Willing?

Approximately one-quarter of human papillomavirus (HPV) infections are acquired by adolescents, with a higher burden among racial/ethnic minorities. However, racial/ethnic minorities have been underrepresented in previous HPV vaccine trials. Ongoing and future HPV vaccine optimization trials would benefit from racially- and ethnically-diverse sample of adolescent trial participants. This study examined factors influencing parental willingness to consent to their adolescents’ participation in HPV vaccine clinical trials and tested for possible racial differences. A convenience sample of parents of adolescents (N = 256) completed a cross-sectional survey. Chi square analyses were used to assess racial differences in parental HPV vaccine awareness and intentions and willingness to consent to their child participating in an HPV vaccine clinical trial. Ordinal logistic regression was used to identify factors associated with willingness. Approximately 47% of parents were willing to allow their adolescent to participate in HPV vaccine clinical trials (30.7% African American and 48.3% Caucasian, p = .081). African Americans had lower HPV vaccine awareness (p = .006) but not lower intentions to vaccinate (p = .086). Parental willingness was positively associated with the following variables: Child’s age (p < .039), Perceived Advantages of HPV Vaccination for Adolescents (p = .002), Parental Trust in Medical Researchers (p < .001), and Level of Ease in Understanding Clinical Trial Information (p = .010). Educating parents about the advantages of HPV vaccines for younger adolescents using low-literacy educational materials and building trust between parents and researchers may increase parental willingness to consent to adolescent participation in HPV vaccine clinical trials.

African-American patients with cancer Talking About Clinical Trials (TACT) with oncologists during consultations: evaluating the efficacy of tailored health messages in a randomised controlled trial—the TACT study protocol

IntroductionLow rates of accrual of African-American (AA) patients with cancer to therapeutic clinical trials (CTs) represent a serious and modifiable racial disparity in healthcare that impedes the development of promising...

Exploring Willingness of Elder Chinese in Houston to Participate in Clinical Research.

Background and objectivesInadequate minority participation in clinical research can threaten the applicability and strength of scientific findings. Previous research suggests that trial participation rates are lowest among Asian Americans, compared to other groups. This study explored barriers to clinical research participation among elder Chinese living in Houston, Texas. Additionally we administered the Trust in Medical Researchers Scale (TIMRS), used previously in researching trust in medical researchers as related to research participation.DesignIn this mixed methods study, a semi-structured interview, including the TIMRS were administered to 30 adults of Chinese ancestry aged 50 years or older recruited from a Chinese community center. Interviews were conducted in English, Mandarin and Cantonese and independently coded and analyzed using thematic content analysis. TIMRS scores were calculated for participants.ResultsParticipants were 70% female, 70% were 60 or elder, all were foreign born and on average lived in the US for 21.8 years. Participants perceived risks to research participation and preferred language concordant research staff. Interviewees were more willing to participate if they perceived personal and community health-related benefits. The overall TIMRS score was 23.9 (±5.0), lower than the overall TIMRS for Whites in a previous study (P < 0.001).ConclusionsThe barriers and facilitators to research participation confirmed previous research among Asians. Our participant TIMRS scores were consistent with decreased levels of trust observed in the original TIMRS study for African Americans as compared and lower than Whites. Employing strategies that utilize language concordant staff who build trust with participants may aid in recruiting elder Chinese, especially if the research is personally relevant to those being recruited.

Development and Psychometric Evaluation of the HPV Clinical Trial Survey for Parents (CTSP-HPV) Using Traditional Survey Development Methods and Community Engagement Principles.

This study describes the development and psychometric evaluation of HPV Clinical Trial Survey for Parents with Children Aged 9 to 15 (CTSP-HPV) using traditional instrument development methods and community engagement principles. An expert panel and parental input informed survey content and parents recommended study design changes (e.g., flyer wording). A convenience sample of 256 parents completed the final survey measuring parental willingness to consent to HPV clinical trial (CT) participation and other factors hypothesized to influence willingness (e.g., HPV vaccine benefits). Cronbach's a, Spearman correlations, and multiple linear regression were used to estimate internal consistency, convergent and discriminant validity, and predictively validity, respectively. Internal reliability was confirmed for all scales (a ≥ 0.70.). Parental willingness was positively associated (p < 0.05) with trust in medical researchers, adolescent CT knowledge, HPV vaccine benefits, advantages of adolescent CTs (r range 0.33-0.42), supporting convergent validity. Moderate discriminant construct validity was also demonstrated. Regression results indicate reasonable predictive validity with the six scales accounting for 31% of the variance in parents' willingness. This instrument can inform interventions based on factors that influence parental willingness, which may lead to the eventual increase in trial participation. Further psychometric testing is warranted.

Prioritizing Approaches to Engage Community Members and Build Trust in Biobanks: A Survey of Attitudes and Opinions of Adults within Outpatient Practices at the University of Maryland.

Background: Achieving high participation of communities representative of all sub-populations is needed in order to ensure broad applicability of biobank study findings. This study aimed to understand potentially mutable attitudes and opinions commonly correlated with biobank participation in order to inform approaches to promote participation in biobanks. Methods: Adults from two University of Maryland (UMD) Faculty Physicians, Inc. outpatient practices were invited to watch a video and complete a survey about a new biobank initiative. We used: Chi-square to assess the relationship between willingness to join the biobank and participant characteristics, other potentially mutable attitudes and opinions, and trust in the UMD. We also used t-test to assess the relationship with trust in medical research. We also prioritize proposed actions to improve attitudes and opinions about joining biobanks according to perceived responsiveness. Results: 169 participants completed the study, 51% of whom indicated a willingness to join the biobank. Willingness to join the biobank was not associated with age, gender, race, or education but was associated with respondent comfort sharing samples and clinical information, concerns related to confidentiality, potential for misuse of information, trust in UMD, and perceived health benefit. In ranked order, potential actions we surveyed that might alleviate some of these concerns include: increase chances to learn more about the biobank, increase opportunities to be updated, striving to put community concerns first, including involving community members as leaders of biobank research, and involving community members in decision making. Conclusions: This study identified several attitudes and opinions that influence decisions to join a biobank, including many concerns that could potentially be addressed by engaging community members. We also demonstrate our method of prioritizing ways to improve attitudes and opinions about joining a biobank according to perceived responsiveness.

Lay attitudes toward trust, uncertainty, and the return of pediatric research results in biobanking

ABSTRACTBackground: Trust plays a role in participants’ reactions to clinical residual biobanks. The purpose of this study is to assess whether trust in medical researchers and negative reactions to uncertainty influence the attitudes of parents of pediatric research participants toward the return of genomic research results from biobanking. Methods: Focus groups were conducted in collaboration with two community-based organizations. Participants completed a demographic questionnaire and the trust in research and intolerance of uncertainty scales. The focus groups were then conducted according to a thematic focus-group guide; discussions were transcribed and analyzed by two trained coders. Results: Emerging themes included the importance of returning research results to both children and parents, sharing results with few limitations based on a child's age, and the desire for results even when researchers had concerns about analytic validity. Negative reactions to uncertainty appear to have influenced only one theme: the paradoxical claim by participants with stronger reactions to uncertainty that they had a “right to information.” Conclusion: Participants prefer to receive most or all of the results produced by genomic research, and they want their children, within variable age restrictions, to have access to that information as well.

Knowledge, Awareness, and Interest in Cancer Clinical Trials among Rural Latinos Following Brief Education by Promotores de Salud

Background: Promotores have been widely used for health promotion in underserved Latino communities and are increasingly being partnered with throughout the country to enhance health care access when there are cultural and economic barriers to care. A community network approach using Promotores de Salud may be a useful strategy for increasing overall knowledge and participation of Latinos in clinical trials. Objective: To assess knowledge, attitudes, and interest related to participating in cancer clinical trials among rural Latinos following receipt of a brief community-based cancer research educational session delivered by previously trained promotores de salud. Methods: Trained promotores de salud conducted 10-15 minute one-to-one educational sessions with Latinos. Participants completed a pre-post assessment on knowledge, attitudes and interest in participating in clinical trials. Results: Over a period of two months, five trained promotores recruited and delivered a single educational session with 228 Latinos. At baseline, 68% of participants had heard about clinical trials, but only 5% had participated in one. Compared to baseline, after training, participants increased significantly their positive views of clinical trials, trust in medical researchers, and belief in general safety of clinical research (p<0.001). Interest in participating in cancer clinical trials increased from 68% to 79% (p<.001). Providing bio-specimens for research purposes (p<0.001) also increased significantly. Conclusion: Use of Promotores de Salud to conduct community-based clinical trials education is a promising approach to promote widespread community participation in cancer clinical trials available to ethnic and racial underserved populations.

Racial/Ethnic Differences in Trust in Health Care: HIV Conspiracy Beliefs and Vaccine Research Participation

Prior research has documented a high prevalence of conspiracy beliefs about the origin of the human immunodeficiency virus (HIV) and the role of the government in the acquired immunodeficiency syndrome (AIDS) epidemic, particularly among racial and ethnic minorities in the United States. Whether such beliefs are a barrier to participation in HIV prevention research is not known. To understand the prevalence of HIV conspiracy beliefs and their relationship to willingness to participate in HIV vaccine research among three racial/ethnic groups. Cross-sectional survey. Six hundred and one community-recruited volunteers (33.0 % White, 32.5 % Mexican American, and 34.5 % African American). We evaluated the level of agreement with six previously described HIV conspiracy beliefs, trust in medical research, and willingness to participate in HIV vaccine research. Multivariate models were used to compare these parameters among the three racial/ethnic groups while controlling for the potential confounding effects of socioeconomic status, access to health care, and other demographic factors. African Americans, Mexican Americans, and whites had similar levels of distrust in medical research. African and Mexican Americans were more likely to endorse one or more of six HIV conspiracy beliefs than whites (59.0 % and 58.6 % versus 38.9 %, respectively, P < 0.001), but were significantly more willing to participate in HIV vaccine research (ORs 1.58, CI 1.10-2.25 and 2.53, CI 1.75-3.66, respectively). Among respondents of all racial/ethnic groups, endorsing HIV conspiracy beliefs was not associated with willingness to participate in research. HIV conspiracy beliefs, while common among all racial and ethnic groups in the United States, do not preclude willingness to participate in HIV prevention research.

Transparency in the presentation of trial results may not increase patients’ trust in medical researchers

One of the expected benefits of sharing trial results with participants is that it may enhance trust in medical researchers (TMRs). In a prospective study on a sample of clinical trial participants, we investigated the effect on the participants' TMRs of providing final trial results to participants via the Internet. Participants in the FNCLCC-PACS04 trial (ClinicalTrials.gov Identifier: NCT00054587) were surveyed on average 6 years after enrollment, when the trial results were available. In the current study, they were randomized to receive (experimental group) or not to receive (control group) a letter informing them that the results of the trial could be consulted on a specific website. TMRs was measured before randomization and 6 months later using mailed self-administered questionnaires. The response rate was 93% (N = 107). TMRs remained unchanged in the control group (mean effect size = -0.06, 95% confidence interval (CI): -0.28 to 0.17, p = 0.617) but decreased in the experimental group (-0.30, 95% CI: -0.53 to -0.06, p = 0.015). However, the difference between the two effect sizes was not statistically significant (p = 0.144). The results obtained here on the disclosure of final trial results to breast cancer patients via the Internet cannot be generalized to all situations involving the disclosure of phase III randomized controlled trial results. Transparency is an ethical research requirement, but it may not enhance participants' TMRs.

7th revision of the Declaration of Helsinki: good news for the transparency of clinical trials.

In October 2008, the 59th World Medical Association (WMA) General Assembly in Seoul adopted the 7th revision of the Declaration of Helsinki: “Ethical Principles for Medical Research Involving Human Subjects.” This new version is the result of an extensive review process which started in 2007 and which received contributions by various national medical associations, researchers, and medical journal editors (1). The 7th revision of Declaration contains important new requirements related to the registration of clinical trials and reporting of their results. Both requirements are indeed appropriately situated among the core principles of contemporary research ethics (Paragraphs 19 and 30). The main purpose of trial registration is to reduce publication and reporting bias and thus provide reliable evidence for decision making, but it can only achieve this if complemented by public reporting of results. Various controversies over the last decades have confirmed the need to firmly reiterate that medical research involving humans has a clear public purpose and that transparency is a crucial requirement to ensure that this public purpose is respected (2,3). A firm commitment of the medical community to transparency should help rebuild trust in medical research, which has been seriously damaged by these controversies. Ensuring transparency and integrity of data also reflects an ethical commitment to respect for research subjects. Indeed, using research subjects (or as we prefer to call them, participants) for research that remains hidden because of corporate or other interests amounts to using human beings as instruments of marketing and undermines their dignity. Finally, transparency in research on humans is also a core component of promoting the physical well-being of research participants and of patients who will end up consuming the products that result from research. Knowing about trials that have already taken place is crucial in preventing unnecessary exposure to potential harms in research and in promoting safe prescription behavior. Changes made to the Declaration, particularly those related to the need for the registration of clinical trials and results reporting, are a clear sign that the medical community is taking the issue of transparency, and public accountability of research seriously. Here we shall briefly present the background to these provisions and address their implications and some of the remaining challenges.

Effects of disclosing financial interests on participation in medical research: A randomized vignette trial

Little is known about the effects of investigators' financial disclosures on potential research participants. We conducted a vignette trial in which 470 participants in a telephone survey were randomly assigned to receive a simulated informed consent document that contained 1 of 2 financial disclosures (per capita payments to the research institution or equity ownership by the investigator) or no disclosure. The main outcome measures were trust in medical research and willingness to participate in a hypothetical clinical trial. Participants in the equity group reported less willingness to participate than participants in the per capita payments group (P = .01) and the no disclosure group (P = .03). Trust in the investigator was highest in the per capita payments group and lowest in the equity group (P < .001). Trust among participants who received no disclosure was also greater than trust among participants in the equity group (P = .04) but did not differ significantly from trust among participants in the per capita payments group (P = .15). Participants in the equity group made 3 times as many negative comments as participants in the per capita payments group; and 10 participants in the equity group spontaneously said they would not participate in the hypothetical trial because of the financial interest, compared with only 1 such participant from the other groups. Although investigators' financial disclosures in research do not substantially affect willingness to participate, potential research participants are more troubled by equity interests than by per capita payments.