Trust In Biomedical Research Research Articles

Abstract A124: An examination of trust in biomedical research among the Witness Project’s community health workers

Abstract The Witness Project® (NWP) was established in 1991 and has maintained its status as one of NCI’s Evidence Based Cancer Control Program (EBCCP) for decades. NWP is a self-sustaining, culturally competent, grass roots level community-based intervention program that uses breast and cervical cancer survivors known as Witness Role Models and Community Health Workers (CHW). With many locations in unserved communities throughout the United States, NWP provides relevant cancer related education and navigates minority residents through successful completions of cancer related screenings. Health disparities are a longstanding problem due in part to underrepresentations of historically underserved populations in research. Increasing minority and underserved individuals’ participation in research has great disparity mitigating potential. A team of newly trained Black and Hispanic NWP CHW (n=25) will be created as part of a larger multiphase preliminary pilot study designed to increase diverse individuals’ participations in research within Roswell Park’s catchment area. Design, Measures, Setting, and Participants. The primary objective of this cross-sectional study is to assess Black and Hispanic CHW’s trust in biomedical research. Secondary objectives are to explore the feasibility and acceptability of 1) NWP CHW training, and 2) an informal educational intervention about the importance of minority representations in research and it potential to mitigate health disparities. CMWs will complete the Perceptions of Research Trustworthiness (PoRT) scale to evaluate their trust and distrust in biomedical research before and after viewing the informal educational intervention. Preliminary Results and Planned Analyses At the time of abstract submission nineteen CMWs have completed their NWP and CITI training and PoRT assessments. Fifteen CHWs were Black (78.9%) and four Hispanic (21.1%). When all 25 CMWs are trained we will calculate overall and individual item Trust and Distrust subscale scores. Regarding feasibility and acceptability of the CHW training and the informal education intervention, semi structured interviews will provide qualitative feedback and independent samples t-test will be used to compare pre-and post-informal education intervention PoRT scores. Citation Format: Julia Devonish, Martin Mahoney, Elizabeth Bouchard, Cassy Dauphin, Abshiro Ali, Veronica Meadows, Jomary Colon, Dee Johnson. An examination of trust in biomedical research among the Witness Project’s community health workers [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr A124.

Integrating primary care, shared decision making, and community engagement to facilitate equitable access to multi-cancer early detection clinical trials.

Effective implementation of cancer screening programs can reduce disease-specific incidence and mortality. Screening is currently recommended for breast, cervical, colorectal and lung cancer. However, initial and repeat adherence to screening tests in accordance with current guidelines is sub-optimal, with the lowest rates observed in historically underserved groups. If used in concert with recommended cancer screening tests, new biospecimen-based multi-cancer early detection (MCED) tests could help to identify more cancers that may be amendable to effective treatment. Clinical trials designed to assess the safety and efficacy of MCED tests to assess their potential for reducing cancer mortality are needed and many are underway. In the conduct of MCED test trials, it is crucial that participant recruitment efforts successfully engage participants from diverse populations experiencing cancer disparities. Strategic partnerships involving health systems, clinical practices, and communities can increase the reach of MCED trial recruitment efforts among populations experiencing disparities. This goal can be achieved by developing health system-based learning communities that build understanding of and trust in biomedical research; and by applying innovative methods for identifying eligible trial patients, educating potential participants about research trials, and engaging eligible individuals in shared decision making (SDM) about trial participation. This article describes how a developing consortium of health systems has used this approach to encourage the uptake of cancer screening in a wide range of populations and how such a strategy can facilitate the enrollment of persons from diverse patient and community populations in MCED trials.

“Do they REALLY trust us”?: Lessons from a volunteer research registry

Abstract Background: All IN for Health is a well-established community-academic partnership dedicated to helping improve the lives of Indiana residents by increasing health research literacy and promoting health resources, as well as opportunities to participate in research. It is sponsored by the Indiana Clinical and Translational Science Institute (I-CTSI). The study’s purpose was to measure trust in biomedical research and healthcare organizations among research volunteers. Methods: The Relationship of Trust and Research Engagement (RTRE) survey was developed utilizing 3 validated scales. The RTRE consisted of 36 items in a 5-point Likert scale with three open-text questions. We conducted 3 focus groups with a total of 24 individuals ahead of the survey’s launch. Recruitment was done through the All IN for Health newsletter. The survey was administered in the summer of 2022. Results: Six hundred and sixty-three individuals participated in the survey. Forty-one percent agreed that doctors do medical research for selfish reasons. Moreover, 50% disagree that patients get the same medical treatment regardless of race/ethnicity. Sixty-seven percent think it is safe to participate in medical research, yet 79% had never been asked to participate. Ten percent believe that researchers select minorities for their most dangerous studies and expose minoritized groups to diseases. Conclusion: The utilization of tools to measure trust will facilitate participant recruitment and will assist institutions and investigators alike in accountability. It is imperative, we work toward understanding our communities’ trust in medical research, assessing our own trustworthiness, and critically reflect on the authenticity of our efforts.

The Robustness Index: Going Beyond Statistical Significance by Quantifying Fragility.

Statistical significance is widely used to evaluate research findings but has limitations around reproducibility. Measures of statistical fragility aim to quantify robustness against violations of assumptions. However, dependence on sample size and single unit changes restricts indices like the unit fragility index and the fragility quotient. The Robustness Index (RI) is proposed to overcome these limitations and quantify fragility independently of the research study's sample size. The RI measures how altering sample size affects significance. For insignificant findings, the sample size is multiplied until significance is reached; the multiplicand is the RI. The sample size is divided for significant research findings until insignificance is reached; the divisor is the RI. Thus, higher RIs indicate greater robustness of insignificant and significant research findings. The RI provides a simple, interpretable metric of fragility. It facilitates comparisons across studies and can potentially increase trust in biomedical research.

547 - Partnering with the community: Facilitating interest and Trust in biomedical research

547 - Partnering with the community: Facilitating interest and Trust in biomedical research

Development and Validation of the Perceptions of Research Trustworthiness Scale to Measure Trust Among Minoritized Racial and Ethnic Groups in Biomedical Research in the US

Historically, trust in biomedical research has been lower among minoritized racial and ethnic groups who are underrepresented in and excluded from research, with the same groups experiencing worse health outcomes. Unfortunately, instruments that measure trust may not capture components of trust relevant to minoritized racial and ethnic groups. To develop and validate a scale to measure trust in biomedical research among minoritized racial and ethnic groups. This cross-sectional, community-based survey study compared trust and distrust in biomedical research among Black, Latino, and White subgroups in the US using the Perceptions of Research Trustworthiness (PoRT) scale. The scale was developed between March 22, 2016, and September 19, 2018, as part of this study, and its structure, reliability, and validity were examined during pilot (n = 381) and validation (n = 532) phases between February 4, 2019, and July 27, 2021. Convenience samples of adult participants (aged ≥18 years) were recruited locally (Nashville, Tennessee, and San Antonio, Texas) and nationally through the ResearchMatch and Cint online platforms. Overall and individual item Trust and Distrust subscale scores were compared. Overall Trust and Distrust scores were compared by race and ethnicity using a Kruskal-Wallis H test and individual item scores were compared using independent samples t test. Of the 532 participants in the scale validation study, 144 (27.1%) were Black, 90 (16.9%) were Latino, and 282 (53.0%) were White. Participants had a median age of 43 years (range, 18-90 years), 352 (66.2%) were women, and 198 (37.2%) had educational attainment levels less than a college degree. Factor analysis of the 18-item PoRT scale revealed a 2-factor structure with two 9-item PoRT subscales (Trust and Distrust), which demonstrated high internal consistency (Cronbach α = 0.72 and 0.87, respectively). Mean (SD) Trust subscale scores were lower among Black (34.33 [2.02]) and Latino (34.55 [1.97]) participants compared with White participants (36.32 [1.81]; P < .001). Mean (SD) Distrust subscale scores were higher among Black (21.0 [2.15]) and Latino (20.53 [2.21]) participants compared with White participants (18.4 [2.03]; P < .001). Individual item results showed that Black and Latino participants were less trusting and more distrusting than White individuals on items related to risks, harms, secrecy, confidentiality, and privacy. These findings suggest that the PoRT scale incorporates trust and trustworthiness concepts relevant among Black and Latino individuals and may allow more precise assessment of trust in research among these groups.

It is not a big deal: a qualitative study of clinical biobank donation experience and motives

BackgroundThe success of biobanking is directly linked to the willingness of people to donate their biological materials for research and storage. Ethical issues related to patient consent are an essential component of the current biobanking agenda. The majority of data available are focused on population-based biobanks in USA, Canada and Western Europe. The donation decision process and its ethical applications in clinical populations and populations in countries with other cultural contexts are very limited. This study aimed to evaluate the decision-making experience of the clinical biobank donors, as well as psychological and social motivators and deterrents of this decision and associated ethical risks.MethodsSemi-structured interviews were conducted in two medical institutions, in St Petersburg (Russia), in 2016–2017, among 13 donors of a clinical biobank (pregnant women, cardiac patients, and patients with multiple sclerosis) and three donation organisers—medical specialists involved in recruiting donors for a clinical biobank. Analysis of interview data was based on qualitative content analysis.ResultsDonors of a clinical biobank express beliefs in the absence of risks associated with the donation. The primary motivators for donating to the biobank were: prosocial, indirect reciprocity (response to or anticipation of an act in kind by a third party), intrinsic motivation (to enhance their self-esteem and satisfying their curiosity about the donation process), and comparability with personal values. A high level of trust in biomedical research and the particular physician can contribute to a favourable decision. The overall decision-making process regarding the biobank donation could be described as quick and not based on a careful reading of informed consent documents. The integration of biobank donation decision-making in the process of medical care might prompt patient to donate to biobank without proper consideration. The specific type of therapeutic misconception—the presence of unrealistic hope that donation could provide a direct benefit for a third person in need was discovered.ConclusionsPatients recruited to a clinical biobank in Russia have virtually no concerns as to the storage of their biomaterials. The donation decision is mainly motivated by prosocial attitudes and other factors that are similar to the motivating factors of blood donation. The fact of going through inpatient treatment and poor differentiation between donation for other people's benefit and for research purposes can make the process of obtaining consent more ethically problematic.

Addressing racial/ethnic inequities in vaccine hesitancy and uptake: lessons learned from the California alliance against COVID-19

Lack of trust in biomedical research, government, and health care systems, especially among racial/ethnic minorities and under-resourced communities, is a longstanding issue rooted in social injustice. The COVID-19 pandemic has further highlighted existing health and socioeconomic inequities and increased the urgency for solutions to provide access to timely, culturally, and linguistically appropriate evidence-based information about COVID-19; and ultimately to promote vaccine uptake. California’s statewide alliance STOP COVID-19 CA (comprising eleven sites), leverages long standing community partnerships to better understand concerns, misinformation, and address racial/ethnic inequities in vaccine hesitancy and uptake. Using data from the California CEAL Communication Working Group, we demonstrate the wide range of strategies, communication methods, languages, and trusted messengers that have been effective in reaching diverse communities across the state. We also showcase challenges and lessons learned, such as the importance of including trusted community partners to share information or provide vaccines. These approaches, rooted in community engagement, are crucial for addressing inequities and responding to future public health emergencies.

Can we know if donor trust expires? About trust relationships and time in the context of open consent for future data use

As donor trust legitimises research, trust is vital for research in the fields of biomedicine, genetics, translational medicine and personalised medicine. For parts of the donor community, the consent signature...

Factors influencing precision medicine knowledge and attitudes.

Precision medicine holds great promise for improving health and reducing health disparities that can be most fully realized by advancing diversity and inclusion in research participants. Without engaging underrepresented groups, precision medicine could not only fail to achieve its promise but also further exacerbate the health disparities already burdening the most vulnerable. Yet underrepresentation by people of non-European ancestry continues in precision medicine research and there are disparities across racial groups in the uptake of precision medicine applications and services. Studies have explored possible explanations for population differences in precision medicine participation, but full appreciation of the factors involved is still developing. To better inform the potential for addressing health disparities through PM, we assessed the relationship of precision medicine knowledge and trust in biomedical research with sociodemographic variables. Using a series of linear regression models applied to survey data collected in a diverse sample, we analyzed variation in both precision medicine knowledge and trust in biomedical research with socioeconomic factors as a way to understand the range of precision medicine knowledge (PMK) in a broadly representative group and its relationship to trust in research and demographic characteristics. Our results demonstrate that identifying as Black, while significantly PMK, explains only 1.5% of the PMK variance in unadjusted models and 7% of overall variance in models adjusted for meaningful covariates such as age, marital status, employment, and education. We also found a positive association between PMK and trust in biomedical research. These results indicate that race is a factor affecting PMK, even after accounting for differences in sociodemographic variables. Additional work is needed, however, to identify other factors contributing to variation in PMK as we work to increase diversity and inclusion in precision medicine applications.

Patients' Knowledge and Attitude Toward Biobanks in Eastern Morocco.

Background: To integrate biobanks into the Moroccan health system and to promote biobanks-based research projects, it is necessary to explore the knowledge of patients, their attitudes toward biobanks, and the reasons that motivate them to participate in biobanks. Methods: Face-to-face interviews were conducted with patients, and data were analyzed using SPSS. Results: One thousand one hundred thirty-three questionnaires were completed. The mean age of patients was 47.74 years (SD 15.26 years). More women (69%) were involved in this survey. Of the respondents, 97% had never heard of the term "biobanks." Knowledge of biobanks varied significantly with respondents' education level. Overall, 80.7% of the participants (n = 914) expressed their willingness to participate in biobanking through donation of biospecimens associated with personnel and health data. Willingness to participate in biobanks was significantly associated with gender and age. We found that the main barriers to participation in biobanks were the lack of trust in biomedical research and concerns about privacy. When asked about the preferred type of consent, the majority of patients (75%) opted for a one-time consent. Conclusion: Despite the lack of knowledge of biobanks among patients in Eastern Morocco, the majority of them expressed willingness to participate in biobanking through donation of biospecimens. However, active participation depended upon a number of factors, notably, the trust in biomedical research and privacy. Therefore, more efforts are needed to increase awareness and promote wider participation in biobanking.

Embedding Public Engagement in Biomedical Research: a Pilot Experience in the Field of Rare Genetic Disorders

In the last decade, international efforts have been focused on public engagement, to foster public involvement in the affairs and decisions of policy-makers and scientists, in order to open a mutual sharing of knowledge, values and beliefs. Our study describes a pilot experience of public engagement in a fringe field of biomedical research which involves caregivers of patients with Cornelia de Lange Syndrome (CdLS). For the 20th anniversary of Italian CdLS family’s association, a workshop focusing on progress and advancement of biomedical research on CdLS was organized for families. At the end participants were invited to complete a 14-item questionnaire, developed using a mixed method strategy with both quantitative (closed-ended) and qualitative (open-ended) data. Parents reported an overall good opinion of biomedical research (81.1%), reported trust in biomedical research (78.4%), and concluded that the basic research is as important as the clinical research (64.5%). However, only 19.4% of parents reported they were satisfied with the communication between researchers and society, and only 13.5% had a good perception of the availability of economic resources for research. Caregivers identified 4 areas of priorities: heuristic, functional, altruistic, and supportive; they reported to be highly satisfied with the workshop for both increasing knowledge about CdLS research, and for building up a network with supportive functions. Public engagement is a good way to inform caregivers about basic research progress, but also for informing researchers on the public’s views and concerns and for getting fresh and interesting perspectives.

Four erroneous beliefs thwarting more trustworthy research.

A range of problems currently undermines public trust in biomedical research. We discuss four erroneous beliefs that may prevent the biomedical research community from recognizing the need to focus on deserving this trust, and thus which act as powerful barriers to necessary improvements in the research process.

Racial differences in two measures of trust in biomedical research.

Lack of trust toward medical research is a major barrier to research participation, particularly among some population groups. Valid measures of trust are needed to develop appropriate interventions. The study purpose was to compare two previously validated scales that measure trust in biomedical research - one developed by Hall etal. (H-TBR; 2006) and the other by Mainous etal. (M-TBR; 2006) - in relation to socio-demographic variables and attitudes toward research. Differences between Black and White respondents were explored. Two nearly identical surveys - one with H-TBR and the other with M-TBR - were systematically administered to a convenience sample. Internal consistency reliability of each scale was assessed. Associations were computed between scores on each scale with attitudes toward biomedical research and demographic variables (i.e., gender, age, race, and socioeconomic status). The difference between White and Black respondents on each TBR score while controlling for age, education, and race was also investigated. A total of 2020 participants completed the H-TBR survey; 1957 completed the M-TBR survey. Mean item scores for M-TBR were higher (F = 56.05, p < 0.001) among Whites than Blacks. Whites also had higher mean item scores than Blacks on H-TBR (F = 7.09, p < 0.001). Both scales showed a strong association with participants' perceived barriers to research (ps < 0.001) and significant, positive correlations with interest in research participation (ps < 0.001). Age and household income were positive predictors of TBR scores, but the effects of education differed. Both scales are internally consistent and show associations with attitudes toward research. Whites score higher than Blacks on both TBR scales, even while controlling for age and socioeconomic status.

Privacy Policy and Technology in Biomedical Data Science.

Privacyis an important consideration when sharing clinical data, which often contain sensitive information. Adequate protection to safeguard patient privacy and to increase public trust in biomedical research is paramount. This review covers topics in policy and technology in the context of clinical data sharing. We review policy articles related to (a) the Common Rule, HIPAA privacy and security rules, and governance; (b) patients' viewpoints and consent practices; and (c) research ethics. We identify key features of the revised Common Rule and the most notable changes since its previous version. We address data governance for research in addition to the increasing emphasis on ethical and social implications. Research ethics topics include data sharing best practices, use of data from populations of low socioeconomic status (SES), recent updates to institutional review board (IRB) processes to protect human subjects' data, and important concerns about the limitations of current policies to address data deidentification. In terms of technology, we focus on articles that have applicability in real world health care applications: deidentification methods that comply with HIPAA, data anonymization approaches to satisfy well-acknowledged issues in deidentified data, encryption methods to safeguard data analyses, and privacy-preserving predictive modeling. The first two technology topics are mostly relevant to methodologies that attempt to sanitize structured or unstructured data. The third topic includes analysis on encrypted data. The last topic includes various mechanisms to build statistical models without sharing raw data.

Trust me, I\u2019m a researcher!: The role of trust in biomedical research

In biomedical research lack of trust is seen as a great threat that can severely jeopardise the whole biomedical research enterprise. Practices, such as informed consent, and also the administrative and regulatory oversight of research in the form of research ethics committees and Institutional Review Boards, are established to ensure the protection of future research subjects and, at the same time, restore public trust in biomedical research. Empirical research also testifies to the role of trust as one of the decisive factors in research participation and lack of trust as a barrier for consenting to research. However, what is often missing is a clear definition of trust. This paper seeks to address this gap. It starts with a conceptual analysis of the term trust. It compares trust with two other related terms, those of reliance and trustworthiness, and offers a defence of Baier’s attribute of ‘good will’ a basic characteristic of trust. It, then, proceeds to consider trust in the context of biomedical research by examining two questions: First, is trust necessary in biomedical research?; and second, do increases in regulatory oversight of biomedical research also increase trust in the field? This paper argues that regulatory oversight is important for increasing reliance in biomedical research, but it does not improve trust, which remains important for biomedical research. It finishes by pointing at professional integrity as a way of promoting trust and trustworthiness in this field.

Understanding public reactions to commercialization of biobanks and use of biobank resources

Biobanks will be essential to facilitate the translation of genomic research into real improvements to healthcare. Biobanking is a long-term commitment, requiring public support as well as appropriate regulatory, social and ethical guidelines to realize this promise. There is a growing body of research that explores the necessary conditions to ensure public trust in biomedical research, particularly in the context of biobanking. Trust is, however, a complex relationship. More analysis of public perceptions, attitudes and reactions is required to understand the primary triggers that influence gain and loss of trust. Further, the outcomes of these analyses require detailed consideration to determine how to promote trustworthy institutions and practices.This article uses national survey data, combined with the results of a community consultation that took place in Tasmania, Australia in 2013, to analyze the specific issue of public reactions to commercialization of biobanks and their outputs. This research will enhance the ability of biobanks to respond preemptively to public concerns about commercialization by establishing and maintaining governance frameworks that are responsive to those concerns. The results reveal that it is possible to counter the ‘natural prejudice’ that many people have against commercialization through independent governance of biobank resources and transparency with regard to commercial involvement. Indeed, most participants agreed that they would rather have a biobank with commercial involvement than none at all. This analysis provides nuanced conclusions about public reactions towards commercialization and equips researchers and biobank operators with data on which to base policies and make governance decisions in order to tackle participant concerns respectfully and responsively.

TMI! Ethical Challenges in Managing and Using Large Patient Data Sets

The advent and expansion of electronic medical record systems and open-access databases are creating a "data tsunami." As this wave descends, we must anticipate and address several ethical and social risks: threats to patient privacy, threats to the reputations of various social groups, and threats to public trust in biomedical research.

Relationships Hold the Key to Trustworthy and Productive Translational Science: Recommendations for Expanding Community Engagement in Biomedical Research

Good relationships between research institutions and communities are an essential, but often neglected, part of the infrastructure of translational science. In an effort to create greater interest among translational science researchers in cultivating relationships with community members, we report the results of a workshop we convened to learn how relationships vital to research are best created and sustained. We highlight common barriers and challenges that hinder relationships. We also provide recommendations that individual research institutions and teams can use to expand and strengthen their relationships with community members. The improved relationships between universities and communities that could result from their implementation should build greater public trust in biomedical research, lead to a stronger commitment to see it succeed, and engender shared values and commitments that will give rise to new rewards, recognition and admonishment to sustain those values and commitments over time, all of which would facilitate translational science.

Collaborative Science and the American Thoracic Society

Maurice Hilleman was the archetype for a translational scientist. He was the key contributor to the discovery and development of vaccines against measles and mumps. For his achievements, he was awarded the National Medal of Science and was recognized by scientists worldwide. Acceptance within both industry and academic environments was a key to his success (1). Beyond medicine, similarly successful collaborative efforts across academia, government, and industry benefit us daily, including, for example, dramatic advances in communication and electronic technology. Recent advances in the treatment of lymphangioleiomyomatosis, based on research conducted by American Thoracic Society (ATS) members and supported by the ATS, provide another example of the value of such collaborative efforts among academic, industry, and government scientists. These stories highlight the benefit of collaboration and open dialogue to the advances in biomedical research. A significant body of scholarship emphasizes the benefit of diverse teams to problem solving (2). However, there are also situations in which relationships between institutions, for example, industry and either academia or professional societies, have resulted in serious concerns about conflicts of interest and have threatened to undermine public trust in biomedical research. To optimize medical advances in a time of shrinking resources, these differing perspectives must be reconciled. Although the ATS has instituted transparent processes to address conflicts of interest, the recent focus on such conflicts has had the unintended consequence of creating barriers to initiatives fostering collaborative efforts across academia, government, and industry. To take full advantage of the potential of these collaborative efforts, a midcourse correction will be necessary. By addressing this challenge, we hope to further the mission of the ATS “to improve health worldwide by advancing research, clinical care and public health in respiratory disease, critical illness and sleep disorders,” while ensuring that perceived conflicts of interest are appropriately identified and managed, promoting ethical conduct as well as public confidence and trust.